Docket Number:
FDA-2016-D-4317
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance sets forth the FDA’s policy regarding compounding and repackaging of
radiopharmaceuticals for human use by entities that are registered with FDA as outsourcing
facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act).
This guidance describes how FDA generally intends to apply section 503B of the FD&C Act to
radiopharmaceuticals compounded by outsourcing facilities. It also describes the conditions under
which FDA generally does not intend to take action for violations of sections 505 and 502(f)(1) of
the FD&C Act when an outsourcing facility repackages radiopharmaceuticals.
 

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