DEA decides on Schedule IV classification for tramadol
Effective Aug. 18, tramadol will be considered a Schedule IV controlled substance according to a new rule published by the Drug Enforcement Administration (DEA) on July 2.
The decision means that veterinary professionals who handle tramadol or tramadol-containing substances will be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to Schedule IV controlled substances, the DEA reported in its Federal Register.
The agency said the Aug. 18 deadline is the conclusion of a 45-day period during which those handling tramadol need to ensure compliance with registration, security, recordkeeping, and reporting requirements.
According to a blog post from Lynne White-Shim, DVM, assistant director in the AVMA’s Scientific Activities Division, the DEA reached its decision after conducting an eight-step analysis, in which it decided that compared to Schedule III drugs, tramadol has a low potential for abuse. The agency also concluded that abuse of tramadol may lead to limited physical or psychological dependence compared to Schedule III controlled substances.
How the updated tramadol classification affects veterinary professionals
The final rule states that any person who handles (manufactures, distributes, dispenses, imports, exports, engages in research, or conducts instructional activities) tramadol, or who wants to handle tramadol:
- Must be registered with the DEA or have an approved application as of Aug. 18.
- Must take an inventory of all stocks of tramadol on hand as of Aug. 18, if the DEA registrant possesses any quantity of the substance.
- Must maintain records in compliance with applicable rules.
If a person possesses tramadol but does not wish to handle the substance, they must surrender their stock of the drug in accordance with 21 CFR 1307.21 or transfer all quantities of tramadol to a person registered with the DEA by Aug. 18.
After Aug. 18, manufacturers must mark all bottles of tramadol with “C-IV”, and it will be unlawful for commercial containers of tramadol to be distributed without that designation.
White-Shim explained in her blog that the new classification of tramadol means that beginning Aug. 18, veterinarians without DEA registration numbers will not be able to prescribe tramadol nationwide. Administration and dispensing from the clinic can still be done by non-DEA registrant veterinarians if acting as authorized agents. She also encouraged veterinarians to follow their state rules, as individual states are sometimes more stringent.