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HHS/FDA | RIN: 0910-AH81 | Publication ID: Spring 2018 |
Title: Amendments to the Final Rule Regarding the 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 | |
Abstract:
This proposed rule proposes to add additional bulk drug substances to the list of bulk drug substances that may be used to compound drug products that qualify for the exemptions in section 503A of the FD&C Act (the List). Currently, the only bulk drug substances that may be used to compound drugs that qualify for the section 503A exemptions are those that are the subject of an applicable United States Pharmacopeia or National Formulary monograph, a component of an FDA-approved drug, or those that FDA has already placed on the List. This proposed rule will identify approximately 30 additional bulk drug substances nominated by stakeholders for the List and explain whether FDA proposes the substance be included on the List. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
EO 13771 Designation: Regulatory | |
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. 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 |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Rosilend Lawson Regulatory Counsel Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Avenue, Building 51, Room 5197, Silver Spring, MD 20993 Phone:240 402-6223 Email: rosilend.lawson@fda.hhs.gov |