Controlled Substance Perpetual Inventory and Monthly Reconciliation

Inspection template for maintaining a perpetual inventory of Schedule II controlled substances and documenting periodic reconciliation against on-hand stock, with discrepancy review and escalation.

Inspection Scope and Inventory Period

• Inspection date and reconciliation period documented
  Record the date/time of the inspection and the inventory period covered by this reconciliation.
• Controlled substance inventory set identified
  Select the Schedule II controlled substances included in this perpetual inventory review.
• Reference to perpetual inventory log available
  Confirm the current perpetual inventory record is available for review and matches the reconciliation period.
• Inspector and witness names recorded
  Enter the inspector name and any required witness or second verifier name.

Perpetual Inventory Record Review

• All Schedule II transactions posted without unexplained gaps
  Verify receipts, dispensing, returns, wastage, transfers, and adjustments are posted in sequence with no unexplained gaps in the record.
• Receipts documented with date, quantity, and source
  Confirm incoming Schedule II receipts are documented with date received, quantity received, and supplier or transfer source.
• Dispensing and administration reductions documented
  Verify reductions to inventory are documented with the transaction date, quantity removed, and supporting record.
• Adjustments and wastage entries authorized and traceable
  Confirm any inventory adjustments, wastage, or reversals include authorization and a traceable explanation.
• Running balance updated after each transaction
  Verify the perpetual inventory running balance is updated after each transaction and remains mathematically consistent.

Physical Count Reconciliation

• Physical count performed for each selected item
  Confirm a physical count was completed for each selected Schedule II item in the reconciliation set.
• Book-to-physical variance recorded
  Enter the variance quantity between the perpetual inventory balance and the physical count.
• Variance is within acceptable tolerance
  Confirm the variance is zero or within the organization's approved tolerance threshold.
• Count performed by authorized personnel
  Verify the physical count was completed by authorized personnel and, where required, independently verified.
• Count location secured during reconciliation
  Confirm the storage area remained secured during the count and access was limited to authorized staff.

Storage Security and Access Control

• Controlled substances stored in locked, access-restricted area
  Verify Schedule II stock is stored in a locked area with access restricted to authorized personnel only.
• Access list current and reviewed
  Confirm the access list for controlled substance storage is current and reviewed for authorized users.
• Security incidents or tampering signs absent
  Check for signs of tampering, unauthorized entry, missing seals, or other security incidents.

Discrepancy Review and Escalation

• Discrepancies investigated and root cause documented
  Confirm any variance was investigated and a root cause or probable cause was documented.
• DEA or regulatory reporting initiated when required
  Verify discrepancies meeting reporting thresholds were escalated to the DEA or applicable regulator per SOP.
• Corrective action assigned with due date
  Document the corrective action owner, action steps, and target completion date.

Closeout and Sign-Off

• Inspection findings reviewed with responsible manager
  Confirm findings, variances, and corrective actions were reviewed with the responsible manager or pharmacist-in-charge.
• Inspector signature captured
  Capture the inspector signature to complete the reconciliation record.