Bill Text: FL S0182 | 2019 | Regular Session | Comm Sub
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Medical Use of Marijuana
Spectrum: Bipartisan Bill
Status: (Passed) 2019-03-18 - Chapter No. 2019-1 [S0182 Detail]
Download: Florida-2019-S0182-Comm_Sub.html
Bill Title: Medical Use of Marijuana
Spectrum: Bipartisan Bill
Status: (Passed) 2019-03-18 - Chapter No. 2019-1 [S0182 Detail]
Download: Florida-2019-S0182-Comm_Sub.html
Florida Senate - 2019 CS for SB 182 By the Committee on Health Policy; and Senator Brandes 588-02162-19 2019182c1 1 A bill to be entitled 2 An act relating to smoking marijuana for medical use; 3 amending s. 381.986, F.S.; redefining the term 4 “medical use” to include the possession, use, or 5 administration of marijuana in a form for smoking; 6 conforming a provision to changes made by the act; 7 requiring a patient’s informed consent form to include 8 the risks specifically associated with smoking 9 marijuana; requiring a certifying physician to make a 10 determination in concurrence with a second physician 11 who meets specified requirements before certifying a 12 patient not diagnosed with a terminal condition to 13 smoke marijuana for medical use; deleting a provision 14 prohibiting a medical marijuana treatment center from 15 dispensing or selling specified products; providing an 16 effective date. 17 18 Be It Enacted by the Legislature of the State of Florida: 19 20 Section 1. Paragraph (j) of subsection (1), paragraph (a) 21 of subsection (4), and paragraph (e) of subsection (8) of 22 section 381.986, Florida Statutes, are amended to read: 23 381.986 Medical use of marijuana.— 24 (1) DEFINITIONS.—As used in this section, the term: 25 (j) “Medical use” means the acquisition, possession, use, 26 delivery, transfer, or administration of marijuana authorized by 27 a physician certification. The term does not include: 28 1. Possession, use, or administration of marijuana that was 29 not purchased or acquired from a medical marijuana treatment 30 center. 31 2. Possession, use, or administration of marijuana ina32form for smoking,inthe form of commercially produced food 33 items other than edibles,or of marijuana seedsor flower,34except for flower in a sealed, tamper-proof receptacle for35vaping. 36 3. Use or administration of any form or amount of marijuana 37 in a manner that is inconsistent with the qualified physician’s 38 directions or physician certification. 39 4. Transfer of marijuana to a person other than the 40 qualified patient for whom it was authorized or the qualified 41 patient’s caregiver on behalf of the qualified patient. 42 5. Use or administration of marijuana in the following 43 locations: 44 a. On any form of public transportation, except for low-THC 45 cannabis. 46 b. In any public place, except for low-THC cannabis. 47 c. In a qualified patient’s place of employment, except 48 when permitted by his or her employer. 49 d. In a state correctional institution, as defined in s. 50 944.02, or a correctional institution, as defined in s. 944.241. 51 e. On the grounds of a preschool, primary school, or 52 secondary school, except as provided in s. 1006.062. 53 f. In a school bus, a vehicle, an aircraft, or a motorboat, 54 except for low-THC cannabis. 55 56 For the purposes of this subparagraph, the exceptions for low 57 THC cannabis do not include the smoking of low-THC cannabis. 58 (4) PHYSICIAN CERTIFICATION.— 59 (a) A qualified physician may issue a physician 60 certification only if the qualified physician: 61 1. Conducted a physical examination while physically 62 present in the same room as the patient and a full assessment of 63 the medical history of the patient. 64 2. Diagnosed the patient with at least one qualifying 65 medical condition. 66 3. Determined that the medical use of marijuana would 67 likely outweigh the potential health risks for the patient, and 68 such determination must be documented in the patient’s medical 69 record. If a patient is younger than 18 years of age, a second 70 physician must concur with this determination, and such 71 concurrence must be documented in the patient’s medical record. 72 4. Determined whether the patient is pregnant and 73 documented such determination in the patient’s medical record. A 74 physician may not issue a physician certification, except for 75 low-THC cannabis, to a patient who is pregnant. 76 5. Reviewed the patient’s controlled drug prescription 77 history in the prescription drug monitoring program database 78 established pursuant to s. 893.055. 79 6. Reviews the medical marijuana use registry and confirmed 80 that the patient does not have an active physician certification 81 from another qualified physician. 