For rural referral centers, sole community hospitals, critical access hospitals, and free-standing cancer hospitals participating in the 340B Program, the term "covered outpatient drug" doesn't include a drug designated by the Secretary under section 526 of the Federal Food, Drug, and Cosmetic Act for a rare disease or condition.
Therefore, manufacturers aren't required to provide these covered entities' orphan drugs under the 340B Program. A manufacturer may, at its sole discretion, offer discounts on orphan drugs to these hospitals.
Orphan Drug Designation List
The Orphan Drug Designation List was updated and developed using the methodology referenced in About the Orphan Drug List. It should be used to govern the quarter October 1 to December 31, 2023.
Orphan Drug Designation List Governing April 1 to June 30, 2023 (XLSX - 474 KB)
About the Orphan Drug List
HRSA develops this list and updates it quarterly. It is based upon specific fields captured from the list of orphan drug designations provided by the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD). The list posted should be the source used by 340B stakeholders to ensure compliance with the orphan drug exclusion. Covered entities may need to conduct additional analyses of the drugs provided on this list to determine the appropriate orphan drugs to exclude from the 340B Program.
HRSA recognizes that orphan drug designation sponsors listed on the FDA orphan drug list may not be the current manufacturer for an orphan drug. The sponsor listed reflects the latest information reported by the sponsor to the FDA OOPD. HRSA encourages 340B stakeholders to work, in good faith, to resolve any potential disputes that may result from the use of this list. HRSA will continue to improve the list that is posted on a quarterly basis to ensure covered entities have the information they need to comply with the orphan drug exclusion.
HRSA uses the following methodology to develop the list:
- Source: FDA OOPD list of orphan drugs
- Search Results: All designations
- Output Format: Download Excel File
- HRSA only included orphan drugs with a status of “Designated” and “Designated/Approved.”
- HRSA only used the following fields: row number, generic name, trade name, designation date, orphan designation, contact company/sponsor.
340B Drug Pricing Program covered entities must ensure program integrity and maintain accurate records documenting compliance with all 340B Program requirements.
Covered entities are subject to audit by manufacturers or the federal government. Failure to comply may make the 340B covered entity liable to manufacturers for refunds of discounts obtained.
Learn more: Program Integrity