340B Drug Pricing Program; Administrative Dispute Resolution Regulation
other · US Department of Health and Human Services · Rule · Published 2020-12-14 · Effective 2021-01-13 · 85 FR 80632
Document
Document number
2020-27440
Federal Register citation
85 FR 80632
CFR reference
42 CFR 10
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
2020-12-14
Effective date
2021-01-13
Abstract
The Health Resources and Services Administration (HRSA) implements section 340B of the Public Health Service Act (PHSA), 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.