ML20198K345
| ML20198K345 | |
| Person / Time | |
|---|---|
| Issue date: | 11/21/1997 |
| From: | NRC |
| To: | |
| References | |
| REF-10CFR9.7 NUDOCS 9801140381 | |
| Download: ML20198K345 (314) | |
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OFFICIAL TRANSCRIPT OF PROCEEDINGS UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION -
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Title:
NRC/ NUCLEAR PIIARMACY AND RADIOACTIVE DRUG MANUFACTURER WORKSIIOP Docket No.:
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Work Order No.: ASB-300-52 i
LOCATION: ROCKVILLE.MD DATE: Friday, Nosember21,1997 PAGES: 1 - 312 i
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l3: NRC/ NUCLEAR PHARMACY AND 4 RADIOACTIVE DRUG MANUFACTURER-_ WORKSHOP. ,
5 ***
6 7: NRC Headquarters Auditorium i
-8' -11545 Rockville' Pike 9 Rockville, Maryland
.'10 Friday, November 21, 1997 11-12 The above-entitled workshop commenced pursuant to 13 notice at 8:35 a.m.
14 15 PARTICIPANTS:-
16 LARRY W. CAMPER 17 DONALD A. COOL, M.D.
18- DONNA-BETH HOWE, MSS 19 ANTHONY TSE, M . D .'
20 ROY BROWN, Mallinckrodt 21 JON MAY, NABP
,22- MARY MOORE, Moore RAD, Inc.
23- -MARK ROTMAN, NIH
'24- KATHY SEIFERT, SYNCOR f 25 : DENNIS-SWANSON, UPMC
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2l 1 PROCERDINGS
[) 2 [8:35 a.m.)-
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3 MR. CAMPER: Good. morning. I'd like to welcome 4 all of you to our workshop today.
5 I am Larry Camper. I am the branch chief for the 6 Medical, Academic, and Commercial Use Safety Branch, 7 Division of Industrial and Medical Nuclear Safety.
8 This public workshop that we're conducting today 9 .
is a noticed workshop. It was noticed in the Federal 10 Register on the 3rd of November.
11 The purpose of the meeting is to discuss two draft 12 regulatory guides, Draft Guide DG-0006, entitled " Guide for 13 the Preparation of Application for Commercial Nuclear 14 Pharmacy Licenses," and Draft Regulatory Guide DG-0007, Ch 15 " Guide for the Preparation of Application for Licenses to
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16 Authoriza distribution of Various Items to Commercial 17 Nuclear Pharmacies and Medical-Use Licensees."
18 As the FRN states, what we would like to try to do 19 today is to share with you and discuss comments which we 20 received on those two particular guides. We want to share 21 with you the staff's current thinking on how we might 22 resolve those comments.
23 And above all, during the discussion today, what 24 we want to try to do is have a lot of active dialogue. We 25 really do want to get your reactions and thoughts as to how l' D ANN RILEY & ASSOCIATES, LTD.
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3 1 the staff.is. proposing to address-those comments and any
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- 2 alternatives that-you might have in. addressing them, In addition to that -- and I'll share more with !
3 4 you in detail when I get a-little bit.-later in the agenda 5- --we also want to try to. discuss a lottof. things:thatlwere 6 comments that were n6c necessarily pertinent-to rule changes 7- but are changes ir. guidance brought about by the i
8 Radiopharmacy Rule. We want to have a rather broad 9 discussion on that to set the stage for some it.';er guidance 10 development, which Dr. Cool will share with you in a few 11 minutes when he makes his commer' 12 I want to take this opportunity to thank the 13- participants for coming. I'd like for each of you to go 14 -- around the table, starting on my left, and introduce
'15 .yourself for the record.
16 And, then, I'll make a couple-of administrative 17 comments, and Don has a few things he wants to say. Then, 18 I'll come back and provide more details as to how we can 19 procead'today and set up some administrative issues for you.
4 20 Then, we'll turn the podiuc over to Research, who will
- 21. _actually start stepping through the comments that were received.--
22-23- So, with those introductory comments, Mark, would 2
24 you introduce-yourself for the record.
25 -
CPT ROTMEN:- I'm Mark Rotman, nuclear pharmacist,
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4 1 National Institutes of Health, f'^') - '2' MR.-BROWN: I'm Roy Brown, Director of Regulatory G'
3 Compliance at Mallinckrodt.
4 DR. TSE: I'm Tony Tse, from the Office of Nuclear ,
'S Regulatory Research, NRC.
6 MS.-HOWE: Donna-Beth Howe, from the Office of 7- Nuclear Medicine, NMSS, in the Academic and Medical Use 8 Branch 9 MR. SWANSON: Dennis Swanson, University of 10 Pittsburgh Medical Center, nuclear pharmacist.
11 MS. SEIFERT: Kathy Seifert, Corporate Radiation 12 Safety Officer and Director of Regulatory for SYNCOR 13 International, also a nuclear pharmacist.
14 MR. MAY: Jon May, consultant pharmacist, here (G) 15 representing the National Association of Boards of Pharmacy, 1b MR. CAMPER: Okay. Thank you very much.
17 We do have one additional participant that will 18 join-us later today who is also a radiation safety officer.
i 19 With those brief comments, then, what I'd like to 20 do at this point in time is turn the discussion over to 21 Dr. Cool.
22 Dr. Cool is the Division Director for the Division 23 of Industrial Medical Nuclear Safety. Don has some what we 24 think will be very interesting comments to share with you 25 about the tone and complexion of this meeting and hcw we'd
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1 -like to proceed. We are very excited about'what we're going 2i to try to a'ccomplish today, and-Don:has some_ comments for i 3 us.
4E DR. COOL: Good morning.- I-hate being pinned 5: .behind a podium, but this is the:only way to have a microphone so that'our court reporter-ean transcribe this i 6_
7' and we can get this on the record.
8 I want to welcome each of you-here today to talk-9 about the' comments and the direction and the approaches to 10 Ltake to guidance in this particular arena.
'll This particular activity has a long and perhaps 12 painful history, at 'least for those of tus who have been 13 involved with it at different stages of time within the 14 agency,.and I would fully _ expect, knowing most of you around
() 15 the table, sitting outside, trying to figure out what in ,
16 tarnation the agency was doing with the activity.
17- The Rule came out now better than two-and-a-half 18 years ago. At that time, a guidance development effort was 19 under way to try and provide _the guidance that goes along
. 20 with the Rule. That's the usual process which the staff has 21 historically used in preparing-rulemakings and guidance 22 documents.
- 23. What happened, of course, was that times have 24 _ changed. Over the last two-and-a-half years, a variety of 25 things have happened.. Maybe the most drastic of those is ANN RILEY & ASSOCIATES,-LTD.
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-6 1 the fact that there has been a significant change in
( ) 2 philosophy-and approach within the agency and direction from 3 our Commission to go back and take a fundamental relook and 4 take a fundamentally new approech to all of our regulations 5, and guidance.
6 Within the agency, it goe6 by the phrase 7 " risk-informed and performance-based." You can put that in 8 quotes. You will probably hear that a number of times.
9 Several of you were at the workshops that we held 10 on the Part 35 rulemaking over the last few weeks, so you've 11 heard a little bit of the explanation. But just so that 12 it's again on the record here, that effort involves sort of 13 two different aspects, as you can tell by the two pieces of 14 the discussion, " risk-informed" and " performance-based."
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(_,) 15 First, in terms of " risk-informed," the 16 Commission has asked the staff overall, within all of its 17 programs, all of the programa that I have, the other 18 programs within the Office of Nuclear Materials Safety and 19 Safeguards in terms of fuel cycle and waste disposal, spent 20 fuel storage, and within the agency in terms of the 21 regulation of the reactors and other kinds of programs, to 22 look at their activities in terms of the risk posed by those 23 activities and users of materials.
24 So, part of the effort is to look and see what are 25 the actual risks posed; what are the kinds of programs and ANN RILEY & ASSOCIATES, LTD.
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-.1 activities,Equantities, and materialsLthat::are being:used;=
J% '2- .thi theory beingTthatithe.kindsfof-regulations',fthe
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3 intensit",.;if;you willi of-the regul'ations,--number ~ofE 4- requiremenes,<--levelLof prescriptiveness'or-5 nonprescriptivenessishould,:'iniat-least2some measure, be<
6- related to the kinds: of risks timposed by- the materials.
7 The second aspect of it being " performance-based,"
-8 that:which is an approach whereby the Commission should.
9- :under this philosophy be moving towards stating the.
10: objectives _to be achieved,_rather than stating all'of'the ill; detailed specifics of how a particular objective should be 12 achieved.-
13 Now, the-Commission, in looking at activities and ,
14: in fact, at-some of the staff requirements memoranda, where 15 it has already told'the staff to_go off and do certain 16 things, has made it fairly clear that-we:are not shifting 17- everything all the way over to the left-hand side, that they 18- fully expect-that there is a range of activities; and that 19 for.some kinds of activities and some kinds of situations a 20 very performance-oriented approach can probably be
-21 implemented _ effectively;-and that there are other
- 22. ' activities, particularly as the risk: increases, where they
-23 would fully _ expect-the. level of prescriptiveness to 24 ' increase.
!25- $Obviously, when=we-start to talk about large
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t quantity materials.or we= start'to talk about reactors or'
'2 other things,.ifl-I'look-atLthe entirety of~the NRC-: program
- f 3 youLcaniwellLimagine there are'some of those things which- !
-4 will'have a greater. deal of specificity in-order to havela 5' level of' comfort that things will be_ properly contained and
-6 controlled that radioactive material will be handled 7 properly, 8 -Within the overall context of-strategic 9 ' assessment, which this-agency has done under the Government 10 .Results Act, and moving forward.as all of the federal
,11 - agencies have within the federal-government, the Commission 12 : looked at a number of issues and had a number of .
13- l direction-setting issues in areas which they particularly 14 examined.
() 15_ One of them related to whole concept of risk in, 16 using risk to a greater extent within its activities.
17 Another one looked at trying to incorporate and have more
'18 interaction with. industry, with various consensus bodies.
19 Some of the names that they threw out are, of course, again 20 from the reactor arena, like the IEEE and some of those, but 21 similarly some of the large professional-societies and 22 : organizations that were going on, 4 23 And another one which they dealt with dealt 24: specifically with the materials'in the medical program. And 25 in.that arena, their direction to the staff was 4
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9 1L fundamentally to-continue with the program that had been ;
l 7(~h: 2i laidiout..
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'3' Specifically in the medical arena',- they made.some-16- decisions with_regards_to'.whether or-not-they'were going to
~5 : consider'and take action on the recommendations of=the 6- National: Academy'of Sciences' report, which they, decided
. 7' they.were not going to pursue.
81 But they asked us to proceed to_try and make our-9- regulatory program more risk-informed, more-
. 10; performance-based, and to do a substantive and substantial 11: revision-of the. Medical Use Program, Part 35. Now, that
- 12 . program;is not the subject of today's discussion, but that 13 underlying framework underlies the discussions we have 14 today. .
Those decisions came out in the late March, April to
- 15 May time frame of this year.
16 The guidance documents that you were commenting on 17- came out at the beginning of March of this yeer and
- 18 therefore, sort of obviously perhaps, did not reflect that
- 19 kind.of direction.in the development process. They had been 12 0 developed through a process of time and finally reached a 21 publication stage, and we now have some new direction.
' 22- Staff is_taking that direction very seriously.
23 So, part of what we're today to do is to go.-back and'take a-
-24 reexamination from:the ground up on these documents. I know 25' -that there.were a lot of1 commentss which you folks made, as ANN RILEY'& ASSOCIATES, LTD.
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d' wel1~as other folks within the community,-looking'.at some of .
l: 2; these documents. [
3- Two things were-originally attempting _to be-
~4 Laccomplished!by the' guidance, and those are two things which 5 still need to beiaccomplished.
6 .The first is:- What kind of guidance is necessary 7 for your'particular arena to help ~you specifically comply, 8 -apply, and use. materials that.was related to or affected by r 9- the " Radiopharmacy Rule"? -But that was from two years ago.
10 -There would be certain things which you would no
-11 longer need to do because it granted some additional
-12' flexibility in a number of things. ,
13 There vill be things which you now have addit onal 14 flexibility in doing, different ways to do it. The Rule now 15 opens the box up, makes it larger.
16 There might be perhaps some additional things 17- which need to be provided, submitted, or submitted in a 18 different way in order to meet the requirements of the Rule.
19 That's stage one: What things are needed.
20 specifically to provide guidance associated with that rule?
21 And then secondly, and in a broader context: What 22- things should we now, as an agency, as a staff. look at and 23 do to upgrade the licensing guidance in this arena, which 24- - goes back to drafts from the early to mid '80s?
25: -Obviously-a lot of things have changed. Our 4
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- 11 philosophies ha've-changed.- The whole technology has-
. ;.x 1x /y ~2 changed..- The~ industry-has changed substantially. \The_ kinds i 3- of_usesihave changed. The-detectors have' changed.-
4 Everything is different essentially.
5 So, that's a. basis from which I imve asked my
-6 staff -- I have asked Larry and_his group to go off and'to 71 now pursue, given the_ Commission direction, a fundamental 8 reexamination of all of the old guidance.
9 The drafts that you were commenting on basically 10 brought forward the older existing guidance. I have asked 111 gr staff to now go back and take a fundamental relook at 12 that,-what'really needs to be looked ac, what things need to 13 be applied for, what things need to be contidered, what 14 things need to be.available:but which there's no particular
() -15 value added from us having reviewed it in terms of some of-16 the procedures and activities.
17 So, it's within that context that I would 18 encourage you to look at all of the comments that have been 19- submitted and to provide additional comments and-discussion 20 and thoughts to my staff today in terms of how to proceed
-21 forward with this revision.
22 Larry, I think, will probably describe in greater 23 detail the kind of-process that we have been going through.
24- 'But this will be another piece in a larger project in terms of the guidance that I have in my program related to the ;
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12 1 materials'-use, byproduct uses of radioactive material, [
(2: -.wheres weLhave : going _ on in _ a: number of f artsnas .ef for ts t_o go 3! back and look~at-the guidance, update it, and' consolidate 4 it, because it exists:in all sorts-of different forms and 5- - pieces in dozens of'different kinds of formats, some of them 6 being draft from the beginning and having_never loneLfinali-7 little bits of technical-assistance-requests and-information 8 notices and all sorts of: things, such that if you-piled it 9 allfup in one place -- and we, in fact,'did that -- it 10 filled up a room, 11 Somewhere within that pile were the five or six
'12 pieces of paper you probably really needed to know about to 13 have a program. -Unfortunately, finding them in that pile --
4 14 .and even for us finding them in the pile -- was becoming an
() 15 almost impossible task. But I have' asked them to go 16- consolidate all that and move that to performance 17 orientation.
18 -We're.looking to take the guidance associated with 19 radiopharmacy, with distribution licenses, in that same kind
'20 of format and style and mind-set as we look at this 21 activity, as_we're locking at each of the other activities.
22 What.that means is, is that the overall guidance 23 .is going to take awhile longer to come out,..because we're 24 going to.go back and review it from the very beginning and
>25 go through that particular: process. So, I envision, in --
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'l fact,.that we'll end up vith two things:
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2 One, in the-fairly near term, responding.to the-
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3 comments-that you've made which are specific to the 4 Radiopharmacy Rule in terms of an addendum or a document-5- that you would have dealing with whst things are needed 6 associated with that Rule.
7 And, then, c more fundamental reexamination and a 8 document which deals with the licensing of 9 radiopharmaceutical use.
~ 10_ I think it's a very interesting thing. It's very 11 much needed. And I.really look forward to hearing the kinds 12 of information that you're going to have, the kind of 13 suggestions that you may give to Larry and Donna-Beth and 14 Tony today and help us be informed on how to proceed through
!n) v 15 that process.
16 I think we've probably got a couple of minutes on 17 your schedule. I'll be glad to answer some of the general 18 questions before Larry gets here and the detail.
19 R3y.
20 MR. BROWN: Don, can you comment on the discussion 21 last year during the strategic assessment on the low-risk 22 aspects of nuclear pharmacy and the likelihood of deemphasis 23 of regulations in this area? Just a general comment. We'll 24 get into this in some more detail later obvioasly.
25 DR. COOL: The Commission, in looking at the whole
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, 14 1 Larena, asked us toLgo back:and-take an examination of the q ) 3L entire program. 1The' staff.is pursuing that in pieces, X_/= ;
3 simply,because'it's almost impossible-to.get a big enough .. ;
at = .' bite - to- gr . them all in. .It.would choke myself'and kill my i
5_ staff in the process.
6 What is going on is a couplecof things: ;
7 The first one is the-revision of Part 35 in terms
, 8- of.the users of materials. We have this effort going on to 9 look at the guidtnce in the radiopharmacy arena, given that 10 that is a more recent rule. 'And the Rule itself, in fact,
- 11
. leans already strongly in the direction of being-somewhat 12 more risk-informed and more-flexible.
13 I would expect chat there will probably be things 14 .that you will identify as part of your comments which ought f) l 15 to go into our list of changes that maybe-ought to be,
- j 16 should be, or otherwise made to the regulations.
17 I have in yet another arena -- the division is a 18 little bit like a three-ring circus plus a couple of more --
19 an effort going on to look at the risk posed by all of the
-20 different kinds of uses of byproduct material which we're regulating. That group is looking at a number of systems, f22 .everything from. radiography to radiators to the unsealed-23 materials, and will-be coming back with some suggestions and 24 approaches about-this time next year.
25 And so some of the things that you may have as t
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15 I suggestionsLand changes for regulation ILwould' expect;we_ j
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i 2' Lwould; wrap within that. approach so that I-can.then-take a' 3 look, atLthis time next year _or'_ thereabouts,_._at what' changes i 1
-4 need to be made in-a_more--or less coherent-fashion within-5 the byproduct regulation arena. .
i
- 6- What would be very-difficult to do, very confusing 7: for ourselves and-for you, I suspect, would.be a whole l 8 series of'little piecemeal pieces as we're trying to bring a 9- inumber of different disparate things ~together,
- 10. And so at this point what I have asked Larry and
- 11- his staff to do is to move and update the guidance based on-12 the existing regulations and to keep a list. And Larry's 13 nickname for the list is "the lemonade list."
14 We will identify.the lemons and then get around to
(~'s 15 making lemonade out of all the lemons and squeeze them down
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16 at some point, but to not go generating a number of small 17 changes to the regulations until I have the more fundamental 18 examination and can take a look at the whole integrative 19 package.
20 So, that's -- that, I hope, brings together for 21 you some of these other activities and I hope pulls it 22- together.
23 The staff recognizes that there are-a lot of 24 things,1radicpharmacy and others, where the kinds and 25 ' quantities of materials simply don't get you to the kinds of. ,
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1 radiation levels, radiation hazards posed by some of the m.
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2 3
other things that are regulated.
You don't have the potential for a source to fall 4 off, get stuck in your pocket, and have substantial b"In.
5 -You don't have the potential for walking past an interlock 6 and being face-to-face with a few hundred thousand curies of 7 something or other. You know, we're going to tzar and take 8 that into account.
9 Any thoughtc, comments, uservations?
10 [No response.]
11 If not, I'm going to ask Larry to proceed and look 12- forward to hearing lots of good things from you. Thank you.
13 MR. CAMPER: Thank you. Okay. I thank you, Don, 14 for those comments.
t'n k,. 15 (Slide.)
16 What I'd like to try to do first, as we proceed 17 now, is to sort of fill in the points on the matrix -- gieen 18 Don's overarching comments and so forth -- uort of tr.ke a 19 look at where are we right now on these particular guidance 20 documents, how we'll try to prceed during today.
21 Interestingly enough, if you look at the guidance 22 documents, DG-00066 and 0007, what the staff did when we 23 created the documents was we created them in reaction to the 24 need to create guidance because of the Radiopharmacy Rule.
25 (Slide.]
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17 1 But when we undertook that action -- and we
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2 actually started it'in 1995, the fourth quarter of 1995 --
( J-3 we also went back and brought forward old guidanco that_was 4 in place, going'back to the 1980s.
.5 In particular, we took existing guidanJe 6 documents, which were known as FC 410-1, which dealt with 7- radiopharmacy; and we took FC 406-4, which dealt with 8 manufacturing and distribution, and we brought those forward-9 in time, made some tweaks to that guidance, factored in the 10 changes that were necessary because of the Radiopharmacy 11 Rule.
12 But interestingly enough, if you look at those 13 guidance documents, you'll find a couple of striking 14 findings. First of all, that something on the order of G
() 15 about 5 percent of DG-0006, which deals with radiopharmacy 16 practice, actually came about in terms of changes resulting 17 from the Rule, whereas about 95 percent of that document was 18 simply a bringing forward of old guidance previously 19 contained in 410-4, 20 So what you actually have, if you lock at.DG-0006,
.21 for example, is that you have some guidance in there that 22 _results from minimal changes that were made to Part 32 as 23 conforming changes when the Radiopharmacy Rule went into 24 effect, 25 You have much radiation safety or operating n
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- 18 l11 guidancet if you will,-.that has?been in. place'forLa number- 1 (3: L 2' - of years, and the regulatory basis;for.it-is-Parti 30.
Q '3- ;Part130, you might recall', is'that_part_of the' regulations 4- which is the-administrative basis for which all_other parts:
3 5 in'that series--- for example, Part 32, Part 35,;Part=36, 6 and so forth -- follow.
_7
_ Part 36 is where~it says that the staff can 8 ~ develop 'infornation needs and guidance _ to ensure- the public
- 9 health and safety is met. It's a rather broad authority, if. ,
10 yott will, in Part 30. So, all the radiation safety guidance yll -that you see in DG-0006 falls from that part.
-12 So, we brought:forth-this whole guidance.- We 13 factorad in those changes which were necessary because of 14 the Radiopharmacy. Rule.-
() 15 Well, similarly, we did the-same type of thing.
16 with DG-0007, which deals with manufacturing and 17 distribution. It turns out that about 50 percent of that 18 guidance document was.affected by the Radiopharmacy Rule, 19 but 50 percent of it was not because it dealt with sealed t
20 sources that were-impacted by the Rule.
121 And I think most of you know', as-being_ <
22 , practitioners of-radiopharmacy, most of-the-changes that 4
-_ 23 took place in the Radiopharmacy Rule were to_ deal with in-24 :Part 35, in that'it-provided substantial adjustments-to 12 5 = :35.100 to 300, dealing with the-flexibility for procurement
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l 19 l 1 and preparation;of radiopharmaceuticals, created <the a
2 authorized nuclear:pharmacisticoncept,:and so forth. I
] ~} -
~
3 So, what you are struck by,. then,1in the final analysis:is that these';midance documents have a little bitL 4-5 'to do with the Radiopharmacy RuleLand a lot to do with 4 6 Lbringing forth rather old and arguably antiquated guidance, 7- as: Don pointed out.
-8 The guidance was developed in the '80s.
It was' ,
l 9 updated in this' effort prior to the new direction by the ,
10 Commission, so we really have a mismatch, i 11- What we're going to try to do today, then,.is to 12 do two things: One, as you'll see when we put the agenda up 13 in a moment, we have divided the agenda into two parts.
-14 (Slide . )
-( ) 15 One part deals with a discussion in both
~
! 16 documents, 0006 and 0007, as it relates to comments that the 17 staff -- comments regard!79 guidance that the staff had put 18 into those documents that.was required by the Radiopharmacy 19 Rule and, to a much larger degree, comments from the various 20 commenters on various issue:, that really do not have much to 21 do with changes mandat61 by the Radiopharmacy Rule.
22 Now we did that.for two reasons: On one hand, we 23 needed to bring'to closure the guidance'for tha
- 24 - Radiopharmacy-Rule, and as we progress in the' discussion 25- today, as I have_said, you will see that there are really-l F's - ANN RILEY &-ASSOCIATES,.LTD.
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- very few comments'that'need to be-addressed to make that
~
L1 -
2: 'happent f But on'a much larger-scale -- and,' frankly, a more 3
-- 4 important scale -- is -to get your observatic,ns andt sharei -
- 5' twith you the comments that were made of a broad nature that j
- 15. deallwith-the guidance at large,.not necessarily linked 1 to
+
7- those changes which we made resulting from_the-Radiopharmacy I
8 Rule.
9 And that becomes terribly important,_for two 10 reasons: In trying to pursue the new pathway, the i ll Commission direction which'was provided to use in DSI-7 and.
12- _12 to move toward a risk-intormed,. performance-based 13 approach, what we need to do is make sure that we subject 14- this guidance to that pathway, do a careful scrutiny in that-
_p-
,V.
15 regard.
16 To accomplish that, what we want to do today is 17 . share with you these comments of the broad nature, get your 18 reaction to them; other observations that you may have, 19 alternatives. And we'll take that information, and we'll 20 move to the second point, which is part of our guidance 21 concolidation project.
222: As Don: mentioned,-we are developing on-the order 23 -of 22 NUREGs over the next few years. What will happen _then 29- :is'that DG-0006 will become one of the NUREGs that will be 251 -developed-some time.during the first half of calendar year
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1 98.*
g-()] -2~ .We'll take-the. comments-that'we-have heard from
~
the commenters.; comments-:that we hearctoday. We'll put ;
4 together a-team,fas we're doing_on all these NUREG 5 documents, that consist of headquarters and regional 6 personnel and agreement state personnel. They will review 7 all the comments _that have gathered.thus far, and that will 8 become a significant factor in creating that NUREG document.
9'_ Once-_that-NUREG document is created, then'it will ,
10 be published for comment for a period of 90 days. Hopefully 11 we'll all accomplish what-I think we all want to oo. The ,
12 guidance then will be much more risk-informed and 13 performance-oriented than it is in the current version.
14 The existing _ guides, FC 410-4 and FC 406-4, we
- (Q
_/ 15' plan-.co go-back and make a supplement to those existing 16 guidance documents to capture only those things, those 17 comments and those actions which are necessary as it relates 18 to guidance required by the Radiopharmacy Rule.
19 There ..tl be minimal changes to it, as you'll see 20 as we progress along today. And, then, by doing that, we 21 will have met the objective of having guidance in place for 22 the Radiopharmacy Rule as it relates to_ manufacturing and 2?, distribution, and to radiopharmacy. And, then, we'll 24-- proceed, as I said, with a NUREG document toward more 25- risk-informed and performance-oriented.
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- 1. And then, finally, the last point up there is --
) 2 you'll note as we step through the agenda -- we'll go
(
3 through two particular documents, 4 If we have-some time this afternoon for much 5 broader discussion, it will be a perfect opportunity -- and 6 we' welcome your comments and thoughts in terms of your major 7 philosophical observations or alternatives to what has been 8 put on the table in either these guidance documents or 9 comments that were raised by the commenters. We are quite 10 open, quite receptive to comments. We very much want to Sut 11 in place a risk-informed, performance-based approach for 12' radiopharmacy.
13 In the final analysis, it is interesting, because 14 if you look at Part 30 -- getting back to Roy's question --
f3
( ,) 15 if you look at Part 30, as I said, it's a very broadly 16 worded part. As it turns out, if I look at Part 32, I find 17 also rather limited information.
18 What that means, in other words, is that many of 19 the radiation safety requirements, many of the operating 20 requirements that you see in the guide -- be it DG-0006 in 21 its current form or in the NUREG that will be prepared --
22 fall frcm guidance. You will have an excellent opportunity 23 to work w.i*h us to influence what that guidance will look 24 like.
25 I would agree totally with Don.that, if one looks
-[) '
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4 23 N (1- ,
-atithe!' documents:that vere createdLin the earlyl'80sl theyj
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d 1
2' Tarefvery much out of date, There c is;very:much prescriptivel +
3J 11nfomatisn- and requirements in, there; You'll have thed ~ :l
.4 opportunity nowJto change thataand to fix'that.
5- :Solthat's' generally;what'we wantito-try to?- _ .
]
6 Laccomplishitoday.. I will-answer any, questions:that:you
.7: 1might:have at this point. :Otherwise,-if you;have'none,iI'11-48 ! turn it-over to Dr. Tse'ofLthe' Office'of Research who-will-i
.c 9 ibegin to step us;through the comments following that-pattern:
.102 .-which I described. Any, thoughts, comments, cbservations?
11'. -(No response.);
12 Okay, Tony. One thing I want to do, just as an 13 administrative matter, when you-have comments, if you could, 14- turn your name card'up with your name facaing. What it-() .- 15 :
~
-does, it helps me to identify the speakers, and it also -
16 makes the reporter's life a lot easier. That way-we'll keep 17 some order amongst all of our enthusiasm. So, if you don't 18 mind doing that, it would help a lot. That way we capture 19' all of_your comments.
~20 Tony,Lwe're covering DG-0006 and 0007.
21- _
We're.gsing to cover DG-0006 first.
22 For the Tacord, the comments.that Dr. Tse will
{
'23 cover first are coriaents by commenters to DG-0006- that dealt with issues.or. changes >resulting from the Radiopharmacy 424
.25 JRule. Dr.-Tse.
-x 4 . "
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,1 . _
DR. TSE: 'As,they-indicated' earlier, what II. willi 2! first discuss is(the issuesfor.the comments on 0006 with
[
31- regard to Radiopharmacy Rule charges..
-t 14' . [ Slide . ]'
- 5; We had
- 32.72 Rule changes several years ago,_and. _-
6 -there's a certr.in amendmontethat comments related-to those 7 amendments 1 would discuss now.
8 [ Slide.)
9- As you know, there-are not too many changes in the 11 0 Radiopharmacy: Rule, the 32.72. So, the. number of comments .
2
._11 relating to these changes are-not:too many. We have several 12 issues, so let'me'go through one by one, 13 The first item is. called "What a Radiopharmacist 14 Could Do," what could they distribute. And the comments
() 15l
-16 are: "We should be able to distribute radioactive drugs to non-medical users, licensees, such as vets or animal
- 17 research people."
18 And second, some people say that "Oh, we should be
-19 able to provide leak test services or calibration services
'to other licensees."
-21 -And the third one is to say that "We should be 22 able to redistribute ~radiochemicals and other non-medical 23: Luse radioactive materials.to other licensees."
24- Now, I'm going to -- this is open for discussion,
.25 scF I will have: a fewf observations, and then we will open for
,.y E
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-25 j 1 discussion. J A
2 (Slide;)
() ~
3 First yis that, with regard to number one :-- ' his -
4_ Lis-anLexample given at.the.endLof-the document. For number-
- S one,fifLyou:look at it -- maybe you cannot see -- 9A through i
6 B,f it: says, " Preparation,' distribution of radioactive -drugs ]
l 7- -to authorized recipients."
8' -' Authorized recipient" doesn't say "only limited 9 to medical-use licensees." Therefore, it's already 10 permitted. You could distribute to other -- like vets for
'11 radioactive drugs.
12 And the secono item, we talk about providing other 13 non-medical use -- no, the other item providing other 14 non-medical-use isotope, which in here, if you look at item
() 15 C in this example, you could r:Gistribute,,the general 16 license. And item D, it's instrumentation calibration,-to i'
17 redistribute calibration sources.
18 And item E would be sealed sources, so that could 19 also'be done under this particular arrangement, as long as 20 it is requested and it's in the license.
21 With regard to radiochemicals, I have a question, i- 22- Essentially, is a part of your pharmacy practice-to 23- : redistribute radiochemicals to other persons?- Anybody_like 24- to --
'25 MR. MAY: Well, pharmacists are restricted in the
[
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'l- amount of, say, prescription drugs _ thatl they can_ distribute
.,s - -
r j 2- outside-ofla_ prescription.
v J 3 -They:can sell prescription drugs or distribute 4: prescription -drugs . to physicians, but ic Tean' t. be more- than 5 15 percent or.their total' amount of. material distributed in 6 that store. This _ is _ a requirement of the Food and Drug 7 Administration to prevent pharmacies from essentially 8_ becoming wholesalers of drugs.
9 So there is a restriction that:FDA has to how much 10 material you can distribute without a prescription, per se. .
Lil Now, how it would impact this I'm not~real sure, but there 12 is an FDA requirement you'd have to be aware of.
13 DA. TSE: Sure. Well, just to carry on this 14 discussion, I think the' regulation says che-licensee -- our
/A .
() 15 _ regulation says that the ljctnccc will not be relieved from 16 FDA regulations.
17D MR. MAY: Right.
18 DR. TSE: So, therefore, that's covered under that 19 part.
- 2 0. MR. MAY: Covered by other existing federal law.
21 .DR._TSE: But if you are within that limit --
22 HR.- MAY: Right.
-23 DR. TSE: ---it1should:be okay.
24- MR. MAY: Absolutely.
25- DR.;TSE: - -Thank you. . Kathy.
((
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1 MS, SEIFC7T: Yes. Part of this, I believe, came ,
() '3 2 from-our comments and relates to the fact that radiochemicals are sometimed required for preparing 4 compounded preacriptions for -- this may not be a -- what we -I 5 would consider a_radiopharmaceutical would be something that 6 perhaps would be approved by the FDA. This may be something j 7 different.
8 It may start with a radiochemica), you prepare a 9 prescription through compounding and distribute it.to a ;
-10 nuclear medicine physician. That is likely not a very'large ;
11 percent of anybody's business, but that's part of the 12 consideration here. Radiochemicals need to be dispensed !
13 under prescription and to a nuclear medicine physician.
14 But --
() 15- DR. TSE: May I follow up a l!.ttle bit with a ,
16 question first?
17 MS, SEIFERT: Suro. ;
18 DR. TSE: What you are saying is that in case a 19 medical use, like a pharmacy in the hospital, they want to 20 prepare something, and they want the raw material to prepare 21 the radioactive drug, they can get -from a manuf acturer of 22' those raw materials. What you are suggesting is that they
'23 can also order from you, and therefore you can redistribute 24 these materials-you-purchase from manufacturers,-and you can 25 redistribute to'these licensees. Is that-what you are q ANN RILEY & ASSOCIATES, LTD.
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i 28 l 1 saying? i
-i 2 MS. SEIFERT: Correct. But they may not have FDA 3 approval..
4 MR. MAY: That's right. !
5 MS. SEIFERT: That's the issue. They may be a !
-6 drug that has not gone through FDA approval. It may be 7 something that is being done on prescription but may not j 8 have FDA approval. ,
9 DR. TSE: Yes, yes.
10 MR. MAY: I would like to add, the availability of i 11 bulk materials has been severely restricted its the )
12 traditional pharmacy, and you'll be impacted by this in 13 radiopharmaceuticals also, I'm sure.
14 You're probably aware that on November 9th the 15= Senate and the House passed a bill called S. 830, which 16 contains a Section 127 which deals with how the rederal ;
17 government -- i.e., FDA -- relates to pharmacy compounding. I 18 And what happened was, much to our chagrin in a 19 way -- our chagrin being the pharmaceutical profession -- a 20 current compliance policy guide in the Food and Drug 21 Administration was actually put. into federal law. There's 22 now a firm federal law that restricts to some extent the 23- amount of bulk materials that pharmacists can obtain. You 24 need to read this and become aware of it, r
25~ But in answer to your question, there is a new set ,
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t 29 l of federal regulations that tells pharmacists how they are
'2 to obtain these materials for compounding, and it's a
(} ,
3 _ hierarchical approach. .Juid it talks about USPN of_ quality ;
4- materials. It talks about, as she said, you must obtain 5 these materials from FDA-approved facilities, which means ;
6 FDA has gone in and inspected those facilities to make sure 7 they adhere to CGMPs.
8 We're not quite sure how it's going to totally I I
9- impact the traditional practice of pharmacy now. There is a ;
t 10 _large organization called PCCA which distributes bulk- t 11 materials, and many of these bulk materials were obtained 12 from overseas sources, and they were obtained from sources i 13 'that did not undergo FDA inspection, so FDA would claim they 14 are adulterated materials.
() 15 It'll be interesting to see how this works, as I l
16 said, now in light of this new federal law, which really 17 does restrict the amount of materials a pharmacy can obtain, t 18 I was curious, when I read through all these 19 materials yesterday, that a letter was sent by Carol Marcus 20 in California and she raises this very specific issue about 21 -- she seen a very apparent omission in the proposed :
22 regulations, and she wonders whether it's by design or 23 oversight. ,
24~ I suggest that it's-probably in recognition of the
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1 and the quality of materials that we have access to in i
,m
( ) 2 compounding operations.
3 The bottom line is there is a new federal law, 4 which I ha'fe been told will probably be signed today by 5 President Clinton. That will impact significantly on the 6 practice of pharmacy.
7 DR. TSE: Yes. Thank you for pointing that out.
8 MR. CAMPER: I think Roy was next.
9 MR. BROWN: Tony, I was just curious. On NRC's 10= interpretation, I have a little bit different spin. An 11 FDA-approved product that the route of administration is 12 different -- like, for example. sulfur colloid on scrambled 13 eggs -- where does this fall in your hierarchy here?
14 DR. TSEt You mean the --
p
( ,) 15 MR. BROWN: Where you have an FDA-approved 16 product, but the route of adminiscration may bo different or 17 it may be modified slightly from the manufacturer.
18 DR. TSE: Well, what do you think we should do for 19 that undec those circumstances?
20 MR. BROWN: Well, that clearly falls under the 21 practice of pharmacy. It's just a question of how NRC will 22 develop guidance or develop their regulations to recognize 23 that.
24' DR. TSE: Yes,-Donna-Beth.
25 MS. HOWE: Roy, right now we have no requirements
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i 31 1 that specify the route of ar cnsate.stion or the use, and so
() 2 3-that has already -been taker t ore of An
- 9 Radiopharmacy Rule. So, once_a druS 2 a W 4@%VM. 1:- is up to the L
4 ,
physician to tase if .c hs /s "2 ce4,a. cur regulations, j 5 That doesn'tLrelfra:4 hi v f Jnn * . S - regulations somewhere '
6 else, but as far as ght adC is concerned, he may use it in- ]t j 7 any route of administration or use. I 8' MR. BROWN - And making any modifications necessary 9 under the practice of pharmacy?_ ;
10 MS. HOWE: Yes. That is what the Radiophacmacy f 11 Rule did.
12 MR.-BROWN: Okay. I just wanted a clarification. l 13 MR. CAMPER: I think Mark wanted to -- t 14 CPT ROTMAN: This comment is for you, Tony, and !
) 15 for Counselor May across the aiele from me. To.the best of 16 knowledge, that FDA Reform Act that had compounding 17_ provisions has a specific exemption for radiopharnaceuticals 18 written right into it.
19 The legal opinion that I have received is that, if 20 . President Clinton signs this bill, nuclear pharmacy will go 21 back to being regulated by the 1984 guidelines that the FDA 22 published on when to register as a ni: lear pharmacy and/er
_23 .as_a manufacturer.
24 So, I don't believe that entire statement you made 25' about bulk-products, whi'ch was designed to apply to the ANN RILEY & ASSOCIATES, LTD, Court Reporters
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1 traditional practice of pharmacy, is going to impuet '
() 2 3
radiopharmacy in any way like you surmised in your statement. ;
4- And, then, to Tony, I'd like to address this whole I i
5 issue of. distribution of radioactive drugs and to whom. The
- 6 way the NRC regulates, through two processes -- or three t
7 processes -- one being the regulations, two being the :
8 licenre condition itself, and to some degree through 9 policies and guidance documents -- we have multiple layers 10 of what I am going to call confusion.
11 I think I know the regs pretty well, but as I read 12 through DG-0006 on page 9, item number 5, it talks about ;
i 13 radioactive materials. For item 5, you should list the 14 radioactive materials you wish to possess by nuclide is chemical and physical form and the maximum amount you should 16 wish to possess at any time. !
17 .For item number 6, you should state the proposed 18 uses of the radioactive materials. So you're asking us to f 19 say what you're going to use it for, but where the confusion l.
20- came was, who can we distribute this to?
21 For instance, if it is a FDA-approved radioactive 22 drug or if it's compounded by a nuclear pharmacist, it's ,
-23 still a radioactive drug. Can we dispense it to anybody who ;
24 has an NRC. license to have that chemical in radioactive '
25 form? ,.
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1 For instance, if you make~-- well, we'll continue !
f'T. 2 with the technetium sulfur colloid example that Roy Brown j D
3 . just gave us a minute ago. If you make that'up.and you have [
4 some left over, and a veterinarian calls, and the 5 veterinarian has an imaging practice, because he's !
6 associated perhaps with some high-tech service, is it -
- 7. permissible to dispense that radioactive drug you made to a 8- veterinarian? I 9 Now, veterinarians are not going to have a Part 35 110 license; they're probably not going to have a Part 32 !
11 license; but they are going to be licensed by either the !
12 state-that you're practicing in or by the NRC. And-that's 13 the kind of question that we were asking. '
14 This guidance document appears or at least gives
() 15 the impression that the only people you can distribute to .
16 are those who are Part 32- or Pact 35-licensed.
17 Now, if we've misinterpreted that because of the la way the guidance got written, it's a simple fix. You need 19 to change your guidance to say that any licensed -- any NRC 20 or authorized -- or, excuse me -- state authorized --
21 licensed practitioner,'whether it be a dentist, a ,
22 veterinarian, a podiatrist, o a physician, can receive
- 23. material. ,
24- And I think that's getting -- I couldn't make it 25- any more si:mple than this, than to state it that way. .
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1 DR. TSE: Yes. Yes. i 2 I think the direct answer to your question is,
(}
3 yes, you may, because we said it in the -- B item there. !
4 And this sheet has the item in there, so -- which {;
5 you;nay distribute to anybody who is -- not anybody, anybody
{
6 who is authorized to receive such a drug, which doesn't mean l
7 - Part 35 licensees only. That's one, f f
8 Second, the Radiopharmacy Rule is structured --
r 9 was structured or is structured in_such a way that we really 10 do-not Lie in to the FDA regulations. .i 11 We say you are not -- you are not relieved from [
12 the FDA or the-regulations, but we do not say you must I i
13- follow FDA regulations. It's FDA's job to see whether you {
14 follow FDA regulations.
() 15 16 So, to answer the earlier question about FDA has a regulation, certainly we would like to know that the 17 regulation will not be impacted upon in such a way -- when -;
l 18 FDA change their regulations, we must change our regulations !
19 as well.
20 That's the way we remove ourself from the -- like ,
21 the words like "FDA-approved," ADA, or whatever, those kinds 22 of words, because otherwise we will be tied into it. ,
- 23 That's the way I try to explain this particular-24 situation, is that you all have responsibility - "you" f
25 meaning the pharmacists -- have responsibilities with ,
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. g.m- r._..--- ,,--,,---_._,,.,.,-_____.a
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r 35 1 respect to radiation safety. That would be NRC.
() 2-3 Anything that is dropped or whatever -- the kind the President signed, the paper -- whatever the requirements 4 there is, it would be under the FDA, another agency. We try 5 to_ separate-them, not tie them together.
6 MR. SWANSON: Like the other -- g 7 DR. TSE: Yes.
8 MR. SWANSON: Now, with regard to your last 9 question, "Is redistribution of radiochemicals part of the 10 practice of pharmacy?"
11 DR. TSE: yes.
.12 MR. SWANSON: It's important, as you look at that 13 question, that you distinguish between the distribution of l 14 radiochemicals-that may be subsequently used in the ,
b s_s/ 15 preparation of a drug for human use, to which the FDA 16 regulations would apply, versus the distribution of a 17 radiochemical -- a redistribution of a radiochemical to 18 somebody that will not be using it in the preparation of a
>19 drug for human use.
20 For example, redistribution to somebody in a 21 research lab that may be using this in an in vitro study or 22 -somebody that may be using it in an animal study. There are 23 two distinct categories.
24 Okay, one is -- first, one is if it's going to be 25 used in' drugs when-the FDA regulations apply. The second
()
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36 1 one, they don't apply.
(T R-)
2 Certainly routine pharmacies -- traditional 3 pharmacies have the right and do routinely redistribute i 4 chemicals -- chemicals -- as witnessed by the fact that 5 probably many of us have gone and bought bottles of salt for 6 our chemistry sets when we were kids, right, from our local 7 retail pharmacy.
8 So, certainly nuclear pharmacies ought to be 9 allowed to distribute chemicals for nonhuman use.
10 Now, what distinguishes nuclear pharmacies is the il fact that these are radioactive chemicals. And where your 12 obligation comes in is in making sure that when they 13 redistribute those radioactive chemicals, it's to someone 14 that's licensed to receive them. And fundamentally that's
() 15 where your interests and authority ought to end.
16 DR. TSE: That's true. That ' s t rue . Yes, with 17 that I agree.
18 But I want to point out -- maybe I did not point 19 out earlier -- the important key in the issue is not whether 20 you may be able to distribute, is that without a separate 21 license.
22 But I think that the comments are we need a 23 separate license to do something. And so I was saying here 24 -- I'm saying here that you don't need a separate license 25 under this -- whatever that -- B, whatever that formula is.
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37 t
1 It's already permitted in certain things.
'2 But the radiochemicals are not in that-form. And
(}
3 therefore I'm just entertaining about discussing the pros 4 and cons, whether they permit that.
5 And so,-anybody else have conments?
6 MR. CAMPER: Mark Rotman had.
7 CPT ROTMAN: Iwouldliketosup[lAmentDr.Tse's 8 statement of a moment ago. - . _ _ .
9 I believe that nuclear pharmacies should have a 10 single license that enables them to practice nuclear 11 pharmacy in a manner totally analogous to the way a 12 traditional pharmacy is licensed to practice traditional 13 pharmacy, meaning that they should be able to redistribute 14 radiochemicals on a limited basis.
Q 15 Iwouldn'tsupportanuclearpharmackgcompeting 1G with a manufacturer, but I would allow them~to: redistribute
~
17 radiochemicals to any authorized user for whatev6r -- or any 18 authorized possessor for whatever purposes'that~ person wants 19 to use_it for. And that would make the licensing of nuclear 20 pharmacies analogous to the licensing of traditional' 21 pharmacies.
22 So, to answer your question one.last time, make 23 the license applicable to all of the differeit"pradtice 124 subspecialties that a nuclear pharmacy would have,; including 25 theidistribution of radiochemicals to research facilities,
+
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38 !
1 to veterinarians, or to hospitals or to other nuclear j
(} 2 3
pharmacies who wish to use them for compounding.
There is a distinction that I want to bring to 3
4 light. There is a difference between a manufacturer and a 5 nuclear pharmacy. And I wouldn't want nuclear pharmacy {
G licenses set up in such a way that they could unfairly 7 compete with manufacturers of radicchemicals, but a limited 8 distribution of radiochemicals when the normal scope of ;
9 their nuclear pharmacy practice would seem to be very 10 reasonable, j 11 MR. CAMPER: Kathy, you had a comment?
12 MS. SEIFERT: Just to agree with Mark. He, in his t
13 elaboration, brought my comment forward, i 14 MR. CAMPER: Let me, then, try to summarize some
() 15 things that we've heard on this particular point for the 16 staff to go back and consider as we proceed, guidance 17 changes and so forth.
l 18 First of all, what I'm hearing is that 19 redistribution of radiochemicals or other non-medical use 20 byproduct material to an authorized recipient, including 21- non-medical types -- for example, veterinarians -- is, in 22 fact, consistent with-the practice of radiopharmacy. Okay?
23 The second thing, I think, that is a take-home 24 point for the. staff is that if I look at condition 9 under i
25 ." Authorized Use," A through B, we said " preparation and e ANN RILEY & ASSOCIATES, LTD.
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39 1 distribution of radioactive drugs" -- includes moly-99 and t
- 2. tech-99 generators to authorized recipients." I think we're 3 okay on the " authorized recipients" aspect of that i F
4 authorization, getting at Mark's concern. l 5 (Slide '. ) ;
6 We may have a pro'olem, though, in terms of where -;
7 it says " preparation and distribution of radioactive drugs."
8 That may be a bit more narrow than it should be, and we 9 should take a look at that in guidance space and perhaps in 10 license space to make a change. Is that pretty much on the -!
11 mark? ,
12 CPT ROTMAN: [ Nods.;
13 MR. CAMPER: All right. Thank you, i 14 MR. BROWN - Larry, I have a question before we
() 15 16 move on.- Can you just explain to us the process that, for example, if you change the way the NRC licenses under Part 17 32, how do you get that information out to the regions to 18 make sure that all the regions issue licenses that are 19 compatible with -- you know, from one region to another?
20 MR. CAMPER: Well, what we do, Roy, is anytime we 21 make a change -- be it standard review plan or the actual 22 license document itself -- they are, in fact, disseminated 23 to the region with instructions to cease and desist using 24 the previous guidance -- and it's cited as to what it is --
- 25. and to henceforth use the new guidance.
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40 1 What I envision would happen here is that when the !
/~ NUREG is created, there will be in that NUREG, as there are l 2
Y,T) !
