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Program Requirements

Interpretive Rule: Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program (PDF)

Federal Register Notice: Availability of Interpretive Rule 07/23/2014

Federal Register Notice: Availability of Interpretive Rule (PDF - 141 KB) 07/21/2014

Program Integrity

340B Drug Pricing Program covered entities must ensure program integrity and maintain accurate records documenting compliance with all 340B Program requirements.

Covered entities are subject to audit by manufacturers or the federal government. Failure to comply may make the 340B covered entity liable to manufacturers for refunds of discounts obtained.

Learn more: Program Integrity

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