- Docket Number:
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guideline prepared by the Food and Drug Administration's Center for Drugs and Biologics states the criteria for determining when a nuclear pharmacy is required to register as a drug establishment.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-1975-N-0008.