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HHS/FDA RIN: 0910-AF89 Publication ID: Fall 2006 
Title: ●Regulations on Fixed-Combination Drug 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, and it would clarify application of FDA’s combination policy to certain natural source drugs and certain synthetic drugs. The regulation would also establish circumstances under which the agency might waive the combination drug requirements for a particular drug. The proposed rule will also address the issue of co-packaging. 
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: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 300.50   
Legal Authority: 21 USC 331    21 USC 351    21 USC 352    21 USC 355    21 USC 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/00/2007    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: 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