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DEA Announces New Regulation for Hydrocodone Combination Products

Aug 26, 2014

The Drug Enforcement Administration (DEA) has announced it will now regulate all hydrocodone combination products as Schedule II drugs under federal law. Schedule II drugs are substances known to be dangerous, prone to abuse, or could lead to severe psychological or physical dependence.

Combination hydrocodone products were previously regulated as Schedule III products under the law. Schedule III is the DEA category for a substance that has accepted medical use, moderate potential for abuse, and the potential for dependency, according to the DEA classification schedule. As a Schedule II substance, hydrocodone combination products will be considered to have a recognized medical benefit, but also a high potential for abuse and dependency. They will be subject to more stringent prescribing controls, such as bans on refills, Regulatory Affairs Professionals Society (RAPS) reports.

Non-combination hydrocodone drugs are already Schedule II drugs. The new policy will affect some of the country's most popular painkillers, including Vicodin, RAPS reports. Food and Drug Administration (FDA) figures indicate that hydrocodone combination products were prescribed more than 130 million times in the US in 2011 alone—a figure that has likely risen since then. The FDA, in recommending the change of classification, says it sought to” balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse.”

The change will make it harder to obtain hydrocodone combination drugs. Some pharmacies don't dispense Schedule II drugs, and in some states nurse practitioners and physicians' assistants are barred from prescribing them, the Los Angeles Times notes in an editorial. The ban on refills could help avert addiction by having patients see their doctor more frequently. But the Times editorial argues that the regulation needs a mechanism to monitor when and how much of such painkillers a patient has already been prescribed.

The scheduling decision is the culmination of a five-year evaluation process begun in 2009.

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