Requirements for the Therapeutic Research Program

(A) Patient Eligibility. Eligibility for the therapeutic researchprogramshallbe limited to patients who experience the nausea and ill-effects of cancer chemotherapy and radiation therapy; glaucoma patients who experience intraocular pressure from glaucoma; and patients with asthma who experience severe respiratory problems or discomfort. (B) Supply. The Department shall contract with the National Institute on Drug Abuse, the National Cancer Institute or other manufacturer, distributor or analytical laboratory for the receipt of a supply of analyzed marijuana in accordance with all applicable state and federal laws. (C) Approval of Institutional Review Board. Prior to the implementation of any study protocol pursuant to the therapeutic research program, the protocol shall undergo the review and approval of an Institutional Review Board in accordance with the provisions of 45 CFR part 46 and 21 CFR part 56, as most recently amended. 724.002: continued (D) Location of Use. A patient may not use the marijuana provided by the program in the presence of persons under the age of 18, in a moving vehicle, or ina public place, or inanymanner inconsistent with the requirements of the program. (E) Record-Keeping. The therapeutic research program established pursuant to 105 CMR 724.000 shall meet all record-keeping requirements of 21 CFR part 312, as most recently amended. (F) Reporting. (1) The Department shall file an annual report of the activities of the program with the Governor and General Court. (2) The therapeutic research program shall meet all the reporting requirements found in 21 CFR part 312 and 105 CMR 700.009, as most recently amended.