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Services for Chemical Import / Export
PharmaDiversion will work with your staff to ensure that you are in compliance with DEA guidelines relating to the IMPORTATION and EXPORTATION of List I/List II regulated chemicals, their storage, their handling, and required DEA reporting of its distribution.
RECORD KEEPING ELEMENTS
- Registration Issues
- DEA Forms 486
- Initiated
- Amended
- Withdrawn
- Domestic Sales and Transactions
- Customer Required Information
- DEA Registered Customer/End-Users
- Use of External Warehouse
SECURITY ELEMENTS
- Means of Diversion of Chemicals
- Facility Storage Areas
- Methods of Transportation
- Security of Harbor Warehouses
General questions
A Mock DEA Inspection is a full-scale simulated DEA compliance audit that mirrors the process of an actual unannounced DEA visit. It helps identify weaknesses in recordkeeping, inventory control, security systems, staff procedures, and due-diligence policies before DEA identifies them. This proactive approach protects your DEA registration, prevents costly enforcement actions, and strengthens internal compliance systems.
Some of the most frequent violations include incomplete or inaccurate inventory records, improper use and handling of DEA Forms 222 and 41, inadequate security measures for controlled substances, poor due-diligence documentation, insufficient staff training, and failure to report loss or theft in a timely manner. Correcting these issues early can significantly reduce legal exposure and operational risks.
Due diligence requires registrants—such as pharmacies, physicians, and treatment centers—to verify that prescriptions for controlled substances are legitimate and medically necessary. This includes reviewing prescription details, validating prescribers, confirming patient identity, monitoring patterns of potential misuse, and documenting all verification actions. Failure to demonstrate due diligence is a common basis for DEA investigations and penalties.
Yes. PharmaDiversion provides post-inspection support including corrective compliance plans, remediation of deficiencies, staff education, policy development, inventory corrections, and assistance in responding to DEA requests. Our goal is to help facilities regain compliance quickly and prevent further administrative, civil, or criminal exposure.
Facilities must maintain accurate records such as DEA Forms 222, 41 and invoices for CIII–CV drugs, perpetual and biennial inventories, ARCOS reporting (where applicable), theft/loss reports (DEA Form 106), and documentation of disposed or returned products. A complete inventory is required every two years, but many facilities perform quarterly or perpetual inventories to ensure accuracy and prevent diversion incidents.
