Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

This information collection supports FDA guidance regarding compounding and repackaging of radiopharmaceuticals for human use by state-licensed nuclear pharmacies, Federal facilities, or other facilities that are not outsourcing facilities and that hold a radioactive materials license for medical use issued by the Nuclear Regulatory Commission or by an Agreement State compounds or repackages radiopharmaceuticals for human use that are not registered as outsourcing facilities. Because these radiopharmaceuticals are not eligible for exemptions from provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to drug production, FDA developed guidance to describe conditions under which the Agency does not intend to take action for violations of sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C Act when a state-licensed nuclear pharmacy or a federal facility that is not an outsourcing facility compounds or repackages radiopharmaceuticals for human use.

The latest form for Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act expires 2021-08-31 and can be found here.