Pharmacy Operations, Recordkeeping, and Inventory
Operating standards
A pharmacy must hold a valid permit, maintain security, and keep records that allow reconstruction of every dispensing event. Records include prescriptions, purchase invoices, inventories, and returns. Records must be readily retrievable for Board inspection.
Key operational areas
- Security: controlled substances must be stored securely; access limited to authorized personnel; alarm and access controls are part of the permit standard.
- Record retention: federal controlled-substance records are kept two years; Arkansas may require longer retention for certain records. Know which records are controlled-substance records versus general business records.
- Inventory: initial inventory on opening, biennial inventory thereafter, and inventory of newly scheduled drugs. Perpetual inventory is a best practice and often a Board expectation for high-risk drugs.
- Returns and recalls: documented processes for returning drugs, handling recalls, and destroying expired stock.
- Automation: automated dispensing systems and counting devices must meet accuracy and recordkeeping standards; the pharmacist remains responsible.
Traps
Questions test who may access controlled-substance storage, how long records must be kept, and what happens when a record is missing. A missing record is treated as a compliance failure even if the drug was properly dispensed.
Worked example
A Board inspector requests purchase invoices for a Schedule III drug from 18 months ago. The pharmacy must produce them - controlled-substance records must be maintained and retrievable within the retention period; failure to produce is a violation.