A checklist of what you need to be prepared for a Board of Pharmcacy inspection.
While a visit from the Board is not something you look forward to, the pharmacy should nevertheless be ready for it at all times.
What does it mean to be ready for an inspection? You might be surprised: not only does it include proper record-keeping, inventory maintenance, and drug security; but also such apparently trivial things as, among other things, dust-free shelves, staff appearance, and bathroom functionality (yes, bathrooms are often inspected too).
If the inspector concludes that the pharmacy provides sub-standard services and does not comply with pharmacy regulations, the Board may commence an administrative action against the pharmacy or issue a citation/fine (depending on the inspector’s observations). Therefore, it is important to anticipate an inspection and prepare the pharmacy and its staff for the process.
The inspection process differs from state to state, but most pharmacy boards focus on a few common things. For example, virtually all boards require that the inspectors introduce themselves and state the purpose of their visit prior to commencing an inspection. Most states allow the inspectors to take pharmacy records off-site (provided they issue a receipt to the pharmacy). And the inspectors are required to provide the pharmacy with the inspection report or written observations after the conclusion of the inspection.
The inspection report is the most important document during the inspection because it lists potential violations, suggestions for improvements, and other concerns of the inspector. An experienced pharmacy attorney, for example, can simply glance at the report and tell you whether it is likely that the Board will commence an administrative action against the pharmacy, issue a citation/fine, or if no further actions would follow.
Therefore, it is imperative for the pharmacy to review the inspection report and address its allegations or observation, if applicable. If, for example, the inspection report states that the pharmacy has no policies and procedures on dispensing controlled substances, the pharmacy should draft such policies and send them to the inspector shortly after the conclusion of the inspection. On the other hand, if the inspector notes that there is expired inventory in stock, prepare a corrective action plan on how this issue had been addressed. I cannot stress enough the importance of the inspection report as an opportunity to avoid a costly license defense in the future.
The inspector may ask you for additional information and documentation as required by your state laws. I had cases where inspectors asked for financial business information (tax returns, billing records, etc.). However, most states provide that pharmacies must only provide access to 1) all stock of dangerous drugs and devices, and to 2) all records of manufacture, sale, acquisition, receipt, shipment, and disposition. Therefore, If the inspector asks anything that is not on the above list or not expressly authorized by a statute, you should discuss the request with your legal consultant to analyze the validity and the Board’s authority for such request.