Florida Senate - 2014 COMMITTEE AMENDMENT Bill No. CS for SB 1030 Ì617332ÄÎ617332 LEGISLATIVE ACTION Senate . House Comm: RCS . 04/23/2014 . . . . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— The Committee on Appropriations (Bradley) recommended the following: 1 Senate Amendment (with title amendment) 2 3 Delete everything after the enacting clause 4 and insert: 5 Section 1. Section 456.60, Florida Statutes, is created to 6 read: 7 456.60 Compassionate use of low-THC cannabis.— 8 (1) DEFINITIONS.—As used in this section, the term: 9 (a) “Dispensing organization” means an organization 10 approved by the department to cultivate, process, and dispense 11 low-THC cannabis pursuant to this section. 12 (b) “Low-THC cannabis” means a substance that contains no 13 more than 0.8 percent of any tetrahydrocannabinol and at least 14 10 percent cannabidiol and that is dispensed only from a 15 dispensing organization. 16 (c) “Medical use” means administration of the ordered 17 amount of low-THC cannabis. The term does not include the 18 possession, use, or administration by smoking. The term also 19 does not include the transfer of low-THC cannabis to a person 20 other than the qualified patient for whom it was ordered or the 21 qualified patient’s legal representative on behalf of the 22 qualified patient. 23 (d) “Qualified patient” means a resident of this state who 24 has been added to the compassionate use registry by a physician 25 licensed under chapter 458 or chapter 459 to receive low-THC 26 cannabis from a dispensing organization. 27 (e) “Smoking” means burning or igniting a substance and 28 inhaling the smoke. Smoking does not include the use of a 29 vaporizer. 30 (2) PHYSICIAN ORDERING.—Effective January 1, 2015, a 31 physician licensed under chapter 458 or chapter 459 who has 32 examined and treated a patient suffering from a physical medical 33 condition, or from treatment for a medical condition, which 34 chronically produces symptoms of seizures or severe and 35 persistent muscle spasms may order for the patient’s medical use 36 low-THC cannabis to treat or alleviate such symptoms if all of 37 the following conditions apply: 38 (a) The patient is a permanent resident of this state. 39 (b) The physician has treated the patient for his or her 40 symptoms or a medical condition in which his or her symptoms 41 were present for at least 2 months. 42 (c) The physician determines the risks of ordering low-THC 43 cannabis are reasonable in light of the potential benefit for 44 that patient. If a patient is younger than 18 years of age, a 45 second physician must concur with this determination, and such 46 determination must be documented in the patient’s medical 47 record. 48 (d) The physician registers as the orderer of low-THC 49 cannabis for the named patient on the compassionate use registry 50 maintained by the department and updates the registry to reflect 51 the contents of the order. The physician shall inactivate the 52 patient’s registration when treatment is discontinued. 53 (e) The physician maintains a patient treatment plan that 54 includes the dose, route of administration, planned duration, 55 and monitoring of the patient’s symptoms and other indicators of 56 tolerance or reaction to the low-THC cannabis. 57 (f) The physician submits the patient treatment plan 58 quarterly to the University of Florida College of Pharmacy for 59 research on the safety and efficacy of low-THC cannabis on 60 patients with such symptoms. 61 (3) PHYSICIAN EDUCATION.—Before ordering low-THC cannabis 62 for use by a patient in this state, the appropriate board shall 63 require the ordering physician licensed under chapter 458 or 64 chapter 459 to successfully complete an 8-hour course and 65 subsequent examination offered by the Florida Medical 66 Association which must encompass the clinical indications for 67 the appropriate use of low-THC cannabis, the appropriate 68 delivery mechanisms, the contraindications for such use, as well 69 as the relevant state and federal laws governing the ordering, 70 dispensing, and possessing of such substance. The first course 71 and examination shall be presented by October 1, 2014, and shall 72 be administered at least annually thereafter. Successful 73 completion of the course may be used by a physician to satisfy 8 74 hours of the continuing medical education requirements required 75 by his or her respective board for licensure renewal. The course 76 may be offered in a distance learning format. 77 (4) DUTIES OF THE DEPARTMENT.— 78 (a) By January 1, 2015, the department shall: 79 1. Create a secure, electronic, and online compassionate 80 use registry for the registration of physicians and patients as 81 provided under this section. The registry must be accessible to 82 law enforcement agencies and to a dispensing organization in 83 order to verify patient authorization for low-THC cannabis and 84 record the low-THC cannabis dispensed. The registry must prevent 85 an active registration of a patient by multiple physicians. 