Firms handling controlled drug substances are regulated under 21 CFR Parts 1300-1321 and must comply with all associated DEA regulations. Our experts include former DEA Diversion Investigators. We are available to visit your site and help with the activities listed below. We also provide remote consulting and provide training both on-site at companies and at off-site seminars. While on-site our experts will tour your facility and make recommendations on material flow, storage, security, facility design, and personnel, and will meet with DEA team members to answer questions and provide advice on areas of concern. Our experts can help you with creating procedures that meet the needs of your particular organization. Our experts are available to visit if there is concern about theft or diversion and can work with you and your local field division, when needed. If requested, on-site visits can include training for employees.
We can assist with:
- Guidance for DEA registration
- Creating procedures for employee screening (background checks)
- Creating procedures to lessen the chances for diversion
- Authoring new SOPs or reviewing existing SOPs
- Facility Design
- Ensuring DEA security requirements are met
- Record keeping
- Quota – Manufacturing and Procurement
- YERS: Year-End Reporting
- Controlled Substances Receipt, Storage, Handling and Shipping
- Inventory Requirements
- DEA Accountability Procedures
- CSOS: Controlled Substance Ordering System
- SOM: Suspicious Order Monitoring
- KYC: Know Your Customer
- Preparing your staff for an unannounced DEA inspection
- In addition to our DEA consulting we can provide on-site training and can conduct DEA audits.
Click here to learn more about our DEA training.