The DEA has finalized its rule to reschedule hydrocodone combination product (HCP) from Schedule III to Schedule II. The only change this rule has is to delete any reference to HCPs from Schedule III. The rule becomes effective on October 6, 2014.

Any hydrocodone that is not in combination with another drug (a single entity) has always been classified as a Schedule II controlled substance. The new non-combination hydrocodone product Zohydro is a Schedule II, and it is the only single entity hydrocodone product on the market.

In Georgia, the State Board of Pharmacy is considering promulgating a rule mirroring the DEA Rule. Such a rule would ensure that pharmacies handle HCPs as Schedule II products, however the rule would not have the force of law in regards to criminal illegal possession or distribution. Georgia law may also be changed, and the 2015 annual drug update for the Legislature may include language to mimic the federal law for HCPs.

Georgia HCP Guidelines:

  • Any HCP prescription written before October 6, 2014 should be treated and filled as a Schedule III controlled substance, including refills as specified below.
  • Refills authorized on a HCP prescription, written and filled before October 6, 2014, may be dispensed up to five (5) times, as authorized, until April 8, 2015 or six months from the date the HCP was originally issued. No additional refills may be authorized, nor can refills be dispensed beyond the six month original issue date. (Example: a HCP prescription issued on August 1, 2014 with 2 authorized refills may be refilled 2 times up until February 1, 2015) **Note: this refill policy comes directly from the DEA HCP rule comments and directives.**
  • Any HCP prescription written on or after October 6, 2014 should be treated and filled as a Schedule II controlled substance.
  • ALL hard copy HCP prescriptions must be issued on security paper as of October 6, 2014.
  • No Refills may be authorized for any HCP prescription written on or after October 6, 2014.
  • No call-in HCP prescriptions are allowed except as authorized in emergencies for C-II controlled substances.
  • After October 6, 2014 APRNs and PAs can no longer order or issue HCP prescriptions.
  • On October 6, 2014, all pharmacies and practitioners should inventory any HCP in their possession or stock by conducting an actual count of each HCP drug. This inventory should be signed and dated and included with the registrant’s biennial controlled substance inventory.

Other than existing requirements for Schedule II controlled substance prescriptions, there are no new limitations or restrictions on how often a HCP can be prescribed. There is no restriction on the quantity of a HCP that can be prescribed on one prescription, nor is there any new requirement that a patient see a practitioner prior to obtaining a new HCP prescription. There are simply no new requirements for HCPs other than they are now classified as C-II instead of C-III controlled substances. HCPs should be maintained the same as any other C-II controlled substance.