Skip to content
English
Contact us
  • There are no suggestions because the search field is empty.

Overview of DEA Audits

A quick reference to what DEA audits involve, what inspectors review, and how pharmacies can stay compliant with controlled substance regulations.

Related Links

For additional resources to support DEA Readiness, click HERE

Overview

The Drug Enforcement Administration (DEA), through its Diversion Control Division, oversees registrants that handle controlled substances to ensure compliance with federal regulations.

The Controlled Substances Act (CSA) establishes policies governing the manufacturing, distribution, importation, exportation, and use of controlled substances. Its purpose is to prevent diversion into the illicit market while ensuring availability for legitimate medical and scientific use.

Pharmacies play a vital role in preventing misuse and diversion. All staff members are responsible for maintaining compliance and protecting public health.

DEA Audits

DEA pharmacy audits may occur randomly and without prior notice. Pharmacies should remain audit-ready at all times by maintaining accurate documentation, proper procedures, and regulatory compliance.

Common DEA Audit Inspection Areas

Licensing and Credentials

  • DEA registration

  • State pharmacy license

  • Pharmacist licenses

  • Pharmacy technician licenses

Personnel and Training

  • Pre-employment screening procedures

  • Staff training on controlled substances compliance

  • CMEA training and self-certification

Security and Storage

  • Physical security of the pharmacy

  • Secure storage of controlled substances

  • Measures to prevent theft and diversion

Controlled Substance Ordering

  • DEA Form 222 (paper)

  • Electronic ordering (CSOS)

Inventory Requirements

  • Initial inventory

  • Biennial inventory

  • Perpetual inventory systems

  • Inventory updates for:

    • Change of Pharmacist-in-Charge (PIC)

    • Changes in drug scheduling

Recordkeeping

  • Receiving records (DEA Form 222, invoices, purchase orders, packing slips, CSOS)

  • Dispensing and distribution records

  • Return records

  • Destruction records (DEA Form 41, waste logs, reverse distributor documentation)

Prescription Records

  • Controlled substance prescription documentation

Inventory Audits and Reporting

  • Physical inventory counts

  • DEA Form 106 (reporting theft or significant loss)

Supplier Documentation

  • Supplier list including name, address, and DEA registration number

Key Takeaway

Consistent compliance, accurate recordkeeping, and secure handling of controlled substances are essential for passing DEA audits and preventing diversion.

 

Disclaimer: These tools and templates are intended for general informational purposes and are provided by Montana Family Pharmacies as a service to pharmacies. While we try to keep the information timely and accurate, we make no guarantees. These tools and templates are not a substitute for legal, regulatory, or professional advice. 

Policies and procedure, templates, checklists, and other tools should be customized to fit the specific needs and regulatory requirements of your pharmacy. 

Montana Family Pharmacies disclaims any liability for any damages, losses, or other consequences arising from the use or reliance on the tools or policy templates.