340B Drug Pricing Program; Administrative Dispute Resolution

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 proposed rule will apply to all drug manufacturers and covered entities that participate in the 340B Program. The proposed rule sets forth the requirements and procedures for the 340B Program's administrative dispute resolution process.