On Monday, July 7, 2014, the Department of Health held its first Rule Workshop on proposed rules dealing with the implementation and regulation of SB1030, the Compassionate Medical Cannabis Act. SB1030 provides for the medical use of low-THC cannabis for persons with specified medical conditions, especially for children suffering from intractable seizure disorders. The prescribed low-THC cannabis is a non-euphoric, liquid form of cannabis and the conditions under which it may be ordered for a patient are strictly prescribed in section 381.986, Florida Statutes. Specifically, it can only be ordered for use after a physician exams and treats a patient for certain medical conditions and finds that there are no other satisfactory alternative treatment options for the patient. If such a determination is made by a qualified physician further restrictions apply to its use in that it can only be ordered for patients who are permanent residents of the state, the physician must register as the orderer of the drug on a "compassionate use registry," the physician must maintain a strict treatment plan for the patient which is reviewable on a quarterly basis by the University of Florida College of Pharmacy for safety and efficacy of its use, and the physician must obtain an informed consent from the patient (or guardian) for its use. It also creates new criminal offenses for physicians and patients who violate the strict provisions of low-THC cannabis ordering and use.
Pursuant to statute, the low-THC cannabis may only be produced and dispensed by 5 regional "dispensing organizations." In order to qualify as a "dispensing organization" the applicant must prove, among other things, that it possesses a valid certificate of registration issued by the Department of Agriculture, that it is issued for the cultivation of more than 400,000 plants, be operated by a nurseryman and have been operated as a registered nursery in the state for at least 30 continuous years. It is estimated that just over 40 nurseries meet the specifications of the statute.
The Department of Health is charged with creating and maintaining the secure electronic "compassionate use registry" and for regulatory authority over the statutorily prescribed 5 "dispensing organizations." Accordingly, DOH drafted proposed rules 64-4.001-.009, F.A.C., and sought public comment on them at Monday's workshop. While several persons took the opportunity to present their concerns with the rules, the two major areas of concern were (1) whether the proposed 5 vertically integrated dispensing organizations, where production and dispensing would occur at the same location could adequately meet the demands of patients and would be reasonably assessable to them, and (2) whether selecting the 5 dispensing organizations by lottery was really in the best interests of the patient and good public policy. At the end of the hearing, DOH committed to considering all the comments and concerns and to holding another workshop after making revisions to the proposed rules. It is expected that the rule making process will be fast tracked and the next hearing scheduled at the end of July or August to meet the requirements of the January 1, 2015, statutory deadline. It is important to note that the rules currently being developed for the Compassionate Medical Cannabis Act are not related to Amendment 2 the medical marijuana ballot initiative that the Florida electorate will vote on in November 2014.
A copy of the proposed rules can be found here.