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HHS/FDA RIN: 0910-AG20 Publication ID: Spring 2009 
Title: ●Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals 
Abstract: The Food and Drug Administration (FDA) periodically reassesses and revises the cGMP regulations to accommodate advances in technology and other scientific knowledge that further safeguard the drug manufacturing process and the public health. In August 2002, FDA announced the Pharmaceutical cGMPs for the 21st Century Initiative. As part of the Initiative, FDA created a cGMP Harmonization Analysis Working Group to analyze related cGMP requirements in the United States and internationally. The cGMP working group compared 21 CFR parts 210 and 211 with the cGMPs of the European Union, as well as other FDA regulations (such as the Quality Systems Regulation in 21 CFR part 820) to identify differences and consider the value of supplementing or changing the current regulations. Based on the cGMP Working Group's analysis, FDA decided to take an incremental approach to modifying 21 CFR parts 210 and 211. In September of 2008, FDA published a final rule revising the cGMP regulations primarily in the areas of aseptic processing, use of asbestos filters, and verification of operations by a second individual; this final rule represented the culmination of the first increment of modifications to the cGMP regulations. The proposed rule identified on this Unified Agenda would begin the second increment of modifications to the cGMP regulations. 
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: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 210    21 CFR 211   
Legal Authority: 21 USC 321    21 USC 351    21 USC 352    21 USC 355    21 USC 360b    21 USC 371    21 USC 374    42 USC 216    42 USC 262    42 USC 263a    42 USC 264   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  02/00/2010    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Paula Katz
Regulatory Counsel, Office of Compliance
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 4314, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6972
Fax:301 847-8742
Email: paula.katz@fda.hhs.gov