3 in all the NUREGs, example licenses. What we would need to )
4 do, as we develop the new license that would be in that 5 NUREG, is take a look at these kinds of issues, make i l
G adjustments in the license itself. I i
7 And then what happens is, once those NUREGs are 8 finalized, the regions are instructed to use that l
9 information for review purposes and to use the licenses that 10 are contained in the NUREG.
11 MR. BROWN: Thank you.
12 -MS, HOWE: Tony got called away, and so I'll be 13 picking up the discussion.
14 Our next major comment that pertained to 32.72 was
() 15 16 the transfer of radiolabeled agents by medical licensees.
And the comment was: Is a medical-use licensee who 17 synthesizes radiolabeled agent 3 to a pharmacy for subsequent 18 cale and transfer able to do this?
19 And for discussion, our initial interpretation is 20 that it would really depend on whether this was a transfer 21 or a commercial distribution.
22 And depending on whether it was a transfer or 23 commercial distribution, the Part 35 licensee who was 24 transferred could do it under their license if it was 25 commercial distribution. You'd have to look to see if they ANN RILEY & ASSOCIATES, LTD.
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1 tmty need a distribution license under 30 or 32.72. ;
L[ ')
\. /
2 We're now open for discussion and comments. Do I f 3 _need to clarify? ,
4 Okay. Kathy, I think you're the first one that
-i 5 looks quizzical.
6- MS. SEIFERT: Maybe I'm just puzzled. Aren't 7 there five licenses for transferring a synthesized 8 radiolabeled agent to a pharmacy? _0kay. So, for instance, 9 a hospital would synthesize a radiolabeled agent, transfer _ :
10 it to a pharmacy for subsequent sale to another hospital.
11 Is that what the-issue is?
12 MS. HCUE: Yes, In other words --
13 MR. CAMPER: That seems to be the issue, yes.
, 14 MS. HOWE: -- that's our interpretation of the 15 comment.
16 MS. SEIFEkt:- Okay. From a Board of Pharmacy ,
17 perspective, is that acceptable?
t 18 MS. HOWE: Mr. May.
19 MR. MAY: Well,-I would-have to say that I would ;
20 not find that objectionable to the Board of Pharmacy.
21 That's more of a -- I would see it as a safety issue 22 regarding -- if the NRC would have no problem with it, I 23 don't see that the Boards of Pharmacy would have a problem 24- with it.
25 I assume these synthesized materials do not ANN RILDYJ& ASSOCIATES, LTD.
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43 1 present a danger to the public unless they would be broken l
( ) 2 open or.something. But is it any more toxic to the 3 pharmacist or the public if-it will be transferred from the 4 synthetic process to a pharmacy than if it went directly I 5 from there to a patient in a hospital? _ ,
6 If it's not a safety issue, I don't think we have l t
7 a regulatory concern aoout it. It is the practice of
{
8 pharmacies we've looked at. ;
9 MR. CAMPER: Well, that's an important comment. >
10- From our standpoint, this is not an issue of safety. Our i
11 Part 35 licensees may transfer materials to other authorized ;
12 recipients. The issue becomes one of "What are we f 13 . licensing? What does the NRC license?"
14 Given that we license a Part 35 licensee for
) 15 medical use, they have the capacity to transfer, the ,
16 distinction that we have to wrestle with is the line between- '
17 a license issued for commercial distribution versus the 18 license used for possession and use, whic.h allows, also, i
19 transfer.
20 I mean, one hospital may transfer to another one 21 or the recipient may transfer to another-one. You know, 22 -you're short on technetium today and I provide you with a 23 dose. But what happens if you begin to provide those= doses 24 for fees? So, that's the problem we have, drawing the 25 distinction between a transfer versus commercial f ANN RILEY & ASSOCIATES, LTD.
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1 distribution.
e
(~~ ) 2- Let's see, I think Dennis was next.
3 MR. SWANSON: Well, a couple of comments. First, -
4 in response to yours, from a radiation safety perspective, !
5 what's the difference? Okay.
6 And secondly, I would disagree with you. I don't 7 think this is the practice of pharmacy. I mean, this is a '
8- different issue, but maybe we just ought to limit it to the 9 NRC comment and the radiation safety issues. As I say, I 10 don't really think it makes much difference how the NRC 11 handles it, okay.
12 You know, my advice to any pharmacy that's doing :
13 this would be the FDA would clearly call this drug j 14 manufacturing if that product is intended for human use. !
(} 15 I speak as somebody that operated under that 16 scenario for several years. And, believe me, we were 17 required to register as a drug manuf acturer. Okay. .
18 But I don't think that's an NRC issue. The NRC 19 issue deals with the radiation protection aspects of this. ,
20 And, again, I'll come back to my comment, "What's the 21 difference?"
22 MS HOWE: Dennis, in this case, it's not the L
23 radiation safety aspect of it. It_in the licensed activity 24 of transfer and distribution.
25 MR. SWANSON - Well, then, you're into, you know, a ANN RILEY & ASSOCIATES, LTD.
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-44 1 semantics issue. .And, you know, the point I'm trying to
.Ic,T 2 make is, if you're truly basing your regulations upon a
\ ,J. 1 3 radiation safety issue, you know, I would allow this to j 4 happen under a radiopharmacy license. But my advice to ;
5 anybody is I wouldn't do it, okay.
6 But I think, if you really want to simplify your 7 regulations, you basically allow the transfer of radioactive 8 materials to authorized users. It keeps it very simple'--
9 okay? -- to get out from under it.
'10 MR CAMPER: Mr. May. l 11 MR. MAY: I would like to just add one comment. l 12 FDA'regards compounding as manufacturing when you cross a 13 certain line. You can't necessarily define a process like l 14 this if it's not in small amounts, as manufacturing. FDA ;
() 15 .doesn't regard it that way.
16 So, I think my comments relate to the fact that if 17 you get beyond a certain point, if you deviate from FDA's 18 regulations as-a compounder of anything, whether it's PET 1 19 radiotracers, which was a-big issue we got into in '95, 20 where they wanted to call all of that manufacturing, we 21 . thought that inpinged on the practice of pharmacy to some ;
22 extent.. We still do. -And Congress apparently thought so, 23; because they revoked all of that thing that FDA went 24 through.
25- .The point is, again, FDA.has very clear ANN RILEY.& ASSOCIATES, LTD.
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45 I I
1 regulations now that deal with compounding. And it a
() 2 3
pharmacist does something on a small scale and does it in light of a prescription, he is ellowaJ to 'obtain the j
4 material and transfer the material on prescription.
l 5 If he goes beyond thdL and starts getting involved [
6 in quantities, large quantit! then he is determined to be !
7 a manufacturer of drugs and ho violatLJ federul FDA 8 regulations, and they will come in and prosecute. j 9 But to set a limit, t'at J you chnnot do something
'10 because it is " manufactured" to begin with, I thinx, is !
r 11 illogical in my opinion.
12 There are very clear roles that PDA he.a, Again, to [
13 determine when you go from traditional compounding to ,
14 manufacturing. FDA will make that distinction. I don't
() 15 think pharmacy should set itself into a box and make it i 16 . easier for the Food and Drug Administration to regulate.
17 MS. HOWE Actually, in this question, it's not 18 ."Does the pharmacy need something else?" It is "Does the 19 medical-use licensee need something else in order to be able :
20- to transfer it to the pharmacy?"
t 21 MR. MAY: But I was asked, "Do the Boards of 22 Pharmacy find objection to something like this?"
33 All I'm saying is don't put yourself into a box L24 and predefine something in light of other federal t
25 regulations.
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46 g, 1 MR. CAMPER: Mark.
~~$ 2 CPT ROTMAN: I'd like to add a little bit to this (d 3 discussion.and maybe drive.a couple of nails into the lid of .
4- the coffin of it so we can put it to bed.
- 5 As someone who radiolabels a large number of very-6 oddball compounds under very-limited conditions, I often do 7 work for people outside of my immediate facility, because'I ]
8 have the expertise and the physical facilities to do so.
9 At one po int in time, I routinely was labeling 10 monoclonal antibodies for imaging of cancer patients in 11 several different research facilities outside of the 12- National Institutes of Health.
i 13 Sometimes we distributed directly from our 14 Radiation Safety Branchito the other facilities, and (O
V
-15 sometimes there was an intermediary that received the '
16 product and redistributed it, f
17 So, I think that this sort of thing that you're 18 describing does happen on a limited basis under certain 19 conditions.
20 But the real issue is the difference between a 21 cooperative, helpful situation in perhaps research and a 22 commercialization of the process. :
23- So, I would answer the question that if the i
24 ' product is sold routinely and becomes a product in 25- commercial distribution on a routine basis, then it-clearly
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47 l 1- has gone beyond'the' simple transfer and has become a 2 commercial process, at which time it seems only fair that
)
3 the NRC license that user as a commercial distributor. j 4 That, again, would be connistent with my earlier i 5 statement, as you don't 'aant a Part 35 licensee competing i i
6 with manufacturers without having to have to play on the ;
,t 7 same field, and that it would be unfair for the j 8 manufacturers to necessarily have to compete against a ;
t 9 Part 35 licensee if the Part 35 licensee is not licented or j l
10 inspected the same way the manufacturers are. !
11 So, in answer to that, I would:say if it's a ;
12 routine, consistent commercial distribution, where there's -
13 clearly profit in mind, then I would say make the Part 35 14 license get licensed to distribute commercially. And I
() 15 16 think that answers your question.
There are going to be situations where thinge are 17 done a little bit'more complex 1y than normal, but there's 18 usually a reason for it. And if the appearance is 19 commercial distribution, then it should be required to have 20 a commercial distribution license. .
21 MR. SWANSON: Now, can I ask a question?
22 You said the concern dealt from the standpoint of ,
23 the medical licensees. And aren't medical licensees 24- licensed to receive materials from people licensed under 7 25 both-Part 32 and whatever the nuclear pharmacy license is ANN RILEY & ASSOCIATPS, LTD. l Court Reporters 1250 I Street, N.W., Suite 300 Washington, D,C. 20005 (202) 842-0034 :
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48 1 going to be?
() 2 3
MR. CAMPER:
can transfer.
They are, Dennis, absolutely. They The issue -- the real problem here, I think, 4 is this issue that Mark raised, and that is, this involves a 5 transfer for subsequent sale to other medical licensees by 6 the pharmacy. So the question becomes, is that something 7 that seemed to be appropriate for the licensee?
8 MR. SWANSON: Okay. And, you know, again,.if you 9 go back and look at what a traditional pharmacy does, I 10 mean, many times a pharmacy will be out of a given drug --
11 and I think this is what Mark is referring to -- and we'll 12 get -- we'll borrow that drug f rom another pharmacy, okay.
13 And the same thing happens in nuclear pharmacy.
14 And so I think you need to allow that transfer
() 15 between pharmacies to occur, okay, which does, you know, 16 routinely happen.
17 And, then, I think where the real issue comes down 18 - I would agree with Mark -- is if that process is being 19 concercialized.
20 And I think -- and, again, not to get hung up in 21 the FDA regulations, but the FDA regulations would say that 22 if a pharmacy is routinely distributing that to another 23 pharmacy on a commercial basis, that fundamentally that is 24 not the practice of a pharmacy, because you don't have the 25 -traditional pharmacy triad of physician-patient-pharmacy.
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() 2 3
And hence that is part of the FDA's regulatory definition of apharmacy practice," is that you have maintain j l
4 that triad. But-certainly the FDA does permit transfer on a !
5 noncommercial basis to a pharmacy.
6 MS. HOWE And that was one of Tony's discussion 7 points on the previous slide, is: When are you beyond wlat 8 we would -- what anyone would consider a normal pharmacy?
9 And now you're into more of another type of licensing 10 situation.
11 MR. SWANSONi Right. So, I think, you know, the 12 distinction there that Mark made is, you know, whether 13 you're truly commercializing this or whether this is a 14 transfer, that would occur as part of courtesy-type things
() 15 or operational-type things.
16 MS. SEIFERT: Another example would be a recent 17 event where molybdenum was not available for a while. And 18 there was a lot of transferring going on at that point just 19 to allow the availability of product to clinicians who 20 needed it. +
21 In fact, it would be appropriate in that case for 22_ a hospital to be able to transfer to a pharmacy the extra 23 technetium that they had to allow that pharmacy to then sell 24' -it to another hospital who didn't have'any technetium. That .
25 :seemed to particularly appropriate in an emergency ANN RILEY & ASSOCIATES, LTD.
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50 l 11 situation. That would go to what Dennis says. l 2 I think it's the term " synthesize" that's getting
<- 3 'me here. I 4 I think in terms of having a Part 35 licensee l 5 compound a product and then-transfer it to a pharmacy and f
- 6. then-transfer it back to another medical licensee, I think 7 it's the " synthesized" part that, to me, as far as FDA rules [
8 go, the way I understand that. So --
l 9 MR. CAMPER: It would not be? ,
10 MS. CEIFERT: It would not be acceptable, the
- 11. " synthesized" part of it. j 12 MR. CAMPER: Yes, I understand. .
13 MS. SEIFERT: .Is that your understanding, Roy?
14 MR. BROWN: Yes. That's a word that gave me some
- 15. concern, too.
16 And, then, I guess a comment I had was, can't the 17 NRC just rely on the FDA if the FDA feels it's a 18 manufacturing facility and they issued a manufacturing 19' license or; register as a manufacturing facility, then they 20 would be-required to have a license under Part 30? And if 21 they don't, then it's the practice of a pharmacy-or the 22 practice of medicine? It's really the FDA's bailiwick, not 23 NRC's.
.24' .MS. HOWE: But.we've gotten out of the practice of
- 25 finding out if you in compliance with>FDA.
We're now 1 ANN RILEY'&' ASSOCIATES, LTD.
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1 independent of that.
2 - MR. BROWN: Well, I'm not saying in compliance
'3 . with FDA, I'm saying if it's -- if the FD.i f ads it f
4 necessary to license that f acility as a ma tuf act. tring 5 facility, then to perform this, they would have to have a' 6 Part 30 license, a distribution license, j 7 MR. CAMPER: Well, in this insta*.1ce, the 8 commenter's question seems to get;at how far can I go or
- 9. what can I do in the context of synthesized radiolabeled 4 10 agents being provided'to a radiopharmacy within the auspices ;
111 of my Part 35 license?
i 12 I think, in the commenter's example, that this'is 13 only a Part 35 license. And, you see, therein comes the 14 quection. Is what they want to do here, should it be a 15 distribution license, as opposed to a Part 35 license?
16 And we've gotten several interesting things. One !
17 is that it seems that if you transfer something like this 18 perhaps occasionally that would seem to be something that l 19 would be acceptable and not require a distribution license.
20 If it becomes routine, that could become problematic.
21 On the other hand, you have to be very careful 22 when you start transferring synthesized radiolabeled agents .
as a Part 35 medical licensee to a pharmacy, because you
~
23 24 might be doing something that's not consistent with FDA. ;
25 MR. BROWN: See, you know, I think the question --
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4 52 !
ll I mean, you're asking some good questions, but I think j 2 .
they're FDA questions you're asking, not NRC questions. ;
3- MR CAMPER: Oh, Roy,-we couldn't agree more. .The l t
4 only issue that we' have here in this is trying to address l 5 the commenters' concern. And that, then, translates into, !
6 for us,-the question of whether or not such a transfer is i
7_ _ consistent with the Part 35 license versus requiring-a 8 Part 32 distributic:. license. We totally agree that it's an >
9 FDA issue.
= 10 The only issue for is what type of license would ;
11_ be required. Do we issue possossion and use under Part 35 12 or do we issue a distribution license. That's the only 13 quescion: What activity are we, in fact, licensing?
14 MR. BROWN: Right. I don't want to beat a dead
() 15 16 horse, but maybe I'm doing a bad job explaining it -- if the Part 35 licensee does not have is not a manufacturing
'I 17 -- ; facility, then the Part 35 lic6nse would be sufficient. If
?. 8 the FDA says, "No, you're a manufacturing facility," then 19 the NRC woald have to come in and issue a license on a 20 Part 32.
, 21 M". CAMPER: Right. Okay.
22 MS. HOWE: It.may be that 32.72 is only for 23' . distribution to medical users. And so in_this case they:may 24 - not fall exactly in 32.72, because they would be commercial -
. 25 dist'ribution,-too, someone-other than a medical user to the 'I i
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53 1 pharmacy, so they would probably come under distribution !
() 2-3 under Part 30, but not'32.72.
MR. BROWN: Yes, I agree. I'm sorry.
4 MS. HOWE: Okay. '[;
5 MR. MAY: Two quick points. One, NRC would be 6 foolish to promulgate regulations or guidances that are in j
-7_ variance with FDA regulations. You have to be aware of what 8 the; are and avoid any direct conflicts, or you're going to ;
9 be hammered on the issue.
10 Two, Kathy is absolutely right, if you focus on ;
11 the werd " synthesize" -- in a traditional pharmacy practice, l'
12 the pharmacist who sells a product to his customers on 13 prescription, perfectly legal. When he synthesizes --
14 l compounds a product, compounds a prescription drug, and
() 15 sells it to another pharmacy for their subsequent sale to a 16 patient on prescription, that's manufacturing according to 17 the Food and Drug Administration.
18 He could provide that to a pharmacy if they are --
19 if they do that routinely themselves and they're out af it, 20 they don't have the bulk material to make it, so he sells it 21- and he's giving them something temporarily, FDA would use 22 their enforcement discretion and say, "We're not going to 23 get concerned about that."
24 But when he' sells that product to another pharmacy 25 for their subsequent resale, that's obviously-in violation 1[ '
\
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'1 of the Food, Drug and Cosmetic Act, He is a manufacturer;- f
) 2 he has to register as suchs he has to go through.GMPs'and i
3 the=whole process.
4 If you're talking about synthesized waterials, 5 you're going to sell them to other pharmacies for their- -j
.6 subsequent resale, they may set it on the shelf or put in '
7 the refrigerator.
8 When they get a prescription and they sell it, FDA 9 would regard that as a manufacturing process. And they 10 would come in and demand CGMPs, et cetera, and you would bet 11 prosecuted, if, again, they exercise their enforcement 12 discretion and decide to do it in the first place.
13 MS . 17WE : I just want to reiterate what Tony said 14 earlier, and that is that we have disconnected ourselves
() 15 from FDA. GJ that if FDA makes rules and changes to its 16 rules, our licensees are not relieved from meeting FDA, but .
17 NRC will not enforce FDA's regulations.
18' MR. BROWN: Let me make one more comment. If you, 19 in the front of your document, say that "You have to adhere 20 to all other federal, state, and local regulations" which 21- are written there -- and that's standard format.
22 But what I'm saying is, it you promulgate a
-23 regulation that allows'that to happen, in clear violation of 24 another federal agency responsibility, I would sit back and 25 say, "Why would somebody do that? Why would somebody do
-s :
.f b -
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55 1 that?"
,-m i ) 2 You're aware of a law that impacts on this LJ 3 I particular aspect. Are you assuming that FDA is going to 4 read this and say, "Oh-oh, they shouldn't do that," and come 5 back to you?
6 I would say it's in your best interests to look at 7 that, if you're aware of it, and say, "That's clearly a 8 violation of FDA law. We should talk to them about it at 9 least before we put something in our regulations."
10 We're inviting trouble.
11 MS. HOWE: That's how our regulations were set up, 12 and we shifted our emphasis so that we are no longer 13 enforcing FDA regulations. We're trying to interpret FDA 14 regulations.
O
( ,) 15 MR. CAMPER: Well, Jon, we don't have a regulation 16 conflict as you're describing. In the case at hand, we 17 would have issued a license to a Part 35 licensee.
18 What I think I'm hearing is that the problem here 19 is not so much whether this transfer -- it's a friendly 20 transfer versus, you know, practice, whether or not there's 21 a distribution license.
22 But the comment that a commenter should see, 23 really, is -- our position snould be is that it appears that 24 what you want to do, in terms of the synthesized 25 radiolabeling, may not be consistent with FDA regulations.
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, a -.s-- + - .+ ,a . . ~ . - , . .a_1.a m,.wa++ +x u.-.s aa~a 56 !
1 program. - And~that's the take-home point.
[~')1 2 Wita regards.to whether-or:not you want to do it, N_/
the transfer versus commercial distribution,_we might view 3
4 it oc asionally from an'NRC standpoint -- whether give the 5 license for distribution versus Part 35 -- we might say such
- 6. a transfer is okay occasionally, it's not. routine,-it 7 wouldn't require a distribution license.
8 - However,-the real problem is if-they appear _to be 9- in conflict with FDA regulations, the answer is you couldn't 10 do it. Is that the bottom line?
11 MR. BROWN: With that explanation, yes.
12 MR. CAMPER:. Okay. Can we move on, in the 13 interest of time?
14 CPT ROTMAN: Larry.
. 15 MR. CAMPER: . Mark.
16 CPT ROTMAN: I would like to just clarify 17 something for Mr. May, 18 Part 35 licensees are medical licensees, like 19 hospitals or perhaps a physician with an office practice. A 20 Part 35 licensee would not be a commercial nuclear pharmacy.
21' A Part 35 licensee could employ a nuclear pharmacist, but it 22 would not be licensed as a pharmacy by either the state that 23 it resided in'or by the NRC. It would be licensed as a.
24 medical facility,.a medical-use facility.
25 So, when you were talking,-you seemed to be under t
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15 7 ,
416 )the--impression thatLa Part 35: licensee ~was'a pharmacy [or a
,2L ;pharmacyf-'-1 anal'ogous;to'a. pharmacy in practice.1 .And, in;- _
3L Lother'words,_.it-could be_a physician doing;something.- ;
=4: Butithe<bottomiline'_is~,;from NRC-points of-: view,
-thereLis really;no' problem with;this. -AsLlong-as the;
~
Si e
.- 6 l = transfer ~from-Part 35'to the PartL32 license, the: pharmacy l;
7 license, is a transfer without economic consequences ~, then 8L it's simply a transfer.
9 If the Part: 32- license -- the intermediary which '
10 receives the synthesized material chooses to redistribute it
, E11 or not, that's_still not;really-a. radiation-safety or an NRC-12- ; regulatory issue, _ItLbecomes:one.of pharmacy practice and--
~13 :FDA regulation. ,
14 And I think that we can-.best say that, you know, ,
() 15J
.16 in-this particular case it's a no-never-mind.
~
-should just ignore-it. There are other regulatory agencies The'NRC 17 that would handle this.
18 MR. MAY: No, my comments didn't -- I have no idea 19 what a Part 35 license means, you're absolutely right.
20 ^ My_ comments dealt with the concept of synthesizing
~
21 -a radiopharmaceutical and transferring it or selling it to-22f ;another pharmacy, a standard pharmacy, and their selling it, 23 then, on prescription or something.
24 The concept is,.if you do that, it's a_ violation 25: ofsthe' Food, DrugEand; Cosmetic Act,. if _ the pharmacy did it,-
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s 58 1 because he is actually acting as the manufacturer. That's
- (~ i 2 the bottom line in my comment.
LJ 3 - MR. BROWN: I agree. And it might even be in 4 violation of _ the Food, Drug and Cosmetic Act if a physician 5 compounded that same --
6 MR. MAY: Absolutely. Absolutely.
7 MR. BROWN: -- or manufactured that same thing. I 8 _ agree.
9 But I just wanted to bring you up to speed on the 10 terminology. Part 35 are medical licensees. Part 32 are
-11 pharmacies.
12 DR. TSE: Part 35 is a license -- to license --
13 medical-use license only for medical use. It does-include 14 the commercial distribution.
r~N
( ,) 15 If somebody wants to do a commercial distribution, 16 they must obtain a Part 32 license.
17 32.72 stated that whoever wants to do this, they 18 must show -- provide evidence to NRC to show whether they 19 either are the-drug manufacturers or they are pharmacies.
20 So, they cannot say, "I'm a pharmacy." Even if 21 the FDA required them to be a drug manuf acturer, they cannot 22 do that, because they have to show evidence.
23 So, we will -- and anybody who wants to do a 24 commercial transfer for. drugs must obtain a Part 32 license.
25 'And this is what this item said, because the public comment
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59 1 ' -- che comment asked this-question, g
- i 2 So, we stated this way, that a pharmacy would be wJ 3 in the middle of the Part 35 license. And the final 4 customer, the middle, is still related. That's how we 5 explain it, this way.
6 MR. CAMPER: Let's take one more comment from 7 Kathy Seifert on this particular question.
8 MS. SEIFERT: Okay. Just a point of 9 clarification. I believe Mark said earlier that a Part 35 10 licensee would not have a pharmacy license. They may very 11 well have a pharmacy license but not for commercial 12 distribution.
13 So, a Part 35 licensee who operates a pharmacy 14 within tneir own institution and does not distribute A) is, 15 commercia?ly still may have a pharmacy license from the 16 Board of Pharmacy.
17 CPT ROTMAN: That's right. Thank you.
18 DR. TSE: Okay. Good discussion.
19 [ Slide.)
20 This one is regarding ANP, the training. Now, the 21 training is tied in with 32.72 by a reference to Part 35, 22 That's why it's related to the Radiopharmacy Rule.
23 Now, in somebody's comments, they said that an ANP
.24 should have at least 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> didactic tra;ning. And in 25 the regulation, in Part 35, the regulation said 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> f)
^~ /
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60
<1 Ltotal,-including didactic and experience. l hf) s 2; 'Now,: this has been done way back, as some people 3 remember.
~4 ~ [ Laughter.)
5- MS. SEIFERT. We're having a little deja vu-here.-
DR. TSE Yes.
6- And I think the advice that we n '
.7 received said,'"Oh, that's a good' idea," because we are ;
8 relying'on the preceptor, ANP, to say that whether his :
student canLindependently operate a pharmacy. ;
9 10 Therefore, this preceptor should have some leeway-
~11 to judge whether -- depending on his student's prior 12 experience, to judge whether he needs 300 hours0.00347 days <br />0.0833 hours <br />4.960317e-4 weeks <br />1.1415e-4 months <br /> didactic or
' 13 250 hours0.00289 days <br />0.0694 hours <br />4.133598e-4 weeks <br />9.5125e-5 months <br /> or 200 or 150 hours0.00174 days <br />0.0417 hours <br />2.480159e-4 weeks <br />5.7075e-5 months <br />. And that's why we make it 14 this way. +
) 15 Somebody come and say, "
Why not require at least i 16 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />?"
17 Now, any thought on this?
18 MR. SWANSON: We've been through this before, 19 okay. . It's far too prescriptive, to specify 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />.
,s L20 You know, it's hard to define programs.- Then, you i 21 end up defining programs to meet the hourly requirements, 22 rather than establishing programs to meet what constitutes-23 appropriate training for ANPs. And we went to the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> 24 ~ to allow flexibility in program design, et cetera.
. 25 -My recommendation-is stick with the current'way
[f W
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it's written--to allowithe-flexibility of;the program.; l; 2: I think there.wasianother cotanent in.here, 'also, 13 :about-it.hasito*- I-saw~oneJof the people':saying'that it1 o q
4 has to bem-- - the: training has toLinclude lectures andi ,
5 laboratoryfsessions. .
i 6; Please, okay) let's stayiout of being that- )
-" ?! ' prescript ive .- It prohibits the design of innovative. J 8 teaching methods. We just1 don't want_to'get into that,z
!F Lokay.- !
101 -
DR. TSE: -Kathy, please, l Ill - MS, SEIFERT: I think a good way to answer this.
122 from the NRC's perspective is~to'say-that this is'a [
13- performance-based orientation to guidance development, !
4 14 because -- that's the'way I understand it -- it1 requires j
) 15 -that.someone has demonstrated competency in X, Y, Z, and has 161 signed off as demonstrated competency.
17 How you get that is sortLof immaterial.
. Seven 18 hundred hours seemed to be appropriate for overall +
19 education. Demonstrated competency in certain areas was 20 appropriate. It's kind of a precursor to performance-based.
- 21- CPT ROTMAN: I'd like to add for the record that 22- this wheel has already been-invented; this wheel has already been: road-testedi this wheel is already flat-proof. I think 24! we should just move on.
25 jut. CAMPER: Okay,'yes. 3 n-ANN,RILEY:& ASSOCIATES, LTD.
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62 1 CPT ROTMAN: As someone who worked very hard to 2 write this Rule, I can assure you it is a consensus document
(~^)-
~'
3 and that no changes are necessary, _ And I believe a 4 consensus of nuclear pharmacists would agree.
5 DR. TSE: Okay. Any other comments? -
6 MR. CAMPER: So noted.
7 DR. TSE: Okay. So noted.
8 [ Laughter.)
- 9. [ Slide.)
10 Again, this is related to ANP and RSO.
11 Somebody commented -- said that the ANP only 12 requires 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> total and this ANP can be RSO. And 13 somebody is not ANP, just wants to become RSO, he needs one 14 year experience plus 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />.
15
_( ) They say, "What's the -- why it's different?"
16 The difference, Mark?
17 CPT ROTMAN: To answer that, I'm going to start 18 with a rhetorical question. What is the difference between 19 apples and oranges?
20 Okay. The training required to be an RSO at a 21 minimal level, speaking only at the minimum necessary :o
- 22. become an RSO, is entirely and completely different than the 23 -training required to be an authorized nuclear pharmacist.
24 It just so happens that authorized nuclear 25 pharmacist training overlaps with and is consistent with the
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63 So.that someone who is an
~
- 1 . majority-of RSO' training.
Lauthorized. nuclear pharmacist can usually step in-and'be an-
{}s- 2_
-- 3 ? RSO in a commercial nuclear. pharmacy!with no additional-- !
4- -training. -However, the reverse'is_not-true.
5: So, you shouldn't try to' link these two and say, l 6 -"One requires this amount of training'and the'other requires
- 7 - .that. How come?" The "how come"-is because one is-an apple
-8 -and one is an orange.
.9 And I.think-what you have here is an attempt-by
~
10 somebody to equate two things thaticannot be equated.
11- DR. TSE: But may I offer a follow-up to this.
12 question?
13 It appears to-be -- the commenter will say -- to
' 14 ' be'an RSO requires certain type of training,. experience. To
() 15 Ebe.an ANP requires additional training, experience.
16 How come, then -- I agree, with apples. oranges, -
17- they're different. But which one should be bigger?
18- An ANP can do two things, to operate a pharmacy 19 and the RSO. But an RSO can only do RSO. How come this RSO 20- requires more experience, one year, as compared to that? I
, -21 think that --
22 CPT ROTMAN: Well, let me answer that question for 23 you rather easily._ Seven hundred hours is not the only
- 24. -requirement to become an ANP. You have to be a licensed i
25 -pharmacist, and you have to have a-preceptor statement. And I
i i
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6 <,
1 in order)to get that preceptor statement,-you'have to i 2 demonstrat'e 'on a performance basis' that- you can do. the job.
3' Now,-if-.you were to-rewrite your regulations, you" 4 might be able to say that'200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of didactic training and 5 a preceptor statement =would be sufficient to become-an..RSO.
6 -But you can't compare the training of the-two and ask why_is 7 one more than the~other, because you're not comparing
- 8. equals.
9 DR. TSE: Yes. Thank you. That's a good 10 explanation.
11 CPT ROTMAN: I think that should answer your-12 question.
13 MR. CAMPER: Well, that's right, Mark. And in our 14 proposed solution, I think you captured that very point. I O
Q 15 mean, what.we tried -- as you all - many of you were at 16 this table through part of this discussion. What we tried 17 to do, of course, was to bring the parallelism to the 18 practice of every pharmacy that existed for an authorized 19 user. An authorized user -- physician, that is -- can be an 20 RSO, or a pharmacist can be an RSO, 21 There is other pathway that e> lsts in Part 35, the 22 .200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of training and the one-year experience, simply an 23 RSO. Similarly, if'you look at our second bullet there,
~24 there.is the-old pathway in FC.410-4-of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> or 500 25 -hours.
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~ 65'
" 1- So,fyou.know, again,-I1think the bottom line for-I\_//
'I 2 the commenterJ-- what I'm hearing-is,' is that the
=;
3 parallelism.that" exists--between an authorized physician user 4 and an> authorized nuclear pharmacist is.an appropriate 5 parallelism.-. They are,-in fact, qualified to be a radiation
- 6. security officer. But1at the same time, there is another-i 7 pathway if;one wants to be an RSO only. But --
8 DR. TSE: Kathy.
9 MS, SEIFERT: One thing I'd like to comment cn1 is ;
10 that as Part 35 is developed, that that be kept in mind;'
11 because my concern is that as that develops, that an RSO is 12 an RSO is'an RSO ir, a medical institution or a nuclear 13 pharmacy or a manufacturing environment, or whatever.
14 And, in fact, I believe that requirement fields
() 15 for an RSO need to be different in this environment.
16 I think that a nuclear pharmacist that's an 10iP is 17 very well qualified to be an RSO in a nuclear pharmacy. I'd 18 hate to put him in a hospital. And I would not put him in a 19 manufacturing environment either.
20 .So, just because of the complexity of what is 21 dealt with-in other areas, I think it's appropriate in a 22- nuclear pharmacy that an ANP can also be an RSO, but maybe 23- not transfer that -- what would you call that --
24 -requir' e ment, or that those-didactic and experiential' 25- . requirements wouldn't transfer to allow them to be an RSO in
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66 1 -a hospital'necessarily.-
(N 2 MR.- CAMPER: .Right.
\ f[ I~thinki t he take-home point -
3- for the staffLthere is that, when you're looking at-
~4 experience for an RSO,: it should be' experience that's 5 ogermane;to the type of practice that they're involved in, 6 whether it be a radiopharmacy, whether it be a. hospital.
7 -And frankly,-even within. hospitals, if you stop and think .
8 about it, there are dramatic differences. That's a good 9 point.
~10 MR. TSE: Yes. Kathy, that's the subject of the 11 next slide. You already explained it to us.
12 MS.-SEIFERT: [ Laughter.)
- 13. [ Slide.)
14- DR. TSE: Okay. Let's go to -- if_no further 15 comments, we'll go to the second one -- the next one.
{)
16- (Slide.) ,
17 'That's exactly the issue, somebody such as that 18 may not have sufficient experience.
19 Now, what's the duties, RSO? I thought duties RSO 20 are mostly related to radio safety programs, condemnations, 21 surveys, et cetera.
22 Mark, you first.
23 -CPT ROTMAN: Okay. I'd like to expand-this 24 discussion-a little bit for several reasons.
25 Under " Issue," I would like to take out the word q ANN RILEY & ASSOCIATES, LTD.
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67 1 aindividuals" and insert the word L " authorized users or 2_ physicians."
(/
\
)
3 Current regulations would allow a board-certified
-4 physician, could-be board-certified in anything the NRC 5 recognized. And in Part 35, that automatically makes them 5_ eligible to be a radiation safety officer.
7 But you can't say that-a board-certified nuclear 8 medicine physician could step into a commercial nuclear 9 pharmacy and act as the radiation safety officer in an 10 efficient or safe manner. There are just too many 11 differences in the practical experiences.
12 However, the basic radiation safety training, the 13 issues that are concerned with and that are universal to 14 radiation safety -- you know, most commonly time-distance n
l ; 15 shielding, dosimetry, some of those issues -- they may very V
16 well be covered in the board certification for a physician.
17 But it's the hands-on intimate knowledge of how a pharmacy 18 operates that would make them ill-trained to be an RSO in a 19 pharmacy.
20 So, the first thing I would want to do would be to 21 change that for our discussion purposes to say 22 " board-certified physicians may not have rufficient 23 experience to serve as an RSO in a physician "
24 However, a board-certified nuclear pharmacist in a 25 Part 35 setting probably could step in and act as an RSO in
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68 i-- -a commercial nuclear-pharmacy. So,JI would like to make.
h-O 2 that distinction.
3 The-second distinction I-would like to make is 4 that.thereLare.two aspects to being-a radiation safety.
5 Lofficer. One-is what you might call-a didactic or.
6 -intellectual training, and the other is more experiential,-
7: the time-that you have spent inLthe laboratory doing things.
8 I'm sure that_the people who are physicians that 9- -are--qualified to'be'RSOs-in a hospital setting have the 10 intellectual capabilities to be an RSO in any setting, but 11 they don't have the practical experience to do it.
12- So, I want to make that distinction when you're
.13 -talking about what you're talking about here.
14 DR. TSE: Maybe I ought to stop the responses. I 15
.(Oj apologize, I think I took these words from the comment 16 without thinking. So, I agree, these should be certified, 17- or certified -- authorized users or physicians and so on.
18 Or there is other board-certified, like Health Physics 19 Society and so on.
- 20. Please.
21- MS. SEIFERT: Just a point about the 22 qualifications for board certification in nuclear pharmacy 23 -requires-4,000 hour0 days <br />0 hours <br />0 weeks <br />0 months <br />s-of practical -- or 4,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> of 24 experience in nuclear pharmacy in order to be 12 5- board-certified,lbe eligible to sit for the board exam. So, tN ANN RILEY & ASSOCIATES, LTD.
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f69
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1 that would certainly cover the' experiential part of-that.
I. L2T And board-certified in other areas,:as Mark said,
- % / . .
3 -maybe they're --
4 DR.- TSEs. I=think they probably_mean__the other 5 areas.- Certainly it will not-include board-certified
-6 nuclear pharmacists to be -- it is not-sufficient for RSO in L7- a pharmacy.-
8 MR. CAMPER: Tony, a question. The commenter used
- 9. the word " individuals." They were not: specific beyond that,
.10 as to'what type of individuals they were referring?
-11 DR. TSE: Well, I do not remember. Probably.
12 Probably. I'd have to check on that.
13 -But -- okay, Donna-Beth.
14~ MS. HOWE: I think they were referring to a A
I,
) 15 specific paragraph. And the specific paragraph listed a 16 whole list of board-certified individuals, and they were
- 17. basically healthy physicists and physicians, i
18 DR. TSE: But_anyway --
19 MS HOWE: That's why you can tie that into 20 physicians.
21 -CPT ROTMAN: Let me add a little to this. I may 22 .have been one of the writers of that comment -- or at least 12 3' one of the early drafters of that comment.
24 If I remember correctly, the draft Reg Guide 25 ' listed, I think verbatim, _ exempted _from -- excerpted --
[)?
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70 41 sorry, takenfout of PartL35 the entire-paragraph which' i5_~s/ L 2 '- listed #allofLthe board-certified specialties-in. medicine. j
-3 whichJwereLeligible to.be radiation safety-officers-in'a -
l c
4- Part"35-isituation and. simply transplanted them'directlyginto 5 .beingl eligible-to be RSOs"in a PartL32 situation. '
And it wasLfor; exactly the reasons ILlisted-
~
6 7- moments-ago:thatLthose comments were made. Physicians may i
8 be very well-trained on an intellectual basisLbut very 97 spoorly trained on an practi' cal' experience basis'to step into i 10 a nuclear pharmacy situation and become the RSO. And that-was the comment thatLwas trying to be made, and I think >
12- ;we're hitting-it nicely here.
13 MR. CAMPER: So, then, the suggestion would be 14 .then, Mark, that, in. fact, the board-certification would not b.
(j 15 necessarily, in-and of-itself, be acceptable?
16 CPT ROTMAN: That'would certainly be the statement 17 I'd want to make. A board-certified nuclear medicine 18 physician may not be suitable to step in and become the i 19 radiation safety officer in a commercial nuclear pharmacy.
20 Perhaps an individual board-certified nuclear 21l medicine physician would have individual experiences that 22 would make that. person suitable for it, t
23- 'But.in a general way of speaking, I-wouldn't think 24 lthat someone whethas' practiced =in a nuclear medicine 25 department in-a clinical' situation all their lives or-all .
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71 1: :their. career could step into a-completelyLdifferent ,
/~"'/(; 2 ' practical'. scenario and operate, efficiently..!So, you would-x-
s .
3' haveito;examineLthose people on a case-by-case basisLtoisee; L4. if they would-fit.
51 DR.cTSE: Roy.
6- MR. BROWN: Yes, I strongly agree'with that. I 7' mean, an authorized user or a physician,'or even an ANP,.you
- 8. can't necessarily take that certification or that level of .
9 training'and'just throw them into_an-RSO position.
L10 I mean, quite a few of those people, if you give-
- 11. them a couple of curies of I-131 and they want them compound 12 them into capsules, design a system to protect themselves-13 and-then the pharmacy and then the_ environment, there are 14 not a whole lot of board-certified physicians that can do
() 15 .that.
16- So, I think, as Mark said earlier, it's really 17 apples.and oranges. I mean, I think a board certification 18 is_a great start, but then I think there are additional 19 _. requirements, too. I feel very strongly about that.
20 DR~. TSE: _Thank_you.
21 Kathy.
22- MS, SEIFERT: What about a board-certified health 23 physicist?
24 MR. BROWN:- Well, that's certification 11n health 25' -physics, rather than certification in the practice of
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72 ,
1 nuclear-medicine. So,.that's an entirely different story.
-2 Yes, I think board-certified health physicists in
'/'")
. %.J 3 mostfcases-could step into that job.- But if it's --
4 obviously, we know if it's a board-certification in a power 5 reactor section, for example, that'may not be applicable to 6 nuclear pharmacy.
7 DR. TSE: Dennis.
8 MR. SWANSON: Yes, I think actually the key comes 9 down to your second bullet there, which is when selecting an 10 RSO, one should choose individuals that have sufficient 11 experience related to your operation.
12 And fundamentally that that's where it lies, 13 because, you know, you can have the opposite argument. I 14 think Kathy brought it up. I really don't think that (n) x_/
15 authorized nuclear pharmacist is qualified to be an RSO for 16 a broad licensed institution either, okay, or a major 17 hospital, institution, because you don't know brachytherapy, 18 so and so forth.
19 So, the key is the second bullet, okay, how you 20 work that in.
21 DR. TSE: Yes.
22 MR. SWANSON: And it probably needs to be 23 evaluated on a case-by-case basis.
24 CPT ROTMAE: Let me add to that a little bit. I
.25 want to read the paragraph that_was written on this <
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.73 a
~
11: particular issue,.because I x think'it very? nicely restates:
2~ ourLarguments:rightLnow.
' 13L '"While;we all agree all..ofEthe-above -
- d- board-certified' professionals may be, qualified _to be-RSOs.-in -
a'me' dical;settingi we2are concerned:and= unsure that;those 5'
-6 board-certified in medical specialties-woulti'be. suitable 7,l lRSOs:in-a1commercia) nuclear pharmacy. ;
'8 "We suggest the NRC;take an'individualLlook at any 2
9- RSO candidate whose credentials; stem solely from a medichl credential such as those listed above to ensure the ,
11 candidate has appropriate. hands-on' experiences. There are-
- 12 differences between radiopharmacy labs and nuclear medicine I 13' departments;and commercial nuclear pharmacies."
14- So, I would say that:the=commenter addressed _this
.p O 15 _. Very, very nicely by excerpting it-and summarizing it so
- 16 abruptly, but perhaps I've taken some-of the appropriateness 17- of the comment out of text.
18 DR, TSE: Let me ask a question. I'm thinking 19 -about prescriptive performance-based. Now, do-you suggest 20 that'for RSO, have some kind of'a general guidance or
- 21: : requirements-to say what type of board-certified or'what 22- type of training:or experience would be suitable for certain
~
- 23. type _of operations? You want to do that?
- 24. Or-you--want to do like Dennis'said, that they all:
25= know the principle .- they all know how to do the job, RSO?'
l i
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74 1 But you've got to look at -- when you're selecting, you need
[) 2 to look at which one is most suitable to your -- have most 3 suitable experience in your type of work.
4 Now, there's two ways you could do it 5 One is to leave it general. Therefore, you can 6 select which one you want.
7 Or leave more specific. Then, the people cannot 8 eve n apply for the RSO positions because of NRC's 9 limitations.
10 MR, SWANSON: But I don't think you can be that 11 specific on it. I mean, it would be inappropriate to say 12 that an RSO who is not an authorized nuclear pharmacist 13 could not be an RSO for a nuclear pharmacy.
14 I mean, some of my better friends come from a (n,) 15 radiation safety officer background and have been doing that 16 operation for centralized nuclear pharmacies for many years, 17 okay. So, you couldn't make that general statement and say, 18 "Well, only ANPs can be RSOs for a nuclear pharmacy." l l
19 I think it comes back to saying, you know, to take 20 a look at it on an individual basis and having the 21 performance requirement: When selecting an RSO, one must 22 choose an individual who has sufficient experience related I 23 to the operation. Okay.
24 And, then, you're going to have to -- and I assume 25 you do, tchen you apply for a license, you look at the 1
l
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75 1- -training and experience of the RSO designated on the
,m (ss 2 license, okay,
)
3 MR. CAMPER: Kathy.
4 MS, SEIFERT: I agree with that 100 percent. Some 5 of our best RSOs are not nuclear pharmacists, the ones that' G are in locations where they focus primarily on RSO activity.
7 However, they have had further experience than the 8 authorized nuclear pharmacists, and I think that goes with 9' that one year of~ experience part of the rule.
10 MR. CAMPER: Let me say what think what I'm 11 hearing to make sure. You do not necessarily agree with the 12 first bullet, the staff's proposed. thinking an this point.
13 You do agree with the second bullet.
14 I think what that might translate into, then, when
(~'s
( ,) 15 we get around to adjusting the guidance in the NUREG, we 16 would go take a look at item 7.3.2, " Proposed Radiation 17 Safety Officer," page 12.of the current document.
18 There's a paragraph at the bottom that says, "The 19 criteria for the RSO evolved from NRC's requirements for 20 PSOs to hospital nuclear medicine programs, because the type 21 of the use and the degree of radiation hazard are quite 22 similar "
23 I don't think I'm hearing an agreement with that 24 pr.rticular paragraph. What I think I'm hearing is we should 25 reexamine whether all those certificutions would be hN/ ANN RILEY & ASSOCIATES, LTD.
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4 76
'l , acceptable tio be 'an RSO]i'n' radiopharmacy, ' and- there should-1/'~' J2 be~some modification of that paragraph that wouldicapture i s)
3: thistidea that the; experience should be: germane'to the type ',
4 of activity which the individual would be-an RSO.
5 I think that' simply.because:one-has this 4 6 - experience-they can do radioactive safety in a nuclear 7- . medicine setting may not, in and'of itself,'be ample for a 8 radiopharmacy setting. Is that-right?_ Okay.
9 DR. TSE:- Thank you.
10 MR. CAMPER:--Great. Oh, yeah, I think we --
. 11 -lookinglat:the-clock,-it's about-10:20.
- 12 DR. TSE: Okay.
13 MR. CAMPER:- We're a little behind. Why don't we 1 41 -take a.10-minute break. Would that be acceptable to 15 everyone?
- 16. Okay. Thank you.
17 [ Recess.}
18 MR. CAMPER: All right, Let's go back on the 19 record, please.
20 Tony.
21 DR. TSE: Thank'you. The next slide is related to 22 supervision.
- 23 [ Slide'. )
- 24 Believe11t or not,_we have a typo there on that
' 25. page. :It's_ supposed to-be " supervise the ANP," and somebody
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~
4 11 somehow modified'it to "ANP's_ supervisor," which is- l
[Y: 12-- incorrect. -And:we do not know how-we got-that. wording.
-(T" We apologize.for
_3 lIt's incorrect. - -It's'not intended to be.-
4- it. But it1should bel" supervise the-ANP."
15 MS. SEIFERT: Page'14?-
6- DR. TSE: -Yes, page 14. There's:a-note. In-the ,
-7L note, if you read that~ note, it will be kind of confusing..
8 No' wonder people are saying-that " Hey, this-is a very l 9 confusing." But if you replace the word " supervise the
.10 ANP," it Will not be so: confusing. l 3
1L1 MS. SEIFERT: That's fine. Thank you.
12 DR. TSE: Also, the last sentence, " implies" --
13 .somebody-s'ys " implied NRC.may require a statement," or-
- 14. " written statement" -- or "a documentation of that " And
() 115-16 that's not the intention of this guidance.
-documentation'is needed. So, that's just a clarifying It doesn't say 17 comment to this item.
18 Any discussion?
19 MR. CAMPER: Is everyone comfortable with that?
-20 DR. TSE: There's probably no discussion. -Any
.21 discussion?
22- If not -- oh, yes, there-is~.
23' MR. BROWN: One point of discussion -- and maybe 24 give me some clarification'-- this implies that the
. 25: -authorizing-nue. ear pharmacist is responsible for insuring i ANN RILEY & ASSOCIATES, LTD.
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i 78 1- that all~ personnel have been properly trained and instructed
- 2 under histsupervision.
-3 DR..TSE:J Yes.
-4 -MR. BROWN: How does this relate 1to what -- Part 5 357 where it's basically the licensee's responsibility?
^
6 DR. TSE - That's right, the licensee. But.
7 certainly the licensee could delegate to the ANP.
L8- MR. BROWN: Okay.
- 9 [ Slide.]
10- DR. TSE: This is the last item. And I'm pretty.
11 sure you all would be interested in this item. This item is 12 related-to the section_we put it in, 32.72, concerning the 13 instrumentation. And it said that we-need to measure all 14 the doses befor6 the commercial distribution.
