View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML
HHS/FDA RIN: 0910-AF89 Publication ID: Fall 2007 
Title: Regulations on Fixed-Dose Combination and Co-Packaged Drug and/or Biological Products 
Abstract: The proposed rule would amend FDA regulations on fixed-combination prescription and OTC drugs. The current regulations require, among other things, that the sponsor of a fixed-combination drug demonstrate that each of the components makes a contribution to the drug’s claimed effects. The proposed rule would create a single set of regulations for prescription and OTC combination drugs and codify existing policy on what kinds of studies are needed to show that the combination drug requirements are met. The proposed rule also would apply these regulations to combinations of biological drug products and to drug-biological product combinations. In addition, the proposed rule would clarify application of FDA’s requirements regarding fixed-dose combinations to certain natural source drugs and certain synthetic drugs. The regulation would also establish circumstances under which the agency might waive the combination requirements for a particular drug or biological product. The proposed rule will also address the issue of co-packaging. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 300.50    21 CFR 330.10    21 CFR 610.17   
Legal Authority: 21 USC 331    21 USC 351    21 USC 352    21 USC 355    21 USC 371    42 USC 262    42 USC 264   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  06/00/2008    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Brian L. Pendleton
Senior Policy Advisor
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Office of Policy, WO 32, Room 4250, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-4614
Fax:301 847-3541
Email: brian.pendleton@fda.hhs.gov