By Jamie Davis, CVPM
Thoughts of a DEA agent walking into our practice to do a site visit sends most veterinary managers and practice owners into a cold sweat. It is no wonder, with a predicted average of 11 violations per practice and a fine up to $15,691 per violation, the impact is substantial (Detweiler, 2023). Let’s take a moment to breathe now, because this might be news to some of you reading this. I want to remind you of the title, we are going to take a “paws” (pun intended) and not panic. We have guidelines to follow! The Code of Federal Regulations and the Controlled Substance Act. While reading these documents might feel as exciting as flipping through stereo instructions (and equally effective as a sleep aid), let’s simplify things by focusing on the key areas that will help you establish or evaluate your DEA compliance program.
Some important facts to start with. First, the DEA registrant is always responsible for the controlled substances that have been purchased/handled/dispensed under their registrant number. I don’t want to bypass the fact that having a DEA registration is a big deal and a big responsibility. It might be commonplace and viewed as necessary to provide comprehensive veterinary care, but it is still something that is issued to the individual by a federal agency after they have met a series of requirements AND accepting all the responsibilities that go along with it. A single DEA number can be collectively used at a location to order, administer and dispense controlled substances but you must have an individual DEA number to prescribe (Young, 2023). Some consider it the lowest risk and a best practice to have every DVM employed by a facility to carry their own DEA license. Second, always check state regulations for the handling of controlled substances. Federal guidelines set the minimum requirements, but states can enforce stricter regulations. Finally, a valid state veterinary license is required to obtain a DEA registration, so it’s critical not to let your veterinary license lapse. Lapsed licenses are reported to the DEA, potentially putting you at unnecessary risk.
Maintaining Accurate Records
All required forms and documentation can be located and provided quickly and easily.
This includes inventory counts, purchase documents, use logs, and disposal records. These documents should be ‘readily retrievable’, meaning that they are accessible, separated from other records (when indicated), and provided when requested without excessive delay. Go through the list below to help you determine the status and retrievability of your records.
- DEA License
- Address specific to the practice location
- Current (not expired)
- Schedule I and II controlled substance logs
- 2 years (federal) or longer (check state requirements)
- Kept separate from other records
- Schedule III-V controlled substance logs
- 2 years (federal) or longer (check state requirements)
- Kept separately from other records
- Biennial Inventory Log (every 2 years at minimum)
- 2 years (federal) or longer (check state requirements)
- Completed by DEA registration or power of attorney with authorized witness
- Check state for additional requirements
- DEA 222 forms
- Completed
- Stored in a locked file cabinet
- CSOS forms
- Invoices & packing slips for controlled substances purchase
- Signed and dated upon receipt
- Separated schedule I & II
- Stored in a locked file cabinet
- Disposal records of controlled substances that have not been designated for a patient (e.g. expired drugs).
Audit Records
Drug logs are audited regularly.
Make sure logs are up to date, all required information is present, and errors or losses have been investigated in a timely manner. Your logs should tell the story of every controlled substance that has been and is currently in your possession. You need to show that when parts of that story are missing, action is taken. Don’t let the DEA be the one to find those gaps. Use the list below to audit your controlled substance logs.
- Up to date - real time whenever possible, but no longer than the same day. Logs DO NOT go home with anyone, ever.
- No missing information
- Account for waste
- Hub loss (use a formula and be consistent)
- Expired drugs that were not used/dispensed
- Non-retrievable (cannot be repurposed)
- Reconciliation (at least weekly)
Staff Training in Hospital Procedures and Proven Process
All staff have been trained in controlled substance handling.
Regardless of position, it is important that all team members know what controlled substances are and how they are to be handled in your hospital, even if their position does not require them to handle them physically. Think of this like a fire drill. We want staff to know what to do, how to act, and who to ask if faced with an issue involving controlled substances. This list is a starting point for your controlled substance training program.
