Handling A DEA Investigation Of A Pharmacy

Tuesday, November 17th, 2015

Pharmacies in the U.S. rarely get visits from the U.S. Drug Enforcement Agency (DEA). Usually, the state authorities will handle inspections and enforcement of regulations concerning pharmacies. However, in cases of drug diversion from pharmacies, and in certain cases of “doctor shoppers” and forged prescriptions, the DEA may need to become involved.

Pharmacy owners and managers should have policies and procedures in place to handle a DEA investigation well before one happens. Being prepared will make the DEA investigation go faster and smoother. Preparation will protect the pharmacy, pharmacists, and other personnel and will keep the pharmacy and its operations within legal parameters. Pharmacies should understand what the DEA is authorized to do during an investigation and what will happen before, during, and after the investigation.

What is the DEA authorized to do during a typical investigation?

The Controlled Substances Act authorizes the DEA to inspect a pharmacy at reasonable times and in a reasonable manner. The DEA can investigate how controlled substances are received, managed, distributed, and stored. The DEA is also authorized to take samples of controlled substances to verify their authenticity and review documentation of shipments and distributions. Investigators are not authorized to inspect any financial, sales, or pricing data, unless authorized by the pharmacy owner or officer.

What happens before a DEA investigation?

If the DEA is performing an authorized inspection, the investigator must state his or her purpose, provide credentials, and present written notice of the inspection authority. Once the proper information has been supplied, the pharmacy representative may give permission for the investigation or refuse it. If the investigation is refused, the DEA representative can go to a judge or magistrate to ask for an administrative inspection warrant. This legal ability to force an investigation is authorized by the inspection clause in the Controlled Substances Act.

It is normally in the best interest of the pharmacy to consent to the DEA’s investigation. However, there are legitimate reasons for an investigation to be denied. These reasons include that the investigation is not during normal business hours or that there is no one available to speak about the pharmacy’s operations. If the circumstances prevent a DEA investigation, the pharmacy can request that it be done at another time.

Once the inspection starts, all personnel in the pharmacy should be informed of the DEA’s presence. All personnel should follow pharmacy protocols for DEA inspections and all interactions with the investigators should remain courteous and professional.

What happens during a DEA investigation?

An authorized person must accompany the DEA investigator at all times during the investigation. The authorized person may be the pharmacist in charge, the pharmacy owner, or other personnel familiar with policies, operations, and record-keeping. The authorized person should provide a single contact point for all communications with the DEA investigator and should make notes of all issues discussed.

The DEA investigator can inspect or copy documents related to the shipping, storage, and distribution of controlled substances. However, the investigator is not authorized to inspect or copy sales data, financial information, or pricing. The pharmacy has the right to decide if financial information will be available or not. The pharmacy should offer to make copies of documents and only provide them if requested by the investigator. The DEA investigator should not be given free access to the photocopy machine or to any pharmacy files.

The DEA can take samples of any controlled substances on the premises. If samples are taken, the pharmacy should take duplicate samples for review and testing. The investigator should be able to tell the pharmacy representative where the testing will be done and provide a receipt for any samples taken. The pharmacy is allowed to request reimbursement of samples of expensive materials. All materials related to a DEA inspection should be kept in one file and each inspection should have its own file to keep materials separate.

No one in the pharmacy should offer a gift to anyone on the DEA inspection team. There should also be no offers to go out for lunch. Both are strictly against the law for DEA investigators to accept. If gifts or meals are offered by pharmacy employees, an FBI investigation could be conducted.

What happens after a DEA investigation?

At the end of a DEA inspection, the investigator will review the findings and ask for comments. The pharmacy should avoid making any comments or commitments while the DEA is reviewing the investigation. The list of findings should be carefully reviewed and the pharmacy can provide a written response to the inspection at a later time.

It is not uncommon for the DEA investigator to find potential problems within most pharmacy operations. The best approach to avoiding issues after the investigation is to implement corrective changes without making any statements of noncompliance.

If your pharmacy needs to prepare DEA investigation policies or respond to an investigation, you need the help of an attorney familiar with these events. Contact Brown & Fortunato, in Amarillo, Texas. You can call us at (806) 345-6300 or visit our offices at 905 S. Fillmore, Suite 400. You can also learn more about our practice areas on our website or Contact Us by email.

This information is subject to change. Please check for updates that are more recent than the published date of this article.