Compilation of Rules and Regulations of the State of Georgia
Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY
Chapter 480-13 - HOSPITAL PHARMACY REGULATIONS
Rule 480-13-.09 - Investigational Drugs

Universal Citation: GA Rules and Regs r 480-13-.09
Current through Rules and Regulations filed through March 20, 2024

Investigational drugs shall be properly labeled and shall be administered only under the personal and direct supervision of the principal practitioner- investigator or his/her authorized clinician(s) with prior approval of the appropriate committee(s) of the hospital. Investigational drugs shall be administered in accordance with an approved protocol that includes any requirements for a patient's appropriate informed consent. Nurses may administer such drugs only after they have been educated regarding such drugs by the clinician or the pharmacist. A central unit shall be maintained wherein essential information regarding such drugs may be obtained. Investigational drugs in use shall be properly stored, distributed, and controlled maintaining the confidentiality of patient-medical staff information. The Director of Pharmacy shall be responsible for policies and procedures concerning use of investigational drugs.

O.C.G.A. Secs. 26-4-27, 26-4-28, 26-4-110.

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