Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry

Issue Date: September 26, 2018
Issued by: Center for Drug Evaluation and Research
Topic(s): Compounding
Status: Final

Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry

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.

Download the Guidance Document