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HHS/FDA RIN: 0910-AF89 Publication ID: Spring 2015 
Title: Regulations on Fixed-Dose Combination and Co-Packaged Drug and/or Biological Products 

The proposed rule would amend FDA regulations on fixed-combination prescription and over-the-counter (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; clarify application of FDA's requirements regarding fixed-dose combinations to certain natural source drugs and certain synthetic drugs; establish circumstances under which the agency might waive the combination requirements for a particular drug or biological product; and 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 U.S.C. 331    21 U.S.C. 351 and 352    21 U.S.C. 355    21 U.S.C. 371    42 U.S.C. 262    42 U.S.C. 264   
Legal Deadline:  None
Action Date FR Cite
NPRM  08/00/2015 
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:
Michael Bernstein
Supervisory Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 51, Room 6240, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3478