Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability.
other · Food and Drug Administration · Rule · Published 2016-06-10 · 81 FR 37502
Document
Document number
2016-13799
Federal Register citation
81 FR 37502
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-3517
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act." The guidance describes FDA's interim regulatory policy regarding the use of bulk drug substances by licensed pharmacists in State-licensed pharmacies or Federal facilities and by licensed physicians to compound human drug products while FDA develops the list of bulk drug substances that can be used in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).