Ga. Comp. R. & Regs. R. 480-34-.06 - Hydrocodone Combination Products

(1) Effective October 6, 2014, Official Code of Georgia Annotated (O.C.G.A.) §§ 16-13-27(4)(C), 16-13-27(4)(D) are hereby removed from Schedule III of the Georgia Controlled Substances Act, O.C.G.A. 16-13-25, et. seq. The following language shall be deleted from O.C.G.A. §§ 16-13-27(4): "(C) Not more than 300 milligrams of dihydrocodeinone (hydrocodone), or any of its salts, per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium; (D) Not more than 300 milligrams of dihydrocodeinone (hydrocodone), or any of its salts, per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts."

(2) Effective October 6, 2014, all Hydrocodone Combination Products (HCPs) in the State of Georgia are Schedule II controlled substances.

(a) Each registrant possessing HCPs must make an actual count inventory of all HCPs as of October 6, 2014 and maintain it with the registrant's biennial DEA inventory.

(b) All HCPs products must be treated as any other Schedule II controlled substance. There can be no oral prescriptions except in the case of an emergency, and all hard-copy HCP prescriptions must be issued on security paper.

(c) For any HCP prescription written and filled before October 6, 2014 with authorized refills, the prescription can be refilled only for the authorized number of refills prior to April 8, 2015.

(3) This rule is based on the following findings of the Board:

(a) that as Schedule III controlled substances, HCPs have an extremely high potential for abuse;

(b) that scientific evidence and scientific knowledge of the pharmacological effects of HCPs demonstrate that the public is at extreme risk if HCPs are not regulated as Schedule II controlled substances;

(c) that the history and pattern of abuse of HCPs as a Schedule III controlled substance and the scope and significance of that abuse support stricter regulation;

(d) that as a Schedule III controlled substance, there exists an imminent peril to the public health and welfare with regard to the abuse of HCPs;

(e) that HCPs have the same risk to the public health of citizens of the State of Georgia as other Schedule II controlled substances already contained in the Georgia Controlled Substances Act;

(f) that as of October 6, 2014, the U.S. Drug Enforcement Administration has removed all reference to HCPs from Schedule III of 21 CFR 1308.13, which places all HCPs under Schedule II of 21 CFR 1308.12.

Notes

Ga. Comp. R. & Regs. R. 480-34-.06

O.C.G.A. §§ 16-13-22, 26-4-28, and 50-13-4.

Original Rule entitled "Hydrocodone Combination Products" adopted. F. Nov. 26, 2014; eff. Dec. 16, 2014. Amended: F. Jan. 23, 2015; eff. Feb. 12, 2015.