Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry September 2018
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
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-2016-D-4317.