ML19325D181
| ML19325D181 | |
| Person / Time | |
|---|---|
| Issue date: | 08/11/1988 |
| From: | Mcelroy N NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Barrall R ILLINOIS, UNIV. OF, CHICAGO, IL |
| Shared Package | |
| ML19325D099 | List: |
| References | |
| RULE-PRM-35-9 NUDOCS 8910190126 | |
| Download: ML19325D181 (2) | |
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AUG 111910 Mr. Raymond C. Barra11 Director. Radiation Protection The University of Illinois at Chicago 33g Clinical Sciences - North Wing Boa 6gge Chicago, IL 60680
Dear Mr. Barrell:
This is in response to your letter of May 23. 1988, to Donna-Beth Nowe Ph.D.,
asking if the NRC regulations permit or prehtbit a licensee with a Type A specific license of broad scope from preparing and using their een radiophamaceutical kits.
Specifically you'ested whether an MC licensee could fabricate and use hits that have neither en accepted " Notice of Claimed Investigational Esemption for a New Drug' (15) nor an approved "New Orve Application * (RDA). but are based on the composition formulation found in US Food and Orv; deinistration (FDA) i approved kits.
t The NRC does not evaluate the safety and efficacy of dmes or approve drugs for human use. The FDA makes this detemination. We refer all such matters to the FDA for clarification. We understand that you have written FDA to
-determine whether the situation you described complies with their regulatory requirements'and " meets with FDA approval."
The NRC authorizes its licensees to prepare and use only reagent kits that are -
the subject of an accepted 1 2 or an approved NOA. These kits are authorized for use under 10 CFR Part 35 regulations and need ne further licensing action.
The only non-INO and non-NOA reagent kits and radiophamaceuticals NRC licensees may use are those used in studies that meet all the.21 CFR'Part 361.1 FDA requirements and that are approved by the Radioactive Drug Research Comeittee.
These are authorized in MC License Item g.." Authorized Use.' Specifically, t -
the authorization to " conduct medical research' is used to express this authorization in the broad-scope medical license.
7 Your non-IND and non-WA reagent kits do'not appear to be approved under 21 CFR 361.1.
If you were an NRC licensee, you would not be permitted to use these o
reagent. kits.
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In the past, the NpC has been asked whether. the Radiation Safety Committee of a NRC medical use 'sicensee with a Type A specific license of broad scope can L,
approve the medical.use of the non-INO and non-NOA reagent kits and L
radiophamaceuticals. We believe the answer to this question is pertinent to your request. The functions of the Committee are outlined in 10 CFR Parts 33 o
and 35. The Committee's primary responsibility is to oversee the organization's radiation safety program.
Nothing in these regulations provides the Committee the authority to approve diagnostic imaging with non-IND or non-NOA reagent kits and radiopharmaceuticals.
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Mr. Raymond C. Barrell 2
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- I hope this information' clarifies the NRC policy on this matter.
If you have i
any questions feel free to contact Donna.Seth Howe Ph.0.. of my staff at (301) 492 0636.
original Siped Bf Norman L IkOfW s
Norman L. McElroy. Section Leader Medical and Academic Section Medical. Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety
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l NAME:08 Howe /11 :lt.McElroy: ATreby DATE:08/ /88 :08//S/88:08/'l/88 IJFFICIAL RECORD COPY f
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b MEMORAN0(St FOR Donald A. Nussb'aumer, Assistant Director i
for State Agreements Program State, Local and Indian Tribe Programs, GPA t
.FROM:
Richard E. Cunningham, Director Division of Industrial and l
Medical Nuclear Safety, l#t55 l
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$USJECT:
APPROVAL 0F NON-IN0/NDA RA0!0PHARMACELITICAL5 This is in response to your memorandum of April 19, 1988, concerning authorization to approve diagnostic imaging and therapy studies involving the use of radioactive drugs not covered by en accepted ' Notice of Claimed Investigational Exemption for a New Drug" (IND) or an approved "New Drug
. Application"-(NOA).
Radioactive Drug Research Committees (RORC) serve a function uhder Food and i
OrugAetnistration(FDA) regulations. Radiation Safety Committees serve a l
function under Nuclear Regulatory Commission (NRC) regulations.
("Numan Subjects Review Committees' are not covered in NRC regulatory requirements).
It has been our understanding in the past that RORC's can approve basic research studies only, and cannot approve diagnostic or therapy studies (see theFDA.enclosedletterpublishedin1985). Your questions pertaining 2 the authority of the Human Subjects Review Comeittee and the Radioactive Drug Reseamh Committee to approve diagnostic imaging and therapy studies for non-INO and non-NOA radioactive drugs is being referred to the FDA for clarification of their drug regulations.
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e The NRC only authorizes its licensees to use radioactive dmgs in accordance with FDA requirements as a matter of administrative policy and as reflected in NRC reislations. Those drugs with an accepted INO or approved NOA are author' zod for use.under 10 CFR Part 35 regulations and need no further i
licensing action.. Those non-INO and non-NOA drugs used in studies that meet n
all the 21 CFR Part 361.1 FDA requirements are approved by the RORC and authorized by NRC License Itan g, " Authorized Use." Specifically,the authorization to
- conduct er, dical research' is used to express ttis authorization in the broad scope medical license, and a specific line item is used for other medical licenses.
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The functions of the Radia' tion Safety Committee of a NRC medical use licensee with a Type A' specific license of broad scope are outlined in 10 CFR Parts 33 and 35. The Consittee's primary responsibility is to oversee the organization's radiation safety program. Nothing in these regulations provides the Committee the authority to approve diagnostic imaging or therapy studies involving the use of non-IND or non-NOA radioactive drugs.
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t Is We will forward the FDA's response to you as soon as we receive it.
If you have any questions feel free to contact Donna-Beth Howe, Ph.D.. of my staff at (301) 492 0636.
Original Signed by Ricurd L Cunningham Richard E. Cunningham. Director Divistoa of Industrial and j
Medical Nuclear Safety.18tSS Esclosure:
As, stated 0157RIBUT!0N: (FC.402)
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