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HRSA Clarifies 340B Orphan Drug Exception But 340B Audit Enforcement Remains Murky

Recently, HRSA publicly announced the issuance of a final rule clarifying when 340B covered entities can purchase and distribute orphan drugs through the 340B Drug Pricing Program. Separately, HRSA quietly posted a report on...more

Big Changes Are Happening With the 340B Drug Program

Things are drastically changing for covered entities under the 340B program. In the last 18 months several factors have led the Health Resources and Services Administration (HRSA) to ramp up its oversight and auditing of...more

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