Florida Senate - 2014 CS for CS for SB 1030 By the Committees on Appropriations; and Health Policy; and Senators Bradley, Bean, Brandes, Galvano, Sobel, Soto, Gardiner, Stargel, and Simpson 576-04518A-14 20141030c2 1 A bill to be entitled 2 An act relating to low-THC cannabis; creating s. 3 456.60, F.S.; defining terms; authorizing specified 4 physicians to order low-THC cannabis for use by 5 specified patients; providing conditions; providing 6 education requirements for physicians; providing 7 duties of the Department of Health; requiring the 8 department to create a compassionate use registry; 9 providing requirements for the registry; requiring the 10 department to authorize a specified number of 11 dispensing organizations; authorizing the department 12 to adopt specified rules; requiring the department to 13 establish the Office of Compassionate Use; providing 14 for inspections of dispensing organizations by the 15 department and law enforcement agencies; providing 16 requirements and duties for a dispensing organization; 17 providing exceptions to specified laws; creating s. 18 385.30, F.S.; encouraging state universities with both 19 medical and agricultural programs to participate in 20 specified Federal Food and Drug Administration 21 approved research directed toward refractory or 22 intractable epilepsy relief in pediatric patients; 23 authorizing participating state universities to 24 annually request a grant from the department; 25 requiring a state university that requests a grant to 26 submit a specified report to the department; providing 27 applicability; creating s. 1004.441, F.S.; authorizing 28 state universities with both medical and agricultural 29 programs to conduct specified research on low-THC 30 cannabis; authorizing the use of current state or 31 privately obtained research funds to support such 32 research; authorizing the department to submit a 33 budget amendment request to use excess funds in the 34 Biomedical Research Trust Fund to implement this act; 35 providing an effective date. 36 37 Be It Enacted by the Legislature of the State of Florida: 38 39 Section 1. Section 456.60, Florida Statutes, is created to 40 read: 41 456.60 Compassionate use of low-THC cannabis.— 42 (1) DEFINITIONS.—As used in this section, the term: 43 (a) “Dispensing organization” means an organization 44 approved by the department to cultivate, process, and dispense 45 low-THC cannabis pursuant to this section. 46 (b) “Low-THC cannabis” means a substance that contains no 47 more than 0.8 percent of any tetrahydrocannabinol and at least 48 10 percent cannabidiol and that is dispensed only from a 49 dispensing organization. 50 (c) “Medical use” means administration of the ordered 51 amount of low-THC cannabis. The term does not include the 52 possession, use, or administration by smoking. The term also 53 does not include the transfer of low-THC cannabis to a person 54 other than the qualified patient for whom it was ordered or the 55 qualified patient’s legal representative on behalf of the 56 qualified patient. 57 (d) “Qualified patient” means a resident of this state who 58 has been added to the compassionate use registry by a physician 59 licensed under chapter 458 or chapter 459 to receive low-THC 60 cannabis from a dispensing organization. 61 (e) “Smoking” means burning or igniting a substance and 62 inhaling the smoke. Smoking does not include the use of a 63 vaporizer. 64 (2) PHYSICIAN ORDERING.—Effective January 1, 2015, a 65 physician licensed under chapter 458 or chapter 459 who has 66 examined and treated a patient suffering from a physical medical 67 condition, or from treatment for a medical condition, which 68 chronically produces symptoms of seizures or severe and 69 persistent muscle spasms may order for the patient’s medical use 70 low-THC cannabis to treat or alleviate such symptoms if all of 71 the following conditions apply: 72 (a) The patient is a permanent resident of this state. 73 (b) The physician has treated the patient for his or her 74 symptoms or a medical condition in which his or her symptoms 75 were present for at least 2 months. 76 (c) The physician determines the risks of ordering low-THC 77 cannabis are reasonable in light of the potential benefit for 78 that patient. If a patient is younger than 18 years of age, a 79 second physician must concur with this determination, and such 80 determination must be documented in the patient’s medical 81 record. 82 (d) The physician registers as the orderer of low-THC 83 cannabis for the named patient on the compassionate use registry 84 maintained by the department and updates the registry to reflect 85 the contents of the order. The physician shall inactivate the 86 patient’s registration when treatment is discontinued. 