82 7. Registers as the issuer of the physician certification 83 for the named qualified patient on the medical marijuana use 84 registry in an electronic manner determined by the department, 85 and: 86 a. Enters into the registry the contents of the physician 87 certification, including the patient’s qualifying condition and 88 the dosage not to exceed the daily dose amount determined by the 89 department, the amount and forms of marijuana authorized for the 90 patient, and any types of marijuana delivery devices needed by 91 the patient for the medical use of marijuana. 92 b. Updates the registry within 7 days after any change is 93 made to the original physician certification to reflect such 94 change. 95 c. Deactivates the registration of the qualified patient 96 and the patient’s caregiver when the physician no longer 97 recommends the medical use of marijuana for the patient. 98 8. Obtains the voluntary and informed written consent of 99 the patient for medical use of marijuana each time the qualified 100 physician issues a physician certification for the patient, 101 which shall be maintained in the patient’s medical record. The 102 patient, or the patient’s parent or legal guardian if the 103 patient is a minor, must sign the informed consent acknowledging 104 that the qualified physician has sufficiently explained its 105 content. The qualified physician must use a standardized 106 informed consent form adopted in rule by the Board of Medicine 107 and the Board of Osteopathic Medicine, which must include, at a 108 minimum, information related to: 109 a. The Federal Government’s classification of marijuana as 110 a Schedule I controlled substance. 111 b. The approval and oversight status of marijuana by the 112 Food and Drug Administration. 113 c. The current state of research on the efficacy of 114 marijuana to treat the qualifying conditions set forth in this 115 section. 116 d. The potential for addiction. 117 e. The potential effect that marijuana may have on a 118 patient’s coordination, motor skills, and cognition, including a 119 warning against operating heavy machinery, operating a motor 120 vehicle, or engaging in activities that require a person to be 121 alert or respond quickly. 122 f. The potential side effects of marijuana use. 123 g. The risks, benefits, and drug interactions of marijuana. 124 h. The risks specifically associated with smoking 125 marijuana. 126 i.h.That the patient’s de-identified health information 127 contained in the physician certification and medical marijuana 128 use registry may be used for research purposes. 129 130 For a patient not diagnosed with a terminal condition, if the 131 certifying physician intends to certify the patient’s medical 132 use of marijuana by way of smoking, the certifying physician 133 must determine that smoking is the only means of administering 134 medical marijuana that is likely to benefit the patient and a 135 second physician must concur with that determination. The second 136 physician must not be registered with the department as a 137 certifying physician for any qualified patients. Such 138 determination and concurrence must be documented in the 139 patient’s medical record. 140 (8) MEDICAL MARIJUANA TREATMENT CENTERS.— 141 (e) A licensed medical marijuana treatment center shall 142 cultivate, process, transport, and dispense marijuana for 143 medical use. A licensed medical marijuana treatment center may 144 not contract for services directly related to the cultivation, 145 processing, and dispensing of marijuana or marijuana delivery 146 devices, except that a medical marijuana treatment center 147 licensed pursuant to subparagraph (a)1. may contract with a 148 single entity for the cultivation, processing, transporting, and 149 dispensing of marijuana and marijuana delivery devices. A 150 licensed medical marijuana treatment center must, at all times, 151 maintain compliance with the criteria demonstrated and 152 representations made in the initial application and the criteria 153 established in this subsection. Upon request, the department may 154 grant a medical marijuana treatment center a variance from the 155 representations made in the initial application. Consideration 156 of such a request shall be based upon the individual facts and 157 circumstances surrounding the request. A variance may not be 158 granted unless the requesting medical marijuana treatment center 159 can demonstrate to the department that it has a proposed 160 alternative to the specific representation made in its 161 application which fulfills the same or a similar purpose as the 162 specific representation in a way that the department can 163 reasonably determine will not be a lower standard than the 164 specific representation in the application. A variance may not 165 be granted from the requirements in subparagraph 2. and 166 subparagraphs (b)1. and 2. 