Getting an inspection call or visit can feel tense. Inspectors are looking for clear things: valid licenses, safe medicine storage, accurate records, and staff who follow written procedures. If you run a pharmacy, knowing exactly what they check lets you fix small problems before they become violations.
Inspectors focus on concrete items. Expect them to verify pharmacy and pharmacist licenses, DEA registration, and controlled‑substance inventories. They'll review dispensing records, prescription labels, and patient counseling areas. Cold chain checks are common: vaccine and insulin refrigerator temps, alarm logs, and maintenance records. For pharmacies that compound, inspectors look for SOPs, compounding logs, and USP <797>/<800> compliance. They also check staff training certificates, error reports, recall documentation, and hazardous waste handling.
During the visit, inspectors may observe workflow, interview staff, and pull random prescriptions. They will check expiration dates, storage conditions, and whether controlled drugs are secured. Digital records are fine, but make sure they’re backed up and easy to access.
Some problems show up again and again. Top citations include unsecured controlled substances, missing or incomplete records, expired stock on shelves, broken refrigerator temperature logs, and lack of documented procedures. Fixes are usually straightforward: lock up controlled meds, run a full inventory reconciliation, remove expired items, and create a dated corrective action note when you fix something.
Here are practical steps to make inspections smooth. Keep a ready binder or secure digital folder with licenses, DEA forms, current SOPs, training logs, vaccine logs, temperature charts, recall actions, and recent quality assurance checks. Assign one person as the inspection point of contact so answers are quick and consistent. Run weekly spot checks for fridge temps and expired meds. Do a monthly mock inspection where someone uses the official checklist to find problems before an inspector does.
What to do during the inspection: be cooperative, stay calm, and answer clearly. Offer requested documents promptly and ask for clarification if a request is unclear. If the inspector points out an issue, document it, correct it if possible on the spot, and prepare a written plan showing what you changed and how you'll prevent recurrence.
Inspections can be routine, complaint‑based, or scheduled. Frequency depends on your state board and DEA cycle. Regular internal audits cut stress and reduce real risks. Spend two hours a week on simple maintenance tasks and you’ll cut the odds of a citation significantly.
Want a quick start? Build a one‑page inspection checklist for daily staff use: license check, controlled access check, fridge temp check, expiry check, and counseling area tidy. Small habits keep your pharmacy safe and inspection‑ready without drama.
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