Text

Forwards Revised Strawman from 910807 Workshop Re Authorized Nuclear Pharmacist
	ML20057B212
Person / Time
Issue date:	10/25/1991
From:	Telford J; NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:	Aylward B, Humpf H, Ponto J; AFFILIATION NOT ASSIGNED
Shared Package
ML19342C263	List: ML20057B152; ML20057B165; ML20057B192; ML20057B208; ML20057B212;
References
	FRN-58FR33396, RULE-PR-30, RULE-PR-32, RULE-PR-35 AD69-1-005, AD69-1-5, NUDOCS 9309200163
	Download: ML20057B212 (71)
	v • d • e

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'o UNITED STATES I '

NUCLEAR REGULATORY COMMISSION A

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i WASHINGTON, D. C 20555 C_

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aatu a BPS:

James Ponto ABSNM:

Homer Hupf

'S NABP:

Beth Aylward Bart Clark Tim Benedict USCEA:

Michael Mosley Janet Reuther Andrew Williams UNM:

Dennis Eshima UPITT:

Dennis Swanson PU:

Anne Smith APHA:

Clyde Cole Cathy Seifert ASHP:

Henry Chilton

Dear Workshop Participant:

During our workshop on August 7, 1991 on establishing an " authorized nuclear pharmacist," I promised to send you a copy of the revised strawman in late October 1991. The strawman has been revised based on our discussions at the workshop. A copy is enclosed for your information.

For ease of comparison, a copy of the original strawman is also enclosed.

There are two major changes:

(1)

We tried to make the three "in-lieu-of" alternatives equivalent to BPS certification, as much as possible.

Each alternative would require nuclear pharmacy experience equivalent to a minimum of 4000 hours0.0463 days 1.111 hours 0.00661 weeks 0.00152 months .

(2)

We added training and experience criteria for nuclear pharmacists to ensure that they are qualified to supervise pharmacy technicians and to manage a nuclear pharmacy.

I look forward to the next workshop after the proposed rule has been published for public comment.

Sincerely, W

ohn Tel ford, C'hief Rulemaking Section Regulation Development Branch Division of Regulatory Applications Office of Nuclear Regulatory Research

Enclosures:

Revised and original strawmen

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CURRENT REGULATIONS RESTRICT THE PREPARATION OF t

RADIOPHARMACEUTICALS TO USING GENERATORS AND KITS BY FOLLOWING:

THE MANUFACTURER'S INSTRUCTIONS.

1 AN AUTHORIZED USER PHYSICIAN'S DIRECTIVE.

O CURRENT REGULATIONS (FOR HOSP. & IND.

PHARMACIES)

ARE SILENT WITH RESPECT TO NUCLEAR. PHARMACISTS:

THEY-CANNOT PERFORM THEIR FUNCTIONS EVEN IF PROPERLY TRAINED AND LICENSED.

O ACNP-SNM PETIhION REQUESTED THAT THE REGULATIONS 1

BE AMENDED.

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o ALLOW LICENSEES TO PREPARE RADIOPHARMACEUTICALS (REMOVING RESTRICTION)

UNDER CERTAIN CONDITIONS.

O ESTABLISH

" AUTHORIZED NUCLEAR PHARMACIST" (ANP)

AND

" NUCLEAR PHARMACIST" (NP).

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SPECIFY RESPONSIBILITIES OF SUPERVISION FOR ANP AND NP.

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PREPARATION OF RADI0 PHARMACEUTICALS i

A LICENSEE MAY PREPARE RADIOPHARMACEUTICALS (IN ADDITION TO ss35.200 AND 30.34)

PROVIDED THAT THEY WILL BE PREPARED:

(1)

BY AN ANP, OR (2)

BY A NP FOLLOWING A RADIOPHARMACEUTICAL PROCEDURES MANUAL THAT WAS APPROVED BY THE

ANP, OR 4

(3)

BY A PHARMACY TECHNICIAN WHO IS:

(I)

BOTH UNDER THE DIRECT SUPERVIS10N OF THE NP AND IS FOLLOWING THE RADIOPHARMACEUTICAL PROCEDURES MANUAL, OR (II)

UNDER THE DIRECT SUPERVISION OF THE ANP.

1 5

ESTABLISH ANP IN REGULATION

" AUTHORIZED NUCLEAR PHARMACIST" IS A NUCLEAR PHARMACIST WHO:

i (1)

IS CERTIFIED AS A NUCLEAR PHARMACY SPECIALIST BY THE BOARD OF PHARMACEUTICAL SPECIALTIES OF l

THE AMERICAN PHARMACEUTICAL ASSOCIATION,; OR (2)

HAS A PH.D. OR M.S.

DEGREE IN NUCLEAR PHARMACY AND 2000 HOURS OF PROFESSIONAL EXPERIENCE IN-NUCLEAR PHARMACY PRACTICE, INCLUDING 1000 HOURS OF SYSTEMATIC INSTRUCTION, OR 6

)

(3)

HAS COMPLETED A RESIDENCY OR INTERNSHIP PROGRAM IN NUCLEAR PHARMACY AND 2000 HOURS OF PROFESSIONAL EXPERIENCE IN NUCLEAR PHARMACY

PRACTICE, INCLUDING 1000 HOURS OF SYSTEMATIC INSTRUCTION, OR 2

(4)

HAS COMPLETED 4000 HOURS OF PROFESSIONAL EXPERIENCE IN NUCLEAR PHARMACY PRACTICE, INCLUDING 1000 HOURS OF SYSTEMATIC INSTRUCTION BY AN ANP.'

7

NOTE:

4 1000 HOURS OF SYSTEMATIC INSTRUCTION INCLUDES:

I COMPOUNDING RADIOPHARMACEUTICALS; PERFORMANCE OF QC-PROCEDURES; DISPENSING RADIOPHARMACEUTICALS; IMPLEMENTATION OF' BASIC RADIATION PROTECTION PROCEDURES AND_ PRACTICES; AND-l 8

CONSULTATION PROVIDED TO PHARMACISTS,

PATIENTS, AND OTHER HEALTH PROFESSIONALS REGARDING:

O THE PHYSICAL AND CHEMICAL PROPERTIES OF RADIOPHARMACEUTICALS, O

PHARMACOKINETICS AND BIODISTRIBUTION OF RADIOPHARMACEUTICALS, AND O

DRUG INTERACTIONS AND OTHER FACTORS THAT ALTER PATTERNS OF DISTRIBUTION.

ANP BY EXEMPTION MAY BE ALLOWED ON A CASE-BY-CASE APPLICATION BASIS.

9

b ESTABLISH NP IN REGULATION

" NUCLEAR PHARMACIST" IS A PHARMACIST WHO HAS A B.S.

DEGREE IN PHARMACY OR PHARM.D. AND A STATE LICENSE TO PRACTICE PHARMACY AND WHO:

(A) (1)

HAS A PH.D.

OR M.S.

DEGREE IN NUCLEAR

PHARMACY, OR (2)

HAS COMPLETED A RESIDENCY OR INTERNSHIP PROGRAM IN NUCLEAR PHARMACY, OR 10-

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HAS COMPLETED 1000 HOURS OF PROFESSIONAL EXPERIENCE IN NUCLEAR PHARMACY PRACTICE,1 INCLUDING 250 HOURS OF SYSTEMATIC INSTRUCTION BY AN ANP ON:.

COMPOUNDING RADIOPHARMACEUTICALS; PERFORMANCE OF QC PROCEDURES; DISPENSING RADIOPHARMACEUTICALS; IMPLEMENTATION OF BASIC RADIATION PROTECTION PROCEDURES AND PRACTICES; AND CONSULTATION PROVIDED TO PHARMACISTS,

PATIENTb, AND OTHER HEALTH PROFESSIONALS REGARDING:

11

O THE PHYSICAL AND CHEMICAL PROPERTIES OF RADIOPHARMACEUTICALS, O

PHARMACOKINETICS AND BIODISTRIBUTION OF RADIOPHARMACEUTICALS, AND O

DRUG INTERACTIONS'AND OTHER FACTORS THAT ALTER PATTERNS OF DISTRIBUTION; AND (B)

HAS COMPLETED 200 HOURS OF SYSTEMATIC INSTRUCTION IN BASIC RADIOISOTOPE HANDLING TECHNIQUES THAT INCLUDES:

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RADIATION PHYSICS AND INSTRUMENTATION, l

RADIATION PROTECTION, l

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MATHEMATICS PERTAINING TO THE USE AND MEASUREMENT OF RADIOACTIVITY, AND RADIATION BIOLOGY; AND (C)

HAS COMPLETED 500 HOURS EXPERIENCE IN HANDLING RADIOACTIVE MATERIAL THAT INCLUDES:

ORDERING, RECEIVING, UNPACKING, AND-i PERFORMING RELATED RADIATION SURVEYS;-

CALIBRATING DOSE CALIBRATORS, SCINTILLATION DETECTORS, AND SURVEY METERS; e

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CALCULATING, PREPARING, AND CALIBRATING f

PATIENT DOSES, INCLUDING USING RADIATION SHIELDS; FOLLOWING INTERNAL CONTROL PROCEDURES TO i

4 ENSURE PROPER LABELING; AND PRACTICING EMERGENCY PROCEDURES FOR

SPILLS, INCLUDING SURVEYS, DECONTAMINATION, AND WIPE TESTS.

L NP BY EXEMPTION MAY BE ALLOWED ON A CASE-BY-CASE APPLICATION BASI'S.

14

RESPONSIBILITIES OF SUPERVISION (A)

THE ANP SHALL:

(1)

INSTRUCT THE SUPERVISED INDIVIDUAL IN THE PRACTICE OF NUCLEAR PHARMACY AND THE PRINCIPLES OF RADIATION SAFETY; l

(2)

DEVELOP, IMPLEMENT, AND PERIODICALLY l

REVIEW APPROPRIATE PROCEDURES TO ENSURE THAT THE RIGHT RADIOPHARMACEUTICAL IN THE kIGHT DOSAGE FORM-IS PREPARED,_

LABELED, AND DISPENSED CORRECTLY-;

15

(3)

REQUIRE THE SUPERVISED INDIVIDUAL TO l

FOLLOW THE INSTRUCTIONS OF THE ANP, AND TO COMPLY WITH APPLICABLE REGULATIONS OR t

LICENSE CONDITIONS OF NRC,

STATE, OR OTHER FEDERAL AGENCIES; (4)

PERIODICALLY REVIEW THE SUPERVISED INDIVIDUAL'S' WORK AND DOCUMENT THE l

REVIEW; l

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BE RESPONSIBLE FOR THE ACTS AND OMISSIONS OF THE SUPERVISED INDIVIDUAL IN THE PRACTICE OF NUCLEAR PHARMACY; (6)

PROVIDE DIRECT SUPERVISION OF PHARMACY TECHNICIANS BY BEING IN THE PHYSICAL l

PRESENCE OF THE INDIVIDUAL PREPARING RADIOPHARMACEUTICALS IN ORDER TO ALLOW l

OBSERVATION AND DIRECT INSTRUCTION; I

1 17

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i (7)

LIMIT THE NUMBER OF INDIVIDUALS UNDER 4

DIRECT SUPERVISION TO A MAXIMUM OF 6; AND (8)

IF AN ANP WOULD LIKE TO SUPERVISE MORE THAN ONE NUCLEAR PHARMACY, A

PLAN._TO ENSURE THAT THE ANP WILL PROVIDE SUFFICIENT SUPERVISION AND OVERSIGHT TO

(

EACH PHARMACY SHALL BE SUBMITTED TO NRC l

FOR APPROVAL.

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THE NP SHALL:

(1)

PROVIDE DIRECT SUPERVISION OF PHARMACY TECHNICIANS BY BEING IN THE PHYSICAL PRESENCE OF THE INDIVIDUAL PREPARING RADIOPHARMACEUTICALS IN ORDER TO ALLOW OBSERVATION AND DIRECT INSTRUCTION; AND (2)

LIMIT THE NUMBER OF INDIVIDUALS UNDER DIRECT SUPERVISION TO A MAXIMUM OF 6.

19

NUCLEAR RbbLkkOR7 COMMISSION

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February 26, 1992 OGC o..*

TRothschild 3) enAmuan JGoldberg STreby JGlenn B-DHowe CJenkins

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SBahadur, RES 2

David A. Kessler, M.D.

Commissioner U.S. Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857

Dear Dr. Kessler:

I am writing to follow up on our telephone discussion on January 28, 1992, regardilhy-the responsibilities of the FDA and NRC with respect to the regulation of radiopharmacies.

More cpecifically, this letter provides further information regarding the regulatory issue faced by our egencies in regulating radiopharmacies, NRC's proposed strategy to resolve this issue, cnd the specific action NRC will take to resolve the Syncor International Corporation pharmacy-directed departure issue.

In the Commission's view, FDA has the expertise to clarify the complex interactions between FDA regulations, state boards of pharmacy, and professional groups associated with radio-pharmaceutical production and use.

Nevebtheless, NRC finds itself in the position of having to address these issues because current NRC regulations and license--conditions require compliance by NRC licensees with the Federal Food, Drug, and Cosmetic Act and adherence to FDA-approved package insert directions.

Thus, NRC's regulations raise issues of the correctness of NRC's j

interpretation of these FDA requirements and the consistency between FDA and NRC application thereof.

NRC vants to remove itself from this position to the extent consistent with our statutory responsibility to protect the public health and safety with respect to radiological hazards.

Therefore, the NRC staff is developing a rule change for Commission consideration that would eliminate NRC regulationsThe which require NRC to interpret and. enforce FDA regulations.

NRC, of course, would retain its re'gulations governing i

radiological protection of the public health and safety, including that of patients.

This rule change would permit alternatives to the current requirement to follow the FDA-l approved package inserts when directed by an authorized user Originated: NM55:D-BHowe i

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3 i e O '; o to c; -f-g l

- physician or when prepared by an authorized nuclear pharmacist.

Tha rule change contemplated would also replace current NRC rcgulations requiring explicit compliance with FDA approval mechanisms for drugs with a general statement that nothing in NRC's regulations relieves licensees from complying with other cpplicable Federal, state, and local requirements governing the Preparation of radiopharmacauticals.

~

i In a related matter, Syncor International Corporation has rcquested amendments of all 26'of its nuclear pharmacy licenses to permit certain specific, as well is future unspecified, pharmacy-directed departures from the manufacturer's FDA-approved instructions for preparing reagent kits.

NRC agreed to issue these amendments as part of a settlement of a lawsuit Syncor filed against.NRC.

Three licenses were amended prior to the rCceipt by NRC staff of a September 26, 1991 letter from Dr. Carl Pcck of your agency sitating that, contrary to the representation f

of the licensee, these deviations "... are not subject to any practice of pharmacy exemption recognized by the FDA."

Twenty-three similar license amendment requests are still pending.

The NRC intends to grant 'the Syncor requests for license amendments cnd also grant associated exemptions from NRC regulations which rcquire pharmacies to demonstrate compliance with the Federal Food, Drug, and Cosmetic Act.

NRC will also consider granting cxemptions and license amendments to other licensees in the same circumstances.

Granting these exemptions and license amendments would be consistent with the proposed rulemaking described above.

Exemptions will be based on the NRC's determination that they are consistent with protection of the public health and safety, including patients, with respect to radiological hazards.

The license amendments and exemptions will cletrly state that they do 1

l not relieve the licensee from complying with other applicable Federal, state, and local requirements governing preparation of radiopharmaceuticals.

Robert M. Bernero, Director of NRC's Office of Nuclear Material Safety and Safeguards, is providing more detailed information cbout the NRC/FDA regulatory problem and the Syncor exemptions to your staff.

He and other NRC staff members met with FDA staff on January 24, 1992, prior to our conversation, to discuss these matters and are expected to meet again soon.

NRC is receptive to I

any comments FDA may have on the Syncor exemptions.

We would appreciate receiving those comments by March 30 because NRC plans to act on the exemptions and license amendment requests shortly thereafter.

NRC's staff will also forward to your staff for discussion draft changes to NRC regulatory language as they are developed.

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. The Commission believes that NRC's course of action will result in a net benefit for both the nuclear medicine community and the 90neral public.

I request your support in this endeavor and look forward to receiving your views on the matters raised in this latter.

' Sincerely, Ivan selin I

1

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3014431863+

93015041757*# 2-SENT BY:FDA - Exec. Sec. Off.

4-14-92 1 4*19ME

DEPARTMENT OF HEALTH h HUMAN SERVICES Putac Hoolth Sen4w l

Pood and Drug Ar.t?._

Rockvmo MD 2057

~

JL-41 14, 1992 Mr. Ivan selin tha t man A '

United states Nuclear Regulatory t%emiaaica Wasnington, D.C.

20555

Dear Chairman salin:

I apologisa for the daley in 'resnanA4*c to your February 26,1992 letter concerning the regulation of radiopharmaceutical drug j

i prodents. We appreciate the efforts of you and your staff to coordinate regulatory g licy with us.

Car New Drug Evaluation staff in the Center fer Drug Evaluatiost and Research has evaluated.the issues yos.. raise.

Based on this:

evaluation, we agree that the actions proposed by the NRC are perfectly consistent with the interests of FDL in regulating radiopharmaceutical prodnots and other uspects of radiopharmaceutical drug===*aahwing.

We believe that the anendmaats proposed for synoor's licenses, as described in the appendix to W 1etter, noting that the MRC license does not relieve the licensee from cosplying with applicable Fnn requirements, appropriately places thg._W AM for enforcement Cif

,the Federal Foos, Drug, and cosmetto Act (FD&C Act) with the FIA.

iWe interpret these==aadad licenses to inSicate snat tne NRC dces not object to certain F=mierected deviations from approved labeling.

mased on this. unders*==*daa,.we will work with the i-involved unclear pharmacies regarding how we interpret the FD&C Act to apply to these deviations.

To assist pharmacies in general in underst-d4=c current agency policy on the applicability of certain provisions of the Fpac Act, our staff has recently prepared the enclosed Compliance Policy Guide on Pharmacy Compound!ng and has begun work on revising our Compliance Policy Guide for Nuclear Pharmacy to olarify ambiguities and to ensure consistency with the guide os, pharmacy compounding.

We will share this Nuclear Pharmacy Omid4 with your staff as soon as it.is prepared.

i, You have' indicated that NRC Staff'is preparing a rule that will eliminate regulations requiring NRC to interpret and enforce FIA regulations.

It is my underst==A4 - that our staffs have scheduled a meeting on this and will work together to develop mutually acceptable language.

Win are especially appreciative of your taking the initiative to involve us in the development of this rule.

r

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SENT BY:FDA -- Exec Sec.. Off '

A-14-911 A*1DPN t 1014411862*

E3011RA1757;# 1.

T Page 2 r'ha i m=n salin.

i Your letter also discussed Dr. rock's september 26, 1991, letta.r i

in which he indicated that, based on information and policy at

~

that time, he did not conclude that Synoor was automatically l

entitled to a

practice of phazancy eseagtion recognised by.the FD&."

Our recently completed policy ott pharmacy. compounding is we believe, consistent with this positica.

We continue to believe that the optimal way to handle reformulating products i n a routine and continuous fashion would be through submission and approval of appropriate data in the form of suppiamental new drug i

applications.

However, given the apparent benefits, as identified by your staff in discussions with FDA staff, of consistent preparation of ei=&stic doses, reduced environmental and pharmacists' exposure to radicanolides through use of centralized radiopharmacies, and better assurance of the availability of appropgiate diagnostic redint a==n-itical dose h

forms, w are prepared'to consider pharmacy operations, including radiophiiirmoor operations, that are consistent with our d3mplianoe goater Guide on anarmacy - u - =' air as falling within the scope or the legitimate praouco os pan.--ay.

we will be pleases to i

assoues this with synoor or other ERC licensees that may wish to compound products in ways -that 3ro artimplicitly described in product labeling.

j Again, we wpreciate the opportunity for involvement in your i

rulemaking and look forward to continued cooperation in coordinating our regulatory responsibi).ities..

1

.ince, air -s,

'i h

/ David M. F.bler, M.

I

[ Cominissioner of Food and Dru'rs j

i Enclosure t

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. SENT BY:FDA - Exec. Sec. Off. I' 4-14-92 1 4:11PN :

3014431563*

9301504175ft# 4 I

I.'-

a FOOD AND DRUG ADMINISTRATION COMPUANCE POUCY GUIDES GUIDE 7132.te CHAPTER 32 - DRUGS GENERAL I

4

SUBJECT:

Manufacture, Distribution, and Promotion of I

Adulterated, Misbranded, or Unapproved New Drugs for

!!uman Use by state-Licensed Pharmacies BACKGROUND l

This compliance policy guide (CPG) reflects longstanding FDA

{

policy that has been articulated in related CPGs, warning letters, and federal court decisions.

FDA recognizes that pharmacists traditionally have extemporaneously compounded and manipulated reasonable aguanti':ies l

of drugs upon receipt!of a valid prescription for an individually,

identified patient front a licensed practitioner.. This traditional activity is not the subject of this cpg.

with respect to such activities, it is important to note that 21 U.S.C. 360(g) (1) exempts retail pharmacies from the registration requirements that include, among other things, a mandatory i

biennial FDA inspection.

The~ exemption applies to "Sh&I:aanim" I

that operate in accordance with state law and dispense drugs l

aupon prescriptions of practitioners licensed to administer such i

drugs to patients under the enra of -*s nractitioners in ehm course of their nref amminnal nractica, and sahich do not l

manufacture, prepare, propagate, compound, or process drugs or

' devices for sale other than in the reaular course of their i

businema of disnansina or selling drugs or devices at reta11" l

(esphasis added).

Dear Dr. Kessler:

IMNS Central Files NMSS Dir. Off. r/f IMAB r/f Thank you for your April 14, 1992 reply to Chairman Selin's NRC File Centt letter concerning the hegulation of radiopharmaceutical drug products.

We are pleased that the Food and Drug Administration is willing to work with the Nuclear Regulatory Commission's licensees that wish to compound products in ways that are not explicitly described in product labeling in order to clarify the applicability of the Food, Drug, and Cosmetic Act to such activities.

On April 16, 1992, our staffs met to discuss a response to the pharmacy issues raised in the 1989 American College of Nuclear Physicians and Society of Nuclear Medjpine petition for rule-making.

The NRC staff believes that the discussions on the pharmacy issue and the NRC interim final rule were very pro-ductive and provided ways to address FDA's concerns.

The Commission appreciates your support and looks forward to continued cooperation and coordination between our agencies.

Sincerely, Kenneth C. Rogers Acting Chairman

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27711 r'

Proposed Rules

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a rai e Vol. 67. No.120 5

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Monday, June 22.1992 f

Th<

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This sectaon of the FEDERAL. REGISTER. the key issues related to three topics authorized user physicianlhall conislo ~

t.

mntains nota =s to the put*c of the which are described below.

a conclusion, through a reasoned and Pmposed hsuance of ndes and The American College of Nuclear professional judgment on the patient's repetions. The purpose of these notices Physicians (ACNP) and the Society of pregnancy and breast feeding status and h to Onre had pemons an Nuclear Medicine (SNM) submitted a provide that status in the written N go, petition for rulemaking requesting that

- directive."

go rules.

