Mechanism for national distribution of delta 9-tetrahydrocannabinol (NSC-134454)

The National Cancer Institute (NCI) is initiating a national THC distribution program by applying to the FDA for its classification as a Group C investigational agent. Since THC is also a Schedule I drug, the distribution system requires strict adherence to Drug Enforcement Agency (DEA) security and safety regulations. Contrary to the usual distribution of Group C drugs, THC will not be available directly to physicians. THC will be made available to hospital pharmacies which are: (1) an NCI recognized Cancer Center (P-30 grant supported), (2) an NCI designated New Drug Study Group, (3) a member of the Council of Teaching Hospitals. Hospital pharmacies that are located in inadequately represented geographic areas when certain criteria are met by them will also be considered. Physicians desiring to prescribe THC need not have Schedule I registration, but should (1) have experience in cancer chemotherapy, (2) have a current DEA registration number, (3) agree to abide by the Guidelines for Use of THC, and (4) be registered with a participating pharmacy. A registered physician may prescribe THC by writing a Research Order for Medication on a usual prescription blank, including, in addition to normal required information, confirmation that patient consent has been obtained and the name of the hospital at which the physician is registered to prescribe THC.