ML19325D144
| ML19325D144 | |
| Person / Time | |
|---|---|
| Issue date: | 09/28/1988 |
| From: | Thompson H NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Schlegel J AMERICAN PHARMACEUTICAL ASSOCIATION |
| Shared Package | |
| ML19325D099 | List: |
| References | |
| RULE-PRM-35-9 NUDOCS 8910190062 | |
| Download: ML19325D144 (5) | |
Text
.
$k a
r SEP t 81988 I
l
(
John F. Schlegel, Pharn.D.
President i
American Pharmaceutical Association 2215 Constitution Avenue, N.W.
Washington, D.C.
20037
Dear Dr. Schlegel:
Your letter of September 13, 1988, to Lando W. Zech, Chairman of the U.S.
Nuclear Regulatory Comission (NRC), concerning requirements for the medical i
L use of byproduct material radiopharmaceuticals has been referred to me for response.
Our regulations in 10 CFR 35.100, 35.200, and 35.300 allow authorized user physicians to administer only radiopharmaceuticals for which the Food and Drug Administration (FDA) has accepted a " Notice of Claimed Investigational I
Exemption for a New Drug" (IND) or approved a "New Drug Application" (NDA).
As you correctly concluded, the purpose of these requirements is to protect the public health ano safety by authorizing only FDA-approved radiopharmaceuticals i
for medical use.
The NRC relies on FDA's programs to evaluate new radiopharma-I cauticals for safety and effectiveness under its IND and NDA regulations, to monitor the administration of radiopharmaceuticals in medical research under the IND regulations, and to monitor the manufacture and product quality of NDA radiopharmaceuticals during its " good manufacturing practice" (GMP) inspections.
We are currently unaware of state boards of pharmacy that duplicate FDA's vvaluation, monitoring, and inspection functions in a similar manner to the l
Agreement States' duplication of the NRC's regulatory activities in their States.
We would welcome specific information on the training of nuclear pharmacists, requirements for certification by the Board of Pharmaceutical Specialties, the I
extent of state boards of pharmacy regulatory programs, and other areas that you believe shoul' be considered regarding this issue.
The NRC Medical and d
Academic Section staff is prepared to meet with you to discuss your concerns and explore whether there are ways of resolving those concerns compatible with our mandate to protect the public health and safety.
Please call Donna-Beth l
Howe, Ph.D., of the Medical and Academic Section at 492-0636 for further coordination.
Thank you for your interest in our regulatory program.
SincereJy, i
J/
Hugh L. Thompson, Jr., Director Offi.e of Nuclear Material Safety end Safeguards l
cc:
Dr. Alfred E. Jones, TDA l
8910390062 890605 PDR PRM 35-09 PDR I
O
j
~
u l
John F. Schlegel, Pharm. D.
2.'
L 1
i.
DISTRIBUTION: (EDO0003958)
ImM5 central File NMSS r/f g
p3MA8 r/f 08 howe NLMcElroy-
)
VLM111er
.l GSjoblem Director's Office r/f i
CJenkfns-l V
Eleckjord NRC File Center i
i c
J t
o 0FC: IMAB
- IMA5
- IMA
- IMM MN5
- NM55
- NM55
........ j........
.e....
NAME:DBH We/11:NLMc roy:JH tin:G:
- REcu gham:RBernero:HTh DATE:09/a5/88 :09AD/88 :09/h3/88:09/N/88:09/M88
- 09/4/88:09A 88
~
OFFICIAL RECORD COPY 4
e n
-,--w----w,
,v' - - - - - ~ ~ - * ' - ' " " - ~ ' ' = ' ' = ~ ~ ' ' ' ' ' ' '
" ' ' * * ' ' ' ' ' ' * * * " * * " " * * ~ ~ ' " " ~ ~ ~
i
}
, & w,\\
e a. w.
y. ~,. 9..9 ;;,.,.
..,, y, ;,.,y Ulst?t38?Afts f
NUCLEAR REGULATORY COMM18810N t
anssenestose;e.c.ssess
,.[ --
EDO Principal Corresponalence Control
+
.h.j...~.
8 a
.. + o.' : 3 -
i
- .v.
i FROM8 DLEa 09/30/M*$
EDO CONTROLa 0003930 >8 DOC DTe 09/.13/SF F1NAL REPLY JOHN F. SCHLESEL, PRESIDENT l
AMRICAN. PHARMACEUTICAL ASSOC.
{
N
-r.' '. h..~
.. R.
7 r
TG8
- t
$, n*.. 7 4,.3<
.g ;
, < *v ny,
~-
sc.,+-
. i..
CHAIRPWM ZECH a.
s 1
u 4.
y
. (%.'tL. CRC NEk-FOR SIONATURE OF..
88 SRN 8 9..
- T
^
7
'y-J.*
' "- :;. ' 4: ]:"1 -
%l
~
TNoMpeastN 9,
~, r.~
u
'~ ;. i.:. J -
i
.;.m*N.*;:.?.w.silc D M M..r..
44
+
CONCERNS: THAT. NUCLEAR' PHARMACISTS ARE.PS
[
DLE TSRERAAttole CP 10. CFR PART 3Fi'? *.e p
i 1.
. te-
~-
t,
..e f Q s.' YD * *,, s.,
CATES.09/16/09.
-r p
e-
' ~, I ASSISMIVTO's CONTACTe
~
I NMSS THOMPRON v
. Nj'::
3PECIAL-INSTRUCTIONS OR REMARKSa L
....=====rM I
l Z;ws Action l
l Due to NMS Director's Office gY 9.27 TV i
l ad Wa/re n
f b
4
.,.4 L
i l
0FFICE OF THE SECRETARY CORRi'3DONDENCE CONTROL TICKET
<PER NUMBER:
CRC-88-Ov34 LOGGING DATE: Sep 15 88 ACTION OFFICE:
.EDO j
AUTHOR:
J.F. Schlegel AFFILIATION:
DC (DISTRICT OF COLUNBIA)
LETTER DATE:
Gap 13 88 FILE CODE: ID&R-14 Pt 35
)
SUR7ECT:
NRC regulation 10 CFR 35.100, 35.2000, and 35.3000 pertaining to nuclear pharmacists
)
1 ACTION:
Direct Reply
)
DISTRIBUTION:
I SPECIAL MANDLING: None l
r NOTES:
DATE DUE:
Sep 23 88 SIGNATURE:
DATE SIGNED:
AFFILIATION:
8 e
nee'd 011. 00 y
DM -
l 30 p Tix.c _--
k 00--0 039 5 6
+
.--..-.----..----.-----Al
"Lf:Q ' _ MRJ '
M
~
-m;~
~;
man _
_4,,,,
i,
i >
a XViv.
f1..
[
4
/ \\
h g
4 d
h t'
i
~.
h
,5
- i 1
r,k j
$bikkd4*L en_.m_
,,____________,__,_,,._()
j
,__ _, __. _ _ _. _ _ _..