~

the NRC amend its regulations Dr. Carol Marcus submitted a petition

- - - - ~ pertaining to the preparation and use of for rulemakifig requesting a modification radioactive drugs containing byproduct of the public dose limits in the revised NUCLEAR REGULATORY material.Two issues of the petition (i.e, 10 CFR part 20."he concern expressed COMMISSION departure from manufacturer's in the petition w s that the revised dose instructions for preparing limit of 100 millirem total effective dose 10 CFR Parts 20,30,32, and 35 radiopharmaceuticals using nuclide equivalent was in conflict with the Worir. shop to Discuss Topics Related Eenerators and reagent kits, and criteria in 10 CFR 35J5 for release of t2 " Pregnancy,' "Radioactrve Drugs,-

departure from package insert patients imm hospitals for those end " Patient Release Crtteria" instmctions regarding indications and patients who have been administered method of administration for therapeutic byproduct material. Durmg the public AGENCY: Nuclear Regulatory radiopharmaceuticals) were temporarily comment period on the receipt of the Commission.

addressed in the interim final rule, that petition by Dr. Marcus, the American became effective on August 23,1990 for College of Nuclear Medicine (ACNM)

Acnoec Notice of meeting.

- 3 years.Three remaining issues are submitted a petition for rulemaking F

cUMMARY:The Nuclear Regulatory whether to allow:(1) Human research specifically related to the release d

Commission [NRC) staff plans to using byproduct material; (2) the use of criteria in 10 CFR 35J5.ne ACNM I;

cenune a pubhc workshop with radiolabeled biological products: and (3) petition suggested that the approach to j

representatives of Agreement States to compounding radioactive drugs (i.e, establishing release cdteria be modified a l, discuss issues related to three topics.

synthesized from reagent chemicals) by to a dose based approach as outlined in The first topic involves the proposed qualified nuc! car pharmacists.%e NRC Report 37 of the National Council on resolution of a petition for rulemaking is in the process of resolving allissues Radiation Protection and Measurements.

7 submitted by the American College of of the petition.

The NRC staffis considering the Nuclear Physicians and the Society of ne NRC is considering issues related appropriateness of addressing these two Nuclear Medicine concerning the to administration of byproduct material petitions simultaneously, and whether preparation and use of radioactive drugs or radiation therefrom to a patient of the existing approach to patient release containing byproduct matenal.The m

childbearing potential without first criteria in 10 CFR 3535 should be second topic involves the adm, istration determining whether the patient is modified.

of byproduct matenal or radiation pregnant or breast feeding. It is a matter l

t therefrom to patients of childbearing Conduct of the Meet.mg of record that some medical use potential who may be pregnant or breast feeding. He third topic involves the licensees have administrated byproduct The workshop will be co-chaired by proposed resolution of petitions for material to patients of childbearing the undersigned and Dr. John E. Glenn, rulemaking submitted by Dr. Carol potential who were pregnant or breast Chief. Medical and Commercial Use d

Marcus and by the American Co!!ege of feeding without knowing the patient's Sa fety Dranch, Division of Industrial and pregnancy or breast feeding status. The Medical Nuclear Safety, NRC.The c nsequences were that unintended moderator will be Mr. John L Telford, f

t a f rrelease f pat ents f m hospitals for thor.e patients who have radiation exposures were delivered to Acting Chief Regulatiocs Development been administered byproduct material.

an embry. Mus, or breast-fed infant.

Branch. Dmsion of Regulatory 4

The NRC is considering adding two App!ications. Office of Nuclear DATT.:The workshop will be held on July more objectives to the Quality Pegulatory Research, NRC. ne i

15 and 16.1992, from 8:30 a.m. to 5 p.m.

Management Program (10 CFR 35.3;) to w od shop will be conducted in a manner or later on the first day and from 8.30 ensure a high level of confidence that that mil facilitate the orderly conduct of a.m. to 3.45 p.m. or later on the second unintended radiation exposures to an business.The transcript of the workshop l

day.

pg.o. fetus, or breast-fed infant will will be a vailable for inspection, and ADDRESSES: Meeting to be held at Lenox be prevented.The objective for all cep>ing for a fee, at the NRC Public inn 3387 Lenox Road NE., Atlanta, GA ra diopharmaceutical administrations Document Roorn. 2120 L Street NW.

30326 (telephone 404-201-5500).

(i.e, diagnostic and therapeutic) would (Lower level). Washington, DC 20555.

roa runTHER INFORMATION CONTACT:

be that. " prior to each administration.

on or about August 31.1992.

Vandy L Miller, Office of State patients of childbearing potential be The following procedures apply to Programs,3D23, U.S. Nuclear Regulatory alerted to notify the authorized user pulhc attendance at the workshop:

Commission, Washington, DC 20555 physician or technologist if they are

1. Questions or statements from telephone (301) 504-2326.

pregnant or breast feeding." The attendees other than participanta (i.e.,

SUPPtiMENTARY 8HFORMATION:The objective for all administrations, for participating representative of each d

objective of the workshop is to conduct which a written directive is required Agreement state and participating NRC a roundtable discussion with pursuant to 10 CFR 35.32(a), would be staff) will be entertained as time representatives of Agreement States on that, " prior to administration, the permits.

l 4

i 27712 Fedcral Register / Vol. 57. No.120 / Monday, June 22, 1902 / Proposed Rules s

2. Seating for the public will be on a Airplane Directorate.1001 Lind Avenue realignment. if necessary.That NPRM -

first-come hrst-served basis.

SW Renton. Washington.

was prompted by an incident in which a Dated at Rockville. Maryland, this 12th day FOR FURTHER INFORMATION CONTACT:

wire loom short circuit caused fire l

ef June 1992.

Mr. Greg Holt. Aerospace Engineer, extinguishant to discharge and pop the For the Nuclean Regulatory Commission.

Standardization Branch, ANM-113, circuit breaker for a brake fan.That

[

Cadton Kammenr, FAA. Transport Airplane Directorate.

condit. ion,if not corrected. could result 1001 Lind Avenue SW Renton.

in electrical short circuiting due to Director. Office ofStatePmsmms.

Washington 98055-4050; telephone (200) chafing of the wire loom in the wing and

[FR Doc. 92-14605 Filed 6-19-02: 8:45 amj 227-2140; fax (200) 227-1320.

the hon,zontal stabilizer.

Comments invited j

^ Airbus Industrie has issued Revision 2, l

Since the issuance of that NPRM.

SUPPLEMENTARY INFORM AT*ON:

i to Service Bulletin A320-24-1044, dated I

DEPARTMENT OF TRANSPORTATION Interested persons are invited to March 3.1992: and Revision 2 to Service f

Federal Aviation Administration participate in the making of the Bulletin A320-24-1045. dated April 9, i

propo.ed rule by submitting such 1992.

14 CFR Part 39 written data. views, or arguments as Revision 2 of' Airbus Service Bulletin they may desire. Communications shall A320-24-1044 provides clanfication of j

[ Docket No. 91-NM-251-AD1 identify the Rules Docket number and the inspection areas by highlighting Airworthiness Directives; Airbus be submitted in triplicate to the address critical zones where wire loom chafing j

industrie Model A320 Series Airplanes 8pecified above. All communications had occurred (wing zones 574 and 67.4 j

received on or before the closing date through panels 574 AB and 674 AB).

l AGENCv: Federal Aviation for comments, specified above, will be leading to engine extinguisher bottle Administration. DOT.

considered before taking action on the discharge.The FAA has revised ACTION: Supplemental notice of p!0 posed rule.De proposals contained paragraphs (a) and (b) of the NPRM proposed rulemaking: reopening of in this notice may be changed in light of accordingly, i

comment period.

the comments received.

The service bulletin revision also

)

Comments are specifically invited on describes a revision to the intervals for

]

tumuARY:This document revises an the overall regulatory, economic. -

repetitive inspections of the wire looms earlier proposed airworthiness directive environmental, and energy aspects of in the wing and horizontal stabilizer (AD), applicuble to certain Airbus the proposed rule. All comments (excluding wing zones 574 and 674

+

f Industrie Model A320 series airplanes.

submitted will be available, both before through panels 574AB and 674AB) from that would have required inspection to and after the closing date for comments. 3.100 to 3.500 flight hours.ne FAA has detect chafing of the wire looms in the in the Rules Docket for examination bY revised the repetitive inspection i

wing and the horizontal stabilizer, and interested persons. A report intervals required by paragraph (b) of i

repair or replacement. protection. and summarizing each FAA-public contact the NPRM to coincide with this change.

I realignment, if necessary. That proposal concerned with the substance of this The service bulletin revision provides I

4 was prompted by an incident in which a proposal will be filed in the Rules clarification concerning the conditions l

wire loom short circuit caused fire.

Docket.

that would require realignment and j

extinguishant to discharge and pop the

.Commenters wishing the FAA to protection of the wire loom.The FAA circuit breaker for a brake fan.This acknowledge receipt of their comments has revised paragraphs (a)(2) and (b)(2) action revises the proposed rule by submitted in response to this notice of the NPRM to include this clarification.

revising the inspection area must submit a self. addressed, stamped Should an o'perator choose to requirements, increasing the repetitive postcard on which the following accomplish the temporary repair l

Inspection intervals, and adding two statement is made:" Comments to required by paragraph (a)(2) or (b)(2) of airpianes to the applicability of the AD.

Docket Number 91-NM 251-AD."The the proposed AD. the operator then The actions specified by this proposed postcard will be date stamped and would be required to accomplish AD are intended to prevent electrical returned to the commenter.

realignment and protection of the loom i

short circuiting due to chafing of the Availability of NPRMs at a specified interval after performing wire loom in the wing and the horizontal the temporary repair. (This requirement stabilizer" Any person may obtain a copy of th.is a

NPRM by submitting a request to the

, is specified m. new proposed paragraph j

DATES: Comments must be received by p33,7,,,,,,,,33,p3,,,gi,,c,,,,,,,

(cn

~

ANM-103. Attention: Rules Docket No.

In addition, this service bulletm, I"

j ADDRESSES: Submit comments in 91-NM-251-AD,1001 Lind Avenue SW.,

revision adds two airplanes to the l

triplicate to the Federal Aviation Renton. Washington 98055-4056.

eflectivity. Since two additional a

Administration (FAA). Transport airplanes that are subject to the unsafe Airplane Directorate. ANM-103.

Discussion condition have been identified, the FAA Attention: Rules Docket No. 91-NM-A proposal to amend part 39 of the has revised the applicability of the 251-AD,2001 Lind Avenue SW., Renton. Federal Aviation Regulations to add an NPRM to include these airplanes.

l Washington 98055-4056. Comments may airworthiness directive (AD), applicable Revision 2 to Airbus Service Bulletin

.be inspected at this location between 9 to certain Airbus Industrie Model A320 A320-24-1045 revises certain

[

a.m.and 3 p.m.. Monday through Friday. series airplanes, was published as a modification numbers, revises the except Federal holidays.

notice of proposed rulemaking (NPRM) effectivity, and describes alternative l

The service information referenced in in the Federal Register on January 10.

materials and material specifications i

the proposed rule may be obtained from - 1992 (57 FR 1120).%et NPRM would that are available to operators.

Airbus Industrie. Airbus Support have required inspection to detect The FAA has revised the proposal to i

Division, Avenue Didier Daurat. 31700 chafing of the wire looms in the wing reflect these latest revisions to the Blagnac, France.This information may and the horizontal ~ stabilizer, and repair service bulletins as additional service i

be examined at the FAA. Transport or replacement. protection. and information sources.

i

/L t

s* ** c s

[

o UNITED STATES

[^

','g NUCLEAR REGULATORY COMMISSION E

WASHINGTON. D. C. 20555

\\

p

[

June 16, 1993 3l b A

The Honorable Joseph I. Lieberman, Chairman Subcommittee on Clean Air and Nuclear Regulation 3

Committee on Environment and Public Works United States Senate Washington, D.

C.

20510

Dear Mr. Chairman:

In the near future the Nuclear Regulatory Commission (NRC) intends to publish in the Federal Recister the enclosed proposed rule.

This proposed rule would amend the NRC's regulations in 10 CFR Parts 30, 32, apd 35 to eliminate certain restrictions regarding the medical u,se of byproduct material.

Specifically, among other things, the proposed rule would incorporate into NRC's regulations the concept of authorized nuclear pharmacists to allow properly qualified pharmacists greater discretion to prepare radioactive drugs containing byproduct material.

Also, the proposed rule would allow physician authorized users greater discretion to prepare and use radioactive drugs containing byproduct material, the use of byproduct material in research involving human subjects, and the use of radiolabeled biologics containing byproduct material.

The Commission believes that the proposed rule, if adopted, would result in a small cost reduction for medical use licensees without compromising the level of protection of public health and safety against radiological hazards.

Sincerely,

/

Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

Federal Register Notice cc:

Senator Alan K.

Simpson

\\

-j

/s a %,I'o s

..c UNITED STATES

', ^

E s NUCLEAR REGULATORY COMMISSION -

I j,

i W ASH WG TON. D. C. 20555 s

/

June 16, 1993

=

The Honorable Richard Lehman, Chairman Subcommittee on Energy and Mineral Resources Committee on Natural Resources United States Hout.e of Representatives Washington, D.

C.

20515

Dear Mr. Chairman:

In the near future the Nuclear Regulatory Commission (NRC) intends to publish in the Federal Reaister the enclosed proposed rule.

This proposed rule would amend the NRC's regulations in 10 CFR Parts 30, 32, and 35 to eliminate certain restrictions regarding the medical d(e of byproduct material.

Specifically, among other things, the proposed rule would incorporate into NRC's regulations the concept _of authorized nuclear pharmacists to allow properly qualified pharmacists greater discretion to prepare radioactive drugs containing byproduct material.

Also, the proposed rule would allow physician authorized users greater discretion to prepare and use radioactive drugs containing byproduct material,' the_use of byproduct material in research involving human subjects, and the use of radiolabeled biologics containi,ng byproduct material.

i The Commission believes that the proposed rule, if adopted, would result in a small cost reduction for medical use licensees without compromising the level of protection of public health and safety against radiological hazards.

Sincerely,

[d

,dm W

Dennis K.

Rathbun, Director Office of Congressional Affairs

Enclosure:

Federal Register Notice cc:

Rep. Barbara Vucanovich

[ga asego' UNITED STATESI

' 'o NUCLEAR REGULATORY COMMISSION W ASHINGTON. D. C. 20555 i

/

s June 16, 1993

[

7NO.

JN 5

^

The Honorable Philip Sharp, Chairman Subcommittee on Energy and Power Committee on Energy and Commerce United States House of Representatives I

Washington, D. C.

20515

Dear Mr. Chairman:

f In the near future 'the Nuclear Regulatory Commission (NRC) intends to publish in the-Federal Reaister the enclosed proposed rule.

This proposed rule would amend the NRC's regulations in 10 CFR Parts 30, 32, and 35 to eliminate certain restrictions regarding the medical die of byproduct material.

+

Specifically, among other things, the proposed rule would incorporate into NRC's regulations the concept of authorized.

nuclear pharmacists to allow properly qualified pharmacists

. byproduct material.

Also, the proposed rule would allow. '

.j greater discretion to prepare radioactive drugs containing_

physician authorized users greater discretion to prepare and use radioactive drugs containing byproduct material,.the use of i

byproduct material in research involving human subjects, and the use of radiolabeled biologics contain,ipg byproduct material.

The Commission believes that the proposed rule, if-adopted, would result in a small cost reduction for medical use licensees without compromising the level of protection of public health and safety against radiological hazards.

Sincerely,

~'

L Dennis K. Rathbun, Director Office of Congressional Affairs 1

Enclosure:

i; Federal Register Notice cc:

Rep. Michael Bilirakis

]

.i

Tu 33396 Federal Register / Vol. 58, No.115 / Thursday, June 17, 1993 / Proposed Rules amendments necessary to clarify or considered the petition on its own update the current regulations.

merits.

DATES:The comment period expires The NRC reviewed the petition and October 15,1993. Comments received identified the following issues:

after this date will be considered if it is A. The petitioners requested that practical to do so, but the Commission authorized users who are physicians (P ysician authonrad users) be given h

is able to assure consideration only for comments received on or before this greater flexibility regarding the medical date' use of radiopharmaceuticals containing I

byproduct material. Specifically, the ADDRESSES: Mail written comments t petitioners requested that these the Secretary, U.S. Nuclear Regulatory physicians be permitted to:(1) Use Commission, Washmgton, DC 20555, radiopharmaceuticals to treat diseases Attention: Docketing and Service that are not listed in the U.S. Food and Branch.

Drug Administration (FDA) approved Hand deh. var comments to 11555 package lasert;(2) use Knethods of Rodville Pike, Rockville, Maryland, administration of radi6 pharmaceuticals between 7:45 a.m.. and 4:15 p.m. on for therapy that are not listed in the Federal workdays.

package insert;(3) use Copies of the draft regulatory analysis radiopharmaceuticals other than those and any pubhc comments received on for which the FDA has accepted an the proposed rule may be examined at:

Investigational New Drug (IND) or an the NRC Public Document Room,2120 approved New Drug Application (NDA);

L Street, NW. (Lower level).

(4) prepare radiopharmaceuticals using Washmgton DC.

radionuclide generators and reagent kits roR FURTHER INFORMATON CONTACT:

in a manner other than in acconiance Samuel Z. Jones or Anthony N. Tse, with the manufacturer's instructions; Office of Nuclear Regulatory Research.

and (5) compound radiopharmamuticals U.S. Nuclear Regulatory Commission, in accordance with State law.

Washington, DC 20555, telephone (301)

B. The petitioners requested that the 492-3738 for Mr. Jones, or (301) 492-NRC recognize the practice of nuclear 3797 for Mr. Tse.

pharmacy by nuclear pharmacists and nuh phah m

a SUPPLEMENTARY INFORMATON:

by the Board of Pharmaceutical

Background

Specialties. Specifically, the petitioners NUCLEAR REGULATORY The Petition for Rulemaking g

e tn a acists be COMMISSION in early 1989, the American College of radiopharmaceuticals as described in Nuclear Physicians (ACNP) and the State or FDA regulations; (2) compound 10 CFR Parts 30,32, and 35 Society of Nuclear Medicine (SNM) radiopharmaceuticals whose NN 3150- AD69 approached the NRC staff with concerns manufacture and distribution are not that the Commission's regulations failed regulated by the State or FDA;(3)

Preparation, Transfer for Commercial to accommodate the functions and prepare radiopharmaceuticals using Distribution, and Use of Byproduct responsibilities of the practice of radionuclide generators and reagent kits Material for Medical Use nuclear pharmacy. At the suggestion of in a manner other than in acx:orciance AGDvCY: Nuclear Regulatory the NRC staff, the ACNP and SNM with the manufacturer's instructions; (4)

Commission.

submitted a petition for rulemaking produce reagent kits; and (5) distribute Am Proped rule, requesting the Commission to amend its radiopharmaceuticals that are not regulations to fully recogrdre the role of regulated by the FDA.

suwuARY:The Nuclear Regulatory licensed nuclear pharmacists and C. Additionally, the petitioners Commission (NRC)is proposing to physicians. On September 15,1989 (54 requested that the NRC: (1.) Permit amend its regulations for the medical FR 38239), the Commission published categories of research using radioactive use of byproduct material. This action is in the Federal Register a notice of dmgs that do not require an IND, such being tak en in response to a petition for receipt of a petition for rulemaking for as research approved by a Radioactive rulemaking. The proposed rule is public comment (PRM-35-9).

Drug Research Committee (RDRC); (2) intended to provide greater flexibility by During the development of the permit the use of radiolabeled biologics allowing properly qualified nuclear ACNP4NM petition, one NRC staff for which the FDA has issued a license pharmacists and authorized users who member provided substantial assistance in response to a product license are physicians greater discretion to in the preparation of the petition, but application (PLA); and (3) clarify its prepare radioactive drugs containing has not participated in the NRC's regulations pertaining to speciSc bypmduct material for medical use. The resolution of the petition or in the licenses of broad scone.

proposed rule would also allow research development of tids proposed rule.

In response to the federal Register involving human subjects using Another NRC staff member reviewed the notice that announced the receipt of the byproduct material and the medical use petition prior to its formal submittal to petition,466 comment letters were of radiolabeled biologics. In addition, the Commission and participated, to received. About 99 percent of the the proposed rule also cxmtains other some extent, in the NRC's resolution of commenters supported and agreed with miscellaneous and conforming the petition and in the development of the petition. After consideration of the the proposed rule. The Commission, public comment letters and consultation

%xuons.cuun muon numtw.

while awar, cf th -

4 ground, with the FDA staff, the Commission m

Federal Register / Vol. 58, No.115 / Thursday, June 17, 1993 / Proposed Rules 33397 determined that some issues should be issuing Syncor's amendments. Until the 3 The NRC will minimize intrusion addressed promptly.

amendments contemplated in this into medical judgments affecting On Augrst 23,1990 (55 FR 34513),

proposed rulemaking are adopted patients and into other areas the Commission published an Interim through the issuance of a final rule, the traditionally considered to be a part of Final Rule to allow, for a period of 3 NRC stands ready to consider similar the practice of medicine.

years,the use of therapeutic license amendment requests from other la conformance with this policy, the radiophannaceuticals for indications commercial nuclear pharmacies.

Commission proposes to elitninate not listed in the package insert and to Meanwhile, to provide relief from the certain restrictions in the NRC

)

allow departures from the recordkeeping requirements contained regulations on the practice of medicine manufacturer's instructions for in the Interim Final Rule,the

, and pharmacy (e.g., compounding), and preparing diagnostic Commission published a final rule provide the authority for research radiopharmaceuticals using entitled "DepaMure From invohing human subjects and the use of radionuc'lide generators and reagent Manufacturer's Instructions; radiolabeled biologics. The Commission kits. In response to the Commission's Elimination of Recordkeeping believes that these restrictions can be request for public comments associated Requirements" (57 FR 45566; October 2, eliminated without compromising the with the Interim Final Rule, eight 1992). This final rule eliminated all the level of protection of public heahh and commer.t letten were received. Seven recordkeeping requirements Based on safety against radiological hazards. The

lette-s supported the mient of the rule the information collected under the Commission recognizes that physicians but disagreed with the recordkeeping Interim Final Rule, bcth the NRC and have the primary responsibility for the -

requirements contained in the rule. One FDA staff agreed that the major trends diagnosis and treatment of their patients comment letter sought clariScation of in departures that could be identified by or human research subjects and the mle. The Interim Final Rule the recordkeeping were already recognizes that the nuclear pharmacists permitted specific de artures only at the discernible. Thus, additional have the primary responsibility for the wntten direction of a hysician recordkeeping was not necessary.

preparation of radioactive drugs. NRC authorized user, and i does not permit ina regulations are predicated on the pharmacy-directed departures.

to workarallel effort, the NRC continued ly trained and assumption that pro 7p on the remaining issues in the adequately informe sicians and ACNP-SNM petition. On August 7,

,R, eco'ns.2derati n an a et n or 1991, the NRC conducted a pubhc pharmacists will make ocisions that w rkshopin Rosemont, Illinois,to are in the best interest of their patients econsi er on 53 cor International Co oration (Syncor)

Present "strawman"languaSe on the or human research subjects.

regarding NRC's terim Final Rule.

trainmg and expenence cntena for Furthermore,the pharmacological authorized nuclear pharmacists to aspects of radioactive drugs, including Among other objections, the petition representatives of the followmg.

drug safety and eUicacy, are regulated assened that the rule violates the AtomicEnergy Act,the Administrative organizations: Board of Pharnlaceutical by the FDA or the States.

S ocialties, American Board of Science The Commission believes that the P

Procedure Act, and NRC's implementing in Nuclear Medicine, National proposed amendments would provide regulations, and that the recordkeeping requirements of the Interim Final Rule Association of Boards of Pharmacy, greater discretion for physician Committee on Radionuclides and authorized users to use byproduct have a direct and negative impact on harmacies.