() 15 So, therefore, the reading of that sentence
- 16. essentially means that every dose goes out of a commercial
- 17. pharmacy needs to be assayed.
18 Now, the commenter said, "No, we do not need to do
'19 that, because if we purchase a dose from radiopharmaco 20- manufacturers and I have not opened it, I have not touched 21 'this package or the contents of the pharmacy, why should I 22 remeasure the dose? If I do that, then I have a higher 23- dose, which is unnecessary." Et cetera.
24 So,_what are you' feelings about that? Should --
25' or should there be - 'they said the pharmacy has'the
[
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79 1- responsibility'to' assure everything that goes out of his or 2 her pharmacy is correct in terms of doses, v
3 -MS.-JEIFERT: I think that there's an ALARA issue 4 here, that a person working with a nuclear pharmacy, to 5 measure everyfmanufacturer-prepared vial -- for instance, a 6 vial of thallium, a vial of I-123 capsules, a vial of things 7 that are already measured, already calibrated, already 8 labeled as such by the manufacturer -- to requite chat an 9 individual in the pharmacy also measure that again -- open 10 that package and measure it again not only is an ALARA
-11 issue, because that person gets a higher radiation dose.
12 But, secondly, the fact that you're opening a 13 manufacturer's package, manipulating-the contents, adds 14 another opportunity for an error, that if something goes
(
( ),/ 15 back in the shield wrong, there's an opportunity for another 16 error.
17 So, I think it's -- I understand that you can --
18 one can get a exemption for this, but it seems like it's an 19 area that is common to all areas of nuclear pharmacy, not 20 only -- and especially_ commercial nuclear pharmacies that 21 would distribute to a large group.
22 DR. TSE: I have a follow-up question. Do you 23 think -- if something goes wrong, who's -- does the pharmacy 24 have a responsibility since I did not measure, therefore I 25 let it--go?
[)
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80 1 'For example, _if something is wrong, the-patient i j ') -[ 2 ' ,gets a dose-which11s incorrect.- Suppose.the hospital-did- .
t
- w/w 3 not measure-for4some reason. Offcourse, they have 4 responsibility, too. But suppose that's the case. And the 5 pharmacy passed out'a drug without measuring. It turns.out ,
6 it's a big, big wrong dose. Does the pharmacy have a
=7= responsibility for that error?
8 MS. SEIFERT: Any-time something like that 9 happens, if suits are filed, everyone is -- from the top to (10 the bottom, and the whole proceos, so everyone'is namad.
Til 'I would feel more comfortable if it would be only 12: necessary to go by the manufacturer's labeling if the 13 product was not at all manipulated.
14' DR. TSE: You mean -- your answer implies if you G
) 15 did not manipulate this package, you have changed the 16 shipping paper, you have co change che shipping paper.
175 MS, SEIFERT; Right.
18 DR. TSE: You send the package off, if something 19; is wrong, the pharmacy does not have any responsibility; is 20 that what.you are saying?-
21' MS. SEIFERT:- The pharmacy has a responsibility 22 for what they sent out.
- 23. But . in regular pharmacy, ' regularly drugs are sent 24 out', without any kind-of measurement or manipulation that ,
.25 goes on, ir, 7 repackaged units.
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- 81. -;
31- :- In; hospital pharmacy and--in community _ pharmacy, ,
^'Y :2- ;that;happens all_theitime... There is'~no measurement that=
[N
.3' goes on. ,
it In thisLease,:partlof.the: issue is that by 15 measuring / products'ini the vials as they come from the. '
'6 manufacturer, if they're not to be manipulated at all, it _
7- increas'es the radiation' dose of.the employee that's doing 8' that.
9 And in a commercial nuclear. pharmacy, when many ,
fl0 doses are handled every iay, and many of_those are. things.
11 1 - that are prepackaged -- I-123 capsules, obviously that's 12 part of Tse's jurisdiction, but ALARA certainly is'-- that's 13 our concern -- if it's not nanipulated as-it comes from the 14 manufacturer.
( ) 15 DR.-TSE: Dennis.
16^ I'm sorry. Who will come first? I forgot to look 17 at this.
18 MR. CAMPER: Mark.
19 DR. TSE: Mark.
20- CPT ROTMAN: Okay. I'd like to add some 11 background information into this discussion so that for the 22 sake of the transcript it will 1xa clear.
23 And what we're dealing with here'is a situation 24 where a radioactive 3 rug can be or-might be manufactured by
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82 1- licensedimanufacturer.. That-drug:would: properly labeled, '
L2- g properly assayed,-properly shielded, and properly delivered f~]'
L 3 .to'anl intermediary _ point,-which might be a commercial-4 . nuclear. pharmacy. .i
-5' It'would seen to beicontrary_to_ common sense,.to-
- 6 -business sense,-to radiation safety, and perhaps' contrary to 7 the point-of view of additional manipulations, introduce 8 -additfonal chances for human error,-to require that that 9 ' intermediary point also assay that; product ---again assav 10 that product, reinvent'the wheel on thatLproduct so to-1 J11 speak.
12 So, I think that any time a product is going to 11 3 pass through your-ruclear pharmacy without doing -- without 14 any manipulations to'it',1without being handled by the Iv \- 15' nuclear pharmacist in any way other'than to move it from the 16 place ehere it's delivered in your pharmacy to the place 17 where it's going to be packaged, boxed, or labeled to go out 18 to it's end-point user, to require additional acsay at that 19 point is -- what I'm going to.say -- is ridiculous. It's 20 ridiculous from many -- many, many reasons.
21 In the traditional world of pharmacy, the nonradioactive world of pharmacy, lots of products come in 23 from the manufacturer;-and the pharmacist slaps a label on 24
.them and sends them out to the customer without any_ quality
~
25 control being done, because the quality control is done at
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1 the licensed manufacturing facility.- l
() 2 3
tit seems, again, contrary to ALARA, contrary to business sense, contrary to common sense to ask a nuclear 4 pharmacist to double-check the work of a licensed FDA l 1
5 manufacturer. :
i 6 How, other things happen at nuclear pharmacies. j 7 Nuclear pharmacies compound products which, in essence, they 7 8; are things that are made in that pharmacy.- They are, thus, 9 assayed in that pharmacy. Those things should require that ;
-10 the doses be assayed, but not things made somewhere else-by_
11 someone else who's also licensed.
12 DR. TSE: I have -- excuse me, maybe I sho21d ,
~ 13 follow up-with two questions first before we-go to the next 14 one.
() 15 When is a commercial -- the now traditional 16 radiopharmacist, the pills, whatever, it has different 17 colors, different sizes, very easy for the person -- the ,
18 pharmacist to recognize what that is and so on. If you ;
19- opened up a pack -- suppose you open a pack, there are ten 20 doses in there. So, you pick some of the older ones when 21 you pick that-one, without manipulating that, just 2? reshipping it, without changing the label, everything, by 23 picking another box, putting your shipping papers on it, .
24 sendfit off. Is there any possibility that could be mixed 2
'25 with some other dosesJaround which may look alike? Although
-l ,
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84 ;
1 -- you know, that's the first question. ,
2- The second_ question is By extension, do you 3 infer -- well, not "do.you infer" -- do I think I can.use ,
4 your' statement to say that maybe the medical-use licensees, j 5 they should not measure either, because it fits the same j 6 situation? What do you think about that? ,
7 CPT ROTMAth Oh, thank you.
8 [ Laughter.]
9 First of all, one of your first points is an issue 10 of ease of product-identification. In the traditional 11 nonradioactive world, there are lots and lots of packaging-12 that have great similarities to it, and there are often
{
13- mistakes made because we-grab the wrong bottle off of a ,
e 14 shelf and slap a label on it. That's a human error issue 15 that's going to happen anytime humans are doing work, ,
16 When you're talking about radioactive drugs, as I 17 have described in this -- what I'm calling a pass-through
{
i 18 situation, there are only a few manufacturers of radioactive 19 drugs in this country.
20 .The labeling and the color-coding and the size and 21 shape of the vials and lead shields that the individual 22 manufacturers use-is sufficiently distinctive from one to ;
'13 the_other that it's probably.not an issue of confusing one 24 product for another,-therefore leading to a mistake.
25 But even if that was the case, I don't believe l r
= ;
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85 1
1 that is an NRC issue. I think that's a Board of Pharmacy
(
. V) 2 and an PDA issue. !
- 3. But to answer your question, if a product is l
4 coming in and all you are doing is taking it out of a box j 5 and putting it into another box, that's a typical 6 practice-of-pharmacy issue. I don't believe it entails any i 7 more or any less likelihood of introducing human. error than i 8 any other act that a pharmacist does. ;
9 Now, the second issue that you brought up -- and I 10 think this is one that needs to be debated on a larger [
11 scale, in addition to any debate we generate here --
12 DR. TSE: Okay. ,
13 CPT ROTMAN: --
if a nuclear pharmacy supplies a 14 properly prepared, properly labeled, properly assayed
() 15 product to an end user, for the same reasons it is wrong to 16 ask a nuclear pharmacy to reassay a product from a 17 manufacturer, it is just as wrong to ask a Part 35 ,
18 medical-use licensee to reassay the work of a commercial 19 nuclear pharmacy.
20 In hospitals and in every other setting, when you 21 get a prescription filled or you order drugs from a 22 . pharmacy, it is not the standard of practice to double-check 23 the work.of the pharmacist who filled it. You do read the 24 label to make sure that it's labeled properly, but you don't 25 do anything else.
b
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i 86 1 You may, like you said, look inside to make-sure !
() 2 3
that -- since you're familiar with a certain product, that it have a certain color or tablet shape.
4 With injectable drugs, whether they're radioactive i 5 or not, that's often a great deal more difficult. But just 6 the same, it is a standard of practice not to double-check :
7 the work. ,
8 When you're dealing with diagnostic radioactive 9 drugs -- which is what, 99.5 percent of all radioactive 10 drugs -- there seems to be no reason that would require or 11 mandate testing the activity of the dose.
12 Now, there are several reasons for that.
13 First of all, the risk is inherently very low from 14 a radiopharmaceutical.
() 15 Secondly, radiopharmaceuticals are delivered in 16 units of activity. You could very well have ordered 25 17 millicuries of one particular radiopharmaceutical and been 18 delivered 25 millicuries of another. Checking the assay of 19 it will not tell you if it's the wrong radiopharmaceutical 20 or not.
21 If you're sincerely concerned about a wrong 22 radiopharmaceutical, then you might want to consider very 23 invasive radiochemical analytical techniques to insure that 24- the radiopharmacy has dono the right work. And I don't-25 really think you want to go down that road.
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87 i So, to answer your second half of your question, 2 for exactly the same reasons it's wrong to ask a nuclear 3 phannacy to check the work of a licensed manuf acturer, it's j 4' yust as wrong to ask an end-user to check the work of a 5 nuclear pharmacy.
L 6 DR. TSE: Thank you for your comment.
7 Roy. i 8 MR. BROWN: I don't think you're going to get much 9 disagreement on this panel.
10 I think any perceived or any slight benefit you 11 may get from reassaying at the pharmacy is dramatically 12 overshadowed by the increased risk you get from reassaying 13 it. You get additional exporure. You run the potential for i 14 airborne activity. You run -- I think it's a greater risk [
15 of mixing doses or confusing doses if you pull it out and 16 assay it.
17 So -- I'll keep my comments short -- I think, all 18 those things considered, it-is not a benefit to reassay in 19 the pharmacy.
20 DR. TSE: Thank you for your comment.
21 MR, CAMPER: Kathy.
22 DR. TSE: Kathy.
23 MS. SEIFERT: One -- just one quick comment for 24 the record. Just to make it clear, the original
'25 manufacturer's-label goes with the package as well. So,
[]
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88 !
1 it's still labeled by the manufacturer.
2 As you. discussed earlier, could things be mixed 3 up? It still maintains the original manufacturer's label, 4 also. So, as it goes to the nuclear medicine department to j
5 -check it, it maintains that original manufacturer's label.
6 DR TSE: Thank yor.
l 7 MR. CAMPER: And, in fact, if you did not have 8 this requirement, you might simply just pass it through and !
9 never change it or open it, for that matter. .
10 MS. SEIFERT: Exactly.
11 MR. CAMPER: You press on a label, and that would ,
12 be it. !
13 MS. SEIFERT: Exactly.
i 14 MR. CAMPER: It should be total pass-through. ;
15 DR. TSB: You need to change the shipping paper. i 16 Dennis. !
i 17- MR. SWANSON: Well, I think a lot of where you go t 18 to with this finally depends upon what you're going to do 19 with Part 35, in that, you know, I happen to believe that l 20 one of the things-that's responsible for our demonstrated 1 21 very low rare of misadministrations in nuclear medicine is .
22 related to the fact that we do have a technology available ,
23 to assay the dose prior to administration. And certainly l 24 that technology is not readily available in any practical 25 sense for traditional drugs, okay.
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89 l 1 I think that, in my opinion, I'd like to see a
() 2 3
dose assayed before it's administered to the patient.
whether that done assay takes place in the nuclear pharmacy, Now, ;
4 okay, in the course of dispensed doses, or whether that dose 5 assay takes place in nuclear medicine, in the case of 6 pass-through doses, I think is irrelevant. ,
7 But I do think if we have the technology available a to assay doses in a ready manner before administration, yes, 9 I do think it's accountable for a portion of our good 10 record. And I'd like to see that capability retained.
11 No , I agree, that shouldn't be duplicated. Okay.
12 If you assay a dispensed dose in a nuclear pharmacy, I would 13 not want to see the medical licensee have to reassay that 14 dose.
() 15 If you pass through a manufacturer's vial in a 16 nuclear pharmacy to the nuclear medicine department and the 17 nuclear medicine department assays that dose, then obviously 18 there's no need for the nuclear pharmacy.
19 MR. CAMPER: Dennis, do up feel that way for a 20 therapy done?
21 MR. SWANSON: Do I feel that way for therapy doses 22 as well? The answer to that is yes. Okay.
23 DR. TSE: Thank you.
24- MR. MAY: And I would just simply say if this 25 concept were applied to traditional pharmacy, there wouldn't I~'\ ANN RILEY & ASSOCIATES, LTD.
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90 1 be a pharmacy. You would shut them all them down. Nobody
() 2 3
could adhere _to this. 'And there's no reason to adhere to it, in my opinion.
4' The manufacturers, at least to provide 5 pharwaceuticals in the nonlabeled area, have to adhere to 6 CGMPs, have to have high standards of manufacture.
7 It doesn't say they-all adhere to it, because FDA 8 is routinely finding problems. But when you get the product 9 in the pharmacy, it's already labeled.
10 You dispense that product with the reputation of 11 the manufacturer. 'And the standard is enforced is by the 12- agency -- in this case NRC and FDA. This would be so 13 wasteful of resources, of time, money, as to defy logic, in 14 my_ opinion. And you would shut down the distribution of D)
(, 15 drugs.
16 Why would somebody have to reassay what somebody 17 has done that has met standards?
18 And in this case, you're no different than the 19 non-radiolabled pharmaceutical industry, who prepare these 20 with high degrees of professionalism. And the manufacturers 21 have to meet everything that a non-radiolabeled 22 pharmaceutical has to manufacture. They're under the Food 23 and Drug Administration. They inspect.these facilities.
24- DR. TSE: Thank you.
25- Dennis.
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91 l 1 MR SWANSON: The only comment to that is, in l t
i 2 fact, I think if you look at the. nuclear medicine and 3 radiopharmaceutical -- or-radiopharmacy industry, our 4- tcandards are even higher than the traditional drug area. -
5 Our rates of administration are substantially lower, ,
6 And again, I think a factor accounting for that is i 7 that we have tha technology ;"allable in our area of f 8 practice to do these assays in a ready manner. And if we -
9 have that technology that everyone c3n do that, I think it's 10 a good thing to do. It's noL a terribly expensive 11 technology.
12 Now, at some point -- you know, all I'm saying is 13 I don't want to see a duplication of assay of doses. I'm in 14 agreement with that. But I do think that there are some 15 positive considerations to making sure a dose is assayed i 16 before giving it to a patient.
17 DR. TSE: Yes, Kathy.
18 MS. SEIFERT: Larry, you asked Dennis about ;
19 assaying therapy doses. I agree with the fact that it !
20 should not be required. But as a qua)ity parameter within a 21 hospital, it's a good idea to do that. I think that's 22 important.
23- And I think that if errors were made in the
-24 process of dispensing in the nuclear pharmacy, there is 25 another check along the way. And for something that has E
?
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i 92 ff 1 therapeutic ramifications, I believe that since that !
l 2 technology is in the nuclear medicine department, it's a 3 good thing to do from a quality perspective, if not-a ;
4 regulatory reason for it, but from a quality perspective.
5 DP. TSE: So, you are distinguishing between 6 whether somebody - "Everybody should be required to do it" f
7 versus "It's good practice. I want to do it? [
-8 MS, SEIFERT: Exactly, f 9 DR. TSE: But the question is if you think you ;
I 10 might want to do it and you may think other people might
'11 want to do it as well, so what's the difference? Do you
- t' 12 want to see somebody who says, "I don't want to measure it, 13' because it's not required for big doses"? ;
i 14 And you probably do not feel comfortable with j 15 that, because this person did not think a prudent step by 16 doing it, assure that -- now, what's the difference between 17 that versus the regulation if we require, so everybody would
. i 18 want to measure those big doses, would that be better or not
- 19 better?
'20 MS. SEIFERT: I think that if you_look at how 21 medicine is done today, people are very interested in 22 quality of medicine and quality of medical practice, and put 23 policies in place to meet those quality standards. I 24 believe that it's more of a quality issue than a regulatory I 25 issue.
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- 93 1- DR. TSE: Thank you.
() 2 3
CPT ROTMAN: Let me again reemphasize this, Tony.
It may end up being related in the long run to how you redo _ l 4 your Part 35, because I know there has been some discussion- !
5 ,
in the Part 35 regulations that there may be a group of 6 licensees who aren't required to have a dose calibrator if j 7 you only receive -- dispense doses from a nuclear pharmacy, j 8 for example. ;
9 And in those scenarios, okay, you know, it may be l 10 the requirement. So, you're going to have to take a look at
.11 whatever happens to Part 35 with this, also. [
12 DR. TSE: Yes. Thank you. ;
13- Mark. (
14 CPT ROTMAN: To echo the sentiments of my
() 15 co-profussionals at the table, if you link this requirement 16 to inherent risk of the activity, it becomes a lot easier to 17 understand requiring the final -- or end-point user assay of 18 a therapeutic radiopharmaceutical. And it becomes very, 19 very difficult to justify that end-point assay for a i 20 diagnostic radiopharmaceutical.
21 And I think if you then look at what the 22 Commission directed the staff to do with respect to the '
23 quality management rule at a minimum, to ensure the accuracy 24 of the dose delivered, identification of the patient, you 25 "can then see that' insuring the assay of a dose is something ANN RILEY-& ASSOCIATES, LTD.
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94 I 1 that is consistent with what the Commission envisioned for ,
() 2 3
the high-risk activities.
DR. TSE: Thank you. I have one more question 4 with regard to this item. We talk about osmma emitters, ;
5 which is easy to do because they penetrate through. But if i 6 it's alpha or beta and they do not have significant_ gamma -- !
7 -is it hard to do? I mean, what do you with that case if you !
8 want to reassay?
9 MR. SWANSON: Well, that has been an issue of 10 discussion as these whole guidelines have been done. I 11 mean, right now the state of practice -- and correct ne if 12 I'm wrong -- is, you know, we base it upon calculations on 13 the manufacturer's assay.
14 So, you know,'you base it upon whatever your .
() 15 specific concentration is at the calibration time and then 16 dispense the appropriate volume of that. And, then, we also j 17 intend to use the dose calibrator to do some subtraction 18 techniques in an attempt to verify that.
19 The fundamental problem is, though, you know, that
-20 _the state of the art of the technology is not such at this 21 point in time to permit an assay as you would with gamma 22- emitters. And so, you know, it would be very difficult to 23 mandate something where the technology is not therei okay?
24 I mean, obviously, if a nuclear pharmacy is .
25 routinely in synthesizing-alpha- and beta-emitter 1 7EN RILEY & ASSOCIATES, LTD.
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i 95 i radiopharmaceuticals, then they're going to have'to have a i
() 2 technology in place that can-do an accurate assay.
But most nuclear pharmacies are involved in simply l
3 !
l 4 dispensing manufacturer-prepared. And in those situations, t
5 at'the state of-the current technology, you've got to allow 6 calculations based upon the manufacturer's assay, because_ l 7 the technology is not there. ;
I 8 MR. CAMPER:- Okay. Let me try to t.mmarize this. ,
i
~
9 Oh, Kathy, I'm sorry. Go ahead.
10 MS. SEIFERT: I agree with that. The other thing 11 that I think is important to realize is that that's how it's !
t 12 done in regular pharmacy as well.
13 And, in fact, when you get a drug, a vial of drug, 14 and you assay -- or you draw out an amount and dispense that 15 amount based on the manufacturer's labeling, the risk to the 16 patient in an error in that case is probably much larger 17 than anything that we'd ever do. So that is indeed an 18 appropriate process if you're talking risk-based.
19 DR. TSE: Thank you. I think Mark has a questjon.
20 CPT ROTMAN: Yes. I just wanted to point 21 something out to you, Tony. You've heard us discuss the i 22 traditional practice pharmacy, the nonradioactive aspects of 23- things and how it would be very counterproductive,'and 24 perhaps in some cases outright impossible, to make an-25- end--point assay, ,
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1 When you talk about very soft beta emitters and f
()
.S/
2 alpha emitters, you are really talking about a situation 3 where it is difficult,_if not impossible, to perform that 4 assay, i 5 So, now, even though it's radioactive, we've sort i 6 of landed ourselves back in the world of traditional 7 practice. And in traditional practice, it's sufficient to 8 gauge the dose to the patient based on- the uenuf acturer's 9 assay, given the appropriate volume to calculate that's
-10 necessary.
11 So, I think you have to accept the fact that there 12 are going to be situations where the technology does not 131 permit something as quick, easy, and painless as the dose 14 calibrator to be used.
'() 15 DR. TSE: Yes. Thank you.
16 MR. CAMPER: Let me summarize what I think we've 17 -heard.
18 Generally there's this feeling that to require 19 measurements, as we currently do Part 32, right, of all 20 radioactive drugs, including pass-through drugs, compromises
- 1 ALARA consideration, doesn't seem to be necessary because 22' it's duplicative. And the bottom line is this, that the 23 dose has been measured.by the manufacturer.
24 Currently in guidance space, as we point out in 25 our _first bullet there,. we had this rule language issue, g
- I.-
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~
1 What we have been doing, of course, is granting exemptions.
2 . We have grated at least that I'm aware of to a largo, (aT- 3 commercial radiopharmacy. l 4- I think the take-home point that I hear is that ,
5 either as part of the Part 35 revision, or perhaps some [
6 separate initiative that might be initiated at some point in .
7 the future, this component of Part 32 should be perhaps ,
-8 changed.- !
9 And I want to let the record show that we have_ !
10 been joined by Mary Moore. Mary is with Moore RAD, ,
11 Incorporated. Mary has a radiation safety and physics type
[
12 of perspective. Mary, welcome. And with that, do you have 13 a comment? j 14 MS. MOORE: Yes, I do.
() 15 16 I can -- part of my past life, I was also an independent auditor of nuclear pharmacies in two states.
i 17 So, I'm aware of the procedures followed.
18 And quite honestly, if the nuclear pharmacy trusts 19 the manufacturer and their procedures, that they have l 20 measured it accurately before it is sent to them, the 21 nuclear pharmacy, I think there's a fairly high comfort 22 level in not requiring the nuclear pharmacy to remeasure it.
23 But I don't know, if I were the pharmacist, -
24 whether my comfort level'would be that high. But I 25' vehemently object to any removal of a requirement that ANN RILEY & ASSOCIATES, LTD.
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98 1 1 _before a patient receives a dose, that dose is measured in- !
2 the hospital. That would give you the requirement on the 3- -manufacturer to have accurately determined the dose. .
4 If the pharmacy wants to act as a pass-through, I i 5 do think they need to inform their customers they are acting l
6 as a pass-through in this situation. But the backup has to 7 be at the hospital. If it is passed through at the hospital l 8 level, then the only check on that is at the manufacturer. !
9 And nobody is infallible.
10 So, I would strongly, if you are going to review !
i 11 the requirements at the hospital level, I would strongly l
12 urge that that not be changed. i 13 And in the situation that was just described, 14 .where because it may be an alpha emitter, or with therapy 15 research on patients the type of equipment may not be 16 readily available, I have a counter to that. Well, I agree, l
17 you do go by the volum6 and the specific activity. But if ;
18 they're going to do that kind of research, then they need to 19 gr* the appropriate equipment, too, which is another issue i
20 anu outside the purview of this one. i 21 .But that's something, just because they don't have :
22 .the equipment, that we take -- in a therapy situation, when
- 23. it's research, you do hav'e to ha creative. But if it 24 becomes standard therapy, then they'd better have the I 25 equipment,~and it better be working correctly-so that-the I
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99 l 1 patient's dose is accurately defined.
2 And the last comment I have is I understand that 3 this is a risk-based perspective from the NRC.- And my.
4 question ist Risk of what?
5 The effective-dose-equivalent. concept is based on 6 a risk of about three things: Fatal cancer -- death is one !
7 of them. l t
8' The National Council on Radiation Protection is 9 recommending effective done be used, not effective dose ,
10 equivalent, because it is a broader-based risk. ,
11 So, when we are talking about risk, could we l
12 please define arisk of whata? Deterministic effects don't 13 count any more? It doesn't matter? It's only fatal cancer ;
i 14 deaths? Nonfatal cancer deaths are acceptable? l 15 So, when the NRC's perspective is on risk, I think 16 there needs to be some kind of delineation of " risk of f
17 what?"
18 DR. TSE: Thank you. Let me try to address your 19- last point. Risk -- when we say " risk-informed," that's in 20 a much broader scale of risk, like this morning Don Cool was 21- talking about therapy maybe much higher risk than 22 diagnostic, that kind of risk.
23 Now, in a micro scale, in a small scale, the-NRC i 24 . regulations, all these are considered, that in Part 20 ;
25 there's a dose.for -- that's a determination risk. And i
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1 l
100 l 1 there is a genetic risk or the body in which the cancer.
l 2 risk. We need'to evaluate all these upper limits of the
[) f 3 set. l 4 So.it depends which risks you talk about. Big --
5 in the big issue, there will be general discussion, all the i 6 risks added together, whether that's big or small compared j 7 to another activity. l l
8 For example, diagnostic versus therapy -- therapy, .
9 -of course, has a much bigger risk, not just to the patient' :
10 - I mean, the patient, it's -- they get the benefit -- to !
- 11 the people nearby or the workers. l 12 The therapy sources give you much more potential ;
13 - for large risks than the diagnostic number.
14 So, it's -- depending which level you talk about, i
() 15 16 there are different answers to that.
Any other questions about this one?
-17 [No response.)
18 That's the.last issue I have. And so thank you.
19 And I come back for the general discussion later -
t 20 on. Thank you. l 21 MR. CAMPER: Right. Tony, are we now moving to l 22- 0006, general comments? ,
23 Okay. We're now going to discuss the comments on 24 draft-Regulatory. Guide DG-0007. This is comments that were 25 --
resulted.for the Radiopharmacy Rule adjustments.
./~'
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101 l 1 MS. HOWE: As I said before-the microphone was !
() 2 3
turned on, this is going to be a long presentation.
exactly one slide. .I have a few more later on.
I have f
t 4 (Slide.) ;
5 But basically the question was -- and we received l t
6 it from many, many commenters -- you haven't really .
l . addressed how we get or distribute radiochemicals. And, in l 8 fact, you also appear to be prohibiting the distribution of ,
9 radiochemicals to nuclear pharmacies, f
10- Now, I will be using, for my point of reference, l t
11 Roy Brown's distribution license to explain to you how this ,
12 works._ And so he can chime in at any point.
13 First of all, we made an error when we revised the 14 title to 0007, the old FC 406-4. It used to be "Various
() 15 Items to Group Medical-Use Licenses."
16 And we said, "Oh, gee, we don't have group j 17 licensees anymore. We'll change it to ' Medical-Use ;
18 Licensees.' ,
19 "And, oh, we shouldn't be making any statement ;
R20 that the pharmacies can't get it. Maybe that's wrong."
21 l Well, we really didn't go back and look at the 22 details of how we distribute things. . In fact, a 32.73 23 distribution license only permits distribution to medical-24 users. And so the-title needs to be revised so that the ;
25 commercial-nuclear pharmacy is-deleted, because that's not t ANN RILEY & ASSOCIATES, LTD.
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s 102 ;
i i the route they receive the materials under. Okay. So, ;
2; that's why we have the first point.
- 3. And-also -- well, that's really.the second point, !
4 on the title.
5 The first point is that the commercial nuclear [
l 6 pharmacies receive radiochemicals and radiopharmaceuticals i l
7 from uanutacturers through a Part 30 distribution. And to 8 Mallinckrodt has a Part 30 license that specifically ;
9 authorizes the manufacture'and distribution of i i
10 radiopharmaceuticals to those authorized to receive it and i 12 also has a license condition that excludes any distribution 12 pursuant to 32.72 on that particular-license, because they !
13 have a second license that is covered by this document.
14 Oka". ;
15 So, we believe that since we really muddied the 16 field up, if we were -- that's something that we would 17 clarify and supplement to.
18 MR. CAMPER: But this point, the first point, it's $
19 actually clear on the license itself -
20 MS. HOWE: It's clear on the license. !
21 MR. CAMPER: --
the condition on the license that ;
22 allows said distribution. 1 23 MS HOWE Commercial nuclear pharmacies can l 1"
24 receive radiochemicals. Commercial nuclear pharmacies can
- 25 receive radiopharmaceuticals from manufacturers.- They're l ANN RILEY & ASSOCIATES, LTD, 4 Court; Reporters.
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i 103 !
l receiving'them. i 2 Their commercial nuclear phannacy license really 3 has two parts to it: One is a possession, the Part 30 part. 'I 4 And the other is a 32.72, which allows them to, then, send i 5 out something to someone else as a radioactivo drug.
6 So, on the possession sido of it, you're already !
7 authorized to receive radiochemicals, you're already 8 authorized to receive pharmaceuticals from manufacturers.
9 At that point, do.we have additional discussion? -l
- 10 Mark.
Il CPT ROTMAN: You'll have to forgive me for perhaps 12 inserting both feet all the way up to rny knees in my mouth ,
13 on this particular issue. I have a little bit of knowledge 14 of how the NRC operaten, and yet I find myself confused by ;
15 this terminology on soveral issues.
16 For instance, I can understand how you might be 17 permitted to possess a radiochemical as a commercial nuclear ,
'18 ' phannacy, because it is necessary to have a radiochemical in !
19 place before you can compound a radioactive drug out of that 20 radiochemical. .,
21 MS. HOWE: That's correct.
22 CPT ROTMAN: However, what about the distribution ;
23 of a radiochemical in small amounts to non-medical users l
-24 like we discussed earlier this morning? ;
Por instance, there may be an academic or a l i
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104 ,
1 veterinary practice. There may be something that needs a !
Q 2 radiochemical in small amounts. And you have it on hand for 3 normal compounding processes, and you want to sell it as a 7 4 radiochemical to these users. Don't you, then, need to have i 5 -- I mean, I am confused at how license process works. j 6 MS. HOWE: Well, what you're discussing now is in i 7 guidance space in the 0006 Reg Guide for the commercial 8 nuclear pharmacy. At this particular point, we're only.
9 discussing the manufacturar, the Mallinckrodt, the --
10 they're not in an NRC state anymore, the Du Pont nuclear and 11- the Squibb license.
And so I think Tony addressed that.- That is one ,
13 of the problems this morning that was brought up, is how do-14 .w e get a nuclear pharmacy to distribute radiochemicals -- j O
15 not already prepared radioactive drugs to other than medical V
16 users, but the radiochemical itself. So, I don't want to go 17 back into that discussion. .
18 This is for the manufacturers. And this is just 19I that a'spect of the manufacturers' business that deals with 20 32.72, which is distribution to medical users. I'm trying 21 to explain that the commercial pharmacies don't receive .
22 their radiopharmaceuticals from Mallinckrodt under 32.72.
23 They receive them-from Mallinckrodt under 24' .Mallinckrodt's Part.30 license, which has a'line item in 25- there that authorizes them to manufacture and distribute to l
1
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105
'l those that are authorized to receive, and that would be a-
/ 2' possession-to-possession license.
13 CPT ROTMAN: Let me try to. summarize, to make.sure l 4 I understand this'. f 5 MS. HOWE: Okay. l 6 CPT RO7 MAN: And, then, I'll give,the floor back 7 to you. l 8 MS. HOWE: Okay.
9- CPT ROTMAN: Part 30 licensees are generally the
]
10 : manufacturers.
11 MS. HOWE That's correct.
12 CPT ROTMAN: And within their license itself, they 13 have line items that allow thent to distribute radiochemicals !
~
14 to people who are authorized to receive them.
15= MS. HOWE: That's correct.
16 CPT ROTMAN: Now, what license do you need to be i s
17 authorized to receive a radiochemical?
18 MS, HOWE: You need a possession license, which l
.19 would be the Part 30' component of the nuclear phamacy
[
20 license. ;
21 The nuclear pharmacy license -- we've actually 22 melded the two together, and so I think that leads to some 23- ' confusion.
24 CPT ROTMAN: Obviously, because you just said the.
25 Part 30 component of a Part 32 license. And --
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1 MS. HOWE: No. The commercial nuclear pharmacy I * .2 license has actually two components. It has a Part 30
\_) '
3 component,.and it has-a132.72 component. !
4 The 32.72' component is what permits them to ;
5 distribute radioactive drugs to-medical users.
6 The Part 30 component is the component that allows ,
~7 the possession of material, the transfer of material from 8 specific licensees to. specific licensees; and in some cases 1
9- also includes-a commercial distribution to users.
10 CPT ROTMAN: So, therefore, you're telling me that ,
11 commercial nuclear' pharmacies are licensed under both 30 and 12 32?
13 MS. HOWE: That's correct.
14 CPT ROTMAN: Okay. Thank you.
() 15 I.think that answers my question.
16: MS HOWE: And that's what Don Cool was talking 17 about this morning when he said we're going to separate out 18 the radiation safety part of it, the Part 30, and we're I 19 going _to handle that under the consolidation program and ,
20 really go back and look and try to regenerate that as 21 risk-informed, performance-enhanced. .
22 But at the same time, we're going to take just' i 23 this small slice of it, 32.72. We're going to supplement ;
24 existing 1985' guidance ---just those things that were dealt >
25 with for the Radiopharmacy Rule, ,
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107 1 CPT ROTMAN: Thank you. I think you answered my ;
2 question..
3 MS. HOWE: Okay. Roy.
4 MR. BROWN Donna, is it possible for a licensee j 5- under Part 30 -- I always thought we were authorized to ship l 6 anything wa wanted to anyone as long as they were licensed t under Part 30 or 35 or 32, 8 MS. HOWE: You also have a very special condition 9 that says "for use in part of tranuf acture and distribution .
10 to those authorized to receive" under Part 9 of your !
1 11- 1icensa.
12 The license is set up -- if you look at the ;
i 13 commercial-nuclear pnarmacy, all licenses are kind of set up 14 the same way. Items 6,.7, and 8 describe the material you 15 can have, its form, its use.
16 And so, somewhere in your list of many materials 17 that you have under your broad scope, you will have certain 18 items that come down into item 9, which authorizes -- it's
- 19. the authorization. And that authorizes you to use the end 20 manufacturer and distribution codes authorized to receive.
21 Now, you also have a license condition in Part 10. ;
22 That license condition in Part 10 sayr that you are not 23- allowed under this license -- the one you can, the broad-24 ' scope -- to distribute to general licensees, persons exempt 25 from licensing.. The old terminology was " medical users."
.(9
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108 i I
- 1- The new terminology would be pursuant to 32.72. Those
{
h>
.s 2
3 require a different license.
MR. BROWN: So, you're saying, this l
l i
4 interpretation, we wouldn't be allowed to ship bulk I-131, j 5 for example, to a Part 43 licensee -- to a commercial f
6 nur' ear pharmacy? l, 7 MS. HOWE: No. You 're. You are, under the Part l 1
8 30.
9 MR. BROWN: Who can we not ship to, a Part 35 l 10 li'.ensee?
11 MS. HOWE: Under'your Part 30, you don't ship to !
12- the Part 35 licensee if it's a radioactive drug and you're i 13 shipping-it under 32.72.
-f 14 MR. BROWN Well, it's not a radioactive drug, ,
(O j 15 ft's a radiochemical.
i j
16 MS. HOWE: Then, you're shipping it as a _
17 radiochemical to the medical user under your Part 30 7
18 license. Because it's not a radioactive drug, so it's not 19 32.72. But it is under your other license, and you are 20 authorized to send it. -
21- MR. PROWN: So --
22 MS. HOWE: It's very confusing.
23 MR.-BROWN So, we can ship both I-131 under our 24 Part 30 broad-scope license to a Part 35?
MR. CAMPER: That's right. You may do.it --
I
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i 109 1 MS. HOWE: That's correct.- [
() 2 3
MR. CAMPER: You may do it, Roy, because you have a condition on your license which grants you the authority 4' to do it. That license -- that part of your license was 5 structured baued upon the organization in Part 30 - '
6- If you're distributing tc 'nedical licensees .
-7 radioactive drugs, that's being done by virtue of the i I
8 authority in Part 32.
9 You have two things going on in that type cf 10 license. A large manufacturer like yourself, you have two 11 things going on in Part 30. You have the radiation safety 12 component of your program, derived from Pat. O. You he.ve -i t
13 just cortain distribution activieles, like the 14 radiochemicals in Part 30, and that's because of a i
, () 15 condition. The other part of it is Part 32 activities.
16 If you look at Part 32 -- let me just try to shed 17 some clarification -- 32 is entitled " Manufacture, ,
18 Preparation, or Transfer for Commercial Distribution of 19 Radioactive Drugs. " - Okay. And that's all Part 32.72 is 20 about.
21 MS, HOWE: And, Roy, you have another license that 1 22 is an MD license. And the MD license is the medical 23 distribution license, which is the 32.72.
24 MR.-BROWN: Right, r
-25 MS. HOWE: And that's how you distribute your
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1 radioactive drugs to medical users. !
) 2 MR. BROWN: Right. But I think we're making this 3 much'more complicated than it needs to be. You know, a
{
4- quick summary would be, any radiochemical can be shipped to l 5 anyone that has a license under Pat 1 30 -- we're licensed 6 under Part 30. ,
7 MS.~ HOWES =Yes.
.L 8 MR. BROWN: Any radioactive drug is shipped under ;
'9 Part 32 to anyone that's authoriued to receive it.
11 0 MS. HOWE: To the medical users. If you're not a 11- medical user, it's being shipped under Part 30. [
12 MR. BROWN: Right.
13 MS. HOWE: In other words, the veterinarians 14 receive it under 30.
() 15 MR. BROWN: That's "hy I said I think it's much 11 6 simpler than we're making it.
17 MS. HOWS: Well, they did . ave -- ;
18 CPT ROTMAN: 'So that how does -- how does a Part i
19 's!. user get a radiochemical?
20 MS. HOWE He has an authorization on his Part 30 1 21 license that allows him to distribute radiochemicals.
22 He has two authorizations. One is for radioactive 23 drugs, and the other is for radiochemicals -- to anyone 24 authorirad to receive it.
25 A Part 35 licensee, if they have a 200 -- a 35.200 i h-\ J' ANN RILEY & ASSOCIATES, LTD.
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. -111, o physicianiand therefore_can prepare, has;the authorization- ,
l2 - ;tof receive 1airadiochemical fi 3m Mallinckrodt. ,
t3 CPT ROTMANi The ..as not clear;at:all'on~the Reg 14; Guide, so'that really.:needs to be made clear.
MS. HOWE: Yes, and we recognize;that.
5 _
6 CPT ROTMAN: Okay.. -
I_have a second question. I !
7 don't understand why we_ have t o have a ~ license condition in'- ,
_ ;, _ _our Part 30 license if.we-can transfer material under.30.41'. >
9= MS. HOWE - 30.41 is -- oh, it was transfer. :
zl0 CPT ROTMAN: Right.
- 11' MS HOWE: You have a -- because not all Part 30 12 licenses have commercial distribution.- And since.you are a 13'- commercial distributor, then you have authorization for 14 commercial distribution.
15 Now, you cannot, under your -- license'es cannot, ,
16 under Part 30,-distribute to general licensees, persons 17 exempt from licensing, or under the medical distribution 18: part of 30.72. So, those are things that are prohibited
.19 under Part 30, and that's why ycm how another license to do
-20 those. things.
21 CPT ROTMAN: I'm getting confused again.
22 MS HOWE: I know. I know, it's -- it is --
23 CPT ROTMAN: Well, what can't we ship'under Part 24 30? I raean - if we want to ship a cesium
- check source to -
.25:
-someone,-I-mean,_we can --
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1h .MS.; HOWES. You'couldLahipLa-cesium check' source.- 1 Nz 7"N j l 2 CPT ROTMANit But;what - .okay, what can't we ship ;
s/ -
q
~3 i Junder-Part 307- :
a ..
-- 4 -- MS.: HOWE:( -Under_Part 30,yyou cannot ship 5" lsomething that=wouldicomefunder 32.72 1 --
g i;p , 6: ~ CPT ROTMAN: -Sure'. >
7: MS. HOWE:- - >to a medical. user, ,
8i CPT ROTMAN: Sure.
9- MS. HOWE . Something.that would:come under 32.74,
- 10
- theisealed sources under 32.74, because those are-also just.
11 to medical users. So, those are~ covered under your MD f
12- Elicense.
13' So, your.Part 30 license essentially distributes
- 14. everything but the MD,:the general,.and the exempt, i 15 CPT ROTMAN: Okay. But, once again, I think it's
-16 very --
.17 - MR.ECAMPER: Well, let meLgive you something to 18- _ ponder, too. It is confusing, I understand. I mean, to 19 know the-intricacies:ofLthe licensing pathway'that falls '
20 from Part 30,-it's not easy.
21- But here's'an interesting thing to think about.
'22 If you11ook at Part~30, look at the complexity of the
- 23 programs:thatLare licensed under-Part 30 -- in this case,.
- 24 manufacturin33----obviously a~very. complicated organization-
~ 25- that; produces many_ radioactive materials and so forth. We f
?
. f'
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113 l 1- ?have done that by virtue <of licenses, license conditions, m.
2; and: guidance.
_(
%. )(
3' The' analogy that I-draw that-comes to my mind is 4 let's take a look at what has happened with broad-scope .
5 licenses-in Part 32.
6 Now, we recently went through and published an 7' advanced notice of proposed rulemaking, where we took a look 8 at modernizing, if you will, Part 33, making it more 9 detailed, and so forth and so on, perhaps subjecting all the 10 practices that we as a regulator have conducted for' years to
'11 issue broad-scope licenses to the sunlight of the rulemaking 12 process. Okay.
13 That generally was met with disfavor. Most 14 commenters said, "No, don't do that. It seems to work the
() 15 way that it is. Why do you want to open this up? If it 16 ain't broken, don't fix it."
17 But what I'm struck by, when I look at the 18 complexities associated with licensing for distributors and 19 manufacturers such as yourself that take place, it's derived 20 from Part 30 -- Part 32 as currently structured -- to my 21 mind set, it begs for clarification regulation. It begs for 22 a revamping of Part 32 to make all this clear.
23 But-I would be willing to bet you if we tried to 24 do that or suggested'doing'that, we'would probably receive 25 -the same type of reaction that we did when we suggested I?%- -ANN RILEY & ASSOCIATES, LTD.
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114
}
L1: modernizing or revisiting 1Part~33. ,
~
You have
--( )- '2 It seems to have worked well for years.
3 the: flexibility that you need to distribute.- I have not
- 4 -- seen a lot of problems from the manufacturers and, of 5 course, radiopharmacists, for that matter. So, if it ain't
- 6 broke, don't.fix it..
7 But-having said all of the above, it is terribly 8' complicated to understand. And I can readily_ understand ,
9 many of your questions.
- 10- MR. BROWN: Yes. Over the years, it has always
= 11~ -been very clear. We really didn't get confused until the 12 , Reg Guide _came out- .
13 [ Laughter.]
14 MR. CAMPER: Well, we readily acknowledge that. ,
D 15 We've got that bullet up there.
1._)
16 MR. BROWN: Well, you do have to make that point 17 very clear.
18 'MS, HOWE: Any other comments?
19 MR. SWANSON: _ Just one question, okay. We 12 0 ' discussed earlier-how a nuclear pharmacy would: distribute a 21 radiochemical in.this part of their practice.
22 You said an interesting thing. I mean,_where 23 nuclear pharmacies have 32 component:and a 30 component 24- ,already as part'of their licensees, would the.30 component 25 -allow-them to distribute radiochemi;als?
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115 ;
1 MS. HOWE - The-mechanism we usexwe'llthave to- '!
L2: .figureLout,-because onlhis:30J11 cense you'reEprohibited_from .
-3 / distributing _32.72. Ifewe had putithem'on the same licensei 14 , - you'd have somethire thatL prohibited- you from doing _it Lthis ' .l 5 way, but-would allow'youLto do something else'another way. l 6 So,- it might be.very confusing -- somethinglwe 1
7' have:to: kind-of discuss. .
8' MR. CAMPERt' The answer to that,-I think, is --
9 .the_ point we-made' earlier, Dennis, when we were talking 4 10 about the fact that -- look at the condition on the-license [
111- /that.says " Preparation and Distribution of Radioactive .;
12 LDrugs - " t 13 1 MS, HOWE:' " Drugs" is already there.
14 MR. CAMPER:' 'Okay, I 15 "---to Authorized Recipients."
16 That's the condition that I was suggesting earlier 17 needed to be revisited for that very reason, the i
- 18 ' radiochemical issue.
19- MS. HOWE: Roy.
20- -MR. BROWN - I did want to mention one other. thing 21 that I was going to hold for this afternoon for the
~
22 philosophical discussion, and that's the question of-the 23- need for a'second license for distribution.
_ 124. -MS.= HOWE: That is one.of our; points-this
!25 af ternoon.- - -
t-
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116 l' MR. BROWN: But I just want to bring that up, and 2 I was holding it for this afternoon.
3- MS. HOWE: Yes. And-it is on our slides for-this 4' afternoon.
5 MR. BROWN- Great.
6 MS. HOWE: Okay. Larry.
7 MR. CAMPER: Okay. Now, that covers, then, 8 DG-0007, comments resulting from the amended Radiopharmacy 9 Rule. Well, it's now 20 minutes until 12:00 -- about 20 10 minutes -- Tony, should we now cover DG-0007, comments other 11 than the Radiopharmacy Rulc? That's what is on the 12 schedule.
13 Yeah, let's do that. Let's go to 0007, comments 14 to this other than those which were derived from the
((h) 15 Radiopharmacy. Rule.
16 And for Mary 's benefit, what that means, Mary, is 17 that when the staff created these guides, these draft 18 guides, we went back and historically brought forth the 19 items that had been in place since about mid-1980s.
20 We made some changes in the guidance resulting 21 strictly from the Radiopharmacy Rule. But most of what we 22- did we brought forth in an effort to try to modernize and 23 get some current guidance on the books.
24 So, what we've done today, if-you'look at the 25 modified agenda, is-we've broken it into comments on the two
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117 l guides-thatiareigermane to adjustments in the guidance
]; <~gv ) resulting from the Radiopharmacy Rule,-comments on the 3: guides that were generally brought _forth not germane-to 4' changes brought about: by the Radiopharmacy -Rule.
5- Now, we're going to talk about that type of 15 - comments for DG-0007. I know that's.just as clear as it_can
~
'7' be.
8- (Laughter.)
9 MS. HOWE: The scary part is~I followed some of 10 it. '
all MR. CAMPER's I know. I saw you nodding in 12 agreement. It's frightening, isn't it?
13 [ Slide.)
14 MS. HOWE: The good news is only have, I think,
- 15. two slides. But they have multiple items on each slide, so 16 it could take us awhile, t
17 - We're going through the general comments. They're 18 not related_to the Radiopharmacy Rule. The very first one 19 is your issue, Roy. And that is: Why do you have to have 20 separate licenses for-distribution and/or possession in 21 manufacturing?=
- 2 2. MR. CAMPER: Well, let me draw one more
- 23. distinction.here for you so you can follow this better.
24 -You'll. note that -- for these general comments now 25 on the, Radiopharmacy Rule-derived, the staff has'not taken a ANN RILEY_& ASSOCIATES, LTD.
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i 118 1 proposed resolution. . Rather, we putLit-out to. stimulate-N f) 2_ discussion, input.