86 2. Authorize at least one, but no more than four, 87 dispensing organizations, to ensure reasonable statewide 88 accessibility and availability as necessary for patients 89 registered in the compassionate use registry and who are ordered 90 low-THC cannabis under this section. The department shall 91 develop an application form and impose an initial application 92 and biennial renewal fee that is sufficient to cover the costs 93 of administering this section. An applicant for approval as a 94 dispensing organization must be able to demonstrate: 95 a. The technical and technological ability to cultivate and 96 produce low-THC cannabis. 97 b. The ability to secure the premises, resources, and 98 personnel necessary to operate as a dispensing organization. 99 c. The ability to maintain accountability of all raw 100 materials, finished product, and any byproducts to prevent 101 diversion or unlawful access to or possession of these 102 substances. 103 d. An infrastructure reasonably located to dispense low-THC 104 cannabis to registered patients statewide or regionally as 105 determined by the department. 106 e. The financial ability to maintain operations for the 107 duration of the 2-year approval cycle. 108 f. That all owners, managers, and employees have been 109 fingerprinted and successfully passed background screening 110 pursuant to s. 435.04. 111 3. Implement a process for timely issuing identification 112 cards to patients registered in the compassionate use registry. 113 The identification card expires 1 year after the date issued. A 114 new identification card may be issued to a patient for whom a 115 physician continues registration and treatment with low-THC 116 cannabis. 117 (b) The department shall monitor physician registration and 118 the ordering of low-THC cannabis for ordering practices that 119 could facilitate unlawful diversion or misuse of low-THC 120 cannabis, and take disciplinary action as indicated. 121 (c) The department shall monitor and inspect the activities 122 of each approved dispensing organization for compliance with 123 this section. 124 (d) The department may adopt rules pertaining to: 125 1. The submission of relevant information to the 126 compassionate use registry in order to issue patient 127 identification cards; and 128 2. Recordkeeping requirements to demonstrate compliance 129 with this section, including maintaining records for the 130 production and finished product testing of low-THC cannabis. 131 (e) The department shall establish the Office of 132 Compassionate Use under the direction of the Deputy State Health 133 Officer to administer this section, including access to the 134 compassionate use registry under ss. 385.30 and 456.61. 135 (5) DISPENSING ORGANIZATION.— 136 (a) An approved dispensing organization shall: 137 1. Maintain compliance with the criteria demonstrated for 138 selection and approval under subparagraph (4)(a)2. as a 139 dispensing organization at all times; 140 2. Maintain and make records available for inspection and 141 desk review by the department and law enforcement agencies; and 142 3. Make all premises, resources, raw materials, finished 143 product, byproducts, and vehicles available for inspection by 144 the department and law enforcement agencies. 145 (b) Before dispensing low-THC cannabis to a qualified 146 patient, the dispensing organization shall verify that the 147 patient has an active registration in the compassionate use 148 registry, the order presented matches the order contents as 149 recorded in the registry, and the order has not already been 150 filled. Upon dispensing the low-THC cannabis, the dispensing 151 organization shall record in the registry the date, time, 152 quantity, and form of low-THC cannabis dispensed. 153 (6) EXCEPTIONS TO OTHER SECTIONS OF LAW.— 154 (a) Notwithstanding any other section of law, but subject 155 to the requirements of this section, a qualified patient and the 156 qualified patient’s legal representative may purchase, acquire, 157 and possess for the patient’s medical use up to the amount of 158 low-THC cannabis ordered to the patient. 159 (b) Notwithstanding any other section of law, but subject 160 to the requirements of this section, an approved dispensing 161 organization and its owners, managers, and employees may 162 acquire, possess, cultivate, and lawfully dispose of excess 163 product in reasonable quantities to produce low-THC cannabis and 164 possess, process, and dispense low-THC cannabis. 