Addendum 7/3/2014: Updated to include information on prescribing and recordkeeping requirements.*
Today the Drug Enforcement Administration (DEA) published its decision to schedule tramadol as a Schedule IV controlled substance. The rule becomes effective August 18 of this year. The DEA’s action was fairly swift, having published its proposal to schedule tramadol just eight months ago (see blog post from November 2013). Upon conducting its eight-step analysis, the DEA found that relative to Schedule III drugs, tramadol has a low potential for abuse and limited physical dependence, and coupled with tramadol’s medical legitimacy, DEA determined Schedule IV to be the most fitting for tramadol.
In its final rule, DEA recognized the use of tramadol and other tramadol-containing products for management of moderate to moderately severe pain. It also defines tramadol as an ‘‘opiate’’ which means DEA believes tramadol is capable of triggering addictions similar to morphine. In veterinary medicine, tramadol has been used in pain control protocols, especially in dogs and cats.
So what does this mean for veterinarians who regularly utilize tramadol in their practices? In some cases, drug-label mandates could cause disruptions in commercial availability. Conversely for tramadol, its scheduling is expected to be helpful from a distribution standpoint, as current differences across state rules have reportedly been logistically challenging for veterinary distributors. In fact, in January of this year, the American Veterinary Distributors Association indicated its support for DEA’s consideration to schedule tramadol, in part, because distributors will be able to operate more efficiently and consistently nationwide.The DEA provided for a slightly extended 45-day window of time for drug sponsors to incorporate a “C-IV” on the label, and for distributors to deplete their current stocks of non-controlled tramadol. As of August 18, containers of tramadol will be labeled with a “C-IV” and all applicable DEA requirements will apply. Remember also to follow state rules, which might be more stringent.
*Tramadol’s scheduling also means that veterinarians who do not have a DEA registration number will not be able to prescribe tramadol nationwide, effective August 18. (Administration and dispensing from the clinic can still be done by non-DEA registrant veterinarians if acting as authorized agents.) Recall that for veterinarians who do have a DEA registration number, Schedule IV substances can be prescribed via written prescription, fax, or call, if acceptable within state rules. Limited refills are acceptable for Schedule IV substances. Biennial inventory and recordkeeping requirements for Schedules III-V also will apply for tramadol. Check DEA’s rules for full details.
For more information on how to comply with DEA rules, see AVMA’s Veterinary Compliance with the Controlled Substances Act and the DEA (member login required) for more detailed information about DEA registration, and and recordkeeping requirements.