3 "We'will provide clarification,-as.we-go through 4' this discussion, as to what we do' currently and why we do 5 it. Okay.
6' But it's not that we're -- we are not trying taa 7 resolve a comment from a commenter's point', because it's not 8 germane to changes brought about by the Radiopharmacy Rule.
9 Rather,.it's designed, at this point, to share with you the 10 comments, to stimulate discussion. And we'll provide
-11 clarification as.to the process as we go through it.
12 MS. HOWE: And so you should think, on each one-of 13 these bullets, that there's another-bullet behind it that 14 says " Discussion." That's your part.
A ls ,) 15 This particular comment also led to a whole series 16 of comments about "Why do I need instrumentation if I don't 17 possess?" "Why do I need this if I don't possess?" "How in s
18 -the world can I distribute-something if I don't possess it?" ,
19 And when we clarify the distribution part, we'll 20 also clarify the idea that if it stays as two separate 12 1 licenses, that the other license contains the radiation 22 safety program. 'And that is where you possess materials
- 23. where they're -- where Roy's company makes radioactive 24 drugs, where they may make radioactivo chemicals, where:they 25 do all of those processes, c
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i 119' 1J And'I3believe part of the reason for; separating
(lE 1 2- them was1 so}that when you had the distribution license, you.
L/
3 didn't have to1 repeat all that stuff-again.
You had it'in
-4 your_ possession: license,.you described what you were going ;
5 --- to do, and that was global J for your program.
- 6. You didn't have to_ repeat who your' authorized 7 users were, who your radio safety officer was, any of those 8- things on the distribution part.
- It also allows for-9 individuals ~that are only distributors. So, can I'open it .
10' for discussion? Mark.
CPT ROTMAN: I'd like to start with something 12_ extremely basic. The term " distribution" seems pretty 13 straightforward and easy to understand. " Manufacturing" -- r 14 I have no problem with that.
(
) 15 But I am a little confused about what the NRC 16 means by " possession." Can you elaborate a little bit on 17 how the NRC defines " possession" in these situations?
18 MS. HOWE: " Possession" is when you-actually.
19- physically take possession of radioactive materials at your 20 site.
21 The NRC,'in its requirements, will allow you to 12 2 own radioactive materials. If you never take possession,
- 23 you don't need a license for it.. And I think that's a paper 24- type of thing.
25- -There are some things in Part'30 that allow you to f(] ANN RILEY & ASSOCIATES, LTD.
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120. ,
1 Ldo-: things:withoutiaflicense. But.in thosel cases you can't f
- (~'s 1 2J <actuallyireceive radioactive" materials at your facility.- *
(,A 3-- >And possession-also goes along with.use.
4 --- MR.'CAMPERi 'Well, let me draw clarify that'. There 5> .are pathways, for example. 'There are general; licenses
-6 authorized in our regulation whereby individuals may possess .
7 radioactive material by virtue of a general license Et contained in the regulation --: smoke detectors.
9 There are pathways'whercby there are materials
- U) that may be provided to individuals _that are_ exempt from
- 11 2 regulation. Example
- Tritium-gas-filled gun sights.
12 By contrast, if you are goinn to possess-material, 13 possess and use them above those levels of activity, it 1 41 :-requires a possession license. We' call that either a
() 15' 16 specific license or a specific license of broad scope.
Then, that allows you to literally possess the material, to 17 handle the material, to use the material.
6 By contract, if you want to distribute the 19- material -- you now possess it, so you can own it. You can 20 manipulate it. You can turn it-into radiopharmaceuticals.
21 and so forth, turn it into therapy products and so forth, 22: but then you distribute it. You need a license to distribute it.
24 'And the reason that you -- the reason that we have
=25z this two-fold structurefis we draw-a distinction --
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121 1: possessing and-using and distributing Because if you're
(( )
- s,x 12 ' going to distribute-it, we'need to know -- for licensing, 3' .you.need:to actually; distribute it to other individuals. It 4- Lgoes-beyond your own possession. Is that --
5 CPT-ROTMAN Perhaps you need to elaborate a 6 little bit about the difference between possession and use-.
7 Because distribution is pretty clear. Manufacturing seems,.
8 to me,.to be perhaps a subset of use. But they use these 9 terms -- -
11 0 MR. CAMPER: . Well, the distinction --
CPT ROTMAN: -- and-they're not very well defined.
fil-
.12 -MR. CAMPER: What you're really -- let me see what
-13 I hear you saying. . What I hear you saying is, to a 14 radiopharmacy, distribution is use. Is that what you're
'15 .saying? It's-part of your use.
16 CPT ROTMAN: Well, it certainly could be.
- 17. MR. CAMPER: I understand. But -- okay. So, 18 again, why the distinction for a distribution license?
19- Because there are limitations on the recipients of products .
20 that are distributed.
21 And in your distribution license, it's 22 characterized as co what type of recipients receive the 23 distributed product..
24 CPT ROTMAN: Well, if~that's the case, then it's 25 isi<mply--a matter of your terminology being perhaps either
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.122 1 foreign or_ confusing to us._ :
) 2 See, in our world as pharmacists,1we're prettyL ,
3 ' clear-about who we can distribute to and what we can 4 distribute to whom. You can't dispense prescription drugs
.5' to anybody unless they either have a prescription for it or 6 they're licensed to possess them, like physicians or other 7 .prescribers, 8 There are a lot of analogies here. But:when you 9 start talking about possession, it seems that if you're-
- 10 . licensed, it seems hard to believe you could be licensed --
11 ~have'a radioactive materials. license but not be allowed to 12 possess it. I think that's probably where the confusion --
13 MR. CAMPER: I don't understand that point.
14 MS. HOWE: Mark, we actually have four different
(_, 15 basic-types of licenses.
16 There is the possession and use license, which 17 generally has no things at the end of it. And I'm talking 18 about for byproduct material, because there are licenses for 19 source and special input.
20 And, then, you've got distribution licenses. And 21 thty carry little designators afterward. There's the 22- such-and-such G license that allows you to distribute to 23 -generally licensed individuals.
12 4 - There is such-and-such-E license, allows you to 25 distribute-materials to individual exempt from licensing.
'(
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123 ,
L1 TAnd,(then, there's'such-and-such MD.- And~the MD-_allowsLyou' .;
) to distribute /to'medicallusers.e 12 -i ik / i
'3~ Land those: licenses,-the G, the E, .andLthe D,Vdon't
- allow you'to. possess. They just allow you . to distribute 'to1
~
4- _
Si those kinde-of recipients.-
q 6 .And you have a Part 30 license that allows _you to' 7' possess,- And-you can distribute to other specific licensees
-8 --- i.e., non-general licensees,_not-people-exempt,cnot
.9 people _getting - medical users under that-Part 30.
And I think koy Brown is about ready to_put_his I
11 1. ' flag out..
1 24 MR. BROWN: Well, I just want to-say thank you-for
- 13. . explaining that..
14 May~I1suggest that in some regulatory guide at
) 15 some point in time perhaps a description of the various 16 ' types of licenses and the codes that go after them, maybe 17 - with pome-generic examples, would be very useful to us in 18 the regulating community, 19 But I still have to admit I find it somewhat 3 20 humorous that-you1could have a license to distribute but no 21- license to possess. I don't know how you would get it in to 22- get it.back out again to reship it if you weren't allow to 23 possess--it. But I guess it just must be something subtle in ,
24 the language that I'm confused about.
25! MS. HOWES- LYou-end up with.two licenses.
p'[
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.-)
.l 124' ,
IMR. : CAMPER: 'You-can't distribute without a
~
11
[~'Y 2 license, :So, I mean, I don't know:where that comes from. :
-X_/ !
3 - You're going to have two. licenses.: You're going to have-4 -license to possess and use materials, a license to 5= ' distribute them.-
6- CPT ROTMAN: Well, when you-say two licenses, I 7 -understand.
8? MR. CAMPER: Okay. 1 9- MS. HOWE: Mary.
- 10 MS. MOORE:- Maybe there is another avenue here'for-11- nuclear pharmacies. Instead of designating them as two .
12 licenses, couldn't that all be combined under one license 13- and a nuclear pharmacy license which incorporates all three 4
14 of these?
'Q
'l _j 15- MS. HOWE: Well, the commercial nuclear = pharmacy '
16 license is a combined license. It has both the Part 30 and 17 the 32.72 components in the same license, which makes it 18 confusing, then, when we start discussing the manufacturer's 19 side of it.
20 But they do have them together. Because when we
.21 first developed the nuclear pharmacy license, it was "What 22 is their business?" Their business is clearly distribution.
23 They're always going to possess the chemicals in order to 24 prepare. We'll give them one license, because they have a 25 very narrow type of practice. And so we can put that
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t 125
- 1. -together'in one. ;
/y . MS.-MOOREs.: Well,_:what you're'saying, then,--is the
~
l2 _
j 3 manufacturers, because:they_have a broader distribution?-
l 4
4- 'Again;lwhy not have -- see,1I don't see the difference, i 5 really, between the: nuclear pharmacy and a nianuf acturer, 6 MS. HOWE: Well, that's--the topic we're discussing 7_ right now, does the manufacturer need a separate license?
8- MS MOORE: I don't'see --
9 MS. HOWE: Should they_be in one? That's the ,
11 0 [ topic that's up here.
-11 MR. CAMPER:- That's the' issue.
12 MS. MOORE: But I don't see the difference, 13 because'in some cases the nuclear pharmacy, particularly if 114. they're preparing a special radiopharmaceutical, they are
-() 15 the manufacturer. They are taking the radiochemicals and 16 producing a radiopharmaceutical.
17 I really don't see the big distinction between the
- 18. manufacturer and the pharmacy. I don't see why they can't 19 have the same type of license --
20 MS HOWE: .Well, we used to consider 1ML radiopharmacists as manufacturers-because it was NRC's word
~22 -- not FDA's word, but NRC's word. And NRC's word combined 23 ! both what a pharmacist did and what'Roy's group did.
- 24. And as a result of the Radiopharmacy Rule, we kind 25 of split that out,-and we said, "Okay, we're now going to _
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126 1 have.a different word, and we're going.to say, 'What-does
(< j) 2 nuclear pharmacy do?'" Well, they really prepare drugs.
- 3. They prepare radiochemicals. They prepare them from already 4 approved kits.
5 But we'll use the word " prepare" and associate 6 that with the radiopharmacy. And then we use the word 7 " manufacture" to kind of distinguish between the groups like 8 Roy's companies.
9 MS. MOORE: Why do we need the distinction?
10 MR. CAMPER: The manufacturer may distribute to a 11 broader category of recipients than would a commercial 12 radiopharmacy.
13 MS, MOORE: I understand that. I understand that.
14 But can't that be incorporated in one license with another
'[ \
( ) 15 license condition for the manufacturer that gives him this 16 broader distribution? It's still a license to distribute.
17 You're just broadening the recipients.
18 MR. CAMPER: Well, perhaps you could, 19 MS. HOWE: See, that's the issue we're going to be 20 exploring.
21 MR. CAMPER: Perhaps you could. I mean, that's 22 the issue to look for.
23 MS. HOWE: That's --
24 MR. CAMPER: I mean, this --
25 MS. HOWE: That-is it.
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127 1- "LMR; CAMPER:L What we're-describing,-Nary, is'a-27 Ilicensing_ practice <--- !
" 3. 'MS. MOORE: Right._ ;
24 EMR.LCAMPERi -- that has been inJplace-for years.- -j
~5 ' Based upon the distinction'that weve discussed, is-it" 6 conceivable that it could be-reexamined and structured
+
7'~ differently and combine the distribution?
8 MS. HOWE: Dennis.
9 MR. SWANSON: Now, an issue there -- there's a j 10' significant difference in the scope and the nature of 11" operations ofLa manufacturer versus a pharmacy, okay. And' l 12 so-if_you try to do_them all'under one_ license. you know, 13- then you're going to have to break that license out-14 according to the scopes of the operations. ;
() 15 And getting back to another issue, okay, I think 16 -- well, I see this distinction of distribution versus 17 possession. And you have manufacturers that only possess 18 Okay.
radioactive materials tlutt don't distribute them.
19 Now, there are many manufacturers that possess
-20 radiochemicals, radioactive materials, that don't 21_ _necessarily distribute those materials outside of that 22 -manufacturing: entity. So, they_are basically -- and correct 1
23- me:if I'm wrong -- licensed under the 30 possession parts of 24 .the. license. .Okay .-
25 And'that would include you, _as it relates to your >
-O[
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128
~
1 possession.
[ .2 EMR, BROWN:; R&D license. l 3 MR.'SWANSON: Right.
4z Now, you,-as a manufacturer,-have another 5 ' component in that. Now you're going to distribute that, 6 okay. And because of that component of your. operation, you 7 have to has the license condition for distribution, okay.
8 That's my understanding of why it was written that way.
9 MR. CAMPER: It's actually a separate license, not
~10 license condition.
'll MR.-SWANSON: A separate license, okay, to address 12' the distribution part of it. That's -- okay.
13 MS. MOORE: I don't see the big distinction, 14 whether it's two separate licenses or one license with
() 15 licensing conditions that-address those two separate l 36 functions. It's still being -- it's still licensed. It is l 17 being identified as separate licensed activities. Excuse 18 the pun.
19 So the identification and-the acknowledgement of i
20 the different issues is there. It's just you're dealing 21 with one centralized document.
22 I know I had one problem when I was-a radiation 23 safety officer when they going to -- we were_in a 24' transition. And-during the transition, it was:a broad l^ 25 Escope. -The irradiator license had to be separated from the h
i.
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129 1 broad-scope license..
[)1 2.- ;Where logic to me and to the previous RSO who was
- A_/- <
3- :trying toido it was combine it. -You identified on the-4 license. The still have to treat- it the same. But you've ,
5 got it -- you're dealing with multiple licenses. - And on an 6 operational' issue, it's much easier to have a centralized 7 occupant, as long as everything is still identified.
8 tou're not changing the conditions or the-9 restrictions or the permissions. It's just, to me, 10 operationally a lot easier to deal with one document than 11 keeping separate boxes for different licenses.
?
12 MR. CAMPER: Well, I'll tell you why vnt do what we 13- have done-with-it. And there are many reasons, but the 14 primary reason is, is that we have assigned programmatic
() 15 codes to different categories of this activity.
16 MS. MOORE: What type of codes?
-17 MR. CAMPER: Programmatic codes. Program codes.
18- And what that does is it allows us to identify the user 19 ~ categories should we need to communicate generically with 20 that body-of licensees.
- 21. For example, let's take a radiator licensee.
22 Let's say there was some problem with occurred with the 23 radiators. We had-the need to communicate quickly with the 24 radiator licensees. They are assigned a separate program 25- note.
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130 1 MS MOORE: Could I comment, too, that if a
(~)
V 2 problem arises separating -- since we're focusing on nuclear 3 pharmacies and the manufacturers, unless it is strictly a 4 manufacturing issue, which would still bring the nuclear 5 pharmacies, that combining or approaching both with the one 6 license in a category, if you have those categories 7 identified, I would expect this group -- it would be the two 8 groups that you would want to reach anyway.
9 MS. HOWE: Well, we actually have a program. code 10 for a commercial nuclear pharmacy. And if we have any 11 issues that we believe are generic to the commercial nuclear 12 pharmacies, we call that program code up and send it to 13 them.
14 We also have a program code for manufacturing and (m) 15 distribution. And, then, there's a manufacturing and 16 distribution pursuant to 32.72-74. And so we can call that 17 program code up and distribute to those licensees.
18 It gets a little more complicated when you've got 19 multiple program codes per license and whether they're all 20 entered in. And those are logistics. Those can be gotten 21 around. But we do right now have different program codes 2?' for those two, because they have different concerns.
23 MS. MOORE: Understood. But I'd recommend, when 24, you're all reviewing this, look at that issue. I don't 25' think reorganizing or maybe putting an addendum onto a O ANN RILEY & ASSOCIATES, LTD.
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, 131 1, program-code with the computerLwhen you're going to call up:
./ x at differentl times, like it would be that difficult. -But I dJ
.w 2
~ don't-know, 3- t 4 I:mean, you've already broken it up into 5 subcategories now. But if you combine ^it, youLmaybe can 6 eliminate some of this, but you may-not wantLto-is what
-7 _you're saying.
8 MR. CAMPER: -Well, it's. kind of interesting. This 9 is-achieved at a certain point.
10 MS. MOORE: RO h, I'm sure.
=11 MR. CAMPER: -Prior to fees, we didn't hear much 12 about this. Well --
13 (Laughter.)
14- But what it does say is that perhapc, since-these d) 15 are'a real concern, that a revisiting of how we have handled 16 this structurally.
17 MS. HOWE: And with the fees respect, we have a 18- different fee category for the commercial nuclear pharmacies 19 than we do for the manufacturers.
20- And so I'm not sure that one is going to be -- one
-21 or-the other -- the same dollar amount as the other is.
22 MS._ MOORE: Well,_isn't there a basic assumption 23 heretthat the manufacturers and the nuclear pharmacies would
. 24- be given the'same-license? And what we're saying is -- or 25 what-I've been saying is, look at it:and consolidate.
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t 132 I
'l MS-HOWE: _ No. HNo, If_youLconsolidate-thosej it
'I 2- : wouldn ' t istage'. _Your fee structure'wouldn't changed,- '
I[G 3 The consolidation-in this case would be'to delete.
4~ some of Mallinckrodt -- the manufacturer's licenses and put 5 those' authorizations in Mallinckrodt's Part 30 license,
~
6 - MS. MOORE:
So,-the fee for-that one license goes-7 . up . -
8 MS. HOWE: Well -- ;
9- MS, MOORE: I think so, 10 MS. HOWE: -Well, no, if you-have different program
-; 11 = _ codes, you get charged the fees for all of them, even if 12 they're on one license -
13 M R ,. C A M P E R :-: Right.
14- MS _ HOWE: Like, if you have -- a teletherapy is
() 15 separate from a broad scope. But if the broad scope also 16 includes something else that would normally have a fee, both 17- will be charged. But I don't want to speak for fees, la because I never get it right.
.19 MR. CAMPER: Right,
- 20. MS, HOWE: Okay, 21 MR, CAMPER: Yes, 22 _MS, HOWE: Roy, 23 MR. CAMPER: 'Let's not get in any deeper here.
24 -MS.. HOWE: Yes.. Roy, 25 MR.! BROWN: I'd like to address really the 7
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1 133
- 1J valueaa'dded benefitEto aLseparate' distribution license-and a
((x/ '{ 2 stay of. business process 1reengineering andLstrategic 3_ rebaselining.
-4: You.know,=I look at the. number of hours that we ;
5 have into a distribution. license renewal application, and 6 it's hundreds of hours.- And I assume -- I hope it's 7 hundreds of hours for the NRC to review itfon the other end.
8_ But I just don't see'the benefit there -- I mean,_the kind
- 9 -of questions we get back on labeling and on calibrations 10 dates. +
11 That's the same thing we do with the FDA, I mean, 12 we-submit all-this information to FDA, they review it 13 extensively. If we make any changes tas labeling _ or 14 calibration or anything, we file-a supplement, and they 15 review it extensively.
16 The questions that we do get, which is not very 17 many -- but the questions we do get when we file our renewal
-18 for our distribution license are things that are really. ,
19 already being covered by FDA. And I really don't see the 20 value-added~ benefit to having NRC come in and review the 21 same thing-that FDA has really been doing.
22 An example may be the CRCPD. The CRCPD has now 23 set up guidelines on the states that follow those. Where if 24 FDA has reviewed it, that's good enough for them. They say 25' if FDA has-reviewed it for a known product, for example, b\_/ ANN RILEY & ASSOCIATES, LTD.
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134 i
' 1 .- ~t hey' don' t ( need ~ any :additionalDinfortaation. :
LI \ _2:
- MS. SEIFERT: The states don't have to follow the-.- .
ds-)? f 3_~ CRCPD.
4 MR' BROWN:. Well, .I.know.-
. But what I'm saying is ,
5 that statesuthat have--adopted that, it has worked out very :I 6 well .1 So, the CRCPD is comfortable.
7f If the FDA has reviewed it, they've looked atiall i
8 the radiological aspects, -they've-looked.at all the labeling l
9 aspe' cts, they've looked at the chielding. They're-satisfied
'10 that that's a sufficient review. And I would propose the L11 NRC adopt that same policy.
12 MS HOW8: Okay. And that's a slightly different >
- 13. issue. And we'll take it under consideration.
14 MR. BROWN:. Well, I mean the idea of you don't --
) 15 wouldn't necessarily need to have a separate distribution 16 license. You'd roll into your Part 30 license and adopt-17 more of a philosophy of "Well, if FDA has already reviewed-18 it, there's-no need for NRC to go back and rereview the same
'19 -information "
2 0 :. MS HOWE: I think for sealed sources and also for 21- radioactive drugs we review slightly different things than 22 FDA, 23 MR BROWN: ' Oh, sure.
24 MS.-HOWE: Andiso:we would not -- we don't review 25 the: FDA labeling and the package inserts anymore. We used
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135 1' to,Lbut we' don't anymore.
T/ 21 I We- justJ- ,now lif you look at :32.72,-you're just~ [
'\_ 3 !
i3 required to have -- and I won't.get them all:right, but you:
4 just have to identify the radioactive material, its 5 activity, the date -- if it's greater than a hundred days, 6 you don't.have to do the date -- and " Caution Radioactive"-
7 or " Danger Radioactive." And that's all the labeling we're 8 requiring now, where FDA-has a lot of labeling. l 9 MR. BROWN: Well, I guess that's my point, is that 10 FDA_is_ locking at that in detail. And the questions we.get 11 .back really don't make a whole lot of sense, frankly, 12 because we've already covered that material with FDA. So, 13- .we're-kind of rehashing old territory when we get the NRC 14 questions back.
I 15 MS. HOWE: Okay. We'll take that.
16 MR. CAMPER: Well -- yes, let me make sure I 17 understand what you're saying. You're suggesting that the 18- FDA1does, in fact, look at the same labeling requirements, 19 identical to those that we are addressing in our 20 -regulations?
21' MR. BROWN Or more specific, yes. Definitely.
22: MR. CAMPER: Each and every -- I mean, each and 23 -every item that --
24; MR. BROWN: Oh, yes, definitely.
25 MR. CAMPER: Ohay.
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t 136 -
1- -MR. SWANSON: It seems like thislis an ideal area L
W
(
N~/-
): 2 -under your_ memorandum of understanding, that you might want-3 ' t-o get together with the FDA and define;what it is they're
- 4. _looking and what it is you-should be looking at. -And once -I 5 you've defined lthat,_make that'information available to 6 manufacturers.- I think that would be really beneficial.
7 You know, because I've got a question. For ,
8- example, is the FDA qualified ,o look at shielding issues?
9 _Okay. I don't really-think so.
10~ So, you~know, it would be really nice if the two f11 agencies. sat down and defined, based uponltheir 12 ' congressional mandates, what it is that they're supposed to 13 be looking at on these labels and should away with doing a 14 review. And I think that's what Roy is saying.
() 15 MR. CAMPER: Kathy.
16 MS. SEIFERT: It seems like it makes that 17 separation of radiation safety versus drug. And it seems 18 appropriate, as we Roy said, that the FDA focus on the drug 19 issues -- and definitely that would have a lot more 20 extensive labeling requirements -- but NRC focus on the 21 labeling and actually performance-related safety.
22 MR. BROWN: That would help, too. And maybe 23- _another good thing to look at is -- Larry, I'm sure you .
.24 . remember this - only a few years ago we had a distribution 25 license:forLeold kits. These were kits that contained no
/]
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137 1 radioactive material at all.
( ) 2 MS. HOWE: And in part of the Radiopharmacy Rule x_/
3 we switched the labeling from the old days to-just radiation 4 safety-type concerns with the identification, half-life, 5 when it was assayed, that type of thing. So, it is now 6 radiation safety-based as far-as the labeling goes.
7 Mary.
8 MS. MOORE: Is there any kind of communication 9 --when the FDA is doing their_ review process, you do your 10 review. Is there any kind of communication between the --
11 or summary documents going back and forth between the 12 agencies?
13' MS. HOWE: I believe there's communication -- more 14 communicaticn on the sealed-source side of it than there is r~N
() 15 on the drug side.
16 MS. MOORE: But that's something you don't -- in 17 the review, since you're both looking at the same product or 18 organization from a different perspective to help streamline 19 it for everybody, if chere could be some kind of final 20 communication of a review.
21 MR.. BROWN: This becomes even, I think, more 22 critically important as you start talking about the license 23 and some-of our discussions in ACMUI on high-dose-race 24 equipment. You know, those types of things, it's 25 particularly important that the dual review take place (E/ ) ANN RILEY & ASSOCIATES, LTD.
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138 1 simultaneously.
j: J
,,'i 2~ .MS. MOORE:
Especially_-since-the high-dose rates are now becomingfmoreLwidely used.
~
3 It's not just.in :
-- 4 radiation l oncology l departments anymore.
5: MR'..SWANSON: I can give you an example. You 6 know,.one of the issues that_came up in the ACMUI_ deals with 7- some-of these beta coded stents that are coming out right 8 ' now . . And_it was'_ interesting -- I think the NRC, as a valid 9; concern, asked does radioactivity come off the stent? Wel?. ,
10 that, to me, is an FDA concern, too, okay.
11 And some, you know -- I mean, it's ridiculous:to 12 require people to address both. And if that can take place 13: simultaneously, it would be a real benefit to the -
14 manufacturers.
("\ MS, MOORE: Well, that's another side, because
( ,/ 15 16 this whole issue is -- with cardiology driving it, it's 17 = going to be moving _ ahead pretty quickly. And cardiologists
-18 do not' typically, in my experience, tolerate any kind of 19 delay.
20 Well -- but:the issue is they don't seem to 21 recognize that they are doing a form of-brachytherapy. They 22 -just feel it's a stent like any others and can be handled 23 accordingly,-and they're really clueless on the whole 24 aspect.
25 ,
So,-with the FDA looking at devices, nuclear
/~Y E/
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139 1 pharmacy is going to get pulled in, because they're going figure they ic call you guys and you'll supply it. The NRC C] 2 3 is going to get involved. It's going-to be 4 multidimensional, and it should be.
5 MS, SEIFERT: Another benefit to that coordination 6 would be timing of-regulmtory guidance and regulatory 7 changes that need to be nade in concert with release of a 8 drug . I think we experienced that recently with the urea 9 d rug . - If coordinating the information to FDA and to NRC can 10 be done, then timing could be coordinated, as well.
11 MS. HOWE The next one is a slightly different 12 question, and that has to do with application. Oh, Mark-do 13- you still have a comment on one of the last two things we 14 were talking about,.before I move on?
() 15 CPT ROTMAN: Yeah, I would like to say something, 16 in a Jeneral way. The manufacturers that we are talking 17 about that mrke radioactive drugs or radiochemicals that 18 could be incorporated into radioactive drugs is a fairly 19 small number. It may even be an outright small number.
20 They are fairly dedicated in the direction and the purpose 21 for which they manufacture and distribute.
22 It would seem that, for those industries, at least 23 the parts of those industr_!.s that are dedicated to making 24- radiochemicals and radioactive drugs that are going to end 25- up in medict:1 use or in research, that perhaps they could be l-
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... i 140 f l' licensed in a manner that would.give theni one license which l t
2 would be possession, use, manufacturing and distribution, 3 all r< sled into one.
4 Unless I was confused -- and it's pretty easy to 5 confuse me -- when you described nuclear pharmacy license, [
6 you said that there was a Part 30 component and a part 32 7 component in them. I asked, did that mean that they were 8 licensed under both, and you indicated'yes. But then, a l 9 little later, you seemed to indicate that it was one license ,
10 that had components of both. [
11 So I guess, depending on how you describe that :
12 particular unicorn, it's still really one license. I think, 13 _for some of the industry that we're describing here, that-t 14 same philosophy could be applied. e
() 15 16 . topic that you're coming up.
However, once you -- I want to address this next The second part of that is 17 that there is a rather large difference in satety aspects 18 and in handling and in uses -- at the end point and wherever 19' -- between sealed sources and unsealed material. As well, 10 if you remember.from the comments to the Reg Guide, there
- 21. was quite a bit of confusion about what, exactly, is an 22 unsealed and what is sealed.
23 So I think that that's a topic that you need to i 24 -help us out a little bit and have some, perhaps, definitions 25 of what the NRC thinks is sealed and how you're going to
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t 141 1 regulate what you think is sealed, and then tell-us that. J
() 2 3-some of the things that we think are sealed are really unsealed in your eyes, j i
i 4 MS. HOWE: Yeah, and one of Tony's bulleto for !
5 this afternoon does discuss that, because we got more l; 6 comments on the 0006 Reg Guide about confusion in 7 terminology between sealed and unsealed and, also, on the i l
8- 0009. So he'll be addressing that this afternoon.
9 'The next point is whether manufacturers need 10 -separate applications for distribution of sealed sources and i il radioactivo drugs. We state that -- I'll leave that for I
12 Tony. Any thoughts on-that? Roy, do you want to see 13 separate applications, same applications?
14 MR. BROWN: I'm waiting to hear the answer to ,
()
s,,.
15 this. That's a good question, i
t 16 MS. HOWE: Well, we don't have an answer.
17 MR. BROWN: I know.
18 MS. HOWE: We're looking for discussion. I can 19- tell you why it traditionally has been done. ,
20 MR. BROWN: Yaah. I guess I still can't see a
- 21 You know, I don't know why we '
'need for separate licensec.
'22; can't roll all these into one license with, if need be, L23 -licenses conditioned for particular sealed sources of
'4 licenses _ conditioned f or- drugs : or. something.- ,
- , 2 5 -The whole licensing process is very cumbersome if ANN RILEY & ASSOCI?JES, LTD.
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I 142 I 1 you have to have a different license for every -- you know, i
() 2' 3
one broad scope license and then one license for every type of product you distribute. It just seems difficult and I
~
4 awkward.
5 MS HOWEt And I think that will go to an even 6 bigger project under the evnsolidation, how we license. l 7 MR. CAMPER: Oh, yeah. Right now, I mean, the reason we do it is because of the distinction -- you have 72 !
8 9 and 74, 74 dealing with sealed sources. So again, it's ,
10 administrative 1y keeping the licenses separate, program 11 codes dasigned, things-like that. ,
12 MS. HOWE: And it's also an ease in review, too, 13 to make sure that, for the distribution side, for sealed +
n i 14 sources, you have everything that you're supposed to have t
() 15 for those sources, and it's not filing a piece over here and 16 a piece over there, and a piece down here, so they may not ;
17 be recognized. I think, historically, that may be one of 18 the reasons we separated them out.
19 MR. CAMPER: I would agree- ,
20- MR. DROWN: Is it possible to have a tiered type 21 approach, similar to what was discussed in the Part 35 22 meetings, where you have a broad scope license, and-then it 23 you do this, then you have another tier, then you go to 24 another tier, depending on what products you distribute, in 25 addition to having the Part 30 license?
['
\-
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143 i 1 MR. CAMPER: That's possible.
() 2 3
MS. HOWE: That's certainly a possibility.
we exhausted the discussion on that one? Okay.
Have Why can't a l 4 manufacturer specify essential elements for the generator 5 sealed source return program? l 6' MR. CAMPER: Did you skip the one about, "Are ,
7 agreement states similarly" -- -
8 MS. HOWE Oh, Are agreement states similarly ;
9 bound by the FDA-NRC memorandum of understanding? Right !
10 now, we bring in the agreement states through the-Office of 11 State _ Programs in the NRC, but there is no separate 12 memorandum of understanding with-the agreement states.
13 MR. CAMPER: I'm not sure if I understand the j 14 question. "Similarly," referring to what? l
'(}
( ,, 15 MS. HOWE: We have a discussion in there that the 16 FDA and the NRC have entered into a memorandum of 17 understanding with the sharing of information, and we have 18 the mechaniums in place for doing that. We have people that 19 contact given people over in FDA and vice versa. We capture 20 the agreement states through the agreement state programs, 21- but they're not listed by state in the memorandum of 22 understanding.
.;~
23 MR. CAMPER: What did the commenter feel about 24 applying --
25- MS.? HOWE: - I-guess it's sharing of information:and
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i 144 1 -- I'm not sure the commenter.knows what our memorandum of
() 2 3-understanding includes totally, so I can't really say.
MR. BROWN: You know, I think an interesting Roy. .
4 approach might be the difference for a manufacturer, for 5 example, if we were to go out and get a new 6 radiopharmaceutical approved using a by-product material !
7 approved versus using a NARM material. The process w(cid go !
8 through the licensing reviews. The approval process is 9' much, much, much different, and from a public policy 10 standpoint, I'm not sure that makes a whole lot of sense.
11 MS. HOWE: And you're saying because the-agreement l 12 -states do things differently or because NARM drugs go 13 through -- NARM drugs don't go through FDA any differently.
14 MR. BROWN: NARM drugs don't go through FDA any
() 15 differently, right. But the way it's handled by the !
16 agreement states, by the non-agreement states, by the states 17 that do nothing is much different than the way NRC handles 18 it. You know, there are some radionuclides that can be 19 produced either in an accelerated aura -- a reactor -- and 20 that brings in the question, you know, the products would be .
21' identical.
22 Why would you have such a separate review
'23 depending on how the radioactive isotope is manufactured?
24 You know, we've had a lot =of luck with getting new NARM 25 radiopharmaceuticals approved through CRCPD states. That
[
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145 1 seemsfto be a pretty good process that's pretty streamlined._ !
i 2 As I said before, their' approach is, if'the FDA has reviewed 3 it, that's sufficient. !
4 MR. CAMPER: Say you -- I'm trying to understand-i 5 your question -- you had the drug approved?
6 MR. BROWN: The distribution of the I
7 radiopharmaceutical to their state. The drug application, 8 the NDA, went into the FDA just as any NDA would go in. I
[
9 meant the distribution of that radiopharmaceutical into l
10 their state.
t 11 MR. CAMPER: So you're saying the distribution 12 license structure --
13 MR. BROWN: There is no distribution license. If 14 we have a new --
() 15 16 MR. CAMPER:
MP. BROWN:
In some states; right?
Right, i
17- MR. CAMPER: What you're saying is, in some states 18 there's not a distribution license. <
19 MS. HOWE Or for NARM. '
20 MR. BROWN: For NARM. What I'm saying is, if we 21- develop a new, say, indium-based radiopharmaceutical --
'22 MR. CAMPER: Right.
L 23 MR. BROWN: The indium is made in our cyclotron, 124 We get that approved by the FDA, we can ship that to 25 California, for example, merely by the fact that the FDA has ANN RILEY & ASSOCIATES, LTD.
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146 l 1 reviewed it and approved the NDA. We don't have to get a
'( ) 2 separate licensei.we don't have-to file with the State of i 3 California; we don't have to do anything as long as the FDA 4 has_ reviewed and approved it, that's good enough for the 5 State of California. ;
6 A few years ago, we had a new cyclotron-based 7 radiopharmaceutical approved by the FDA. Then we went out 8 to try to got it into all 50 states, and all 50 states-9- handled it very, very differently. Some states said, "Sure r
.10 no_ problem. The FDA has reviewed it. Bring it on in." ;
11 Other states said, "Well, no. We need to have 12 somebody review it. Have NRC review it." And we went to 13 NRC, and we, of course, knew the answer before we asked-the 14 question. Nrc said, "No, we don't have jurisdiction over
() 15 cyclotron-produced materials."
16 Some states said, "Well, you have to get some 17 state to approve it before we'll allow it in our state," and 18 so we said, "Okay, we'll figure out a state to work with."
19 We turned to the State of Missouri. The State of 20 Missouri said, "I'm sorry, we're not capable of reviewing 21 and approving that new radiopharmaceutical."
22 So then we went to the State of Illinois, which 23 was a neighboring state, and they said, "Sure, no problem.
24- We would be glad to review and approve it for you. We have 25 .a' couple of nuclear pharmacies.in Illinois."
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147 1 We talked to the State of Tennessee; we talked to
() 2 3:
the State of Texas. Some states required two states to approve it.before they-would review-it and approve it. On j
i 4- state told us, "Well, you have to have it approved by a 5' state that touches the State of Missouri." [
6 So we went through all.these hoops, and what ended '
I 7 : Up-is that it took us six months to get this new 8- radiopharmaceutical -- that had already been in use in some i 9 states for six months -- it took us that long to get it -
10 approved in all 50 states and then get it distributed in 50 11 states. In my mind, that's not-good public policy, to allow {
12 a new radiopharmaceutical-in one state but not another.
13 MS. HOWE: But if you have another new >
E 14 radiopharmaceutical, you still have to go through the same
() 15 hoops?. Or is there now an overall process?
16 -MR. BROWN: It's getting better. It's getting '
17 better.
18 MS. HOWE Some of the states have decided to be a r 19 little more flexible?
20- MR. BROWN: Yeah, it's definitely moving in.the 21 right direction. We still difficulties in a few states, but 22 it has gotten much, much better.
23 MS. SEIFERT: We've had that same experience, and H2 4 ' to-distribute in-particular states and to distribute across 25 state' lines where:it is approved, states where it's.not
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e rg -r ' , - . - e - +
i 148 >
1 approved. We've also had the same experience with sealed f 2 sources', where certain agreement states-weren't accepting
(}
3 certain sealed sources for a period of time. It's very 4 confusing.
5 MS. HOWE: Tearry, you're in the wrong Reg Guide. l t
6 MR. CAMPER: Well, I was just going to look at --
t 7 in our guide, basically, we do not restrict what they may l 8 distribute. We only say it has to be approved, period.
9 Correct? 'Because-we don't actually review and approve a i
.10. procedure. r e
11 MS. HOWE: No.
12 MR. CAMPER . So I'm hoping there's no restriction
-13 in our authorizing language.
1 14 MR. BROWN: Well, our license has to be amended to
() .15 include'that new radiopharmaceutical before we can ,
16 distribute it -- for by-products, of course.
17' MR. CAMPER: Oh, sure.
18 MS. HOWE: If you're making a new 19 radiopharmaceutical that has the same isotope -- '
20 MR. BROWN: The same as what?
21 MS. HOWE: .The same isotope. You still to come 22 in?.
23- MR. BROWN: By-product?
24- MS. HOWE . By-product. Then you don't have to 25 come in-to us,-fdo you?
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149 i 1 MR. BROWN: Yeah, i I~ f 2 MS. HOWE: Okay. '
(m,/ -
3- MR. BROWN: You mean, say, a radiopharnaceutical 4 using technetium, where we come up with a new 5 radiopharmaceutical using technetium? Yes, we do. ;
6 MS. HOWE Okay. I know the'MA part of it is !
i 7 gone. .j
-8 MR.-BROWN: Right.
9 MS. HOWE: Pharmacies don't need it.
10 MR. SWANSON: And why is that? I mean if you're 11 only; distributing the cold kits, what difference does it 12 make-to the NRC?
13 MS. HOWE No, no, not the cold kits.
14 MR. SWANSON: So technetium is not a good example,
() 15 If you had-an --
16 MR. BROWN: Say, for example, rhenium-186. If 17 we-had one rhenium-186 radiopharmaceutical on our license, 18 if we came up with a second rhenium-186-based 19 radiopharmaceutical, we would get an amendment.
20 MS. HOWE: Okay. ,
21 MR. SWANSON: But your problem lies with the NARM 22 stuff primarily, because there's no central mechanism to 23- approve the distribution of the NARM materials.
L24 MR. BROWN - Well, I guess I'm saying two things, 25 and-it might be what's confusing. We've-had difficulty; (O ANN RILEY & ASSOCIATES, LTD.
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I 1 getting new NARM radiopharmaceuticals approved in the .
- 2 states.
} '
3 MR. SWANSON: Oh. Approved for distribution in 4 the states.
i 5 MR. BROWN: Approved for distribution in the l 6 states. But then, I'm also saying why can't NRC adopt a 7 -program where -- like some of the states do, the states that !
'8 follow CRCPD -- why can't the NRC-say, as long as FDA has 9 ' reviewed and approved it, then we go ahead and distribute
~
10 it?
11 If there needs to be a separate review of just the 12 radiation shielding or something, that would be fine, but 13 the process we go through to amend a license to get a new
- 14. radiopharmaceutical approved is very long and lengthy, and f 1
15 .the renewal of the licenses is very time-consuming.
N~ ,
16 MR. SWANSON: So there netts to be -- actually, 17 what there needs to be at the FDA level is a recognized -- I 18 mean recognizcd by both NRC and states -- review of the 19 radiation safety aspects of radiopharmaceuticals, which 20 would seem to solve a lot-of the problem.
21 RMR. BROWN: Yeah, that would help, or maybe even
' i
-22 'either the CRCPD doing everything or.the NRC doing 23 everything, but at least make it ; uniform.
24i MR. CAMPER: That's an interesting point, because 25- theLlast issue we were discussing,' interface between FDA and !
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l 151 i 11 'NRC, ~is.a lot easier to put your hands'around, because it l
() 2 3
really gets back -- I looked at 32.72 while we were talking.
If you look at 32.72 (a) (4), it talks about f
l P
4 labeling. I mean, "The label must include the radiation 5 caution symbol and the words, ' Caution, Radioactive 6- Material,' or.' Danger, Radioactive Material,' the name of 1
7 ~ the radioactive drug or its abbreviation and the quantity of 8 radioactivity at a specified date and time."
9 Are we going to say, for radioactive drugs with a 10 half life greater than 100-days, the time may be a minute? >
t l11 -1 mean, if FDA were covering that particular labeling' issue ;
-1 12- in its review, then we could in turn put some words that 13 then simply reference review by FDA or something.
14 Now, the latter problem that you're talking about
() 15 is a much bigger problem to get your hands around. It will l 16 require much more review. But the's that's not to say that- l;
- 17. it.can't be -- ,
18 MR. SWANSON: That would be an interesting issue 19 for the NRC to take to the FDA as a memorandum of 20 underatanding, because it's obviously a big problem.
21- MR. CAMPER: I agree, it is a big problem, and'it 22~ is an area that we could explore, ,
23 MR. BROWN: The issue of labeling and calibration J
24 time seems to be a big issue with NRC. Every time we renew 25- our: license or add a new radiopharmaceutical, the whole-j ) ANN RILEY_& ASSOCIATES, LTD.
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i 152 i 1 question of!why is it calibrated for'this data? Why is that f
() 2 3
date on the label? In the-industry, there's quite a practice of cal date versus label date and things like that, !
4 and that is reviewed with FDA, and it's always an issue with 5 NRC, it seems like. !
6 MS. HOWE:- Have-you added any since '95? t 7 MR. BROWN: Yeah. It has gotten better.
8 MS, HOWEt It may also be in a problem that we 9 don't have guidance out for our regions for reviewing things _
l 10 -under the new radiopharmacy, other than --
11 MR. BROWN: That's kind of what prompted my 12 question earlier about how do you communicate to the 13 regions, because it may be a case where it's settled in !
14 Washington, and it may or may not be communicated to the t 15 people doing the reviews.
16 MS. HOWE: And my guess is you'll still have those 17 problems unt.'. we go through tha licensing consolidation 18 program'and we really look at and see what details need to i 19 he there snd what details don't need to be there. My guess 20 is, the details that you currently are asked for, you won't 21 be asked for at that point.
22 iiR . CAMPER: This is an intriguing area because of
{
23 a couple of things. On the regions receiving guidance, we
-24 have not finalized the standard requirements for the regions 25 ~on these changes we're going to be getting to.
The guidance l
p\
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i i
153 !
I 1 is what's first, and out of that the standard requirements l
() 2 3-evolve.
But-if I step back for a moment and look at this l
}
4 issue of the drug labeling, most of us have been around long l i
5_ enough to go back to the days when the NRC was the reviewer !
6 for- radioactive drugs. Then that moved over to the FDA in l 7 1975, I believe. Then you look at the movement that took l i 8 place with the Radiopharmacy Rule in 1995.
9 It may well be that the next step in this ;
10 _ continuing evolution would be to more closely communicate ;
11 and interact with FDA and make sure that, look, if the l
12 Nuclear Regulatory Commission has concerns about ;
i 13 radiopharmaceuticals or radioactive drugs in terms of :
14 labeling or shielding or issues that you're looking for,
() 15 either the FDA would do that or we would do it, or we can 16 share technical resources if need be, so that, ultimately, 17 this whole process would be smoother.
18- We've been working on this for 25 or 30 years now, 19 and it may well be that's the next step indicated in the i 20 continuing evolution. This is really a very intriguing 21 comment, actually.
22 MR. SWANSON: I would bring the CRCPD into that at 23 the_same time, also, to address the NARM issue. We might as 24 well do that at the same. time. That, I think, is a bigger 25_ problem.
i
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154 ;
1 MR. CAMPER: I think it is. I agree with that !
2 point totally, Dennie. My observations of the conversation 3 -- including some of the ones here at the table -- have been 4 .that what the states are doing now is really quite variable.
5 For example, the Radiopharmacy Rule changes that 6 we put in place in '95. Some aspects of that were item 7 compatibility. There are literally still states that issue 8 licenses for each and every radiopharmaceutical. Still- l 9 Maine, specifically. l t
10 So a lot could be done, perhaps, and maybe the [
11 CRCPD, you're right, has a very crucial role to play in that ;
12 procean. It's all over the place. It really is. It must ;
13 be terribly difficult for pharmacies, for the manufacturers, ;
14 particularly.
15 MS. HOWE I would also like to point out that 16 32.72 also recognizes you could be registered with a state 17 as a drug manufacturer now. I think we've only seen one of 18 those, and he really looked more like a pharmacy than 19 anything else. So we don't have a lot of experience on-that 20 aspect of states registering drug manufacturers and states 21 registering drugs to be manufactured, so we'll keep that in 22 mind, too. .
23' MR. CAMPER: Do you have a comment, Mary? '
24 MS. HOWE: Mary.
25 MS. MOORE: Yes, I do. When I read this, my l
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i 155 1 impression was the question ~that agreement states, what came 2 out at the Part 35 wcrkshopj there was a clarification in 3 that'the agreement _. states' regulations have to be compatible j t
-4 with -- I was always under the impression it-had to be ;
5 equivalent to the NRC. j 6 MS. HOWE: No.
7 MS. MOORE: They just have-to be compatible.
{
8 - MS. HOWE: And there are levels of compatibility. :
9 MS. MOORE:- Well, that figures, because it l
?
.10 wouldn't -- nothing is simple.
11 MR. CAMPER: Mary, it's actually compatible and
-12 ' adequate. [
13- MS. MOORE: Compatible and adequate.
14 MR. CAMPER: Two_ categories, compatibility and 15 adequacy.
16 MS, MOORE: Well, one of the topics that came up i 17- was OMP. Should the agreement states have to follow it? My 18 knee-jerk reaction was, if we in the non-agreement states
- 19. have to, then they have to.
-20 That was this independence of the states, the 21 ' agreement states, since they-do have this range for 22 independence, that was my interpretation of this. Just 23 because the NRC and the FDA have a memorandum of 24 understanding,. that does .not carry over tc, the agreement
~
25- Latates, because_they may not;have agreed to it.
+
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156 i
1 MR. CAMPER: That's correct. Most of these l
() 2 3
particular things that we're discussing right here -- what happens, when we create a regulation, the Commission assigns ,
4 to it a level of compatibility. It can be variable.
5 There used to be Divisions 1 througn 4. They now 6 have gone through a recent change because of a change in our 7 compatibility policy. They're now identified by a different 8 nomenclature.
9 But the idea is that there are certain things that 10 you would expect states to do, as the old Division 1 11 compatibility, which meant, for example, definitions had to 12 be verbatim.
13 Division 2 carried with it certain encumbrances 14 upon the state. You had to have something to address it
() 15 that had to ha at least as stringent or as much of a 16 requirement as licensing or guidance as opposed to 17 regulation.
18 And then it went on. Purther on down the scale, 19 it was relaxed more and more. The Quality Management Rule 20 was an item of compatibility. It was both Divisions 1 and 21 2, as I recall. Definitions were 1, and the actual 22 implementation requirements to put in place a OM program 23 under 35.30 were a Division 2 item of compatibility.
24 States were supposed to do that. They had three 25 years to do it. States were provided flexibility on that
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L 157 1 timeline for that particular Rule requirement, because it
()
2 was so terribly controversial.
3 A number of the agreement states did, in fact, put l 4 it in place, and some did not. A few did not. I think on 5 the order of, like, nine or ten did not, because they were 6 so vehemently opposed to the concept of imposing it upon the 7 medical community.
8 MS. MOORE: Well, this raises the issue, that 9 whatever the FDA and the NRC agree to do, the states retain 10 the right not to go along with it -- the agreement states. ,
11 The non-agreement states, unless you have it as a licensing 12 condition or a regulation, will probably opt for their own 13 independent review, which is not going to get anybody any 14 further along with the cooperative and streamlining efforts. !
