The U.S. Food and Drug Administration announced on October 24, 2013 that it intends to recommend that products containing hydrocodone should be reclassified from Schedule III to Schedule II of the federal Controlled Substances Act, to increase controls on the use and misuse of opioid products. Hydrocodone is a narcotic pain reliever that is found in drugs such as Vicodin and Lortab. The FDA has become increasingly concerned about the nationwide epidemic of prescription painkiller abuse, and has made efforts to address this problem. (See our blog post “FDA Takes Steps to Address Epidemic Levels of Prescription Painkiller Abuse” dated May 3, 2013).
Schedule II of the Controlled Substances Act is a more restrictive schedule than Schedule III. The scheduling system, which is overseen by the U.S. Drug Enforcement Administration, classifies drugs into five distinct categories, or schedules, depending on a drug’s accepted medical use and its potential for abuse and addiction. The abuse rate is considered a significant factor in the scheduling of a drug. Schedule I drugs are the most dangerous class of drugs with a high potential for abuse and potentially severe psychological and/or physical dependence. Schedule II drugs are drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. Schedule III drugs are drugs with a moderate to low potential for physical and psychological dependence.
The FDA’s proposed schedule change will require patients to take prescriptions for hydrocodone-based pain pills to a pharmacy, rather than having a doctor call it in. In addition, the proposed schedule change will reduce the number of refills patients could obtain without seeing a physician again. Current rules allow patients to refill hydrocodone-based prescriptions five times during any six-month period before having to return to a doctor for a new prescription.
The FDA expects to submit its formal recommendation to the U.S. Department of Health and Human Services in early December 2013. The recommendation is then expected to be adopted by the U.S. Drug Enforcement Administration in 2014.