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GUIDANCE DOCUMENT

Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment May 1984

Download the Final Guidance Document
Final
Docket Number:
FDA-1975-N-0008
Issued by:
Guidance Issuing Office
Center 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.

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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:

Dockets Management
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.

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