Ga. Comp. R. & Regs. 480-34-.03

Current through Rules and Regulations filed through November 21, 2024

Rule 480-34-.03 - Sodium Oxybate

This Chapter was adopted to protect the health, safety, and welfare of the public. This Chapter places Sodium Oxybate (known as Xyrem) that is contained in a drug product for which an application has been approved under Section 505 of the Federal Food, Drug and Cosmetic Act under Schedule III, of the Georgia Controlled Substances Act, Code Section 16-13-28(a)(2-25). The Board finds that:

(a) Sodium Oxybate has a high potential for abuse;

(b) It appears to have an addictive effect on the human body;

(c) It is regarded as a threat to public health and safety by other states, as well as the U.S. Drug Enforcement Administration;

(d) It has a history of increasing abuse;

(e) The abuse and need to obtain the drug results in multiple uses and combinations, and multiple violations of the law;

(f) It has the same risk to the public health of the citizens of the state of Georgia as any substance already contained in the Controlled Substances Act;

(g) It has shown great potential for physiological dependence;

(h) It is not a precursor of a substance already scheduled in Georgia;

(i) It is about to be placed under Schedule III of the federal Controlled Substances Act.

Ga. Comp. R. & Regs. R. 480-34-.03

O.C.G.A. Secs. 16-13-22, 26-4-27, 26-4-28.

Original Rule entitled "Sodium Oxybate" adopted. F. Jan. 3, 2003; eff. Jan. 23, 2003.