What to Expect in a California Board of Pharmacy Inspection

Our firm has been representing California pharmacists, pharmacy technicians, pharmacy owners, compounding and other pharmacy entities for a combined 50-plus years.  We’re often asked to advise clients on what to expect when the Board inspectors perform an inspection of the pharmacy—usually, these inspections are random and no notice is given.  Thus, all pharmacy owners and pharmacists, including PICs (Pharmacists In Charge) should be know what to expect.

---

Beginning of the Inspection

To begin with, an inspector will always identify himself/herself with an ID badge and will usually leave a business card for future reference, or for follow up documentation transmittal.

The inspector is required to give you a receipt for any documents/records/Rxs, etc. taken from the pharmacy.

The inspector will will go over their inspection report and leave a copy of it with the pharmacist on duty or the PIC.  Most inspectors will do their best to answer questions about compliance with pharmacy law and how best to improve areas of concern during the inspection.

Pharmacy Staff Obligations

Staff must provide access to the pharmacy for the inspector during business hours.  Do NOT even think about throwing out an inspector or arguing with him/her.  This can lead to serious disciplinary problems and more inspections in the future.  Many clients retain our firm to consult with as the inspection is occurring, to help guide them through the dos and don’ts for an optimal outcome.

Staff must give the inspector access to all dangerous drug stock, including devices stocked in the pharmacy.  

Access to all records of manufacture (especially compounding logs/quality control testing), sale, acquisition, receipt, shipment and disposition (reverse distributor/expired stock).

The inspector must be allowed to take samples as required, with a receipt provided for them.

Documents Which Must Be Available

There are certain records pharmacies must have available at all times in case of an inspection.  This includes electronic and paper records.

An example of these records includes:

• Written records of consultation when drugs dispensed.
• Past inspection reports.
• Pharmacy self-assessments.
• Staff license documentation.
• List of pharmacist and pharm tech initials.
• DEA 222 forms (Paper forms required for ordering Schedule I and II drugs).
• Power of Attorney for DEA 222 form.
• DEA biennial inventory records.
• Drug take-back records.
• Wholesaler invoices for drugs.
• Records of drug returns.
• Records re: drug destruction.
• Off-site records waiver.
• Pedigrees for purchased medications.
• Inventory reconciliation reports.
• Drug loss reports.
• Controls refill reports.

Policies and procedures, some of which include: Quality assurance reports, med error policy, theft and impaired licensee policy, after hour deliveries, repackaging policies, automated drug delivery systems, and many others.

Protocols for the following: opioid antagonists (i.e. Narcan), HIV PrEP/PEP, refusal to dispense grounds, immunizations (including proof of training and BLS certification), Advance Practice Pharmacist, etc.

Other Items Which May Be Inspected

• DEA Registration.
• Drug expiration dates/no expired stock on shelves.
• DEA/Drug take-back bins.
• Hot water functional.
• Interpreter available notice/notice to consumers posted.
• Patient consult area clearly marked.
• Confidential patient counseling area available.
• Pharmacy’s permit posted.
• Out of state licenses posted.
• Prescription labels/verification initials.
• Prescription records.
• Record storage.
• Expired/recalled drugs separated from stock/clearly marked.
• Refrigerator temperatures correct/medical fridge alarm functional.
• General security of pharmacy.
• Policy for receipt of drug deliveries.

After the Inspection

Inspector may issue a correction notice, with pharmacy often required to submit proof of the corrected item(s) at a future date.  Excellent record keeping is crucial here.

If a violation of pharmacy law is noted, pharmacy will receive a written notice, which can include:

• A citation (with or without fine)
• Letter of Admonishment
• Case referred to Attorney General for filing of serious discipline (Accusation/Petition to Revoke Probation/Interim 
• Suspension Order (“ISO”) in extreme cases.

Later on, an investigative interview with a Board inspector may be requested—this is when you really need to have counsel with you!  Do NOT attend such an interview alone.      

Note that letters of admonishment and citations are not considered discipline, but both may be appealed.  This is the time to contact the attorneys at Brown & Brown as these cases are not do-it-yourself matters.  They require the many years of experience we possess to successfully change a stubborn Board’s mind about noted violations you may disagree with.

In general, the better a pharmacy’s record keeping and policies and procedures, the better an inspection will go.  

If you have been inspected, or suspect you may be soon, give our office a call for a FREE initial conference so you can be well prepared to deal with what is usually a very stressful and overwhelming experience which can result in revocation of your license if not handled correctly.