87 (e) The physician maintains a patient treatment plan that 88 includes the dose, route of administration, planned duration, 89 and monitoring of the patient’s symptoms and other indicators of 90 tolerance or reaction to the low-THC cannabis. 91 (f) The physician submits the patient treatment plan 92 quarterly to the University of Florida College of Pharmacy for 93 research on the safety and efficacy of low-THC cannabis on 94 patients with such symptoms. 95 (3) PHYSICIAN EDUCATION.—Before ordering low-THC cannabis 96 for use by a patient in this state, the appropriate board shall 97 require the ordering physician licensed under chapter 458 or 98 chapter 459 to successfully complete an 8-hour course and 99 subsequent examination offered by the Florida Medical 100 Association which must encompass the clinical indications for 101 the appropriate use of low-THC cannabis, the appropriate 102 delivery mechanisms, the contraindications for such use, as well 103 as the relevant state and federal laws governing the ordering, 104 dispensing, and possessing of such substance. The first course 105 and examination shall be presented by October 1, 2014, and shall 106 be administered at least annually thereafter. Successful 107 completion of the course may be used by a physician to satisfy 8 108 hours of the continuing medical education requirements required 109 by his or her respective board for licensure renewal. The course 110 may be offered in a distance learning format. 111 (4) DUTIES OF THE DEPARTMENT.— 112 (a) By January 1, 2015, the department shall: 113 1. Create a secure, electronic, and online compassionate 114 use registry for the registration of physicians and patients as 115 provided under this section. The registry must be accessible to 116 law enforcement agencies and to a dispensing organization in 117 order to verify patient authorization for low-THC cannabis and 118 record the low-THC cannabis dispensed. The registry must prevent 119 an active registration of a patient by multiple physicians. 120 2. Authorize at least one, but no more than four, 121 dispensing organizations, to ensure reasonable statewide 122 accessibility and availability as necessary for patients 123 registered in the compassionate use registry and who are ordered 124 low-THC cannabis under this section. The department shall 125 develop an application form and impose an initial application 126 and biennial renewal fee that is sufficient to cover the costs 127 of administering this section. An applicant for approval as a 128 dispensing organization must be able to demonstrate: 129 a. The technical and technological ability to cultivate and 130 produce low-THC cannabis. 131 b. The ability to secure the premises, resources, and 132 personnel necessary to operate as a dispensing organization. 133 c. The ability to maintain accountability of all raw 134 materials, finished product, and any byproducts to prevent 135 diversion or unlawful access to or possession of these 136 substances. 137 d. An infrastructure reasonably located to dispense low-THC 138 cannabis to registered patients statewide or regionally as 139 determined by the department. 140 e. The financial ability to maintain operations for the 141 duration of the 2-year approval cycle. 142 f. That all owners, managers, and employees have been 143 fingerprinted and successfully passed background screening 144 pursuant to s. 435.04. 145 3. Implement a process for timely issuing identification 146 cards to patients registered in the compassionate use registry. 147 The identification card expires 1 year after the date issued. A 148 new identification card may be issued to a patient for whom a 149 physician continues registration and treatment with low-THC 150 cannabis. 151 (b) The department shall monitor physician registration and 152 the ordering of low-THC cannabis for ordering practices that 153 could facilitate unlawful diversion or misuse of low-THC 154 cannabis, and take disciplinary action as indicated. 155 (c) The department shall monitor and inspect the activities 156 of each approved dispensing organization for compliance with 157 this section. 158 (d) The department may adopt rules pertaining to: 159 1. The submission of relevant information to the 160 compassionate use registry in order to issue patient 161 identification cards; and 162 2. Recordkeeping requirements to demonstrate compliance 163 with this section, including maintaining records for the 164 production and finished product testing of low-THC cannabis. 165 (e) The department shall establish the Office of 166 Compassionate Use under the direction of the Deputy State Health 167 Officer to administer this section, including access to the 168 compassionate use registry under s. 456.61, and s. 385.30. 