() 15 I know that when paladium went under the state 16 regulation, at least New jersey, they bent over backwards to 17 facilitate the adoption for the licensees who were using it 18 and needed to switch it from the NRC license to the state 19 license. That was facilitated.
20 But on the review of the drugs and all, I don't 21 know how the state -- and I should know this in New Jersey 22 -- but how they go through it, whether they're streamlined 23 or not.
24 I do know that the Commission on Radiation ,
25 Protection for the State of New Jersey strongly defends
-- /
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r 158 j 1 its area of writing the regs. They strictly and strongly l 2- step back and look at, just because CRCPD has agreed to do 3 it doesn't mean that-the Commission will adopt it and will ;
4 draft their regulations accordingly and will recommend to j 5 the state commissioner to go along with it.
6 But the CRCPD is apparently, from what I'vt seen i 7 able to determine, the only centralized group for the !
8 states. So, based on the discussion we heard this morning, 9 be it agreement states, non-agreement, this CRCPD is another 10 mechanism, the NRC can communicate with the agreement :
11 states. This gives them another mechanism to look at this !
12 whole streamlining issue, and if the FDA joins the NRC, then .
13 I can see how the streamlining could be affected very well, 14 Dut isn't there something~-- I don't know if it 15 goes back to the Atomic Energy Act or whatever -- that 16 delineates areas that you folks are supposed to be looking 17 at, versus the FDA? If you transfer over to the FDA all of l 18 the radiation safety reviews for new radiopharmaceuticals, :
19 are the waters getting too muddy? {
20 MR. CAMPER: Well -- the answer to you -- we have 21 a very broad mandate under the Act. What has happened over 22 time with regard to radiopharmaceuticala and radioactive 23 drugs, we have increasingly passed that responsibility to '
24 the FDA. As I said, we used to literally review 25 radiopharmaceuticals. That was transferred to the FDA. ;
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159 l 1 We used to use what's now the Advisory Committee ;
2 on Medical Use of Isotopes -- it was another name in those
]
-3 days which I' don't recall -- but what we had done is we --
i 4' and we did that because, clearly, as far as the NRC was ;
5 concerned, the FDA was better suited to do that. ;
6 And then, gradually, what has happened over time r 7 is-that, in addition to the actual review and approval, 8 we've entered into a memorandum of understanding. We're 9 trying to find ways to avoid dual regulations.
-10 I think what's intriguing about the comments this !
11 morning, though, is that, while we can sit here and, 12 hopefully, give a reasonably intelligent, logical reason for 13 why we have the licensing structure we have, it is 14 increasingly clear, certainly, to me that there are areas of 15 duplication between the two agencies.
16 But on your point, Mary, though you are right in 17 the sense that, though the CRCPD is an extremely important, 18 valuable organization -- it does an awful lot to try to -
19 pursue consistency among the states -- of course, 20 ultimately, the otates may or may not choose to embrace 21 CRCPD's suggeuted approaches. They are, in the final 22 analysis, only two-fifths of the question, and they do it ,
23 varying degrees.
24 I don't know.-- I mean, in the perfect world -- -
~25 and I've.had this discussion with a number of you around the ANN RILEY & ASSOCIATES, LTD.
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160 {
1 table over the years -- in the perfect world, we would have
- 2. a consistent approach in this country to all these issues. [
3 But our government structure, we have-50 states, and 50 ,
4 state jurisdictions, the federal government. I imagine they 5 started this discussion at the Constitutional Convention, 6 acttially. This is a carry-on. l l
7 I don't know if we'll ever get consistency, but to 8 the extent that we can talk.with the Organization of I 9 Agreement States, that CRCPD can talk to other federal 7
- 10. agencies and try to put some sense into all of it, then we i
11: should do that. I think it's incumbent upon us to do that.
12 I don't know if we'll ever get there or not, but we can_ !
13 .certainly take steps in the right direction. Progress, if ,j 14 not perfection. l 15 MS MOORE: Well, now, with the increased f
16- communication between the FDA and the NRC, you're going to 17 end up streamlining it. The'CDRH, which is focused on the 18 .X-ray equipment -- and those guys will kill me for bringing 19 this up --
20 MR. CAMPER: Right. ;
21- MS. MOORE: --but they'have the expert se. They 22 _have health physicists there, and they have medical 23 physicists. So they do:have the technical expertise to do 24 :the review. They used to years ago. I don't know. They've -;
25' been spread out so-thin, I don't know if they do_or not.
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161 ;
l' But it's, again, the mechenism for increased -
-x .
(s/ ) 2 communication and avoiding duplication. If you could just l i
3 avoid a percentage of the duplication, I think the 4- manufacturers and the pharmacies would give a big sigh of ;
5 relief.
6 MR. CAMPER: Yeah. Point well made. Mark 7 CPT ROTMAN: Yeah, I want to ask something. It 8 you need a license amendment to distributs-a new radioactive 9 drug, I can understand to a certain degree that aspect of 10 it. Are there any regulations or guidance, any documents 11 that clearly lay out the requirements, from the radiation ;
12 safety point of view, for the NRC to give a license
~
13 amendment for a new radioactive drug?
14 Now, I understand that the FDA approves the
) -15 radioactive drug for distribution nationwide. I understand 16 that there are DOT regs as far as shipping. There's Part 20 17 that describes a lot of radiation safety issues.
18 But is there some main document you could go to.
19 and say, "Okay. We've got FDA approval now, and here's this 20 long checklist of all the things necessary to get NRC
- 21. approval of this document"? Because, after all, ionizing
- 22. radiation is ionizing radiation, whether it comes from 23 by-product material or from NARM material.
24 It would seem to me that if there was a central 25 set:of regulations-or.a central set of-guidance that was
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162 l 1 agreed upon by all to get this license amendment for a new l 2- ' radioactive drug, that that could be used as the stamp of 3 approval from a radiation safety point of view-to take to l l
4 all 50 states or the agreement states and the non-agreement {
5 states and Lord knows what else may be the provinces that f 6 you might distribute to.
l 7- Can you elaborate on that a little bit, or am I l
8 just having some sort of hallucination here? !
9 MR. CAMPER: Well, when we go through the process 10' of adding another radiophamaceutical, and given that it's ;
11 an-approved radiopharmaceutical at that poind, our concerns 12 are primarily twofold.
13 One is accountability as to what is being 14 distributed. We have felt, as an operational parameter, 15 that it's appropriate to know what we are authorizing 16 distributors -- in-this case, medical distributors, but it 17 would be true for non-medical distributors -- what it is ;
18 -that we're authorizing them to distribute.
19 We could have concerns, from a radiation safety
-20 standpoint, in terms of handling, storage and use of these 21 materials that you would need to know as you go about i 22 . authorizing, but it's more about, in the case of 23 radiopharmaceuticals, knowing that it is, in fact, an 24- approved radiopharmaceutical and accountability of what's ,
25' being distributed.. i e
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163 i
1 Now, the_only way that we ever impose anything !
() 2 upon agreement states is through the compatibility ;
3 regulation. That is met with mixed feelings by the states. l 4- Generally, it's fair to say that agreement states are not I 5 partictlarly warmed by the idea of compatibility. It has l
6 always been an area of contention between agreement states l 7 and NRC.
8 There are many reasons for that, and many of them ;
9 are legitimate on behalf of the agreement states, because 10 they have a different process than we do. We have five i 11 commissioners; we're a fedecal agency. They have to deal i 12 with state legislatures, different administrative i 13 procedures. It's not just that they don't want to go. It's !
14 a very complicated political situation. [
O' 15 But we don't, then, in turn, have any mechanism 16 whereby we can put in place some guidance that we might use !
17 for accommodating this process that you're referring to that ,
18 then, in turn, the state could use. They might opt to uke 19 it, and some do use the process and our guidance. Some tune 20 variations thereof. ,
21 But again, I don't know if we could ever [
22 voluntarily get to a consistent throughout all 50 states and l 23 federal ptrisdictions to conduct the type of review that 24 you're referring to.- I don't know. I just don't know how ,
25 we would do that.
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t i I think that the best mechanism we-have, and I 2 . think it's something that, certainly, it's fair to say -
, that 3 - the NRC is increasingly trying to'do over the last several 4 years, is to enhance our communication with the CRCPD and j 5- with the Organization of Agreement States, recognizing that .
6 we have ditferent approaches to regulation, recognizing that I
-7 we have different jurisdictional issues, we have different !
8 administrative and legal structures. f 9 I do sense, though, that there's.a growing effort +
- 10 amongst all these players to try to communicate more in the 11 common interest and good of standardizing and making 12 consistent as best we can. But ultimately, most of it is !
13 still a voluntary process, and certainly in the context of I
-14 guidance, which is where I think you are. -
15 CPT ROTMAN: Can you address the issue of guidance 16 a little bit? You've talked about the mechanism, but is i 17 there someplace that someone could go to get the guidance so 18 that ---maybe Roy would like to see the guidance so that he 19 - knows that he has checked off every box and that he can take 20 this fulfillment of guidance to each of the individual' 21 - states and not have to reinvent the wheel.
22 MR CAMPER: - Mark, the guidance that we use in ;
23 going.through our review process to add an additional
- 24 . radiopharmaceutical to a distribution component of a 25 - manufacturer's license is available. It is available.- It ANN RILEY & ASSOCIATES, LTD.
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i 165 1 focuses upon those two or three key points that I made, but ,
.f
() 2 3
it_is certainly available.
document.
It is a publicly available l
4 MS. HOWE: It is the document we're reviewing. ;
- 5 MR. CAMPER
- And it is mostly the document that i
6 Ot're reviewing.
t 7 MS HOWE It is the FC 406-4. '
-8 MR. CAMPER: 406-4. ,
9 MS. HOWE That's its function. Do we still have
.10 questions over on this-side, or comments? Kathy.
11 MS. SEIFERT: I don't have a question, but I just !
12 have a comment. I think that -- I'm not here as a pLtient 13 advocate. I'm here as a nuclear pharmacist, but as a 14 nuclear pharmacist, I also feal compelled to advocate for
() 15 the patient.
16 As a patient, when a new radiopharmaceutical comes 17 out -- and no Roy described, it might be available in some [
18 states and not in other states -- I would have a hard time
- 19. understanding why I couldn't receive a particular 20 radiopharmaceutical that was approved by the FDA. -
21 I happen to live in Florida -- or whatever state 22 it is. I guess Florida hasn't stood in the way of that as 23 much as others. But I would have a hard time understanding 24 why an.FDA-approved radiopharmaceutical would not be 25- available to me just be;ause I lived in a particular state.
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I 136 i i So, to me, that's a compelling' reason for congruency. !
() 2 3 one.
MR. CAMPER:
We are a diligent crowd.
I note that it's almost quarter to I am proud of you. Let me l
i 4 take Dennis's comment, and then I suggest that we break for :
1 5 lunch. Let's try to keep it.to a half an hour and then come ,
6 back, and we'll continus. Dennis. l l
7 MR. SWANSON: All I really have to say is I think ;
8 it's important that the Organization of Agreement States, !
9 CDR -- whatever it is -- and the NRC do work out soma kind R1-0 of working relationship with the FDA.
11 You know, a lot of the reason why people want 12 regulation of radioactivity at the state levels, they thinh 13 they have more voice in it. Well, to me, that works the ,
14 other way.
() 15 If you've got central agencies that have a policy, ;
16 and the states aren't abiding by that, and that state's 17 policies are restricting access, then it's up to the people i
18 in those states to go to their state people and say, "Look. ,
19 National organizations have a good };, icy here. Why aren't 20 we complying with it?" I think that's the way you address 21' the problem. So I think that it's important that you do 22 that.
23 MR. CAMPER: Thank you. Okay, let's break. .
12 4 (Whereupon, at 12:00 p.m., the meeting was 25 ~ recessed, to reconvene at 1:00 p.m., this same day.]
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-167 1 A~F T E R H O O N SESSION
[)
'V 2 (3:00 p.m.)-
3 MR. CAMPER: All right, Donna-Beth, where were we?
4 MS. HOWE: The next comments was, "Why.can't the 5 manufacturer" -- and the next two are really kind of 6 . parallel. In other words, "Why can' t the manuf acturer just 7 specify essential elements for the generator return or the 8 sealed source return?" Well, no, they're not quite the 9 same.
10 So it's a question that we have a lot of detail in 11 the generator return part and the sealed source return part 12 on what licensees have to be informed about as far as 13 packaging and shipping and those types of things, and they 14 want to know, well, can't we just add some elements and not
() 15 go into that detail? That's the gist of the comment. Roy 16 MR. BROWN: I just have a general comment. I 17 always would like to see NRC be less prescriptive and maybe
-18 go with the concept of this is a broad-scope license and, 19 theoretically, these guys know what they're doing, and 20 consequently, we don't have to tell them every step that 21 needs to go into a generator return program.
22 I guess I always opt for less prescriptive 23 regulations and maybe let the broad-scope license operators 24 have broad-scope license and give them a little bit of 25 latitude.
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+ 1 MS'. HOWE:: Yeah.
- I- think, u in - this - raepect,
- the I iO f
A. ,1 121 : detail'is;not necessarily'because you're broad-scope, but. f e
because-we think the/ people:that are sending them_back'to 4- -you may-not be as experienced. -But. good-comment. Any other- ,
t 5' .commentsLon this issue?- Mary.-
6 MS. MOORE: 1 Real quick, following up'on-your l 7- (comme at, _anythingL dealing with. shipping and DOT regs is 'a 3 real. weak _ area, I think, infeverybody's program. Everybody-9 has copies of Part'20 and 19 and 30, 32 -- whatever - -Title 10 =10. But the: DOT' reg issue and acquiring those regs and
- 1 11 knowing which ones are appropriate, to me -- I don't know if
'12 l the pharmacies have that problem, but I know hospitals-do, 13'
~
so the information-to the recipient on how to ship it back - .
14 to you, any information youzcan give the licensee,
() 15 ; broad-scope or whatever, is always-appreciated.
16 14S. HOWE: I-think the comment is, if we-can just 17 list {our elements -- just tie us to the. elements; don't tie 18 us'to the details.
19 MR. BROWN: Real_quickly, what all the
{
9.0 ;manuf acturers ch) -- I know-Mallinckrodt does this, and I've 4
21 :- seen DuPont, Merck's and Amersham's. programs, too. All.the -i; 12 2 . manufacturers'have'very specific instructions to the
~
'23 _custouers.
'24; Most'of them: include-labels and all the: paperwork lin a1veryfdetailed,Jstep-by-Ftep.ihstruction on' exactly how
_2 5_
a -
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I 1169 il to:do it to follow the DOT-regs.- So_the manufacturers try; Lto go out of their way to_make'sure it; stays simple for thel
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3 (hospital.
{; 4 MS.-HOWE: .The-nextione is, "Why should a 5 manufacturer specify the anticipated-_use of sealed sourcas 6- if they're included in the Sealed Source and Device 7- Registry?" They're saying that the use is already included i 8 when NRC or an agreement state does the bealed source review ;
9 and puts it into the. registry, so why do we have to repeat 10 _it? Any comments?
11 'MR. CAMPER: .W hat context was the question asked?
12 MS HOWE: We asked them to specify the use of the 13 sealed sources, and they said, "Well, why do we hava to do 14 this if we already do it in the registry?" I think it was
. .r
( 15 primarily to cover those that haven't gotten to the registry 16- yet, and we also want to make sure that they're distributed 17 for a use that.was covered in the registry. Well this is 18 looking pretty good.
19 [ Slide.)
20 We probably misstated the first one. The comment
- 21. was that, in the sealed source device, in the sealed source
-22 . return, we also have an area on waste management, and so L23 they; wanted us to make a comment in the waste management 24 that the returned' sealed sourcer weren't characterized as-25 waste. I believe that's what they wanted. In some cases, ANN RILEY & ASSOCIATES, LTD.
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170 1: they will be waste; in other cases, they won't be waste.
(\
.( ! 2 Any comments?
% ,/
3' MR. BROWN: I think that's an important 4 distinction. I'm glad you recognize that. Especially with 5 generator returns, too. I mean, clearly, those are not 6 waste.
7 MS. HOWE: The generator returns are not waste?
8 MR. BROWN: They're not radioactive waste, no.
9 MS. HOWE: Don't you handle them as radioactive 10 waste? In other words, you separate out the column from the 11 rest of it and handle that, but then you ship the rest of it 12 back.
13_ MR. BROWN: Yeah. I mean we're getting into the 14 definition of radioactive waste. They're not shipped back (n _, 1 15 as radioactive waste is what I meant.
16 M9. HOWE: Oh.
17 MR. BROWN: Once they get back to the 18 manufacturer, they're broken down and the columns end up 19 being radioactive waste, but they're not being shipped back 20 as radioactive waste. That's an important distinction with 21 the compacts and the restrictions on radioactive waste 22 -leaving a particular geographic compact.
23- MS. HOWE: So what ycu're saying is they're just 24 shipping it as radioactive material.
25 MR. BROWN: Returned goods, right.
,n
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- 171~
i l'
^MS.! HOWE: =Because'yoularen't a: waste' broker,. so
,e .
- [a 3 2
- you don'tiwant'to even have anybody.put'those words near. ---
s I)- :
l
<3: your name at all.
4 MR._ BROWN: Exactly.;
5 MS HOWE . Okay. :IJthink we: understand the-6 comment a little'better now.- ,
7: HIf no waste _ management,is required, does that mean
.8- Ja licensee is rolelyoa broker?- Well, the reason you don't; i
9: have-waste managementiin the-regulation is because it's not-10 _a possession license, and so any. waste management questions:
11 would be handledcunder the possession license. So that-area -
-12 is put'non-applicable so the licensee knows they don't-have 1; to submit ^their: waste management; program for this particular 14 distribution license. It.does not mean you're a broker.
- 15- 'Any additional comments? This.is good.
16 I thought that we ought to be addressing-imports.
17- In other words, when you're importing radiopharmaceuticals 18 or you're importing sealed-sources and then distributing.
19 Roy, do you have any comments on this one?
20 MR. BROWN: If:you did address it, what would be-
. 21 - the extent of it?-'What would be-the scope of the-22 ' regulations? I'm not sure. what 'chey're askir.g. f;e here. I 23 can understand imports, but I can't understand how NRC would 24' ' regulate..those' imports.
"2 51 -lMR. SCAMPER: Was the commenter more specific?
1 . -
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f 172 1 MS. HOWE: I don't have the comments with me right 7.
( 2 now, but lLt was essentially, we didn't address how the J-3 manufacturer's going to import sealed sources or import 4 radiopharmaceuticals and then distribute them -- if you're a 5 distributor, and you're importing the materials.
6 MR. BROWN: That would be different from your 7- normal distribution license? I don't understand the 8 question, I guess -- by the commenter.
9 MR. CAMPER: What steps are involved in that, or 10 what is the regulatory process with receiving imported 11 material? I assume that's what the commenter meant.
12 MS. HOWE: And maybe when we go back to look at 13- si t , we'll see if there is a place in there to talk about 14 distribution of products that are received from overseas and p
1 ,/ 15 then distributed out, the 32.72.
16 MR. CAMPER: I mean, for example, do you need an 17 import license? I think that's the pertinent p, nt.
18 MS. MOORE: An import license to import 19 radioactive materials?
20- MR. CAMPER: From abroad? Well, there are import 21 and export licenses.
22 MS. HOWE: Some things can be imported and 23 exported under a general license, too.
24 MR. BROWN: - Well, most of the things we're talking 25 about are exempt from those import and export liccnses, ANN RILEY & ASSOCIATES, LTD.
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173 21 aren'tLthey?: -
'21 MS. HOWES. I thinkLso. i 3' ~MR. BROWNii _I1mean-the quantities-and the types of 4- i materialsi l L
5 MR. CAMPER:" I;believe so, but perhaps-the
~
u- 6. commenter-is trying to better understand how that process 4 7- works and is suggesting that guide could have more?
~
8 Linformation about'it.
9 MS. MOORE: Well, I know we also issue ---if.a 4
.10' forei~gn country wants to import'a source or something into 11 -the U.S.,.they have to have somebody in the U.S. --
12- MR.-CAMPER: As a distributor.
13- MS. MOORE: . -- holding a license aus a distributor.
14 .Maybe that's what-they're_getting to here.
() 15 MR. BROWN:_ I'm just not aware of any problems the 16 .w ay the regulations are written now, is the best way to
-17 summarize it.
.18 _
MS. HOWE: The guide is for, distribution by-19 manufacturers only. It should address distributors who are 20 not manufacturers. _In other words, someone that's just 21- solely a distribut .., didn't make.the product initially. So
-- 2 2 - rI think we can look into that. Any comments on it?
.23 MS. MOORE: Aren't the nuclear pharmacies often in 12 4 .that role of distributor only, rather.than manufceturer?-
- 25 MS.' HOWE: --But that's a different Reg Guide. This v
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y 174 1 -is~a comment?that's based only,on the= manufacturer Reg .
.g):
(-
=
2- Guide. This is another question aboutrif you don't possess, 3 why do we have instrumentation requirements?- And that's-4 because-32.72 does: address,-you_shall have instrumentation.
'5 for the measurement of. >
~ 6 -. MR. CAMPER: This is another variation of the same 7 issue discussed earlier.
8 MS. HOWEr' Yes, it's a variation of the same 9' issue, except for, in this particular case, we really do
- 10. :have a requirement in 32.72 to have instruments and
-: 11 procedures, where the other one was more global about how 12 can.I pos0ibly distribute if.I don't possess anything?
13- This one was a comment that, instead of providing 14 detailed information on the shielding -- I think Tony has a
,. 15- similar question from the radiopharmacy in the 0006 -- why 16.- do we have to provide all the shielding for each vial, 17- syringe, container? Why can't we just give a surface dose 181 rate so-that you could meet a surface dose rate, but you
, 19 'could change the shielding?f It would be more flexible. I
- 20. see-I have multiple flags.
21- MR.-CAMPER: Mark was'first.
- 22. MS.--HOWE . Mark.
23 MR. CAMPER: -Kathy, then Mary.
24- CPT ROTMAN: I know that I was involved in some of 25 the commentary on this subject.for.this Reg Guide, as well A
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175 11 fasl0006.
2- It's~probably not the place,:at;this-workshop,-to get~into a.wholeL-lot'of detail, except;to_say-that suppliers 4: ofilead and oths; factors.must be taken:into account when
-5' -you'refdealing with shipping and shielding, so that if you 6 lock;yourself intoJa certain configuration and-thickness 2and
?
7 alloy concentration of lead,_ you really.have reduced your 8- . flexibility dramatically.
p '
-9 The issue in' radiation safety should be the_. dose-11 0 that can be achieved, the dose that someone might receive in 11 handling this particular shielded product. It shouldn't be 12 in the actual nuts and bolts of how the shielding is 13 designed.
14 As long as the performance aspect of it is the
() 15 same at the end -- meaning that the dose rate is kept to a 16 certain specified amount -- the licensee should be allowed 17 to use whatever they to achieve that. That gives them the
- 18. flexibility to go with different economic conditions, 19- different suppliers, as needs may be.
20 So I would say that you should set a dose rate for 21 the surface of the package or the final container, and how 22' that's achieved is_ immaterial, as long as it is achieved.
23- .MS. HOWE: And so you see-the-dose rate as being a
~
~
2 4 -- more1 flexible approach than going.back with the shielding, 25c ;even'though-shielding can then be used to calculate to get'a
~ -
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-176 12 Ldosel rate?
2 'CPT ROTMAN: - Well', I would.say_yes,-I think thatia
~
~
3- dose; rate-is more flexible. .But unless.;you get-righi down 14 'to-determining-the' method of-casting-and the actual Sz _ concentration'ofilead in the. shielding or the metal .
6J ;compositionfin tha--shielding, youican't;just assume._that n '7: it's pure lead and-that it's going to have_a certain ;
8 attenuation factor _per millimeter.
9: If you do that, you could-be grossly. wrong, 110- depending on how'well it's-casted.and a number'of other-l 11~ factors - So I would say that the most important thing isi ,
-12 the dose rate and not how the shield is-constructed.
'13L MR._ CAMPER: Kathy was next.
14 MS, SEIFERT: .I agree. I think this_is a perfect
(
~
15 opportunityLfor NRC to go toward the performance-based
'16; -analysis and look at the dose-rate instead of a specific 171 -shielding,-specificLpackaging. You could change the 18 packaging on the inside, make the box larger. You could 19 have different packaging.-
. 20. 1MS.-HOWE: Well, at that point, you're getting
. 21 into the DOT. This shielding istfor a different part of the E2 2 - ' requirement. This is a requirement ~that_there has to be
=23- adequate shielding forithe user, the medical user. >
4 24 MS; SEIFERT: Okay. Same' comment.
25- .MR. CAMPER: Mary. ;
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177 1 MS. MOORE: Okay. I was back with F.athy in the
[~') i_ 2 box and the size and shape, 3- MS. HOWE This is not DOT. DOT requirements are 4 still in place. There is a requirement in 35 and also, I 5 believe, in 32 that says that you h -3 to have adequate 6 shielding for the safe handling at the medical user's 7 -facility.
8 MS. MOORE: Well, that, then, is on the medical 9 user's side, not the pharmacy.
10 MS. HOWE: It's required on the pharmacy side that 11 you describe the shielding so that we have some indication 12 that it's going to be adequate at the medical users.
13 MS. MOORE: I'm in favor of the flexibility, but 14 as the end-point user, I would want to know not only n
() 15 exposure rate -- and I do chink the exposure rate is a great 16 tool to use, and I'm in favor of the flexibility, but I also 17 want to know about the durability, that with all the 18 flexibility and options, I want to make sure that the 19 shielding is going to remain intact.
20 As Mark said, if the purpose is achieved and it 21 maintains it, fine. But I also want to make sure it's such 22 that it's not going to fracture or cause the syringe to 23- rupture or the vial to rupture, because it's not sturdy 24 enough or the integrity of the shielding is another aspect 25 that needs to be addressed. But you can categorize those I' ' ANN RILEY & ASSOCIATES, LTD.
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178 1 according-to isotope or energy of the radioactivity as well
(')
\_
- 2. as the type of radioactivity.
3 You do need the flexibility,-but I want something 4 that I know is not only going to shield it but the integrity 5 of the shielding is maintained.
6 MS. HCWE: Ju3t for clarification, the requirement 7 is 32.72 (a) (3) . It says, "In the shielding provided by 8 packaging to show it is appropriate for the safe handling 9 and storaga of radioactive drugs by medical use licensees."
10 It's 831 9htly dif ferent f rom DOT > Your points are well 11 taken.
12 MR. CAMPER: Roy.
13 MR. BROWN: I would caution NRC to make sure 14 they're not too prescriptive in this area, because it's not O)
( ,
15 as easy as meets the eye. You could take a $5 opportunity 16 $10 product -- you know, a very inexpensive product -- and, 17 all of a ; sudden, slap a $20 shield on it to meet a 18 prescriptive requirement, and, all of a sudden, the cost of 19 the radiopharmaceutical is increased dramatically.
20 Larger generators, if you're very prescriptive, 21 you may force manufacturers to go from a lead shield to a 22 depleted uranium shield, and, all of a sudden, you're going 23 from a $25 shield to a $1,500 or 1 $2,500 shield. So it's 24 really no*. always that black and white, and I would really 25 caut. ion NRC in being too prescriptive here.
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179-1 LI think there are a41otLmoretthings that'go into
.g.
-2" it-.that need to be' considered'--5overall' economics,. A L A R A ,-.-
' Q')-
3: dollars,well" spent,'you know, those types ofLthings, not 4 !just the dose rate should be thist or that.
-5 MS. HOWE: Well, in:this case,-you're asked.to 6 'soecify.what:your. shield is and describe how it's' adequate.
7- Do you see that being' prescriptive?
8 MR. BROWN:- Well, I'm just saying that we hadLmade 9 mentioned -- some of the other, earlier comments --1about-10 setting up a standard'or basing it on a certain dose rate.
11' I'm.just cautioning everyone that that may require a jump 12 from a lead safe to a DU safe, for example, and all of a l13. ' sudden, the cost of your lead safe goes up a hundred-fold.
14- MS. HOWE: Okay. So you're saying the dose
.D
-V 15 rate --
16 MR. BROWN: I mean the dose rate should be 17 considered, but'not by itself.
18 MS. HOWE: It has its own drawbacks.
19 MR. BROWN: Right.
20 MS. HOWE: As well as the lead shielding has its
'21 drawbacks. Kathy.
122 MS. SEIFERT: I agree with that 100 percent, and 23 also,.by changing shielding material, you would have-to do a 24 =new. license: amendment. I'm not sure NRC is interested in L25 .doing a lot of license ~ amendments for pharmacies, in
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L 180 1 fparticular,. but this,nof course, relates to manufacturing.
['j 2" I know that this, also, we'11: talk about in 0006, u
3' but'if we~ wanted-to change our--lead pigs from one 4 -configuration to another, it meant license-amendments for 5 us. I'm not sure that-was really effective use of our time 6' 'or your time.
7 MR. BROWN: -Meanwhile, there are other things that-8 need to be considered, too. For example, on generators, 9 -Mallinckrodt and the other manufacturers.all offer auxiliary 10 shields to the generators. The manufacturers tend to ship 11 maybe less shielding in the generator, realizing that when-12 it gets to the hospital or the pharmacy on the other end, fit 13 will-be put in an auxiliary shield.
14 That's a shield that is very expensive and stays
() 15 -there.. Rather than increase every generator you buy by 16 $$100 cur $1,500 or whatever, just get it to the pharmacy, 17 get it to the hospital, and put it in the auxiliary shield.
18 So.once it gets to the hospital and is put into use, the ,
19 dose levels are much, much lower than they.are when it 20 . leaves the manufacturer.
21 MS, HOWE: What does your auxiliary shield look 22- like? How many sides?
-23 MR. BROWN: . We have two: generators right now. On
-24 the'DTE-generator,Jit's a right-angle cylinder.
25 MS. HOWE: Okay. So it's all sides, except for ANN RILEY & ASSOCIATES, LTD.
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1 181 1 the top.and the bottom.
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()
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2 MR. BROWN: Right. And our old generator style,-
3 the UTK style, is all sides, as well.
4 MS. HOWE: Okay.- I was only asking because we had 5 an old note about three-sided ones --
6 MR. BROWN: Right.
7 MS. HOWE: -- and we thought that was ancient 8 history. We wanted to just kind of make sure, a 9 MR. BROWN: I read that, yeah.
10 MS. HOWE: So it sounds to me we have both pros 11 and cons on using shielding as a performance standard and 12 also using dose as a performance standard. Tony, 13 DR. TSE: This is one of the topics in the other 14 -- in my set of viewgraphs, also, so I intend to discuss O( j 15 with you on that, but I may as well do it now.
16 I think you suggested some alternative to say the 17 dose rate criteria. You say something about dose rate. But 18 I wonder, how could you set that dose rate? Roy already 19 mentioned, if I have a shield with certain dose rate 20 outside, it may be hot, but that's okay, because when this 21 thing goes to somewhere else, they have another shield.
22 If it's not enough -- how do you determine what's 23 enough? In transport, it is even more important, because --
24 dose rate per hour at the surface, the only limit is 25 outside. So what is sufficient? If you talk about dose
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182 1 rate, somehow, somebody will ask you what is the dose rate-() 2 3!
per hour at'certain centimeter or-surface is okay.
_ difficult to see, how do you describe that?
Kind of 4- MS HOWE: Roy.
5 MR.: BROWN: Tony, that's an interesting point, 6' because also things that go into the amount of lead 7- shielding used on a'particular product, things like 8 transportation are considered, because you're limited in how -
9 many TI -- how many transport indices you can put on an 10 airplane. '
11 So the more lead you use, the lower the TI and the 12 more packages you can get on an airplane. So not only is 13 the use and the manufacturer's amount of lead considered,.
14 but also the transport considered, too, and that goes into
() 15- the equation on how much lead do we put around this new 16 product when we originally design it.
17 DR TSE: That's right.
18 MS. HOWE: Roy, is it a problem for you to cpecify 19 lead or shielding in your products?
20 MR. BROWN: Well, it's not a problem. It's-21_ probably more of a problem when we start ~getting_ questions 22 back, like, "Why did you choose this?" and "Why did you do
, 23_ that?" and "Why don't you use more lead?"
24 Then we've got. to go through the litany, "Well, we 25 looked at the transport index. We looked at the auxiliary l[\~' ANN'RILEY & ASSOCIATES, LTD.
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4 183 1 shield. We looked at'this. -We looked-at that."
2 'As I'said before, it's really not.a value-added
.3 exchange. We end up answering questions that are really not 4 -appropriate and questions that really,_by the time-we're f 5 done,.we're really no.further along, and the_public health 6- and safety is not.any better,off-a.!ter-going through that-7 litany of questiens and answers.
8 MS.. HOWE: Mark._
9 CPT ROTMAN: Oh, boy. At the risk ofLgetting shot 10 for bringing this up,.I think that Dr. Tse mentioned 5
11L something very interesting. How do you determine what this 12 magical dose rate at the surface of this package, this 13_ product'is going to-be? Who determines that, and does it 14- change from one product to the next? Does it change from 15 one manufacturer to the next, from one licensee to the next?
16 I mean we haven't really talked about any of those things.
17 I'm just going to mention that, not too long ago 18 -- actually , it was earlier this year -- the NRC published-19 in a Final Rule -- is it 35.75? Patient Release Criteria.
20 It says something nice, like the patient that's released 21' will not -- exposure-to the general public from this patient 22 is not likely to. exceed 500 MR in-the course of a year.
23 All right, whatever the rules are -- you can make 24 some judgments about how much this particular package-is
- 25. likely to expose.a member of the_ general public to during
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T184 1 the time it leaves the manufacturer until the time it fI
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2 becomes the possession of the final. user, and you can work 3 backwards and divide it out'over so many hours or whatever 4 you got to do and make a guess.
5- It shouldn't be too hard to come up with some 6 reasonable numbers for the-surface'of a final product 7 container, because you can work bt t. *ds just from the 8 surface of the package. The DOT regs still' apply.
9 So you know you can't have something so hot on the 10 surface of the final container that it exceeds the packaging 11' requirements for DOT. So I don't think this number is going 12 to be so hard to come up with, or at least a range of 13- numbers that are acceptable.
14 MS. HOK3: But the final container can be here, O-( ,) - 15 and the DOT package can be here.
16 CPT ROTMAN: Right.
17 MS. HOWE: They're not the same place.
18 CPT ROTMAN: I'm not saying they're the same 19 r. amber or they're the same place. However, in order to 20 achieve a number at the surface of the final package, the 21 DOT regs, the inside surface dose rate cannot_ exceed a 22 certain point. We've got time, distance and shielding here.
23 It's just basic laws of physics.
24 So that dose rate number that we hold our 25 licensees to, to say, "We don't care what shielding you use
'[
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185
-l' as long aslit doesn't exceed this," maybe you could even not .
12- 1come;up.with a---number and;just-say-the*..-.Under the normal' 3= i:shippingiprocedures of DOT, this dose--rate =at the' surface of
_ 14: Lyourifinal package will be such'that your product, when 5 ! shipped,-is in compliance with DOT regs. Therefore, you never'have to give a number,-and-the manufacturers _are going 7- .to'do that anyway,-because they have.to do'that.
-8_ MS. HOWE: The only point I have on-that is that-9 you'makeLa clear distinction-that this.is not that-level for 10 DOT, vc you have other things you can do to meet DOT. This-11 1 is supposed to'be at the surface ofLthe outer container, so 12 for the safe handling by the medical use licensee, they're 13 not exactly equivalent.
- 14. Right now, in the FC 406.4, the licensee tells us s
() 15 what the level is. .There is no level that you have to be 16 below. They just tell us what the level is, and then that 17 is standard for that particular configuration.
18 CPT ROTMAN: You have to remember that you are 19 dealing with relatively short half life material that is 20 . going to be used and administered to a human being, most 21 likely, so the amount of time that.it is in the hands of the 22 final user.iscreally limited.
'23 The final us_r is monitored by film badge,_
24 (probably-at an extremity and a body badge. The final user 25 has.their area that they work in: monitored for dose = rate.
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186 1 Ik) you have plenty of controls to ensure that the worker
[)
V 2 doesn't;get over-exposed from this final container.
3 You know that this final container, when it's 4 packaged for shipment, cannot exceed a certain amount on the 5 dose rate. I think that, if you work backwards from there, 6 you- can come up with a case that you really don't even need 7 to assign a number to this final contained, or you-can 8 assign a range of numbers, but you don't have to be specific 9 about it.
10 I think that Dr. Tse's concern about how do you
-11 assign this number, I think, after you give that some 12 thought, it's not terribly difficult to come up with that 13 number.
14 MS. HOWE: Mary, r
( 15 MS. MOORE: Well, my job is usually to keep the 16 end user exposures down. Depending on -- in Mark's 17 scenario, DOT regs would determine the upper limit for 18 shipment. The limit on the container, once you unpackage 19 it, could set off the area alarms, could exceed whatever the 20 shielding in that area -- if there is any shielding-in the 21 hot lab area.
22 I'm getting a little nervous here with this 23- open-en3ed amount of exposure. If the box is big enough, 24 you're going to stay within DOT's regs, but when you go to 25 unpack it and you're actually handling it, all of a sudden (9
'w/
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t-187-1 the exposure to personnel may go-up.. The idea is_to keep; l 2 them:down. ,
3- If.you go with a-dose rate,=I-think you need some 4 -kind of ballpark~on.the-surface of a container. The 5: flexibility for the manufacturer =or the pharmacy in-6 -distributing it should be there to allow them to use.
7 equivalent material that may be cheaper but still 8- -_ effectively givesLthe same shielding.
9 If they change the shape, but the shielding 10- -effectiveness is-not changed, I don't see where that's a' big
' ll- deal, as long as they can attest to that. But, as Mark's
- 12. point is what is the ballpark. number'that is considered-13 ' safe outside the lead shielding?
14 And remember, a lot of the hospitals will keep
() 15- some of the lead pigs because, when they're doing their 16 multi-dose vials or mixing up some, they're going to use it 17 for internal shielding, too. The thicknesses of the lead, 18 I've noticed when I went to borrow a few lead pigs, was 19 always very different.
20 So there is a variation in the shipping container-21 itself right. The user is dependent on the pharmacy to 22 -package it in such that when they unpack it and they're 23 handling it -- and while everybody does use technetium, and 24 that's short-lived, but other people are using other 25- -long-lived isotopes that they are there for a.while.
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k 188-1 .If-the hot' lab facility does not have anything
- 2- ;much more thanlan L shield, then--that whole; background level f\_-)
in thatihot-lab-has gone_up-unnecessarily. So, to-me,'the -
4 Edose_rateHis a_very.important-one.
_The_ integrity of the s 5 -shielding is-a very important one.
6 I think there should be flexibility,-but whatever 7 that dose' rate is, it can't be so restrictive that the cost t
8 has to-go up astronomically. But, in shipping the 9 . generators, I'm a-little concerned for the people that-are s10 transporting it, unless the outside-container is so large 11- 'that that's keeping the exposure down until they can put it 12- into the auxiliary shield. Then it's just a matter of real' 13 quick transfer.
14 But a lot of the hot labs, a lot of the hospitals l]s_j 15- in the nuclear cardiology' facilities and what have you, they 16 may have a closet that they can lock. It's not shielded, 17 and the delivery goes in there, and that's it. So they're 18 really-dependent on the pigs that you ship these containers-19 in for their own internal shielding.
20 MS. HOWE: Roy.
21 MR. BROWN: I just wanted to mention a couple of 22 ~ additional points. The nuclear medicine technologists and 23- the nuclear pharmacists are very intelligent people. All 24 these-products we have out there are competitive products; 25' there are other' manufacturers. Most of the products, all
- .)
(
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'189' 1 :the manufacturers areimaking.- !
r s-
- ( t 2 The-technologists and nuclear-pharmacists know. .I
- x. / ,
-3 mean they're not goingLto buy one manufacturer's. product ifi 4- it's twice-or even 25 perceat higher 1than the competitor's.
5 I mean the amount of shielding-we~put in our products is-a ;
6 -competitive issue, and the: technologists kr.ow that.and the
-7 pharmacists know that. ;
8 So that's another kind:of self-regulating things.- .;
9 'Mallinckrodt doesn't want to be known as, "Oh, they've got ,
10 those hot products." We want people to think, "Well, ill they're-nicely shielded, and then we'll get a low dose rate 12 from the Mallinckrodt products." So-that is a 13 self-regulating type of thing, too. All these things really 14 .need to be consideria That's why a bland-and-white dose 15- rate, byz itself, I'really. don't think will work. All these 16 other things need to-be considered, as well.
17- On-Mary's comment on the transportation end, all 18 the manufacturers work very, very closely with the 19 transporters. We know what their dose rates are. We know 20 what their film badge results are. We work closely with 21- DOT. Believe me, we build that into our calculations 22 A lot of-times-we've gone back and added 23L additional lead shielding -- not for our benefit, and, I'm 24 ' sad to say, not for.the hospital's-benefit, but for the R25 : -transporter's-benefit.
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190 1 Sometimes, inisome situations,_ they've needed EadditionalJ1ead-shielding ~on generators, for example. We' L[).
w 2
3; putfitLin there. The hospital ~was fine,_'but'we put it in 4- for,the transport'ers-in betweens-- 9o that's another' thing SE thatineeds to go into the equation and is ti?.lly not~a l
- 6~
- simple type thing.- Allfof these things need to.be' 7 considered at once. !
81 -MS. HOWE:, Okay. Kathy, 9 MS._,SEIFERT: A question for you. Now, as it'
-10 stands now -- the_way I-understand it --
a manufacturer ill -would submit a product and chielding configuration, and NRC
-12 would approve it or not approve'it or ask questions, Is 13" there a standard that that's measured against?
'14 MS. HOWE: No. It varies from product to product.
-15 I know, in our standard review plan, it is more an
- 16. .information point, If it's really outrageous, we_would 17 -probably.go back. But.I believe, in the standard review 18 plan, it says it's'not unusual for -- and then it gives a 19 pretty large number, a certain kind of products that might 20 be sent. So there is no number there that they're reviewing 21 against, Mary, 22 MS. MOORE: I'm sitting here, thinking about rad 23 waste-and category of drums that have gone through 24 _ performance testing:and all,that, and if they meet that r25 -category, they're classified a certain way.
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191 1_ Is there a classification for -- I'm going to say
('G ) 2 lead pigs, for want of a better word, just so we're 3 concentrating on the internal package -- that would allow 4 the manufacturer and the pharmacies, if they're using that 5 kind of classified or categorized shield, if they put that .
6 in their application, then they don't have to list all the 7 nitty-gritties, because it will fall under that? I'm trying 8 to give a way to help them streamline.
9 MS. HOWE: The way it's set up now is -- and this 10 is in the old 406.4 -- you give the container the maximum 11 activity that you expect to have in the container, describe 12 the shielding that you expect to use for that container.
13 Then NRC will do a calculation. Or we may also ask for a 14 dose, and then it's e'/aluated.
) 15 MR. CAMPER: We ask them to "Specify-the 16 radionuclide in its chemical and physical form, describe the 17 packaging, state the maximum activity per type of container, 18 describe the type and thickness of shielding that you apply 19 for each type of container, then indicate the maximum 20 radiation level to h6 .Tpected ac the surface of each 21 shielded container when filled with the maximum activity."
22 Paragraph 32.72 (a) (3) of 10 CFR Part 32 applie 23 specifically to safe hanaling and storage of the final 24 source container by group medical licensees, so it is not 25 acceptable to.say that you comply with DOT regulations only.
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- n. . . . --_ - . .- , . .. .~ .
192
=1i MS.. HOWE:j That=partididn't change. That part
/~w . :
Tpretty much stayed the:same.--
{J 2 :- .
MR. _ BROWN: ' LYeah, that part has- always been a -
- - 3) .
~4; iproblem.,-Let.me.take a typical? product, I-131 therapeutic 1
-S e capsules. Weihave, I think, 15 differentLsizes of one '
61 millicurie.all the way up to 150-millicuries.
i 7 LMS. HOWE: Richt.
8l MR.~ BROWN ~ And weshave maybe-eight different --- ,
9 MS. HOWE: Shieldings. ,
10 MR. BROWN: -- thicknesses of shielding,'and then- d 11 1 weLalways' match up, "Well, these sizes go in this. safe;-
-12 these sizes go -in this size ' safe," and- then we calculate- the ,
13 radiation fields from that, and then we calculate how long 14 'before the calibration date we ship that. All those things I 15 get put.into this huge matrix, and that's what we send in 16 when we send'our either amendment in or lanewal in.
1?_ MS HOWE: Right. ;
a 18 MR. BROWN: and every once in a while, we're.
19- questioned on, "Well, why did you-pick this safe or that
.20 safe?" and'the exchange takea place from there. The has 21' been a pretty time-consuming process in the past.
Okay.
~
- 2:L MS. HOWE: So, it sounds like, Mary, we 12 3 - willLbe looking.at more detail when we get into the
~
24- Lconsolidated guidance part to see.what-we can do for 25 fl'exibility. _
- ' h.
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193 li Generic' comment -- requirements for amendaent 2- every time'you make a change'is too_ restrictive. I don't-
-3s see;any heads shaking no on'that'one.-: Mary. <
4 MS. MOORE: Do the nuclear pharmacies and the 5 ~ manufacturers and distributors allowed ministerial changes J 6 -- as are hospitals?-
7 RMS. HOWE: No , they are not. -
-8 MS. MOORE: Could that be considered? Maybenthat ,
19 would give them=a little more flexibility and' decrease some 10 of.--
fil MR. CAMPER: Oh, it can absolutely be considered.
12 No question about that.
13 (Laughter.]
14- MS. HOWE . It can be considered in one or two
/ )
'e, it can be considered by regulation, which would
'(_/ 15 ways.
16 mean probably amending Part 30, and that would be very 17 global, or it could also be done in regulatory space, where 18 certain areas that might not be considered to be a safety 19 hazard,-you would be designated. You could change this 20 parameter.
21 WE have a sample of that type of change in the 22 Radiopharmacy Guide with the notification in case of ,
23- emergency. There's an asterisk and a blank space, and you 26- can change the number and lenation of your decontamination 25 kits, and you can change the name and. address of the RSO, f
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4 94-1 because we don't really need-to know that detail when we're -
() 2 approving the' application. So It could be something like -
'3 that.
4 MR. CAMPER: We could take a look-at -- given my 5 earlier comment that, pretty much what we seem to impose-
-6 upon manufacturers or radiopharmacies derivet from the broad 7 authority in Part 30 and manifests itself as guidance, we 8 could certainly -3 cok at making - flexibility in tha guidance 9- for certain kinds of ministerial changes.
-10 The tning that we would probably have to do if'we 11 did that, though, is confer with the Office of General IL Counsel, because the problem that I have is, wnen yea start 13 defining a ministerial change in one part, like Part 35, and 14 it is not defined in Part 30 currently,'you run into a 15 question of, do I need to put this in regulatory space, or 16 is it sufficient to do it only in guidance space?
17 I would probably, from a problematic standpoint, 18 try to argue that it's sufficient to do it in guidance 19 space. That may or may not be legally correcc, though. But 20 it is certainly something that could be examined, yes.
21- MS. HOWE: I think there's also a concept, if we 22- go to more flexible performance-oriented responses, then you 23 won't-need as many amendments, because you'll be able to 24 . change the. details-without-changing the overall goal.
25 MR. CAMPER: As a matter of principle, we f~'N g
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i 195 i i
1 .certainly agree with.the concept of_ increasing flexibility !
() 2 3
at ndpoint. There have clearly got to be some kinds of.
changes that could be made that don't compromise public l 4 health e.nd safety,-provide a bit more flexibility _and reduce 5 the need to amend and spend the cost'every time you do that. !
i 6 It's a question-of examining it and determining what they l 1 e i 1 might be, figuring out it we- can do it strictly in guidance.
8 MS. HOWEt Jon.
9 MR. MAY: As you probably all know, FDA did that f 1
10 very thing several years ago. At one time, they required to l 11 he notified before any change was made in a drug product.- 'l.1 12 You could change the manufacture of the rubber stopper; you !
i 1 13 could change the color from green to blue,- and they had to 14 - notify the agency of that change and get an approval before
( 15 they could made the change.
16- Many years ago, they changed that procedure to I 17 allow the manufacturers a great deal of discretion in 10 deciding what was significant and what was not significant. ,
19 Now, they make a lot of changes that were considered
-20 important at one time.
21 They make the changes. . They go into production, I 22 and then they notify the agency they made these changes.-
23- The agency reviews it and says, "That's fine. That's 24 inconsequential.' '
25' If-theyfdo something very important, if they
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196 1 change something very important, then they'll get battered
/~ ~'N 2 by the agency, but't!>ey've been given the discretion to make O
3 an intelligent dec'inions on things that do not impact 4 greatly on the product. This is not diffurent, es I view 5 it.
