DEA Bumps Hydrocodone-Combination Products to Schedule II Drugs

The U.S. Drug Enforcement Administration (DEA) has reclassified hydrocodone-combination products as the more restrictive Schedule II drugs in an attempt to curb drug abuse. The DEA published the Final Rule in the Federal Register on Aug. 22. The Final Rule will take effect in 45 days and will apply to “all pharmaceuticals containing hydrocodone currently on the market in the United States.”

“Almost 7 million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents,” said Michele Leonhart, DEA administrator, in a press release. “Today’s action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available.”

Schedule II drugs are substances with accepted medical uses that have a high potential for harm and abuse, according the Controlled Substances Act. Hydrocodone-combination products contain both hydrocodone (a Schedule II drug) and other ingredients like acetaminophen, and were originally classified as Schedule III drugs.

The move to reschedule hydrocodone-combination products was initiated by petition from a physician in 1999, according the DEA. The DEA then submitted a request to the U.S. Department of Health and Human Services for a medical and scientific evaluation of hydrocodone-combination products and for a scheduling recommendation. They found that the addition of other drugs did not diminish the potential for abuse of hydrocodone-combination products.