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Hydrocodone products to get Schedule II classification

Thursday August 28, 2014
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Combination hydrocodone products, currently considered Schedule III drugs, will be reclassified as Schedule II because of their high risk for abuse, according to a new regulation issued by the U.S. Drug Enforcement Administration, which will take effect in in October.

The DEA’s Final Rule, published Aug. 22, said the decision to move hydrocodone combination products to the more-restrictive Schedule II, which are those with as drugs with a high potential for abuse, was based on recommendations by the Department of Health and Human Services and supported by the DEA’s evaluation of relevant data.
HCPs are drugs that contain both hydrocodone, which by itself is a Schedule II drug, and specified amounts of other substances, such as acetaminophen or aspirin. However the addition of nonnarcotic substances like acetaminophen to hydrocodone “does not diminish its abuse potential” and may lead to severe psychological or physical dependence, according to a news release,

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

The Schedule II designation means the drugs will be subject to tighter government regulations, including more stringent prescribing practices. The most commonly prescribed combination product affected by the ruling is hydrocodone plus acetaminophen (marketed as Vicodin or Lortab).

“The DEA finds that the scientific, medical, and epidemiological data are robust and support rescheduling HCPs into schedule II of the CSA,” the DEA stated in its Final Rule. “Various drug abuse indicators for HCPs indicate that HCPs are widely diverted and abused at rates largely similar to that of oxycodone products [Schedule II]. “Individuals are taking these drugs in sufficient quantities to create a hazard to their health, and abuse of HCPs is associated with large numbers of deaths.”

Read the Final Rule http://go.usa.gov/mc8d.


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