Ga. Comp. R. & Regs. R. 480-34-.15 - Additional Compounds under Schedule V

(1) This rule was adopted to protect the health, safety, and welfare of the public. This rule places an additional compound as specifically identified here under Schedule V of the Georgia Controlled Substances Act, Section 16-13-29 as follows:

(1.5) Epidiolex: A drug product in finished dosage formulation in its original container that has been approved by and labelled in compliance with the U.S. Food and Drug Administration (FDA) that contains cannabidiol (CBD) derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols.

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

(a) that the FDA approved the drug Epidiolex for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. Epidiolex is an oral solution that contains CBD extracted from the cannabis plant.

(b) that the U.S. Drug Enforcement Administration (DEA) did seek a medical and scientific evaluation or scheduling recommendation from the U.S. Department of Health and Human Services (HHS) with respect to the Epidiolex formulation. In responding to that request, HHS advised DEA that it found the Epidiolex formulation to have a very low potential for abuse and therefore, recommended that if DEA concluded that control of the drug was required under the Single Convention, Epidiolex should be placed in Schedule V of the Federal Controlled Substance Act (CSA).

(c) that the Board has considered, based on available information, the potential for abuse; scientific evidence of its pharmacological effects; the state of current scientific knowledge regarding the drug; the history and current pattern of abuse; the scope, duration, and significance of abuse; and the potential of the drug to produce psychic or physiological dependence liability.

Notes

Ga. Comp. R. & Regs. R. 480-34-.15

O.C.G.A. §§ 16-13-22, 16-13-29, 26-4-5, 26-4-27, 26-4-28.

Original Rule entitled "Additional Compounds under Schedule V" filed as Emergency Rule 480-34-0.35-.12 on Nov. 5, 2018; effective Nov. 5, 2018, to remain in effect for a period of 120 days or until the effective date of a permanent Rule covering the same subject matter superseding this Emergency Rule is adopted, as specified by the Board. Adopted: Permanent Rule of the same title. F. May 9, 2019, eff. May 29, 2019.