March 9, 2012—The Health Resources and Services Administration (HRSA) has posted a document on the Office of Pharmacy Affairs (OPA) Web site clarifying its policy on 340B covered entity audits.
The March 5 document, called a policy release, notes that the 340B statute permits the federal government and drug manufacturers to audit covered entity records pertaining to entities’ compliance with the prohibitions against drug diversion and duplicate discounts.
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