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Exclusions › Orphan Drugs

Baker Donelson

Final Rule on 340B Orphan Drug Exclusion Imposes New Compliance Requirements on Covered Entities and Contract Pharmacies

Baker Donelson on

The 340B program permits eligible hospitals and other “safety-net” providers (Covered Entities) to purchase covered outpatient drugs from pharmaceutical manufacturers at significant discounts. The Affordable Care Act and the...more

King & Spalding

HRSA Issues Final 340B Orphan Drug Exclusion Rule: Agency’s Narrow Interpretation of Statutory Prohibition Puts Compliance...

King & Spalding on

On July 23, 2013, the Health Resources and Services Administration (HRSA) issued a final rule clarifying the orphan drug exclusion for certain covered entities created by the Affordable Care Act (ACA) (“Final Rule”). The...more

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