165 (c) An approved dispensing organization is not subject to 166 licensure and regulation under chapter 465, and the owners, 167 managers, and employees of a dispensing organization are not 168 subject to licensure and regulation for the practice of pharmacy 169 under chapter 465. 170 Section 2. Section 385.30, Florida Statutes, is created to 171 read: 172 385.30 State university participation in approved studies 173 and clinical treatment plans.— 174 (1) All state universities with both medical and 175 agricultural research programs, including those that have 176 satellite campuses or research agreements with other similar 177 institutions, are encouraged to develop or participate in 178 Federal Drug Administration-approved studies and clinical 179 research treatment plans using low-THC cannabis as defined in s. 180 456.60 which are directed toward refractory or intractable 181 epilepsy relief in pediatric patients as authorized by s. 182 1004.441. 183 (2) Each state university that is selected to participate 184 in a Federal Drug Administration-approved study or clinical 185 treatment plan described in subsection (1) may request from the 186 Department of Health a grant of up to $100,000 annually. 187 (3) To be eligible for the annual grant, the participating 188 medical college or medical school must submit a report to the 189 Department of Health by January 1 of each year which contains, 190 at a minimum: 191 (a) The gender and age of each patient participating in the 192 study or clinical treatment plan during the calendar year; 193 (b) The names of participating physicians; and 194 (c) The level of seizure reduction in each participating 195 patient during the calendar year. 196 (4) The grant award decisions of the Department of Health 197 pursuant to this section are not subject to chapter 120. 198 Section 3. Section 1004.441, Florida Statutes, is created 199 to read: 200 1004.441 Refractory and intractable epilepsy treatment and 201 research.—Notwithstanding chapter 893, state universities with 202 both medical and agricultural research programs, including those 203 that have satellite campuses or research agreements with other 204 similar institutions, may conduct research on low-THC cannabis 205 as defined in s. 456.60. This research may include, but is not 206 limited to, the agricultural development, production, clinical 207 research, and use of liquid medical derivatives of low-THC 208 cannabis for the treatment for refractory or intractable 209 epilepsy. Current state or privately obtained research funds may 210 be used to support the activities authorized by this section. 211 Section 4. The Department of Health may submit a budget 212 amendment request using excess funds from the Biomedical 213 Research Trust Fund to implement this act during the 2014-2015 214 state fiscal year. 215 Section 5. This act shall take effect July 1, 2014. 216 217 ================= T I T L E A M E N D M E N T ================ 218 And the title is amended as follows: 219 Delete everything before the enacting clause 220 and insert: 221 A bill to be entitled 222 An act relating to low-THC cannabis; creating s. 223 456.60, F.S.; defining terms; authorizing specified 224 physicians to order low-THC cannabis for use by 225 specified patients; providing conditions; providing 226 education requirements for physicians; providing 227 duties of the Department of Health; requiring the 228 department to create a compassionate use registry; 229 providing requirements for the registry; requiring the 230 department to authorize a specified number of 231 dispensing organizations; authorizing the department 232 to adopt specified rules; requiring the department to 233 establish the Office of Compassionate Use; providing 234 for inspections of dispensing organizations by the 235 department and law enforcement agencies; providing 236 requirements and duties for a dispensing organization; 237 providing exceptions to specified laws; creating s. 238 385.30, F.S.; encouraging state universities with both 239 medical and agricultural programs to participate in 240 specified Federal Drug Administration-approved 241 research directed toward refractory or intractable 242 epilepsy relief in pediatric patients; authorizing 243 participating state universities to annually request a 244 grant from the department; requiring a state 245 university that requests a grant to submit a specified 246 report to the department; providing applicability; 247 creating s. 1004.441, F.S.; authorizing state 248 universities with both medical and agricultural 249 programs to conduct specified research on low-THC 250 cannabis; authorizing the use of current state or 251 privately obtained research funds to support such 252 research; authorizing the department to submit a 253 budget amendment request to use excess funds in the 254 Biomedical Research Trust Fund to implement this act; 255 providing an effective date.