ML20057F813
| ML20057F813 | |
| Person / Time | |
|---|---|
| Issue date: | 08/06/1993 |
| From: | Glenn J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Surmeier J NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA) |
| Shared Package | |
| ML20057F790 | List: |
| References | |
| NUDOCS 9310190176 | |
| Download: ML20057F813 (2) | |
Text
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og UNITED STATES.
NUCLEAR REGULATORY COMMISSION..
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AUG ' 61993 HEMORANDUM FOR:
John J. Sormeier, Acting Assistant Director State Agreements Program Office of State Programs FROM:
John Glenn, Chief Medical, Academic, and Commercial Use' Safety Branch Division of Industrial and Medical Safety, NHSS q
SUBJECT:
PRODUCT LICENSE A'PPROVAL (PLA)-
This letter is in response to a letter.NMSS received from a Dr. Melvin Fisher of Cytogen Corporation dated March 30, 1993, regarding an-oversight in NRC..
regulations. Cytogen recently received a Product License Approval.(PLA)~from L
the FDA for its cancer imaging agent Oncoscint CR/0V, radiolabeled with In-mechanism}llisanacceleratorproducedradioisotope.
PLA is an'FDA approval 111.
In-functionally equivalent to the NDA, issued from the Center for Biologics Evaluation and REsearch. The NRC regulations in_10 CFR Part 35:are
't silent on Product License Applications (PLA). The Agreement States have followed the NRC's lead, and are also silent on PLA's.
In' June 1989, the Society of Nuclear Medicine and America College of Nuclear Physicians petitioned NRC to reduce certain regulatory' restriction', and to allow the use of radioactive biologicals. As a result, NRC published a-proposed rule in June-1993 to address, among other things, the-PLA issue. 'The proposed rule language for 10 CFR Part 35.200 is:
35.200 Use of unsealed byproduct material for imaging and localization studies.
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l A licensee may use for imaging and localization studies any unsealed byproduct material prepared for a medical use that is either:
(a) Obtained from a manufacturer or preparer oli_ censed pursuant to 10 CFR 32.72 or equivalent
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Agreement State requirements; or (b) Prepared by'an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in 35.920, or an individual under the supervision'uf either as specified in 35.25.
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9310190176.930922 PDR STPRC ESGCEN PDR;
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John J. Surmierer l j
j This will eliminate the issue of NRC regulatory silence on PLA's.
Since it i
L is no longer necessary to reference any FDA approval mechanisms.
I This staff has discussed the Cytogen letter with' members of your staff, who in turn have discussed it with the NRC's Agreement States.
As a result of these
-discussions, the RII Agreement State Officer distributed a Bulletin by the State of Georgia to its Medical Licensees, to all Agreement States within Region II. This. Bulletin specifically addresses how medical licensees in Georgia may amend their radioactive materials licenses to utilize Oncoscint CR/0V.
A further development of these discussions concerning Agreement State regulation of PLA's, is that Part G, "Use of Radionuclides in the Healing Arts Committee (SR-6)" of the Council of Radiation Control Program Directors i
(CRCPD) penned an article on the regulatory problems associated with Oncoscint CR/0V for the CRCPD Newsletter published in April or May 1993 and dis,tributed to Agreement States.
In summary, the NRC does not regulate the medical use of In-lll, but we request that you inform the Aareement State Procram Directors of the proposed regulatory amendments which will address the PLA issue.
This office encourages the Agreement States to allow the use of PLA's through whatever mechanism is most efficient for each state.
Biological products are controlled by the Public Health Service Act (PHS Act)(42 U.S.C. 262), the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301 et. seq.) and the regulations promulgated thereunder.
The PHS'Act requires that biological products be licensed before their sale, barter, or exchange in interstate commerce. The Bureau of Biologics of the Food and Drug Administration is responsible for licensing biological products.
To be licensed, an investigational biological product must be developed and tested to ensure that it is safe, pure, potent, and effective.
A biological product undergoing development is subject to the investigational new drug regulations prescribed in 21 CFR 312.1 and 601.21..."
John E. Glenn, Chief Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety, NMSS
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