Placement of Carisoprodol into Schedule IV

By Jena Marion, Pharm.D. Candidate c/o 2013

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On December 12, 2011, the Administrator of the Drug Enforcement Agency (DEA) ruled to place carisoprodol (Soma®) into Schedule IV of the Controlled Substances Act (CSA).  Carisoprodol has been in use since it was approved for marketing in the U.S. in 1959 with the indication of “relief of discomfort associated with acute, painful musculoskeletal conditions” for short-term use of up to two to three weeks.  Prior to this ruling, carisoprodol was a controlled substance in 17 states, not including New York or New Jersey.  In October 2009, the US Department of Health and Human Services recommended that carisoprodol be a controlled substance.

The decision was based on several factors, including its actual or relative potential for abuse, its historical and current patterns of abuse, and the adverse effects reported from use of the drug.  The FDA utilized data from its Adverse Event Reporting System (AERS) to conclude that carisoprodol results in “harm to individuals and the public.”  Serious adverse events such as drug dependence and withdrawal symptoms were also reported.  Adverse events occurred when carisoprodol was used alone or in combination with both licit and illicit drugs, and the medication has been “implicated as a factor in vehicle accidents due to driver impairment.”  Carisoprodol is often seized from persons and places engaged in illegal activities that use other controlled substances, including diazepam, cocaine, methamphetamine, and others.  In 2008, the DEA’s National Forensic Lab Information System (NFLIS) reported enough identifications of carisoprodol to rank it above codeine, lorazepam, hydromorphone, and methylphenidate as the most widely abused drug.

The FDA concluded that carisoprodol is a CNS depressant and is primarily abused in combination with other drugs of abuse such as opioids, benzodiazepines, cocaine, and marijuana.  Furthermore, its abuse was calculated to be at a rate similar to those of benzodiazepines, which are currently placed into Schedule IV of the CSA.  Its potential for abuse and the physical and psychological dependence is less than that of Schedule III drugs.

Beginning January 11, 2012, carisoprodol will be a Schedule IV compound in the Controlled Substances Act.  “Any person who engages in the manufacture, distribution, dispensing, importing, exporting, as well as any person who possesses the drug will be subject to the provisions of the Act and DEA regulations, including the Act’s administrative, civil, and criminal sanctions which are applicable to schedule IV controlled substances.”

More information, including the complete list of regulatory requirements, is available at http://tinyurl.com/carisoprodolcsa.