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Hydrocodone Combination Products Move to Schedule II

After a 15-year process, the change occurs October 6

Hydrocodone combination products (HCPs) will move from Schedule III to the more-restrictive Schedule II under the Controlled Substances Act following a review process that proceeded in fits and starts for 15 years. The change will take place on October 6, 2014, under a final rule published in the Federal Register by the Drug Enforcement Administration (DEA).

HCPs contain both hydrocodone, which by itself is a Schedule II drug, and specified amounts of other substances, such as acetaminophen or aspirin. Nearly 137 million prescriptions for HCPs were dispensed in 2013. The most frequently prescribed HCPs combine hydrocodone and acetaminophen (such as Vicodin and Lortab). Some HCPs are approved as cough suppressants (such as Hycodan or Mycodone).

Substances ranging from amphetamines to opium are on Schedule II, which includes products with a high potential for abuse that may lead to severe psychological or physical dependence. HCPs will be subject to Schedule II rules and sanctions regarding registration, security, labeling, packaging, manufacturing quotas, inventory, records, and reports.

No prescription for HCPs issued on or after October 6, 2014, can authorize refills. Any prescriptions for HCPs that are issued before that date and authorized for refilling may be dispensed in accordance with the law until April 8, 2015.

The Controlled Substances Act (CSA) places substances with accepted medical uses into one of four schedules. The substances with the highest potential for harm and abuse are placed in Schedule II, and substances with progressively less potential for harm and abuse are placed in Schedules III through V. Schedule I is reserved for controlled substances with no currently accepted medical use and lack of accepted safety for use.

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

When Congress passed the CSA in 1970, it placed HCPs in Schedule III even though it had placed hydrocodone itself in Schedule II. The current analysis of HCPs by the Department of Health and Human Services (HHS) and the DEA shows they have a high potential for abuse, and adding nonnarcotic substances like acetaminophen to hydrocodone does not diminish that abuse potential.

Data and surveys from multiple federal and nonfederal agencies show the extent of abuse of HCPs. For example, Monitoring the Future surveys of eighth-, 10th-, and 12th-graders from 2002 to 2011 found that twice as many high school seniors used Vicodin, an HCP, nonmedically as used OxyContin, a Schedule II substance that is more tightly controlled.

In general, substances placed under the control of the CSA since Congress passed it in 1970 are scheduled or rescheduled by the DEA. Scheduling or rescheduling of a substance can be initiated by the DEA, by the HHS Assistant Secretary of Health, or on the petition of any interested party.

The rescheduling of HCPs was initiated by a physician’s petition in 1999. The DEA asked HHS for a scientific and medical evaluation of HCPs and a scheduling recommendation. In 2013, an FDA Advisory Committee voted to recommend moving HCPs to Schedule II by a vote of 19 to 10. After HHS forwarded this recommendation to the DEA, the agency published a proposed rule in the Federal Register on February 27, 2014, soliciting public comments. Almost 600 were received; a small majority supported the change.

Sources: DEA; August 21, 2014; Federal Register; August 22, 2014.

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