# Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability.
> **Food and Drug Administration** · Notice of availability. · Published 2016-06-10 · 81 FR 37502
## Document
- **Document number:** 2016-13799
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 37502
- **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).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/06/10/2016-13799/interim-policy-on-compounding-using-bulk-drug-substances-under-section-503a-of-the-federal-food-drug)
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