167 1. A licensed medical marijuana treatment center may 168 transfer ownership to an individual or entity who meets the 169 requirements of this section. A publicly traded corporation or 170 publicly traded company that meets the requirements of this 171 section is not precluded from ownership of a medical marijuana 172 treatment center. To accommodate a change in ownership: 173 a. The licensed medical marijuana treatment center shall 174 notify the department in writing at least 60 days before the 175 anticipated date of the change of ownership. 176 b. The individual or entity applying for initial licensure 177 due to a change of ownership must submit an application that 178 must be received by the department at least 60 days before the 179 date of change of ownership. 180 c. Upon receipt of an application for a license, the 181 department shall examine the application and, within 30 days 182 after receipt, notify the applicant in writing of any apparent 183 errors or omissions and request any additional information 184 required. 185 d. Requested information omitted from an application for 186 licensure must be filed with the department within 21 days after 187 the department’s request for omitted information or the 188 application shall be deemed incomplete and shall be withdrawn 189 from further consideration and the fees shall be forfeited. 190 191 Within 30 days after the receipt of a complete application, the 192 department shall approve or deny the application. 193 2. A medical marijuana treatment center, and any individual 194 or entity who directly or indirectly owns, controls, or holds 195 with power to vote 5 percent or more of the voting shares of a 196 medical marijuana treatment center, may not acquire direct or 197 indirect ownership or control of any voting shares or other form 198 of ownership of any other medical marijuana treatment center. 199 3. A medical marijuana treatment center may not enter into 200 any form of profit-sharing arrangement with the property owner 201 or lessor of any of its facilities where cultivation, 202 processing, storing, or dispensing of marijuana and marijuana 203 delivery devices occurs. 204 4. All employees of a medical marijuana treatment center 205 must be 21 years of age or older and have passed a background 206 screening pursuant to subsection (9). 207 5. Each medical marijuana treatment center must adopt and 208 enforce policies and procedures to ensure employees and 209 volunteers receive training on the legal requirements to 210 dispense marijuana to qualified patients. 211 6. When growing marijuana, a medical marijuana treatment 212 center: 213 a. May use pesticides determined by the department, after 214 consultation with the Department of Agriculture and Consumer 215 Services, to be safely applied to plants intended for human 216 consumption, but may not use pesticides designated as 217 restricted-use pesticides pursuant to s. 487.042. 218 b. Must grow marijuana within an enclosed structure and in 219 a room separate from any other plant. 220 c. Must inspect seeds and growing plants for plant pests 221 that endanger or threaten the horticultural and agricultural 222 interests of the state in accordance with chapter 581 and any 223 rules adopted thereunder. 224 d. Must perform fumigation or treatment of plants, or 225 remove and destroy infested or infected plants, in accordance 226 with chapter 581 and any rules adopted thereunder. 227 7. Each medical marijuana treatment center must produce and 228 make available for purchase at least one low-THC cannabis 229 product. 230 8. A medical marijuana treatment center that produces 231 edibles must hold a permit to operate as a food establishment 232 pursuant to chapter 500, the Florida Food Safety Act, and must 233 comply with all the requirements for food establishments 234 pursuant to chapter 500 and any rules adopted thereunder. 235 Edibles may not contain more than 200 milligrams of 236 tetrahydrocannabinol, and a single serving portion of an edible 237 may not exceed 10 milligrams of tetrahydrocannabinol. Edibles 238 may have a potency variance of no greater than 15 percent. 239 Edibles may not be attractive to children; be manufactured in 240 the shape of humans, cartoons, or animals; be manufactured in a 241 form that bears any reasonable resemblance to products available 242 for consumption as commercially available candy; or contain any 243 color additives. To discourage consumption of edibles by 244 children, the department shall determine by rule any shapes, 245 forms, and ingredients allowed and prohibited for edibles. 