Investigational Drugs

(1) The pharmacist in charge in coordination with the institutional facility, medical and nursing staff and, if appropriate, the pharmaceutical manufacturer, shall develop policies and procedures for the approval, management, distribution and control of investigational drug studies. The process shall ensure that such studies contain safeguards for the patient, for the institution and for the scientific integrity of the study. Each patient or the patient’s legal guardian must freely consent, in writing, to treatment with the drugs, unless otherwise not required by federal law. The pharmacist is responsible to the institution and to the principal INSTITUTIONAL AND ALTERNATE OR ALTERNATIVE CHAPTER 1140-04 INFUSION PHARMACY PRACTICE SITES investigator for seeing that procedures for the control of investigational drugs are developed and implemented when needed. (2) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.