Reference answer · 340b-program · reviewed quarterly
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Review cadence: quarterlyUnderlying federal data: refreshed weekly to annual per source
Q&A library · 340b-program

What documentation does HRSA require as auditable records for 340B contract pharmacies?

HRSA defines auditable records as the original documentation supporting each 340B transaction, verifying that every dispensed drug traces to an eligible patient encounter. Covered entities must retain source materials such as patient charts, prescriber credentials, pharmacy claims, and signed contract pharmacy agreements that demonstrate compliance and oversight during audits.

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