Products that contain hydrocodone reclassified to Schedule II

August 26, 2014
Area(s) of Interest: Drug Prescribing/Dispensing Emergency Services Public Health 

The federal government published new rules last week that will govern hundreds of medicines containing hydrocodone. These drugs will be reclassified as Schedule II substances, in line with oxycodone and morphine.

This reclassification will apply to all drugs that contain both hydrocodone, which by itself was already classified a Schedule II drug, and specified amounts of other substances, such as acetaminophen or aspirin. As Schedule II drugs, patients will be limited to up to a 90-day supply of medication and will have to see a provider to get a refill. (Under the Schedule III classification, a prescription could be refilled five times before the patient had to see a physician.) Physicians will not generally be allowed to call, fax or e-mail in a prescription to a pharmacy; instead, patients will have to present a written prescription.

California exceptions for emergencies and that apply to skilled nursing facilities, intermediate care facilities and hospice care remain in effect. (For more information on these exceptions, see CMA On-Call document #3201, "Controlled Substances Prescribing.")

The reclassification will not impact the ability of physician assistants and nurse practitioners to write orders for hydrocodone products. State law currently allows physician assistants and nurse practitioners to write orders for controlled substances (Schedule II – Schedule V) under appropriate physician supervision. 

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

The new rule was published in the Federal Register on August 22 and will go into effect October 6, 2014.


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