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GUIDANCE DOCUMENT

Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry September 2018

Final

Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry

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.
 


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.