# Section 503A Bulks List Final Rule Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability
> **Food and Drug Administration** · Notification of availability. · Published 2019-05-24 · 84 FR 24027
## Document
- **Document number:** 2019-10953
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 84 FR 24027
- **CFR reference:** 21 CFR 216
- **Publication date:** 2019-05-24
- **HHS docket:** Docket No. FDA-2019-D-2011
## Abstract

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "Section 503A Bulks List Final Rule Questions and Answers--Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with the final rule establishing the list of bulk drug substances that can be used in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2019/05/24/2019-10953/section-503a-bulks-list-final-rule-questions-and-answers-guidance-for-industry-small-entity)
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