FDA Guidance - Pharmacy Compounding of Human Drug Products

Draft Guidance - Pharmacy Compounding of Human Drug Products Under Section 2 503A of the Federal Food, Drug, and Cosmetic Act

This guidance announces FDA‟s intention with regard to enforcement of section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 353a) to regulate entities that compound drugs, now that section 503A has been amended by Congress to remove the advertising and solicitation provisions that were struck down as unconstitutional by the U.S. Supreme Court in 2002. Several parts of section 503A require rulemaking and consultation with a Pharmacy Compounding Advisory Committee to implement. This guidance explains how those provisions will be applied pending those consultations and rulemaking. It also describes some of the possible enforcement actions FDA may bring against individuals or firms that compound drugs in violation of the FD&C Act. This guidance does not apply to registered outsourcing facilities under section 503B of the 26 FD&C Act. Guidance for outsourcing facilities has been issued separately. See Guidance 503A and guidance 503B.

For details see: Guidance 503A and Guidance 503B

Posted by Tim Sandle