6 MS. HOWE: Yeah. Currently, right now, we don't 7 have either ministerial changes written into the regulations 8 for these kinds of licensees or notification procedures 9- written into the regulations. That's not to mean that we 10 couldn't in the future, but that's an interesting concept to 11 explore.
12 MR. CAMPER: Roy.
13 MR. BROWN: Anything you can do to increase 14 flexibility would be appreciated by the licensed community.
A 15 (v) A lot of times we've had the interpretation from the 16 regional offices, as well, that even enhancements to the 17 programs we need to have anandments for. So it becomes 10 difficult, and sometimes it prevents you from making an 19 immediate change, a change for the better, because you have 20 to and do the license amendment process.
21 As Jon pointed out, with the FDA change, that has 22 resulted in better products and improvement in public and 23 safety done overnight, rather than having to wait for 6 to
-24 12 to 18 months for an NDA supplement or something. So any 25 kind of flexibility _you could build in would be greatly
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197 1 appreciated.
() 2 3L MS, HOWE:
MS. SEIFERT:
Xathy.
I agree with that, particularly in )
4 the area of floor plans in the pharmacies, for instance. d l
5 I'm not sure how that works for manufacturing facilities, l
6 -but occasionally we'll have the need to move a particular 7 piece of equipment like a hood to another area. ife ;
8 certainly consider the radiation safety aspects or that l l
9 while we make that decision. If we could just do that and 10 then notify. l 11 One of the examples of that would be the hood that 12 we use to radiolabel white cells. We would sometimes like 4J to move that to an area that is more sterile or more ;
14 aseptic, where it would improve the end product
() 15 significantly. We have to amend our license before we can i 16 do that within the restricted area.
17 MS. HOWE: That's the extent of my slides.
18 MR. CAMPER: All right. Thank you, Donna-Beth.
19 All right,1 Tony. Let's see, we now got to 20 DG-0006, Comments Resulting from other than the
'21 Radiopharmacy Rule, I believe. This focuses upon the 22 -staff's attempt to bring forward old guidance, previously 23 _ contained in FC 410.4. It clearly needs the most work.
24 REMARKS OF ANTHONY TSE 25 DR. TSE: This is term as a general comment, b
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i l; _ _ . _ .
u .. _ _. _, _ _ . . _ , . . . , . _ . - . _ _ _ _ . . . . _ . _ . . . . _ . . - . . ~ . . _ , . . , _ _ . . _
t 198 l 1 meaning the comments are not specific to the change in ;
() 2 3
32.72. Some items have already been discussed, so it we see the item, we can skip that.
This is 0006 general comments f
4 [ Slide.] >
5 First, the title says< " Regulatory Guides Versus t
6 Regulations." Essentially, these have already been ;
7 discussed. They should not contain more restrictions than-8 regulations, and it should not introduce more requirements.
9 It should indicate that other procedures may also be 10 acceptable.
11 We already talked about the next item. If it's 12 too prescriptive, then the licensee will be required to 13 submit amendment.
14 And the last one, somebody said, even though NRC
() 15 said so, that's not the case. So I just want to say, like 16 the first bullet, regulatory guides should not be more 17 restrictive.than the regulations. But I thought that maybe 18 some suggestions could be made, like a gaod house practice, 19 as a suggestion, or we have certain standard procedures as a 20 suggestion. It may be useful to know what you all think 21 about this.
t 22 MR'. CAMPER: Can I set the stage for this?
23' DR. TSE: Yes.
24 MR CAMPER: This is really an. ares where I really 25 would-like some thoughtn and some help. I've been at this a
'"Mx/
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- E l , - , , , . - .. , ., . - - - . - . . . , - - . - - - . . , - - , . - . - . , - , -
199 i long_ time. I've been at it this side of the fence as a regulator, and I've been on the outside as the licensee.
'2 3' I'v4 been at it from an RSO, and I've been at it from a -l i
4 -consultant. I8ve seen this from many sides. !
5 Here's the dilemma that I see that the NRC has.-
6 Any regulator,'there's one or two ways you can go. You can d
7 either develop fa.rly voluminous, detailed prescriptive-8 regulations-, something like, arguably, OSHA does, or take an 9 approach where your regulations are relatively skeletal in i
10 nature.
11- You can hopefully make them more
-12 performance-oriented and capture the big ticket items. -And ;
13 ~t hen what you do is you try to put in place guidance. -A Reg
{
14 Guide is supposed to be to tell them how to implement '!
15 -particular regulations.
16 Then what you do is you go about putting in
- .7 guidance space an example pathway that regulator would find l
18 -acceptable for meeting that particular regulatory 19 requirement.
20 Now, I agree with the commenters totally that a 21 . Reg Guide should never be a mechanism whereby an agency --_a 22 regulator -- imposes more restrictions than the Rule-23 requires.- The challenge is to put in place a set of .
24' criteria:-- guidelines and so forth ---that applicants can ;
25- use on the one hand to understand what it is that the--
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P 200 f 1 regulator is looking for to satisfy this requirement. -
2 The regulator, in turn, is looking for something
[}
3 that.it_can say', "Well, if the licensee gives us this, then
{
4 I can make a conclusion that.we have satisfied our ,
5 obligation to meet public her.? th and safety." '
i 6 Where it gets very difficult is for the license !
I 7 reviewers, because these are folks -- health physicists --
8 who sit out there in the region, have to review a submittal. ,
i 9 invariably,.they're looking for something to> gauge that- -;
10 submittal against, because ultimately they're going to have :
J11 -to sign that license and say that you, Mallinckrodt, or you, ;
i 12 SYNCOR, or you, the licensee, or what have you, have in fact l
13 presented a program that is adequate to protect the public 14 health and safety, and I've gauged against some criteria, r 15 Now, of all the things that we do, it strikes me
])
16 that guidance d.relopment is the area where industry should 17 most importantly weigh in, because what you do when you do i 18 that is you're actually helping us develop the criteria 19 against which applications are gauged, i
20 I wou?1 argue, in fact, that guidance is far more 12 1 important than regulation, because the regulations -- ;
22- certainly under our historical approach, being rather 23 skeletal or broad in nature, if you will, much more detailed .
24- in terms of implementation' requirements -- is sort of where s 251 the rubber meets the road, as the cliche goes.
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201 1 So the question is, what is the best mechanism
(} 2 3
whereby we can, in guidance space, place those minimal things, things that must be addressed by an applicant, and 4 do so in a way that it doesn't give the impression that you 5 are, in fact, imposing additional regulatory requirements, 6 so that, ultimately, that license reviewer can, in fact, 7 review an application, issue a license, and do so knowing 8 that they can say that I did review-it against an 9 established criteria.
10 How do we achieve that? How do we best achieve it? That's what our dilemma is when'it comes to this 12 question of, you're ptoposing more through guidance .han
=13 your regulation requires. I'm really searching for a way to 14 -do that.
( 15 I think one of the positive things this agency is 16 doing is to continue to find ways to get participants like 17 yourself in the regulated industry involved in the guidance 18 development, careful line-by-line review of guidance, and is 19 it reasonable? Is it acceptable? Is that what we should 20- do? Is there a better way to do it? Are we doing it better 21 'than we used to? We really need help with this, because 22- it's a real aggravating point with the regulated community.
23 Mary.
24 MS. MOORE: There is one plus on the Reg Guide 25 -that you did not mention. It standardizes the reference ANN RILEY 5 ASSOCIATES, LTD.
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1- against which the individual reviewers in all of the regions ..
() 2 3
-- if they're using it, then thero's a standardized 1 reference. That's a plus, j 4 There are publications. -I know the AAPM and i 5 Health Physics is doing -- the societies are doing more. !
6; _I'm assuming the pharmacy societies and what have you, the
{
7 Lmanufacturers, they ha'e codified standards of practice.
l 8 They have updated practices as equipment develops, what have i t
9 you. Those are resources that are available to the j 10 regulatory bodies.
11- Now, I'm old enough and been in the field-long [
'12 enough to remember how ALARA came about. That was cute. ,
-l
.13 You didn't get a license renewed if you didn't say you were ;
I
'14 committing to ALARA. I think that's probably up there -- 1
~ 15 it's one of those. f 16 The other is beinq on a standards-writing group
-17 for the HPS or the AAPM and listening to, "You know, guys, 18 'if we write this, it's going to show up in the regs ". So it .
19 goes_from guidance to regulatory, mandatory. I don't know 20 if the resentment is still there as much as it was. They {
21 were very, very resentful that what was being proposed as tw ,
22 acceptable method of doing something all of a sudden became 23 ^de facto law.
=
24' So, in looking at trying to standardize the review 25: process -- because I think that protects the licensee -- if i
i
=[ )J 3' '
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i f
203 ,
1 there is such a~ wide range for the license? reviewers to I 2 follow, that bogs them down. Too many personal preferences f
3 can come into play. We will not have a level playing field i 4 ~across the board. ,
5 On the-other hand, you can certainly identify in a i
6 Reg Guide proposal -- I personally like Reg Guide 10,8 for 7- the medical-licensees, which-I know is going to be updated t 8 or replaced. i like it because it has in it a prescriptive I 9' way that, if I-need it, I can go that way.
10 If I don't li;te it, I can submit equivalent or 11 -acceptable practice, and I can support my position, usually, !
12 by' referencing something the AAPM put out or-the Health 13 Physics Society has put out.
14 So if the NRC, when they look at their Reg Guides, 15 propose alternatives -- national professional society f 16 standards or whatever -- that gives you some flexibility.
17 It also does allow and identify the range of flexibility of !
18 what is_ acceptable for the license reviewer ,
19 MR. CAMPER: So that translates, then, in guidance .
20 space, into some language that would point. out to applicants i 21 that they might opt to use --
22 MS. MOORE: Absolutely.
23 MR. CAMPER: -- established standards such as -- ,
24 MS.-MOORE:
The model used in Reg Guide 10.8. It says, Here's a model," or "See Appendix XYZ," or " Submit 25 "
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204 1 your own." And that works.
Yeah, that's interesting.
- (/%)
2 MR. - CAMPER: Your last ,
l 3 comment is interesting, because there is some language in-l 4 here somewhere in all of these guides that does-state that 5 one can submit an alternative.
6 I'm beginning to wonder, though -- I had a l t
7 conversation with Dave Nichols earlier, representing the 8 S&M. Ons of the concerns that Dave raised was that it 9 doesn't seem to be as clear to people that alternative 10 procedures could be submitted, would be entertained. So 11 perhaps one of the things that would be a positive change 12 would be to make it more clear, to enhance that part of the ,
13 Guide that talks about the capacity to use alternative l
, 14 procedures.
( 15 Your suggestion seems to take it a step further in 16 that, perhaps, not only could you say that or enhance that, 17 but you could also make it clear that there are othar 18 standards -- AAPM standards and so forth -- monographs, S&M, 19 and what have you. -Those could be cited as examples.
20 That's a good suggestion.
21 MS. MOORE: Also, you can -- as I know I've done 22 in the past - take your Reg Guide or your appendices and 23- modify specific contents within the body of that. You don't 24 have to change the whole thing, but there are certain 25 - restrictions or certain. modifications. I won't graph; I'll
, ?
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205 1 use a table - and that's equally acceptable. 'That message j
/~'i 2 needs to get out that yes, you can modify what you've O
-3 presented, as well as replace. !
4 MR. CAMPER: Okay. Mark.
5 CPT ROTMAN: Well, I have a, shall we say, 6 conflicting point of view with my partner here onLthe table. !
7 I think first I would like to address something that Larry 8 Camper talked about, that it's difficult for license-9 reviewers to look at a piece of paper and make a decision 10 labout whether application is going to be operated in a safe 11 manner or whatever their concerns are.
12 To that I would simply say that perhaps the 13 reviewers need to be better educated or better trained or a 14 different kind of professional. The example I give is that,
() 15 again, in the traditional world of pharmacy -- and we have 16 Dr. May here, who can perhaps add to this -- there are no 17 regulatory guides from any state board of pharmacy that tell 18 you how to get a license to practice pharmacy or to get a 19 license for a pharmacy.
20 The regulations tell you -- from state to state, 21- of course, they vary -- how many square feet of counter 22 . space you need and how much security and whatever, and you 23 apply _for a license, and you tell the state board, "I have
- 24. complete _all this."
.25 They do a pre-licensing inspection, and then they1 h.
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206 11 send you on your way, because-you are, in fact, a 2 professional. You have been educated by a school of
( }
3 pharmacy;~you have passed a competitive board examinations [
4- and you~are supposed to be able to practice without any ,
5 guidance from the state Board of Pharmacy.
6 It seems to me that when we are dealing with f
7- licensing a. nuclear pharmacy -- and this is a nuclear 8 pharmacy Regulatory Guide -- there shouldn't be a whole lot t
9 of-direction necessary for someone who is capable of 10- . independently operating a commercial nuclear pharmacy, and 1 11 that should be a bottom-level requirement. They shou.'t be !
-t 12 able to do it in order to get a license. They shouldn't 13- need to be spoon-fed a whole bunch of details.
14 Now, you talked about, if you have a
() 15 performance-based regulation, then you can have a Regulatory ;
16 Guide that gives you some-details on how to comply with the 17 performance-based regulation. I would say that's fine, but 18 some of the regulations we have now are incredibly .
19 prescriptive, and there's no need for a Regulatory Guide to ,
20 be even more prescriptive than the regulations.
21- Let's talk about 35.50, the dose calibrator 22' requirements. I mean that lays it out, chapter and verse,.
23 . what you have to do. Then you look at the Regulatory Guide, .
.and it further restricts you from that1plus or minus ;
25- 10 percent to a plus or minus 5 percent. And in some
( 'Y Ds-[
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207 l i
1 licenses that are still in existence today for, I think it's -
i 2 the geometry, you're limited to a'2-percent variation. Now, 1
-3 talk about a ratchet-down effect. I mean that's incredille.
4 So there's another aspect of this that.you have to 5 - consider, and perhaps the NRC management doesn't i.ee this as 6 often; perhaps the NRC needs to take a look at this and do 7 some asking of people. But what is the average delay time !
8 if'you choose to write your own license and not adopt a l 9 Regulatory Guide? -
10 If you adopt a Regulatory Guide, there's a comfort 11 level. The NRC can stamp it, " Yep, they're going to do !
But if you write your own, somebody has i 12 this. We're fine."
i 13 got to review it and analyze it and make all sorts of 14 decision processes on it, and that delays it, so that 15 discourages people from doing anything other than taking the 16 fastest route to get back into business. !
17 So I think that Regulatory Guides have got some 18 significant problems associated with them, especially the 19 way they have been historically laid out. I think the whole 20 paradigm needs to be shifted. I think the NRC needs to take i
21 a look at maybe starting over from scratch with them.
'22 MR. CAMPER: Well, a couple of comments. I 23 certainly agree with you that there are aspects of Part 35 24' that are very prescriptive. .Without question. I think 25 - there are a number of ways in which they could be relaxed. ,
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y- * .,%--, -,9~-,- ..my,.ws -cw,c.- ,.m_,.y,%,,,y ,,-,,,,,,,-,3-- y orw,- c-+-, =
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o + S &- SL +~+u 4 _v s >nA-w- 5- A cek's---4% wJe4+M-- i ^^- J 208 1 I totally agree with you on that point.
() 2 3-
.Your comment, though, that one goes through and becomen a pharmacist -- see, the dilemma that we face is not 4 the question of whether that radiopharmacist'-- or even that
~5- physician -- can practice radiopharmacy adequately. The 6 question is, has the licensee -- has organization that is 7; the licensee put together, is it demonstrating a viable 8 program?
9_ I think you would probably agree that different
-10 organizations structurally put together varying degrees of 11 quality in their overall radiation safety program and in 12 their procedures and conduct of their overall program. They 13 really do.
14 So it'u not a qu9stion of the practitioners'
-( 15 innate ability to do a good job by virtue of their training 16 and experience and certification. Rather, it is, is that 17 licensee constructing a viable program, of which the 18 authorized nuclear pharmacist ie only one component --
19 albeit a terribly important component, but only a component.
20 The dilemma that we have is we have to ultimately 21 pass judgment and issue a license which says that we're 22 satisfying our obligations in Part 30. And so, then, the
- 23. question becomes, against what do we gauge that?
24 It'does come down -- this is-what I said before.
25 I think that guidance is terribly important, and one of the
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209 1 things I think we need to do is have you help us identify Ih 2 those bottom-line issues to be addressed in the guide, how V
3 - might they best be addressed.
4 How, Mary's suggestion was, of course, in addition 5 to listing, perhaps, some information criteria, you could 6 cite other organizational approaches -- AAPM, S&M and so 7 forth and so on.
8 But I guess what I'm really saying, Mark, in the 9 final analysis, from our perspective, it goes beyond the
-10 practitioner -- it really does -- to the question of the 11 licensee's program.
12 Kathy.
13 MS. SEIFERT: I have a little different take on 14 it. I understand Mark's position on that, and a little
() 15 different look at it is, we, of course, apply for licenses 16 in agreement states all the time. We pretty much know what 17 NRC is going to say, but every time we deal with another 18 agreement state, it's another story. And of course, 19 agreement states also go br.ck to Reg Guides that NRC 20 publishes and uses that as guidance documents.
21 One way, perhaps, that might be a possibility to 22 have approved procedures that would meet NRC's expectations, 23 and then, also, maybe some performance-based elements that
.24 would need to be met for a licensee-developed procedure, so 25 that the licensee, when developing an alternate procedure,
[)
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210 1 would know what was going to be expected, bot.. by NRC and, 2 perhaps, by agreement states, and if a licensee wanted to go 3- ahead and de"elop'another procedure, it would at least know (
4 what-boxes needed to be' checked, what things needed to be j 5 addressed.- ,
6 That may be another way of doing it, but look at l
'7 it more from a performance-based analysis-perspective is a ;
8 possibility.
9 MR. CAMPER: Okay. Roy. j 10 MR. BROWN: ,I agree with some of the comments made l 811 earlier about some of the Reg Guides that are out now being ,
12- too prescriptive. Can we discuss for a few minutes the l 13- possibility cf developing industry standards?- This came up I 14 last year during the strategic rebaselining. It came up 15 again during Part 35.
16 I mean how would the NRC feel about, for example, 17 going back to the lead shielding on the sources going out to 18 .the manufacturers? What : the industry got-together and-19 said, "As an industry, we feel these criteria are j 20 acceptable"? -- you know, either dose rates this much, or i
~21 exposures to drivers are so much -- and say, "From the l 22 manufacturers' perspective, we feel this is the industry 23 standard, and we feel anyone coming in for a license should
~24 be compared to the industry standard "
- 25 MR CAMPER . Well, Roy, certainly the Commission, b
- . 1
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211 1 in DSI-7, indicated to the staff it should_be looking at
() 2 3
ways _to utilize industry standards.
My perception, then, is that commission - I know, t
4 certainly the management -- feels vecy strongly that 5 industry develops standards that we could, in turn,Eembrace, ,
6 either in our regulations or in the guidance. That is a 7 very positive thing to do.
8 I know I'm on record as having said it many times, ,
t 9 even prior to-DSI-7. From a regulator's standpoint,-it is [
10 far better to have the industry develop the standards and !
11 have the regulator embrace them, because the regulator-is 12- then in a position to say, "We addressed the issue, 13 addressed that concern in terms of public health and safety. !
14 Now, better buy in, because the industry (9veloped the 15 standard."
16 One of the chings that is going on in the revision 17 of Part 35 is a look at how we can maximize industry 18 standards. I take it from your suggestion that what we 19 ought to be doing, as we proceed to develop the NUREG on 20 DG-0006 on radiopharmacy, we ought to be doing the very same 21 thing. What industry standards are out there? How might we 22 best embrace them, either in terms of referencing them in 23~ some fashion in that they are an' alternative pathway that 24' can be'used?
~25 The take-home point back to you, I think, is-that t
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212 I
i you're-right. There may be some areas where the industry i 2 could get together'and develop some other standards that 3 . don't-exist now-we could, in turn, embrace. I think that's [
4 a win-win situation. I think it's'a marriage made in heaven -
5 -- the industry and the regulators.
6 MR. BROWN: Yeah, Well, the manufacturers have ;
7 discussed this in the past, and we are willing to do that. j i
So if we come up.with a: shopping list for manufacturers of 8 (
i 9 radiopharmaceuticals, where;do we need industry standards, ;
10 we would be'willing to put together a. working group to-I 11 developLthose. We've used those'in the past, like ANSI 12 standards on DOT package testing and things like that, so I 13: think that's something our industry would be willing to do. ,
14 MR. CAMPER: That's good. Other comments. Okay, 15 Tony'.
I 16- DR TSE: I think the discussion.is very 17 -worthwhile. One problem is the performance-based 18 regulations. How do you make sure that-the public health l
19 and safety is assured?' That's kind of difficult, so we need
+
- 20. guidance.
21 On the issue of saying that Reg Guides should be 22 indicating-that other procedures may-also be acceptable, I -
23 think all'the gaides ha"o-a paragraph or some place 24 . indicating =that, but it may not-be-frequent _enough.- It may not be prominent enough. People may not see it. But.we all ANN RILEY'& ASSOCIATES,.LTD.
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213 1 have that.
() 2 3
In submitting amendment,-we already talked about
-- for example, somebody mentioned in the shielding 4 discussion, maybe you could say similar material shieldings 5 with equivalent effectiveness. This allows you to not 6 reduce the effectiveness. Maybe you can replace this with
-7 that without amendment, and that's a reliable way, too.
8- It's a good suggestion. So I think it's difficult, but we ,
9 are-doing that.
10 As Larry said, we are trying to see what the best f 11 we can do, and the industry standards are a very good l 12 ' suggestion.- In fact, we sometimes adopt industry standards 13 as Reg Guides. We endorse it as a Reg Guide. However, 14 sometimes it may not be the whole industry. Maybe NRC will
() 15 find there are additional requirements needed, so maybe they 16 take exception to a few items. That's certainly, the agency 17 should have a way of doing soe Yes?
18 MR, BROWN: Obviously, the industry would want ;
19 something in return. Nothing comes for free. But I can 20 envision the industry developing standards, for example,
- 21 like the amount of lead shielding you use, and then, that 22 way, when we go in.for a license amendment on a new 23 radiopharmaceutical, we don't submit any shielding criteria, 24- any dose rates. We just say, "This new radiopharmaceutical ,
25 product shielding complies with Standard XYZ."
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I 214 I i
1 That's what we would hope for. That way, we would
'l 2- .be willing to invest the time and effort --
3 MR. CAMPERi That's understood.
4 MR. BROWN: - -to develop the standard, and then 5 that would give us some --
6 MR. CAMPER: That was clearly understood, Roy. ,
7 That would be the way it would work. And given, again, that ,
8 we don't -- certainly don't have any plans at this point to i
9 undertake a major change to Part 30 or Part 32, for all the
-10 reasons we cited earlier today. ;
11 But in guidance space, if those standards were 12 available, what could happen is that, on that part where you 13 have shielding, for example, you could say that the licensee 14 may commit to the fact that its shielding meets standards. l 15 That aeems to be doable.
16 MR.' BROWN: The radiopharmaceutical manufacturers 17 already have an industry trade group by the name of CORAR, 18 the Council on Radionuclides and Radiopharmaceuticals, and 19' it most likely would be a group of CORAR or CORAR working 20 with an established group like ANSI to develop those ,
21 standards.
22 DR.-TSE: I know the CORAR name well. .
23 MR BROWN: I just wanted the record to reflect
-24 that. l 25 MR SWANSON: In a' technology-oriented area like ;
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- 2151 1 radiopharmaceuticals and nuclear pharmacy, I think it's 2 imperative that you do something like that, because I don't 3 think there was any -- I don't think your regulatory process 1 4 .is capable with keeping up with the advancement of the 5 technology,-whereas it's fairly for us, working as groups, l 6 to evolve standards and to change our standards as the new l 7 -technology comes up, It allows you to keep abreast of the i i
8 new technology in a more rapid fashion than what your ;
9 regulatory process would allow you to do.
-' 10 MR. CAMPER: I tend to agree with that, and Mark-11 Rotman's-example of the current dose calibrator -- or the 12 moly breakthrough, I should say -- moly breakthrough assay 13 requirement. I think that's an area right where the 14 regulations have not been able to Keep up with the evolving t 15 technology.
16 DR. TSE: And that's a good point. We need to 17 adopt the performance-based for that raason.
18 MR CAMPP1: Right, t 19 DR. TSE: One of the reasons, anyway.
20 MR. CAMPER: Absolutely.
21 DR. TSE: Is it finished, this slide?
22 MR. CAMPER: I think so, Tony.
23 DR TSE: Thank you. The second one, it$s also, I ,
24 have-some comments about why do we need this Reg Guide, ,
25 - which we already talked about quite a bit. ,
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I 216 l
-i 1 (Slide.) ,
[). 2 Mark already said, " Hey, we're all professionals,-
v and we don't need the Reg Guide." '
3 That's the first item.
4 The second item says at a significant cost. The third item i 5 says', "Why do we need this guide now until we finish the 6 assessment?" Anybody have points on that one? I think, l 7 nort of we touch on each of these. So if anybody have a 8 . discussion, I would like to hear. Otherwise, I would go to 9 the next one.
10 (No response.)
11 No? We will go to the next one.
12 (Slide.)
13 Next is also some comments on problems with this 14 guide, and says that we work in isolation, but I believe we 15 work pretty closely with our colleagues. And second says 16' that wa did not take our medical visiting fellows' and the 17 current ACMUI members' advice, which I believe we did. It [
18 may not be verbatim or may not be 100 percent, but we 19 certainly considered seriously and adopted what we feel what 20 - we feel appropriate.
21 The third one, that is true, which we adopt to
'22 update-the older guide,-use to older guide to publish-the i
23- new guide. We realize that now, and therefore we now t
- 24. suggest we're not going to do that. We're going to have an
-25 amendment for this specific _part, and we're-going-to change P
.[
'V-
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217 1 part of this. letter.
() ;L 3
Land last one is -- we realize that, too.
old days, we were always kind of prescriptive.
In the Now we l 4 figure some way. how do we change in to a more 5 performance-based or risk-informed regulation and other 6 -regulatory documents which include the guide. That's the i
7 reason we are discussing, like the first slides, how do we 8 make it useful and not too burdensome and fulfill ;
9- everybody's -- regulatory side and industry side, they both 10 are satisfied for-both missions.
111 So any discussions on this one? ;
12 MR. CAMPER: I have an observation, though. On I 13 the last two, as Tony said, you're right on both points. We t
14 clearly did that. We really didn't work in isolation, as
() 15 Tony.said, but we can do more. We'll do more by developing 16 this particular-guidance under the NUREG concept. We'll put 17 it out'again for public comment, try to find ways, like this ,
t 18 session, to get your input. Mary.
19 MS. MOORE: As a comment, while you are welcoming 20 the input, and the regulated community welcomes the dialogue j 21 and the ability to give input, if there were a topic that '
22- the input were universally in agreement, and the NRC was not 23 in agreement, it would behoove everyone to know why, that if 24 suggestions - now, I don't:know-if you can do it for every 25- one, but I knowLthe FDA, if you send them in writing, they 1004 RILEY & ASSOCIATES, LTD.
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i 218 i
,have to respond, and-I-guess you folks do,-too. [
2 But the second half of this, to avoid, _"Are you
(
3 working in isolation?" Well, if you are, then you deserve t
4- that criticism. If you are not, and it's due to lack of 5 feedback of what rationale was followed, and that's why the i 6 change was not implemented or why the change was implemented ,
7 .a certain way,-I think it would go u long way to maintaining 8 the dialogue. l 9' -MR.-CAMPER: I couldn't agree more, and I think it 10' is the latter,-not the former. I think it really is that'we 11' -- not so much that we worked in isolation, but that we l
12 didn't necessarily take every suggestion or that we didn't-i 13 provide feedback that we could have provided as to our ;
'14 rationale.
15 My' colleague to the right here, Dennis Swanson, 16 knows very well tnat he had some concerns. He has done it.
17 Dennis is a member of the ACMUI. Dennis had challenged us, ,
18 and the Committee agreed, that perhaps the agency was not 19 doing as good a job as it could of providing feedback as to ,
20 what happeras to ACMUI's recommendations. t 21 Wu made a substantial procedural change. We;now 22 -share with the committee, during subsequent meetings, t
23 recommendatiens of a non-rulemaking nature and what we did 24; with-them and what-the disposition was and why. With 25 regards to rulemaking, we go back, and we will now have_a f
's '
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-219 1 line item in-the statements of consideration that address-() 2 3-what was done with the ACMUI recommendations.
We have not done as good a job in that area as Snr 4- could, providing feedback as to A, what was the logic and 5 the rationale? Why did we go the way that wo did? and B, 6 what, particularly, we didn't choose about the 7 recommendations and why. So we do need to do that better.
8 No question. Mark.
9 CPT ROTMAN: I would like to ask that, while 10 you're in the process of doing better at responding and
-11 giving us feedback in terms of how and why the Commission 12 made decisions based on our input or-ignoring our input or 13 modifying our input, that, at the same time, some at least 14 semi-rigorous science be applied to some of those.
() 15 I think that, if you look at the fourth bullet 16 here, the last three words, " risk-ignoring guide," there 17 were some things in this Regulatory Guide that 18 scientifically just were not justifiable. If you looked at 19 the mathematics associated with calculating the dose based 20 on exposure rates, it came out to be such an'insignificantly 21 small number that it probably would never even be seen on a 22 film badge, 23 If the Commission chooses to go a certain 24 direction on a^ regulatory philosophy, it would be nice to 25 have some scientific discussion of the impact of that
= /^%
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220 1 philosophy or that policy. In terms of dose reduction to 2 the workers or dose reduction to the public, instead of just
[\_J-)
3 talking about the Commission feels more comfortable going 4 this way, it would be nice to know why the Commission feels -
F more comfortable about this.
6 When we go to apply for a license or a license 7 amendment or do something, we have to show dose rates and 8 numbers, and we have to comply with smokestack emissions, -
9 and we have to make all kinds of scientific measurements, 10 and ee're expected to support those scientifically with 11 appropriate math and everything else.
12 It would seem to me, if the Commission takes a 13 certain policy, it would be nice for us to see the 14 scientific rationale that led to that policy so that we can fh q,,) 15 see it and make it a great deal easier to understand and 16 support.
17 MR. CAMPER: I agree, that's a sound point. It's 18 very difficult to disagree with that point. I think, again, 19 looking at this particular guide, it's very easy to say what 20 I'm about to say, and that is, if one goes back and looks at 21 some of the numbers and thresholds in this particular guide, 22 it clearly goes back to the 80s.
23 My observation is that the mind set in those days 24 was "a conservative number is a good number " Perhaps that 25 didn't-meet with a great deal of disenchantment from the
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I 221-1- regulated community in those days, but if we fast-ferward in ;
2 time now, a. couple of very interesting things are happening.
3 One is, the regulated community seems to be i i
4 saying, "Well, now, wait a minute. No one disagrees that }
5 conservative is not a good thing, but conservative to the l 6 point of carrying with it absurdity and/or just unbearable -
~7 costs to achieve those levels.is totally unreasonable.a 8 Clearly, some of the guidance in there, going back ;
9 to-the 80s, is clearly not. consistent with the Commission's 10 direction today, and if-you're going to be risk-informed, a ll- then you have to apply better science. You have to have 12 some reasonable, scientific, defendable basis for why you 13 settle where you settle. l 14 That is an excellent point. I think it's quite ;
-15 ~ consistent with what the Commission is asking the staff to 16 do . - Don't just choose conservative numbers or ALARA because 17 it's a' safe thing to do. Rather, come up with some values 18 that are meaningful, scientifically defendable, and apply an f
19 appropriate level of regulatory presence accordingly. !
20 So I think what you're saying is right on the 21 mark, and I think that, hopefully, we are moving that way.
22 Hopefully, the staff is moving that way. Kathy. l MS. SEIFERT:
23 Another issue with this Reg Guide is 24 the timing of it. I know Don talked about that earlier 25 today but I wanted to make mention of that. The Rule came O
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222 1 into effect the end of 1994, I believe, December 1994. Now
() 2 3
it's nearly-December 1997, and we're talking about it now.
I commend NRC for taking another tack now with l
4 Part 35, in that , the way I understand it, as the new 1 l
5 Part 35 comes out, Reg Guides will come out concurrently. I ,
l 6 know that's a Herculean task to do, but I think it's 7 important for the regulated community to make that-happen. ;
8 MR. CAMPER: Couldn't agree more. It is a 9 difficult task, but guides should be published at the same 10 time as the rule. I-could sit here and bore you with why lL1 this one is so far delayed. There are some good reasons. ;
12 It has been delayed for a number of reasons. I'm not going ;
13 to defend that or make excuses for it. You're totally 14 right.
) 15 That's what we're trying to do. That's what we 16 will be doing with Part 35. That's what we now do with all, !
17 so There'has been a marked change in that regard. We put in 18 place, for example, this year an addition to Part 34.
19 Guidance was available for licensees to use within 30 days.
20 That's what we have to do. You're absolutely right. Jon.
21- MR. MAY: I just-wanted to say, when I looked at 22 that slide and read those comments, I felt like I-wanted to 23 pinch myselt. I worked for FDA for 10 years and saw them 24 make some.veryLbad decisions based on both science and i a
-25 policy, and I-never saw anything from the agency saying 4 ANN RILEY-& ASSOCIATES, LTD.
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. = . . -e. se es ,<, ,,,-,e..- ,s. --=--see-m narr / ar w- v e, evwm--*wmww-s---e-w rt + rn =vae .~er= ='=-9,r"s'--- 7 <**+m -*re* r
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-223 <
11 - something :like ' tliat . ,
' 2.$ ~ I look back=at '95'and pet radiotracers,-and I l
-./ ,
3- . thought theyLwere'doing_a Very wrongLthing'then,3and so does_ ; j 4 everybody else -':b) this room that was at that meeting. . But- l 1
5 they~ proceeded-to do what they did, and-it took an~Act of l 6 - Congress to; turn that around.
-7 I just.want to say I congratulate _you for-having. !
Er the guts to take a different position ~on comething-and move ;
9- _ forward with :it .and actually put it ':b1 writing, because I 10 might carry this over to the Food and Drug Administration' ,
11 and let them take a look'at_it. l 4
12 [ Laughter.)
13 This'is what needs to be done by people who are 14 - involved in making these' monumental decisions and, too A
(,,). -
15- often, it's just swept under the rug. It's refreshing to me 3 16 to actually see this. I really am quite impressed.
17 MR. CAMPER: Thank you, Jon. I appreciate that, 18 i and on behalf of the agency, we thank you for that. We are 19 - trying. We are really very much trying. The Commission has 20 clearly sent a signal-that it wants to do things 21 differently. Staff and management want to do things
=22L differently. We-have a ways to go. We'll try harder, and 23 we'll-get more input. .But thank you for.that. It's good to 24 ' be recognized.
Thank you.
25 1Anything-else on this one?- ,
~
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- 2 2 '. e
'1' (No response.) ,
s f-v ~
2' DR. TSE: The next one. Unfortunately,=I took the 4-%( )h -
3$ = next - one out ,;.sof I - have '-just- ~a . littlef thing;here.; What-i 4- happensJin the next oneL-- youthaveKthe-viewgraph. - It says-5- Definitions-or.DifferentETerminologies." In the viewgraph 6 -there;are several-different items--I want,to say.- 1
!?- One of them, this morning,.somebody said, "And
-8 sealed."- So I said, dOh, gosh, I should not take those
- 9' : slides out." Bat 1anyway, I'm just going to indicate, there
' 10 < - are'some commente to say the. units and terminologies:are l11- confusing.
' 12 One of them is,-we use license material, r 13 ,by-product material, radioactive material, radioactive 14' . drugs, and they are' all' kind of interchangeable. Not in 15 terms of radioactive drugs. That's a specific item. All 16' 'the rest are. interchangeable, and therefore we need some 17- -clarification'which way you mean. That's the first one.
.18- - The-second one is the sealed and the unsealed,
'19 L essentially saying that, in FDA's view,.maybe the unsealed
- 20 .becomes sealed, so everything becomes confused. That's the
- 21 second one..
22~ ' The third one -- it's an old problem -- is-that
-23: roentgen versus rems. It says, " Hey, the survey meter says 24: . roentgen.' In.NRC's regulation,.Youtdon't even have a_
u : 25 ~ -
definition' of: this'. It doesn't: exist, so how do we use 1
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225 1 this?' So the commenters suggest that we should clarify
[L ,c') 2 _those different' terminologies so that people know what they_
3 should do.
4- I think it's very usaful, but the unsealed and 5 sealed is a problem. FDA uses " sealed," meaning that 6 somebody_put in the container, or it's closed. That's 7 sealed. Is that how ticy define that?
8 Or my own thinking is that sealed actually --if 9 you talk about use -- at the time of uce then becomes 10 unsealed. Even if it's a sealed bottle that, when you use 11 it, you have to open the_ bottle and the radioactive material 12 goec unsealed. So I wonder, how would you feel to solve 13 this problem, the sealed versus unsealed?
14 MR. CAMPER: Mark.
I 15 CPT ROTMAN: I think that this is really something 36 quite easily sclved. It doesn't really matter, in the end, 17 exactly how you define your terms, but what is important is 18 that you define your terms. In this Regulatory Guide, as 19 you mentioned, there were a lot of terms used somewhat 20 interchangeably, but they weren't necessarily 21 interchangeable terms, from the regulated community's point 22 of view.
23 Your issue of " sealed" versus " unsealed" -- if the 24 NRC had taken a paragraph to describe what'they considered 25 sealed material and unsealed material, .from their point of
- O
\_/
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-226 J
1L iiew,_and?then said, "Throughout' this Ldocument,:- we'.ve' used 2- thelterm,-" unsealed," to.mean," most offthese comments would 3 _have gone.away'. '
'4 'I.had-an'English teacher inithe 10th grade.Lthat 5 .said,'at the-very firstJday.of class, " Define your terms." ]
6: I'think that's something that could~be taken toLheart by the 7c agencylas.a way to do-better in their communications with -
8 -the regulated. community.
'9 CR.-TSE: Thank you. I think that applies to all
/10 the other terminology, as well. .
lij MR. CAMPER: Exactly.
I 12 DR. TSE: .Any other?.
13 MS. MOORE: -On the " sealed" versus " unsealed,"'~I 14 quite honestly was very surprised this was an issue.. Maybe
- 15. it's because I spend so much time in radiation oncology, buc -
16 ref'erence standards, all of those little things that have to 17 be leak-tested every six months, it was never any clouded 18- ' issue from the licensee's point of view, and I never sensed 19 any in the_ nuclear pharmacy. What had to be leak-tested, t
. 20~ thoseiwere the sealed sources.
- 21 After talking-to Mark,.when he said, "Well,'you '
~
22 could have a vial, and it's: sealed." Yes, no air is getting 23 into that,-but it's very fragile. Sealed 7ources, to me,
- 24
- always have-the. concept of sturdiness,. durability, because 25 .they were embedded, usually covered in metal.
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227-
-And then I'm sitting here,~thinkingfabout it, andi
'l-
-[) 2 -thinking, "Well,- no, dum-dum, that's not.true," becauce the
- \ /
- 3 dose calibrator reference sources are-in vials. They may be 4 glass, but.they may be plastic. So there's.a real point- ,
5 'here.-
6 But your comment-about, you can access them for 7 use, that the use_means they become unsealed, maybeLis'the 8 pathway, because embedded doesn't work. It does for
-9 brachytherapy, and it does for check sources for-10 . instrumentation, but it'doesn't necessarily for the-11 reference standards and for dose calibrators.
12 So I commend you. I would go on the same track of 13 accessibility. I don't know.
14 CPT ROTMAN: I just want to make a point here 1
() 15 think that needs to be made. I don't want to spend a lot of 16 time debating " sealed" versus " unsealed" and definitions, 17 because I think whatever definition you make, as long as 18- it's used consistently and well-published, we'll be happy 19 with it.
20 Br if you have-a sealed source that is allegedly 21 sealed and encapsulated, then why is it necessary to 22 smear 9ipe the damned thing to see if it leaks or not.
23 Well, if it leaks, then it isn't really1 sealed, is it? I 24' ask you that.
25 MS. MOORE: Good point, Mark.
t
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228 1 .CPT ROTMAN: But within the licensing guidance and {
2 ~ within the sample license, there1was-some'. terminology-that 3 was-very, very confusing to us as members of the regulated
- 4. community. It stemmed around the use of-the word, 5- " unsealed," as a substitute for any. chemical or physical 6 form that_the radioactive material might be in. .
7 Yet,:further in the document, it required a list 8 of_every single chemical and physical form that the licensee 9 ;might possess. So we're thinking to ourselves, well, if in 10 one hand it's okay to say " unsealed," and it means everything, then why do they want a list? There was a lot 12 of contradictions, a lot of confusion about what was really 13 wanted, what was really needed, and why were these things 14 asked for?
O)
(s, 15 So that's why I say, from the very beginning, 16- start with a set of definitions, use them consistently 17 throughout, and if we then have questions about something, 18 at least we have a level playing field from which to debate.
19_ DR. TSE: I just want to make a comment on your 20 sealed sources, why you need a leak test. Because nobody is 21 perfect. Sealed sources, somebody welding it, maybe have a
-22' :little hole there. -It may not be 100 percent perfect. The 23 -sources may leak.
24 Or maybe, under. pressure, the sealed source is-25 supposed to be tested as.to certain criteria. Maybe ANN RILEY-&' ASSOCIATES, LTD.
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.229 1 somebody did not.make a very good test and it could leak.
l ) -2 MR.. CAMPER: Well,. it's also unsealed if it
(/
3 becomes compromised over time.
4 DR. TSE: That's right.
5 CPT kOTMAN: I can understand that very well, and
- 6. especially with very, very high-level sources that might be 7 tound in a radiologic situation -- I mean radiography for 8 pipelines or perhaps in a reactor situation.
9 On the medical side and on the radiopharmacy side, 10 that's really not much of an issue. I don't know that 11 anybody has ever had a sealed source that they use in their 12 dose calibrator turn up leaking.
13 MR. CAMPER: Yea, they have, Mark.
14 CPT ROTMAN: Okay. How often does that happen?
(~h
(_) 15 One in a 1,000? One in 10,000? One in 100,000?
16 MR. CAMPER: It's not a frequent occurrence, but 17 it does happen occasionally. Yes, you're right. It's a low 18 frequency of occurrence, but it does happen, and in some 19 cases, it's leaks of some consequence.
20 CPT ROTMAN: Thank you.
21 MR. CAMPER: . consequence in terms of removable 22 contamination levels.
23 DR. TSE: Right. Another terminology somebody 24 questioned is the use of the word, " tolerance," in there and 25 the " safety margin." I looked at these words. I said, p
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230 1 "These are complementary to each other." If the safety.
[ )- 2 margin-is 20 percent, tolerance is 80 percent. So we need
\J 3 to explain those terms. Okay. So I'll go to the next one.
4 [ Slide.]
5 I think that this item has already-been discussed 6 several times.
Why do we need to send a license amendment 7 for list of a new chemical or physical form? I think the 8 answer to your question, you are right.
9 That's what happened, but it's because we have a 10 combination of new items with the old items, and they show 11 up in the old item, and we did not remove them. That's a 12 problem, so we can avoid that by not using material for the 13 old guides and new guides together, and the possession 14 limits.. Yes, Mary.
?
!( ,) 15 MS. MOORE: I don't see any difference for nuclear 16 pharmacies versus medical licenses. If we wa.it to increase 17 our possession limits, it requires an amendment. If we want 18 to add a new radiopharmaceutical, a new isotope to our 19 license that we were not previously licensed for, we have to 20 amend our license. That's generic. I don't see where the 21 nuclear pharmacy is any different from the other licensees 22 on this.
23 MR. BROWN: I had a question, not along the same 24 lines, maybe, but along the opposite lines. Why aren't 25 radiopharmacy licenses written as broad scope, any isotope 3
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231 l' to 83? I mean assuming they're. approved,fassuming-they're
( I 2- :-drug products and things lika-that.
-V 31 MR CAMPER: Why aren't they?
4 MR. BROWN: Yeah.
'5 MS. MOORE: Would the "as needed for use"-meet the 6 ' requirement?
7 MR, SWANSON:- Does this come down to, 8 fundamentally, the skill of the person writing the license?
9 .MR. CAMPER: Well, I think, historically, what it 10 has to do with is the idea that you are authorized a n 11 large-scale radiopharmacy operation. The idea is to know 12 what_ materials are being handled in what quantities and to 13 know that the program is manageable.
14 Now, could you broaden it to the 3 through 83 I 15 concept, perhaps? Historically, I believe, though, that's 16 why we've' set it up the way we have. The idea is that we 17 know what material and what quantity of material and that 18 the-programs coincide with that.
19 MR.-BROWN: Are there any nuclear pharmacy 20 licenses with authorized use for 3 to 83? I don't know of 21 any.
22 MR. CAMPEP: Not that'I am aware of.
23 MS. MOORE:- There's a point here, too. If nuclear 24 pharmacies could have a broa3-scope license with the 3 to 83 1
25 as needed, but then, rather than an amendment, send in, say, i ANN RILEY & ASSOCIATES, LTD.
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232 8 1 -an annual report, that would give you the information;you
,m want, and then they.wouldn't have to amend their license.
Jx.s;-
3 It would be somebody's_ keeping a tally on what isotopes 4 you're_using in the activities, I would assume. Otherwise, 5 you wouldn't know whether your revenue was --
6 MR. BROWN: Well, I'm just thinking, in terms of 7 streamlining and business practices reengineering and things 8 like that, if the nuclear pharmacy can justify a broad-scope 9 type of use and they can make the NRC feel comfortable, they 10 have the resources and the talent to really run a 11' broad-scope program like that. I don't see a reason why 12 there couldn't be a broad-scope type of license.
13 MS. MOORE: The pharmacies would need to be aware 14 of the credentialing of individuals in the program, then, 15 other than the nuclear pharmacists and the RSO, which is a 16 point that, when we get to the next one, I was going to 17 raise.
R18 MR. CAMPER: Well, Roy, I think your comment 19 raises the challenge for the staff to consider as we develop 20 this. I mentioned to you that, in each case, our challenge 21 is risk-informed, performance-oriented consistent with 22 existing regulations.
23 What you're really saying -- and Mary capturc* it 24 very well -- from a streamlining, process reengineering --
25 in fact, maybe you said it, Roy -- standpoint, we should
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233 1 reexamine, is there something that we can_do that would (ml 2 allow this. process to be streamlined?
.v 3 The 3 through 83 question is a good one to put on 4 the table now, and there may be other ways that we can 5 modify our existing licenses requirements. One of the 6 things we'll do in this NUREG, as I said earlier today, 7 there will be an example license or licenses that will have 8 to be constructed, also. As we create this guidance, we 9 want to put in place an example license.
10 So we'll take that challenge and take a look at 11 it. That's a good point. And then we'll subject the model 12 license to comment. So, certainly, I can't commit to what 13 it will look like, but I will commit to the tact that we 14 should put that-issue on the table for review. It's a
/~N
'\m,) 15 challenge we mentioned. Mark, 16 CPT ROTMAN: I would like to address a couple of 17 these from a slightly different point of view. I would 18 support, if not necessarily a broad-scope approach of 3 to 19 83 with an approach where the nuclear pharmacy can simply 20 possess and distribute any unsealed radioactive material 21 that's going to be used in medicine or in research -- and 22 you could broadly define medicine to include veterinary 23- medicine use -- and leave it at that.
24 It's going to be very unusual for a commercial 25 nuclear pharmacy -- and that's the only thing I could fM ANN RILEY & ASSOCIATES, LTD.
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234 l
- 1 envision here being licensed under'Part-32 -- to use a whole
?x 2 lot of the oddball isotopes. There's certainly not going-to
)
3- be any economic _ incentive to have things _around that do~not 4- generate income.
-5 So you're not going to have-a-lot of unusual 6 isotopes in your possession, simply because they're 7 expensive, and you have a very limited chance of selling 8 them. It would seem to me it's going to be somewhat 9 self-regulating in terms of what they're going to actually 10 have on hand, but you want to allow them the flexibility to 11 have or co get thing quickly and easily should the need 12 arise.
13 I can envision a situation where, maybe, an 14 interesting article is published in the Journal of Nuclear
) 15 Medicine, talking about a certain compound can be labeled 16 with an unusual isotope and be used in a certain kind of 17 pain palliation or whatever, and some doc wanting to 18 prescribe it. He starts calling the local commercial 19 nuclear pharmacies and they say, "Look, I can't get that for 20 you. It's not on my license."
21 Now, I know this happens fairly routinely, because 22 there are a number of researchers who like to use things 23 like Carbon-14 or tritium-and Sulfur-35 in some compounds, 24 and they can't get anybody to make it.for them because none 25- of the-commercial nuclear pharmacies are licensed for those f~s
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235
- 11 _ isotopes.
