Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
other · Food and Drug Administration · Rule · Published 2016-06-10 · 81 FR 37500
Document
Document number
2016-13798
Federal Register citation
81 FR 37500
Type
Rule
Action
Notice of availability.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2016-06-10
HHS docket
Docket No. FDA-2015-D-3539
Abstract
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act." The guidance describes FDA's interim regulatory policy regarding outsourcing facilities that compound human drug products using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).