Policies & Procedures Review (340B)

A Policies & Procedures (P&P) Review is a systematic evaluation of a covered entity’s written 340B compliance policies to assess whether they are current, complete, and consistent with both HRSA requirements and the entity’s actual operations. P&P reviews are a standard component of 340B audits and readiness assessments.

Key areas evaluated in a P&P review include: patient eligibility determination, diversion prevention, duplicate discount prevention, contract pharmacy management, data integrity, staff training, and corrective action processes. Reviewers assess not only whether policies exist, but whether they are specific enough to guide staff behavior, whether they reflect current program requirements, and whether actual operations align with what the policies describe.

Outdated, vague, or missing policies are among the most common findings in HRSA audits. A P&P review identifies these gaps before an audit occurs, allowing the covered entity to update its documentation and reduce audit risk.