Today, the Health Resources and Services Administration (HRSA) released a notice of proposed guidance regarding the 340B Drug Pricing Program. The Federal Register version of the guidance is available here. The proposed guidance will be open for public comment for 60 days, through October 27.
This large piece of guidance (previously dubbed the “Mega Reg”) has been long-awaited by all stakeholders involved with the 340B Program. If it progresses through to final form, it will offer guidance on a variety of different aspects of the 340B Program.