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The Definitive California Pharmacy Board Inspection Prep Checklist

Pharmacies in California must undergo regular inspections from the California Pharmacy Board. As a healthcare industry business owner, you must make the necessary arrangements to get ready for inspections. An inspection checklist can help you prepare for such an audit.

You must take these inspections seriously. The Board may issue a fine or take administrative action against your pharmacy if an inspector concludes that your pharmacy does not comply with all the regulations.

Continue reading to discover what a pharmacy inspection is. Learn how to prepare for an inspection with the help of this definitive guide on the California Board of Pharmacy Inspection Checklist.

Pharmacy Inspection Defined

A pharmacy inspection is conducted by each state’s pharmacy board to ensure that the standards for registered pharmacies are fully met, according to the General Pharmaceutical Council. The pharmacy team must show tangible proof that they meet these standards.

This inspection focuses on determining if the pharmacy:

• Provides excellent services to patients
• Sells good quality products to patients
• Is compliant with the official pharmacy regulations

The inspection procedure may vary from state to state. Nevertheless, many pharmacy boards have certain things in common:

• Practically all boards require the inspectors to introduce themselves and explain the purpose of the visit before they begin the inspection.
• Many states permit inspectors to bring pharmacy records off-site as long as they issue a receipt to the pharmacy.
• Most states require inspectors to give an inspection report to the pharmacy after the evaluation is complete.

The inspector will work with the pharmacy team as a whole instead of addressing just the individual owner, pharmacist, or superintendent. Aside from checking on the pharmacy’s practices and documentation, the inspectors will also evaluate the quality of service and products offered to patrons.

Ultimately, the pharmacy owner is responsible for meeting pharmacy standards in the state. Nevertheless, the inspection may occur even if the owner or superintendent is not currently present when the inspector arrives. This ensures that a pharmacy maintains acceptable standards every day, not just when the owner or superintendent is in attendance.

What To Expect From a California Board of Pharmacy Inspection

The California Pharmacy Board conducts these inspections to safeguard the health and well-being of your patients. These inspections also serve as an educational opportunity. You will have the chance to request guidance from inspectors and ask questions about pharmacy laws.

These are the steps that you can expect an inspector to take during a pharmacy inspection in California:

• The inspector will introduce themselves by presenting a board-issued badge. They will give you an official business card.
• The inspector shall maintain a respectful, professional manner.
• The inspector will issue a receipt for any pharmacy records that they take off-site.
• The inspector shall provide a copy of the inspection report to the pharmacist.
• The inspector will share relevant information and answer inquiries regarding pharmacy regulations.

In turn, the Board expects your cooperation during the inspection procedure. These are the steps that your pharmacy team should perform during an inspection of your California pharmacy:

• Your team should grant the inspector access to your pharmacy during regular business hours.
• Your team should permit the inspector to review the stocks of dangerous drugs and equipment.
• Your team should allow the inspector to read the records of your pharmacy related to manufacturing, acquisitions, sales, receipts, shipments, dispositions, etc.
• Your team should permit the inspector to collect samples.

You and your pharmacy team are also encouraged to share your feedback regarding your inspection experience.

California Board of Pharmacy Inspection Checklist

Your pharmacy team should store hard and electronic copies of any important records and documentation at your pharmacy to be prepared for an inspection.

The California Board of Pharmacy expects your pharmacy to have the following documents available during business hours:

• Previous inspection reports
• Pharmacy self-assessments
• Master list of pharmacist and technician initials
• Staff license copies
• DEA 222 forms
• Power of attorney to execute DEA 222 forms
• Drug take-back records
• DEA biennial inventory
• Drug returns records
• Wholesaler invoices
• Destruction records
• Inventory reconciliation reports
• Off-site records waiver.
• Pedigrees for drugs purchased
• Reports on controlled substances refills
• Policies:
  • Quality assurance reports
  • Job description of pharmacy technician
  • QA for medication errors
  • Pharmacist absence for meals
  • Theft and impaired licensees
  • Interpretive services
  • After-hours deliveries
  • Automated Drug Delivery Systems
  • Repackaging previously dispensed drugs
  • Common electronic files to avoid the unauthorized release of patient data
• Protocols:
  • Immunizations
  • Nicotine replacement
  • Refusal to dispense drugs on ethical, moral, religious grounds
  • Emergency contraception
  • Procedures performed according to BPC section 4052.2
  • Advanced practice pharmacist

Aside from these documents, policies, and protocols, these are the additional items that the inspector will check:

• Drug expiration dates
• DEA registration
• Drug take-back receptacles
• Prescription records
• Prescription labeling
• Hot and cold running water
• Location of restroom
• Confidential waste disposal
• Patient consultation
• Interpretive services poster
• Notice to consumers poster
• Out-of-state licenses
• Posted pharmacy license and renewal
• Staffing ratio
• Security features
• Quarantine area for recalled and expired
• drugs
• Refrigerator and freezer temperatures
• Transmission of CURES information
• Pharmacy key possession
• Identification or name tags for the pharmacy team

Request for Expert Guidance

Preparing for a pharmacy inspection is a necessary process that ensures smooth, continuous operations for your pharmacy. However, getting ready can be a complex, time-consuming process.

Get in touch with our legal experts who can help you successfully meet all the items from the California Pharmacy Board inspection checklist requirements.