5 Tips for Acing a Board of Pharmacy (BOP) Inspection

Nothing throws off your day quite like a surprise visit from the Board of Pharmacy (BOP). One moment you’re having a typical shift. The next, you’re scrambling to answer the inspector’s questions all while prescriptions are backing up.

With the right preparation, you can turn these inspections from stressful events into just a routine check-in. Having everything organized, accessible, and ready to go will help you, as well as the inspector. They’re just as ready to check your pharmacy off the list so they can move on to the next stop.

Navigating a BOP inspection

When a BOP inspector arrives, be sure to ask them for official identification. It's best practice to ensure that the person entering your pharmacy is authorized to conduct the inspection.

If you’re not the Pharmacist-in-Charge (PIC), it’s a good idea to notify your PIC and any other supervisors if the PIC is not on duty. Escort the inspector to a designated area of your pharmacy and begin the process once they’re verified.

Why the BOP may inspect your location

Pharmacy inspections can happen for several reasons, including:

• Routine yearly or bi-yearly compliance check

• Follow-up from a previous inspection

• Change in pharmacy ownership

• Reported incidents or complaints

• Suspicious activity

• High-risk medication preparation, such as sterile products

Regardless of the reason, the inspector can review anything in your pharmacy for state and federal regulations.

How long does a BOP inspection take

Even for a pharmacy in good order, an inspector can take up to 1 hour of work time — or more. The timing depends on your pharmacy’s size, the quality of your recordkeeping, and reason for the inspection. Being well-prepared and cooperative can help the inspection go quickly.

Here, we’ll review five tips to help you pass a BOP inspection with flying colors.

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1. Have a designated inspection specialist

Every pharmacy should have a designated inspection specialist. Having a go-to team member keeps the pharmacy ready for inspection. It also promotes accountability.

Inspection specialists are typically a PIC or lead technician. They should be familiar with all recordkeeping systems, policies, and procedures. They should also ensure that all staff pharmacists and technicians are up to date on pharmacy regulations.

Tip: Consider signing up for your state BOP’s email newsletter, if they have one. This is a streamlined way to stay in the know on state regulation changes when they happen.

2. Create and keep a compliance binder

Keeping a dedicated location for compliance documents is one of the most effective ways to be ready for an inspection. You can store these documents in a large binder or file box. Be sure to label each document and use sheet protectors when necessary. The entire pharmacy staff should know where your compliance collection is located so you’re still ready for the inspection in case your compliance specialist isn’t working.

Your compliance collection should contain everything an inspector could ever ask for. Here’s some important items to include in your compliance binder or file box:

• Table of contents or labeled tabs (so the inspector can easily navigate the binder)

• Locations of all records that aren’t in the compliance binder

• Pharmacy policies and procedures

• State-specific record requirements

• General and professional liability insurance

• List of current staff and certificates and/or licenses

• Training documentation

• Pharmacist key log

• Most recent controlled substance inventory

• Drug Enforcement Administration Power of Attorney and controlled substance ordering system (CSOS) documentation

3. Ensure records are labeled and easy to find

It’s best to clearly and specifically label all areas and containers where records are kept. Physical records should be filed front-facing so they’re easy to locate at a glance. Make sure they’re in chronological order, too.

For example, your invoices for C3-5 medications can be stored in a box labeled “C3-5 Controlled Substance Invoice Records” — making sure to also highlight the associated date range and retention time.

Organized labeling helps ensure that anyone can quickly find what they need without confusion. It also lowers the risk of misplacing important records. The labels should include the record title, date range, and when the document can be destroyed or archived based on your state’s regulations.

4. Clean up and maintain your archived records

Too many pharmacies “send and forget” their archived records, meaning the records are sent to storage without ever reviewing them again.

Unfortunately, this can expose the pharmacy to liability. This is especially true if an inspector asks for records that have been stowed away or when records are kept longer than they should be. If the minimum number of years to keep records has been reached, discard those records; otherwise, they’ll become a liability.

Whether your records are sent off-site to a warehouse via third party or are stored on-site in a storage room, ongoing maintenance is key. It’s a good idea to keep a log, either physically or digitally, of your records. This allows you to track what records enter storage, when they were added, and when they should be removed. If you keep a paper log, be sure to keep that log in the compliance binder or filing system.

What’s more, you can schedule a routine review of your records once a month or once a quarter. Use this time to assess what records are due for archiving or disposal according to your state’s retention policy. And many off-site storage vendors have an online portal for you to track boxes, which is the best way to maintain archived records.

5. Review the BOP inspection checklist

Many U.S. states publicly post their pharmacy inspection checklists on their websites. This is not only for the inspector, but also as a tool for PICs to audit themselves. After all, the primary role of the BOP is to protect the public’s health. By preventing compliance mistakes, the board can further that mission.

Make it a point to print out the inspection checklist once or twice a year and use it to conduct a thorough internal review. Go through each item as if you were the inspector. For each item on the checklist, write a brief response noting whether you meet the requirement. And if not, create a plan for what needs to be updated to be compliant.

Good to know: Inspection checklists are updated regularly as laws change. So, in addition to helping you maintain compliance with existing laws, printing the checklist will also help you keep up with changing laws.

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Written by:

Sheila Marie, PharmD

Sheila Marie, PharmD, is a licensed pharmacist in Virginia, New York, and the District of Columbia. She has worked in the pharmacy industry for 12 years and currently works as a community pharmacist.

Edited by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.

Reviewed by:

Christina Aungst, PharmD

Christina Aungst, PharmD, is a pharmacy editor for GoodRx. She began writing for GoodRx Health in 2019, transitioning from freelance writer to editor in 2021.

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