ML19289G112
| ML19289G112 | |
| Person / Time | |
|---|---|
| Site: | Crane  |
| Issue date: | 05/18/1979 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| References | |
| NUDOCS 7906260367 | |
| Download: ML19289G112 (2) | |
Text
_
~
~' '
DRAFT
[: ;
IE Circular 79-Dcte:
Page 1 of CLARIFICAl' ION OF REQUIREMENTS FOR PROCUREMENT, PROCESSING, AND DISTRIBUTION OF RADI0 PHARMACEUTICALS FOR HUMAN USE DESCRIPTION OF CIRCUMSTANCES:
Several radiopharmacists have reported confusion concerning requirecents of the Food and Drug Adminis tration (FDA) and the Nuclear Regulatory Commission (NRC) relative to approved practices for procurecent, processing and distribution of radiopharmaceuticals for human use.
The apparent source of this confusion is a provision of FDA rules and o f some State Pharmacy Laws which allows any phar =acist to use generic che=icals in the manu f acture o f drugs except when such manufacture results in the finished article being a "new drug."
The NRC requires that all procurecent o f radioac tive materials to be used as hu=an use ra d iopha rma c eutic a ls be from suppliers who distribute the product indicated "For Human Use" in accordance with the Federal Food, Drug, and Cosmetic Act.
Th e s e requirements apply to all radiopharmaceuticals in vivo intended for' administration to humans as part of # diagnostic or therapeutic procedures.
The basis for this NRC requirement is a FDA ruling specifying that all radiopharmaceuticals are considered to be "new drugs" for regulatory purposes.
Consequently, exemptions which may authorize any pharmacist to use generic chemicals in the manufacture, processing, or packaging of a drug do not apply to radiophar=aceuticals unless the person preparing the dosage form holds an approved new-drug application (NDA) authorizing such activities.
Some licensees have requested guidance on how to distinguish between " chemical grade" and " phar =aceutical grade" radioactive mate rial.
Chemical grade radioactive materials intended for nee only by holders of approved NDAs or for purposes not involving administration of the product or the radiation therefrom to a hu=an are typically labeled substantially as follows :
" Caution: For Manufacturing, Processing or Repacking.
Pharmaceutica 11y unrefined.
Not tested for sterility or freedom from pyrogens.
Not for human use in present form."
(i E; ;
'5 o
s s.
79062603(g ^
SoiCmW 2 ML_. _.
-5
~
DRAFT
. 2-Holders of approved NDAs further process and test the radioact ive chemicals prior to redistribution.
Th e s e tests are generally beyond the scope of activities of the routine radiopharmacy opera tion.
The redistributed product is generally specifically labeled as intended for human use directly or after a
further processing in accordance with detailed instructions provided in the package insert by the holder o f the NDA.
Such user processing is typically limited to requirements for dilution and /o r final assay prior to administration of the produc t to the patient.
The NRC is aware of at least three licensed radicpharmacies wh ich procured, repackaged, and dis tr ibuted chemical g rade xenon-13 3 ga s.
They had obtained bulk supplies of the gas from a supplier who did not d is t r ibute the preduct in a form sui table for human use.
Two of the rad io ph a rma c ie s were licensed by an Agreement State and one by the NRC.
None o f the radiopha rmacies held FDA approved NDAs for the manuf acture o f Xe-133 radiopharmaceuticals and none cenducted any of the FDA required testing necessary to properly certify that the product was of pha rmaceutical grade and was safe for distribution as a human use radiopharmaceutical.
All licensees engaged in the procurement, processing, and d istribution o f radiopharmaceuticals for human use and all licensees who administer radiopharm-aceuticals to humans should be aware that the FDA exemption which allows pha rma cis ts to use generic chemicals in the ce= pounding of certain drugs does not apply to radiopharmaceuticals and should ensure that all radioactive material procured for the ultimate purpose of administra tion to humans is procured only from suppliers who distribute their product indicated "For Hu=an Use" as described above.
No written response to this Circular is required.
If you require additional in forma tion regarding this subject, c on ta c t the Director of the appropriate NRC Regional of fice.
Enclosure:
,7
)
List of IE Circulars cJi U/U Issued in 1979
_._