Ga. Comp. R. & Regs. 480-34-.14

Current through Rules and Regulations filed through November 21, 2024
Rule 480-34-.14 - Sodium Chloride Injection for Catheter Flush
(1) This rule was adopted to protect the health, safety, and welfare of the public. Sodium chloride injection in quantities of 10cc or less, when used as a catheter flush solution to act by physically occupying space within a catheter and exerting pressure on the patient's circulating blood, is hereby deleted from the dangerous drug list as referenced in Official Code of Georgia Annotated (O.C.G.A.) § 16-13-71(b)(867).
(2) This rule is based on the following findings of the Board:
(a) that sodium chloride injection in quantities of 10cc or less does not have a high potential for abuse;
(b) that the Board has considered the 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, the potential of the drug to produce psychic or physiological dependence liability; and
(c) that the Federal Food and Drug Administration concluded that sodium chloride injection (saline injection or flush), when used as a catheter flush solution and acting in this manner, this solution meets the definition of a device in that it affects the structure or function of the body, and does not achieve its primary intended purposes through chemical or metabolic action.

Ga. Comp. R. & Regs. R. 480-34-.14

O.C.G.A. §§ 16-13-71, 26-4-5, 26-4-27, 26-4-28.

Original Rule entitled "Sodium Chloride Injection for Catheter Flush" adopted. F. Nov. 19, 2018; eff. Dec. 9, 2018.