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| HHS/FDA | RIN: 0910-AF89 | Publication ID: Spring 2008 |
| 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 | |
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Legal Deadline:
None |
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Timetable:
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| 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 | |
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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, 10903 New Hampshire Avenue, Building 1, Room 4324, Silver Spring, MD 20993-0002 Phone:301 796-4614 Fax:301 847-3541 Email: brian.pendleton@fda.hhs.gov |
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