Member Alert: FDA Reschedules Hydrocodone Combination Products from Schedule III to Schedule II

August 22, 2014

August 22nd, 2014

The Final Rule rescheduling hydrocodone combination products (HCPs) from schedule III to schedule II of the Controlled Substance Act was published in the August 22, 2014 Federal Register. The new Rule takes effect October 6, 2014, 45 days from publication. Oral and Maxillofacial Surgeons who prescribe hydrocodone combination products should be aware of the following prescribing requirements now that these drugs are in schedule II:

  • Schedule II controlled substances require a written prescription that must be signed by the practitioner.
  • Refilling a prescription for a schedule II controlled substance is prohibited.
  • Prescribers may transmit a Schedule II prescription to the pharmacy by facsimile. The original Schedule II prescription must be presented to the pharmacist for review prior to the actual dispensing of the controlled substance.
  • In an emergency, a practitioner may phone-in a prescription for a Schedule II controlled substance to the pharmacy, and the pharmacist may dispense the prescription provided that the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period. The prescribing practitioner must provide a signed, written prescription to the pharmacist within seven days.
  • While some states and many insurance carriers limit the quantity of controlled substance dispensed to a 30-day supply, there are no specific federal limits to quantities of drugs dispensed via a prescription.
  • As of December 19, 2007, an individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a schedule II controlled substance.

Specific conditions permitting such multiple prescriptions may be found at http://www.deadiversion.usdoj.gov/faq/mult_rx_faq.htm.

The FDA's Final Rule to reschedule HCP from Schedule III to Schedule II originated in 2009 with a request from the Drug Enforcement Administration. In response, the FDA held several public hearings on the proposed move. AAOMS responded to these hearings as follows:

October 16, 2012: the AAOMS and the ADA provided joint comments to the FDA, and in January 2013, the FDA accepted our joint testimony during a hearing on this important matter.

February 2013: Then-AAOMS president Miro A. Pavelka, DDS, MSD, testified before a separate FDA panel about the benefits of HCPs for oral and maxillofacial surgery patients and the potential difficulties of making legitimate pain prescriptions available to patients once HCPs are rescheduled.

In addition to providing comments at the FDA's hearings, the AAOMS, ADA and others submitted comments noting our opposition to DEA's proposed action in February 2014.