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GUIDANCE DOCUMENT

Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance June 2016

Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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 held unconstitutional by the U.S. Supreme Court in 2002 (see section II below). Several parts of section 503A require rulemaking and consultation with a Pharmacy Compounding Advisory Committee to implement. This guidance explains how the provisions will be applied pending those consultations and rulemaking. This guidance also describes some of the possible enforcement actions FDA can bring against individuals or firms that compound drugs in violation of the FD&C Act.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.