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HHS/FDA | RIN: 0910-AH10 | Publication ID: Spring 2015 |
Title: Regulations on Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act | |
Abstract:
FDA will propose regulations to define and implement certain statutory conditions under which compounded products may qualify for exemptions from certain requirements. |
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Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Long-Term Actions |
Major: Undetermined | Unfunded Mandates: No |
CFR Citation: 21 CFR 216 | |
Legal Authority: 21 U.S.C. 353a 21 U.S.C. 353b 21 U.S.C. 371 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
Small Entities Affected: Businesses | Federalism: Undetermined |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Kalah Auchincloss Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6208, Silver Spring, MD 20993 Phone:301 796-0659 Email: kalah.auchincloss@fda.hhs.gov |