The Drug Enforcement Agency moved Thursday to stem a rise in the abuse of powerful painkillers by listing hydrocodone-combination products as Schedule II drugs under the Controlled Substance Act.
The action, which takes effect in 45 days, will tighten the government’s regulatory control over the drugs and boost criminal penalties for anyone caught illegally dealing or possessing them.
Pure hydrocodone drugs have been listed as Schedule II drugs since the advent of the list in 1971. But hydrocodone-combination products (HCPs) — those made with specified amounts of other therapeutically active non-narcotic ingredients — were listed as the less-restrictive Schedule III.
The move, first considered a decade ago, follows findings that abuse of hydrocodone combinations has risen dramatically in recent years.
“There have been large numbers of deaths and emergency department visits associated with abuse of HCPs,” the agency said in a final rule to be published Friday. “Based on these considerations, the DEA believes that the high abuse and dependence potential and harm associated with HCPs support rescheduling into schedule II of the CSA.”
The Department of Health and Human Services, initially opposed to the action, is now supportive. The DEA’s action doesn’t affect the controversial drug Zohydro, approved by the Food and Drug Administration last fall over the objections of the agency’s own advisory board.
Zohydro, considered a pure hydrocodone drug, is already listed on Schedule II, meaning there are limits on prescriptions, refills are prohibited and there are increased security and reporting steps required in the drug’s administration.