- I-think that that has a negative' impact on;a Y l A, /-
- 2- .certain" amount:of medical research and a certain amount of '
' 3~ ' medical practice.- Grantedtit is a small amount, butcit.does
.have-an impact.
f4 .
~
-5_ Now, the second issue, possession-limits. Again, ;
6 -for-the same economic _ reasons,; nuclear pharmaciesfare not 7 going tx) stockpile large amounts of isotopes. They all go 8 awayLrather quickly, and alllof them that are used;commonlyf 4 9 in medicine have-a relatively short half life.
10 Most places have gone to just-in-time inventories, 11 so that they just get replacements as it's needed, because ,
12 it's expansive to have~ things sitting around and decaying.
13- So to have_a possession limit seems to be an awful lot of
'14- extra-paperwork when it's really never going.to be an issue
-U 115 in a= centralized or commercial nuclear pharmacy.
16 But the last point I want to make is that, suppose 17 you have a possession limit, and you set it so that you try 18 to run pretty close to it, and you keep turning over your 19 inventory.- A manufacturer - -perhaps as a way to gain 20 . competitive edge -- giveslyou an extra day of calibration on 21 something. All of a sudden, that shipment comes in, and 22 whoop - -the alarms go off. You're over your possession 1
23 limit.
24- It_'wasn't an intentional effect on your part in 25 order;to-get more in.' Maybe it's-just that the product that
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236 1 Lyou normally bought andlkeptlon hand chang'ed a little bit.
'Y- -2 - Maybe_- it 's that- the day of: delivery changed. All of a
-[J sudden, you're over-your possession limit.- ,
4- So you want to build,in flexibility for these ;
5- : guys, and a way to do that is to not have afpossession 6 limit, because they're not going to stockpile this stuff.
7 They're not going to have a lot of itfon' hand.
8: Econom3cally, it'would be suicidal to do that.1 9 We're not talking about a broad-scope license like 10 a huge research facility where you want to have an idea of 11 .how much they're going to have on hand, because you know 12 -that a nuclear pharmacy is going to turn it over as fast as 13 , they can-.
14 MR. CAMPER: Mary.
I) 15 MS.' MOORE: I'm not quite sure I agree with 16 everything Mark was saying. Doing licenses, your possession
- 17 . limit is not just what you're going to be shipping out to 18 the licensee. It's also your rad waste, as well as your 19 residual, as well as what's coming in that same day.
20 So, when you do a license, you always make your 21 ; possession limit as large as possible, as large as they'll 22 buy. In a nuclear pharmacy, the possession limit can be l
. 23- huge, so you're never over your possession limit.
-24 I didn't understand, if the manufacturer changes
- 25 packaging, how that_ pushes you over your possession limit --
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237 1 on this comment.
2 MR. CAMPER: The_ quantity of material that they
{)
- 3. would ship. In other words, they would only ship an amount 4 of certain size,-which may put you over-your possersion 5 limit. I think that's what you're getting at. Right, Mark?
6 CPT ROTMAN: Yeah. If the manufacturer changen 7 the packaging to give you an extra day of calibration as an 8 economic incentive --
9 MS. MOORE: Through the nuclear pharmacy?
s 10 MR CAMPER: Yeah.
11 CPT ROTMAN: Say you buy your thallium in a 12 certain size vial, two days pre-cal. The manufacturer has a 13 special, and they want to increase their circulation, and 14- _they give you an extra day of calibration. So now you get (A,) 15 it three days before calibration.
16 MS. MOORE: Okay.
17 CPT ROTMAN: Whoop! All of a sudden, you've got 20 18 percent more than you ever planned on. If you combine that 19- with, perhaps one standing order getting canceled because 20 the cardiologists at that clinic are out of town, and you've 21 got more junk on hand than you planned for, you don't want 22 to be in violation.
23 Now, certainly, you could set your limit at the 24 sky, but then it's an unrealistic possession limit. If you 25 set your possession liinit way up there, then, theoretically, ANN RILEY & ASSOCIATES, LTD.
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238
- 1- Lyou've got;to have1the facilities - the shielding _and all-() (2z 3=
the?other things necessary to-handle that: possession limit.
-I think that that's somewhat being deceitful-to do 4- =that,-as well'. So I say, for commercial nuclear pharmacies, 5 why_even-set a possession limit at-all?
'6_ MS.-MOOREr- Because you then have to have your 7 shielding designed to_ handle whatever your-estimated maximum 8 is, and then if you don $t know what that estimate maximum
-9 is, how do you do it?
10 MR. CAMPER: Right. Exactly. -.That's what I was ,
-11
-about to - the blue-collar logic behind this approach is.
i 12, that you submit a program, and you describe facilities --
13 shielding, ventilation system,'et cetera, et cetera -- and
, 14. that implies, then, in turn, that you could have a program
_15 with a certain possession. That's the blue-collar logic 16' Jbehind that.
17 The other point, on the 3 through 83, one of the
'18 things that I would challenge our team that creates the 19- NdREG to look at is what is it that we look for or expect 20 .from a broad-scope licensee -- by comparison to 21~ manufacturers or radiopharmacies -- that leads us_to give a 22- broad-scope-license for-3 through 83 authorization?
23 MS. MOORE: Unlimited, but as needed.
= 24- MR. CAMPER:- Right.. So I think you'11' find.that -
1 25- there. clearly must'be some expectations of the broad-scope-e ANN RILEY & ASSOCIATES, LTD.
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239 1- ' licensees that we don't have on this side of the_ equation. !
n lQ :
Wetwould have-to put a handle on what that might'be.-
=3 _
MR.' BROWN: Yeah.. I think you could_-- you would 4 4 want to lock for more,_and you have a right to deserve more 5 for somebody that wants a broad-scope license, and then that ,
6 would be a~ reasonable request, 7 I have a couple of real-world examples on the 8_ possession limit. This summer, as Kathy mentioned before, 9 when there was a worldwide molybdenum shortage for a few 10 - days, we ran into'a couple of cases where pharmacies,_for
~ 11 whatever reason, had their possession limit no more than one ,
12 technetium generator, not to exceed 3 curies.
13 And granted, they started off only needing
,, 14 1 curie,- and then they went to 1-1/2, and they went to 2, 15- and they slowly were going up, bumping their head on the one 16 generator not to exceed 3 curies, although they were 17 routinely getting a 2-1/2-curie generator.
18 When the moly strike happened this summer, there 19 weren't as many 3-curie generators being made. There were 20 only.2-curie generators being made, so all they could get
' 21. was one 2-curie generator.
22 They said, if we needed more technetium, the only 23 option was to ship a-recond generator, and they couldn't do it,1because they can-only have one generator; they can only 251 go to_3 curies, yet-they needed the technetium. Granted it s; -
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1 240 11 - was_probably the pharmacy's-fault they were that-close to
~
2 their possession-limit, but-it happens,. It's a real-world1 z ;
- (_)U l
=3 situation, j
- 4. .The other-thing;that happens'all-the time,
- -as Mark
' mentioned,-is certain sizes. Sometimes, when the pharmacy '
~6 'or1the hospital: reorders a size, a manufacturer doesn't 7 'always have that exact size, and you have to bdmp them 8 either'up or down. Sometimes,-if-they're close to their 9- possession limit, you-can't give them what they want without 20- goingiover their possession limit.
11 You can point and say, "
Well, it'c really the -
12- phnrmacy's fault," which it probably is, but any time-it 13 inhibits the practice of medicine, I think something should-14 be looked at.
n-Q 15 MR. CAMPER: Yeah. Good point.
16 MS, MOORE: Isn't there an access route in that 17 kind of situation to call the region and expedite an 18- emergency amendment?
. 19 MR. CAMPER: Yes, there is.
20 MR. BROWN: There were several of those granted 21 this summer.
22 MR. CAMPER: There were several granted this 23 particular summer,-and a few years ago -- like.four or five 24 years ago, I think, now, we issued an emergency order that 25- granted expanded possession, t
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l 241 1 MS. MOORE: When you say size, are you talking
[^ t gj 2 about activity levels?
3 MR. BROWN: Mm-hmm.
4 MS. MOORE: Speaking of definitions.
5 MR '. CAMPER: Okay, Tony. Where are we?
6 DR. TSE: I have just a queution or so on this.
7 If you have any isotopes, then would that involve 8 instrumentation if it's pure alpha or betas involved? So 9 ther' fore, do the licensees have to have some 10 instrumentation?
11 CPT ROTMAN: The regs already cover that, Tony?-
12 DR. TSE: Okay.
13 CPT ROTMAN: If you're going to make alpha or beta 14 emitters, you have to have the appropriate instrumentation.
O
( ,)
t 15- It's in 32 already.
16 DR. TSE: Thank you. Do you think we can have a 17 few minutes' break?
18 MR. CAMPER: We certainly can. In fact, it's now 19 3:06. Why don't we take 10 minutes.
20 DR TSE: Thank you.
21 MR. CAMPER: Fifteen at most, please.
22 [ Recess.]
t 23 DR TSE: This is a training experience again, but 24 in a more general sense.
25 -[ Slide.]
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'242-11: The L first question is/ "Can-I"also,- at the-main
- .2 Lfacility,Lserve_as.RSOLfor. satellite facilities?" ' ' Now,lIl 13_ ~ imagine <that must beldependention how far the-satellite j
- facilities 1are_away et. cetera. So I wonder what you;are_
=
5- thinking about whether that should be a good idea or.not a
- 6 }- good idea,or it: depends under what situation. Does.anybody
=7 Lhave some_-- Mary.. ;
8: - MS. MOOREi! I have a whole l'otLto say on the~whole'
{
9 . issue of training experience, but looking at the :three .
.10_ questions immediately, number one, if_we go along with the_ '
11 same_. concept of a broad-scope license, then I don't-see any.
- 12. 1 difference. You.can have the radiation safety officer with 13 jdesignated individuals, based on their training and a 14 experience, to act as deputy:RSOs'at different sites.
15 That's'certainly feasible, 16 Is a pharmacy required to train the carrier [
17 personnel who picks up and delivers packages to a pharmacy 7 18 :You better believe they are. They chould be. They should 19 be required to make-sure.all of their personnel that are 20- handling radioactive material are trained. >
21: On the. third-point, I don't know if it's necessary 122J .for them to be required to provide DOT information on'the-
' regs, but ;it 's - a smart move -- speaking as a customer -- if
~
-23 m24L the pharmacy can: help _them with the-DOT-regs, obtaining-them-for interpreting.them.or.providing the labels.
~
25:
[ .
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243 1- -If one pharmacy-does it and the other one doesn't,
[Q,j i- 2 there'll be a leaning ards'the pharmacy that does, 3 because the DOT _regs, in dealing with it, is a nebulous, 4 cloudy area in most hospitals, I believe.
5 But getting back to the second point, I have a 6~ real problem with nuclear pharmacies that will:use their 7- drivers to prepare unit doses. I have a real problem with 8 pharmacies that use secretaries and other non-trained 9 personnel, not only to prepare unit doses, but to run the 10 sterility tests and wnat have you.
11 The nuclear pharmacist who is in charge of that 12 facility, if they're under the gun from their management to 13 cut costs, then this happens. I've seen it. I don't think 14 it should be allowed, and if it requires regulation to force
/7
( ,) 15 the issue, then so be it.
16 But credentials of support personnel -- and if we 17 go along with the broad-scope license idea and the whole 18 structure of broad-scope license, which means radiation 19 safety committee, radiation safety officer, radiation safety 20 staff, training of personnel -- goes with the whole package.
21 MR. CAMPER: Mark.
22 CPT ROTMAN: I really wasn't going to say anything 23 about this, but I think I want to. add my two cents worth, 24 just to the tail end of what Mary commented on a minute ago.
- 25. If you keep in mind a traditional broad-scope
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244
_ 1 1' license - -perhaps a'model would[be a'large biomedicali
.2 .research: facility where they'treatLpatients,-where thsy do__
l 3 medical r_esearch on-patients,.wherei they do bench'research,- -l 14' 'in vitro-sorts of:research, and they have a-radiation' safety 5 connittee) they have a radiation safety branchi ; they have -
6 all of-everything that they would possibly need -- and.you-7_- compare that'_to:a_commercialinuclear pharmacy that's simply
-8 given a 3 to 83= sort.of provision in their license, it very-9 quickly becomes clear that-you're comparing apples and
'10 ; oranges.
- 11. The' commercial nuclear pharmacy is only going to 12 be preparing doses for human use or perhapa doses for
-13 research use,'maybe even, perhaps, some radiochemical 14 solutions for in vitro or' bench-top _research, but.they're 15 going to-be'doing it at the direction of an authorized user L
16 _ someplace.
17 They're not going to be doing any imaging of 18 patients. They're not geing to be doing any therapy of 19 patients. They're not even_ going to inject a patient in the
-20 nuclear pharmacy. . All-they're going to be doing is what 21 pharmacists do,-filling orders that they're given by some 22 sort of prescriber.
23: -If the~ regulations, as they exist today -- 32.72
~
24 - -provideLfor;their ability to use: alpha and beta emitters 25 .--1provided, of-course, they have the' appropriate c- .. ANN'RILEY:& ASSOCIATES, LTD.
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245 1 instrumentation.tofmeasure doses and-to do the proper
(\_ /l l 2 surveys-when1using those. oddball =-- when I say, "oddbal2,"-
3- 'they'reL not traditional (in the practice of: medicine now 7 -
4 sorts;of. isotopes, then it is'a really-small leap to let 5; them use any isotope-they want within'that range, because 6 .any isotope.they'want within-that range is either going to
~
7 be a photon emitter, a beta: emitter, or_an alpha emitter, or 8 a combination thereof.
9 If. the regs already address photon emitters, beta 10 emitters and alpha emitters, then there isn't a whole' lot.of
-11 add'itional things that the nuclear pharmacy: needs to do.
12- So they're not going to.need a radiation safety 13 -committee because they're not going to be making decisions-14 about what is given to a patient or who has got credentials-I) 15 to use radioactive material in a human, beceuse they're not 16 doing any of those things. They're just filling 17 prescriptions -- or if you want to call-them. orders -- for 18 their customers, for lack of a better word.
.19 Therefore, this whole issue about comparing them 20- to a broad-scope license is really kind of a red herring, 21 because they're never going to be real broad-scope licenses.
22 They're going to be nuclear pharmacies that have some
- 23. expanded-isotope availability to them, and I think that's 24 maybe the best:way to think of them.
25 MR CAMPERr .. Mary.
.b
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246 1 =MS. MOORE: When-I was talking about radiation
[s_- '2 safety committee,;there's'a corporate' office that has sites. ~'
1 3 'I-said.to-Roy, "Where are you located?"- St. Louis,-but !
4 Mallinckrodt'has facilities. Syncorrhas1-locations
- 5 throughout many states.
6- There could be a-corporate radiation safety group 7 . committee' overlooking the operations and setting the 8- radiation safety standards for that. company-that each of the 9 individual sites would be expected to maintain. Number one.
10 When I said about-the-broad-scope license concept 11 in regard to training,.in some pharmacies, per shift there
-.12 ;may be one nuclear pharmacist. I am amazed at the ability 13: that I've seen demonstrated by these individuals. They're 14 highly trained; they're very capable, p.,
is ,/ 15: But at some facilicies, the nuclear pharmacist is 16 one person, and then they have support personnel. Many are 17 nuclear medicine technologists that are fulfilling the 18 prescriptions. Others, they're anybody they can pull off 19 the line.
20 If the nuclear pharmacy makes a mistake, that 21 mistake can be distributed among 5, 6, 20 hospitals, 20 22 sites. If there is a contamination incident that is not 23 detected at-the pharmacy and ends up being transmitted to 24 all of-these other facilities, that's not run-realistic.
25: =Ifithe drivers'aren't trained to recognize damage,
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-247 ~i
- 1. ~something that happens>to a carrier, or how to transport the_
_2 ' shipments '- whatever other topics:-we: can bring in . -- they-
- 3 :can mess up. Something verylsimpleJean become unnecessarily 4 compounded and difficult for'everybody involved.
5 Training and experience of everybody in the 6: process is key to making.any; radiation safety program work.
7 Your concept that the_ nuclear pharmacy is just dealing with 8 very-simple diagnostic levels -- all-they have to do is fill 9 .up a bunch of syringes and ship them out -- in some cases, 10: .is accurate.
Ell _ But.they_may be filling 1',000 of those on first run._ Then they.have to deal with second run, and maybe 13- they' re of fering a third run. It is amazing-to watch ---
14 depending on a busy one, maybe from 12:30 in the morning
.(s ,/ 15 - until 5:00 the next day -- how' organized, structured, 16 superbly these labs do work if they have properly trained 17- people. That training -- I cannot emphasize enough,
-18 training and experience of everybody involved in the process
- 19. "is key.
20- MR.-CAMPER:- Kathy.
21 MS SEIFERT: I have no quarrel at all with 22 training and experience. I run-the Training and Experience 23- Department for us,.and we certainly are interested in L24: .w ell-trained people and well-qualified people to do the job.
- 125- -; Going back to this, though,.can RSO at a main
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-248-
'1: pharmacy. serve asfan RSO.for'a. satellite. facility? That; tray N M '
- 2 :betappropriate in some' situations where,.say, if you have'a, J3- =cityolike Los Angeles,Jwhere you may h' ave-'one central-
"4 pharmacy'thatidispenses mostlofithe doses;-in the morning;.
~5 -for instance,-whenithe traffic lis.not bad.
6' - But if you have other-pharmaciesJin the Los 7 Angeles area that may open'upllater in the day -- they're
- 8- operating pretty much-as one unit of a group of pharmacies, 9' with1 satellites and sort of a hub' central pharmacy'- Jit-10 seems appropriate that the RSO for the main facility also a til -operate as.the RSO for the ancillary satellite facilities,-
12 since~the satellite f ;ilities are_ pretty much_in-the same 13 operation.-. ,
i 14 I think that's where that question comes from,-if
'rO
^
15
-( ,/ La: person who serves as an RSO can serve as the RSO in more 16 than one licensed facility. In our case, they're all under i 17 the same license, but not in agreement. states. That was the 18 question there.
19 I think the second question relates to not
- 20 'necessarily. pharmacy-personnel who pick up_and deliver 21 packages', but common carrier, common courier personnel.
22 JThat.was the issue in that one.
- 23 - DR. TSE: Carrier.-
- 24. .. MS. SEIFERT: That was the issue there. There.are 25: DOT requirements,'certainly.. Is the pharmacy required to
.h. 's- _
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249' 1: train-all the personnelifor aEcarrier who would pick up and jf3J. 2 deliver, not-pharmacy personn'el,-but,-for instance, to carry 3 to--- is-the pharmacy. required-to train the FedEx people, 4 for instance? -
That's the question.
5 -MS. MOORE: No, but the NRC -- so help me, I have [
6 spent days on the phone, being passed from one office to the 7 next with Federal Express and UPS.- They will refuse -- one 8 . will refuse to deliver other than to a warehouse. FedEx
- 9. will at least deliver to the hospital. But when they--- if 10- they would deliver to Purchasing, fine, even though'they're-11 designated to go to Nuclear Medicine. Oh, well, it's a new
-12 man. The training of these --carriers -- I'm slipping into 13 " characters," but carriers --
14 [ Laughter.)
15 --
I'm sorry, but goes back to you guys. If you 16 are allowing these businesses to act as interface between 17 the pharmacies and the licensees, the hospitals and the 18_ imaging centers, what have you, then either DOT or you folks 19 need to trke a look at their training.
20 The pharmacies shouldn't be required to it. The 21- hospitals shouldn't be required to do it. But if they'are 22 legally allowed to transport these materials, then somebody 23 should-be overseeing them, and.somebody should requdre that 24 company to.have_them trained.
12 5 When they deliver, they bring in 40 or 50 I ' ANN RILEY & ASSOCIATES, LTD.
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<1 packages. They.-don't care what's radioactive or not. .They (h 2
-3 may;havelseparate, bills of lading - Jwhat do you call that paperwork? --ranyway, separate paperwork.
I don't know if
~
~4 they even have a clue what:they're dealing wi*h or how to 5 handle'it.
6: MR. CAMPER . That's interesting. <It's an 7 intriguing issue. The common carriers are not covered in 8 our' report.
9 MS. MOORE:. Well, somebody needs to cover it.
10 DR. TSE: I have some explanation later on, after
' 11' the discussion is finished.
12 MR. BROWN- I'm going to jump in here. I don't 13 think it is.a regulatory vacuum. I think the DOT 14 regulations are pretty -clear '.a terms of what is required, A
a
). 15 what's required in terms of controlling TI, the number of TI 16 handled, the requirements for handling any HAZMAT material, 17 including radioactive material. If they handle more than a 18 certain number of TI, they're required to get an exemption 19 that requires a very. detailed radiation protection program.
20 So I think DOT does a good job, and NRC and DOT 21 have an MOU between the two of them to look at the transport-22 side of'it. It has been our experience that the couriers 23 out-there.really are making a pretty good attempt to follow
- 24 - .the regulationsLand, in most cases, doing a pretty good job.
251 'In some cases,=we've-had to supplement their own 4
['N N
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251 1 training with us going'out and training some of the
() 2
-3 couriers, so that's not to say that's not going to happen in every case. .
4 We do a lot of work with the carriers through an-5 _ association called Radiopharmaceutical Shippers and Carriers 6 Conference, where the manufacturers essentially have 7 developed some training programs that_we give to the 8 carriers to use - videotape training programs, written 9 training materials -- but there certainly are quite a-few 10 DOT regulations out there for training-requirement, training 11 and experience.
12 MS. MOORE: Well, I'm glad to hear that you folks 13_ are doing that. I think it's beyond your call. I'm glad 14 you're doing it, but when they deliver 40 packages with the
() 15 radioactive shipments mixed in with the bandages, I don't 16 think they're following any kind of training or segregating 17- or even identifying, when they deliver it to a Purchasing
.18 = Department, what's radioactive and not. Plus, then, if it's 19- leaking, they've contaminated the whole shipment.
20 MR. BROWN: Yeah, it sounds like you definitely 21 have seen-some isolated ptablems.
22 MR. CAMPER: Tony, I assume, from this ccmment, 23 that guide says that the radiopharmacy should, in fact, 24 -train courier personnel.
25- DR. TSE: _W ell, I think, after Dennis has his O ANN RILEY.& ASSOCIATES, LTD.
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252 1 comments, then I'll explain. j 4
() 2 3
MR. CAMPER:.
MR. SWANSON:
Oh, okay.
Well, actually, what the guide says
{
I 4 is, "If a person making deliveries of radioactive material !
5 at the licensee's facility is likely to receive a dose in r 6 excess of 100 millirems in a year from the licensee's 7 -activity." I think the important clause there is "from the 8 licensee's activity." !
- i. -9 Certainly, I think there is an obligation to train
- s. 10 shippers respective to radiation exposures at their own ,
t t
1- 11 *acility. That's where it ends. If I'm running a nuclear 12 pharmacy, I don't have the obligation to train them on how 13 to handle till radioactive materia 2 s for all license 1
14 activities. It's'not my responsibility, nor shculd we be
() 15 imposing that_ responsibility on nuclear pharmacies.
- 16 I think, the last bullet, same thing applies. You 17 know, if a imedical institution ir. assuming a responsibility 18- from the DCT regulations for shipping back medical waste or 19 unused syringes, et cetera, to the nuclear pharmacy, then ;
20 they're responsible. Okay? They're responsible under the r
21 DOT regulations.
22- You-can't force nuclear pharmacies to assume that i
23' responsibility for them. Okay?- Now, if the nuclear 24- pharmacy wishes to assume that' responsibility _for them,- !
- 25 that's a different-issue.- But to force a nuclear pharmacy ANN RILEY & ASSOCIATES, LTD.
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253 l
1 via these guidelines to ast,ume responsibility for providing ;
j } 2 ,- appropriate instructions and what goes along with that is 3 'just plain' inappropriate, j 4 DR. TSE: Yeah, I think you summarized correctly.
.5 Roy, I'm very impressed about your knowledge about DOT. You -
6 are rights DOT did this way. ;
7 MR. BROWN: Oh, yeah.
8 DR. TSE: I mean'they have regulations like that.
MR. BROWN: Well, this may be another area where 9L 110 -maybe-an industry standard is the way to go, that certain i
11 training for pharmacy drivers or whatever -- you know, I 12 develop an industry standard that this is the boilerplate 13- training program or something. ,
14 You know, a lot of that stuff is in place, so ;
() '15 16 I -
..,at's another area we could probably incorporate it as an industrial standard, 17 MS. MOORE: I'm still confused. l 18 DR. TSE: Yes.
19 MS. MOORE: Is it for pharmacy drivars, their own t
20 employees, that we're talking about requiring training, or 21 is for the common carriers?
22 DR. TSE:- I think, when we put the carrier in, i
23 that means ABC Van Line. That's called carrier. The person 24 who ships the material is called shippec, and then the
-25 ~ person who --
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254 I 1 MS. MOORE: I understand that, but the nuclear 2 pharmacies have their own drivers. They load the shipment 3 in their car. They train them. Those are the ones they j 4 train'. l 5' DR. TSE: Of course. That's their employees. j 6 That's not carrier personnel. ,
7 MS. MOORE: Well, it's not their responsibility to j 8 train the carriers. It's the carriers in question.
l 9 DR. TSE: Well, that's the question. Wait a :
i
- 10. minute. I think that Dennis just said it. If a carrier 11 personnel -- carrier, meaning coannon carrier -- comes to l
12 your facility, as a result of, in your facility, receiving '
1? more than 100 millirems per year, NRC's Part 20 says you ;
14 need to train them.
15 MS. MOORE: Okay. But if they're coming for a
-16 pickup, and, as a result of being on site, they could 17 receive more than 100 millirem in a year, then that's the 18 -same as any licensee. That is differant from requiring the 19 pharmacy to train these character -- carriers -- I'm sorry.
20- My subconscious is getting in here.
l 21 (Laughter. )
22 MR. CAMPER: Freudian slip.
- 23. MS. MOORE: My frustration level with dealing with 24 'them -- the carriers in how to handle the packages. That's 25 a'different issue. That should be UPS and FedEx's- ,
)
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._ - _ ._ __ _ __ . _ _ . . - _ _ _ _ . _ _ _ ~.
t 255 l' responsibility. . The protection.J they have to take while
(~s_/
) 2 .they're on site -- yes, there is a little bit of overlap in 3 handling the packages -- but in safely transporting them, 4 that's outside the purview of nuclear pharmacies.
5 DR. TSE: That's right. >
6 MR. BROWN: Let me point out, this was covered ;
7 pretty thoroughly by the NRC in Generic Letter 95-09, where 8 it really addressed what the fixed facility's 9 -responsibilities were, dealing with both their own drivers 10 -and carrier personnel.- So I think'it was pretty clearly 11 . delineated in that Generic Letter.
12 DR. TSE: But that says at their facility. If i 13 you're transporting en route, that's the carrier.
-14 MR. BROWNi But it also addressed carrier
() 15 personnel coming into a fixed facility.
16 DR. TSE: That's right.
17 MR. BROWN Where, if ABC Courier -- your example 18 -- came into a Mallinckrodt facility and picked up a 19 package. -
20 DR. TSE: Yes.
21 MR. BROWN: Also, I would point out that I think 22 it's the responsibility of any nuclear pharmacy that's out ,
23 there to make sure any courier they're using really has 24 their act together as far as DOT regs.
25 DR.-TSE: That's right.
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256 l' MR. BROWN: And that's not a regulation, and it
\
(d 2 3.
should not be a regulation, but that's just good business, MS. MOORE _ Yeah, but you shouldn't be required to 4 have to do that.
S' MR. BROWN: You get into a liability issue there, 6 and-I'm not --you do?
7 Yeah.
8 DR. TSE: So let ine summarize. In the first 9 question --
10 'MR. CAMPER: I'm sorry. I have a more intriguing c.
11 question that we need to take a look at.
12 DR. TSE: Sure.
13 MR. CAMPER: This is interesting. It says, 14 " Shippers and carriers of radioactive material must also r
15 receive appropriate training. If a person making deliveries 16 of radioactive material at licensee's facility is likely to ,
17 receive" -- is likely to receive - "a dose in excess of 100 18 millirem in a year from licensee's activity, licensee is 19' responsible-for ensuring that person has received training 20 as specified in Part 19."
21 Now, 20.1301 says, " Dose limits for individual 22 public." These carrier personnel would be members of 23 public. 1301(a) says, "Each licensee shall conduct H24 ' operations so that" - - -
25 -MR. BROWN . Whoa, whoa, whoa, whoa. Back up. I
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i 257 l
- 1. don't think carrier personnel are members of the public.-- l
/
V I 2- DR. TSE: 'They're workers.
3 MR. CAMPER _ They are exposed. Are they I 4 occupational workers? !
5 MS. MOORE: No . - UPS and FedEx? No. ,
6 1MR . CAMPER: They're not badged occupational !
t
- 7. workers. '
8 MR.- BROWN: They fall under OSRA regulations.
19- -
MR. CAMPER: They fall under OSHA regulations?- j 10- MR. BROWN: 1910-96. j 11' LMR. CAMPER: But what class of workers are they?
~12 MR. BROWN: As radiation workers, while they're 13- dealing with radioactive material.
14 MS. MOORE: But who's film-badging them? t
() 15 MR. CAMPER: Are they badged? ;
16 MR. BROWN: They're not necessarily -- the idea of f 17 the DOT regulations and the' limits of TI per package and 18 ' total number of=TI per-vehicle, total number of TI per 19 shipment is ba.1ed on a premise that, provided you meet these ;
s 20 TI' requirements, then you don't have to have a radiation 21 l protection programf you don't have to have dosimetry, and on
- 22 and on and on.
23 DR. TSE:_ That's right. .
~241 -
MR.-BROWN: The-whole premise of the-DOT regs and. '
~
'25 - the.,TI and the' separation distance was all based on having
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i' 258 i i that in lieu of a radiation protection program. ;
[4 x_
j 2 CPT ROTMAN: Is that why you can have a sole 3 shipment and you can badge the driver and he-can go above i 4 what the existing TI would be? !
5 MR. BROWN: Right. l 6 MR. CAMPER: Well, where I was going with this --
7 I'll have to look into that -- but it's not clear-to me, if-i 8 I read.1301, how a licensee can allow such a situation to 9 occur 1-- if, in fact, these are members'of.the public, not 10 occupational workers.
.11 MR. BROWN: Well, as I said before, I don't have a 12' copy of Generic Letter.95-09 with me, but I think that's 13 addressed specifically in there, and I think that generic ..
14' letter was written exactly in response to this. I wish I
() 15 had a copy with me.
16 DR. TSE: That's exactly like-he said, 17 MS. SEIFERT: An order for someone to get that 18 kind of dose, they would almost have to be in the restricted .
i 19 area.
4 20 DR. TSE: That's.right.
21 MR. CAMPER: Yeah, they would. That's correct.-
22 Th6y would.
23' MS. SEIFERT:
Physically, common couriers don't >
24 even go --'at least in a nuclear pharmacy, don't go in a 25' restricted area.. They may be in a manufacturing facility 1
[A _/ -
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t 259 l
1 where they're. picking.up boxes, which is considered a 2 restricted area..like a loading dock may be considered a 3 restricted area. But in-a nuclear pharmacy, that would not ,
4 be the case.
5 MR. CAMPER: Mary. 7 J6 .MS. MOORE: The other thing is, too, among the .
f 7 medical licensees, there was great concern that each of the- [
t 8 hospitals and centers using it were responsible for the i 9 training of the drivers. That was a big issue not too long 10 ago, because, when you say licensee, you have one licensee i
-11 on the pickupr you have another licensee at the delivery, t 12 So which licensee is it? .
13- At the delivery, if they deliver, as a lot of the 14 licenses have specified, down to the nuclear medicine hot 15 lab, now they really are in a radiation area, where at the 16 = pharmacy, I've never seen any pickup drivers way back where. -
17 the hot areas are. They're usually more towards the front i 18 or;an area that is very low-level.
19- MR. BROWN: This is exactly the discussion that 2 0 '- went on back in 1995,.and to complicate that even further, 21 the courier wan going from licensee.to licensee to licensee 22 to licensee. Is he-br.dged and. trained in every facility he 23 goes into? l 24 CPT ROTMAN: -And who's responsible? i 254 .MS MOORE: And who's responsible? _Right.
, i
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260 1 Exactly.
() 2 3
MR. BROWN The exact discussion was held back in 1995 after the Generic Letter came out.
4 DR. TSE: Anyway, let me summarize this.
5 MR. CAMPER: I'm sorry, Tony. Do we have a >
6 general feeling among the group on that point? Should this 7 training been provided to these carrier personnel?
8 MR. SWANSON: As it relates to exposure related to 9 your activities, relating to the licensee's activities. But 10 no, the responsibility really can't go beyond that.
11 MS. MOORE: And Larry, there needs to be 12 clarification on this whole issue, where you're going from 13 license to licensee, and the person who's doing it is not an 14 employee of any of those licensees.
() 15 This reminds me of Rent-a-Tech, where you go to an 16 agency and have one of their employees fill in for one of 17 your ill -- while you're monitoring them on site, it's still 18 that person's employer's responsibility to monitor and keep 19 tabs on their exposure histories and what have you.
20 I do think that these carriers -- these people 21 work for that carrier, and while there needs to be a 22 dialogue -- and obviously, the Nuclear Pharmacy Group has 23 entered into a dialogue with these common carriers -- but 24 there are too many licensees involved that they can't share 25 the training, because they have no control over who is going ANN RILEY & ASSOCIATES, LTD.
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261 1 to oe-representing the' carrier.
2 'DR. TSE: Well, the idea is that if the licensee's 3 estimate is expected, that this-carrier-driver will receive
=4- more than 100 millirem in a year at=the facility, then the 5- licensee will want to make sure that this person is trained 6 somehow. Who trains him, it doesn't-matter. They have to 7 be trained.
8 MS, MOORE: That is not, in my opinion, a valid or 9 a fair' burden to put on a nuclear pharmacy, the same way.
10 it's not a fair burden to put on the hospital or the imaging
~
11 ' center. It's fair into your access point,-where someone 12 -would be in a certain area of their facility -- as Dennis 13 said, while they're on site.
-14 DR. TSE: That's right.
15 MS. MOORE: And estimate the amount of time. Yes, 16 that's a simple procedure to do, because you would do that 17 not just for a carrier, but anybody coming inta your 18 facility.
19 DR. TSE: That's right.
20 MS. MOORE: So that, ce facto, is inherent in the 21 program. But to carry it into a requirement for cotMon 22 carriers making deliveries, you can't do that, because you 23- ' don't:know what they're carrying in.- You don't know how the 241 -box'was prepared or anything else. I_mean it's just not-25 fair at either end. -It-has got to be whoever the carrier is ANN RILEY & ASSOCIATES, LTD.
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I, working for --:on training.
t 2 DR. TSE: Well, that's the question.
3 MS. MOORE: . Yeah.- To my opinion, it's not fair to 4 require it of thh pharmacy or the hospital. l l
5- DR. TSE: Well, the question is if this person -- !
6 regardless of whether=he's employed by you or not -- will -
7 leceive more than 100 millirem in'a year at.your facility'. l 8 Now, if.your answer is yes~, you do nothing. still it's not 9 ,our responsibility to train this persor.?
f I do?.,'t think it's their !
10 MS. MOORE:
11- responsibility to train the person. I think it's their 12 employer's respons.%ility.to train the person to carry out ;
13 that person's responsibility, which includes delivering 14 radioactive meterials, picking up at nuclear pharmacies,-and 15 Idelivering to hospitale 16 If the powers that be -- whoever regulates this. I i
17 group -- deem it approprirte for common carriers to do this, i 18 then it's the responsibility of the common carriers to train 19 the people, same way it's the nuclear phannacy's l 20 responsibility to train their people; it's the hospital's 21 responsibility to train theirs.
22 DR. TSE: Okay. Then would you think it's your ,
23 l responsibility.to make aure that--- you' hire some carriers 24- .to pick up your packdges - Do-you-want to make sure their 25 people are trained, or you don't~need to make sure? :
r
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263 1 MS. MOORE: I would like confirmation from their-() 2 3
employers that they've trained their people.
DR. TSE: I think that's acceptable.
4 MS. MOORE: And I would like some information on 5 what kind of training they had, but that may be beyond the
- 6. scope, and only because I'm picky.
7 DR. TSE: Any other has comments on this 8 viewgraph?
9~ [No response.]
.10 If not, let me summarize. As I understand it, 11 there can be a central RSO depending on different 12 situations. You cannot generally say yes or no, ,
13 Second one, it appears that some people believe 14 thac the pharmacy does not have a responsibility. Does
() 15 anybody believe they do have a responsibility if it's l
-16' greater thanl100 millirema per year in your facility?
17 MR. SWANSON: Well, let me clarify. You have a l 18 responsibility to train-the carrier as it relates to the !
)
19 activities the carrier performs in your facility. -!
20 DR TSE: That's right. .
I 21 MR. SWANSON: Because, likewise, you cannot put 22 all of that treining back on their employer, because their 23 employer doesn't-know -- you've got a carrier that's ]
24- delivering to 30 facilities. .Each facility is going tc have 25 its own characteristics.- Okay?
l O -
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i 264 ,
1 So each facility needs to do training respective j rx to the activities that that carrier.may do in their
? i
-(>~-) ~
3 facility. I do think that that's a reasonable 4 responsibility. But to require a given licensee or facility 5 to train a' carrier for all their radiation safety issues is ;
6 Anappropriate.
7 MR. BROWN: Tony, I think that wording in 8.2.1 is !
8 .right out of the Generic Letter. I'm pretty _sure. j 9 DR. TSE: It's possible.
11 0 MR. BROWN:
The Generic Letter requiring that the 11 licensee do something if they receive over 100 millirems.
12 MR. SWANSON: And the key clause here is "from 13- activities _in your facilities."
14 MR. BROWN . Exactly.
()
3 15 DR. TSE: Okay. The third one, the comment is 16 '
that a pharmacy really does not have a responsibility to 17 train how to comply with DOT regs. It would be nice to 18 provide them, but it'should not be saying, " Hey, you are 19 required to provide." 'Thank you. Yes.
20 MS. MOORE: The comment I want to throw out on the 211 table for consideration is -- because Kathy's mouth fell 22 open when I said about training _a support personnel or 23 _anyone-who is preparing the doses.
24 -As I understand'it from.my reading of-the regs and ,
25 what have you, the regs only. address the requirements of the ANN RILEY & ASSOCIATES, LTD.
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265
~
1 nuclear pharmacist and the RSO with the idea -- and I
() 2 3
understand, historically, when the State of New Jersey looked into this, that there's a pharmacy assistant concept, 4 where the pharmacist trains anyone to fulfill prescriptions, 5 and that this is carried over into the nuclear pharmacy 6 area.
7 Based on my experience with the loopholen that 8 I've seen, I do think there needs to be some kind of 9 identification of the criteria for-credentialing of the 10 individual preparing doses.
11 MR. SWANSON: A comment on that. First of all,
-12 the Reg Guide and the regulations clearly specify that 13 individuals that in the course of their appointment are 14 likely to receive a dose in excess of 100 rems must be
() 15 instructed according to 19.
16- The extent of the instructions must be 17 commensurate with potential radiological health protection 18 problems presented in the workplace and consistent with the 19 type of work they're going to be doing.
20 That training requirement is in there . It does 21 appear in the regulations, You are obligated to train the 22 people commensurate with their activities. Okay? There is 23- no doubt.
24 MS. MOORE: Okay.
25 MR. SWANSON: Traditional pharmacy' allows the use
-( \ ')
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266 1 of p'tarmacy technicians working under the supervision of a ;
( ) 2 pharmacist. Therefore. you need to allow nuclear pharmacies 3 to allow the use of technicians working under the 4 supervision of a nuclear pharmacist. That also appears in :
5 this training guidance.
6 MS, MOORE: I don't have a problem with the 7 terminology. What I have a problem with is someone with a 8 limited education who doesn't understand what's being 9 presented because they don't have the scientific background 10 or the ic.ath background to understand the training, and it's 11 monkey see, monkey do.
12 I'm afraid the pharmacy technician idea -- I'm 13 assuming they've had enough science courses or background 14 information. No? Well, to ma, there's a difference in (m
15 looking at a prescription for 10 pills of 5 milligrams of 16 penicillin versus how do I decay this, draw up a certain 17 volume to get a certain activity, and not expose myself and 18 to be able to recognize going from photons to betas or 19 alphas. !
20 I think it's an area of liability for the 21 pharmacy, and I think it's an area of liability for the
-22 hospitals.
23 MR. SWANSON: I wouldn't disagree with you in the 14 least. Okay? People better be doing this. They need to be 25 doing it for many reasons. First of all, to be compliant
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l 267 i i
'1-with the-regulations that already exist here, but probably-() 2 3
more so from the liability considerations.. Okay?
But you know, what I hear you wanting to do is l
4 creating a whole new category called nuclear pharmacy !
5 . technicians with a specific set of training requirements. !
i
-6 MS. MOORE: 'Well, I'll tell you, in the hospital, ;
7 we;can't just have secretaries doing it. .They have to have 8 some; kind of:credentialing. Now, from state to state, you j L9 can have secretaries doing it. The-NRC doesn't have any t 110 kind of: requirement. As long as the physician'says it's 11 okay,-a-secretary can do it. In'otheristates you must have 12 -licensed personnel doing it, such as licensed nuclear !
13 medicine techs. :
14 MR. SWANSON: Well, let me also remind you the NRC
( 15: regulations currently don't recognize nuclear medicine 1 16 technologists.
17 MS, MOORE: I know they don't.
i 18 MR. SWANSON:- There's no training or experience 19 required.- ;
20 MS. MOORE: I know.
. 21 MR. SWANSON: So now you're wanting to create a :
22 ! separate category-to address' pharmacy technicians?- I'mLnot
- 23 sure.whether --
L24 MS. MOORE: No. I think the whole broad question i.
25 needs -- there's credentialing of physicians, nuclear -
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268 ;
1 pharmacists.and physicists, but you leave out credentialing i 2 of the individuals that are actually preparing it and
[} "
3 injecting it. Some states require licensure; others don't.
4 So it's a whole mixed bag _out there, j
5 But it came home to me very-strongly when I saw it _
(
6 with the phatracy, because there an error is not going to 7 affect five or six patients. hit could affect 50 or 60 in 8 one day. The pharmacies I'm sure are very well aware of it, 9 but in cost-cutting, it's an options it's a loophole, i
10 Does it have-to be that formalized licensure? I
-11 don't know. I think it's an issue that-needs to be ,
12 addressed and reviewed. What are the credentials of the ;
13 people preparing the radiopharmaceuticals, be it in a 14 nuclear pharmacy, be it in a hospital hot lab? That's where
() 15 16 the breakdown occurs.
DR. TSE: Please go ahead.
17 MS. SEIFERT: First of all, my mouth dropped open 18 because you said drivers drawing doses. That was why my 19- mouth dropped open.
20 MS. MOORE: I've seen it.
21 MS. SEIFERT: Not because of non-licensed
~22 -personnel. Because, quite frankly, the pharmacy technician 23 . rules are evolving over time in the pharmacy regulatory 24- areas. - As that evolves, it looks like~they may or may not-
.25 go toward licensing, ANN RILEY & ASSOCIATES, LTD.
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269 l 1 But certainly the activities that are acceptable
() 2 3
activities for a pharmacy technician -- and that's under the direct supervision of a pharmacist, and the pharmacist is 4 responsible -- as those people are well trained and may or 5 ~ may not have certain educational background, but would have :
6 been through a training program that. Would be specific to 7 those activities, those kinds of things are being addressed ,
8 in_the pharmacy regulations on the use of pharmacy l 9 technicians. You can probably speak to that, Jon. [
1 10 MR MAY: Yeah. That's a real hot area right now, 11 in fact.- Pharmacy techs are growing by leaps and bounds, 12 the numbers. State boards are being faced with "Should,we :
13 license them or should we register them? Should we give >
14 them tests?"
() 15 There.is an organization in the U.S. that is .
16 administering a test for pharmacy techs. They're not 17 required to take it, but a lot of techs are taking it, .ind
-18 they're getting " certified" as pharmacy techs. It's easier 19 to transfer from one job to another if you have that 20 certification.
21 In most states, you don't have to have a college 22 degree to be a pharmacy tech. You can come out of high 23 school. Some require a high school degree or equivalency.
124 Some are trained by the pharmacist. Other states'have a set
'25 of-requirements that'all pharmacy techs-in that: state must ANN RILEY'& ASSOCIATES. LTD.-
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270 1 fulfill. They're not very complicated. :
-[ 2' My main comment would be, what drives that is the 3 economics of tne profession. It's shifting its-paradigm.
4 It's shifting from the prescription to patient care. Who's 5 going to fill the prescriptions? They're going to be techs.
6 Who's going to be coi'.deling and doing cognitive services?
l 7_ Hopefully, it's going to be the pharmacist. j, 8 If there was ever a need, as I see it, for someone >
l 9 to get involved in making sure that nuclear pharmacy 10 technicians receive proper training, it's going to be the 11 nuclear pharmacy profession. 4 12 You're going to have to drive that, not the boards 13 of pharmacy in the individual states, because, by and large, 14 you're a very small part of it all. It's being driven by i 15 chain drugstores; it's being driven by the practitioners.
16 But in your area, you need to probably start 17 demanding that there be-some type of nuclear pharmacy techs, 18 and if you want them certified, someone comes up with an 19 exam and try to work with the boards of pharmacy to require 20 that they be certified, but I think you're going to have a 21 problem-there unless you can show a specific need. But 22: you're going-to have to drive that element of it in overall 23 technicians, as I see it. ,
I 24- MR CAMPER: Jon, I assume-under that model that 2 51 pharmacy.techs are filling these prescriptions under the b
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271 1 supervision --
() 2 3-MR. MAY: Absolutely. Under the supervision of a pharmacist, correct. .And if that falls short, and if there 4 is a problem, it's the pharmacist's license that's going to 5 be yanked, not the tech. The tech has no license, per se.
6 So the pharmacist has to do the job of 7 supervising, because the threat of -- not federal regulation 8- .or state regulation -- it's called civil liability and 9 lawsuits'-- is driving it.- If they don't do the job
-10 properly, and a pharmacir.t makes a mistake and someone gets 11 1 . sued,' oh my_ God, you could lose the store or the farm, the 12 life, the everything.
13 So there is a tremendous economic and legal <
14 implication behind all this. So they do supervise. The 15 problem is getting to be that more and more states are i 16 getting into a higher ratio of techs to pharmacists. Some i
17 states, it's one to one. No more. Some states, it's two to 18 ones some states, three.
19 Other states are now going into unlimited, as long
-20 as you justify the need for those techs. So you can have a 21 large operation where a pharmacist is supervising maybe four 22 techs. There, you have less time to watch and make sure
- - 23 that what they're doing-is correct.
24 How far.can you stretch that until you lose J25 ' control? That's all in this evolutionary process. This is
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272 f I
l' what's happening in pharmacy today, and it's good if, in l 2 fact, there is control over it,=because pharmacists can do i 3 what they're trained more.to do than to just' fill that
~4 prescription. a 5 And then, in nuclear, you need to have probably at .
6- least~-- I' don't-know if they should be higher-trained -
7 personnel,_but you'have a need'that's far more, probably, f 8 demanding ~than filling a routine prescription. ;
9- MS. MOORE: - The states-that we checked -- New 10_ Jersey and Pennsylvania -- the pharmacy boards didn't ,
11-- recognize pharmacy _ technicians or pharmacy assistants.
12: 'There's nothing in their regs. Has that changed, that ;
i 13 boards are now recognizing thece people as an entity?
~14 MR. MAY: Oh, they are, and holding the ,
' 15' pharmacists responsible.
16 MS. MOORE: Well, the pharmacist is responsible no 2 17 mat'er what.
18 MR. MAY:~ Absolutely, 19 MS, MOORE: But to have a group that was in 20 existence but ignored by the boards, it was like, "What do 21- you-mean?" And they said, " Yes, we know, but we don't' 22- _ recognize it." So if at.least they're recognizing it, then-
,23_ there's going to be-some kind of-focus on training.
24- MR.7 MAY:_ That's_ correct.
25- t L MS . - ~ SEIFERT : It's evolving, and also the group of I -ANN RILEY & ASSOCIATES, LTD.
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I 1 nuclear pharmacists through APHA is developing standards. ;
() 2:
3 They are,.of course,: voluntary standards, and-I think --
MS. MOORE: But at'least they're starting. .
4 MS. SEIFERT: Right. -
5 MS. MOORE: Okay. !
6 MR. MAY: And all states are moving toward 7 registering them, quite frankly, so they know who they are, !
r J B- where they're working, and tney can take action if t
9 nscessary.
