HRSA finds problems in 49% of 340B audits for fiscal year 2025
Issue
HRSA published fiscal year 2025 340B audit results on May 15, 2026, with adverse findings at 49% of 115 audited entities, down from 64% the year before. Of those, 75% had incorrect OPAIS records, 50% had to repay drug makers and 21% had sites terminated.
About 90% of audits are now chosen by risk, so accurate OPAIS records matter.
Key points
- 49% adverse findings (down from 64% FY24, still nearly 1 in 2 audited)
- 75% of adverse findings = incorrect OPAIS records (master-data governance gap)
- 50% required to repay manufacturers; 21% had site terminations; 68% re-audit failure rate
- About 90% of audits now target entities by risk, such as tips, prior findings or complex contract pharmacy setups.
Sources for this story
HRSA Office of Pharmacy AffairsPart of
- 340B drug pricing
HRSA audits and repayment
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FQHC Talent. (2026, May 15). HRSA finds problems in 49% of 340B audits for fiscal year 2025. Source: HRSA Office of Pharmacy Affairs. Retrieved November 11, 2026, from https://www.fqhctalent.com/intel/hrsa-fy25-340b-audit-results-49-percent-adverse-may-2026