Section 340B(e) of the Public Health Service Act (PHSA) states the term "covered outpatient drugs" doesn't include a drug selected by the Secretary of Health & Human Services under Section 526 of the Federal, Food, Drug, and Cosmetic Act for a rare disease or condition for these 340B entities:
- Rural referral centers
- Sole community hospitals
- Critical access hospitals
- Free-standing cancer hospitals
Manufacturers aren't required to provide these covered entities with orphan drugs under the 340B Program. A manufacturer may choose to offer discounts on orphan drugs to these hospitals.
Orphan drug designation list
We encourage stakeholders to access publicly available up-to-date information in the U.S. Food and Drug Administration's (FDA) Office of Orphan Products Development (OOPD) database to find the orphan drug status of covered outpatient drugs.
Covered entities and their partners may need to analyze drugs on the OOPD list to decide which orphan drugs to exclude from the 340B Program and the appropriate time frame. We encourage 340B stakeholders to resolve any potential disputes on access to orphan drugs.
How to use the OOPD database to create a list of currently designated orphan drug products:
- Navigate to: FDA OOPD Database
- Enter in the Search Results field: All designations
- Enter in the Output Format: Download Excel File
- Filter the Orphan Designation Status Column to include "Designated" and "Designated/Approved."
Program integrity
340B Drug Pricing Program covered entities must ensure program integrity and maintain accurate records documenting compliance with all 340B Program requirements.
Manufacturers or the federal government may audit covered entities. Failure to comply may make the 340B covered entity liable to manufacturers for refunds of discounts obtained.