This guidance sets forth the Food and Drug Administration’s (FDA or Agency) interim regulatory
policy concerning compounding using bulk drug substances under section 503A of the Federal Food,
Drug, and Cosmetic Act (FD&C Act or Act). Section 503A of the FD&C Act includes certain
restrictions on the bulk drug substances that can be used in compounding and directs FDA to develop
a list of bulk drug substances that can be used in compounding under that section. FDA is
developing this list of bulk drug substances (the 503A bulks list), and this guidance describes
FDA’s interim regulatory policy for licensed pharmacists in State-licensed pharmacies and Federal
facilities and for licensed physicians that compound human drug products using bulk drug substances
while the list is being developed.
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.