169 (5) DISPENSING ORGANIZATION.— 170 (a) An approved dispensing organization shall: 171 1. Maintain compliance with the criteria demonstrated for 172 selection and approval under subparagraph (4)(a)2. as a 173 dispensing organization at all times; 174 2. Maintain and make records available for inspection and 175 desk review by the department and law enforcement agencies; and 176 3. Make all premises, resources, raw materials, finished 177 product, byproducts, and vehicles available for inspection by 178 the department and law enforcement agencies. 179 (b) Before dispensing low-THC cannabis to a qualified 180 patient, the dispensing organization shall verify that the 181 patient has an active registration in the compassionate use 182 registry, the order presented matches the order contents as 183 recorded in the registry, and the order has not already been 184 filled. Upon dispensing the low-THC cannabis, the dispensing 185 organization shall record in the registry the date, time, 186 quantity, and form of low-THC cannabis dispensed. 187 (6) EXCEPTIONS TO OTHER SECTIONS OF LAW.— 188 (a) Notwithstanding any other section of law, but subject 189 to the requirements of this section, a qualified patient and the 190 qualified patient’s legal representative may purchase, acquire, 191 and possess for the patient’s medical use up to the amount of 192 low-THC cannabis ordered to the patient. 193 (b) Notwithstanding any other section of law, but subject 194 to the requirements of this section, an approved dispensing 195 organization and its owners, managers, and employees may 196 acquire, possess, cultivate, and lawfully dispose of excess 197 product in reasonable quantities to produce low-THC cannabis and 198 possess, process, and dispense low-THC cannabis. 199 (c) An approved dispensing organization is not subject to 200 licensure and regulation under chapter 465, and the owners, 201 managers, and employees of a dispensing organization are not 202 subject to licensure and regulation for the practice of pharmacy 203 under chapter 465. 204 Section 2. Section 385.30, Florida Statutes, is created to 205 read: 206 385.30 State university participation in approved studies 207 and clinical treatment plans.— 208 (1) All state universities with both medical and 209 agricultural research programs, including those that have 210 satellite campuses or research agreements with other similar 211 institutions, are encouraged to develop or participate in 212 Federal Food and Drug Administration-approved studies and 213 clinical research treatment plans using low-THC cannabis as 214 defined in s. 456.60 which are directed toward refractory or 215 intractable epilepsy relief in pediatric patients as authorized 216 by s. 1004.441. 217 (2) Each state university that is selected to participate 218 in a Federal Food and Drug Administration-approved study or 219 clinical treatment plan described in subsection (1) may request 220 from the Department of Health a grant of up to $100,000 221 annually. 222 (3) To be eligible for the annual grant, the participating 223 medical college or medical school must submit a report to the 224 Department of Health by January 1 of each year which contains, 225 at a minimum: 226 (a) The gender and age of each patient participating in the 227 study or clinical treatment plan during the calendar year; 228 (b) The names of participating physicians; and 229 (c) The level of seizure reduction in each participating 230 patient during the calendar year. 231 (4) The grant award decisions of the Department of Health 232 pursuant to this section are not subject to chapter 120. 233 Section 3. Section 1004.441, Florida Statutes, is created 234 to read: 235 1004.441 Refractory and intractable epilepsy treatment and 236 research.—Notwithstanding chapter 893, state universities with 237 both medical and agricultural research programs, including those 238 that have satellite campuses or research agreements with other 239 similar institutions, may conduct research on low-THC cannabis 240 as defined in s. 456.60. This research may include, but is not 241 limited to, the agricultural development, production, clinical 242 research, and use of liquid medical derivatives of low-THC 243 cannabis for the treatment for refractory or intractable 244 epilepsy. Current state or privately obtained research funds may 245 be used to support the activities authorized by this section. 246 Section 4. The Department of Health may submit a budget 247 amendment request using excess funds from the Biomedical 248 Research Trust Fund to implement this act during the 2014-2015 249 state fiscal year. 250 Section 5. This act shall take effect July 1, 2014.