Radiopharmaceuticals of the U.S.

matenalin the practice of medicine.

nuclear kober 19,1990, Syncor alsoCouncil for Energy Awareness, Also, the proposed amendments would OnOc filed a " Petition for Review" with the American Pharmaceutical Association, incorporate into the regulations the U.S. Court of Appeals for the District of American Society of Hospital concept of an authorized nuclear Columbia Circuit (Syncortnfernotional Pharmacists, and three graduate schools pharmacist to allow properly qualified of harmacy. Subsequently, the NRC pharmacists greater discretion to P

Corp. v. NRC, NO 90-1495). The petition asked the court to review and also discussed the proposed resolution prepare (including compound) set aside portions of the " Interim Final of these issues in meetings with the radioactive drugs containing byproduct Rule " especially the recordkeeping FDA, the NRC's Advisory Committee on material for medical use. In response to requirements in 10 CFR 30.34(i)(1)(1-11). the Medical Uses ofIsotopes (ACMUI),

the petition for rulemaking,the Also, Syncor requested that the NRC and the Agreement States.This Commission is proposing to:

amend its nuclear pharmacy license to proposed rulemaking is the evolutionary

1. Allow physician authorized users permit certain pharmacy-directed result of numerous meetings with the to use therapeutic radioactive drugs departung in addition to the Interim aforementioned groups.

containing byproduct material for indications or methods of Final Rule's physician-directed The ProPmd Modincations administration not listed in the FDA-departures. Syncor and the NRC staff apeed to hold the court action in In a policy statement published on approved package insert; abeyance for a period of several months February 9,1979 (44 FR 8242), entitled

2. Allow physician authorized users to give the NRC an opportunity to

" Regulation of the Medical Uses of to use radioactive drugs containing respond to Syncor's request. After Radioisotopes: Statement of General byproduct material for research considerable interaction among the Policy." the NRC stated:

involving human subjects; NRC, Syncor, and the FDA, the 1.The NRC will continue to regulate

3. Allow physician authorized usera requested license amendments for the medicaluses of radioisotopes as to use radiolabeled biologics containing pharmacy-directed departures were necessary to provide for the radiation byproduct material; granted. Because of the generic interest safety of workers and the general public.

4. Allow medical use licensees and this licensing action might have had for

2. The NRC will regulate the radiation commercial nuclear pharmacies to other commercial nuclear pharmacy safety of patients where justified by the depart from the manufacturer's licensees, the NRC, on June 26,1991, risk to patients and where voluntary instructions for preparing radioactive sent each of these licensees a letter standards, or compliance with these drugs using radionuclide generators and informing them of the NRC's action in standards, are inadequate.

reagent kits;

33398 Federal Register / Vol. 58, No.115 / Thursday, June 17, 1993 / Proposed Rules

5. Allow medical use licensees and bypmduct material" in these sections of

7. In part 35, the Commission is commercial nuclear pharmacies to the proposed rule.

proposing to change the lower limit for compound radioactive drugs using

3. The Commission is proposing to testing dose calibrators for linearity byproduc material; modify the definition of " medical use" from 0.37 Megebecquerel (10

6. Delete the existing regulations in parts 30 and 35 by replacing the term microcuries) to 1.1 Megabecquerels (30 related to the nonradioactive reegent

" human beings" with the term " patients microcuries) for consistency with 10 kits; and or human research subjects" to include CFR 35.32, " Quality Management

7. Clarify regulatory requirements for the administration of byproduct Program."

specific licenses of bmad scope.

material to an individual who is

8. In regard to the accuracy, linearity, Table 1 summarizes the requests participating in a researth procedure. In and geometry tests of dose cel:brators, made in the petition and the addition, the Commission proposes to the Commission is pmposing to replace Commission's responses, delete ' ' language in the defkiition of the requirement for the Radiation Safety In addition to the proposed

" medico use" that the administration of Officer's (RSO) signature with the amendments in response to the issues ' byproduct material be in the practice of mquirement for the identity of the I

raised in the petition, the Commission medicine in accordance with a license individual actually performing these i

is proposing related or miscellaneous to practice medicine. The definition of tests. This proposed change is necessary I

amendments to parts 32 and 35. In other terms in part 35 [e g., physician) to identify the individual who actually general, the objective of these proposed include this licensing concept.

Performed these tests. Furthermore, this 3mendments is to clarify, update, and With this proposed definition, diange would provide additional time

.imphfy the current regulations.

applicable requirements in part 35, such im the RSO to devote to other radiation S ocifically,these roposed as misadministration reporting and cafety issues.110 wever, this change P

amendmentsinclu e:

quality mana ement program.would w uld not affect the responsibilities of

1. In part 32, the Commission is also apply to uman research subjects; the RSO that are defined in existing 10 pro osing to replace the word thus, an equivalent level of protection CFR 3E21.

"ra iopharmaceutical" with the term would be provided for both patients and R The Comm,ssm, n is pmposing to

~ radioactive drug" m proposed 5 32.72.

human research subjects.

update the regulations by recognizing This change is necessary to include both several certificatwn boards in the tsdiopharmaceuticals and radiolabeled t in pan 32, the Comm.,,

training and experience requimments.

ssion is biologics in part 32.

PmPosing to clarify the existing

10. The Commission is proposing that

2. In pan 35, whenever applicable, the regulations regarding the labeling of licensees may allow authorized users Commission is proposing to use the syrmges, dals, generatms, or other and authorized nuclear pharmacists term " unsealed byproduct material" containers of radmact2ve drugs. This who meet certain requirements to use in stead of "radiopharmaceutical" or PSP Sed change is necessary to avoid byproduct material without the licensee confusm.n over the types of information first obtaining a license amendment

" radioactive drug." This proposed to be subntitted.

change is intended to indicate that the from the NRC. Therefore, the Commission's regulations regarding the

5. In part 32, the Commission is Commission is proposing to delete the medical use of bypmduct material are proposing to replace the text in provisions in part 35 addressing visiting focu.wd on radiation safety and are t 32.72[b) because it is obsolete.

authorized users.

separate from FDNs regulations

6. In discussing the proposed

11. The Commission is pmposing to regarding radioactive drugs. However, to regulations concerning transfer of modify the requirements for recentness prevent massive cha iges in part 35. the radioactive drugs, the Commission has of training of certain authorized users, word "radiopharmaceutical" will noted later in this preamble that it is

12. The Commission is proposing to continue to be used in ex2 sting sections sometimes necessary to transfer a add requirements regarding the for which no modifiutions are dosage of a radioactive drug on a case-preparation of byproduct material for proposed and for sections in which the by-case basis from one medical use medical use under the supervision of a only modification is to mplace he word licensee to another medical use physician authorized user and to

" patient" with the term " patient or licensee. These case-specific transfers provide comparable requirements human msea:t.h subject." Thus, the would not be considered commercial regardmg the supervisory word "radiopharmaceutir.al" will be transfers by the NRC and, therefore, responsibilities of authorized nuclear used as the equioent of " unsealed would not require a part 32 licemse.

pharmacists.

TABLE 1.-SUWARY OF REQUESTS IN THE PsmON AND THE COWSSION'S RESPONSES Request

Response

Perrrut authorized users to use radiopharmacau'ica% for therapeu*ic Permit phyucian aut*omed users w% are gdt*ied for therapeut6c M-uses not wvered in the padage sosert.

mirustraton to use radicactrve drugs for therapeutic uses not cov-ered in 1Se package insert.

Parmrt authorized users to use radoactive drugs ff res,sarch involving Permit ptyfscan authonzed users to use ra% ectr e drugs for re-v human subHcs search, provded that human research gutWs are protected PerrrW1 authorized users to use ra%iabeled biologu.

Perm #t ptrysictan authorized users to use rarieolabeled beo6 ragas, pro-veed that dosages of alpha-or-bet &errdtang radtorx;chdes are trw,asured.

PortrWt truedrA use ncensees and pharmacies b depart from package Permit physician authorized users ard authorized nuc6 ear pharmacWs inserts when urang generators aM kitz.

who meet certain training and emerience critena to depart from package inserts when usang generatars ard nuts.

Permit rnMecal use ncensees and charmacies to use byproduct rnate-Par nft phys,cian authortzed ur.e's and autSorized nuclear pharmacists rtal b compound radaom:$ve drugt who rnest certain traineng and expenence critana to prepare (irckd ing cornpound) radract;ve drugs.

Federal Register / Vol. 58, No.115 / Thursday, June 17, 1993 / Proposed Rules 33399 TABLE 1.-

SUMMARY

OF REQUESTS IN THE PETITION AND THE COMM!SSION'S RESPONSES-Continued

Response

Request Perrrut nuclear pharmacrsts to prepara reagent kits...

Dekste NRC regulat>ons on reagent kits which do not contain byprod-uct materlat Thus, nucisar pharmacists wouki be able to prepare re-agent kits under apphcable law.

Clanty requirements on hcenses of broad scope Clanfy the requirements by adding two exemptions in part 35.

13. The responsibilities of the Section 32.72(o)

" group licensees" would be replaced Radiation Safety Committee would be This paragraph would be modified to with the phrase " medical use licenS**S "

modified to reflect the activities which add the word " prepare" and the phrase the proposed changes to part 35 would

" transfer for commercial distribution" Section 32.72(ol(4) authonze.

to more accurately reflect the operations Discussion of Proposed Regulatory Text of nsees regulated under tins The Commission proposes to modify

$ 32M@M to M h p d Section 30.4.

Definitions information that should be contained on Section 32.72(o)(1) the label to be affixed to each container The definition of" medical use" The pmposed amendment to this of a radioactive drug.This action is would be modified to conform to the paragraph is an editorial change to proposed to ensure that the information corresponding definition proposed for replace "$ 30.33 of this chapter" with on the label would include information 10 CFR 35.2. This definition would b" "10 CFR 30.33 "

specified in existing 10 CFR 35.60(b) modified by replacing " patients" with and 35.61(b).

" patients or human research subjects" Section 32.72(ol(2)

Also, the Commission proposes to to include the administration of The Commission proposes to modify replace the phrase "each package" by byproduct material to an individual this paragraph to recognize radioactive the phrase " labels to be applied to who is participating in a research drug manufacturers holding registration containers of radioactive drugs, as procedure.

by the FDA, or eppropriate State specified in 10 CFR 35.60(b) and in addition, the modifications would agencies, as well as commercial nuclear 35.61(b) * * * " for the same reason as delete the current statement in this pharmacies licensed by State Boards of for the proposed changes in defmition that the byproduct matenal Pharmacy (SBPs) and nuclear

$ 32.72(a)(3), discussed above.

be administered in the practice of pharmacies operating in Federal ~

In addition, the Commission is also medicine in accordance with a license facilities. ne intent of this paragraph is proposing to delete the last sentence of issued by a State or Territory of the to clarify that commercial nuclear

$ 32.72(a)(4)(i) because it is obsolete.

United States, the District of Columbia, pharmecies are covered under this Furthermore," time of sssay" would or the Commonwealth of Puerto Rico.

section.

be added to the existing "date of assay."

This change would be mai, because: (1)

Radioactive drugs transferred from a This information is r.ocessary for This aspect of the definition is included commercial nuclear pharmacy to determining the dosage, at the time of defmitions in part 35 another licensee in the normal course of administration, for radioactive drug in other existind" user and physician);

(e g., authorize business are considered commercial containing radionuclides with short and (2) the definition of " medical use" transfers by the NRC and require a part half lives.

would include asearch involving 32 license. However, the Commission The Commission also proposes to human subjects.

recognizes that in the course of patient delete the provision in $ 32.72(a)(4)(ii) care or in the conduct of research that required FDA approval before Section 30.34 Terms and Conditions of procedures,it is sometimes necessary combining labeling information. In Lcenses for licensees to transfer a dosage of a addition, the remaining phrase of the radioactive drug on a case-by-case basis existing $ 32.72(a)(4)(ii) "the labels, Section 30.34(i) provided interim fr m ne medical use licensee to leaflets or brochures mquirod by this relief from the restrictions that licensees an ther medical use licensee. These paragraph are in addition to the labeling follow the manufacturer's instructions ecific transfers would not be re utred by the Food and Drug case-s[ered commercial transfers by the A mmistration (FDA) would be when preparing radiopharmaceuticals c nsi using radionuchde generators and reagent kits. This reposed rulemaking NRC and. therefore, would not require replaced by "NRC s labeling a Pad 32 bcense.

mquirements are independent of would eliminate t ese restrictions.

"9".mments of the M;This proposed Food and Drug Thenfore, the Commission proposes to Section 32.72(oJf3)

Admmistration (FDA).'

de1ete $ 30.34(i) in its entirety.

The Commission proposes to modify sentence would be moved to the Section 32.72 Manufacture, this paregraph to clarify the type of existing 6 32.72(a)(4)(i) which would be Preparation, or Transferfor Commercial information that should be submitted te.enamed $ 32.72(a)(4).

Itis proposed Distribution of Radioacike Drugs the NRC. The words " packaging" and amendment would not p eclude use of Containing Byproduct Materialfor

" package"in the existing 6 32.72(a)(3) one label if it contains all the required Medical Use Under 10 CFR Part 35 could be interpreted as referring only to information.

the external transportation package (e g.,

The Commission proposes to retitle cardboard box). In the proposed Section 32.72(b) this section to more accurately reflect

$ 32.72(a)(3), the words " * *

per viel, The Commission proposes to revise the operations of licensees (i.e.

syringe, generator, or other this paregraph because the existing text manufacturers and commercial nuclear container * * * " would be used to is obsolete.

pharmacies) regulated under this clearly indicate the types of information The Commission proposes raw text section.

to be submitted. In addition, the phrase that would allow an " authorized

33400 Federal Register / Vol. 58, No.115 / Thursday, June 17, 1993 / Proposed Rules nuclear pharmacist"(or individual A pad 32 " authorized user" who does Section 32.72(d) working under the supervision of the not currently possess a valid state This aragraph is necessary to remind

" authorized nuclear pharmacist")

pharmany licensure or registration part 32 icensees to comply with working in a commercial nuclear would not be grandfathemd as an applicable FDA, other Federal, and State pharmacy to prepare (includmg authorized nuclear pharmacist because-requirements in addition to applicable compound) radioactive drugs. The NRC under state law, this individualis not NRC requirements. Compliance with is using the phrase "pmpare radioact2ve qualified to be a pharmacist. liowever, NRC irements does not eliminate drugs" in a general sense to mclude: (1) such an individual may wo k in a the nee to comply with other lawful Using radmnuclide generators and nuclear phannacy under the supervision requirements. Ilowever, it is not the nonradioactive reagent kits to produce of an authorized nuclear pharmacist.

intent of the Commission to perform b prod t rra er a ar ot basic The Commisdon proposes to require inspections to ensure compliance with ingredients to compound radioactive licensees to submit a copy of the FDA or State requirements nor to drugs.

individual's board certification, the enforce those regulations.

Cunent regulations require that a part license, or the permit, and the state Section 32.73 Manufacture and 32 licensee may not depart from pharmacy licensure or registration to tire Distribution of Genemfors or Reagent manufacturer's instructions when NRC within 30 days of the date that the Kits for Preparation of preparing radioactive drugs unless: (1) licensee permits the individual to work Radiopharmaceuticals Containing A license amendment has been granted as an authorized nuclear pharmacist.

Byproduct Material permitting the departure; or (2) the This proposal would reduce the departure has been requested by a licensees' burden because such a The Commission proposes to delete this section in its entirety. Because physician authonzed user. This notification would replace the currently radionuclide generators would be requirement restricts the ability of required license amendment and the included as a radioactive drug in qualified nuclear harmacists to associated amendment fee which are proposed S 32.72, it is no longer practice their pro ession which could currently necessary before a licensee necessary to include the generators in otherwise mclude, but for NRC n

may allow an authorized nuclear S 32.73. In addition, the Commission is

[#I eyRC N "v s brad oactiv"pharmacist to work in its facility. In proposing to discontinue regulating s

additwn, the proposed action would reagent Lits because they do not contain restnction can be eliminated provided also eliminate the delay associated with byproduct material.

that the pharmacist meets the training t

icense a and experience requirements in ew 0 e n \\t 10 CFR Part 35 Medical Use of

}

o pon pro $ nosed 10 CFR 35.980.

BJProduct Material mcei t to verify diet the re9uirements of P

'I e Commission is proposing to define the terms " medical use" and Proposed $ 32.72(b) have been met.

The Commission is proposing to

" authorized nuclear phannacist" in part During the review process, the NRC can replace the word " patient" with trie consider an individual's character in term " patient or human esearch 32 by referencing the definition of these t

terms in proposed 10 CFR 35.2. The addition to credentials in determining subject" as stated in the sections of part definition of " medical use" would be whether the individual should be 35 which the Commission is proposing modified to add the term " human approved as an authorized user or to amend. Ilowever, only those sections of art 35 which are otherwise being research subject" to include the authorized nuclear pharmacist, such as P

administration of byproduct material to verifying that the individual has not amended are included in the section-by-an individual who is participating in a committed or caused others to commit section " Discussion of Proposed research procedure. It is necessary to any willful violations of the Regulatory Text" which follows. The define an " authorized nuclear Commission's regulations. At the time sections not included in that discussion phannacist" because the proposed of the next licensing action, the names are: 5% 35 2 (the definitions of amendments would provide of approved individuals would be listed misodmimstrofion and written pharmacists with the authority to on the license, without fee, as an directive), 35.32,35.33,35.60,35.75, possess and use byproduct material in authorized nuclear pharmacist.

35.310,35.315,35.404,35.406,35.410, the practice of nuclear pharmacy.

35.415,35 610, and 35.615.The purpose For purposes of part 32, an au'thorized Section 3212/c) of using the phrase " patient or human nuclear pharmacist also includes those research subject"is to make it explicit individuals who are currently licensed The Commission proposes to add this that licensees must follow the or registered by a state as a pharmacist paragraph to explicitly require part 32 requirements of part 35 whenever and who are also designated, as of the licensees to measure and record each byproduct material or radiation effective date of the final rule, as an dos ge of radioactive dmgs before therefrom is being administered either

" authorized user" on a nuclear transferring these drugs to a medical use to a patient or to a human research pharmacy license issued by the licensae. This proposed change is subject. It is necessary to provide an Commission under 10 CFR pan 32 to necessary so that the proposed relief to equivalent level of protection for both work as an authorized nuclear 10 CFR part 35 medical use licensees patients and human research subjects.

pharmacist. The Commission believes with respect to measurements can be that this limited "grandfathering" is granted. In proposed S 35.53, medical SPCf'on 35.2 Definitiont justified because: (1) currently, these use licensees would not be required to Authonzed nuclear pharmacist. The

" authorized users" essentially meet the measure unit dosages of alpha-and beta-Commission proposes to add this new training and experience criteria for an emitting radioactive drugs obtumed definition. It is necessary to define an authonzed nuclear pharmacist as from part 32 licensees before authorized nuc' ear pharmacist because specified in proposed 10 CFR 35.980(b) administering these unit dosages to the proposed ameadments would (t), and (2) these " authorized users" arv patients or human research subjects.

provide pharmacists the authority to currently working in a nuclear Thus,it is necessary for the part 32 possess and use byproduct material in pharmacy.

licensees to make these measurements, the practice of nuclear pharmacy

t l

FederalgRegister / Vol. 58, No. Its / Thursday, June 17, 1993 / Proposed Rules 33401 independent of the supervision of a Medical use. The Commission is applicable provisions of part 35, such as physician authorized user, proposing to modify the definition of requirements related to the definition would specify three

" medical use" by replacing the term misadministrations and the quality groups ofindividuals that would be

" human beings" with the term " patients management program, also apply to a qualified as authorized nuclear or human research subjects" to include human research subject. Thus, an pharmacists: (1) Individuals certified by the administration of byproduct equivalent level of protection would be the Board of Pharmaceutical Specialties material to an individual who is provided for both patients and haman (BPS) as a board certified nuclear participating in a research procedure.

research subjects.

pharmacist (BCNP), (2) individuals Currently, the NRC allows by license The Commission is also proposing to identified as authorized nuclear condition specific medical use licensees delete the current statement in this pharmacists on a Commission or of broad scope to perform research definition that the byproduct material Agreement State license, or (3) involving human subjects using be administered in the practice of individuals identified as authorized byproduct material. Because part 35 is medicine in accordance with a license nuclear pharmacists on a permit issued silent on iesearch involving human issued by a State or Territory of the by a Commission or Agreement State subjects using byproduct material, part United States, the District of Columbia, specific licensee of broad scope. The 35 specific medical use licensees of or the Commonwealth of Puerto Rico.

individuals in the second and third limited scope may only conduct such This change is being made because this groups must meet the training and research if the NRC grants a license aspect of the definition is included in experience requirements specified in amendment to do so. The effects of the other existing definitions in part 35 the proposed 5 35.980(b).

current regulatory framework are to (e g., authorized user and physician).

Authorized user. The Commission is inhibit or delay research activities by Phcrmacist. The Commission is proposing to modify the definition of specific medical use licensees of limited proposing to add this new term to

" authorized user" to include those scope.

define a pharmack in part 35 to individuals who are: (1) board certified Medical research involving human complement another new definition by at least one of the boards listed in subjects not using radioactive material

" authorized nuclear pharmacist."

paragraph (a) of SS 35.910,35.920, is currently conducted by large medical Section 35.6 Provisions forResearch 35.930, 35.940,35.950, or 35.960; (2) anstitutions and community hospitals identified as an authorized user on a through, for example, their participation involving Human Subjects Commission or Agmement State limnse, in regional and national research The Commission is proposing to add or (3) identified as an authorized user programs. Such research may lead to a this section to address the protection of on a permit issued by a Commission or better understanding of diseases, the rights of human subjects who would Agreement State specific licensee of improved diagnostic and therapeutic be involved in researth using byproduct koad scope. The individuals in the methods, new or better drug products or material. The Commission believes that 4

second and third groups must meet the medical devices, or essential basic most research involving human subjects training and experience requirements scientific information.

using byproduct material is currently.

specified in paragraphs (b) or (c) of Current regulations require ell conducted, funded, supported, or 65 35.910 cr 35.920, or paragraph (b) of medicalinstitutions to have a Radiation regulated by another federal agency

$$ 35.930,35.940. 35.950, or 35.960.

Safety Committee whose responsibilities which has implemented the Federal Proposed 6 35.13 would eliminate, include oversight of all uses of licensed Policy for the Protection ofHuma, under certain conditions, the material. Other part 35 licensees are subjects (56 FR 28002: June 18,1991).

8 requirement for a licensee to submit an required to have a Radiation Safety Therefore, the rights of human subjects amendment to list an authorized user on Offir:er who has such responsibility. The involved in such research activities its license. Instead, proposed 35.14 Commission believes that restrictions on would be protected by the other federal would require specific licensees of research can be reduced provided there agency funding the research under the limited scope to provide a copy of the are certain additional protections of Provisions of the Federal Policy.The individual's board certification, the human subjects as described in Federal Policy has been implemented by license, or the permit to the Commission proposed $ 35.6.

