Prepare for a Pharmacy Inspection BEFORE It Happens

You can help your pharmacy pass inspections with flying colors...and avoid steep fines, practice restrictions, and license suspensions.

In a recent case, a pharmacy was fined several million dollars by the Justice Department for filling Rxs incorrectly and not tracking inventory properly.

Use these strategies and follow your pharmacy's policies when the board of pharmacy, DEA, or FDA shows up at your door.

Before an inspection. Always be prepared...most inspections won't be announced ahead of time.

Ensure all necessary information is kept up to date, organized, and readily available. Some of the top-requested documents are current licenses, drug invoices, and controlled substance inventory.

Keep in mind that many states also require you to keep fridge and freezer temperature logs...and compounding logs.

If you're unsure what your state requires, check your state board's website...look for their resources that help you prep for an inspection.

Be aware that regulatory agencies may also check Rxs for appropriate days' supply, drugs, and directions...and issue fines or other penalties for errors. Ensuring accuracy for every Rx you process...and clarifying " use as directed" sigs...will help prevent problems.

During an inspection. Ask for identification. Verifying proper ID helps prevent unauthorized entry into the pharmacy.

Get your pharmacist or pharmacy manager...and help retrieve requested documents or Rxs.

Answer questions honestly and concisely...and don't guess.

After an inspection. Most regulatory agencies give a time frame for any corrections to be completed. Work with your pharmacy manager to meet these deadlines...the inspectors may return to check compliance.

Get our new cheat sheet, Pharmacy Inspection Basics, for more advice on handling pharmacy inspections.

Key References

  • Int J Pharm Compd 2017;21(2):95-102
  • www.jointcommission.org/about/jointcommissionfaqs.aspx
  • www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm564681.htm
Pharmacy Technician's Letter. Oct 2017, No. 331013



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