Pharmacy Operations, Recordkeeping, and Inventory
Core concepts
Operational compliance covers prescription records, retention periods, security, access control, and inventory. Prescriptions and dispensing records must be retained for the required period and be retrievable for inspection. Controlled substance records must be maintained separately or readily retrievable and reconciled. Know the requirements for biennial inventory, the handling of returns and reverse distribution, and the documentation of transfers and partial fills.
Traps
- Assuming electronic records need no backup or that paper records can be discarded early.
- Confusing inventory reconciliation with the biennial inventory requirement.
- Missing documentation for partial fills, which must be recorded.
Rule of thumb
If it changed the drug's location, quantity, or legal status, it must be documented and retrievable. If it can't be produced on inspection, treat it as not done.
Worked example
A pharmacy fills a Schedule II prescription in two partial fills. Each partial fill must be documented, and the total dispensed cannot exceed the prescribed quantity. The record must show dates, quantities, and the pharmacist responsible.