DEA Audits and DEA Inspections Lawyers

Controlled substances are classified into five schedules according to their potential for abuse, medical usefulness, and safety. Pharmacies must obtain a license from the DEA in order to dispense controlled substances, which are also subject to other regulations. In addition, pharmacies and pharmacists must comply with state laws, which often mirror the federal regulations.

DEA Audits

The DEA typically audits pharmacies to ensure compliance with the Controlled Substances Act and the DEA’s own regulations. Audits are also typically initiated when there are concerns about a specific pharmacy or pharmacist. These audits are meant to review a pharmacy’s compliance with the applicable regulations. They typically involve a review of the pharmacy’s license, recordkeeping, and security procedures. The DEA will also look at the manner in which controlled substances are controlled, stored, and dispensed. If the DEA finds that a pharmacy is in compliance, the audit will be closed. If the audit reveals that a pharmacy has committed an infraction, the DEA may initiate disciplinary proceedings to impose a civil fine or revoke the pharmacy’s license.

DEA Investigations

In addition to audits, the DEA regularly conducts investigations of pharmacies and pharmacists based on reports of suspicious activity or illegal dispensing of controlled substances. These investigations typically involve interviews with the pharmacy’s employees, customers, and other pharmacies in the area. The DEA will also look at the pharmacy’s recordkeeping procedures and the manner in which it controls and stores controlled substances. If the DEA finds that a pharmacy or pharmacist has committed an infraction, it may initiate disciplinary proceedings to impose a civil fine or revoke the pharmacy’s license.

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Legal Scenario: What Would You Do?

Scenario

Federal agents execute a search warrant at your medical practice, seizing patient records and prescription logs.

Can they take patient records without patient consent?

Attorney's Answer

A valid federal search warrant overrides HIPAA privacy protections. However, the warrant must be properly scoped. An attorney can challenge overly broad warrants and move to suppress improperly seized evidence.

This is general information only. Contact us for advice specific to your situation.

DEA Inspections