Data / Federal rules / 2024-08262
340B Drug Pricing Program; Administrative Dispute Resolution Regulation
The Health and Human Services Department published this final rule in the Federal Register on April 19, 2024. It took effect on June 18, 2024.
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What the agency says
The Health Resources and Services Administration administers section 340B of the Public Health Service (PHS) Act, which is referred to as the "340B Drug Pricing Program" or the "340B Program." This final rule will apply to all drug manufacturers and covered entities that participate in the 340B Program. The final rule sets forth the requirements and procedures for the 340B Program's administrative dispute resolution (ADR) process. This final rule revises the 340B administrative dispute resolution process set forth in the Code of Federal Regulations.
Key facts
- Document number
- 2024-08262
- Type
- Final rule
- Action
- Final rule
- Agency
- Health and Human Services Department
- Published
- April 19, 2024
- Takes effect
- June 18, 2024
- Dates
- This final rule is effective June 18, 2024.
- Docket
- Docket No. 2021-0004
- Regulation ID (RIN)
- 0906-AB28
- Code of Federal Regulations
- 42 CFR 10
- Topics
- Biologics; Business and industry; Diseases; Drugs; Health; Health care; Health facilities; Hospitals
- Significant
- Yes, under Executive Order 12866
- Pages
- 17
Other documents from the Health and Human Services Department
Everything from the Health and Human Services Department · Rules on biologics · Rules on business and industry · Rules on diseases · Published in April 2024
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.