340B Orphan Drug Exclusion
Whether an orphan-designated drug is excluded from 340B pricing for an entity.
Open the tool → Runs in your browser. Data leaves only if you deliberately send a problem report from the interactive tool.
Example
- Covered entity type
- Critical access hospital
- The drug has an FDA orphan designation
- Yes
Result: Excluded: for a critical access hospital, a drug with an orphan designation is not a covered outpatient drug under 340B, whatever it is used for (42 U.S.C. 256b(e)).
The tool opens with these values already filled in. Replace them with your own.
What you enter
- Covered entity type
- The drug has an FDA orphan designation
How this is calculated
Citation
42 U.S.C. 256b(e): for free-standing cancer hospitals, critical access hospitals, rural referral centers and sole community hospitals, a drug with an orphan designation under 21 U.S.C. 360bb is not a covered outpatient drug. Read the source ↗
A reference and educational tool. Not medical, legal, or financial advice, and not a substitute for clinician judgment.