United States DEA Pharmacy Investigation Lawyer

Attorneys for DEA Audits and Inspections of Pharmacies Throughout the U.S.

The Drug Enforcement Administration (DEA) oversees matters related to controlled substances in the United States, and it regularly conducts investigations meant to prevent the unlawful distribution of these drugs. The DEA often looks at pharmacies as potential sources of drug diversion and drug trafficking. Regular audits are performed to ensure that pharmacies are following the correct procedures, or the DEA may investigate a pharmacy based on suspicious activity or reports of unlawful dispensing of controlled substances. Pharmacies and pharmacists should obtain representation from a skilled attorney to make sure their rights are protected during a DEA audit, inspection, or investigation.

The lawyers at The Law Offices of Joseph J. Bogdan, Inc. are highly experienced in pharmaceutical matters, and we regularly represent clients in cases involving DEA registration, professional licensing, PBM audits, DMEPOS accreditation, and other legal issues affecting pharmacies. Attorney Joseph Bogdan is a registered pharmacist and a trusted pharmacy consultant, and he often serves as an expert witness in pharmaceutical cases. With our understanding of pharmacy law, we can work with pharmacies to protect their DEA registration and avoid issues that could impact their ability to handle controlled substances.

Issues Addressed in a DEA Pharmacy Inspection

Before the DEA performs an audit or inspection of a pharmacy, it must receive informed consent from the holder of a DEA certificate of registration, or it must obtain an administrative search warrant. Before consenting to an investigation, a registrant should consult with an attorney who can advise them of their rights and make sure they understand what the DEA is allowed to do and what information should be provided to investigators.

A DEA investigation will often be focused on potential violations of the laws surrounding the dispensation of controlled substances while also reviewing a pharmacy's controls against the unlawful diversion of prescription drugs. An investigation may address:

• Ordering of controlled substances - A pharmacy is required to use the proper forms (DEA Form 222) or CSOS when ordering prescription drugs, and it should maintain records of all drugs that are ordered and received. A pharmacy is also required to maintain compliance with the Drug Supply Chain Security Act (DSCSA) by ensuring that all suppliers and distributors are licensed or registered and responding appropriately to any concerns about counterfeit medications.
• Inventory management - The DEA may review the controlled substances that a pharmacy keeps on hand and the procedures used to monitor this inventory and protect against drug diversion. A pharmacy is required to keep inventory records for at least two years.
• Prescription fraud monitoring - A pharmacy must have procedures in place to make sure the prescriptions it receives are valid. The DEA may look into concerns that a pharmacy has not properly investigated illegitimate or unnecessary prescriptions before dispensing controlled substances to patients. A pharmacy's patterns of filling prescriptions may also be investigated, including in cases where one doctor regularly sends prescriptions for a particular drug to the same pharmacy or where patients travel a significant distance to fill prescriptions at a pharmacy.
• Security - The DEA may review the measures a pharmacy has taken to prevent the theft of controlled substances, including while they are on the pharmacy's premises or while they are being transported.
• Transfer and disposal of controlled substances - A pharmacy must comply with all applicable regulations when transferring drugs to other parties or disposing of prescription medications. A pharmacy may be held accountable for improper drug disposal even if it has outsourced these tasks to another party.

Contact Our National DEA Pharmacy Inspection Lawyers

If the DEA is conducting an investigation of your pharmacy, The Law Offices of Joseph J. Bogdan, Inc. can make sure you respond correctly to any requests and avoid potential penalties. We will provide you with guidance on what information you should turn over, and we will help you protect against any issues that could threaten your DEA registration or your pharmacy license. Contact our office today at 630-310-1267 for a free consultation.