# List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act
> **Food and Drug Administration** · Final rule. · Published 2019-02-19 · Effective 2019-03-21 · 84 FR 4696
## Document
- **Document number:** 2019-02367
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 84 FR 4696
- **CFR reference:** 21 CFR 216
- **Publication date:** 2019-02-19
- **Effective date:** 2019-03-21
- **HHS docket:** Docket No. FDA-2016-N-3464
## Abstract

The Food and Drug Administration (FDA or the Agency) is issuing a final rule to establish criteria for and identify an initial list of bulk drug substances that can be used to compound drug products in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs. Specifically, the Agency is placing six bulk drug substances on the list. This final rule also identifies four bulk drug substances that FDA has considered and is not including on the list. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of a future rulemaking.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2019/02/19/2019-02367/list-of-bulk-drug-substances-that-can-be-used-to-compound-drug-products-in-accordance-with-section)
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