WASHINGTON-- Tough new restrictions on the powerful, highly addictive hydrocodone combination painkillers, such as Vicodin, will take effect in mid-October as the federal government elevates the opioid drug to Schedule II under the Controlled Substances Act.
The notice, to be published Friday in the Federal Register, announces that the change takes effect in 45 days.
The move from Schedule III to Schedule II follows years of requests from the Drug Enforcement Administration, which argued that the drug was overprescribed, creating drug addictions and too often diverted to the black market.
The Controlled Substances Act places drugs into four categories. Drugs in Schedule I, such as LSD and heroin, are determined by the Food and Drug Administration to have no medical use and are illegal. Drugs in Schedule II have an accepted medical use, but also have high potential for abuse.
Hydrocodone, by itself, is already listed in Schedule II. The new rule adds drugs that contain both hydrocodone and other substances such as aspirin or acetaminophen, the active ingredient in Tylenol.
Opiate painkillers are among the most abused prescription medicines in the U.S., DEA Administrator Michele Leonhart said in a statement. Adding non-narcotic drugs, such as aspirin, to narcotic painkillers doesn't make them less addictive, Leonhart said. Monitoring the Future's survey of high school seniors found that twice as many of the students abused Vicodin than abused the more tightly controlled narcotic painkiller OxyContin.
"Today's action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available," Leonhart said.