- Controlled Substance Standard Operating Procedure
- Controlled Drug Logging Procedure
- Controlled Drug Destruction Procedure & Log
- Controlled Drug Key Authorization Form
- Controlled Drug Non-compliant waste investigation procedure
- Controlled Drug shipment receipt process
- Controlled Substance Biennial Inventory process & log
- Team training log documenting all team members completion of training upon hire and annually thereafter.
- Controlled Substance DEA reporting process
- Roles and responsibilities for controlled substance management
Security and Storage
Effective controls and procedures are in place to prevent theft and diversion of controlled substances.
The DEA provides detailed description of some of these controls, but not all. Make sure that everything from staff selection to how controlled drugs are stored to how issues involving loss have been addressed. Go through the security checklist for your location to evaluate the status of your controls surrounding controlled substances.
- Employee Selection
- Background Check (not required by the DEA, but strongly recommended)
- Drug Testing (not required by the DEA, but strongly recommended)
- Screening Statement Completed (DEA Title 21 CFR section 1301.90)
- Training/Personnel
- Written policies and procedures outlining controlled substance handling and record keeping requirements.
- Consistent employee training that is documented at time of hire and annually.
- Theft/Diversion prevention
- Division of duties (the person that orders is not the same person that receives).
- Utilize double verification (two authorized team members) whenever possible.
- Report unresolved discrepancies or significant loss within one day using DEA Form 106.
- Dispose of un-used product with appropriate pharmaceutical waste disposal product (e.g. RxDestroyer, Cactus Sink) and record in the log with two witnesses (Gochenauer, 2024).
- Dispose of expired products with reverse distribution company.
- Maintained logs with regular reconciliation, annual inventory and biennial inventory.
- Storage
- Controlled substances are security stored in a unit that is permanently affixed or secured to an immovable object that utilizes appropriate key or code to access (based on location and access to that area in the building).
- Transportation of controlled substances off premises, such as a house call, ensures that drugs are secured during transit and any unused product is returned to primary storage immediately after use and usage is documented (Detweiler, 2023).
- Schedule II controlled substances are separately stored
- Do not commingle non-DEA schedule drugs with controlled substances in storage, even if they are controlled at the state level (Detweiler, 2023).
- Shipments of controlled drugs are entered into inventory immediately by authorized employee or securely stored until they can be.
- Expired drugs are securely stored before destruction.
- Dispensed drugs are securely stored before pick-up.
- Physical Security
- Electric Alarm System that is functional
- Self-closing/self-locking exterior doors
- Doors are not propped open
- Security cameras are used
- Positioned correctly to show activity around controlled substance storage/use/documentation.
- 60-90 days of retrievable security footage (best practice)
Achieving and Maintaining Compliance
As discussed at the beginning of this article, these lists provide a solid foundation for identifying potential DEA violations related to your controlled substance policies. They can also guide you in developing these policies for a new practice. However, the ultimate responsibility for complying with all federal and state regulations rests with the DEA registrant. I strongly recommend further review of the DEA Diversion Control Division website, including their Q&A section, as well as consulting local resources such as your state veterinarian, state veterinary practice act, and your area veterinary medical association. Staying informed about regulatory changes is crucial for protecting yourself from costly violations in the event of a DEA inspection.
Disclaimer: Jamie is not a DEA agent or DEA specialist. Specific questions should be directed to the DEA Diversion Control Division at 1-800-882-9539 or DEA.Registration.Help@dea.gov.
About the Author
References:
Detweiler, K. (2023, November 30). 10 ways to get on the DEA’s naughty list. Today’s Veterinary Business. https://todaysveterinarybusiness.com/dea-lets-talk-drugs-1223/
Gochenauer, A. (2024, March 6). Common DEA violations - and how to avoid them. Veterinary Medicine at Illinois. https://vetmed.illinois.edu/2024/03/06/common-dea-violations-and-how-to-...
Young, N. (2023b, November 14). The use of controlled substances in veterinary medicine with dr. Natalie Young, PharmD, BCSCP, FACVP: Vetgirl veterinary continuing education blog. VETgirl. https://vetgirlontherun.com/the-use-of-controlled-substances-in-veterina...