Preparing for a pharmacy inspection can be daunting, but with the right strategies and guidance, you can navigate the process with confidence and ensure your pharmacy meets all regulatory requirements.

Review State and Federal Regulations

Understand the requirements

Familiarize yourself with the latest state and federal regulations governing pharmacy practices, including the DEA, FDA, and state board of pharmacy requirements.

Compliance updates

Ensure all staff members are up-to-date on these regulations and have access to the latest compliance resources.

Organize Documentation

• Licenses and permits: Ensure all pharmacy, pharmacist, and technician licenses are current and properly displayed.
• Controlled substance records: Maintain accurate and up-to-date records of all controlled substances, including purchase, dispensing, and inventory logs.
• Prescription files: Organize prescription records, ensuring they are easily accessible and comply with state and federal retention requirements.
• Staff training records: Keep detailed records of staff training and continuing education.

Conduct a Self-Audit

• Inventory management: Perform a thorough inventory check, focusing on controlled substances. Ensure all medications are accounted for and stored properly.
• Prescription verification: Review a sample of prescriptions to verify proper documentation, including patient information, prescriber details, and drug dispensed.
• Compliance with labeling: Ensure that all prescriptions and over-the-counter medications are labeled according to regulations.

Prepare the Pharmacy Environment

• Cleanliness and organization: Maintain a clean, well-organized pharmacy environment. Ensure that all medications are stored correctly, and there are no expired products.
• Security measures: Verify that all security systems, including alarms, surveillance cameras, and controlled substance storage, are functioning properly.
• Temperature control: Check that refrigerators and freezers are maintaining appropriate temperatures for medication storage.

Train Staff for Inspection Day

• Inspection protocol: Inform your staff about the inspection process and their roles. Assign specific tasks to ensure a smooth inspection.
• Customer service: Remind staff to remain professional and courteous during the inspection. Their behavior can impact the outcome.
• Mock inspections: Conduct a mock inspection to simulate the experience and identify any areas needing improvement.

Communicate with the Inspector

• Be prepared: Have all necessary documentation readily available. Assign a point of contact to guide the inspector through the pharmacy.
• Answer questions accurately: Ensure that staff members are prepared to answer any questions the inspector may have. If uncertain, it’s better to check records than to provide incorrect information.
• Follow-up: After the inspection, review the inspector’s findings and take immediate action to address any deficiencies.

Post-Inspection Review

• Address deficiencies: If any issues were identified during the inspection, create a corrective action plan and implement it promptly.
• Continuous improvement: Use the inspection as an opportunity to improve your pharmacy’s operations and ensure ongoing compliance with all regulations.

By following this checklist, you can ensure that your pharmacy is well-prepared for an inspection, helping to maintain compliance and avoid potential penalties.

Ensure Your Pharmacy is Inspection-Ready!

Are you prepared for your upcoming pharmacy inspection? At RX Advisor, we offer various turnkey solutions regarding pharmacies including pharmacy inspection preparation services to help you navigate the complexities of regulatory compliance. From document organization to staff training, we’ve got you covered.

Contact us today to schedule a consultation and ensure your pharmacy is fully prepared!