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# FDA Proposes to Revise Rx Fixed-Combo Drug Regs
- URL: https://www.fdaweb.com/fda-proposes-to-revise-rx-fixed-combo-drug-regs/
- Published: 2016-01-04T12:00:00.000Z
- Updated: 2026-09-15T02:24:15.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134325

*Federal Register* Proposed rule: FDA is proposing to revise its regulations on prescription fixed-combination drugs to apply the regulations to both prescription and nonprescription fixed-combination and co-packaged drugs and combinations of active ingredients under consideration for inclusion in an over-the-counter monograph. These products must meet specific evidentiary requirements for approval. The proposed revisions would harmonize the requirements for prescription and nonprescription products and make them consistent with long-standing agency policy. To view this proposed rule, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2015-12-23/pdf/2015-32246.pdf?ref=fdaweb.com)