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HHS/FDA | RIN: 0910-AH29 | Publication ID: Fall 2015 |
Title: ●List of Bulk Drug Substances that May Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act | |
Abstract:
FDA is developing a list of bulk drug substances that may be used to compound drug products under section 503A of the Food, Drug, and Cosmetic Act. This list will identify drug substances that are not the subject of an applicable United States Pharmacopeia or National Formulary monograph, or a component of an FDA-approved drug, that may be used in compounding under section 503A. This proposed rule will identify the criteria for evaluating bulk drug substances for inclusion on the list. It will propose an initial set of substances for inclusion on, and exclusion from, the list. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 216.23 | |
Legal Authority: 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 353a 21 U.S.C. 353b 21 U.S.C. 355 21 U.S.C. 371 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: James Flahive Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, Building 51, Room 5197, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-9293 Email: james.flahive@fda.hhs.gov |