§ 10.3 Definitions.

For the purposes of this part, the following definitions apply:

Administrative Dispute Resolution (ADR) Process means a process used to resolve the following types of claims, including any issues that assist the 340B ADR Panel in resolving claims:

(1) Claims by covered entities that may have been overcharged for covered outpatient drugs purchased from manufacturers; and

(2) Claims by manufacturers of 340B drugs, after a manufacturer has conducted an audit of a covered entity (pursuant to section 340B(a)(5)(C) of the Act), that a covered entity may have violated the prohibitions against duplicate discounts or diversion.