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 clinical trials using cannabidiol on qualifying patients with severe forms of epilepsy.
B. Any physician licensed by the State Board of Medical Licensure and Supervision or the State Board of Osteopathic Examiners, practicing 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;
2. Receives a license from the United States Drug Enforcement Administration; and
3. Receives a registration from the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control.
C. Such physician, acting as principal investigator, may include subinvestigators who are also board certified, practice in an academic medical center in this state, and treat patients with severe forms of epilepsy. Such subinvestigators shall be required to comply with the licensing requirement provided in paragraphs 2 and 3 of subsection B 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, the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control, and the National Institute on Drug Abuse.
E. Nothing in this section shall be construed to prohibit a physician licensed in Oklahoma from applying for Investigational New Drug authorization from the United States Food and Drug Administration.
F. The Oklahoma State Bureau of Narcotics and Dangerous Drugs Control shall have the authority to inspect and test samples of cannabidiol used in this state pursuant to the provisions of this act.
Added by Laws 2015, c. 203, § 4, emerg. eff. April 30, 2015.
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