MEDICINAL USE OF MARIJUANA
620--12.1(204) Purpose. To establish a research program for the investigational medical use of marijuana. Nothing in these rules will preclude the use of any available dosage forms of marijuana or tetrahydrocannabinols.
620--12.2(204) Definitions. For the purpose
of these rules, the following terms shall have the meaning in
12.2(1) "Board" means the Iowa Board of Pharmacy Examiners.
12.2(2) "Drug control program administrator" or "administrator" means the executive secretary of the board or a person appointed by the board.
12.2(3) "Marijuana" means that substance as defined in section 204.101(16) Code of Iowa.
12.2(4) "Tetrahydrocannabinols." Isolated or synthetic equivalents of substances contained in the plant or resinous fibers of cannabis sp., and/or synthetic substances, derivatives, and their isomers with similar chemical structure and pharmacological activity as defined in 104.204(4)"q" Code of Iowa or Part 1308.11(d)(20) Code of Federal Regulations Title 21 revised as of April 1, 1978.
12.2(5) "Physicians advisory group" shall mean a committee of at least three physicians organized by the board for the purpose of advising and counseling the board. This advice and counsel shall include the following areas:
a. Designation of diseases or symptomatic conditions to be treated with marijuana or tetrahydrocannabinols.
b. Recruitment and selection of qualified clinical investigators.
c. Assist in the preparation of a plan or protocol for the study which will meet FDA standards and approval.
12.3(1) Physicians who wish to participate as clinical investigators shall submit their names to the administrator for approval by the physicians advisory group. The administrator shall collect such data as is deemed necessary by the advisory group and as required by the Food and Drug Administration, Public Health Service, Department of Health, Education and Welfare.
12.3(2) The administrator, with approval of the board and the concurrence of the physicians advisory group, shall prepare and file a "Notice of Claimed Investigational Exemption for a New Drug" (FDA Form 1571) with the federal Food and Drug Administration, Department of Health, Education and Welfare.
12.3(3) Concurrent with federal approval of the "Notice of Claimed Investigational Exemption of New Drug" and thereafter, the administrator shall be responsible for insuring adherence to the approved protocol by all parties involved. The administrator shall make quarterly reports on the progress of the program to the board. The administrator shall be responsible for program compliance with all state and federal requirements.
12.3(4) Clinical investigators approved by the board will be registered in accordance with the provisions of section 204.302, Code of Iowa and with Part 1301.32(6) of Title 21 Code of Federal Regulations.
12.3(5) This research program will terminate on June 30, 1981, unless one or more of the following takes place:
a. Legislative action extends the time period.
b. Marijuana or tetrahydrocannabinols are removed from Schedule I of the Federal Controlled Substances Act (Part 1308.11, Title 21, CFR) and placed in a classification which would allow their legal medical use and distribution.
c. Termination of the FDA approval to conduct clinical investigations with marijuana.
These rules are intended to implement Acts of the Sixty-eighth General Assembly, First Session, Senate File 487.