246 Medical marijuana treatment centers may not begin processing or 247 dispensing edibles until after the effective date of the rule. 248 The department shall also adopt sanitation rules providing the 249 standards and requirements for the storage, display, or 250 dispensing of edibles. 251 9. Within 12 months after licensure, a medical marijuana 252 treatment center must demonstrate to the department that all of 253 its processing facilities have passed a Food Safety Good 254 Manufacturing Practices, such as Global Food Safety Initiative 255 or equivalent, inspection by a nationally accredited certifying 256 body. A medical marijuana treatment center must immediately stop 257 processing at any facility which fails to pass this inspection 258 until it demonstrates to the department that such facility has 259 met this requirement. 260 10. When processing marijuana, a medical marijuana 261 treatment center must: 262 a. Process the marijuana within an enclosed structure and 263 in a room separate from other plants or products. 264 b. Comply with department rules when processing marijuana 265 with hydrocarbon solvents or other solvents or gases exhibiting 266 potential toxicity to humans. The department shall determine by 267 rule the requirements for medical marijuana treatment centers to 268 use such solvents or gases exhibiting potential toxicity to 269 humans. 270 c. Comply with federal and state laws and regulations and 271 department rules for solid and liquid wastes. The department 272 shall determine by rule procedures for the storage, handling, 273 transportation, management, and disposal of solid and liquid 274 waste generated during marijuana production and processing. The 275 Department of Environmental Protection shall assist the 276 department in developing such rules. 277 d. Test the processed marijuana using a medical marijuana 278 testing laboratory before it is dispensed. Results must be 279 verified and signed by two medical marijuana treatment center 280 employees. Before dispensing, the medical marijuana treatment 281 center must determine that the test results indicate that low 282 THC cannabis meets the definition of low-THC cannabis, the 283 concentration of tetrahydrocannabinol meets the potency 284 requirements of this section, the labeling of the concentration 285 of tetrahydrocannabinol and cannabidiol is accurate, and all 286 marijuana is safe for human consumption and free from 287 contaminants that are unsafe for human consumption. The 288 department shall determine by rule which contaminants must be 289 tested for and the maximum levels of each contaminant which are 290 safe for human consumption. The Department of Agriculture and 291 Consumer Services shall assist the department in developing the 292 testing requirements for contaminants that are unsafe for human 293 consumption in edibles. The department shall also determine by 294 rule the procedures for the treatment of marijuana that fails to 295 meet the testing requirements of this section, s. 381.988, or 296 department rule. The department may select a random sample from 297 edibles available for purchase in a dispensing facility which 298 shall be tested by the department to determine that the edible 299 meets the potency requirements of this section, is safe for 300 human consumption, and the labeling of the tetrahydrocannabinol 301 and cannabidiol concentration is accurate. A medical marijuana 302 treatment center may not require payment from the department for 303 the sample. A medical marijuana treatment center must recall 304 edibles, including all edibles made from the same batch of 305 marijuana, which fail to meet the potency requirements of this 306 section, which are unsafe for human consumption, or for which 307 the labeling of the tetrahydrocannabinol and cannabidiol 308 concentration is inaccurate. The medical marijuana treatment 309 center must retain records of all testing and samples of each 310 homogenous batch of marijuana for at least 9 months. The medical 311 marijuana treatment center must contract with a marijuana 312 testing laboratory to perform audits on the medical marijuana 313 treatment center’s standard operating procedures, testing 314 records, and samples and provide the results to the department 315 to confirm that the marijuana or low-THC cannabis meets the 316 requirements of this section and that the marijuana or low-THC 317 cannabis is safe for human consumption. A medical marijuana 318 treatment center shall reserve two processed samples from each 319 batch and retain such samples for at least 9 months for the 320 purpose of such audits. A medical marijuana treatment center may 321 use a laboratory that has not been certified by the department 322 under s. 381.988 until such time as at least one laboratory 323 holds the required certification, but in no event later than 324 July 1, 2018. 