15 Federal departments or agencies (not within 30 days of the date that the The proposed provisions include including NRC) and includes licensee permits the individual to work requiring a licensee who conducts provisions, among others, for obtaining as an authorized user.

research involving human subjects to:

Institutional Review Board (IRB) review However, before allowing a physician (a) Possess a part 35 license authorizing and approval of the research activities who does not have board certification medical use. (b) implement the Federal and informed consent from the human (or is not listed on a license or a permit) Policy for the Protection of Human subjects.The NRC understands that to work as an authorized user, the Subjects or comply with specific NRC complianm with the Federal Policy by specific licensee of limited scope must licensing requirements, and (c) have a institutions conducting research continue to submit a license amendment physidan authorized user who will involving human subjects is achieved and obtain NRC approval.The NRC will supervise the administration of the through the use ofletters of assuranm review the notifications upon receipt to byproduct material.

of compliance and certain reporting verify that the requirements of proposed The Commission believes that requirements.

6 32.72(b) have been met. During the review process, the NRC may considar, information gathered through research.

This section proposes to allow the although it may not benefit the licensees covered by the Federal policy character in addition to credentials in individual subject of the research, has as adopted by another Federal agency to determining whether the individual the potential to benefit the society at conduct human research without prior should be approved as an authorized large. Therefore, given adequate NRC approval. If a licensee's activities user or authorized nuclear pharmacist, protection of the rights and radiological such as to verify that the individual has safety of human research subjects, it is

' For a wpy of tbs Federal Solry for the not committed or caused others to ap.ro riate to r: nit this activit NM1," S* ""*c" I"'"Y commit any willful violations of the ur hermore under the pro d

Commission's regulations, definition of" medical use,"

20892. int.p.ons tamassaoos.

\\

33402 Federal Register / Vol. 58, No.115 / Thursday, June 17, 1993 / Proposed Rules are not funded by another Federal apply for a Type A specific license of Section 35.15 Exemptions Regarding agency which has adopted the Federal broad scope under to CFR part 33.

Type A Specific Licenses df Broad Policy, the licensee would need to apply Scope Section 3533 License Amendmer,ts for and obtain approval of a specific ne Cmunission is pmposing to amendment to its NRC license Prior to The Commission proposes to modify clarify requirements on Type A specific conducting research involving human paragraph (b) of this section to delete licenses of broad scope by adding the subjects using byproduct matenal.

the term " visiting authorized user."

proposed exemptions. This proposed During the review of the hcense amendment application, the NRC would Instead, under the proposed provisions, section would specify that an the licensees could allow, without a application for and receipt of a license ensure that the proposed research license ameadment, an individual to amendment would not be necessary for would receive approval of the IRB and work as an authorized user provided the following actions:(1) Permit a new that the individual is: (1) Certified by a authorized user or authorized nuclear c

1 T eC rnis on i sol ng P armacist to work under the license; h

public comment on the number and board listed in subpart J (2) identified type of research activities which would as an authorized user on a Commission and (2) permit a change of the area of not be funded by another Federal or Agreement State license, or (3) use of byproduct maten,al within the agency which has adopted the Federal identified as an authorized user on a address identified in the hcense. Also, Policy and, thus under the proposed permit issued by a Commission or 8Pecific licensees of broad scope would rule, would require a licenso Agreement State specific licensee of be exempt from certam notification mquirements specified in proposed amendnient.

broad scope. However, the licensee The focus of NRC inspections would would be required to provide a copy of U[ese changes are being made to 4

be to confirm that both types of an individual's board certification, the ensure that the proposed rule conforms licensees have obtamed rior IRB license, or the permit to the Commission with the current practice regarding Type review and a preval of 2e research within 30 days of the date that the A specific licensees of broad scope.

activities an informed consent of the licensee permits the individual to work Under current practice, the other tr ss' ion is soliciting public as an authorized user (See pmposed prescriptive and performance e

5 35.14).

comment on whether it should broaden requirements of Part 35 apply to Type l

or narrow its focus to require The Commission also proposes to add A specific licensees of broad scope.

compliance with all or none of the an exception for authorized nuclear Because a Part 33 specific licensee of provisions of the Federal Policy or pharmacists to this section like the broad scope is required to establish equivalent license cond2tions In making exception for authorized users.

more complete admmistrative Procedures and controls to ensure comments, consideration should be Secti n 35R NMificatwn radiation safety than a Part 35 licensee, given to the fact that all the radiation the exemptions would not reduce safety provisions of 10 CFR part 35 are In addition to the existing notification pmtectim of public health and safety.

proposed to be made applicable to requireanent, the Commission proposes research m, volving human subjects-to amend this section to require speciSc Section 35 22 Radiation Sofety Section 35 7 FDA, Other Federol, and licensees of limited scope to submit a Committee State Requirements copy of an individual's board The Commission is proposing to This soction is necessary to remind artdcadon,6e Ucense, or de permit amend paragraph (b)(2) to apply this medical use licensees to comply with as discussed in S 35.13. This proposal section to authorized nuclear w uld reduce licensees' burden because pharmacists in the same manner as for applicable FDA, other Federal, and State requirements. However, it is not the this notification would replace the authorized users, intent of the Commission to perform currently required license amendment The Commission also proposes to inspections to ensure compliance with and is associated amendment fee require the Radiation Safety Committee FDA or State requimments nor to which are currently necesrary before a to review an individual's certification, enforce those regulations.

specific licensee of limited scope may license, or permit, and determine, based allow an authorized user to work in its on the proposed $ 35.13(b)(1) through Section 35 n License Required facility. In addition, the proposed action (b)(4), whether to allow the individual The Commission is proposing to add would also eliminate the delay to work as an authorized user or paragraph (c), in parallel with the associated with the license amendment authorized nuclear phannacist without existing paragraph (b), to this section-process. The NRC will review the submitting a license amendment for The new paragraph (c) would permit an notifications upon receipt to verify that NRC approval.

mdividual to prepare unsealed the requirements of this section have Section 35.25 Supervision byproduct material for medical use been met. In addition, the NRC would under the supervision of an authonzed verify at that time that this individual Existing paragraph (b) would be has not committed or caused ancier mdessnated as paragraph (c).

nuclear pharmacist or authorized user who is a physician. Also, the eu. ting The Commission is proposmg to add paragraph (a) would be revised by individual to commit anY willful a new paragraph (b) to address the vi latims of the Commission,s replacing the phrase " paragraph ib)"

supervisory responsibilities of the with " paragraphs (b) or (c)."

regulations. At the time of the next licensee, the authorized nuclear licensing action, the name of this pharmacist, and the physician Sc( tion J512 Application forlxense, individual would be listed on the authorized user who prepare unsealed Amendinent, or Renewal license, without fee, as an authorized byproduct material for medical use.

~

The Commission is proposing to add user. The Commission also proposes to Specifically, under the proposed paragraph (e) to this section. This epply this section to authorized nuclear paragraph, an authorized nuclear paragraph would remind part 35 pharmacists in the semo manner as for pharmacist or a physician authorized medical use licensees that they may authorized users.

user would be able to permit

Federal Register / Vol. 58, No.115 / Thursday, June 17, 1993 / Proposed Rules 33403 individuals to prepare unsealed Section 35.50 Possession, Use, dosages obtained from a n..aacturer byproduct material for medical use, Cahbmtion, and Checks of Dose or a commercial rev% phemacy for provided that the individuals are Calibrators C.L a wasons: (1) The adequately supervised. This section The Commission is proposing the instrumentation for measuring activity describes the level of supervision that following modifications to this secti'.4 f alpha-or beta-emitters is expensive an authorized nuclear pharmacist or a (1) In paragraph (a), the phrase and not commonly available m a physician authorized user would be

" photon-emitting" would be inseued to medical use licensee's facility; (2) the frequency of using alnha-or beta-required to provide to individuals who clarify that this section is applici ble emitters for most medical use licensees are preparing unsealed byproduct only to photon-emitting radionuclides.

material for medical use under their This modification would avoid 1s very low; and (3) the manufacturer or supervision.

confusion between this section and the commercial nuclear pharmacy P

2 7 (c') t Section 35.27 Visiting Authorized User ?n sages of top me su each m nts t ea The Commission is p posing to alpha-or beta-emitting radionuclides.

dosage of a radioactive drug prior to delete this section whic permits a (2) The Commission is proposing to transfer for commercial distribution.

visiting authorized user to work for a use the term " radionuclides" instead of Section 35.53 Measurement of Dosages period of 60 days each year without a the term "radiopharmaceuticals." The of Unsealed Byproduct Materialfor license amendment. Under proposed new term is broader and would include Medical Use 5 35.13(b), the concept of a visiting radiolabeled biologics as well as g

g authorized user would no longer be radio armaceuticals.

necessary. Any individual who meets (3) paragraph (b)(3) re arding the m dify this t' o as fo ows:

h.neanty test of the dose ca ibrator, the 5 35.13(b)(1) through (b)(4) would be

would be repfamd by the phrase " dosages of lower limit for the test would be permitted to work in a hcensee's facility either temporarily or permanently.

changed from 0.37 megabecquerel (10 g

g gg g

However, under proposed 5 35.14, the microcuries) to 1.1 megabecquerel (30 licensee would be required to provide a nucmcunes). This modification is g

copy of the individual's board necessary for consistenc with the certification, the license, or the permit requirements of the Qua ity word unseM i,s proposed to to the NRC' Management Program ($ 35.32) and proposed 5 35.53(c)(3).

emphasize that this section applies only Section 35 49 Suppherfor Sealed (4)1n paragraphs (e)(2) through (e)(4) to unsealed byproduct material for Sources cr Devices for Medical Use regarding records on the accuracy, medical use. This section does not linearity, and geometry tests of dose apply to sealed sources such as The Commission is proposing t calibrators, the Commission is-teletherapy or brachytherap)y sources.

(2) Existing paragraphs (a and (b) modify this section as follows:

proposing to require the identity of the The title of this section would be individual actually performing these have been combined as proposed modified to indicate that this section tests rather than the Radiation Safety Paragraph (a). However, the would only apply to sealed sources or Officer's (RSO) signature. This proposed measurement requirements are the devices for medical Use change is necessary to identify the same.

The Commission is proposing to individual who actually perfo'rmed (3) The new text of paragraph (b) delete the reference to $5 32.72 and these tests. Furthermore, this change would require medical use hcensees to 32.73 in the roposed $ 35 A9(a) would provide additional time for the measure dosages of alpha-or beta-because, uncher the toposed rule, the RSO to devote to other radiation safety emittmg radionuclides, except for unit issues.

dosages obtamed from a manufacturer requirements applic ble to unsealed byproduct material for medical use Section 35.52 Possession, Use, hed use ns es ou d be would be incorporated into the.

Cahbration, and Checks of required to measure dosages that will be proposed $$ 35.100,35.200, and 35.300.

Instrumentation to Measurr Dosages of administered to patients or human Furthermore, the proposed rule would Alpha-and Beta-EmittinE research sub}ects.

allow medical use licensees to prepare Radionuclides The measurement mquirements of (including compound) radioactive The Commission is pmposing to this section would not apply to unit drugs. Therefore, limitmg suppliers of require medical use licensees to possess dosages of alpha-or beta-emitting radioactive drugs to manufacturers or and use instrumentation to measure radionuclides because the manufacturer commercial nuclear pharmacies would alpha-or beta-emittin radionuclides.

or the comrnercial nuclear pharmacy no longer be necessary. However, the New radiolabeled biofogics are being must measure the dosage before requirements applicable to sealed developed which have potential benefits distributing it to a medical use licenses.

sourws or devices as specified in for diagnosis and treatment in medicine. Also, the proposed rule would allow a

$ 32.74 would remain in the proposed Some of these biologics may contain licensee to use the combination of 5 35 A9(a).

alpha-or beta-emitting radionuclides several measurements and calculations In addition,the Commission is that do not emit photons of sufficient to determine the dosage because it may proposing to delete existing $ 35.49(b).

energy or frequency to be detected or not be possible to measure alpha-or Under the proposed rule, all the quantiSed in a dose calibrator. Thus, beta-emitting re tuclides by a single h

requirements applicable to reagent Lits this section is proposed so that medical measumment.

would be deleted because the esagent use licensees would be able to (4)la paragra

.,, 0.3 7 kits do not contain byproduct material.

determine that the correct dosages will megabecquerel (n.mcrocuries) would Therefore, this paragraph would no be administered to patients or human be changed to 1.1 megabecquerels (30 longer be necessary The existing research subjects.

microcuries). This modiScation is

$ 35.49(c) would be redesignated as The measurement requirements of necessary for consistency with the

$ 35.49(b).

this section would not apply to unit rsqoirements of the Quality w

33404

' Federal Register / vol. 58, No. Its / Thursday, June 17, 1993 / Proposed Rules -

Management Program (S 35.32). Also, authorized user who meets the training would require the individual to follow because the radiological risk associated requirements speci6ed in S 35.920, or an the procedums, with a dosage of 1.1 megabecxyuerels (30 individual under supervision of either, (6) The Commission recognizes that, microcuries)is small,it is unnecessary as specified in proposed S 35.25.

In the course of patient care or in the to require more than just recording that In addition, the Commission is conduct of research procedures,it is the dosage is less than 1.1 Proposing to modify this section as sometimes necessary to transfer a megabecquerels (30 microcuries).

follows:

dosage of a radioactive drug, on a case-(1) The phrase " unsealed b duct by-case basis, from one medical use Section 35.700 Use of Unsealed material prepared for medi use" licensee to another medical use Bypmduct Matenalfor Uptale, Dilution, would be used. This phrase includes licensee. These campecific transfers and Excmtaon "WD" and "NDA." as speciSed in the would not be considemd commercial The current S 35.100 requires medical existing S 35.100, and other radioactive transfers by the NRC and, therefore, use licensees to use only byproduct drugs containing byproduct material would not require a part 32 license, material in a radiopharmaceutical for that are not specified in the existing Licensees should be aware that other uptake, dilution and excretion for which S 35.100.

than infrequent transfers may require a the FDA has accepted a " Notice of (2)ne supplier or papams of license for commercial transfer of Claimed lovestigational Exemption for a unsealed byproduct material for medical byproduct material.

New Drug"(IND) or approved a New use would be specified under this Section 35.200 Useof Unsealed Drug Application (NDA). no effect of section. A bconsee may obtain this restriction is to prohibit a heensee byproduct matenal from a manufacuer Bypmduct MaterialforImaging and localization Studies from using other types of radioactive or a commercial nuclear, pharmac'd' y

(3) This proposed section woul Paragraph (a) of the current S 35.200 drugs such as those approved by a Radioactive Drug Researth Comrnittee allow licensees to use unsealed restricts medical use licensees to use (RDRC), unless a heense amendment is byproduct material to prepare byproduct materialin a received authorizing their use.

(induding compoundJ radioactive drugs radiopharmaceutical for which the FDA The Commission believes that these by physician authorized users who meet has accepted an IND or approved an restrictions can be eased without S 35 920, authorized nuclear NDA. The effect of this restriction is to compromising the level of protection of pharmacists, or individuals under their prohibit a licensee from using other public health and safety against supervision. The NRC is using the types of radioactive drugs such as those radiological hazards because of certain phrase " prepare radioactive drugs" in a approved by a Radioactive Drug conditions which must be met general sense to include: (a) using Research Committee (RDRC), unless a (discussed below). In addition, the radionuclide generators and license amendment is received that Commission recognizes that physicians nonradioactive reagent kits to produce authorizes such use. Furthermore, have the pnmary responsibility for the radioactive drugs and (b) using paragraphs (b) and (c) of the current diagnosis and treatment of their patients byproduct material and other basic section require licensees to follow the or human research subjects.

ingredients to compound radioactive manufacturer's instructions for eluting Commission mgulations are predicated drugs. -

radionuclide generators and preparing on the assumption that pmperly trained (4J This proposed section would reegent kits unless a departure is and adequately informed physicians mquire a priysician authorized user who directed by a physician authorized user.

will make decisions that are in the best wants to pmpare radioactive drugs to The Commission believes that these interest of their patients or human meet the requirements speciSed in restrictions can be eased without research subjects. Furthermore. the existing $ 35.920. Training and compromising the level of protection of pharmacological aspmts of radioactive e xPerience requirements specified in public health and safety against drugs, including drug safety and existing SS 35.910 and 35.930, although radiological hazards because of certain efficacy, are regulated by the FDA.

adequate to administer byproduct conditions which must be met Detalled discussions of proposed material, would not be sufficient for (discussed below). In addition, the changes are presented below.

preparing radioactive drugs. Similar Commission recognizes that physicians The Commission is proposing to use training and experience requirements have the primary responsihihty for the the term "unsaaled byproduct material" for authorized nuclear pharmacists are diagnosis and treatment of their patients instead of the term proposed in 6 35.980.

or human research subjects and "radiopharmaceutical"in this pmposed (51 This proposed section would also rocognizes that the nuclear pharmacists snction. This is proposed to avoid the allow an individual under the have the primary responsibility for the connotation that the Commission is supervision of a physician authorized preparation of radioactive drugs, rvgulatmg drug safety and eff wcy. The user or an authorized nucleer Commission regulations are predicated word " unsealed" is proposeo to pharmacist to use byproduct material to on the assumption that pas rly trained emphasize that this section opnlies only prepare (induding compound) and adequately informed p sicians l

to unsealed byproduct material for radioactive drugs. A part 35 medical use and pharmacists will mala sions medical use and does not apply to licensee operatmg a nuclear pharmacy that are in the best interest of their sealed sources such as teletherapy or to prepare radioactive drugs for use patients or human research subjects.

brachytherapy sources.

within the licensee's facility would not Furthermore, the pharmacological This proposed modification would be required to obtain a part 32 license.

aspects of radioactive drugs, including provide medical use beensees with the unless the nuclar pharmacy transfers drug safety and efScacy, are regulated maximum flexibility to use any radioactive drugs for commercial by the FDA.

byproduct material for medical use distnbution. The proposed rule Detailed discussions of proposed provided that the material is: (1) language in 5 35.25 would require the changes are presented below.

Obtained from a manufacturer or supervising physician authorized user (1) The Commission is proposing to I

pmparer heensed pursuant to 10 CFR or authorized nuclear pharmacist to use the term " unsealed byproduct 32.72; or (2) prepared by an authorized instruct the individual on radiation material"instead of the term nuclear pharmacist.a physician safety principles and procedures and "radiopharmaceutical" in this proposed 1

1

1 Federal Register / Vol. 58, No.115 / Thursday, June 17, 1993 / Proposed Rules 33405 section to avoid the connotation that the Section 35.300 Use of Unsealed byproduct material from a manufacturer Commission is regulating drug safety Byproduct Materiaifor Therapeutic or a commercial nuclear pharmacy.

and efficacy. Also, this phrase includes Administmtion (4) This proposed section would "LND" and "NDA." as speciSed in the allow licensees to use unsealed Paragraph (a) of the current $ 35.300 byproduct material to prepare existing $ 35.200. and other radioactive restricts medkal use licensees to use (including compound) radioactive drugs drugs containing byproduct material

, na that are not specified in the existing a aja g r which the FDA u

I"

$ 35.200.

P

$ 35.920, authorized nuclear has accepted an IND or a proved an pharmacists, or individuals under their (2) This proposed modification would NDA. Also, this paragra requires supervision, provide medical use licensees with the bcensees to comply wit the packago (5) This proposed section would also maximum flexibility to use any insert instructions regarding indications allow an individual under the byproduct material for medical use and method of administration unless a supervision of a physician authorized provided that the materialis:(a) departure is directed by a physician user or an authorized nuclear obtained from a manufacturer or authorized user.

preparer licensed pursuant to 10 CFR pharmacist to use byproduct material to

- 32.72 or (b) prepared by an authorized While recognizing that therapeutic prepare (including compound) nuclear pharmacist, a physician dosages resuit in greater radiation radioactive drugs. The proposed rule authorized user who meets the training exp sure, the Commission believes that language in $ 35.25 would require the these restrictions can be eased without supervising physician authorized user requirements specified in 6 35.920. or an individual under supervision of either, comprmnising the level of protection of or authorized nuclear pharmacist to as specified in proposed 5 35.25.

Public health and safety against instruct the individual on radiation (3) The suppher or preparer of radiological hazards because of certain safety principles and procedures and unsealed byproduct material for medical conditions which must be met would require the Individual to follow (discussed below). In addition, the the procedures.

use would be specified under this section. A licensee may obtain Commission recognizes that physicians (6) The Commission recognizes that, byproduct material from a manufacturer have the pnmary responsibility for the in the course of patient care or in the or a commercial nuclear pharmacy.

diagnosis and treatment of their patients conduct of research procedures,it is (4) This proposed section would r human research subjects.

sometimes necessary to transfer a allow licensees to use unsealed Commission regulations are predicated dosage of a radioactive drug, on a case-8 b "'8"" tion that properly trained by-case basis, from one medical use byproduct material to prepare and adequate [y informed physicianslicenses to another medical use (including compound) radioactive drugs will make decisions that are in the best licensee. These caespecific transfers by physician authorized users who meet

$ 35420. authorized nuclear interest of their patients or human would not be considered commerdal research subjects. Furthermore, the transfers by the NRC and, therefore, pharmacists, or individuals under their P armacological aspects of radioactive would not require a part 32 license, h

supervision. The NRCis using the S

n 35.900 Radiation Safety y are la e yt e A.

n 1e inc u

( u ng radionuclide generators and Detailed discussions of proposed The Commiss,on is proposing to nonradioactive reagent kits to produce changes are presented below.

i radioactive drugs; and (b) using (1) The Commission is proposing to modify this section to recognize the byproduct material and other basic use the term " unsealed byproduct certification in nuclear medicine by the ingredients to compound radioactive material"instead of the term RoyalCollege of Physicians and,

drugs.

radiopharmaceutical"in this proposed Surgeons of Canada and in radiation (5) This posed section would also section to avoid the connotation that the oncology physics by the American allow an inTvidual under the Commission is mgulating drug safety Board of Medical Physics.

supervision of a physician authorized and efficacy. Also, this phrase includes Section 35.910 Tminingfor Uptale, user or an authorized nuclear "IND" and "NDA," as specified in the Diiution, and Exention Studies pharmacist to use byproduct material to existing 5 35.300, and other radioactive prepare (including compound) drugs containing byproduct material The Conunission is proposing. as radioactive drugs. The proposed rule that are not specified in the existing

{mme{ded to odify g

language in 5 35.25 would require the

$ 35.300.

in nuclear medicine by the Royal supervising physician authorized user (2) This proposed modification would Coll *ja.of Pli sicians and Surgeons of e

Y harmacist to provide medical use licensees with the or authonzed nuclearfon radiation Cana instruct the individua maximum flexibility to use any safety principles and procedures and byproduct material for medical use Section 35.920 Tminingfor1maging would require the individual to follow provided that the materialis:(a) and localization Studies the pmcedures.

obtained from a manufacturer or The Commission is pmposing, as (6) The Commission recognizes that.

Preparer licensed pursuant to 10 CFR recommended by the ACMUI.to modify in the course of patient care or in the 32.72 or (b) prepared by an authorized this section to recognize the certification conduct of research procedures, it is nuclear pharmacist, a physician in nuclear medicine by the Royal sometimes necessary to transfer a authorized user who meets the trainin8 College of Physicians and Surgeons of dosage of a radioactive drug on a case-requimments specified in S 35.920, or an Canada' by-case basis, from one medical use individual under supervision of eihr.

licensee to another medical use as specified in proposed 5 35.25.

