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Pharmacy Compliance Review Checklist

A general educational framework for periodic internal review.

Educational use only: This checklist is general and does not include every requirement for every pharmacy.

Licensing & Governance

  • Pharmacy and professional licenses are current.
  • Ownership, PIC, address and board records match current operations.
  • Renewal and reporting deadlines are tracked.

Prescription & Patient Records

  • Records are complete, retrievable and retained appropriately.
  • Transfers, clarifications and prescriber communications are documented.
  • Patient profile information is maintained according to policy.

Controlled Substances

  • DEA registration is current.
  • Required inventories and ordering records are complete.
  • Loss/theft and suspicious-order procedures are documented.
  • Storage and security are appropriate.

HIPAA & Information Security

  • Privacy and security policies are current.
  • Workforce training is documented.
  • User access is role-based and promptly removed when needed.
  • Incident and breach procedures are documented.

Policies, Training & Quality

  • Policies match actual workflow.
  • Training and competency records are maintained.
  • Medication incidents and near misses are reviewed.
  • Corrective actions are documented and followed up.

Inventory, Storage & Recall

  • Temperature-sensitive products are monitored.
  • Expired, recalled and quarantined products are segregated appropriately.
  • Recall actions are documented.

Payer & Audit Readiness

  • Credentialing information is current.
  • Audit documentation is retrievable.
  • Prior corrective actions are completed.