10, MR. CAMPERt What I need to do on this issue, I'm
- 11. going to need to time-box it, one more minute of comment, i 12 because we've got a few things to cover yet. ,
13 We've said a lot about the training and experience 14 issue, and we've got about three or four pages to get
() 15 through, and general discussion.
16 MS. MOORE: Kathy made me feel better, and Jon, [
17- when they told me they're now recognized as a group, and 18 they're registering. That means there's going to be some 19 kind of oversight.
20 MS. SEIFERT: Internally, we have a whole program.
21 MS. MOORE: You guys ch).
22 MS SEIFERT: Probably more -- but again, that's f 23-not everybody.
-24. ;MS. MOORE: No. And the NRC left the door open.
25 MS. SEIFERT: Right.
3
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k 274 L 1 MS, MOORE: Again, the NRC goes -- one'of the 2: major roles the NRC plays _is: uniformity and consistency, so, 1( )
3_ basica11yi you level the playing field. Whether people 4 ' agree with how you've leveled it is a different issue, but 5 at least you're the focal point.
6 MR.' CAMPER: :. utorically, we have examined this 7 issue of should-we have some minimum level of training and 8 experience in our regulations. We took that issue to the 9: ' Advisory-Committee on the Medical Use of Isotopes. It has 10 been a-few years ago, now -- three or four years ago --
- 11- .five, perhaps ---and the general feeling was a resounding 12 -" No, we don't need to be there," that these individuals were
~ 13 adequately supervised.
14' -In many cases, they are, .in fact certified or have
- 15 'gone through some training programs. The sense that the p.
16 ACMUI sent to us was this wasn't an area that we needed to 17 be in.
- 18 MR. MAY
- That's for the states to regulate, this 19 training for techs.
- 20= MS. MOORE: Well, they can't on the pharmacy 21 -techs.
22 MR. MAY: Pardon?
23- MS.' MOORE: The pharmacy boards supersede the --
24 .like in~New Jersey, the Commission was going -- I was 25- pushing hard.cand we found we were superseded by the
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275 1 pharmacy board, who didn't even recognize the existence of
[)
LJ 2 pharmacy techs.
3 MR. MAY: In the fsture, they will all be :
4 registered, I'm sure, and maybe beyond that. Maybe they 5 will get into a licensure at some point. But it's moving.
6 It's evolving into a better situation, a more controlled 7 situation.
8 MS. MOORE: Good.
9 MS. SEIFERT: But these are two different groups.
10 Mary talked about nuclear medicine technologists.
11 MS. MOORE: Right.
12 MR. CAMPER: Okay, let's move on, Tony -- just to 13 keep things going.
14 DR..TSE: This item relates to facility and
() 15 equipment. The first item is, "Why do we have to submit to 16 NRC a diagram showing each area of intended use?" So if I 17 did that, then we would have to submit a license amendment 18 each time we change it. We already discussed a little bit 19 about that, the general philosophy of that.
20 MR. CAMPER: Actually, I think points 1, 3, and 21 4 --
22 DR. TSE: The fourth one. Third and fourth is 23 shielding.
24 MR. CAMPER: Talked a lot about, and I think --
25 DR. TSE: Yeah, we already talked a lot.
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276 1 MR.. CAMPER: Yeah. I think what I-have heard-is l
!i b 2_ that there should'be some flexibility in that area. Perhaps G'
3 ministerial changes or the like would be an' appropriate .
- 4. mechanism to use to allow that to happen. Any other :
5 thoughts.different than that on those three points? l 6 DR. TSE: Mary. -
7 MS, MOOREs- On the first one, every licensee that [
t EF I know of has.to submit a diagram._ Now, Kathy's point'about I 9; if they want'to move a hood or something,!and they're not-10 changing anything significant, you can. update it and notify 11 it. 'It doesn't have to be a license amendment. I can see :
12 that, but I can:also see why -- I think there's a good 13- rationale for having a diagram and everything on a piece of 14 paper located.-
() 15 .
It helps particularly in the groups -- be it a 16 hospital or a pharmacy -- that are dealing with generators. [
I 17 You make sure it's not next to the nursery. Not that yours 18 ~ would be, but the hospital's might be.
19 _I think it's good practice for everybody involved >
20 to have a layout, because it helps with future planning, as well as evalusting whether you have enough space and which 22- way you can go. But to have to be a-whole license '
R2i amendment, I think the ministerial change idea or the 24- notification would simplify a lot for everybody.
25; MR. CAMPERt Mark, i
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1 CPT ROTMAN: I think, on some issues, once again, {
O g '2 -I'm going to stay true to form and disagree with my l 3 counterpart here.
4 First of all, we are dealing with i>mmercial j 5 nuclear pharmacies under this Reg Guide and under Part 32,
-G. so there's not much likr lhood that your generator storage 7 area'is going _to be adjacent to a wall where there's a ;
8 nursery. !
9 -But besides that, every nuclear pharmacy that is-
-.10 in existence today has common elements in place. There are f
11 certain things you need o practice nuclear pharmacy. I i
12 mean.I think just listing the fact that you're going to have ,
13 these elements and that you re going to use them according 14 _to the owner's manual, or according to the-standards of l' practice or whatever, should be sufficient.
16 As an in-house or as a_ corporate control issue, ,
17 I'm sure there are going to-be architectural plans and j
'18 diagrams and all sorts of things. That's one thing that 19 makes good sense _for designing and building a facility.
20- -Tnere's human ergonomic issues. There are issues of_ output 21 per square-foot, all sorts of things that are related to hcw 22 your facility is laid out, 23 That is different than submitting.a diagram of +
24 your facility to the_ Nuclear Regulatory Commission when ,
25 you're applyin's for a-license, because 3f', at some point in O ANN;RILEYL& ASSOCIATES,_LTD.
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1 278 ;
t 1 time, you want to_ change that or you want to make a chango' .j 2 in'it, perhaps.a: hood manufacturer comes up with a go,a ;
'wf~ )</
3 deal. You're-then stuck with a situation'where you have to 4 amend your license. ,
5 The NRC knows very well what's involved, as far-as ;
6 ' equipment goes, in a nuclear pharmacy practice. We're going
-7 to be committing to, hopefully, this last bullet here, :
l 8 performance-based criteria .as f ar as shielding necessary ~to -!
L9 keep dose rates to a known amount. It's very well
'10 established how things are stored and, in waste areas, how
'll much shielding is needed.
12 This is a pretty well-established profession. I 13' , mean nuclear pharmacies have been around since -- I guess 14 '73 was the first known one, so that's what? 24 years now? !
() 25 I don't think there's a wholo lot that-the NRC can find in a 16 plan that's going to improve upon that when you l'ook at the 17 . corporate and the total experience that's out there. To 18 submit a plan like this, I think, is juet busy work that 19 limits your flexibility. l 12 0 MS. MOORE: I disagree with Mark, as usual. No, 21 actually, from the pharmacies I've seen -- and Kathy could
.22i discuss this more than I can -- depending on where they are 23 located and if it's a new area, it may be a smaller lab, and 1 24- then they may'want to' break through the wall or expand. I 25 think.it's_a good standard-practice for everybody, and i
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279 1 pharmacies are not'the only ones that have to submit a x - - -
J ) 2- diagram. But I don't think it has to be a license v.
3 amendment.
4 MR. CAMPER: Well, I gueas, from our standpoint as 5 regulators,- we come back to the issue that I raised earlier.
6 What would our reviewers need to see or know to ensure that 7 the facility that you intend to :se as a radiopharmacy in 8 fact protects public health and safety?
9 Now, I think what I heard Mark saying is that, in 10 -lieu of seeing a diagran. and knowing where the hood is and 11 where the lid blocks are placed and so forth and so on, that 12 there-cay be some standardized criteria that already the 13 pharmacies put in place and that a commitment could be made 14 that said criteria is being satisfied, (n,) 15 I don't know if there's a standerd that would 16 specify that criteria, but I think that's what I'm hearing.
17 Mark, is that about it?
18 CPT ROTMAN: I wor ~ 3ay that's as good a 19 description as I would give. I would just add that, to be 20 more consistent with the non-radioactive world of licensing, 21 perhaps the issue should not be one of a review of a diagram 22 and a list o* equipment that's to be bought to determine 23 safety, and perhaps the issue should be-a pre-startup 24 inspectien.
25 Then you get to walk through, and you get to find n
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280 l =out. I'think a lot canlbe squeezed-into a:idiagram that may;
.(
N N- 12 :necessarily not work in reality. So I would say a; diagram
- Q ): '
3z -is just an exercise:in paperwork.--It doesn't really tell
- 4 you
- anything about how the facility is going to operate once 5 it's up and running, and the best way to do that is to 6 ' inspect it.
Otherwise,:I would think that the NRC might be 8: able to get away without actually visiting a site to inspect 9 it. They could simply:say, " Send us all of your records.
10: -Send us diagrams and maybe some videotapes of how your E11 people operate.- We'll inspect-you from headquarters."
12 MS. MOORE: People would pay them to do that.
13 MR. CAMPER: Kathy,--I think you were next.
14 MS. SEIFERT. I' don't really have a disagreement
) 15 with submitting diagrams. In the first place I know it's --
16 it may be a philosophical discussion, but practically, it's 17: not a problem.
18 My issue just-is that if we could make changes, 19- say, within a restricted area that didn'tz impact radiation 20; safety, that that would not be a-problem, that it could just 21- be a notification or even-just do it. If it doesn't impact 22' radiation safety, make any difference with.that, that would 23 -be. fine. I wouldn't have any problem at all with that. I 24L :certainly don't have a problem with submitting diagrams.
In 25: . fact, internally,.we use diagrams 1anyway.
m_
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1- MR., CAMPER: Mary.
./ g .
2 MS. MOORE: I gotfthe impression"when Mark was. i 1]
13 speaking;that_the diagrams submitted-were-not representative
~
4 of tbe actual site ~. Usually, they take the' architectural 5 plans and'look at-it and take that:as the, diagram and submit 6 iti.with-the caveat-that if something has to be changed, 7 they'll notify them,- or as part of'the-licensing thing.
'8 .But-if you-don't do this, you're in real trouble-9- if they come out on the first inspection and find that there 10 was a: gap in the understanding,-and-your first inspection 11- - could be brutal . -You're probably=better-off_giving the 12- diagram of where everything=is up front.
13 I don't understand why the_NRC can't recommend 14- something if they want-to. recommend it, as long as it- +
15 doesn't have to be followed' on-the second point.
16 DR. TSE: On the second point, the commenter said 17 that-they can-be located anywhere. What difference does it 218 make in terms of fire, explosion and so on, whether they're 19 locat'ed in an industrial complex, a shopping center, in a-20- hospital, or even a residential area? ,
21 Although the guide did not say you must notilocate 22 lin a residential area. The guide did not say that. It'just' L 23- said it's maybe.not a. good idea to locate there. =But this
-24. -commenter saya even_that-it should not be made, that 25 recommendation.
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. 282 1
-- 3
-1: zTheLguide'did say, though, iffyou-~go"into-locate- :
1 2! N a-residentialLarea,Lyou i need1to provide something to say1 l 3" that-you'reinotuin conflict with the local zoning laws._ So! ,
4' LI wonder your feeling about this suggestion.3 -
5 MS.;MOOREt 1 My; feeling _is you can recommend 6 - whatever you:want.: The; idea of locating where.public access q 17- 'is. minimal,~I'm assuming, is_so'it would-give'-you more 8 -' .le'ewayJas~far'as shielding-goes. . You won' t' have - to worry :so -
9- much;about the perimeter exposures or internally, it could
-: 10 be'a benefit. ,
'llo So, as-far.as'I'ntconcerned, anybody can recommend 12: whatever they want.- If you're not holding anybody tolit; 13i nff they do, myfcoution would have-not been -- I wouldn't=
-14L have thought of zoning. :But 'f you are in a residential
() 15 area, release criteria -- worst case scenario' kind of
.1'6 release and exposure to that population -- I~think would 17 have to-be addressed.
- 18 MR. CAMPER: Kathy.
1 19- MS. SEIFEaT: Locating a pharmacy _in many 20- different states, in many different situations -- we have 1 21- 120 in'the United States. We've never been turned down on a
- 22. location, but.we:just sort of have_ourfown internal l' 23: criteria. . Sometimes we're-in hospital's; sometimes we're-in 1
1241 -->mostiof-the, time', we're:Lin industrial 1 areas, but we've '
-25 never been-turned down. We just--think-about it in terms of +
.h. .N /:
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283 1 . radiation ~ safety, as well.
[\
.O 2 (Slide.]
3 DR. TSE: In terms of instrumentation, there are 4 several' points stated, comments here. One is about two 5 calibration-points par decade is excessive. One point 6 should be sufficient. And then, the use of electronic 7 methods for calibration should be permitted.
8- Third is for linearity test.. The commenter says 9 that maylie they should not be required to go way up to- the 10 total curies in a moly generator, but to the maximum they 11 want to measure accurately, like dispense a multi-vial, 12 whatever the maximum that they need to measure. Therefore, 13 it doesn't have to go up to 16 curies, for example. It may 14 not be feasible to do.
(O j 15 So these are their comments.
16 MR. CAMPER: Mary.
17 MS. MOORE: When we say two calibration points per 18 decade, I'm assuming that's per scale, because usually the 19 scale is a decade.
20 Going back to when I was in school, that was 21 standard calibration practice. It has never been considered 22 excessive. That's the standard calibration practice. Now, 23 I'm not sure where the origin of that comment is.
24 The electronic method of calibration should be 25 permitted. I think that depends on the type of equipment.
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284 1 I don't have enough_ calibration expertise forithe different
't ; kinds of equipment 1to see when it is or isn't. I don't like
'(v)l .
3 it, because I=want to know what-theoresponse of survey 4~ meters is-from actual exposure, being in a radiation field, 5 not-someone pulsing electric current through *t. 1 6- The same thing with dose calibrators or well 7 counters or what have you in the counting equipment. I have 8 a higher comfort level if-a radiation source is used,=but my 9 expertise is limited in calibration. I do think there's a 10 variation of some type of equipment where you could get away
-11 with it periodically, but somewhere along the line, you need 12 a radiation source for your calibration,
- 13 And the third _one, I don't see why the pharmacies 14 should be any different from other licensees who are r (_j 15 permitted for linearity tests to start, use the maximum V
16 activity that they use and go down to, now, the 30 mics. I 17 _ don't see why they would have to elute the entire generator 18 if that's far in excess of the maximum that they ever count.
19- So the maximum dose that they measure is the upper l!mit of 20 the-test, I think is fair.
.21 MR. CAMPER: Mark.
22 MS, MOORE: Don't tell me we agree.
23 CPT ROTMAN: Well, I've got to report I may 24 actually agree with Mary en something.
-25 As far as these three bullets here, the-first c
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285 l' aulleti---I'm no expert on calibration points, and:I really.
}) 2 ' don't wantLto address that except,--if you think of the range s-3L that.a-survey: meter may have,._it may have several different-4 decade settings --'O.1, 1.0, 10X, maybe-even 100X -- which '
i' 5 represents. sort-of.a continuum scale from perhaps barely-6 detectable or undetectable.all the way up-to a pretty-high-
.7- ' dose rate.
8; .If you think of the necessity to create a line on 9j a graph up through these different scales, if you've got one 10- point _in~each one of the decades, you have, then,'three, 11 four, or five points on this line already, which seems to ma 12 to be-enough to decide if the line is linear or straight or
~3 not. Other than that, I don't want to say any more, because 14 I'm a pharmacist, I'm not-a calibration purson.
) 15 On point number two, the use of electronic methods 16 for calibration, I would simply say that I would support 17' that, with one addition to it. 'If you calibrate-your meter 18 electronically, as long as you test it in the end to make 19_ sure it performs in real-life situations, that should be all 20 that's necessary, 21 If you calibrate it electronically, and then you 22 hold'it in front of a couple of different sources, and it
'23 gives you the-reading you want to have, that should be the 24- end of it. You shouldn't.have to say that it can only be 25 done one way or-the other. As long as you get the ANN RILEY & ASSOCIATES, LTD.
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'286 11 performance::end of it and-that_it__ responds in:the
,~; ,
- appropriate dosage-range when it'siin that appropriate-l] '2 [
13 field, that should be. sufficient. I don't think it's-t 4 = redundant at all.
- 5. MS MOORE - Me either. I think you're right. But t
>6- if;they're doing it electronically, then they. don't do it-
- 7. with the radiation source at=all.
-It's simply electronic.
.8 CPT ROTMAN: then I would have to say that,- if i
'9 _you're doing it electronically, you have no way to know if 10 - it;really performs in the real world, and I wouldn't trust
-11 it, then.
12 For the last point -- this is the one I agree with
-13_ Mary on. If you think of dose in terms of the largest 14 amount.a nuclear pharmacy would assay-and label and
) 15 distribute or ship or sell-to a customer, that is an assay 16 that the customer may depend on for drawing doses-for a 17 person. That should be the largest dose that the nuclear pharmacy has to insure is accurate.
19 To ask that the nuclear pharmacy make the entire 20 eluate from a-large generator the starting point for-a 21_ linearity test could actually be insane. At least my dose 22 = calibrator says, right in its instruction manual, that its 23 -upper limit is.8 curies. If you were to have a large E24; _aenerator, a 15-curie generator, and you're eluting-it the 25- first couple'of days,--you may not bc able to do a linearity I
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287 1 -test oniit. iYou1may_not even be'able'to assay your eluate 21 with it; JAtbleast-that's my dose calibrator.
So I think~:that, again, this is-an example'of.
L4 where the' Regulatory Guide-was_more restrictive'than the (52
- regulations.= I mean clearly,=if-you(look in-35.50, it : says,-
61 "from the largest dose _you shall administer to a patient"-
17 down-to 30 microcuries.
8s - So-to say tr a nuclear pharmacy that you have-to 97 do it from the largest dose:you will prepare down to 30 210 microcuries is even more restrictive than'the regst to begin 111' with, but to add.the total _ amount of a generator eluate on 112 -top of_that'is absolutely absurd. It's contra-ALARA. It's 13 expensive. I can't think of any reason why you would want 14- to do that.
l( 15L -Yet somehowLit got.into this Regulatory Guide, and.
16 I would like to challenge it out and challenge the NRC'to 17 put in something that seems to be regulatory-friendly,
'18 ALARA-friendly, and makes sense based on what is really 19 done.
20 MS. SEIFERT: To that point, it's not possible to 21: measure the eluate from_a new generator for the large ones.
-22: They're 15-curie, 12-curi'e generators, currently, and have
.23 been using that: technology for-quite some time.
24 .-So that's not possible, but one suggestion might 25' 5be to: start the linearity test for.a nuclear; pharmacy;at the
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- 288 H 1- highest level of.a kit they typically make.- So, for
() '2 3-Linstance,;if they're making a 400-millicurie. kit, then start the linearity at 400 and go down to the 30-microcurie level.
4 As far as the electronic method goes,Jit's my S understanding that'the electronic method, in itself, is a f
6f . validated procedure. . In order totbe an appropriate- ,
7 Lprocedure,- it has to be validated. So, again, I'm not a b calibration export, either, 4
9 MR. CAMPER: Mary.
10 MS. MOORE: Just so you know, for the MQSA, the 11 Mammography Quality Standards Act, and the FDA requirements 12 and the NUREGs are coming out with the requirement for 13 _mistraceable calibration of the ion chambers, and I don't 14- think they accept'this. .It's fine for, like, an interim
() 15 check, but you still need a radiation source to be able to-16- accurately -- vou know what the exposure rate is supposed to -
17 be-at that distance from that source, and if your survey-
.18 meter is not measuring that, you could have a real problem.
19 For other kinds of equipment that we use, this 20: Tvery well may be, but'somebody with more expertise in
-2 17 -calibration needs to11ook at that, other than me.
U22 : MR. CAMPER: Donna-Beth.
23 MS, HOWE: Kathy,;just.for a-point of 24~ clarification, when you've got one of these large 25 ' generators,'at anyJpoint do-you have to give the specific
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289 1, activity?
.V1
. 2 MS. SEIFERT: Oh, sure.
- 3 MS. HOWE: And then how do you do that?
4; MS SEIFERT: You take an aliquot. So,-say you-5' think'you have 15 curies and 30 milliliters, you pull off a 6' -milli iter,~because^you're going to need to do that anyway 7 to prepare a kit, and so you pull of a milliliter, measure
- 8. that, and then you do the multiplication.
9 MS. HOWE: So that could be the highest activity
.10 that you measure. It may not be.
11' MS. SEIFERT: It could be. Whatever the highest 12 activity that you typically would do. The preparation of-a 13' kit, I would say, would probably be higher than what an 14 aliquot would be. It could go either way. I shouldn't say (b ,r 15 one way or the other, at least in our operations.
16 MS. HOWE: So if you were using the aliquot 17 system, and that was your highest activity, then you would 18 want to make sure you're linear on that, because that's 19 going to affect all the things afterwards.
20 MS. SEIFERT: Sure.
21 MS. HOWE: Are you saying that you're also going 22 to be double-checking the rest of them, so that's not as 23 important?
24' AS. SEIFERT: Oh, sure. Yeah, you check all of 25' them.
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290
- 1. MR. CAMPER: Other comment son this one?
j 2 DR. TSE: Well, I-have.a question for Mark. Mark,
-3 I understan'dzthat you have to do_a: moly breakthrough test.
4 ;Would you be able:to do a moly-breakthrough test by using an "
5 aliquot of an eluate?
G CPT ROTMAN _ Well, since you brought this up,
? absolutely. Yes.- You couldn't do a moly assay in the 8 traditional mechanism if you could not-measure the amount of 9 technetium, because you need to have an amount of technetium 10 in_ order to measure the amount of molybdenum. So you would 11 certainly_take an-aliquot and treat it as if it was the 12 entire elution, 13 The difference, then, would be you would multiply-14 your number by the volume of the elution. The answer to (3
\s j 15 your question is you could do a moly assay by the same 16 mechanism.
17 DR. TSE: But your dose calibrator, it is 18 linearity.down to 30 microcuries. Do we need to measure
'19 much lower than that?
-20 CPT ROTMANs I'm sorry. You're going to have to 21 elaborate a'little bit.
12 2 DR'. TSE: Your dose calibrator linearity test is
'23 to the maximum to 30-microcuries.
24 CPT ROTMAN: Yes.
25 DR. TSE: Now, when you make aliquot and test for
,~ .
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- 1) moly breakthrough,:do you;need__to measure the curies much f( h 12 ilesssthanc301microcuries?
E3- - CPT RO7 MAN: ; Oh, boy. I would say:that, the' 1 4- imajority'of the time, your moly assay is in.microcuries, .
Si small7 numbers of microcuries.. My-experience-is'that,:
6= . traditionally,-~it's less than 10. Sometimes it goes-as high j
-7! as-12 microcuries. So)you're measuring molybdenum below:the 8- level of linearity,-belowLthe level of testing for linearity )
-9 in your' dose-calibrator.
11 0 ' Even going _back to before_the Radiopharmacy ~ Rule,-
111: whenithe lower limit for.linearity was 10 microcuries,1you 12 -would stillebe below that even back then. .You're clearly in- ;
13 a range _where the-dose-calibrator is not optimized _for-4 l14 accurate' reading.
15 DR'. TSE: Thank you, _ This is_the last page. Now 16 we are discussing the comments related to safe use of 17 radioactive material. In one of the items in the guide, it
'18_ says food and drink shall not be stored in the are s'where 19 -radioactive-material is used.- A commenter said that we 20- should be allowed :taa store food and drink used for .
=21 preparation of radioactive drugs.-
x 22. Second, the guide:says that'radiosolutions must be
-23 . labeled <at all times, essentially at=all times. But the
-24 commenters say, "No, we: cannot do it during the H25 L ; preparation."
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l 292
- 1. The third one is the radioiodines in capsules.
-(o) 2 Most radiciodine.is in capsules. Then why does the pharmacy 3 have to measure, to use a bioassay for all the people who 4 handle this, because the capsules would not have very much 5 dose?
6 So these are the comments we have. I wonder 7 whether anybody has any suggestions. Mary.
8 MS. MOORE: When I first read this, I thought they 9 were recommending that food and drinks be stored in the same 10 -- you know, everybody's lunch, and I didn't think that 11 would be appropriate.
12 But for che food or drinks used for the -
13 preparation of radioactive drugs, I don't see a problem with 14 that, as long as the food or the drink does not receive O
( ,) 15 cross-contamination from a radioactive material that you 16 don't want to be incorporated in that food. So there needs 17 to be some care, but in order -- what is it? Sulfur colloid 18 in the eggs or something?
19 MS. SEIFERT: Yeah. Scrambled eggs and sulfur 20 colloid, but people have different variations of that.
21 MS. MOORE: Yeah. Well, you know, the egg's going 22 to get labeled anyway, so it's easier to have it in a 23 restricted area. So I don't have a problem with that, as 24 long as tech doesn't get labeled into it, so the patient is 25 going to get~ tech and sulfur colloid and that kind of stuff.
73 i'
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293 1 As far as the second one goes, I'm not sure I w/
) 2 really understand it.- If it's not radioactive -- or is this 3- theyLdon't know the activity because the labeling isn't 4 completed? And if it's not completed, then is it really 5 radioactive? So does.it have to be labeled until it's 6 radioactive? I don't understand.
7 If it's radioactive, and you know the activity, 8 then you should label it. If you don't know the activity, 9 it should still be labeled as radioactive and ballpark it, I
'10 guess. I don't know. But have some clue that it's not a 11 microcurie, but maybe it's a curie. I don't know.
12 If it's not radioactive, then it doesn't need to 13 be labeled. ~ If it is, and the activity is unknown, you 14 could indicate that or something. It doesn't make sense to
,O
( ,/ 15 me.
16 MR. CAMPER: I'm like you. Does ths guidance 17 imply, Mark, that -- you can't possibly identify the 18 activity in a source until you know it.
19 CPT ROTMAN: Let me address this, because I think 20 this is something that probably stems from the NRC meaning 21 well.and wanting to do the right thing. However, it could 22 easily be misinterpreted and become a license violation, a 23 regulatory violation. It could end up in regulatory space 24.- in the enforcement terms.
25 Number 16 on page 33 is where it stems from, and
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294 i
1- it reads,E" Radioactive solutions will be confined'in covered ;
2_ containers that'are; clearly-idcutified and labeled with the 3- name_of the_ compound,-radionuclide_date, and activity."'
4- .Now,-that's.fineuif the product has already been made and .
5 .it's awaiting shipment or some other thing.
6 But if you're in the process of making something, !
7 and you've. injected technetium into a vial,,and it's part of
?
8 a procedure to make-it, you're not' going-to know what the 9 . compound'is at the moment. It's-not going to be properly
=10 labeled. It's something in an interim stage. But if it ,
11 'were to be grabbed by an inspector at that moment, it would 12 be in violation of number 16.
13- Now, when you say these earts of things in-here, 14 you set up a situation'where you're asking for something i( ) 15 'that's unrealistic to comply'with, and that's exactly what 16 the~commenter was saying.
17 MS, MOORE: But don't you know how much technetium 18 you injected into the cortainer?
f 19 CPT ROTMAN: You may know within 25 millicuries,
- 20. but-you may_not know exactly.
21 MS, MOORE: Put "plus or minus 25 millicuries."
-22 CPT ROTMAN: But see, now-you're in a situation 23_ where you're in the middle of making something, and you've
-24 got-to_stop-and handwrite out a label and stick it-on 25 something,_and then you've got to go over and get something-h\/- ' ANN RILEY.& ASSOCIATES, LTD.
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295 1f -else and inject it in there. It may dilute ~it; it may (s_- )- 2_ change it.
3- You're asking for a lotlof additional work that 4 really is directly interfering with the practice-of 5~ pharmacy. I don't think-it's necessary.
6 MS. SEIFERT: Mark, are you asking about.the steps 7 along the way, that you'have concern that this would be-8 'nterpreted that every step along the way would have to be i
9 labeled with the exact activity, et cetera? Not once it's 10 prepared, right?
11 CPT ROTMAN: Well, that's the literal 12 interpretation of number 16, 13 MS. SEIFERT: That's what I thought. Okay.
14 That's what you're talk.4ng about.
, ) 15 CPT ROTMAN: And if the NRC does not intend that, 16 then number 16 should not be worded the way it is.
17 DR. TSE: I think the commenter essentially la interpreted that the way that you said.
19 MR. CAMPER: They clearly must have, That's a 20 good point, Mark. That could be clearer.
21 MS. MOORE: And may I finish on the third one?
22 DR. TSE: Yes, Mary.
23 MS. MOORE: "Most radioactive doses are in 24 capsules." I wish_they were. Different hospitals I deal 25 with, the physicians want liquid iodine because, depending
,~~
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296 1 on the scheduling, then they can adjust.the dose-accordingly (m) 2 when the patient gets there or treat several patients.
3 One health physicist,that I respect tremendously 4 refuses, at his institution,.and fights against capsules 5 because you have a point source in the stomach then, and he 6 thinks the stomach gets too high a dose.
7 I love it_because you don't have the 8 volatilization issue, so there are different philosophies.
9 Whoever the commenter was, I would suggest that the 10 statistics be checked. My impression is that most 11 radiciodine doses are not capsules.
12 MR. CAMPER: Interestingly enough, this particular 13 issue was fascinating to me to see, because we did go 14 through some scientific literature research about three or (D
( ,/ 15 four years ago on this question. We did find, based upon 16 the research, that the literature described loss of iodine 17 from capsules at different rates.
18 MS. MOORE: I've been looking for that reference.
19 MR. CAMPER: Because we were considering granting 20 and exemption -- performing bioassay for use of capsules 21 only, but, after conducting that research and talking to 22 some manufacturers, we found out that it might not have been 23 appropriate to grant to exemption for bioassay because there 24 is -- although you're right, the volatilization rate is 25 lower -- but.there is some loss of iodine, I think.
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297 Do;youLremember-the percentage?-
1- MS.. MOORE:
v~c
'lA/.'t 2 Becausetthe vials, I thinkcit's.20: percent when you take the 3- - cap off or something'like~that'.=
4 MR.LCAMPER: I don't,' as we speak, Mary,-but I 5- could:try"to-resurrect what we did. It was interesting to--
61 look:at it.
7' MS. MOORE: Because this is an issue'we run-into, 8 whether you vent the dose or not and where you vent it and
~
9 if.it's liquid or-if-you have to do that with capsules and-
':101 the-whole-thing.- That would be appreciated if you could
^ 11~ find that.
- 12 MS, SEIFERT: I agree with Mary.
c13 - MS, MOORE: Kathy wants a copy, too.
L 14 .MS. SEIFERT: As probably the largest dispenser of 15 radioiodine in the country, they aren't all capsules, ao I 1
l' 16 don't think think is really even a -- this is kind of a moot 17 point, anyway.
18 MR. CA!!PER : Mark.
-19 'CPT ROTMAN: One more issue, back on number 16,
- 20 that I read out loud. It prescribes that the containers be 21' covered, as well. And again, covered with lead with a --
22 how covered? Throw a towel over it? There's some stuff 23 there that may go back to an era when there were lots of J241 open; beakers with radioactive solutions in them but that's 25- not how pharmacists practice today.
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298 1- .-The'lastLissue,1the third bullet,,with respect to
[2: handling; capsules, I think this needs to'be looked at, and I
- 31 think there needss to beEsome bioassay- data- e
- :amined.
.4 This'is case ~that I want-to present..--If you are a 5 commercialinuclear pharmacy, and you're currently required 6 to assay capsules that come in, because you're not allowed 7 to pass them through unassayed, you're really not doing anything but-dropping a vial which contains a capsule into a 9 dose calibrator, tand then you're putting it back in its
- 10 - lead shield, and it's going on its way.
11 It seems a little bit excessive, OD either the 12 Part-35 end or the Part 32 end, _ to require a bioassay when .
13 you've really never manipulated the capsule in any 14 'significant way.
() 15 Now, I know, recently there was some enforcement 16 action on the Part 35 basis egainst the United States Army 17 at Walter Reed because they felt that --
and their pharmacy 18 is simply radioassaying the radiciodine capsulate to ensure t
19 that they were the: proper dose and then dispensing them to 20 _the therapy-physician-for administration to the patient --
21 did not-constitute preparation of the' capsules, and, in 22- fact, there was no evidence that there had ever been a 23 -thyroid hazard'or a thyroid uptake by any of their nuclear
-24. ; pharmacists associated with this sort of minimal impact use 25 .of' iodine, assaying it.
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i 299 1 So I teally think that there could be some logic 2 te-tnis.
( If you open up your iodine shie d inside of a 3 proper biological-safety cabinet or a chemical fume hood and 4 you let it vent and you assay it, I don't think that there's 5 any particular evidence that thyroid burdens are going to be 6 accumulated by this.
7 Now, granted there are going to be people who arn 8 sloppy, but to blanket require that people do things and get 9 their thyroid bioassay within 72 hours8.333333e-4 days <br />0.02 hours <br />1.190476e-4 weeks <br />2.7396e-5 months <br /> of preparing a
\
\ 10 therapy capsule dose, when all they did was take it, throw 1
q 11 it in the dose calibrator, and send it out, is an e.' pensive; 12 time-consuming requirement, and I don't believe there's a 13 whole lot of evidence to show that it's going to prevent any 14 thyroid doses.
15 MR. CAMPER: Mary.
16 MS. MOORE: I have a question for Mark -- and 17 Kathy may know. With the prescriptions now for 200 18 millicuries and the old 100-millicurie therapv doses getting 19 to be passe in some places to where there may be more than '
20 one capsule coming in order to complete that dose, do the 21 pharmacies ever combine -- when they're trying te ill a 22- prescription for 200 millicuries, unpack the individual 23 capsules and put it in one container and ship that to the 24 hospital?
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i experience has been that, the vast majority of the time, the
( 2 dose comes in a single container with all of the capsules in
'v) 3 ;- it, if there is more than one capsule. However, we're more 4 of an end product user in that respect than a commercial 5 nuclear pharmacy, so I'm going to defer to SYNCOR to give an 6 answer to that one.
7 MS. SEIFERT: In our case, we compound the 8 capsules, so we prepare them, and they're all prepared at 9 the same time, put in the same vial, and dispensed all in 10 the same package.
-11 MS. MOORE: Because I've seen it in one hospital 1 12 where the nuclear medicine tech was dumping the capsules out 13 of individual, and then, in others, I've thought,-no, 14 they're getting them all together in one vial, which meant f~)
(_,/ 15 somebody at the pharmacy was dumping the capsules in.
16 MS, SE! RT: It could be that, in the first case 17 you cited, they were getting them directly from the 18 manufacturer, in which case the manufacturer may -- they 19 need 150, they'll send them 100 and a 50, becaure they don't 20 have a package of 150 that's appropriate. But n t' e 21 practice of pharmacy, you can compound those things specific 22 to patient need.
23 MS. MOORE: Okay. Well,:the other issue, too, 24 with Mark's point about if you're just taking the glass vial 25 out and putting it in a dose calibrator at the pharmacy and bV ANN RILEY & ASSOCIATES, LTD.
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301' 11 then transmitting'it, if:that has any kind of-contamination =
(mc -
)
'\ . on it, then;the: pharmacist handling it, granted, should have
=3- gloves on - Ewhich I would--~ expect they_would -i butlthere 4' could'be some contamination-issues which you would want:a
-5 bioassay, You would be-tracking not just volatility, but 6- _any possible contamination.
7- MS.-SEIFERT: We would want them to handle it with P Itongs.
9 RMS. MOORE: Good point.
_CPT ROTMAN: I just think that!the real meat of 11 the-issue is going to be reviewing some bioassay data for .
112 people who routinely assay capsules of iodine to determine 13 if-~they ever do get'a thyroid burden. I think that's;really 14 the issue. If-you don't see-that:at all or very,-very
/i i
'\s,/ 15 rarely, then perhaps you have-an avenue where.the 16 regulations can be made a little more flexible.
17 MS. MOORE: Mark just raised an extremely 18 important point. -It goes to the equipment used for the.
19 bioassay.
-:20 In.some conversations with some colleagues with 21 some of the thyroid probes and the computer systems used,
'22' th'e sensitivity variation from different models apparently.
23 exceeds anything I ever thought. There.has been some-124 . informal cautioning of " Check your equipment" because the
- 25- sensitivity in minimum detectable activity for that system f7 ANN-RILEY &' ASSOCIATES,'LTD.
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302 1 may be too high, that you're not going to pick up any kind (v) 2 of thyroid burdens.
3 But then the con to that is, well, if it's high 4 for minimum detectable activity, but it's still below any 5 kind of physical concern, but the detectability may be an 6 instrumentation issue, as part of that issue, rather than 7 no, there's nothing there.
8 MS. SEIFERT: Every time we do bioassay, we check 9 minimum detectable activity, and as much iodine as we 10 dispense, we very seldom get any thyroid burden.
11 MS. MOORE: I have found any yet, either.
12 MS. SEIFERT: Once in a while, there'll be 13 somathing if somebody spilled some iodine, but --
14 MR. CAMPER: Can we move on?
(q,)
15 DR. TSE: This is the last viewgraph. Again, I 16 apologize, because this page is reversed, but fortunately 17 you have the page.
18 Now, this one is relatively simple. The commenter 19 says, for defacing the labels, the guide should include the 20 method which is allowed and Information Notice 97-03. Now, 21 that essentially said that, if your vial is sealed in a 22 container or barrier and the barrier is not going to be
'23 opened, and that will be sent to an incinerator for n'
[ 24 incineration, then you don't need to deface that vial.
25 I think the answer to that is, yes, we should.
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303
. 1 MR.: CAMPER: That's a no-brainer. I mean,_if-it's (N 2 saidin-an IN,lwe ought to say'it in guidance. We will, but x) 3- that needs to be-addressed.
4 :MS. MOORE:- The'second bullet, it says it's not
- 5. necessary to deface labels.or vials if the vials are' sealed
'6- .in a-barrel-that will not be opened' prior'to -- oh, prior to 7_ -
_ incineration.
8 DR..TSE: This is'the end. There.were many 9 _ comments, but I'm not going-through all of them.
10 1 MR._ CAMPER:. _That's all the comments. Right, 11 1 Tony?
12 DR. TSE: Yes. +
13 MR. CAMPER: -We had a session scheduled on the
'14 . agenda at the-end of.the day,.and I think we've really sort I 15 of been in and out of.that general space all day long. I 16 guess I would like to try --
li DR. TSE: Larry, for clarification for the record, 18 this is now all the comments. This is all the comments I'm 19 presenting at this workshop.
20 MR. CAMPER: Okay. Thank you.
21 DR TSE: Thank you.
22 MR. CAMPER: I guess I would kind of like to 23 finish up with-just a couple of questions for you. One, 24 what's your general reaction to the approach we're trying to 25- use in' terms of not finalizing DG-0006 at this time, but O ANN RILEY & ASSOCIATES, LTD.
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304" 1- -rather,.? dealing with<in:the NUREG under the' Guidance?
) 2 Consolidation Project, as we' discussed and described earlier 3 -this morning?
4 And secondly, is there something more that we-5 -could do-than what we have done here today, than what we'll-
-6 do when_we put that into.that guidance format and subject _it-7 -to the 90-day comment period?
8' So what do you think about that appccach, and,-
L9 then, is there something more we can or should do?
E10 MS ', SEIFERT: I've lived with a for-comment Reg Ill ' -Guide for 10-years or more. Your. approach will be to amend 12- that one? Is that right? My understanding.
13 MR. CAMPER: The approach will be to.take the'old 14 guide,--which is FC 406-4 --
15 MS. SEIFERT: We've got that one.
16 MR. CAMPER: -- which you have. We will take this 17_ guide, as well,ithe 0006. We will look at those two 18 documents, factor in the comments that we have heard today, 19 and, under the general guidance-that were given to the-teams 20 creating the guidance documents now, to pursue a 21' risk-informed, performance-oriented approach consistent with 22 existing regulation, create a different NUREG document.
23 That NUREG document would contain guidance-24 -information.- It would contain_ sample licenses. -It would
-25 contain an application pathway that.a licensee could use, a
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305 1 :checkl'ist.of things you mayl commit to using,iif you wantito,-
- 2' Lor ~ submitting alternatives.-
'3- It will contain what'we call an audit: list. -
The
~4 - audit list 'is built upon our inspection field notes.: The 5- idea of that.particular-part of the guidefis that licensees a
6 should have an idea of what we're going to go looking for 7 -when we come to inspect.
~8 And, as we-construct that, built upon these two-9 Edocuments, the comments we've received, try to do so with 10 this current thinking of risk-infotaed, 111 ~ performance-oriented.
12 As we have said from the outset -- Don said it
-13 earlier in his comments this morning -- I would only echo 14 him, and I think you would probably agree -- if you look at
() 15 the existing document, 406.4 -- wnich was, I think, built in 16 1985 -- it certainly doesn't seem to embody that approach, 17 It's much more specific and prescriptive and so forth.
18 Do you generally feel that is a reasonable, 19 - worthwhile approach, and is there something more that we can 20 do than that.to get input to try to bring to bear the-21 - risk-informed, performance-oriented concept?
22 MS. SEIFERT: =I think it's a good approach, 23 actually. I think that it will -- I'm not sure what your 24- time frame isTMa the NUREG. Do you have any idea?
'25 -MR. CAMPER: Yeah, I don't know exactly, because ANN-RILEY & ASSOCIATES, LTD.
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306 1 I've got to make some adjustments now on the overall
,n
\
I 2 schedule for the NUREGs --
O 3 MS.-SEIFERT: Sure.
4 MR.' CAMPER: --
in view of this development. But 5 my guess is we would certainly be putting it out next year.
6' MS. SEIFERT: Oh.
7 MR. CAMPER: We probably would start it -- under 8 our model that we use in developing the guidance documents, 9 it takes us about five months to create it. It goes out for 10 comment for three months, then four months to finalize it.
.11 That becomes a function of how many comments you get.
12 But I would imagine that we would probably start 13 it some time in the first quarter or so of next year -- next 14 calendar year, '98 -- and it would be out for review tO
( ,) 15 probably mid-year or so. I would say somewhere along in 16 July-August-September time frame.
17 MS. SEIFERT: I think that's totally appropriate.
18 I think that to spend a lot of time doing a final version of 19 this one and then go to that, it will take a lot longer to 20 come to the end result, which is what everyone wants anyway, 21 is the performance-based approach.
22 MR. CAMPER: Right.
23 MS. SEIFERT: We've been going along with this 24 one, and it has been difficult sometimes to know exactly 25 where NRC would stand because of the old document from 1985,
[)
\/
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307 1 but we seem to have resolved that, at least within our
() 2 3
organization, through this time frame, and I would rather you spend your time'on the new scenario than this one.
4 MR. CAMPER: The only thing we will do un the old 5 documents, on 410-4 and 406-4, is that we will make a :
6 supplement to them to capture those guidance adjustments ,
7 that would strictl$ the result of the Radiopharmacy Rule.
8 NJ. SEITERT: That's good.
9 MR. CAMPER: Then, of-course, that will get bucked 10 forward as we take a look at -- ultimately, 410 and 406-4 11 will be superseded by the NUREG. Now, I don't know, as I 12 set here, whethat there will be one NUREG or whether there -
13 will be two NUREGo. We'll work that out. But the NUREG 14 subject matter for both manufacturing and distribution and
() 15 for commercial radiopharmacies, whether it's in one NUREG-or 16 two, we'll see. Are there thoughts on that? Mary.
17 MS. MOORE: I agree with what Kathy has said, but 18 also, when the draft is out for comment, I would strongly 19 urge you to distribute it as widely as you can. Obviously, 20 the nuclear phar:.acies have to have the major input, but the 21 other societies that would be involved.
22 I feel bad, from your perspective on these 23 workshops, that the word was not able to be distributed as 24 widely as I think some people perceived it was. I think you 25 _ will suffer from the lack of input, although today you had ANN'RILEY & ASSOCIATES, LTD.
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1 -enough variation, I think, in opinions that you go across 2 the board But a-broader outreach -- when Mark and I are 3- together, you a hays know you get opposite opinions -- a 4 broader outreach, I think, would help.
5 MR. CAMPER: Okay. ' Good point. Mark.
l
-6 CPT RCTMANs First I would like to commend you on i 7 your. Attitude, position and concern for getting some of 8 .these important issues worked out and corrected. I think 9_ that's wonderful. I know-that_it was not particularly 10 pleasant having all those concentric circles painted on your 11 chest and on your back and being the' recipient of lots of 12 slings and arrows, but you seem to have survived it quite i 13 nicely.
14 The second_ aspect of it is that we have a fairly 15 mature, well-est.ablished nuclear pharmacy community. I 16 don't believe that, in the next year or two, there are going ;
17 to be hundreds of applications for nuclear pharmacy i
- 18. licenses.-
19: I think that most of up .re either in the business ;
20 or may be goingfto expand the business, but we pretty much 21 know what_we're doing, so a delay in getting good guidance 22 is not going to be bad for business. It's not going to hurt 23 any-patientJ.- -I don't think it's going to cause any 24- problems. I-think we all'would like very much to see what a ,
25' performcnce-based NUREG/ Regulatory Guide-looks like.
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309 1 I think that you probably will do these things, I 2 but in case they weren't in your mind, I'll bring them up 3 now. 'As it's developed at.d you have chapters or sections -- l q
4 or whatever you want to call'them -- that are ready to be l 5 100ked at by the regulated community, !
6 it might be nice to put them on your electronic j 7 bulletin board, perhaps to get some early feedback on, maybe i 8 so they can be tweaked or certain issues can be fixed. I ,
9 -know-that the electronic media doesn't address everybody, i
.10 -but a lot of us who are very vocal in the regulated
-11 . community are conversant with it, so we would be able to 3 12 give you some early feedback.
f 13- Other than that, I wish you luck.
14 MR. CAMPER: Mary, 15 MS, MOORE: May I do a postscript to that?
16 MR. CAMPER: By all means. Only as long as you
-17 agree, of course.
18- [ Laughter.)
19 MS MCORE: I do.- In fact, a comment, in that, t
20 after the Part 35 workshop, I carried the message to some of ;
21 my colleagues that there was disappointment here that more 22 people were not, using the Web page or the Internet and the 23 announce. net,t on the Part 35 and the changos. The comment 24 was: that they couldn't fin.1 it. They were looking for it, 25 bur they couldn't: find it.
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310 1 So, if you follow Mark's s'.ggestion, which 10
( ) 2 concurrent with my broader outreach or distributi>n of the 3 information so you get enough input, is there some way for ,
4 us old paper folk that aren't conversant, a way of 5 identifying where the new one is on your Web page or your-6 site on the Internet? Or have it in a couple of places in a 7 cross reference? I know some people gave up after, like, a 8 half hour or an hour trying to find the Part 35 changes. '
9 MS. SEIFERT: It was just noted on the NRC page, 10 "For Part 35 changes, see" -- whatever that site was. It's 11 a separate site, right?
12 MR. CAMPER: Yeah.
13 MS. SEIFERT: I looked for it the other day. I 14 cot.ldn ' t find it, but I did know it from another direction.
O(_j 15 MR. CAMPER: Well, we do have an NMS home page in 16 all of these guidance documents. They're all making their 17 way to that NMS home page.
18 MS. MOORE: Well, maybe a few electronic crumbs 19 along the way will help people get tl.ere.
20 (Laughter.)
21~ MR. CAMPER: Yeah. These are good suggestions. I 22 know, on these guidance documents that we're creating, we 23 did have one that was intriguing in that it was - Part 34, 24 which is radiography -- we had a revision of Part 34 which 25 _ went into effect this year.
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I 311 1 When we were creating our NUREG, it was quite I
( ^s) 2 _ unique, as compared to the others, becauce it was, in fact, !
3 addressing a new regulation, wlereas the others are 4 consolidating and updating the old guidance, trying to make 5 it risk-informed, performance-oriented, and tr.ey go out, as 1
6 I said, at some point for 90 days of comment.
7 But I had thought about the idea that, given the 8 interest 'n this particular regulation and guidance and 9 given what I think will be fairly significant changes from j 10 the old guidance, that it would be of value, somehow, in 11 _that developmental process to get some pulsing from you.
12 We'll definitely take a look at how we might do tha: . That 13 is a good idea.
14 MS. MOORE: You are to be commended for the 15 outreach and for having the workshops, very much so.
16 MS. SEIFERT: I agree.
17 MS MOORE: I think everybody benefits from it, 18 and everybody learns f rom it.
19 MR. CAMPER: Thank you very much. The success of 20 those workshops depends on folks just like yourselves. We 21 want the input, need the input, and your candor, your 22 comments, and your thought processes are greatly 23 appreciated.
24 With that, we'll call it a wrap, and wu thank you 25 ve'y
. much.
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l 312 :
1 [Whereupon, at 5:00 p.re., the meeting was
'2 concluded.) l
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