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HHS/FDA RIN: 0910-AF89 Publication ID: Fall 2020 
Title: Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph 
Abstract:

The final rule amends FDA regulations on fixed-combination prescription and over-the-counter (OTC) drugs. 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 final rule harmonizes the combination drug requirements into a single set of regulations for both prescription and OTC combination drugs and codifies existing policy on what kinds of studies are needed to show that the combination drug requirements are met. The final rule also applies these regulations to combinations of biological drug products and to drug-biological product combinations; clarifies application of FDA's requirements regarding fixed combinations to certain natural source drugs and certain synthetic drugs; establishes circumstances under which the Agency might waive the combination requirements for a particular drug or biological product; and addresses 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: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
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
Timetable:
Action Date FR Cite
NPRM  12/23/2015  80 FR 79776   
NPRM Comment Period End  03/22/2016 
NPRM Comment Period Reopened  04/18/2016  81 FR 22549   
NPRM Comment Period Reopened End  05/18/2016 
Final Rule  06/00/2021 
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:
Diana Pomeranz
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, Building 51, Room 6288, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:240 402-4654
Fax:301 847-8440
Email: diana.pomeranz@fda.hhs.gov