340B Drug Pricing Program; Administrative Dispute Resolution Regulation
other · US Department of Health and Human Services · Rule · Published 2024-04-19 · Effective 2024-06-18 · 89 FR 28643
Document
Document number
2024-08262
Federal Register citation
89 FR 28643
CFR reference
42 CFR 10
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
2024-04-19
Effective date
2024-06-18
HHS docket
Docket No. 2021-0004
Abstract
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.