Pharmacy Operations, Personnel, and Facility Standards
Operations questions test the pharmacist-in-charge role, facility security, equipment, temperature control, and personnel supervision.
Facility and security
- The pharmacy must be licensed at its physical address, have a secured prescription area, and limit access to authorized personnel.
- Controlled substances must be stored securely; Schedule II stock needs locked storage or an equivalent secure area.
- Refrigerators and freezers need temperature monitoring and documented excursions; vaccines and biologics require cold-chain compliance.
- Equipment must be clean, calibrated, and maintained; compounding areas follow USP standards.
Personnel
- The pharmacist-in-charge is responsible for compliance, training, and recordkeeping. Pharmacists supervise technicians and interns; tasks must match the person’s credential and training.
- Maintain current licenses and DEA registrations on site or readily retrievable; post required notices.
- Written policies should cover dispensing, counseling, returns, recalls, and emergency procedures.
Worked example
A technician trainee answers the phone and gives dosing advice. This is improper. Counseling and clinical judgment require a pharmacist. The trainee may take a message and route the call, but the pharmacist must provide the advice and document it.
Traps
- Letting unlicensed staff counsel or verify prescriptions.
- Storing CII with general stock.
- Ignoring temperature excursion documentation.
- Operating after a PIC leaves without required Board notification.