Section 35.930 Tminingfor limnsee. These case-specific transfers (3) ne supplier or preparer of Therapeutic Use of Unsealed Byproduct would not be considered commercial unsealed byproduct material for medical Mafenai transfers by the NRC and, therefore, use wouldbe specified under this The Commission is proposing to would not require a part 32 license.

section. A licensee may obtam amend $ 35.930(a)(2) to recognize the

33406 Federal Register / Vol. 58, No.11S / Thursday, June 17, 1993 / Proposed Rules certification in radiation oncology by responsible for handling, preparing, and adequate protection of the public health the American Board of Radiology (ABR). distributing radioactive drugs to and safety, For example, $$ 35.920 and in 1987, the ABR renamed " therapeutic multiple medical institutions. Thus, 35.980 provide the radiation safety radiology" as " radiation onmlogy" but authorized nuclear pharmacists training and experienw criteria for the criteria for certification remain the potentially impact the radiological authorized users and authorized nuclear same. Therefore, it is necessary to safety of patients or human research pharmacists that are important recognize both cactifications, subjects at many medicalinstitutions.

prerequisites for ensuring that The effect of these training requirements byproduct material is handled safely. It Section 35.940 Tmm..2ngfor Use of will provide sufficient assurance that should be noted that changing $ 35.920 Bmchythempy Sources individuals satisfying these training to a Division 2 item of compatibility The Commisalon is proposing to criteria will safely prepare and would impact those authorized users amend $ 35.940(a)(1) to recognize the distribute radioactive drugs.

who want to compound radioactive u

certification in radiation oncology by In this section, the Commission is drugs as well as those authorized users the American Board of Radiology (ABR). proposing two methods for an who only want to perform imaging individual t qualify as an authorized procedures currently allowed under Section 35.950 Tminingfor Use of nuclear pharmacist:

$ 35.200. The Agreement States would Sealed Sources for Diagnosis (1) In paragraph (a), the Commisalon be allowed to establish requirements The Commission is proposing to is proposing to recognize certification that are more stringent than NRC's amend $ 35.950{a)(1) to recognize the by the Board of Pharmaceutical requirements, but not less stringent.

certification in radiation oncology by Specialties as a nuclear pharmacist as It would be appropriate for Agreement the American Board of Radiology (ABR) satisfying the traininf requirements.(2)ln paragraph (b in lieu of board States to adopt the remaining sections of and the certification in nuclear medicine by the Royal College of certification, an alternative method to Part 35 in this proposed rulemaking, but Physicians and Surgeons of Canada.

qualify for an authorized nuclear it is not necessary to require an degree pharmacist is proposed. A candidate i untformity between NRC an the Section 35.960 Tminingfor would be required to- (i) Complete 700 States. Therefore, a Division 3 item of Telethepy hours in a structured educational compatibility would be appropriate for The Commission is proposing to program consisting of both didactic such sectims.

amend $ 35.960(a)(1) to recognize the training and supervisod experience in a The Commission is currently certification in radiation oncology by nuclear pharmacy, and (ii) obtain a reevaluating its practices concerning the the American Board of Radiology (ABR). written certification from a preceptor implementation of the provision in the that the candidate has achieved a level Atomic Energy Act which rovides that Section 35.961 Tminingfor TelethemPyPh 5icist of competency sufficient to the Agreement States regu atory 7

independently operate a nuclear programs are to be compatible with The Commission is pmposing to pharmacy.

NRC's. This reevaluation willinclude modify this section to recogniza the early snd significant involvement of the certification in radiation encology Implementation Plan and Agreement physics by the American Board of State Cornpatibility Agreement States. At the conclusion of this effort, the Commission will Medical Physics.

The effective date of this amendment implement generic guidance on the wmld be 6 maths after the publication application of compatibility.

Section 35.972 Recentness of Tmining of the final amendment in the Federal Existing $ 35.972 required that an,

For comp"rison, the existing Register indwidual's training must have been on Juiy 15 and 16,1992, the NRC mmpatibility levels are as follows:

acquired within the last 5 years. The held a workshop with representatives of definitions in $ 30.4 are Division 1 items 23 A reernent States to discuss the draft of C mPatibility; $ 32.72 is a Divi,sion 2 Board of PIgrmaceutical Specialties (BPS) recertifies board certified nuclear rule fanguage for the proposed item of compatibihty; the definitions pharmacists IBCNP) every 7 years.

rulemaking.The Agreement State ass ciated with the quality management Based on BPS's 11 years experience participants expressed a clear consensus rule and rnisadministraums in $ 35.2 with recertification, the Commission is that this proposed rulemaking be either am han 1 items of wrnpatibility;

$$ 35.32 and 35.33 are Division 2 items proposing to replace 5 years with 7 not an item of compatibility or the ynars. This action is necessary to lowest level of compatibility possible.

f mmpatibility; $ 35 8 is a Division 4 achieve consistency for recentness of IIowever, because this amendment stem of mmpatibility; and all other training requirements among authorized has safety significance for Agreement sections of part 35 are Divm,on 3 items users, Radiation Safety Officers, State licensees as well as NRC licensees, of mmpatibihty.

teletherapy physicists, and authorized this proposed amendment would be an The NRC expects Agreement States to nuclear phannscists. The Commission is item of compatibility for the Agreement adopt rules required to maintain mquesting public comment on which States. All definitions contained in compatibility within three years after period (estber 5 or 7 years)is more

$$ 30.4 and 35 2 would be Division 1 NRC's rules become effective. Some appropriate and the basis for any items of compatibility. The definitions Agreement States, faced with recommendation.

contained in this rulemaking must be administrative and resource constraints, N~"***

Y

- - W Authorized Nuclear Pharmocist State licensees so that consistency will attain and may pre {er that NRC extend Section 35.960 huiningfor be maintamed.

flexibility in such cases to allow the The Commission is proposing to add Additionally, the Commission States to implement the requirements e new section that would contain believes that 5$ 32.72,35 6,35.22(b)(2),

through license conditions. The NRC specific training requirements for en 35.25,35.50,35.52,35.53,35 920, requests public comment on permitting authorized nuclear pharmacist. This 35.972 and 35 980 should be Division 2 Agreement States flexibility in this adion is necessary because an items of compatibility, because these regard, and if permitted, under what authorized nuclear pharmacist may be mquirements are necessary to ensure conditions.

Federal Register / Vol. 58, No.115 / Thursday, June 17, 1993 / Proposed Rules 33407 Finding of No Significant data needed, and compkting and impact should notify the Commission Environmentalfmput Availability mviewing the collection of information. by a letter that indicates the following:

The Commission has determined Send comments regarding this burden (a) The licensee's size and how the under the National Environmental esumate or any other aspect of this proposed regulation would result in a Policy Act of 1969, as amended, and the c lhctim ofinfwmation, including significant economic burden or whether Commission's regulations in subpart A suggestions for reducing this burden, to the resources necessary to implement of 10 CFR part 51, that the proposed the Information and Records this amendment could be more amendments,if edopted,would not be Management Branch (MNBB-7714),

effectively used in other ways to a major Federal action significently U.S. Nuclear Regulatory Commission, optimize the safety of petients or human affecting the qual;ty of the human Washmgton, DC 20555, and to the Desk research sub}ects, as compared to the environment, and therefore an Ofnar, OTice of Information and economic burden on a largar bcensee; environmental impact statement is not Regulatory Affairs, NEOB-3019 (3150-(b) How the proposed regulation requimd. The proposed amendmmits 0001, -0010, and -0120), Office of could be modified to take mto account I

would provide gmater flexibility for Management and Budget. Washington, the licensee's differing needs or physician authorized users to use DC 20503.

ca b e

byproduct materialin the practice of Regulatory Analysis the detriments that would be avoided,if lb a7s'o cbr r e frIt h The Commission has prepared a draft the proposed regulation were modified c

l regulations the conapt of authorized regulatory analysis on this pmposed as su ested by the licensee; hannacists to permit properly nyulation. The analysis examines the id) ow the proposed regulation, as nu qua e ; rmacists to prepare benefits and impacts considered by the modified, could more dosely equalize radm, active drugs contalmng byproduct Commission. The draft n gulatwy the impact of NRC regulations or create analysis is available for inspection at the more equal access to the benefits of NRC Public Document Room at 2120 L Federal programs as opposed to e r >os amer e

ou allow physician authorized users Ereeter Street NW. (Lower levell, Washington, providing special advantages to any d'

d DC. Single co ics of the draft analysis individual or group ar alla e Samue nsa rod ci ed con ning byproduct m i ied wou d I de ately p ect material. The proposed amendments Y

would also allow authorized nudear (NF0FIMATON CONTACT heading).

the public hoalth and safety' pharmacists greater discretion to The Commission mquests public Backfit Analysis prepare radioactive drugs containing comments on the draft regulatory The Commission has determined that byproduct material. It is expected that analysis. Comments on the draft the backfit rule,10 CFR 50.109, does not there will be no increase in radiation regulatory analysis may be submitted to exposure to the public or to the the NRC as indicated under the -

apply to this proposed amendment because this amendment does not environment beyond the exposurus ADDRESSES heading.

involve any provisions which would currently resulting from delivering the Regulatory Flexibility Certificstion ~

impose backfits as defined in 10 CFR byproduct material or radiation fro 50.109(a)(1). Therefore, a backfit b' product material to patients or human As required by the Regulatory analysis is not required for this y

research subjects. The draft Fl"xibility Act of 1980,5 U.S.C. 605(b),

proposed amendment.

environmental assessment and finding the Commission certifies that,if of no significant impact on which this adoptedethis propc, sed rule would not List of Subjects determination is based is available for have a significant economic knpact on t o CFR Part 30 inspection at the NRC Public Document a substantial number of small entities.

Room,2120 L Street NW. (Lower Level). This proposed rule would affect medical Byproduct material, Cn.minal penalty, Washington, DC. Single copies of the use licensees induding some private jT

] }8 l

draft environmental assessmet.t and the ractice physicians. Some of these

{icensees would be considered small Nudear materials, Radiation protection findicg of no significant impact are i

(

available from Samuel Z. Jones or entities under the NRC's size s'andards Reponing and recordkeeping i

Anthony N. Tse (Mee FOR FURTHER (56 FR 56072; November 6,1991). The mqummenk JNronuArioN CONTACT heading).

proposed amendments would provide 10 CFR Pan 32 Paperwork Reduction Act Statement

[r IE#

"E u

b uct JP'..

materials, Criminal penalty, Rad' iation This propowd rule amends materialin the pr.actice of medicme.

information collection requirements that The proposed amendments would als protaction, Reporting and recordkeeping mquirements.

are subject to the Paperwork Reduction incorporate mto the regulations the Act of 1980 (44 U.S.C. 3501 et saq). This concept of authorized nuclear 20 CTR Pad 35 rule has been submitted to the Office of pharmacists to allow properly qualified Byproduct material, Criminal penalty.

Management and Bud et for review and pharmacists greater discretion to Drugs, Health facilities. Health 6

approval of the paperwork prepare (induding compound) professions,Incnrporation by referunm.

requirements.

radioactive drugs containing byproduct Medical devices,Nudsar materials, The reduction in public burden for material for medical usa. This occupational safety and health, this collection ofinformation ja rulemaking,if adopted, would reduce Radiation protection. Reporting and estimated to be a savings of 420 hours0.00486 days 0.117 hours 6.944444e-4 weeks 1.5981e-4 months regulatory burdens on medical use n,rMeeping mquirements.

per year for 300 NRClicensens, or an licenwes induding small entities.

For the reasons set out in the average 1.4 hours4.62963e-5 days 0.00111 hours 6.613757e-6 weeks 1.522e-6 months per year per licensee, Any small entity sulpx:t to this preamble and under the authority of the induding the time for mviewing mgulatica who determines that bocause Atomic Energy Act of 1954, as amended, instructions, soarddag existing data of its siza,it is likely to bear a the Energ~y Reorganization Ad of 1974, sources, gatlwring ano maintaining the disproportionate adverse ecxmomic as amended, and 5 U.S.C. 553,the

l

?

33408 Federal Register / Vol. 58, No.115 / Thursday, June 17, 1993 / Proposed Rules Commission is proposing to adopt the PART 32-SPECIFIC DOMESTIC the shielding provided by the packaging i

following amendments to 10 CFR parts LICENSES TO 9,ANUFACTURE OR to show it is appropriate for the safe l

30,32, and 35.

TRANSFER CERTAIN ITEMS handling and storage of the radioactive druhs b medical use licensees; and CONTAINING BYPRODUCT MATERIAL l

PART 30-RULES OF GENERAL (4 A abelis affixed to each container APPUCABILITY TO DOMESTIC

5. The authority citation for part 32 of a radioactive drug to be transferred UCENSING OF BYPRODUCT continues to read as follows:

for commercial distribution. The label MATERIAL Authority: Secs. 81,161,182,183,68 Stat.

must include the name of the 935,948,953,954, as amended (42 U.S C radioactive drug or its abbreviation,

1. The authority citation for part 20 2111,2201,2232,2233), sec. 201, sa Stat.

quantity of radioactivity, and date and continues to read as follows:

1242, as amended (42 U.S.C 5641).

time of assay. In addition, the label for Authority: Sacs. 81,82,161,182,183,186,

6. In S 32.8, aragraphs'(b) and (c) are the syringe or syringe radiation shield 68 Stat. 935,948,953,954,955, as amended-revised to rea as follows:

must also contain the clinical procedure sec. 234,83 Stat. 444, as amended (42 U.S.C to be performed or the patient's or the 2111,2112,2201,2232,2233,2236,2282);

$ 32.8 information cotiection human research subject's name.

secs. 201, as amended.202,206,88 Stat.

requirementa: OMB approval.

Furthermore, the label, or the leaflet or 1242, as amended. 1244,1246 (42 U.S.C brochure that accompanies the

'68 (b) The approved information radioactive drug must contain a Section 30.7 also issued under Pub. L.

collection requirements contained in statement that the U.S. Nuclear 95-601, sec.10,92 Stat. 2951 (42 U.S.C.

this part appear in $$ 32.12,32.14, Regulatory Commission has approved 5851). Section 30.34(b) also issued 32.15,32.16,32.17,32.18,32.19,32.20, distribution of the byproduct material to under sec.184,68 Stat. 954, as amended 3 2.22, 32.25, 3 2.26, 3 2.29, 32.51, 32.51 a, persons licensed to use byproduct (42 U.S.C. 2234). Section 30.61 also 32.52,32.53,32.54,32.56,32.57,32.58, material pursuant to 10 CFR 35.100, issued under sec.187,68 Stat. 955 (42 32.61,32.70,32.71,32.72, and 32.74.

35.200, or 35.300, as appropriate, and to U.S C. 2237).

(c) This part contains information persons who hold an equivalent license

2. In S 30.4, the definition of medical c llection requirements in addition to issued by an Agreement State. The label, use is revised to read as follows:

those approved under the control or the leaflet or brochure must also note number specified in paragraph (a) of that other regulatory approvals may be 6 30.4 Definitions.

this section. These information required. NRC's labeling requirements collection requirements and the control are independent of requirements of the Medical use means the intentional numbers under which they are U.S. Food and Drug Administre. tion internal or 3xternal administration of ap oe a.

2 11 orm 313 is

1) A licensee described by byproduct material or the radiation therefrom to patients or human research approved under control number 3150-paragraph (a)(2)(iii) or (iv) of this section may prepare radioactive drugs subjects under the supervision of an 0120'(Reserved]

(21 for medical use, as defined in 10 CFR authorized user.

7. Section 32.72 is revised to read as 35 2, provided that the radioactive drug

{o;}ow3:

is prepared by either an authorized

3. In 5 30.8, paragraphs (b) and (c) are nuclear pharmacist, as defined in to revised to read as follows:

$ 32.72 Manuf acture, preparation, of CFR 35.2, or an individual under the transfer for commercial distribution of supervision of an authorized nuclear 9 30.8 information collection radioactivo drugs conta1ning byproduct pharmacist as specified in 10 CFR 35.25.

requirementa: OMB approval, material for medical use under part 35, (2)In addition, for purposes of this (a) An application for a specific section, an authorized nuclear (b) The approved information license to manufacture, prepare, or pharmacist is a pharmacist who is collection requirements contained in transfer for commercial distribution currently licensed or registered by a this part appear in SS 30.9. 30.11,30.15, radioactive drugs containing byproduct state to practice pharmacy and 30.19,30.20,30 32,30.34,30.35,30.36, material for use by persons authorized designated, as of the effective date of the 30.37,30.38,30.41,30.50,30.51,30.55, pursuant to part 35 of this chapter will final rule, as an " authorized user" on a and Appendix A.

be a proved if:

nuclear pharmacy hcense issued by the II e appucant satisfies the general Commission under this part.

(c) This part contains information requirements specified in 10 CFR 30.33; (3) A licensee shall provide to the collection requirements in addition to (2) The apphcant submits evidence Commission a copy of the mdividual,s those approved under the control

.a e apphcant is at least one of the board certification, the license, or the number specified in paragraph (a) of f Il Win 8:

Permit, and the state pharmacy this section. These information (i) Registered or licensed with the licensure or registration, respectively, collection requirements and the control U.S. Food and Drug Admtmstration for each individual within 30 days of numbers under which they are (FDA) as a drug manufacturer; the date that the licensee permits, approved are as follows:

(ii) Registered or licensed with a state pursuant to this section, the individual (1) In 85 30.32,30.37, and 30.38, NRC egency as a drug manufacturer; to work as an authorized nuclear Form 313 is approved under control (iii) Licensed as a pharmacy by a State pharmacist.

~

number 3150-0120-Board of Pharmacy; or (c) A licensee shall possess and use (2)In 6 30.36, NRC Form 314 is (iv) Operating as a nuclear pharmacy instrumentation to measure the approved under control number 3150-within a Federal medicalinstitution.

radioactivity of radioactive drugs. The 0328.

to The applicant submits information licensee shall have procedures for use of on the radionuclide; the chemical and the instrumentation. The licensee shall 930.34 (Amended]

physical form, the maximum activity measure, by direct measurement or by

4. Section 30.34 is amended by per vial, syringe, generator, or other combination of measurements and removing paragraph (i).

cor.tainer of the radioactive drug: and calculations, the amount of radioactiv2ty

Federal Register / Vol. 58, No.115 / Thursday, June 17, 1993 / Proposed Rules 33409 in dosages of alpha, beta, or photon-license that authorizes the medical use research subject, dated and signed by an emitting radioactive drugs prior to of byproduct material; or authorized user prior to the transfer for commercial distribution. In (3) IdentiSed as an authorized user on administration of a radiopharmaceutical addition, the licensee shall:

a permit issued by a Commission or or radiation, except as specified in (1) Perform tests beforo initial use, Agreement State specific licensee of paregraph (6) of this defmition, periodically, and following repair, on broad scope that is authorized to permit containing the following information:

each instrument for eccuracy, linearity, the medical use of byproduct material.

and geometry dependence, as

11. Section 35.6 is added to read as appropriate for the use of the Afedical use means the intentional follows:

instrument; and make adjustments internal or extemal administration of when necessary; and byproduct material or the radiation

$ 35.6 Provialons for research involving (2) Cbeck each instrument for therefrom to patients or human red human subjects.

constancy and proper operation at the subjects under the supervision of an A licensee may conduct research beginning of each day of use-authorized user.

involving human subjects using (d) Nothing in this section relieves tht byproduct material provided that the licensee from complying with applicable FDA, other Federal, and State Afisodministration means the research is conducted, funded, administration of:

supported, or regulated by another requirements governing radicadive gg)...

Federal Agency which has implemented drugs.

(i) Invohing the wrong patient or the Federal Policy for the Protection of -

5 32.73 Pemoved) human msearth subject, or wrong Human Subjects. Otherwise, a licensee

8. Section 32.73 is removed.

radiopharmaceutical; or shall apply for and receive approval of a specific arnendment to its NRC limnse PART 35-MEDICAL USE OF (2)...

Im m c nducting such researth. Both BYPRODUCT MATERLAL (i) Involving the wrong patient or types oflimnsees shall, at a minimmn,

9. The authority citation for part 35 human research subject, wrong btam informed consent from the contmues to read as follows:

radiopnarmaceutical, or wrong route of human subjects and obtain prior review administration, or and epproval of the research activities Authority: Sacs. 81,161,182,183, es Stat.

by an Institutional Review Board."

935. 948,953,954, as amended (42 U.S.C

' 12. Section 35.7 is added to read as 2111,2201,2232,2233h sec. 201,88 Stat.

I3}...

foUm 1242, as amended (42 U.S C 58411, (i) Involving the wrong patient or

10. In $ 35.2, the definitions of human researth subject, or wrong 935.7 FDA, other Federst, and State authorized nuclearpharmacist and A*"**""'

pharmacist am added and the Nothingin this part relieves the definitions of authorized user, medical (4) * *

licensee fmm cx>mplying with use, paragraphs (1)(i), (2){i), (3)(i), (4)(i),

(i)Inv lying the wrong patient or applicable FDA, other Federal, and State (5)(i), (6)(t), and (6)(ii) of the definition human msearch subject, wrong mode of requirements governing radioactive of misodrninistnrtion;and the treatment, or wmng treatment site; drugs or devices.

introductory sentence of the definition of written directwe are revised to read (5)...

t 35.s mended]

as follows:

(i) Involving the wrong patient or

13. In 6 35.8, paragraph (b) 1s revised human research sub}ect, wrong to read as follows:

$ 35.2 Definit one.

radioisotope, or wrong tmatment site (excluding, for permanent implants.

(b) The approved info'rmation Authorized nuclear pharmacist means seeds that were implanted in the correct collection requirements contained in a pharmacist who is:

site but migrated outside the treatment this part appear in SS 35.6,35.12,35.13, (1) Currently board certified as a site);

nuclear pharmacist by the Board of 35.14,35.21,35.22,35.23,35.29,35.31, 35.50,35.51,35.52,35.53,35.59,35.60, Fharmaceutical Specialties; m) * *

35.61,35.70,35.80,35.92,35.204, (2) Identified as an authorized nuclear pharmacist on a Commission or (i) Involving the wrong patient or 35.205,35.310,35.315,35.404,35.406, Agrdement State license that authmires human research subject, wrong 35.410,35.415,35.606,35.615,35.630, the use of byprodud materialin the radiophannawutical, wrong route of 35.632, 35.634, 35.636, 35.641, ~3 5.643, administration, or when the 35 645,35.647, and 35.980.

praction of nuclear pharmacy; or administered dosage differs from the (3) Identified as an authonzed nucicar pharmacist on a permit issued by a Prescribed dosage; and

14. In $ 35.11, regraph (a)is revised Commission or Agmement State specific hu an m an b

s5 limnsee of broad scope thatis

$1 effective dose equivalent or 50 mms p

u in the r ice of dose equivalent to any individual organ. I 35.11 ucerme rewired.

(8) A Person shall not manufactum, nuclear pharmacy.

' Pharmacist means an individual produce, acquire, m ive, possess, use, Authanzed user means a physician.

dentist, or podiatrist who is:

licensed by a State or Territory of the or transfer byproduct material for (1) Board certified by at least one of United States,the District of Columbia, medical use except in amon!ance with

~ the boards listed in paragraph (a) of or the Commonwealth of Puerto Rico to a specific license issued by the

$ $ 35.910, 35.920, 35.930, 35.940, practica pharmacy.

Commission or an Agmement State, or 35.950, or 35.960, as allowed in paregraphs (b) or (c) of (2)Identined as an authorized user on Wntren chrective means an orderin this section.

a Commission or Agreement State writing for a speciEc patient at human

l 33410 Federal Register / Vol. 58, No.115 / Thursday, June 17, 1993 / Proposed Rules (c) Anindividualmayprepare (2) ne licensee's mailing address in the licensee's written quality unsealed byproduct material for medical changes.

management program, as appropriate to use in accordance with the regulations (c) The licensee shall mail the that individual's use of byproduct in this chapter under the supervision of documents required in this section to material; an authorized nuclear pharmacist or -

the appropriate address identified in (2) Require the supervised individual authorized user as provided in $ 35.25,

$ 30.6 of this chapter.

to follow the instructions given unless pmhibited by license condition.

