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.