Drug Production Activities of Pharmacies, Physicians, Federal Facilities and Outsourcing Facilities

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Some pharmacies, federal facilities, physicians, and outsourcing facilities engage in various drug production activities that may not be addressed in sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The following table lists current FDA draft and final guidance documents addressing some of these activities.

Note that although most of the drug production activities described below are not addressed in sections 503A or 503B, such as repackaging, in certain cases FDA’s guidances indicate the agency generally does not intend to object to these activities provided that certain conditions are met.

Drug Production Activity  Addressed in Section 503A? Addressed in Section 503B? FDA Draft or Final Policy Documents
Compounding human drugs Yes Yes Multiple guidances, for example:
Repackaging human drugs No No Final guidance: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
Mixing, diluting, or repackaging biological products No No Final guidance: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
Compounding radiopharmaceuticals Provision excludes radiopharmaceuticals from its scope. Provision does not explicitly exclude radiopharmaceuticals Draft guidances:
Repackaging radiopharmaceuticals No No


Page Last Updated: 06/22/2018
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