18. Section 35.15 is added to read as pursuant to paragraph (b)(1) of this i

15. In 5 35.12, paragraph (e) is added follows:

section and to comply with the r

to read as follows:

regulations of this chapter and license

$ 35.15 Exemptions regarding Type A conditions; and 9 35.12 Application for license, specific licenses of broad scope.

cmendmenW renwal.

(3)Periodicall review the work of the A licenses possessing a Type A supervised indi dual as it pertains to specific license of broad scope for preparing byproduct material for (e) An applicant that satisfies the medical use is exempt from the medical use and the records kept to requirements specified in 10 CFR 33.13 following:

reflect that work.

may apply for a Type A specific license (a) The provisions of $ 35.13(b);

of broad scope.

o (b) The provisions of $ 35.13(e)

16. In 6 35.13, paragraph (b) is revised regarding additions to or changes in the $ 35.27 [ Removed]

to read as follows:

areas of use only at the addresses

21. Section 35.27 is removed.

6 3 35.13 ueense amendments.

specified in the license:

22. In 5 35.32, paragraphs (a)(2) and (c) The provisions of 5 35.14(a); and (b)(1){i) are revised to read as follows:

(b) Before it permits anyone to work (d) The provisions of $ 35.14(b)(1) for as an authorized user or authorized an authorized user or an authorized 5 35.32 Quality management program.

""C nudeQ ac er e license, 9.

3 n $ 35 2, p agraph (b)(2)is

) That, prior to each administration, t

(nan authorized user certified by therevised to read as follows:

the patient's or human research subject s identity is verified by more organizations specified in paragrepb (a) $ 35.22 Radiation Safety Committee, than one method as the individual of $$ 35.910,35.920,35.930,35.940, 35.950, or 35.960; named in the wn.tten directive; g...

(2) An authorized nuclear pharmacist certified by the org'anization specified in (2 (i) Review, on the basis of safety (b) * *

paragraph (a) of $ 35.980; and with regard to the training and II)...

(3) Identified as an authorized user or 8xPenence standards in subpart J of this (i) A representative sample of patient an authorized nuclear pharmacist on a Part, and approve or disapprove any and human research subject Commission or Agreement State license individual who is to be listed as an administrations, that authorizes the use of byproduct authorized user, an authonzed nuclear ~.

materialin medical use or in the pharmacist, the Radiation Safety Officer,

23. In 5 35.33, paragraphs (a)(2), (a)(3),

practice of nuclear pharmacy, or a teletherapy physicist before (a)(4), (b), and (c) are revised to read as respectively; or submitting a h, cense application or foows. (4) Identified as an authorized user or request for amendment or renewal; or an authorized nuclear pharmacist on a. (ii) Review, pursuant to S 35.13(b)(1) 5 35.33 Notificationa, reports, and records permit issued by a Commission or through (b)(4), on the' basis of the board of misadministretions. Agreement State specific licensee of certification, the license, or the permit (a) * *

broad scope that is authorized to permit identifying an individual, and approve (2) The licensee shall submit a written the use of byproduct materialin medical or disapprove any individual prior to report to the appropriate NRC Regional use or in the practice of nuclear allowing that 6dividual to work as an OfSce listed in 10 CFR 30.6 within 15 pharmacy, respectively.

authorized - er or authorized nuclear days after discovery of the pharmacist; misadmuustration. The written report must include the licensee's name; the

17. Section 35.14 is revised to read as follows:

20. In $ 35.25, paragraph (b) is Prescribmg physician's name; a brief redesignated as paragraph (c) and a new description of the event; why the event

$ 35.t 4 Notifications. paragraph (b)is added to read as occurred; the effect on the patient of the (a) A licensee shall provide to the follows. human research subject; what Commission a copy of the board improvements are needed to prevent certification, the license, or the permit $ 35.25 supervision-recurrence; actions taken to prevent for each individual within 30 days of recurrence; whether the licensee the date that the licenses permits the (b) A licensee that permits the notified the patient or the human individual to work as an authorized user Preparation of byproduct material for research subject (or either individual's or an authorized nuclear pharmacist medical use by an individual under the responsible relative or guardian), and if pursuant to $ 35.13(b)(1) through (b)(4). supervision of an authorized nuclear not, why not, and if the patient or the (b) A licensee shall notify the pharmacist or physician who is an , human research subject (or either Commission by letter within 30 days authorized user, as allowed by individual's responsible relative or when: $ 35.11(c), shall require the supervising guardian) was notified, what (1) An authorized user, an authorized authorized nuclear pharmacist or information was provided to that nuclear pharmacist. Radiation Safety physician who is an authorized user to: individual. The report must not include Officer, or tehdherapy physicist (1) Instruct the supervised individual the patient's or the human research permanently discontinues performance in the preparation of byproduct material subject's name or other information that of duties under the license or has a for medical use and the principles of could lead to identiScation of the name change; or and procedures for radiation safety and patient or the human research subject.

l Federal Register / Vol. 58, No.1:5 / Thursday, June 17, 1993 / Proposed Rules 33411 (3) The licensee shall notify both the the misadministration, why it occurred, for each volume measured, the date of referring physician and the patient or the effect on the patient or the human the test, and the identity of the the human research subject (or the research subject, what improvements individual performing the test. patient's or the human research. are needed to prevent recurrence, and

26. Section 35.52 is added to read as j

subject's responsible relative or the actions taken to prevent recunence. follows: l guardian), of the misadministration no R) Aside from the notification 6 35.52 Possession, use, callbration, and later than 24 hours after its discosery, requirement, nothing in this sectmn check of instruments to measure doseges unless the nferring physv, ian affects any rights or duties of licensees of alphe-or beta-emitting radionuclides. personally informs the licensee either and physicians in relation to each other. (a) This section does not apply to unit that he will inform the patient or the patients or human researth subbets (or dor. ages of alpha-or beta-emitting human research subject (or either either mdividual's responsible relative rad;onuclides that are obtained from a mdividual s responsible relative or or guardian) mcnufacturer or preparer licensed guardian) or that, based on medical

24. Sectmn 35.49 is revised to read as judgment, telhng the patient or the follows:

pursuant to 10 CFR 32.72 or equivalent human research subject (or either Agreement State requirements. individuaPs resIionsible relative or 535.49 Suppl 6ers for sealed sources or (b) For other tiaan unit dosages devices for medical use. obtained pursuant to paragraph (a) of guardian) would be harmful to the patient or the human research subject. icensee may use for medical use this section, a licensee shall possess and g The licensee is not required to notify th on 3 patient or the human research subject (a) Sealed sources or devices radioactivity of alpha-or beta-emitting ~ (or either individual's responsible manufactured, labeled. packaged, and radionuclides. The licensee shall have {wdu g s gge relative or guardian) without first distributed in accordance with a license consulting the referring physician. If the issued pursuant to 10 CFR part 30 and referring physician or the patient or the 5 32.74 or the eqmvalent regulations of-measure. by direct measurement or by b dmemmM human research sub}ect (or the patient's an Agreement State; or or the human research subject's (b) Teletherapy sources manufactured calculations, the amount of radioactivity responsible relative or guardian) carmot and distributed in accordance with a in dosages of alpha-or beta-emitting I be reached within 24 hours. the licensee license issued pursuant to 10 CFR part radionuclides prior to administration to shall notify the patient or the human 30 or the equivalent regulations of an g research subject (or either individual's Agreement State. in addition, the licensee shalh responsible relative or guardian) as soon

25. In 5 35.50, paragraphs (a), (b)(3)'

(1) Perform tests before initial use, as possible thereafter. The licensee may and (e)(2) through (e)(4) are revised t periodically, and following repair, on not delay any appropriate medical care read as follows: each instrument for accuracy, linearity, for the patient or the human research cnd geometry dependence, as 5 35.50 Possession, use. calibration, and eppropriate for the use of the subject, mcluding any necessary check of dou calibrators. instrument; and make adjustments remedial care as a result of the misadmmistration, because of any delay (a) A licensee shall possess and use a when necessary; and dose calibrator to measure the activity of (2) Check each instrument for (4 If tShe atient or the human dosages of hoton-emitting constancy and proper operation at the research su lect (or either individual's red onti o admijis rat n to 0 7 35 53 e secti l$eading and responsible relative or guardian) was notified, the licensee shall also furm,sh, (b) * *

paragraphs (a), (b), (c)(2), and (c)(3) are within 15 days after discovery of the (3) Test each dose calibrator for revised as follows:

misadministration, a written report to linearity upon installation and at least $ 35.53 Measurement of dosages of the patient or the human research quanerly thereafter over the range of its unaaled byproduct meterial for mecical subject (or either individual's use between the highest dosage that will use. responsible relative or guardian) by be admtmstered to a patient or human sending either: researth subject and 1.1 megabecquerels (a) Measure the activity of each (i) A copy of the report that was (30 microcuries); and dosage of a photon-emitting submitted to the NRC; or radionuclide prior to medical use. (ii) A brief description of both the [e)* * * (b) Measure, by direct measurement or event and the consequences as they may (2) For paragreph (b)(2) of this section, by combination of measurements and affect the patient or the human research the model and serial number of the dose calculations, the activity of each dosage subject, provided a statement is calibrator, the model and serial number of an alpha-or beta-emitting included that the report submitted to of each source used, the identity of the radionuclide prior to medical use, the NRC can be obtained from the radionuclide contained in the source except for unit dosages obtained from a licensee. and its activity, the date of the test, the manufacturer or preparer licensed (b) Each licensee shall retain a record msults of the test, and the identity of the pursuant to 10 CFR 32.72 or equivalent of each misadministration for five years. Individual performing the test. Agreement State requirements: The record must contain the names of (3) For paragraph (b)(3) of this section, (c) * *

all individuals involved (including the the model and serial number cf the dose (2) Patient's or human research prescribing physician, allied health calibrator, the calculated activities, trie subject's name, and identification personnel, the patient or the human measured activities, the date of the test, number if one has been assigned:

research subject, and the patient's or and the identity of the individual (3) Prescribed dosage and activity of human research subject's referring performing the test. the dosage at the time of mecsurement, physician), the patient's or the human (4) For paragraph (b)(4) of this section, or a notation that the total activity is research subject's social security the model and serial number of the dose less than 1.1 megabecquerels (30 number oridentification number if one - calibrator, the configuration of the microcuries); has been assigned, a brief description of source measured, the activity measured

33412 Federal Register / Vol. 58. No.115 / Thursday, June 17. 1993'/ Proposed Rules

28. In 5 35.f,0, paragraphs (b) and (c) individual under the supervision of

$ 35.315 Safety preceutions. are revised to read as follows: either as specified in 5 35.25. (a) For each patient or human

31. Section 35.200 is revised to road research subject receiving 5 35.60 Syrbge shlekts and h as follows:

radiopharmaceutical therapy and hospitalized for compliance with (b) To identify its contents, a licensee 5 35 200 use of unseeneoypro&.ct 5 35.75 of this chapter. a limnseo shall: shall conspictously label each syringe, meterial for imaging and localization studies. or syringe radiation shield that contains a syringe with a radiopharmaceutical. A licensee may use for imaging and msead subbct's door with a The label must show the localization studies any unsealed .. Radioactive Materials" sign and note radiopharmaceutical name or its byproduct material prepamd for medical on the door or in the patient's or human abbreviation, the chmcal procedure to use that is either: research subM's chart where and how be performed, or the patient s or the (a) Obtained from a manufacturer or long visitors may stay in the patient's or human re eearch subject s name. preparer licensed pursuant to 10 GR the human research subject's room; , (c) A licensee shall require each 32.72 or equivalent Agreement State (3) Authorize visits by individuals mdividual who prepares a requirements; or under age 18 only on a ' case-by-case radiopharmaceutical kit to use a syrm, ge (b) Prepared by an authorized nuclear basis with the approval of the radiation shield when prepanng the kit pharmacist, a physician who is an authorized user after consultation with and shall require each mdividual to use authorized user and who meets the the Radiation Safety Officer; a syringe radiation shield when requirements specified in S 35 920, or an administering a radiopharmaceutical by individual under the supervision of (5) Either monitor material and items tryoction unless the ut,e of the shield is either as specified in 6 35.25. removed from the patient's or the contraindicated for that patient or

32. Section 35.300 is revised to read human research subject's room to human research subject.

as follows:

29. Section 35.75 is revised to med as determine that their radioactivity cannot be distin8*'hed from the natural follows:

$ 35.300 the of unsealed tryproduct materiet for therapeutic odmhistrat6en, background radiation level with a $ 35.75 Release of patients or human radiation detection survey instrument research ouNects contshing A licensee may use for therapeutic set on its most sansitive scale and with radiopharmaceuticals or permanent administr:1 tion any unsealed byproduct no interposed shieldmg, or handle them implant.. material prepamd for medical use that is as radioactive wasta. either: (a) A licensas may not authorize (6) Provide the patient or the human release from confinement for medica] (a) Obtained from a manufacturer or research subject with radiation safety care any patient or human research preparer licensed pursuant to 10 GR guidance that will help to keep subject administered a 32.72 or equivalent Agreement State radiation dose to household members radiopharmaceutical until either: mquirements; or and the public as low as reasonably (t) The measured dose rate from the (b) Prepared by an authorized nuclear achievable before authorizing release of patient or the human research subject is pharmatist, a physician who is an the patient or the human research less than 5 millirems per hour at a authorized user and who meets the subject. distance of one meter; or requirements specifiad in 6 35.920, or an (7) Survev the patient's or the human (2) The activity in the patient or the individual under the supervision of research subject's room and private human research subject is less than 30, either as specified in 5 35.25. sanitary facihty for removable millicuries.

33. In $ 35.310 the introductory text contamination with a radiation tb) A limnsee may not authorize of paragraph (a), and paragraphs (a)(1) detection survey instrument before release from confinement for medical and (a)(5) are revised to read as follows: assigning another patient or human care of any patient or human msearch researth subject to the room. The room I I-S*

I Y "'INCTI*"- must not be reassigned until removable subject administered a permanent implant until the measured dose rate (a) A licensee shall provide radiation contamination is less than 200 from the patient or the human research safety instruction for all personnel disintegrations per minute per 100 subject is less than 5 millirems per hour caring for the patient or the human square centimeters; and at a distance of one meter. research subject receiving 30 Section 35.100 is revised to read radiopharmaceutical therapy and (b) A licenses shall notify the as follows: hospitalized for compliance with Radiation Safety Officer immediately if 5 35.75 of this chapter. To satisfy this the patient or the human research [ Qj' YP'* duct requirement, the instruction must subject dies or has a medical emergency. de cribe the licensee s procedures for-

35. Section 35.404 is revised to read as studies' (1) Patient or human research subject follows:

A licensee may use for uptake. control; dilution or excretion studies any 635.404 Rekame of patlants or human unsealed byproduct material prepared resserch sut>)ects treated with temporary for medical use that is either: (5) Notification of the Radiation implants. (a) Obtained imm a manufacturer or Safety Officer in case of the patient's or (a)Immediately after removing the preparer licensed pursuant to 10 GR the human research subject's death or last temporary implant source from a 32.72 or equivalent Agreement State medical emergency. atient or a human research subject, the requirements; or .icensee shall make a radiation survey of (b) Prepamd by an authorized miclear

34. In 5 35.315, the introductory text the patient or the human research pharmacist, a physician who is an of paragraph fa), and pangraphs (a)(2).

subject with a radiation detection authorized user and who meets the (a)(3), (a)(5), (a)(6). (a)(7). and (b) are survey instrument to confirm that all requirements specified in 5 35.920 or an revised to read as follows: sources have been removed. The

Federal Register / Vol. 58, No.115 / Thursday June 17, 1993 / Proposed Rules 33413 licensee may not release from implant therapy. To satisfy this a treatment or after a door interlock confinement for medical care a patient mquirement, the instruction must interruption; or a human research subject treated by describe: temporary implant until all sources have boon removed.

40. In 5 35 615. paregraphs (d)(3) and (b) A licensee shall mtain a record of (3) Procedures for patient or human (e) are revised to wad as follows:

research subject control; patient or human tesearch subject 635.615 Safety precautions. surveys for three years. Each record }P Radiatm.mtedures for notificatmn cf the must ' include the date of the survey, the (d)... n Safety Officer if the patient or (3) A radiation monitor must be name of the patient or the human - research subject, the dose rate from the the human research subject dws or has checked with a dedicated c. heck source i patient or the human research subject a medical emergency. for proper operation each day befom the I expressed as miHirem per hour and teletherapy unit is used for treatment of 1 measured at one meter from the patient 3a. In 5 35.415, the introducto:y text patients or human research subjects. ( or the human research subject, the of paragraph (a), and paragraphs (a)(1), l survey instrument used, and the initials (a)(2), (a)(3), (a)(5) and (b) am revised to (e) A licensee shall construct or equip of the individual who made the survey. wad as follows: each teletherapy room to permit

36. In S 35.406, aragra hs (a),(b),

ms obahn d 6 pa&M or w and (c) are revise to reac as follows: 6 35.415 Safety precautione. the human msearch subject from the - (a) Por each patient or human teletherapy unit console during 635AD6 Brachytherapy sources inv researt.h subject receiving implant irradiation. (a) Promptly after removing the: therapy, a licensee shall: 41, in 5 35 900, paragraphs (a)(6) and from a patient or a human research (1) Not quarter the patient or the (a)(7) are added to read as follows: subject, a licensee shall retum human research subject in the same brachytherapy sources to the storege room with an individual who is not $ 35.900 Radiation Safety Officer. area, and count the number returned to receiving radiation therapy unless the ensure that all sources taken from the licensee can demonstrate compliance (a) * *

storage area have been retumed.

with the requirements of 5 20.105(b) or, (6) American Board of Medical (b) A licensee shall make a record of for licensees implementing the Physics in radiation oncology physics; brachytherapy source use which must provisions of 55 20.1001 through or include: 20.2401,5 20.1301(a) of this chepter at (7) Royal College of Physicians and (1)The names of the individuals a distance of one meter fmm the Surgeons of Canada in Nuclear permitted to handle the sources; implant; Medicine; or (2) The number and activity of sourtes removed from storage, th" (2) Post the patient's or human patient s or the human research research subject's door with a

42. In 5 35.910, paragraph (a)(4) is subject's name and room number, the

, Radioactive Materials" sign and note added and paragraphs (b)(2)(i), time and date they were removed from on the door or in the patient's or human (b)(2)(iii), and (b)(2)(v) are revised to research subject's chart where and how read as follows: storage, the number and activity of the sources in storage after the removal, and long visitors may stay in the patient's or the initials of the individual wh human research subject's room-~ removed the sources from stcrage; (3) Authorize visits by individuals (3) The number and activit of under age 18 only on a case-by case (a).. sourws returned to storage, tf>e patient's bas.a with the approval of the (4) Nuclear medicine by the Royal or the buman re<,earch subject's name j e) a,d Colle e of Physicians and Surgeons cf " tio and room number, the time and date th Cana a;or they were mtumed to storage.the (b) * *

number and activity of sources in (5) Provide the patient or the human (2) * *
storage after the retum, and the initials research subject with radiation safety (i) Examining patients or human of the individual who returned the Euidance that will help to keep researth subjects and reviewing their souwes to storsee.

radiation dose to household members caso histories to determine their (c)Immediately after implanting and the public as low as reasonably suitability for radioisotope diagnosis, sources in a patient or a human research achievable before releasing the limitations, or contraindications; subject the licensee shall make a individualif theindividualwas radiation survey of the patient or the administemd a permanent implant. (iii) Administering doseges to patients human research subject and the area of (b) A licensee shall notify the or human msearch subjects and using use to confirm that no sources have Radiation Safety Officer immediately if syringe radiation shields; heen misplaced. The licensee shall the patient or the human researth make a record of each survey. subject dies or has a medical emergency. (v) Patient or human research subject

39. In 5 35.610, paragraph (a)(1) is followup; or 37, In 35.410, the introductory text of revised to read as follows:

paragraph (a), and paregraphs (a)(3) and (a)(5) are revised to read as follows: 535.610 Safety instruction. 43, In 5 35.920, paragraph (a)(4)is added and pangraphs (b)(2)(iii). 8 535.410, Safety instruction. (1) The procedure to be followed to (b)(3)(i), (b)(3)(iii), and (b)(3)(v) are revised to road as follows: (s) The licensee shall provide ensure that only the patient or the radiatior safety instruction to all human research subject is in the 5 35.s20 Training for im gtng and personnel caring for the patient or the treatment room before turning the locattration stadw. nuun msearth subject undergoing primary beam of radiation on to begin

l l 33414 Federal Register / Vol. 58, No.115 / Thursday, June 17, 1993 / Proposed Rules (a) * * * (a)

survey meters, and,if appropriate, (4) Nuclear medicine by the Royal (1) Radiology, therapeutic radiology, instruments used to measure alpha-or College of Physicians and Surgeons of or radiation oncology by the Amedcan beta-omitting radionuclides; Canada; or Board of Radiology; (C) Calculating, asanying, and safely (b) * * *

(b)

paparing dosages for patients or human (2) * * *

(3)

research subjects; (iii) Calculating and safely preparing (iii) Calculating the teletherapy doses (D) Using administrative controls to 4

patient or human research subject and collaborating with the authorized avoid mistakes in the administration of I dosages; user in the review of patients' or human by(product material; research subjects' progress and E) Using procedures to prevent or (3) * *

consideration of the need to modify minimize contamination and using j

(i) Examining patients or human originally prescribed doses as warranted Proper decontamination procedures: [ research subjects and reviewing their by patients' or human msearch subjects-and case histories to determine their reaction to radiation; and (2) Has obtained written certification. signed by a promptor authorized suitability for radioisotope diagnosis. nuclear armacist, that the above limitations, or mntraindications:

48. In $ 35.961, paragraph (b)is trammg as been satisfa l

C mP eted and that the m,ctori y redesignated as paragraph (c) and a new l dividual has (iii) Administering dosages to patients paragraph (b)is added to read as or human research subjects and using follows: aclueyed a level of competency syringe radiation shields; sufEctent to independently operate a 3 35.961 Training for toiethorapy physicist. nuclear pharmacy. (v) Patient or human research subject Dated at Rockville. Maryland, this 10th day followup; or (b)is certified by the American Board ofJune,1993. of Medical Physics in radiation For the Nuclear Regulatory Commission. h "C I SY P YSIC8; ' S**ual I '"

44. In $ 35.930, the section heading and plows:aragraph (a)(2) are mvised to read Secretaryof the Conuru'ssion.

as fo.

49. Section 35.972 is revised to read IFR Doc. 93-14152 Filed 6-16-93. 8:45 aml.

9 35.930 Training for therapeutic use of unsealed byproduct materiet $ 35.972 Recentness of training. The training and experience specified (a) * *

in this subpart must have been obtained (2)The American Board of Radiology within the seven years preceding the in radiology, therapeutic radiology, or date of application or the individual radiation oncology; or must have had related continuing education and experience since the

45. In $ 35.940, paragraph (a)(1) is required training and experience was revised to read as follows:

completed.

