Tramadol moves to Schedule IV classification

The Drug Enforcement Administration (DEA) ruled this week that the pain reliever tramadol is now classified as a Schedule IV controlled substance (CS).

The DEA final rule comes after 13 states, including Arkansas, Mississippi, and New York, already opted to list tramadol as a controlled substance. In fact, just this week, Ohio reclassified tramadol as a Schedule IV substance, effective September 1, 2014.

Starting August 18, 2014, the DEA will require manufacturers to print the “C-IV” designation on all labels that contain 2- [(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol (tramadol). Plus, pharmacists and other DEA registrants “who possesses any quantity of tramadol on the effective date of this final rule: must take an inventory of all stocks of tramadol on hand as of August 18, 2014,” according to the DEA final rule.

In addition, all “prescriptions for tramadol or products containing tramadol must comply with 21 U.S.C. 829.”

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Tramadol has become quite a problem for law enforcement, as many abusers have switched from hydrocodone products to tramadol. In fact, the Ohio Automated Rx Reporting System found that tramadol prescriptions throughout the state have increased 93% since 2007, compared to a 0.7% increase for hydrocodone combination products and a 29.9% increase for oxycodone products.

“[The trend] used to be oxycontin, but it’s kind of fallen to the wayside. Now it’s tramadol,” said a law enforcement official quoted in an Ohio State Board of Pharmacy report on the re-classification. “I think maybe what’s happened, or why tramadol has increased, is with oxycontin getting changed, [abusers] can’t crush it like they used to.”

Meanwhile, the DEA changed the usual effective date for this type of change from 30 to 45 days to provide “reasonable” time for registrants to comply with handling requirements for a schedule IV drug. These include adjusting suspicious monitoring systems to include tramadol orders and moving tramadol products into a warehouse cage.

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The DEA received 27 comments on the proposed rule on moving tramadol to Schedule IV, with 16 in support of the change. Dissenters were concerned about having access to the drug, a claim that the DEA disputed since “schedule IV controlled medications are already available for legitimate medical use,” the agency said in the final rule.