An audience-engagement tactic I like to use during live events is to present a slide showing commonly used drugs in veterinary medicine. I ask attendees to identify the scheduling of each controlled substance. The exercise gets people to interact and debate. I have played this interactive game for years now, and it’s always an eye-opener. I once assumed that veterinarians and credentialed technicians would know each drug’s schedule and not fall for my trick questions. Unfortunately, my assumption about DVMs as gold-star students was wrong. For the most part, practice managers and technicians are familiar with the schedules, as they often handle drug ordering, receiving and inventorying on behalf of veterinarians.
To be clear, controlled substances are not created equally, particularly in how they are scheduled. If you don’t know the classifications of the drugs you work with, you set the stage for a litany of noncompliance violations that will compound and snowball.
Federal Scheduling
Federally scheduled controlled substances fall into one of five descending categories (I, II, III, IV and V). The factors include a drug’s medical efficacy, safety, potential for abuse and diversion, and physical and psychological dependency.
The U.S. Food and Drug Administration and the Drug Enforcement Administration are involved in the scheduling. The FDA evaluates the scientific and medical evidence associated with a drug’s accepted medical uses, potential for abuse, risk of dependence and pharmacological effects. Those findings serve as recommendations to the DEA regarding whether a drug should be scheduled and how. The DEA is not bound by the FDA’s recommendations and has the final say.
State Scheduling
States typically align with the DEA’s controlled substance scheduling framework but may enact additional regulations. When scheduling controlled drugs, states can:
- Follow the DEA schedules. Maine, Nevada, Texas and the District of Columbia are examples of places where controlled substance schedules mirror the federal classifications.
- Enact more restrictive schedules. State scheduling and enforcement of certain drugs is rising due to the opioid epidemic and increased risks of diversion, abuse and addiction.
- For example, the following drugs are controlled substances in various states but not federally:
- Gabapentin: Schedule V in Alabama, Kentucky, Michigan, North Dakota, Tennessee, Virginia and West Virginia
- Propofol: Schedule IV in Alabama, Georgia and North Dakota
- Proin (phenylpropanolamine hydrochloride): Schedule V in Mississippi, Louisiana, West Virginia, Iowa and Arkansas. In Oregon, phenylpropanolamine, the active ingredient in Proin, is Schedule III.
States can also vary significantly in how they schedule a substance. Xylazine is a controlled substance in eight states.
- Schedule I: Florida
- Schedule III: Delaware, New Jersey, Ohio, Pennsylvania and South Dakota
- Schedule IV: West Virginia
- Schedule V: Rhode Island
In some instances, a state may schedule a controlled substance at a level higher than its federal classification. South Dakota did it in 2023 with pregabalin (Lyrica), moving it to Schedule IV from DEA Schedule V and making it subject to more stringent requirements and legal repercussions.
Conflicting Classifications
Federal scheduling is a baseline requirement that must be followed in all states. However, differences in how federal and state laws classify substances sometimes lead to challenges and conflicts. The ongoing debate over cannabis and marijuana is an example.
Federally, cannabis remains a Schedule I controlled substance even though 39 states legalized it for medicinal use and 24 for recreational use. The contention is ongoing, particularly over how cannabis laws are enforced.
Schedule-Based Reporting
In some states, a substance may not be scheduled at the state level but can still have requirements for how it is prescribed, dispensed and reported. For example, gabapentin is not a state-scheduled controlled substance in Wyoming, but a prescription for it must be reported to Wyoming’s prescription drug monitoring program.
Connecticut doesn’t schedule gabapentin as a controlled substance, but dispensing the drug there must be revealed to the Connecticut Prescription Monitoring and Reporting System in the same way other DEA-controlled substances must be reported (weekly for veterinarians and daily in human health care).
At other times, states that follow DEA scheduling use their prescription drug monitoring programs for enhanced oversight. For example, California follows DEA scheduling frameworks but requires any dispensed controlled substance to be reported to the Controlled Substance Utilization Review and Evaluation System within one working day.
Drugs of Concern
In addition to DEA-controlled substances, veterinarians frequently work with drugs that might be scheduled at the state level only or not scheduled. However, those drugs are at risk for diversion and abuse due to their ability to be taken in conjunction with controlled substances. Drugs of concern, while not subject to the same penalties as DEA-scheduled controlled substances, should not be dismissed. Whether or not scheduled at the state level, they include gabapentin, medetomidine, dexmedetomidine, propofol, Proin, trazodone and xylazine.
That’s a lot of information to digest, but you must understand it to comply with DEA and state regulations. Knowing how the drugs you prescribe are scheduled is imperative, as is how you order, inventory, log, secure, store, waste and dispose of them.
The “D” in DEA and FDA stands for drugs. Failing an inspection could result in significant fines and the possible loss of your DEA license.
SOME DEA-CONTROLLED SUBSTANCES
- Schedule II: fentanyl, hydrocodone, hydromorphone, morphine, oxycodone, pentobarbital
- Schedule III: buprenorphine (including Simbadol in liquid form and topical Zorbium), ketamine, telazol, Tylenol with codeine (containing less than 90 milligrams of codeine per dose)
- Schedule IV: butorphanol, diazepam, midazolam, phenobarbital, tramadol, oxazepam
- Schedule V: pregabalin (Lyrica), cough medicine containing certain amounts of codeine
OTHER REQUIREMENTS
The higher a controlled substance is on the schedule, the harsher the potential penalty. Always keep these requirements in mind.
- Licensing and registration: Practitioners and entities that order, store and prescribe federally controlled substances must have a DEA registration and all required state licenses, permits or registrations. Failing to follow state-level rules can lead to state board violations, federal notification and DEA violations.
- Ordering: Schedule II controlled substances must be ordered by the DEA registrant or an individual granted power of attorney. The responsibility includes filling out and signing DEA Form 222 or using the DEA’s electronic Controlled Substance Ordering System and Form 222e.
- Security and storage: DEA-controlled substances must be securely stored and properly separated from non-DEA-controlled products, including drugs scheduled at the state level only.
- Recordkeeping: Records documenting all activities involving DEA-controlled substances must be maintained at the registered location for the current two-year period (or longer, depending on your state). Schedule II records must be retained separately from Schedule III, IV and V records and non-DEA-controlled substance records.
- Waste and disposal: Controlled substance waste remaining from administration, leakage, breakage, spillage or other event that renders a drug unusable or non-retrievable must be properly disposed of and undergo final destruction if expired or not entirely depleted.