DEA Classifies Soma as a Schedule IV Controlled Substance

In December 2011, the Drug Enforcement Agency decided to federally control carisoprodol as a Schedule IV controlled substance under the Controlled Substance Act (CSA). This law went into effect on January 11, 2012.

If you are a pharmacy tech, it’s important for you to know that carisoprodol is now subject to the same laws and regulations as other Schedule IV drugs in a pharmacy. However, certain storage, manufacturing and freight forwarding security requirements are not applicable until April 10, 2012. Package labeling must also be compliant, with “C-IV” present on the label, by this same date.

To determine if a drug should be considered a controlled substance, the DEA must determine that there is sufficient evidence of eight factors.

• Factor One: The actual or relative potential for abuse. Abuse is defined as using a drug for non-medical purposes for its positive psychoactive effects.
• Factor Two: The scientific evidence of the drug’s pharmacological effect. and the state of current scientific knowledge regarding the drug.
• Factor Three: The state of current scientific knowledge regarding carisoprodol.
• Factor Four: Carisoprodol’s history and current pattern of abuse.
• Factor Five: The scope, duration, and significance of abuse.
• Factor Six: The risk to the public health.
• Factor Seven: Its psychic or physiological dependence potential.
• Factor Eight: Whether the substance is an immediate precursor* of a substance already controlled.

*Definition when used as a chemistry term: a chemical that is transformed into another compound, as in the course of a chemical reaction, and therefore precedes that compound in the synthetic pathway

After reviewing the evidence presented by the FDA and others promoting the controlling of carisoprodol, the DEA found that it was sufficient to prove that carisoprodol should be federally controlled.