ENROLLED 2014 Legislature CS for CS for SB 1030, 1st Engrossed 20141030er 1 2 An act relating to cannabis; providing a short title; 3 creating s. 381.986, F.S.; defining terms; authorizing 4 specified physicians to order low-THC cannabis for use 5 by specified patients; providing conditions; 6 prohibiting specified acts by physicians or persons 7 seeking low-THC cannabis; providing criminal 8 penalties; requiring physician education; providing 9 duties of the Department of Health; requiring the 10 department to create a compassionate use registry; 11 providing requirements for the registry; requiring the 12 department to authorize a specified number of 13 dispensing organizations; authorizing rulemaking; 14 providing requirements and duties for a dispensing 15 organization; providing exceptions to specified laws; 16 creating s. 385.211, F.S.; defining the term “low-THC 17 cannabis”; authorizing certain medical centers to 18 conduct research on cannabidiol and low-THC cannabis; 19 authorizing state or privately obtained research funds 20 to be used to support such research; creating s. 21 385.212, F.S.; requiring the department to establish 22 an Office of Compassionate Use; authorizing the office 23 to engage in specified activities; authorizing 24 rulemaking; amending s. 893.02, F.S.; revising the 25 term “cannabis” as used in the Florida Comprehensive 26 Drug Abuse Prevention and Control Act and as 27 applicable to certain criminal offenses proscribing 28 the sale, manufacture, delivery, possession, 29 dispensing, distribution, or purchase of cannabis, to 30 which penalties apply; creating s. 1004.441, F.S.; 31 defining the term “low-THC cannabis”; authorizing 32 state universities with both medical and agricultural 33 research programs to conduct specified research on 34 cannabidiol and low-THC cannabis; authorizing state or 35 privately obtained research funds to be used to 36 support such research; providing an appropriation to 37 the department for research of cannabidiol and its 38 effect on intractable childhood epilepsy; specifying 39 how biomedical research funding for research of 40 cannabidiol and its effect on intractable childhood 41 epilepsy shall be awarded; specifying who may apply 42 for such funding; providing an effective date. 43 44 Be It Enacted by the Legislature of the State of Florida: 45 46 Section 1. This act may be cited as the “Compassionate 47 Medical Cannabis Act of 2014.” 48 Section 2. Section 381.986, Florida Statutes, is created to 49 read: 50 381.986 Compassionate use of low-THC cannabis.— 51 (1) DEFINITIONS.—As used in this section, the term: 52 (a) “Dispensing organization” means an organization 53 approved by the department to cultivate, process, and dispense 54 low-THC cannabis pursuant to this section. 55 (b) “Low-THC cannabis” means a plant of the genus Cannabis, 56 the dried flowers of which contain 0.8 percent or less of 57 tetrahydrocannabinol and more than 10 percent of cannabidiol 58 weight for weight; the seeds thereof; the resin extracted from 59 any part of such plant; or any compound, manufacture, salt, 60 derivative, mixture, or preparation of such plant or its seeds 61 or resin that is dispensed only from a dispensing organization. 62 (c) “Medical use” means administration of the ordered 63 amount of low-THC cannabis. The term does not include the 64 possession, use, or administration by smoking. The term also 65 does not include the transfer of low-THC cannabis to a person 66 other than the qualified patient for whom it was ordered or the 67 qualified patient’s legal representative on behalf of the 68 qualified patient. 69 (d) “Qualified patient” means a resident of this state who 70 has been added to the compassionate use registry by a physician 71 licensed under chapter 458 or chapter 459 to receive low-THC 72 cannabis from a dispensing organization. 73 (e) “Smoking” means burning or igniting a substance and 74 inhaling the smoke. Smoking does not include the use of a 75 vaporizer. 76 (2) PHYSICIAN ORDERING.—Effective January 1, 2015, a 77 physician licensed under chapter 458 or chapter 459 who has 78 examined and is treating a patient suffering from cancer or a 79 physical medical condition that chronically produces symptoms of 80 seizures or severe and persistent muscle spasms may order for 81 the patient’s medical use low-THC cannabis to treat such 82 disease, disorder, or condition or to alleviate symptoms of such 83 disease, disorder, or condition, if no other satisfactory 84 alternative treatment options exist for that patient and all of 85 the following conditions apply: 86 (a) The patient is a permanent resident of this state. 87 (b) The physician determines that the risks of ordering 88 low-THC cannabis are reasonable in light of the potential 89 benefit for that patient. If a patient is younger than 18 years 90 of age, a second physician must concur with this determination, 91 and such determination must be documented in the patient’s 92 medical record. 