Section 503A Bulks List Final Rule Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability
other · Food and Drug Administration · Rule · Published 2019-05-24 · 84 FR 24027
Document
Document number
2019-10953
Federal Register citation
84 FR 24027
CFR reference
21 CFR 216
Type
Rule
Action
Notification of availability.
Category
other
Sub-agency
Food and Drug Administration
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).