Data / Federal rules / 2025-24153
Statutory Updates to Branded Prescription Drug Fee Regulations
The Internal Revenue Service published this proposed rule in the Federal Register on January 2, 2026. Comments closed on March 3, 2026.
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What the agency says
This document proposes amendments to regulations regarding the annual fee imposed on covered entities engaged in the business of manufacturing or importing certain branded prescription drugs. In response to the replacement of the Coverage Gap Discount Program with the new Manufacturer Discount Program by the Inflation Reduction Act of 2022, the proposed regulations would make updates regarding the discounts, rebates, and other price concessions used to determine branded prescription drug sales under Medicare Part D and would update for prior statutory changes. These proposed regulations would affect persons engaged in the business of manufacturing or importing certain branded prescription drugs.
Key facts
- Document number
- 2025-24153
- Type
- Proposed rule
- Action
- Notice of proposed rulemaking
- Agency
- Treasury Department; Internal Revenue Service
- Published
- January 2, 2026
- Comments due
- March 3, 2026
- Dates
- Written or electronic comments and requests for a public hearing must be received by March 3, 2026. Requests for a public hearing must be submitted as prescribed in the "Comments and Requests for a Public Hearing" section.
- Docket
- REG-103430-24
- Regulation ID (RIN)
- 1545-BR16
- Code of Federal Regulations
- 26 CFR 51
- Topics
- Drugs; Reporting and recordkeeping requirements
- Pages
- 5
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Everything from the Internal Revenue Service · Rules on drugs · Rules on reporting and recordkeeping requirements · Published in January 2026
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.