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HHS/FDA | RIN: 0910-AI88 | Publication ID: Spring 2024 |
Title: ●Amendments to the Current Good Manufacturing Practice Regulations for Drug Products | |
Abstract:
FDA is proposing to amend the Current Good Manufacturing Practice Regulations for Drug Products. The proposed amendment will clarify and modernize the regulations by adding requirements for quality management systems and controls over components and drug product containers and closures. |
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Agency: Department of Health and Human Services(HHS) | Priority: Section 3(f)(1) Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Yes | Unfunded Mandates: Private Sector |
CFR Citation: 21 CFR 210 21 CFR 211 | |
Legal Authority: 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 355 21 U.S.C. 360b 21 U.S.C. 360bbb-7 21 U.S.C. 371 21 U.S.C. 374 42 U.S.C. 262 42 U.S.C. 264 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: YES | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: Yes | |
Agency Contact: Ashley Boam Health Science Administrator Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, Building 51, Room 4192, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-6341 Email: ashley.boam@fda.hhs.gov |