93 (c) The physician registers as the orderer of low-THC 94 cannabis for the named patient on the compassionate use registry 95 maintained by the department and updates the registry to reflect 96 the contents of the order. The physician shall deactivate the 97 patient’s registration when treatment is discontinued. 98 (d) The physician maintains a patient treatment plan that 99 includes the dose, route of administration, planned duration, 100 and monitoring of the patient’s symptoms and other indicators of 101 tolerance or reaction to the low-THC cannabis. 102 (e) The physician submits the patient treatment plan 103 quarterly to the University of Florida College of Pharmacy for 104 research on the safety and efficacy of low-THC cannabis on 105 patients. 106 (f) The physician obtains the voluntary informed consent of 107 the patient or the patient’s legal guardian to treatment with 108 low-THC cannabis after sufficiently explaining the current state 109 of knowledge in the medical community of the effectiveness of 110 treatment of the patient’s condition with low-THC cannabis, the 111 medically acceptable alternatives, and the potential risks and 112 side effects. 113 (3) PENALTIES.— 114 (a) A physician commits a misdemeanor of the first degree, 115 punishable as provided in s. 775.082 or s. 775.083, if the 116 physician orders low-THC cannabis for a patient without a 117 reasonable belief that the patient is suffering from: 118 1. Cancer or a physical medical condition that chronically 119 produces symptoms of seizures or severe and persistent muscle 120 spasms that can be treated with low-THC cannabis; or 121 2. Symptoms of cancer or a physical medical condition that 122 chronically produces symptoms of seizures or severe and 123 persistent muscle spasms that can be alleviated with low-THC 124 cannabis. 125 (b) Any person who fraudulently represents that he or she 126 has cancer or a physical medical condition that chronically 127 produces symptoms of seizures or severe and persistent muscle 128 spasms to a physician for the purpose of being ordered low-THC 129 cannabis by such physician commits a misdemeanor of the first 130 degree, punishable as provided in s. 775.082 or s. 775.083. 131 (4) PHYSICIAN EDUCATION.— 132 (a) Before ordering low-THC cannabis for use by a patient 133 in this state, the appropriate board shall require the ordering 134 physician licensed under chapter 458 or chapter 459 to 135 successfully complete an 8-hour course and subsequent 136 examination offered by the Florida Medical Association or the 137 Florida Osteopathic Medical Association that encompasses the 138 clinical indications for the appropriate use of low-THC 139 cannabis, the appropriate delivery mechanisms, the 140 contraindications for such use, as well as the relevant state 141 and federal laws governing the ordering, dispensing, and 142 possessing of this substance. The first course and examination 143 shall be presented by October 1, 2014, and shall be administered 144 at least annually thereafter. Successful completion of the 145 course may be used by a physician to satisfy 8 hours of the 146 continuing medical education requirements required by his or her 147 respective board for licensure renewal. This course may be 148 offered in a distance learning format. 149 (b) The appropriate board shall require the medical 150 director of each dispensing organization approved under 151 subsection (5) to successfully complete a 2-hour course and 152 subsequent examination offered by the Florida Medical 153 Association or the Florida Osteopathic Medical Association that 154 encompasses appropriate safety procedures and knowledge of low 155 THC cannabis. 156 (c) Successful completion of the course and examination 157 specified in paragraph (a) is required for every physician who 158 orders low-THC cannabis each time such physician renews his or 159 her license. In addition, successful completion of the course 160 and examination specified in paragraph (b) is required for the 161 medical director of each dispensing organization each time such 162 physician renews his or her license. 163 (d) A physician who fails to comply with this subsection 164 and who orders low-THC cannabis may be subject to disciplinary 165 action under the applicable practice act and under s. 166 456.072(1)(k). 167 (5) DUTIES OF THE DEPARTMENT.—By January 1, 2015, the 168 department shall: 169 (a) Create a secure, electronic, and online compassionate 170 use registry for the registration of physicians and patients as 171 provided under this section. The registry must be accessible to 172 law enforcement agencies and to a dispensing organization in 173 order to verify patient authorization for low-THC cannabis and 174 record the low-THC cannabis dispensed. The registry must prevent 175 an active registration of a patient by multiple physicians. 