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HRSA Clarifies 340B Orphan Drug Exclusion

by Jason B. Reddish
Powers Pyles Sutter & Verville, PC - Washington Office

Barbara Straub Williams
Powers Pyles Sutter & Verville, PC - Washington Office

August 6, 2013

Previously published on August 1, 2013

On July 23, 2013, the Health Resources and Services Administration (HRSA) promulgated a final rule - and the 340B program’s first regulations - to implement a statutory provision that restricts Critical Access Hospitals (CAHs), Sole Community Hospitals (SCHs), Rural Referral Centers (RRCs), freestanding cancer hospitals, and their contract pharmacies, from purchasing “orphan drugs” at 340B-discounted prices (Final Rule). In addition, HRSA defined a group purchasing organization (GPO), which impacts disproportionate share hospitals (DSHs), children’s hospitals, and cancer hospitals. The regulations are effective on October 1, 2013. The Office of Pharmacy Affairs (OPA) also published Frequently Asked Questions (FAQs) about the orphan drug exclusion, which are available on its website.


The views expressed in this document are solely the views of the author and not Martindale-Hubbell. This document is intended for informational purposes only and is not legal advice or a substitute for consultation with a licensed legal professional in a particular case or circumstance.

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