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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 drugs 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 FDAs 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 4245, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-4614
Fax:301 847-8616
Email: brian.pendleton@fda.hhs.gov

 
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