Your Partner in DEA Regulatory Compliance
PharmaDiversion provides comprehensive DEA compliance consulting services designed to help pharmacies, physicians, manufacturers, treatment facilities, and chemical import/export operations meet federal regulatory requirements, strengthen recordkeeping and security controls, and prevent enforcement actions.
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Services for Pharmacies
PharmaDiversion will work with you and your pharmacy staff to ensure that your pharmacy is in compliance with federal laws and DEA regulations relating to the purchase and dispensing of controlled substances. DEA when performing unannounced inspections will review the pharmacy DEA required records, evaluate the security of controlled substances and evaluate the pharmacy “Due Diligence” policies pertaining to the dispensing of opioids as part of a patient pain management program.
RECORD KEEPING ELEMENTS
- Use of DEA 222 or Electronic Order Forms
- Invoices for CIII to CV Drugs
SECURITY ELEMENTS
- Alarm Systems
- Use of Cellular Back-Up Alarm
- Use of Internet Cameras
- Storage on Pharmacy Shelves
- Use of CCTV in Pharmacy Area
- Photo ID from Patients for CII / CIII Narcotics
- Use of Gates (interior / exterior)
- Access Card Usage
- Use of Pharmacy Technicians
- Background Investigation (pre-employment)
- Drug Destruction ( DEA From 41)
STORAGE
- CII Drugs vs CIII-V Drugs
- Use of Floor Safes & Cabinets
- Perpetual Inventory
- Drug Handling by Employees
- Storage on Pharmacy Shelves
- OTC Pseudoephedrine Products
- Pharmacy CMEA Certification
- CMEA Use of a Log Book
- CMEA Storage of Products
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.
