340B Drug Pricing Program Reporting Requirements

In response to the statutory mandate of section 340B(a)(5)(C) to permit the Secretary or manufacturers to conduct audits of covered entities and because of the potential for disputes involving covered entities and participating drug manufacturers, HRSA developed an informal voluntary dispute resolution process for manufacturers and covered entities who, prior to filing a request for resolution of a dispute with HRSA, should attempt in good faith to resolve the dispute. HRSA published a notice in 1996 and a policy release in 2011 on manufacturer audit guidelines and the informal dispute resolution process (61 FR 65406 (December 12, 1996) and “Clarification of Manufacturer Audits of 340B Covered Entities,” Release No. 2011-3).

The latest form for 340B Drug Pricing Program Reporting Requirements expires 2022-11-30 and is listed under ICR 201909-0915-002.