Final Rule: 340B Drug Pricing Program; Administrative Dispute Resolution Regulation

The provisions of this final rule include a process to resolve (1) claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers and (2) claims by manufacturers, after the manufacturer has conducted an audit of a covered entity as authorized by section 340B(a)(5)(C) of the Public Health Service Act, that a covered entity has violated the prohibition on diversion or duplicate discounts.  HRSA will post the final rule on the 340B Drug Pricing Program website.