(A) A statewide investigational new drug application may be established in this State, if approved by the United States Food and Drug Administration to conduct expanded access clinical trials using cannabidiol on qualifying patients with severe forms of epilepsy.

(B) Any physician who is board certified and practicing in an academic medical center in this State and treating patients with severe forms of epilepsy may serve as the principal investigator for such clinical trials if such physician:

(1) applies to and is approved by the United States Food and Drug Administration as the principal investigator in a statewide investigational new drug application; and

(2) receives a license from the United States Drug Enforcement Administration.

(C) Such physician, acting as principal investigator, may include subinvestigators who are also board certified and who practice in an academic medical center in this State and treat patients with severe forms of epilepsy. Such subinvestigators shall comply with subsection (B)(2) of this section.

(D) The principal investigator and all subinvestigators shall adhere to the rules and regulations established by the relevant institutional review board for each participating academic medical center and by the United States Food and Drug Administration, the United States Drug Enforcement Administration, and the National Institute on Drug Abuse.

(E) Nothing in this article prohibits a physician licensed in South Carolina from applying for Investigational New Drug authorization from the United States Food and Drug Administration.

HISTORY: 2014 Act No. 221 (S.1035), Section 2, eff June 2, 2014.