The Rules Have Changed for Hydrocodone Combination Products

The Drug Enforcement Agency (DEA) has issued its final rule rescheduling hydrocodone combination products (HCPs) as a Controlled Substance Schedule II, effective October 6, 2014.

HCP prescriptions with refills that are issued before October 6, 2014 may be dispensed under the DEA rules for Schedule III–V controlled substances until April 8, 2015. However, state law (if more stringent) and some insurance and pharmacy processes may not allow these refills.

In addition, pharmacies with HCPs in containers labeled as Schedule III are authorized to continue dispensing these drugs, but other HCP containers are required to be labeled as Schedule II.

The following points highlight the impact on healthcare professionals and patients:

If you are a prescriber:

  • HCP prescriptions must be written on a hard copy, original prescription, or electronically transmitted where e-prescribing of C-IIs is allowed.
  • HCP prescriptions cannot be faxed or called into a pharmacy.
  • HCP prescriptions cannot be refilled unless issued before October 6, 2014.
  • If appropriate and allowed by a prescriber's state, the prescriber can write multiple HCP prescriptions in order to provide a 90-day supply and indicate the earliest fill date on each prescription.
  • Inform patients with HCP prescriptions of the new requirements in obtaining prescriptions after October 6, 2014.

If you are a pharmacist:

  • HCP prescriptions cannot be accepted by telephone or by fax.
  • HCP prescriptions cannot be refilled.
  • HCP prescriptions must be written on a hard copy, original prescription, or received by e-prescribing where allowed.
  • Temporary inventory issues may arise with the change from Schedule III to Schedule II.
  • Inform prescribers and patients which prescription refills will be valid after October 6, 2014.

If you are a patient:

  • HCP prescriptions issued before October 6, 2014 will most likely not be refillable due to state law, insurance, and pharmacy quality and safety operations.
  • Check with your health insurance plan with regards to honoring existing refills.
  • New HCP prescriptions will not have refills.

For more information visit FederalRegister.gov.

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