Controlled Substances Therapeutic Research Program

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  1. There is established under the Georgia Composite Medical Board the Controlled Substances Therapeutic Research Program, which shall be administered by the board. Under the program, the board shall act as a sponsor of state-wide investigational studies, utilizing as drug investigators individual physicians who elect to participate in accordance with the guidelines and protocols developed by the board. Such guidelines and protocols shall be designed to ensure that stringent security and record-keeping requirements for research drugs are met and that participants in the program meet those research standards necessary to establish empirical bases for the evaluation of marijuana as a medically recognized therapeutic substance. The board shall promulgate such rules and regulations as it deems necessary or advisable to administer the program. In promulgating such guidelines, protocols, rules, and regulations, the board shall take into consideration those pertinent rules and regulations promulgated by the United States Drug Enforcement Administration, the United States Food and Drug Administration, and the National Institute on Drug Abuse.
  2. The program shall be limited to patients who are certified to the board by a physician as being:
    1. Cancer patients involved in a life-threatening situation in which treatment by chemotherapy or radiology has produced severe side effects; or
    2. Glaucoma patients who are not responding to conventional controlled substances.
  3. No patient may be admitted to the program without full disclosure by the physician of the experimental nature of the program and of the possible risks and side effects of the proposed treatment.
  4. The cost of any blood test required by the United States Food and Drug Administration prior to entrance into the program shall be paid by the patient seeking entrance into the program.
  5. Only the following persons shall have access to the names and other identifying characteristics of patients in the program for whom marijuana has been prescribed under this article:
    1. The board;
    2. The review board created by Code Section 43-34-124;
    3. The Attorney General or his or her designee;
    4. Any person directly connected with the program who has a legitimate need for the information; and
    5. Any federal agency having responsibility for the program.

(Code 1933, § 84-904A, enacted by Ga. L. 1980, p. 82, § 1; Ga. L. 2009, p. 859, § 1/HB 509; Ga. L. 2017, p. 774, § 43/HB 323.)

The 2017 amendment, effective May 9, 2017, part of an Act to revise, modernize, and correct the Code, substituted "the United States Drug Enforcement Administration, the United States Food and Drug Administration" for "the Federal Drug Enforcement Agency, the Food and Drug Administration," near the end of subsection (a); and substituted "the United States Food and Drug Administration" for "the federal Food and Drug Administration" in subsection (d).

RESEARCH REFERENCES

Am. Jur. 2d.

- 25 Am. Jur. 2d, Drugs and Controlled Substances, §§ 17, 19, 239. 39 Am. Jur. 2d, Health, §§ 4, 9.

C.J.S.

- 28 C.J.S., Drugs and Narcotics, §§ 213, 225, 226.


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