The California State Board of Pharmacy has published an inspection checklist to guide pharmacies on what to inspect during an inspection.
The brochure elaborates on the process to be followed by the inspector. For example, the inspector must provide the pharmacy with:
- a business card;
- a receipt for any records taken from the premises;
- a copy of the inspection report (TIP: This is a the most important document during the inspection. Review it with your counsel to determine on how to address the inspector’s concerns (if any) to avoid an administrative action);
- information about pharmacy laws and regulations (TIP: This is your chance to ask any burning questions. But be prepared that you may not receive answers to all the questions that you may have).
During the inspection, the pharmacy should provide access to:
- All stock of dangerous drugs and devices;
- All records of manufacture, sale, acquisition, receipt, shipment and disposition.
TIP: The inspector is allowed to take samples of products (e.g. compounds).
To streamline the inspection, you should have the following records readily available (TIP: have an inspection folder):
- Past inspection reports.
- Pharmacy self-assessments.
- Copies of staff licenses.
- Master list of pharmacist and technician initials.
- DEA 222 forms.
- Power of attorney to execute DEA 222 forms.
- DEA biennial inventory.
- Drug take-back records.
- Wholesaler invoices.
- Records of drug returns.
- Records of destruction.
- Off-site records waiver.
- Pedigrees for drugs purchased.
- Inventory reconciliation reports.
- Controlled substances refill reports.
- Quality assurance reports.
- QA for medication errors.
- Theft and impaired licensees.
- Pharmacy technician job description.
- Pharmacist absence for meals.
- After hours deliveries.
- Interpretive services.
- Repackaging previously dispensed drugs.
- Automated Drug Delivery Systems.
- Common electronic files to prevent unauthorized release of patient
- Refusing to dispense on ethical, moral, religious grounds.
- Emergency contraception.
- Nicotine replacement.
- Advanced practice pharmacist.
- Procedures performed pursuant to BPC section 4052.2.
Additional documentations and issues that the inspector will review:
- DEA registration.
- Drug expiration dates.
- Drug take-back receptacles.
- Hot/cold running water (separate from restroom).
- Confidential waste disposal.
- Interpretive services poster.
- Notice to consumers poster.
- Restroom location.
- Patient consultation.
- Posted pharmacy license and renewal.
- Out-of-state licenses.
- Prescription labeling.
- Prescription records.
- Quarantine area for expired and recalled drugs.
- Refrigerator/freezer temperature.
- Security features.
- Staffing ratio.
- Transmission of CURES data.
- Wearing identification or name tag printed in at least 18-point type.
- Possession of keys to the pharmacy
TIP: Keep the Board’s guidance at the Pharmacy to serve as a checklist of all documents that have to be readily available for an inspection. Update and review your inspection folder periodically.
Sometimes the inspector may ask information that is not on this checklist. For example, I represented pharmacies in inspections where they were required to produce tax returns, articles of incorporations, billing records, etc. Such requests should be discussed with your legal counsel to analyze the validity and the Board’s authority for such requests.