Ga. Comp. R. & Regs. 480-13-.09
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.
Ga. Comp. R. & Regs. R. 480-13-.09
O.C.G.A. Secs. 26-4-27, 26-4-28, 26-4-110.