Pharmacy is a world filled with regulations. The U.S. Department of Justice is just one agency enforcing some of those regulations and they can show up at your pharmacy at any time to confirm you are following them. Here are the basics of what they are looking for.
First, if they come there will always be a minimum of two people. No DOJ agent will come alone. Second, if your pharmacy has a registration insured for controlled substance dispensing they have the authority to inspect. They will, however, ask for your consent. You do have the right to refuse at that moment, but make no mistake if you do, they will be back.
Their inspection will consist of:
1. Reviewing your records.
In general they want to see how you handle your business and related documents. They will confirm you do your due diligence such as vetting your suppliers or employees. They will review your biennial inventory. TIP: be sure to include whether the inventory was done at beginning of business or close of business.
2. Performing an audit
The inventory must be spot on. It is a problem whether it is short or there is overage. TIP: Know where all the drug supply is. In the words of an inspector, “it should not be a treasure map adventure”. If the audit comes up short and then you remember you have some meds stored in a back room that does not make a great impression.
3. Reviewing storage and security
The premises must be secure. The security needs may be different but need to meet the needs of where your pharmacy is located. In other words, if you are in a high crime area you will need to show a higher level of security than a pharmacy in a lower crime area or one not street facing. You should know what you need to do to keep the place as secure as possible and you will be expected to do that. TIP: Call the local DEA if you have questions on whether you are doing enough.
One final TIP: Keep the documents you know they will ask for in a binder which is readily retrievable. It will take some pressure off and will also show them you are organized and handle your business with detail.
This post is related to:
Opioid Stewardship & Drug Diversion Prevention
