# 340B Drug Pricing Program; Administrative Dispute Resolution Regulation
> **US Department of Health and Human Services** · Final rule. · Published 2020-12-14 · Effective 2021-01-13 · 85 FR 80632
## Document
- **Document number:** 2020-27440
- **Category:** other
- **Sub-agency:** US Department of Health and Human Services
- **Federal Register citation:** 85 FR 80632
- **CFR reference:** 42 CFR 10
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2020/12/14/2020-27440/340b-drug-pricing-program-administrative-dispute-resolution-regulation)
---
*AI Analytics · CC0 1.0*