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Services for Narcotics Treatment Facilities
Narcotic Treatment Facilities operate under strict DEA regulations when dispensing Methadone and other controlled substances. PharmaDiversion supports your team in maintaining full compliance with DEA requirements, including recordkeeping, security, storage, and reporting. Our guidance helps prevent regulatory violations, safeguard patient safety, and protect your DEA registration during inspections or audits.
RECORD KEEPING ELEMENTS
- Use of DEA Forms 222 for CII Drugs
- Invoices for CIII to CV Drugs
- ARCOS Reporting
- Quotas (Bulk Manufacturers)
- Inventory Tracking Records
- Real-Time Tracking System
- Identifying Lots and Batches
- Use of Batch Records
- Expired Drugs
- Theft & Lost Reports (DEA Form 106)
- Drug Disposal
- Documenting Returned Products
- Manufactured Reject Products
- Reporting Excessive Purchases
- Reporting Suspicious Purchases
SECURITY ELEMENTS
- Alarm System/CCTV
- Employee Screening
- Employee Access to Controlled Substances
- Building Security
- Use of CCTV Systems
- Security Force
- Shipping / Receiving Dock Areas
- Waiting Area for Drivers
- Facility Exit / Entrance Doors
STORAGE
- Use of Safe
- Dispensing Log for Methadone
- Perpetual Inventory of each Methadone Bottle
- Annual / Quarterly Inventory
- Annual / Biennial Inventory
- Storage of Drugs to be Destroyed
- Expired Drugs
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.