176 (b) Authorize the establishment of five dispensing 177 organizations to ensure reasonable statewide accessibility and 178 availability as necessary for patients registered in the 179 compassionate use registry and who are ordered low-THC cannabis 180 under this section, one in each of the following regions: 181 northwest Florida, northeast Florida, central Florida, southeast 182 Florida, and southwest Florida. The department shall develop an 183 application form and impose an initial application and biennial 184 renewal fee that is sufficient to cover the costs of 185 administering this section. An applicant for approval as a 186 dispensing organization must be able to demonstrate: 187 1. The technical and technological ability to cultivate and 188 produce low-THC cannabis. The applicant must possess a valid 189 certificate of registration issued by the Department of 190 Agriculture and Consumer Services pursuant to s. 581.131 that is 191 issued for the cultivation of more than 400,000 plants, be 192 operated by a nurseryman as defined in s. 581.011, and have been 193 operated as a registered nursery in this state for at least 30 194 continuous years. 195 2. The ability to secure the premises, resources, and 196 personnel necessary to operate as a dispensing organization. 197 3. The ability to maintain accountability of all raw 198 materials, finished products, and any byproducts to prevent 199 diversion or unlawful access to or possession of these 200 substances. 201 4. An infrastructure reasonably located to dispense low-THC 202 cannabis to registered patients statewide or regionally as 203 determined by the department. 204 5. The financial ability to maintain operations for the 205 duration of the 2-year approval cycle, including the provision 206 of certified financials to the department. Upon approval, the 207 applicant must post a $5 million performance bond. 208 6. That all owners and managers have been fingerprinted and 209 have successfully passed a level 2 background screening pursuant 210 to s. 435.04. 211 7. The employment of a medical director who is a physician 212 licensed under chapter 458 or chapter 459 to supervise the 213 activities of the dispensing organization. 214 (c) Monitor physician registration and ordering of low-THC 215 cannabis for ordering practices that could facilitate unlawful 216 diversion or misuse of low-THC cannabis and take disciplinary 217 action as indicated. 218 (d) Adopt rules necessary to implement this section. 219 (6) DISPENSING ORGANIZATION.—An approved dispensing 220 organization shall maintain compliance with the criteria 221 demonstrated for selection and approval as a dispensing 222 organization under subsection (5) at all times. Before 223 dispensing low-THC cannabis to a qualified patient, the 224 dispensing organization shall verify that the patient has an 225 active registration in the compassionate use registry, the order 226 presented matches the order contents as recorded in the 227 registry, and the order has not already been filled. Upon 228 dispensing the low-THC cannabis, the dispensing organization 229 shall record in the registry the date, time, quantity, and form 230 of low-THC cannabis dispensed. 231 (7) EXCEPTIONS TO OTHER LAWS.— 232 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 233 any other provision of law, but subject to the requirements of 234 this section, a qualified patient and the qualified patient’s 235 legal representative may purchase and possess for the patient’s 236 medical use up to the amount of low-THC cannabis ordered for the 237 patient. 238 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 239 any other provision of law, but subject to the requirements of 240 this section, an approved dispensing organization and its 241 owners, managers, and employees may manufacture, possess, sell, 242 deliver, distribute, dispense, and lawfully dispose of 243 reasonable quantities, as established by department rule, of 244 low-THC cannabis. For purposes of this subsection, the terms 245 “manufacture,” “possession,” “deliver,” “distribute,” and 246 “dispense” have the same meanings as provided in s. 893.02. 247 (c) An approved dispensing organization and its owners, 248 managers, and employees are not subject to licensure or 249 regulation under chapter 465 for manufacturing, possessing, 250 selling, delivering, distributing, dispensing, or lawfully 251 disposing of reasonable quantities, as established by department 252 rule, of low-THC cannabis. 253 Section 3. Section 385.211, Florida Statutes, is created to 254 read: 255 385.211 Refractory and intractable epilepsy treatment and 256 research at recognized medical centers.— 257 (1) As used in this section, the term “low-THC cannabis” 258 means “low-THC cannabis” as defined in s. 381.986 that is 259 dispensed only from a dispensing organization as defined in s. 260 381.986. 