Delving into DEA regulations for veterinary practices

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It’s been said that once the Drug Enforcement Administration (DEA) gets into your practice, it can be difficult to get them out. Really difficult. The best way to keep them out? Follow controlled substance rules and regulations to a T. Easy enough, right? Gulp. That’s where Jan Woods, who is the cofounder of Ask Jan for Help (askjanforhelp.com) as well as the regulatory and practice operational consultant for Veterinary Business Advisors, comes to the rescue. In a recent multipart Fetch dvm360® virtual conference session sponsored by Epicur Pharma, Woods addressed some of the most common questions and issues that come up.

For example, do you know who takes precedence when setting the DEA controlled substance laws that impact your practice? Is it the state government, federal government, state pharmacy board, or state veterinary board? Answer: whichever organization has the most stringent regulations.

“You need to know which regulation is the most stringent and follow it,” said Woods. “That’s why it’s important that you know all of your state regulations plus the federal regulations. And keep in mind, not only do regs change frequently, they are often confusing and contradictory.” Gulp.

Even the seemingly simplest aspects of controlled substance regulations can make you scratch your head a bit and doubt yourself, which is perhaps why basic things like incomplete and inferior record keeping and failing to dispose of your controlled substances according to state and federal regulations are 2 of the most common violations cited by the DEA, with the former topping the list. Diving a bit deeper into these recurrent issues, Woods asked, “Do DVMs working at your hospital each have to have their own DEA number? What about relief vets?” Not sure? Read on.

Who does (and doesn’t) need to register with the DEA

Let’s start with the basics. Who can handle controlled substances? According to the DEA Pharmacist’s Manual, “Under the Controlled Substance Act, the term ‘practitioner’ is defined as a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which the practitioner practices or performs research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research. Every person or entity that handles controlled substances must be registered with the DEA or be exempt by regulation from registration.”¹

But that doesn’t describe the majority of practices. Summing up Title 21 Code of Federal Regulations (CFR) §1301.22, Woods noted that practitioners may dispense and administer controlled substances without a DEA number of their own only when acting as an employee or agent under the direct supervision of a practitioner who is registered with the DEA.² So, can an associate veterinarian without a DEA number legally administer or dispense a controlled substance using the practice owner’s registration? Yes (whether or not that’s a good idea is another story and is discussed below). Can they legally use the owner’s registration number to write a prescription? No. However, Woods noted that practitioners who are agents or employees of a hospital that is registered with the government as a hospital may administer, dispense, and even prescribe controlled substances using the hospital’s number, but this comes with a long list of stipulations.

Letting your associates practice without a DEA number is risky business

According to Woods, it’s best if everyone in your practice has their own DEA number, and it’s a policy she followed in her former position as a practice owner. For one, she doesn’t think it’s fair for the registered doctor to have to assume all of the responsibility for the actions of the practitioners dispensing and administering controlled substances with the registrant’s number. Additionally, what happens when the registered veterinarian is out for lunch, out sick, or on vacation? How can that person supervise when they’re off the premises? You’d have to know and follow your state’s regulations for direct, immediate, and indirect supervision in such cases, Woods said.

The waters get even murkier when it comes to keeping complete and error-free records—and, as you’ll remember, incomplete and inferior record keeping is one of the primary violations cited by the DEA. Woods said the DEA approaches its investigations primarily by following the controlled substances through the “closed system.” The organization looks at the company that makes the drugs, the distributor, the registrant who orders the drugs, how the controlled substances are received, how they’re secured, how they are logged, and finally how those drugs are dispensed or administered to the end user (eg, the pet or the pet parent). Properly demonstrating your role and compliance in this closed system requires detailed documentation, and all of your records and logs must match up. This obviously becomes more difficult when 1 doctor can prescribe and the other (or others) can’t—especially when you consider the need to show a valid veterinarian-patient- client relationship.

What about relief veterinarians?

Woods’ first piece of advice for relief veterinarians: Check your state requirements. “A lot of states require a separate state DEA number, as well as a federal number,” she explained. “Some states require that state number to be enacted before you have your federal number, or you can’t even get your DVM license.”

According to Title 21 CFR §1301.12(a), “A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person.”³ However, Woods said that the DEA has provided a limited exception to this requirement. “Practitioners who register at 1 location in a state but practice at other locations within the same state are not required to register with the DEA at any other location in that state at which they only prescribe controlled substances,” she continued. “But if they maintain supplies of controlled substances, administer, or directly dispense controlled substances at a location, practitioners must register at that location.”³ Again, she reminded the doctors to check their state regulations, as they can differ from state to state.

If you’re hopping between multiple states and practices, Woods said it’s a good idea to talk to the registration division of your local DEA office. But in general, she said that relief practitioners who plan to administer, dispense, or prescribe controlled substances in more than 1 state have the following options: They may obtain a separate DEA registration in each state where they plan to administer, dispense, or prescribe controlled substances, or they may transfer their existing DEA registration from 1 state to another as needed by contacting the DEA Registration Service Center (800-882-9539) or visiting DEAdiversion.usdoj.gov.

“If you’re a relief doctor doing home visits, the DEA told me that the doctor must be registered with the DEA at their home address,” Woods explained. “The DEA also told me to tell each relief DVM that they must follow all applicable state and federal controlled substance regulations and be prepared for an audit within your home.”

While DEA-registered veterinarians are permitted to transport, administer, and dispense controlled substances to unregistered locations, such as a client’s home or pasture, Woods noted that they cannot take them to a location where another DEA registration is in force. For example, she continued, if you’re doing relief work at ABC Clinic and they have their own controlled substances, you are to use their controlled substances and not bring your own supply into the clinic.

And what do practice owners need from relief veterinarians? According to Woods, practice owners, medical directors, or practice managers should have copies of the following documents in a file for each relief DVM providing veterinary services at the practice:

• Their current DVM license
• Their current DEA license
• Their current state DEA license (if you’re in a state where one is required)
• Their professional liability insurance (PLIT)

One more way you can avoid transgressing DEA registration rules

Here’s a simple way to avoid a visit from the DEA: Stay up to date on your veterinary license. “Did you know that if you are late renewing your veterinary license, most veterinary boards are obligated to report your unrenewed DVM license to the DEA,” Woods said. “Why? Because if you don’t have a license to practice veterinary medicine, you certainly can’t have a DEA license.”

Sarah Mouton Dowdy is a freelance writer and editor in Kansas City, Missouri.

References

1. Pharmacist’s manual: An informational outline of the Controlled Substances Act. US Department of Justice Drug Enforcement Administration Diversion Control Division. 2020. Accessed December 7, 2020. https://www.deadiversion.usdoj. gov/pubs/manuals/(DEA-DC- 046)(EO-DEA154)_Pharmacist_ Manual.pdf
2. US Department of Justice Drug Enforcement Administration Diversion Control Division. Exemption of agents and employees; affiliated practi- tioners. CFR §1301.22. March 24, 1997. Accessed December 7, 2020. https://www. deadiversion.usdoj.gov/21cfr/ cfr/1301/1301_22.htm
3. US Department of Justice Drug Enforcement Administration Diversion Control Division. Separate registrations for separate locations. CFR §1301.12. Amended December 30, 2016. Accessed December 7, 2020. https://www.deadiversion.usdoj. gov/21cfr/cfr/1301/1301_12.htm