Pharmacy Management, Recordkeeping, and Inventory Requirements
What must be kept, and for how long
Prescription records, hard copies, transfer records, purchase invoices, inventories, 222 forms, powers of attorney, temperature logs, and compounding records must be retrievable and complete. Federal rules require controlled substance records for at least two years; Ohio requires prescription and dispensing records for three years, so three years is the working floor. Records must be available for inspection during business hours.
Inventory
A biennial inventory of all controlled substances is taken every two years, on any date, at opening or close of business. Schedule II counts are exact; Schedules III–V may be estimated unless the container holds more than 1,000 units. The inventory records date, time, signature, and whether it was taken at opening or close. Ohio also expects a perpetual inventory of Schedule II stock, reconciled at receipt and dispensing.
Movement of drugs
- Purchases: invoices from licensed distributors; 222/CSOS for Schedule II.
- Returns: reverse distributor with the required forms; never "sold back" informally.
- Destruction: non-retrievable, witnessed, documented.
- Recalls and expired stock: quarantined and segregated, with records.
Worked example
A hydrocodone bottle breaks and 18 tablets are lost. The pharmacy does not simply adjust the perpetual count. It documents the incident, records the loss, updates the perpetual inventory, and reports a theft or significant loss to DEA and the Board as required. "Significant" is judged on the pattern and quantity, not one bottle alone.
Traps
- Relying on the two-year federal minimum and destroying year-three records.
- Estimating a Schedule II count instead of counting exactly.
- No reconciliation between the perpetual count and the biennial inventory.
- Returning controlled substances to a wholesaler without the correct documentation.