View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML
HHS/FDA RIN: 0910-AF08 Publication ID: Spring 2005 
Title: Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls 
Abstract: The proposed rule would amend the packaging and labeling control provisions of the current good manufacturing practice regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons. The proposal would also permit the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 211.122   
Legal Authority: 21 USC 351   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/29/1997  62 FR 40489   
Final Action  To Be Determined    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Howard P. Muller
Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440
Email: howard.mullerjr@fda.hhs.gov