50. Section 35.980 is added to subpart

$ 35.940 Training for use of brachytherapy I to read as follows: sources. ' $ 35.980 Training for an authorized nuclear P armacist. h (a) * (1) Radiology, therapeutic radiology. The licenses shall require the or radiation oncology by the American authorized nuclear phannacist to be a Board of Radiology; pharmacist who: fa) Has current board certification cs I

46. In $ 35.950, paragraph (a)(1) is a nuclear pharmacist by the Board of revised and (a)(4)is added to read as Pharmaceutical Specialties, or follows:

(b)(1) Has completed 700 hours in a structured educational program 6 35.950 Training for use of sealed consisting of both: o urces for segnosis. ( ) Didactic training in the following l (a) * (A) Radiation physics and (1) Radiology, diagnostic radiology, instrumentation; thera eutic radiology, or radiation (B) Radiation protection; q onco ogy by the American Board of (C) Mathematics pertaining to the use i Radiology; and measurement of radioactivity; (D) Chemistry of byproduct material (4) Nuclear inedicine by the Royal for medical use; and College of Physicians and Surgeons of (E) Radiation biology; and Canada; or (ii) Supervised experience in a nuclear pharmacy involving the

47. In $ 35.960, paragrepbs (a)(1) and following:

(b)(3)(iii) are revised to read as follows: (A) Shipping, receiving, and performing related radiation surveys; - 535.960 Training for tenseerapy. (B) Using and performing checks for proper operation of dose calibrators,

1 l I on recycled paper Federal Recycling Program 1

UNITED STATES FIRST CL ASS MAIL NUCLEAR REGULATORY COMMISSION PosTAct AND FtES PAID usNnc WASHINGTON, D.C. 20555-0001 FERMIT NO. G 67 Of TICI AL BUstNESS FEN ALTY FOR PRIVATE USE. 5300

[_ r Draft Regulatory Analysis .h N + N For Proposed Rulemaking Entitled " Preparation, T.ansfer for Commercial Distribution, and Use of Byproduct Material for Medical Use" 10 CFR Parts 30, 32, and 35 1. .Backaround 1.1 Statement of the Problem A petition for rulemaking (PRM-35-9) concerning the medical use of byproduct material was submitted jointly by the American College of Nuclear Ph sicians (ACNP) and the Society of Nuclear Medicine (SNM). The petition 3 requested that the NRC amend its regulations to fully recognize the role of licensed nuclear pharmacists and physicians. The petition addressed issues related to the preparation and use of radioactive drugs containing byproduct material for diagnostic, therapeutic, or research purposes. In addition, I certain portions of the existing regulations in Parts 32 and 35 need to be updated, clarified, or simplified. This proposed rulemaking has been prepared in response to the petition and to provide miscellaneous amendments to update or clarify the existing regulations. 1.2 NRC's Policy Statement on the Medical Use of Radioisotopes In a policy statement published on February 9, 1979 (44 FR 8242), entitled " Regulation of the Medical Uses of Radioisotopes; Statement of General Policy, the NRC stated: 1. The NRC will continue to regulate the medical uses of radioisotopes i as necessary to provide for the radiation safety of workers and the general public. 2. The NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or compliance j with these standards, are inadequate. 1 i

3. The NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine. In conformance with this policy, the Commission proposes to eliminate certain restrictions in the NRC regulations regarding the preparation and use of byproduct material for medical use. In addition, the Commission proposes to provide the authority to licensees to conduct research involving human subjects and to use radiolabeled biologics. The Commission believes that these restrictions can be eliminated without compromising the level of j protection of public health and safety against radiological hazards. The Commission recognizes that physicians have the primary responsibility for the diagnosis and treatment of their patients and recognizes that the nuclear pharmacists have the primary responsibility for the preparation of radioactive drugs. NRC regulations are predicated on the assumption that properly trained and adequately informed physicians and pharmacists will make decisions that are in the best interest of their patients. Furthermore, the pharmacological aspects of radioactive drugs, including drug safety and efficacy, are regulated by the U.S. Food and Drug Administration (FDA). 1.3 Earlier NRC Actions f following receipt of the petition, the NRC, in consultation with the FDA, determined that some issues of the petition should be addressed promptly. .i On August 23,1990 (55 FR 34513), the Commission published an Interim Final Rule to allow, for a period of 3 years, the use of therapeutic radiopharmaceuticals for indications not listed in the package insert and to allow departures from the manufacturer's instructions for preparing diagnostic radiopharmaceuticals using radionuclide generators and reagent kits, provided that certain recordkeeping requirements were met. Based on the records l collected from the affected licensees, both the NRC and FDA staff agreed that i the major trends in departures that may be identified by the recordkeeping are already discernible and collecting additional data is unnecessary. On October 2,1992 (57 FR 45566), the NRC published a rule eliminating the recordkeeping requirements. 2 ~

In a parallel effort, the NRC continued to work nn the remaining issues in the petition. On August 7, 1991, the NRC conducted a workshop in Rosemont, Illinois, presenting strawman language on the training and experience criteria for authorized nuclear pharmacists to representatives of the following organizations: Board of Pharmaceutical Specialties, American Board of Science in Nuclear Medicine, National Association of Boards of Pharmacy, Committee on Radionuclides and Radiopharmaceuticals of the U.S. Council for Energy Awareness, American Pharmaceutical Association, American Society of Hospital Pharmacists, and three graduate schools of pharmacy. Subsequently, the NRC l also discussed the proposed resolution of these issues in meetings with the FDA, the NRC's Advisory Committee on the Medical Uses of Isotopes (ACMUI), and the Agreement States. This proposed rulemaking is the evolutionary result of numerous meetings with the aforementioned groups. 2. Ob.iectives The objective of this proposed rulemaking is to grant the petition and to eliminate certain restrictions in NRC's regulations regarding the medical use of byproduct material without compromising the level of protection of public health and safety against radiological hazards. 7 Specifically, among other things, the proposed rule would incorporate into NRC's regulations the concept of authorized nuclear pharmacists to allow properly qualified pharmacists greater discretion to prepare (including compound) radioactive drugs containing byproduct material. Also, the proposed rule would allow physician authorized users greater discretion to prepare and use radioactive drugs containing byproduct material, the use of byproduct material in research involving human subjects, and the use of radiolabeled biologics containing byproduct material. In addition, the proposed rule also contains other miscellaneous and conforming amendments necessary to update or clarify the current regulations. f t i 3

L 3. ALTERNATIVES Two alternatives have been considered for the petition: maintain the status quo or grant the petition. The first alternative would continue to restrict physicians and pharmacists in the medical use of byproduct material. This alternative would continue to require NRC medical use licensees to meet the current prescriptive regulations which restrict the activities of nuclear physicians in the 3 preparation and use of radioactive drugs. In addition, this alternative would continue to restrict the activities of nuclear pharmacists in the preparation of radioactive drugs. Therefore, this alternative was not further considered. The second alternative, promulgation of a proposed rule to grant the petition, would provide greater flexibility for physician authorized users to use byproduct material in the practice of medicine. The proposed amendments would also incorporate into the regulations the concept of authorized nuclear 3 pharmacists to allow properly qualified pharmacists to prepare (including P compound) radioactive drugs containing byproduct material. The Comraission believes that granting this petition would eliminate certain restrictions j regarding the medical use of byproduct material without compromising the level of protection of public health and safety against radiological hazards. 4. Brief Descriptions of the troposed Amendments In response to the petition for rulemaking, the Commission is proposing to: r 1. Allow physician authorized users to use therapeutic radioactive drugs containing byproduct material for indications or methods of administration not listed in the FDA-approved package insert; 2. Allow physician authorized users to use radioactive drugs containing byproduct material for research involving human subjects-3. Allow physician authorized users to use radiolabeled biologics containing byproduct material; I 4. Allow medical use licensees and commercial nuclear pharmacies to depart from the manufacturer's instructions for preparing radioactive drugs using radionuclide generators and reagent kits; 4 e .m.m

i 5. Allow medical use licensees and commercial nuclear pharmacies to - compound radioactive drugs using byproduct material; 6. Delete the existing regulations related to the nonradioactive reagent kits; and i 7. Clarify regulatory requirements for specific licenses of broad scope. Table 1 summarizes the requests made in the petition and the Commission's responses. I In addition to the proposed amendments in response to the issues raised in the petition, the Commission is proposing related or miscellaneous amendments to Parts 32 and 35. In general, the objective of these proposed l amenaments is to clarify, update, and simplify the current regulations. Specifically, these proposed amendments include: l. In Part 32, the Commission is proposing to replace the word "radiopharmaceutical" with the term " radioactive drug" in proposed & 32.72. This change is necessary to include both radiopharmaceuticals and radiolabeled biologics in Part 32. 2. In Part 35, whenever applicable, the Commission is proposing to use 4 the terms " unsealed byproduct material for medical use" or " radioactive drug" instead of "radiopharmaceutical." This proposed change is intended to j indicate that the Commission's regulations regarding the medical use of byproduct material are focused on radiation safety and are separate from FDA's regulations regarding radiopharmaceuticals. However, to prevent massive changes in Part 35, the word "radiopharmaceutical" will continue to be used in the sections for which modifications are not proposed. Thus, the word "radiopharmaceutical" would be equivalent to " unsealed byproduct material for medical use" or " radioactive drug" in the sections that are not modified by this proposed rule. 3. The Commission is proposing to modify the definition of " medical use" in Parts 30 and 35 by replacing the term " human beings" with the term " patients or human research subjects" to include the administration of byproduct material to an individual who is participating in a research procedure. In addition, the Commission proposes to delete the language in the definition of " medical use" that the administration of byproduct material be 5 p

b Table 1 i Summary of Requests in the Petition and the Commission's Responses Reauest

Response

Permit authorized users to use Permit physician authorized radiopharmaceuticals for users who are qualified for therapeutic uses not covered in therapeutic administration to the package insert. use radioactive drugs for therapeutic uses not covered in the package insert. Permit authorized users to use Permit physician authorized radioactive drugs for research users to use radioactive drugs involving human subjects. for research provided that human research subjects are protected. Permit authorized users to use Permit physician authorized radiolabeled biologics. users to use radiolabeled biologics provided that dosages of alpha-or beta-emitting radionuclides are measured. Permit medical use licensees and Permit physician authorized pharmacies to depart from users and authorized nuclear package inserts when using pharmacists who meet certain j generators and kits. training and experience criteria j i to_ depart from package inserts when using generators and kits. Permit medical use licensees and Permit physician authorized pharmacies to use byproduct users and authorized nuclear material to compound radioactive pharmacists who meet certain drugs. training and experience criteria to prepare (including compound) radioactive drugs. Permit nuclear pharmacists to Delete NRC regulations on prepare reagent kits. reagent kits which do not contain byproduct material. Thus, nuclear pharmacists would be able to prepare reagent kits under applicable law. Clarify requirements on licenses Clarify the requirements by i of broad scope. adding two exemptions in l Part 35. 6 l l I i

in the practice of medicine in accordance with a license to practice medicine. The definition of other terms in Part 35 (e.g., physician) include this licensing concept. With this proposed definition, applicable requirements in Part 35, such as misadministration reporting and quality management program, would also apply to human research subjects; thus, an equivalent level of protection would be provided for both patients and human research subjects. 4. In Part 32, the Commission is proposing to clarify the existing regulations regarding the labeling of syringes, vials, generators, or other containers of radioactive drugs. This proposed change is necessary to avoid confusion over the types of information to be submitted. 5. In Part 32, the Commission is proposing to delete the text in 32.72(b) because it is out of date. 6. In discussing the proposed regulations concerning transfer of radioactive drugs, the Commission has noted later in this preamble that it is sometimes necessary to transfer a dosage of a radioactive drug on a case-by-case basis from one medical use licensee to another medical use licensee. These case-specific transfers would not be considered commercial transfers by the NRC and, therefore, would not require a Part 32 license. 1 7. In Part 35, the Commission is proposing to change the lower limit for testing dose calibrators for linearity from 0.37 Megabecquerel (10 microcuries) to 1.1 Megabecquerels (30 microcuries) for consistency with 10 CFR 35.32, " Quality Management Program." 8. In regard to the accuracy, linearity, and geometry tests of dose calibrators, the Commission is proposing to replace the requirement for the Radiation Safety Officer's (RS0) signature with the requirement for the identity of the individual actually performing these tests. This proposed change is necessary to identify the individual who actually performed these tests. Furthermore, this change would provide additional time for the RS0 to devote to other radiation safety issues. However, this change would not affect the responsibilities of the RSO that are defined in existing 10 CFR 35.21. 9. The Commission is proposing to update the regulations by recognizing several certification boards in the training and experience requirements. 7 ~~_ _ _. _ _ _. _ _ _ _ _ _ _ _ _ _ _ _ _ _ _. _ _ _ _ - _ _ _ _ - -. -. _ _.. _ _ _ _ _. -. _ _ _ _ _ _ _ _-._

A ^ i 10. The Commission is proposing that licensees may allow authorized users and authorized nuclear pharmacists who meet certain requirements to use byproduct material without the licensee first obtaining a license amendment from the NRC. Therefore, the Commission is proposing to delete the provisions in Part 35 addressing visiting authorized users. 11. The Commission is proposing to modify'the requirements for recentness of training of certain authorized users.

12. The Commission is proposing to add requirements regarding the preparation of byproduct material for medical use under the supervision of a physician authorized user and to provide comparable requirements regarding the supervisory responsibilities of authorized nuclear pharmacists.

13. The responsibilities of the Radiation Safety Committee would be modified to reflect the activities which the proposed changes to Part 35 would authorize.

5. ESTIMATION OF COST IMPACT .1 G1NERAL DISCUSSION The NRC has about 2,000 medical use licensees (licensed under Part 35) l S and about 50 licensees who manufacture or prepare radioactive drugs (licensed under Part 32). Agreement States have approximately twice the NRC's licermees l mentioned above. It is expected that the requirements proposed in this rulemaking would be a matter of compatibility for the Agreement States: all f proposed definitions contained in 66 30.4 and 35.2 would be Division 1 items i of compatibility; proposed sections 32.72, 35.6, 35.22(b)(2), 35.25, 35.50, f 35.52, 35.53, 35.920, 35.972 and 35.980 would be Division 2 items of l compatibility; and the remaining proposed sections in Part 35 would be l Division 3 items of compatibility. The cost estimates shown below are for affected NRC licensees only. Therefore, the total cost impacts (i.e., for NRC and Agreement State licensees) associated with this proposed rule would be approximately 3 times the cost to the affected NRC licensees. i a 8 i i I

i i The cost estimates are based on the following: o Fee per license amendment 5460 o Unit labor costs (unloaded)- For licensee staff - Physician * $85/ hour - Scientific staff * (e.g. nuclear pharmacists) $50/ hour - Technical staff * (e.g. medical technologists) $30/ hour - Clerical staff $15/ hour For NRC (and Agreement State) staff

550/ hour
Includes prorated amounts for clerical staff.

5.2 IMPACTS TO AFFECTED NRC LICENSEES Each section of the proposed rule has been evaluated in terms of the cost impact (i.e., increase, decrease, or no change as compared to the cost under existing situations) to_ affected licensees. In calculating the cost impacts, the cost savings are expressed as positive (+) values and the cost increases as negative (-) values. The cost impact of each proposed section is discussed below except for those sections that obviously have no cost impacts. l Table 2 is a summary of the impact to affected licensees for each proposed section. i 5.2.1 PART 30 - RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL 6 30.34 Terms and conditions of licenses. I The proposed amendment would delete paragraph ! 30.34(i) in its entirety. Under the existing paragraph, licensees are permitted to depart from FDA-approved package inserts. Under the proposed rule, this permission would be moved to Part 32 for commercial nuclear pharmacies and to i Part 35 for medical use licensees. Therefore, there would be no cost impact associated with this proposed amendment. 9 0 4

E { Table 2 i Summary of impacts to NRC Licensees t Proposed No. of Amend, Impact /yr Section permission, or Hours $/hr Fee Savings: + No. Record, etc./yr Costs: l t Part 30 30.4 No cost (See footnote 1) 30.34(i) No cost (See 5.2.1 of this analysis) Part 32 i 32.72(a) No cost.(See footnote 2) 32.72(b) 20 license 4 hours $50 $460 + $13,200 i amendments eliminated 50 license 2 hours $50 $460 + $28,000 amendments i eliminated j 50 notifications 1/2 hour $30 - $750 j required j 32.72(c) No cost (See 5.2.1 of this analysis) 32.72(d) No cost (See footnote 3) [32.73) I license 32 hours $50 $3,600 + $5,200 application eliminated 32.74 No cost (See footnote 3) f i I i 10 1

-) { Table 2 (Continued) j Summary of Impacts to NRC Licensees { i Proposed No. of Amend, impact /yr i i Section permission, or Hours 5/hr Fee-Savings: +. No. Record, etc./yr Costs: - l Part 35 35.2 No cost (See footnote 1) 35.6 2 license 8 hours 585 5460 - 52,280 l amendments required 35.7 No cost (See footnote 3) t t 35.8 No cost (See footnote 2) r I 35.11 No cost (See footnote 3) i 35.12 No cost (See footnote 3) i 35.13 200 license 2 hours $50 5460 4 5112,000 l amendments eliminated t 10 license 2 hours 550 5460 - 55,600 amendments required j i - 53,300 j 35.14 220 notifications 1/2 hour $30 required 35.15 No cost (See footnote 2) l 35.22(b)(2) No cost (See footnote 2) 35.2 No cost (See footnote 2) I [35.27] 100 records 1/6 hour $15 + 5250 eliminated i 35.49 No cost (See footnote 4) j t = 1 11 i i I e I

Table 2 (Continued) Summary of Impacts to NRC Licensees Proposed No. of Amend, Impact /yr Section permission, or Hours $/hr Fee Savings: + No. Record, etc./yr Costs: - 35.50 No cost (See footnote 3) 35.52 No cost (See 5.2.3 of this analysis) 35.53 No cost (See footnote 2) 35.100 to 20 license 2 hours $50 $460 + $11,200 35.300 amendments eliminated 35.610 to No cost (See footnote 2) 35.972 - $1,000 35.980 20 certifications I hour $50 required Subtotal Savings + $169,350 Costs - 5 12,930 Savings (for NRC licensees) + $156,920 Total Savings (for NRC and Agreement State licensees) + $470,760 footnotes: 1. This is a definition, thus no cost impact. 2. This is a clarification or update which would not substantively change the current practice. 3. This is to provide a reminder to licensees, to grandfather an l existing situation, or to conform with changes made in other sections or chapters. 4. These requirements or a portion of the existing requirements are moved to other sections. 12

i 5.2.2 PART 32 - SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN f ITEMS CONTAINING BYPRODUCT MATERIAL 4 l s 32.72 Manufacture. preparation. or transfer for commercial distribution of radioactive druas containina byproduct material for medical use under Part 35. t 32.72(b) (1) Proposed 5 32.72(b) would allow commercial nuclear pharmacies _ to depart from FDA-approved package inserts and to compound radioactive drugs, without obtaining a license amendment from the NRC. Therefore, a cost saving is expected due to the elimination of these license amendments. Assuming 20 amendments requesting departures or compounding would be eliminated per year and 4 hours of scientific staff's time would be avoided for preparing an application for a license amendment, the cost saving is estimated to be: 20 amend /yr x (4 hrs / amend x $50/hr + $460 fee / amend) = + 513,200/yr. (2) This proposed paragraph would allow commercial nuclear pharmacies l to permit an individual to work as an authorized nuclear pharmacist, without obtaining a license amendment from the NRC, if the individual is: (1) certified by the Board of Pharmaceutical Specialties; (2) listed on a Commission or an Agreement State license; or (3) listed on a permit issued by a specific licensee of broad scope as an authorized nuclear pharmacist. This proposed provision would eliminate a current licensing requirement that requires a licensee to obtain a license amendment from the NRC before permitting an " authorized user" to work. I Assuming 50 amendments requesting to add the names of the " authorized users" would be eliminated per year and 2 hours of scientific staff's time would be avoided for preparing an application for amendment, the cost saving is estimated to be: 50 amend /yr x (2 hr/ amend x 550/hr + $460 fee / amend) = + 528,000/yr. (3) This proposed paragraph would require licensees to provide to the NRC a copy of the individual's board certification, the license, or the permit, and the state pharmacy licensure or registration, respectively, for 13 o

) each individual within 30 days of the date that the licensee permits, pursuant to this section, the individual to work as an authorized nuclear pharmacist. Therefore, a cost increase is expected due to this proposed notification requirement. Assuming 50 notifications would be required per year and 1/2 hour of technical staff's time would be needed for preparing a notification, the cost increase is estimated to be: t 50 notifications /yr x 1/2 hr/ notification x $30/hr - - $750/yr. I 32.72(c) This paragraph is proposed to clarify that Part 32 licensees measure and record dosages of radioactive drugs, including those containing alpha-or beta-emitting radionuclides, before transferring these drugs to a medical use licensee. Currently, these licensees already possess measurement instrumentation, perform the measurements, and record the dosages to provide information required under existing 9 32.72(a)(4){i). Therefore, there would be no cost impact associated with this proposed amendment. I 32.73 Manufacture and distribution of cenerators or reaaent kits for oreparation of radiopharmaceuticals containina bvoroduct material. The section would be deleted in its entirety. This section requires that a licensee shall obtain a specific license from the NRC before the licensee may manufacture or distribute radionuclide generators containing I byproduct material or reagent kits. Under the proposed rule, the existing requirements related to radionuclide generators would be moved to the proposed 5 32.72. However, the existing requirements related to these reagent kits would be deleted because they do not contain byproduct material. Therefore, a cost saving is expected because the proposed elimination of the application for a license to manufacture or distribute these reagent kits. The fee for NRC's review of an application to manufacture and distribute a new type of reagent kit is $3,600 per application. Assuming 1 application j would be eliminated per year and 32 hours scientific staff's time would be 14 w

l avoided by the licensee to prepare the application, the cost saving would be. I application /yr x (32 hrs /appi x $50/hr + $3,600 fee / appl) - + $5,200/yr. 3 5.2.3 PART 35 - MEDICAL USE OF BYPRODUCT MATERIAL l 35.6 Provisions for research involvina human subjects. 1 This proposed section would allow licensees to conduct research using byproduct material involving human subjects provided that the research is conducted, funded, supported, or regulated by another Federal Agency which has implemented the Federal Policy for the Protection of Human Subjects. 4 Otherwise, a licensee shall apply for and receive approval of a specific amendment to its NRC license before conducting such research. Thus, a cost-increase is expected. However, the NRC believes that most human research i involving byproduct material is currently conducted, funded, supported, or regulated by another Federal agency. Assuming 2 license amendments would be needed per year and 8 hours of physician's time would be needed to prepare an application for amendment, the cost increase would be: 5 2 amend /yr x (8 hr/ amend x $85/hr + $460 fee / amend) = - $2,280/yr. i s 35.13 License amendmen11 4 (1) Proposed paragraph (b) of this section would allow medical use licenses to allow an individual to work as an authorized user, without submitting a license amendment to the NRC, if the physician authorized user is: (a) certified by the appropriate certification boards; (b) listed on a Commission 0:- Agreement State license; or (c) listed on 'a permit of a i Commission or Agreement State specific licensee of broad scope. Under current regulations, a license amendment must be obtained before the individual may work as an authorized user (except for a visiting authorized user). Thus, a cost saving is expected due to the elimination of these license amendments. Assuming 200 license amendments would be eliminated per year and 2 hours of scientific staff's time would be avoided for preparing an application for amendment, the cost saving would be: 15 h