261 (2) Notwithstanding chapter 893, medical centers recognized 262 pursuant to s. 381.925 may conduct research on cannabidiol and 263 low-THC cannabis. This research may include, but is not limited 264 to, the agricultural development, production, clinical research, 265 and use of liquid medical derivatives of cannabidiol and low-THC 266 cannabis for the treatment for refractory or intractable 267 epilepsy. The authority for recognized medical centers to 268 conduct this research is derived from 21 C.F.R. parts 312 and 269 316. Current state or privately obtained research funds may be 270 used to support the activities described in this section. 271 Section 4. Section 385.212, Florida Statutes, is created to 272 read: 273 385.212 Powers and duties of the Department of Health; 274 Office of Compassionate Use.— 275 (1) The Department of Health shall establish an Office of 276 Compassionate Use under the direction of the Deputy State Health 277 Officer. 278 (2) The Office of Compassionate Use may enhance access to 279 investigational new drugs for Florida patients through approved 280 clinical treatment plans or studies. The Office of Compassionate 281 Use may: 282 (a) Create a network of state universities and medical 283 centers recognized pursuant to s. 381.925. 284 (b) Make any necessary application to the United States 285 Food and Drug Administration or a pharmaceutical manufacturer to 286 facilitate enhanced access to compassionate use for Florida 287 patients. 288 (c) Enter into any agreements necessary to facilitate 289 enhanced access to compassionate use for Florida patients. 290 (3) The department may adopt rules necessary to implement 291 this section. 292 Section 5. Subsection (3) of section 893.02, Florida 293 Statutes, is amended to read: 294 893.02 Definitions.—The following words and phrases as used 295 in this chapter shall have the following meanings, unless the 296 context otherwise requires: 297 (3) “Cannabis” means all parts of any plant of the genus 298 Cannabis, whether growing or not; the seeds thereof; the resin 299 extracted from any part of the plant; and every compound, 300 manufacture, salt, derivative, mixture, or preparation of the 301 plant or its seeds or resin. The term does not include “low-THC 302 cannabis,” as defined in s. 381.986, if manufactured, possessed, 303 sold, purchased, delivered, distributed, or dispensed, in 304 conformance with s. 381.986. 305 Section 6. Section 1004.441, Florida Statutes, is created 306 to read: 307 1004.441 Refractory and intractable epilepsy treatment and 308 research.— 309 (1) As used in this section, the term “low-THC cannabis” 310 means “low-THC cannabis” as defined in s. 381.986 that is 311 dispensed only from a dispensing organization as defined in s. 312 381.986. 313 (2) Notwithstanding chapter 893, state universities with 314 both medical and agricultural research programs, including those 315 that have satellite campuses or research agreements with other 316 similar institutions, may conduct research on cannabidiol and 317 low-THC cannabis. This research may include, but is not limited 318 to, the agricultural development, production, clinical research, 319 and use of liquid medical derivatives of cannabidiol and low-THC 320 cannabis for the treatment for refractory or intractable 321 epilepsy. The authority for state universities to conduct this 322 research is derived from 21 C.F.R. parts 312 and 316. Current 323 state or privately obtained research funds may be used to 324 support the activities authorized by this section. 325 Section 7. (1) As used in this section, the term 326 “cannabidiol” means an extract from the cannabis plant that has 327 less than 0.8 percent tetrahydrocannabinol and the chemical 328 signature 2-[(1R,6R)-6-isopropenyl-3-methylcyclohex-2-en-1-yl] 329 5-pentylbenzene-1,3-diol, or a derivative thereof, as determined 330 by the International Union of Pure and Applied Chemistry. 331 (2) For the 2014-2015 fiscal year, $1 million in 332 nonrecurring general revenue is appropriated to the Department 333 of Health for the James and Esther King Biomedical Research 334 Program and shall be deposited into the Biomedical Research 335 Trust Fund. These funds shall be reserved for research of 336 cannabidiol and its effect on intractable childhood epilepsy. 337 (3) Biomedical research funding for research of cannabidiol 338 and its effect on intractable childhood epilepsy shall be 339 awarded pursuant to s. 215.5602, Florida Statutes. An 340 application for such funding may be submitted by any research 341 university in the state that has obtained approval from the 342 United States Food and Drug Administration for an exploratory 343 investigational new drug study of cannabidiol and its effect on 344 intractable childhood epilepsy. For purposes of this section, 345 the Biomedical Research Advisory Council created under s. 346 215.5602, Florida Statutes, shall advise the State Surgeon 347 General as to the direction and scope of research of cannabidiol 348 and its effect on intractable childhood epilepsy and the award 349 of research funding. 350 Section 8. This act shall take effect upon becoming a law.