Docket Number:
FDA-2015-D-3539
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance sets forth the Food and Drug Administration’s (FDA or the Agency) interim regulatory
policy concerning compounding by outsourcing facilities registered under section 503B of the
Federal Food, Drug, and Cosmetic Act (FD&C Act or Act) using bulk drug substances. Section 503B
of the FD&C Act includes certain restrictions on the bulk drug substances that outsourcing
facilities can use 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 that list of bulk drug substances
(the 503B bulks list), and this guidance describes FDA’s interim regulatory policy regarding
outsourcing facilities that compound human drug products using bulk drug substances while the list
is being developed.
 

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