200 amend /yr x (2 hr/ amend x $50/hr + $460 fee / amend) = + $112,000/yr. (2) This proposed paragraph would permit medical use licenses to allow an individual to work as an authorized nuclear pharmacist, without submitting f l a license amendment to the NRC, if the authorized nuclear pharmacist is: (a) certified by the certification board; (b) listed on a. Commission or Agreement State license; or (c) listed on a permit of a Commission or Agreement State specific licensee of broad scope. However, if the individual does not meet the criteria stated above, a license amendment must be obtained by the licensee'before the individual can work as an authorized nuclear pharmacist. Thus, a cost increase is expected due to the proposed requirement for these license amendments. Assuming 10 license amendments would be required per year and 2 hours of scientific staff's time would be needed for preparing an application for amendment, the cost increase would be: 10 amend /yr x (2 hr/ amend x $50/hr + $460 fee / amend) = - $5,600/yr 5 35.14 Notifications. In addition to the existing notification requirement, the NRC proposes to amend this section to require specific licensees of limited scope to submit a copy of an individual's board certification, the license, or the permit as discussed in 6 35.13. Thus, a cost increase is expected. Assuming 220 notifications would be needed (200 notifications for authorized users and 20 notifications for authorized nuclear pharmacists) and 1/2 hour of technical staff's time would be needed for preparing each notification, the cost increase would be: 220 notification /yr x 1/2 hr/ notification x 530/hr - - $3.10^/yr. 5 35.27 Visitino authorized user. I The NRC is proposing to delete this section because, under the proposed rule, the concept of a visiting authorized user would no longer be necessary. Since a recordkeeping requirement in the existing section would also be eliminated, a cost saving is expected. 16 C

i Assuming 100 records per year would be eliminated and 10 minutes cf clerical staff's time would be avoided for each record, the cost saving would be: 100 records /yr x I/6 hr x $15/hr = + $250/yr. 6 35.52 Possession. use. calibration. and check of instruments to measure dosaaes of aloha-or beta-emittino radioactive druas. This paragraph is new and would require Part 35 licensees to possess instrumentation to measure the radioactivity of alpha-or beta-emitting radioactive drugs, except for unit doses obtained from manufacturers or commercial nuclear pharmacies. Most alpha-or beta-emitting radionuclides are used in radiolabeled biologics which are still under new drug investigation. Under current practice, licensees preparing radiolabeled biologics containing alpha-or beta-emitters in their own facilities or purchase qualities of these radiolabeled biologics from manufacturers or commercial nuclear pharmacies other than unit doses already have instrumentations to measure the doses. In addition, licensees who purchase only unit doses would be exempt from this section. Therefore, no cost impact is expected. l 5 35.100 Use of unsealed byproduct material for uptake. dilution. and t excretion studies. 9-35.200 Use of unsealed byproduct material for imaoino and localization -j studies. 9 35.300 Use of unsealed bvDroduct material for therapeutic administration. The proposed amendments in these three sections would allow medical use licensees to compound radioactive drugs using byproduct material without obtaining specific license amendments. Therefore, a cost saving is expected. Departures from FDA-approved package inserts and manufacturers' instructions are already permitted under the Interim Final Rule. j Assuming 20 amendments per year would be eliminated and 2 hours of l scientific staff's time would be avoided to prepare each application, the cost savings would be: 20 amend /yr x (2 hr/ amend x $50/hr + $460 fee / amend) = + $11,200/yr. 17 j -m

i O 6 35.980 Trainina for an authorized nuclear charmacist. This proposed section would require authorized nuclear pharmacists to 3 meet the training and experience criteria. Because the criteria proposed in j this section are nearly identical to those in the current licensing guidance, there would be no cost impact to implement this section, with an exception of requiring a written certification from preceptors. Thus, a cost increase is expected. Assuming 20 certifications would be written per year and I hour of scientific staff's time would be needed to complete each certification, the cost increase would be: 20 certification /yr x 1 hr/ certification x 550/hr - - $1,000/yr. Total impacts to affected NRC licensees The cost impact to affected NRC licensees is estimated to be a saving of $156,920 per year (See Table 2). t 5.3 ]MPACTS TO AFFECTED AGREEMENT STATES LICENSEES Since Agreement States have approximately twice the NRC's licensees, the impacts for Agreement State licensees associated with this proposed rule would be approximately twice the impact to the affected NRC licensees. Therefore, { the savings for Agreement State licensees would be: 2 x 5156,920/yr = + $313,840/yr. 5.4 TOTAL IMPACT TO AFFECTED LICENSEES The impact to both the NRC licensees and Agreement State licensees would be a savings of l $156,920/yr + 5313,840/yr = $470,760/yr. f 18 6 o w

5.4 [0ST IMPACT TO NRC The predominant factor affecting the NRC's operating costs as a result of this proposed action. is the decreased number of license amendments which will no longer need to be processed by the NRC. However, this impact is already addressed in the cost impact to the licensees and is included as the 1 change in fees charged to the licensees. 5.5 1MPACT TO AGREEMENT STATES Since the requirements proposed in this rulemaking would be expected to l be a matter of compatibility for the Agreement States, each Agreement State l would be required to adopt certain sections of the proposed rule. The impact -[ to the Agreement States would be associated with the adoption of certain i sections of the proposed rule into their State regulations. The impact for each Agreement State may be estimated as follows: o Draft a proposed rule 40 hours j o Review by an Advisory Committee 8 bours [ Send the proposed rule to NRC for review 4 hours I o ) o Prepare a final rule 20 hours \\ Impact for an Agreement State 72 hours Since there are 29 A yeement States, the total impact to the Agreement i States to incorporate certain sections of the proposed rule is estimated to be: 29 Agreement State x 72 hrs / Agreement State x $50/hr = - $104,400. l l I 6. BENEFITS This proposed rule would benefit the public by permitting medical use licensees to increase the scope of the applications of radioactive drugs and j to increase efficiencies in the preparation and use of radioactive drugs. j Specifically, this proposed rule would provide physician authorized users greater flexibility in the medical use of byproduct material. Similarly, the proposed rule would permit qualified nuclear pharmacists to use byproduct i 19 i

L material to prepare radioactive drugs. Even though the proposed rule would eliminate cer+ sin restrictions related to the medical use of by byproduct material, the NRC believes that additional safeguards against radiological hazards are included in the proposed rule that will continue to ensure adequate protection of public health and safety. 7. DECISION RATIONALE Based on the above analysis, NRC believes that the proposed rule, if adopted, would provide physician authorized users with greater flexibility to use and would allow authorized nuclear pharmacists to prepare radioactive drugs containing byproduct material. The NRC believes that additional safeguards against radiological hazards are included in the proposed f amendments that will continue to ensure adequate protection of public health and safety. Therefore, the NRC is publishing the proposed rule for public comments. i b i r i, l ? + 20 o

DRAFT ENVIRONMENTAL ASSESSMENT FOR PROPOSED AMENDMENTS T0 10 CFR PARTS 30, 32, AND 35, " PREPARATION, TRANSFER FOR COMMERCIAL DISTRIBUTION, AND USE OF BYPRODUCT MATERIAL FOR MEDICAL USE"; ~ FINDING OF NO SIGNIFICANT IMPACT 1. Introduction The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations for the medical use of byproduct material. This action is necessary to respond to a petition for rulemaking and to fully recognize the role ef licensed nuclear pharmacists and physicians. The petition for i rulemaking (PRM-35-9) was submitted by the American College of Nuclear Physicians and the Society of Nuclear Medicine. The proposed rule is intended to provide greater flexibility for authorized user physicians to prepare and use radioactive drugs containing byproduct material. The proposed rule would also incorporate into the regulation the concept of authorized nuclear pharmacists to allow properly qualified pharmacists greater discretion to prepare radioactive drugs containing byproduct material. The major features of the proposed amendments include: (1) allowing medical use licensees to depart from the U.S. Food and Drug Administration (FDA) approved package insert instructions regarding the preparation and use of radioactive drugs; (2) creating the concept of an " authorized nuclear pharmacist" and specifying training and experience requirements; (3) allowing authorized nuclear pharmacists and physician authorized users to use byproduct material to prepare radioactive drugs; (4) allowing the use of byproduct material in research involving human subjects; and (5) allowing the use of radiolabeled biologics. 2. Need for the Amendment: Rejection of the No Action Alternative The proposed amendments have been developed to grant the petition for rulemaking. The Commission recognizes that physicians have the primary responsibility for the diagnosis and treatment of their patients, and recognizes that the nuclear pharmacists have the primary responsibility for the preparation of radioactive drugs. The Commission's regulations are f

predicated on the assumption that properly trained and adequately informed physicians and pharmacists will make decisions that are in the best interest of their patients. Furthermore, the pharmacological aspects of radioactive drugs, including drug safety and efficacy, are regulated by the FDA. Therefore, the proposed amendments would allow physician authorized users greater discretion in the medical use of byproduct material, and allow i authorized user physicians and authorized nuclear pharmacists greater discretion to prepare radioactive drugs containing byproduct material. This no-action alternative is not favored because the Commission's regulations are more restrictive than FDA and State pharmacy regulations. Moreover, the current regulatory philosophy of linking NRC regulations (e.g., 10 CFR 35.200) to FDA approval of package inserts to ensure the radiation safety of radioactive drugs does not allow NRC licensees sufficient flexibility to use or prepare radioactive drugs. The Commission believes that greater flexibility can be provided while continuing adequate protection of public health and safety. 3. Impact on the Public and the Environment The proposed amendments would have no significant impact on the public and the environment. The additional research activities allowed by the proposed amendments are expected to be small in comparison to the current total activities involving radioactive drugs containing byproduct material. Therefore, the proposed amendments would not cause a significant increase in { the total activity. Furthermore, allowing compounjing could reduce radiation exposures to workers. For example, allowing the use of specific additives could decrease the volatility of certain radioactive drugs, thus, reducing the concentration of radionuclides in air. In other cases, exposures may increase if a licensee markedly increases the amount of compounding, however, such a scenario is extremely unlikely and the workers are protected under the provisions contained in 10 CFR Part 20. Therefore, it is expected that there would be no increase in radiation exposure to the public, health care workers, j .or the environment, beyond the exposures currently resulting from the l preparation and administration of radioactive drugs containing byproduct l i 2 1 1

material. Thus, there would be no discernible impact on the public or the environment resulting from the proposed amendments. 4. List of Agencies and Persons Consulted and Identification of Sources Used The NRC held public meetings concerning the preparation and use of radioactive drugs containing byproduct material. Appropriate suggestions from i the meetings have been incorporated in the proposed amendments. The following table lists the date, location, and the groups represented at each meeting. l Public Meetinas Held Date Location Groues Reoresented 08/07/91 Rosemont, IL Board of Pharmaceutical Specialties American Board of Science in Nuclear Medicine National Association of Boards of Pharmacy Committee on Radionuclides and Radiopharmaceuticals of the U.S. Council for Energy Awareness American Pharmaceutical Association American Society of Hospital Pharmacists Purdue University-School of Pharmacy and Pharmacal Sciences University of New Mexico-College of Pharmacy University of Pittsburgh-School of Pharmacy 07/15/92 Atlanta, GA Agreement States: AL, AR, AZ, CA, CO, FL, GA, 07/16/92 IL, KS, KY, LA, MD, NC, ND, NE, NH, NV, NY (including NY city), OR, SC, TX, UT, WA. 11/07/91 Reston, VA Advisory Committee on the Medical Uses of 05/08/92 Reston, VA Isotopes 10/23/92 Rockville, MD 3

i 5. Finding of No Significant' Impact l The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations -in Subpart A of i 10 CFR Part 51, that the proposed amendments, if adopted, would not be a major Federal action significantly affecting the quality of the human environment, l t . and therefore an environmental impact statement is not required. The proposed amendments would relax certain requirements and eliminate specific i restrictions associated with the medical use of byproduct material. The Commission believes these proposed amendments would provide greater flexibility in the medical use of byproduct. material while_ continuing to adequately protect public health and safety. It is expected that this l proposed rule, if adopted, would not cause any significant increase in radiation exposure to the public or radiation release to the environment j beyond the exposures or releases currently resulting from the medical-use of - r byproduct material. j l f i i l I l l 4 y.. . m

=. cc: Tse? Jones File ( ) dm UNITED STATES ((Yxtg/'.i, /i NUCLEAR REGULATORY COMMISSION 's " ~ Office of Public Affairs i %.,7..+ Washington, D.C. 20555 i t No. 93-80 FOR IMMEDIATE RELEASE Tel. 301-504-2240 (Thursday, June 17, 1993) l, i, k NRC PROPOSES CHANGES TO INCREASE FLEXIBILITY IN MEDICAL USES OF NUCLEAR MATERIAL e The Nuclear Regulatory Commission is considering changing its regulations for the medical use of nuclear material to provide greater flexibility for authorized user physicians and qualified pharmacists. The proposed changes are responsive to a petition for rulemaking submitted to the NRC by the American College of Nuclear Physicians and the Society of Nuclear Medicine. Notice i of receipt of the petition and opportunity for public comment was published in the Federal Register on September 15, 1989. l The Commission has already addressed some issues raised in the ACNP-SNM petition by publishing, on August 23, 1990, an interim rule that allows, for a period of three years, specific 1 departures from the package inserts under the direction of_a physician authorized user. i Previously, NRC regulations restricted medical use licensees i to using or preparing certain radioactive drugs in accordance with the Food and Drug Administration (FDA) approved package inserts, although FDA generally does not require physicians or pharmacists to follow these inserts. In addition, current NRC regulations do not specifically allow medical use licensees to use byproduct material in research 1 involving human subjects, in radiolabeled biologics (bloo'd and other body materials to which radioactive material has been added) and in preparing radioactive drugs. In response to the petition, the Commission is proposing to amend its regulations to (1) Allow departures from FDA-approved package inserts regarding the preparation and use of radioactive drugs by deleting the remaining restrictions of the interim rule published on August 23, 1990; f f

(2) Include the concept of an " authorized nuclear i pharmacist" and specify training and experience requirements; (3) Allow physician authorized users and authorized nuclear pharmacists to use byproduct material to prepare radioactive i drugs; (4) Allow the use of byproduct material in research involving human subjects; and (5) Allow the use of radiolabeled biologics containing byproduct material. The proposed changes also include miscellaneous changes to clarify, update and simplify the current regulations, such as accepting certification in nuclear medicine by the Royal College of Physicians and Surgeons of Canada. The Commission does not believe that these proposed changes will result in any significant increase in radiation exposure to the public or the environment beyond the exposures currently resulting from medical uses of nuclear material, t Interested persons are invited to submit written comments on the proposed regulations by October 15. The comments should be addressed to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC'20555, Attention: Docketing and Service Branch. UN'TED STATES j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C:. 20555-0001 omCIAL BUSNESS PENALTY FOR PRIVATE USE, $300 l i US NRC-RES DIV REGULATORY APPLICATION DEPUTY DIVISION DIRECTOR l NL/S-007 WASHINGTON DC 20555 ) h l .f f PfvNTED ON N CYCLfD PA8TR 1,,1,lil....lil.l.1,iliimllil i

m i NOTICE OF OFFICE OF MANAGEMENT AND BUDGET ACTION -Y bD) bk'~' F l ~' -I i l i TO: BRENDA JO SHELTON (MNBB-7714) ACTION-DATE NRC CLEARANCE OFFICER { U.S. NUCLEAR REGUL ATORY COMMISSION WASHINGTON, D.C. 20555 Nuclear Regulatory Commission 08/18/93 i ) ON 07/16/93, YOU REQUESTED APPROVAL OF THE FOLLOWING INFORMATION COLLECTION: TITLE: SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL -- 10 CFR PART g2 [ AGENCY. FORM NOS.: IN ACCORDANCE WITH THE PAPERWORK REDUCTION ACT, WE HAVE TAKEN THE FOLLOWING I F ACTION ON THIS INFORMATION COLLECTION: APPROVED FOR USE THROUGH 05/31/96. 0MB NO. 3150-0001. THE OFFICE OF MANAGEMENT AND BUDGET CONTROL NUMBER'MUST BE DISPLAYED IN ACCORDANCE hITH 5 CFR 1320. UNLESS OTHERWISE PROVIDED IN = REMARKS," EXPIRATION DATES MUST ALSO BE DISPLAYE0 AS REQUIRED BY 5 CFR 1320. l t EFFECT ON BURDEN: RESPONSES REPORT ING HOURS j PREVIOUS STATUS 0 0 NED STATUS 5,360 2A)240 DIFFERENCE 5,360 Ig,240 l EXPLANATION OF DIFFERENCE: i ADJUSTMENTS CORRECTION-ERROR 0 0 j CORRECTION-REESTIMATE O O CHANGE IN USE O O l PROGRAM CHANGES INCREASE 5,360 14, 240 l OECREASE O O i ~ REMARKS: I i s

NOTICE OF OFFICE OF MANAGEMENT AND BUDGET ACTION PAGE 2 { OMB NO. 3150-000I ABSTRACT: 'RADI0 ACTIVE MATEIALS, RA0!ATION SAFETY, BYPRODUCT MATERIAle NUCLEAR MEDICINE

THE PROPOSED RULE WILL ALLOW PROPERLY QUALIFIED NUCLEAR PHARMACISTS AND AUTHORIZED USERS GREATER DISCRETION IN PREPARING RADIOACTIVE DRUGS DITHOUT SUBMITTING AN APPLICATION.

1 ALLOWANCE LETTER: NO FUNCTION: ON PLAN: NO EXCEED BUDGET: NO 3504(H): NPRM NO. OF FORMS: I USE: PUBLIC REQUEST: REINST i RESPONDENTS: 249 RESPONSES: 5,360 HOURSp#240 AFFECTED PUBLIC: STATE /LCL GOV E BUS / INST C NON-PROFIT INST / SMALL BUSINESS: YES ACTIVITY TYPE: PURPOSE: REG / COMP FREQUENCY: OCCAS C QTLY G ANNL L OTHER COLLECTION METHOD: MAIL S/A RETENTION: COLLECTION AGENT: RCDKPNG RQT CONFIDENTIALITY: NO COMPULSORY STATUS: MANDATORY FEDERAL COST: PUBLIC COST: REVIEWER: Ron Minsk i = - =- ACTION 1 AUTHORIZING OFFICIAL !IITLE: DEPUTY ADMINISTRATOR!DATE APPROVED BY: !/S/ JAMES B. MACRAE FOR ! OFFICE OF INFORMATION 108/18/93 1 !AND REGULATORY AFFAIRS AMPORTANT: BECAUSE THIS INFORMATION COLLECTION HAS BEEN APPROVED, PLEASE SEND TO THE 0.M.B. AS SOON AS AVAILABLE: UNE COPY OF THE FINAL PRINTED (OR OTHERWISE REPRODUCED) REPORT FORM, OR REPORTING OR RECORDKEEP ING REQUIREMENT, TRANSMITTAL LETTER, INSTRUCTIONS, AND ANY DOCUMENT dEING SENT TO EACH RESPONDENT.

NOTICE OF OFFICE OF MANAGEMENT AND BUDGET ACTION t_ i s ) TO: BRENDA JO SHELTON (MNBB-7714) ACTION DATE NRC CLEARANCE OFFICER U.S. NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555 Nuclear Reguldtory Commission 08/L8/93 ON 06/07/93, YOU REQUESTED APPROVAL OF THE FOLLOWING INFORMATION COLLECTION: TITLE: MEDICAL USE OF BYPRODUCT MATERIAL _-- 10 CFR PART 35 AGENCY FORM NOS.: IN ACCORDANCE WITH THE PAPERWORK REDUCTION ACT, WE HAVE T AKEN THE FOLLOWING ACTION ON THIS INFORMATION COLLECTION: APPROVED FOR USE THROUGH 08/31/96. OMB NO. 3150-0010. THE OFFICE OF MANAGEMENT AND BUDGEI CONTROL NUMBER MUST BE DISPLAYE0 IN ACCOR0ANCE WITH 5 CFR 1320. UNLESS OTHERWISE PROVIDED IN " REMARKS," EXPIRATION OATES MUST ALSO BE DISPLAYED AS REQUIRED BY 5 CFR 1320 EFFECT ON BURDEN: RESPONSES REPORTING HOURS PREVIOUS STATUS d,422.955 18,788 NEW STATUS ST422e955 ~.. -302-,944 0 284,155I' DIFFERENCE EXPLANATION OF DIFFERENCE: ADJUSTMENTS j CORRECTICN-ERROR 0 0 i CORRECTION-REESTIMATE O 284,156 CHANGE IN USE O O PROGRAM CHANGES i INCREASE O O l i OECREASE O O AEMORKS: i I I I

NOTICE OF OFFICE OF MANAGEMENT AND BUDGET ACTION PAGE 2 OMB NO. 3150-0010 ABSTRACT: ' RADIATION SAFETY, RADI0 ACTIVE DRUGS, NUCLEAR MEDICINE, BYPRODUCT MATERIAL' THE PROPOSED RULE WILL ALLOW PROPERLY QUALIFIED NUCLEAR PHARMACISTS AND AUTHORIZES USERS GREATER DISCRETION IN PREPARING RADIOACTIVE ORUGS WITHOUT SUBMITTING AN APPLICATION. j ALLOWANCE LETTER: NO FUNCIION: ON PLAN: NO EXCEED BUDGET: NO 3504(H): NPRM NO. OF FORMS: I USE: PUBLIC REQUEST: REVISION RESPONDENTS: 2,400 RESPONSES: a,422,955 HOURS: 302,944 AFFECTED PUBLIC: STATE /LCL GOV E BUS / INST C NON-PROFIT INST SMALL BUSINESS: YES ACTIVITY TYPE: PURPOSE: REG / COMP FREQUENCY: OCCAS & OTHER COLLECTIOh METHOD: RKP RQT RETENTION: 5 YRS COLLECTION AGENT: RCDKPNG RQT CONFIDENTIALITY: NO COMPULSORY STATUS: MANDATORY FEDERAL COST: 51,120 PUBLIC COST: REVIEWER: Ron Minsk l i ACTION ! AUTHORIZING OFFICIAL ! TITLE: DEPUTY ADMINISTRATOR!DATE APPROVED dY: !/S/ JAMES d. MACRAE FOR ! OFFICE OF INFORMATION 108/18/93 1 !AND REGULATORY AFFAIRS 1 IMPORTANT: DECAUSE THIS INFORMATION COLLECTION HAS BEEN APPROVED, PLEASE SEND 10 THE O.M.B. AS SOON AS AVAILABLE: ONE COPY OF THE FINAL PP.INTED (OR OTHERWISE REPRODUCED) REPORI FORM, OR REPORTING OR RECOROKEEPING REQUIREMENT, TRANSMITTAL LETTER, INSTRUCTIONS, AND ANY DOCUMENT BEING SENT TO EACH RESPONDENT.}}

ML20057B212

Contents

Text

Dear Workshop Participant:

Enclosures:

Dear Dr. Kessler:

Dear Chairman salin:

SUBJECT:

Dear Dr. Kessler:

Dear Mr. Chairman:

Enclosure:

Dear Mr. Chairman:

Enclosure:

Dear Mr. Chairman:

Enclosure:

Background

Response

SUMMARY

Response

Response

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ML20057B212

Text

Dear Workshop Participant:

Enclosures:

Dear Dr. Kessler:

Dear Chairman salin:

SUBJECT:

Dear Dr. Kessler:

Dear Mr. Chairman:

Enclosure:

Dear Mr. Chairman:

Enclosure:

Dear Mr. Chairman:

Enclosure:

Background

Response

SUMMARY

Response

Response

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