325 e. Package the marijuana in compliance with the United 326 States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss. 327 1471 et seq. 328 f. Package the marijuana in a receptacle that has a firmly 329 affixed and legible label stating the following information: 330 (I) The marijuana or low-THC cannabis meets the 331 requirements of sub-subparagraph d. 332 (II) The name of the medical marijuana treatment center 333 from which the marijuana originates. 334 (III) The batch number and harvest number from which the 335 marijuana originates and the date dispensed. 336 (IV) The name of the physician who issued the physician 337 certification. 338 (V) The name of the patient. 339 (VI) The product name, if applicable, and dosage form, 340 including concentration of tetrahydrocannabinol and cannabidiol. 341 The product name may not contain wording commonly associated 342 with products marketed by or to children. 343 (VII) The recommended dose. 344 (VIII) A warning that it is illegal to transfer medical 345 marijuana to another person. 346 (IX) A marijuana universal symbol developed by the 347 department. 348 11. The medical marijuana treatment center shall include in 349 each package a patient package insert with information on the 350 specific product dispensed related to: 351 a. Clinical pharmacology. 352 b. Indications and use. 353 c. Dosage and administration. 354 d. Dosage forms and strengths. 355 e. Contraindications. 356 f. Warnings and precautions. 357 g. Adverse reactions. 358 12. Each edible shall be individually sealed in plain, 359 opaque wrapping marked only with the marijuana universal symbol. 360 Where practical, each edible shall be marked with the marijuana 361 universal symbol. In addition to the packaging and labeling 362 requirements in subparagraphs 10. and 11., edible receptacles 363 must be plain, opaque, and white without depictions of the 364 product or images other than the medical marijuana treatment 365 center’s department-approved logo and the marijuana universal 366 symbol. The receptacle must also include a list all of the 367 edible’s ingredients, storage instructions, an expiration date, 368 a legible and prominent warning to keep away from children and 369 pets, and a warning that the edible has not been produced or 370 inspected pursuant to federal food safety laws. 371 13. When dispensing marijuana or a marijuana delivery 372 device, a medical marijuana treatment center: 373 a. May dispense any active, valid order for low-THC 374 cannabis, medical cannabis and cannabis delivery devices issued 375 pursuant to former s. 381.986, Florida Statutes 2016, which was 376 entered into the medical marijuana use registry before July 1, 377 2017. 378 b. May not dispense more than a 70-day supply of marijuana 379 to a qualified patient or caregiver. 380 c. Must have the medical marijuana treatment center’s 381 employee who dispenses the marijuana or a marijuana delivery 382 device enter into the medical marijuana use registry his or her 383 name or unique employee identifier. 384 d. Must verify that the qualified patient and the 385 caregiver, if applicable, each have an active registration in 386 the medical marijuana use registry and an active and valid 387 medical marijuana use registry identification card, the amount 388 and type of marijuana dispensed matches the physician 389 certification in the medical marijuana use registry for that 390 qualified patient, and the physician certification has not 391 already been filled. 392 e. May not dispense marijuana to a qualified patient who is 393 younger than 18 years of age. If the qualified patient is 394 younger than 18 years of age, marijuana may only be dispensed to 395 the qualified patient’s caregiver. 396 f. May not dispense or sell any other type of cannabis, 397 alcohol, or illicit drug-related product,including pipes,398bongs, or wrapping papers,other than a marijuana delivery 399 device required for the medical use of marijuana and which is 400 specified in a physician certification. 401 g. Must, upon dispensing the marijuana or marijuana 402 delivery device, record in the registry the date, time, 403 quantity, and form of marijuana dispensed; the type of marijuana 404 delivery device dispensed; and the name and medical marijuana 405 use registry identification number of the qualified patient or 406 caregiver to whom the marijuana delivery device was dispensed. 407 h. Must ensure that patient records are not visible to 408 anyone other than the qualified patient, his or her caregiver, 409 and authorized medical marijuana treatment center employees. 410 Section 2. This act shall take effect upon becoming a law.