Okla. Stat. tit. 63, § 63-2-802

This is the official text of Okla. Stat. tit. 63, § 63-2-802, part of Oklahoma’s Stat. tit. 63, — part of the compiled statutory law of Oklahoma, published by the state as "Stat. tit. 63,." Browse the sections below, each linked to its official government source.

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Clinical trials using cannabidiol – Principal

Official statutory text

investigators.

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.

Oklahoma Statutes - Title 63. Public Health and Safety Page 1051

Status: in_force · Read it on the official government site

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