FDA Reschedules Hydrocodone Combination Products from Schedule III to Schedule II

Categories: Blog

You may ask why?  Because 46 people die every day from overdose of prescription pain medication.  

The FDA Final Rule came down, rescheduling hydrocodone combination products from schedule III to schedule II of the Controlled Substance Act was published in the August 22, 2014 in the Federal Register.

What does this mean?  That mean any medication that contains hydrocodone cannot be called into a pharmacy any longer.

The new Rule takes effect October 6, 2014, 45 days from publication.

Here are the rules:

  • 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.

Below is an alphabetical list of all the hydrocodone containing medications in the US market:

  • Hycet
  • Hycodon
  • Ibudone
  • Lorcet
  • Lorcet Plus
  • Lortab
  • Maxidone
  • Norco
  • Reprexain
  • Rezira
  • Tussigon
  • Vicodin
  • Vicodin XR
  • Vicodin HP
  • Vicoprofen
  • Zamicet
  • Zohydro ER
  • Zydone