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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.

 
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
Timetable:
Action Date FR Cite
NPRM  02/00/2025 
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