Bill Amendment: FL S0182 | 2019 | Regular Session
NOTE: For additional amemendments please see the Bill Drafting List
Bill Title: Medical Use of Marijuana
Status: 2019-03-18 - Chapter No. 2019-1 [S0182 Detail]
Download: Florida-2019-S0182-Senate_Floor_Amendment_Delete_All_897266.html
Bill Title: Medical Use of Marijuana
Status: 2019-03-18 - Chapter No. 2019-1 [S0182 Detail]
Download: Florida-2019-S0182-Senate_Floor_Amendment_Delete_All_897266.html
Florida Senate - 2019 SENATOR AMENDMENT Bill No. CS for CS for CS for SB 182 Ì897266NÎ897266 LEGISLATIVE ACTION Senate . House . . . . . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— Senator Brandes moved the following: 1 Senate Amendment (with title amendment) 2 3 Delete everything after the enacting clause 4 and insert: 5 Section 1. Paragraphs (g) and (j) of subsection (1), 6 subsection (4), paragraphs (c) and (d) of subsection (6), 7 paragraph (e) of subsection (8), subsection (14), and subsection 8 (15) of section 381.986, Florida Statutes, are amended to read: 9 381.986 Medical use of marijuana.— 10 (1) DEFINITIONS.—As used in this section, the term: 11 (g) “Marijuana delivery device” means an object used, 12 intended for use, or designed for use in preparing, storing, 13 ingesting, inhaling, or otherwise introducing marijuana into the 14 human body, and which is dispensed from a medical marijuana15treatment centerfor medical use by a qualified patient. 16 (j) “Medical use” means the acquisition, possession, use, 17 delivery, transfer, or administration of marijuana authorized by 18 a physician certification. The term does not include: 19 1. Possession, use, or administration of marijuana that was 20 not purchased or acquired from a medical marijuana treatment 21 center. 22 2. Possession, use, or administration of marijuanain a23form for smoking,in the form of commercially produced food 24 items other than edibles,or of marijuana seedsor flower25,except for flower in a sealed, tamper-proof receptacle for26vaping. 27 3. Use or administration of any form or amount of marijuana 28 in a manner that is inconsistent with the qualified physician’s 29 directions or physician certification. 30 4. Transfer of marijuana to a person other than the 31 qualified patient for whom it was authorized or the qualified 32 patient’s caregiver on behalf of the qualified patient. 33 5. Use or administration of marijuana in the following 34 locations: 35 a. On any form of public transportation, except for low-THC 36 cannabis not in a form for smoking. 37 b. In any public place, except for low-THC cannabis not in 38 a form for smoking. 39 c. In a qualified patient’s place of employment, except 40 when permitted by his or her employer. 41 d. In a state correctional institution, as defined in s. 42 944.02, or a correctional institution, as defined in s. 944.241. 43 e. On the grounds of a preschool, primary school, or 44 secondary school, except as provided in s. 1006.062. 45 f. In a school bus, a vehicle, an aircraft, or a motorboat, 46 except for low-THC cannabis not in a form for smoking. 47 6. The smoking of marijuana in an enclosed indoor workplace 48 as defined in s. 386.203(5). 49 (4) PHYSICIAN CERTIFICATION.— 50 (a) A qualified physician may issue a physician 51 certification only if the qualified physician: 52 1. Conducted a physical examination while physically 53 present in the same room as the patient and a full assessment of 54 the medical history of the patient. 55 2. Diagnosed the patient with at least one qualifying 56 medical condition. 57 3. Determined that the medical use of marijuana would 58 likely outweigh the potential health risks for the patient, and 59 such determination must be documented in the patient’s medical 60 record. If a patient is younger than 18 years of age, a second 61 physician must concur with this determination, and such 62 concurrence must be documented in the patient’s medical record. 63 4. Determined whether the patient is pregnant and 64 documented such determination in the patient’s medical record. A 65 physician may not issue a physician certification, except for 66 low-THC cannabis, to a patient who is pregnant. 67 5. Reviewed the patient’s controlled drug prescription 68 history in the prescription drug monitoring program database 69 established pursuant to s. 893.055. 70 6. Reviews the medical marijuana use registry and confirmed 71 that the patient does not have an active physician certification 72 from another qualified physician. 73 7. Registers as the issuer of the physician certification 74 for the named qualified patient on the medical marijuana use 75 registry in an electronic manner determined by the department, 76 and: 77 a. Enters into the registry the contents of the physician 78 certification, including the patient’s qualifying condition and 79 the dosage not to exceed the daily dose amount determined by the 80 department, the amount and forms of marijuana authorized for the 81 patient, and any types of marijuana delivery devices needed by 82 the patient for the medical use of marijuana. 83 b. Updates the registry within 7 days after any change is 84 made to the original physician certification to reflect such 85 change. 86 c. Deactivates the registration of the qualified patient 87 and the patient’s caregiver when the physician no longer 88 recommends the medical use of marijuana for the patient. 89 8. Obtains the voluntary and informed written consent of 90 the patient for medical use of marijuana each time the qualified 91 physician issues a physician certification for the patient, 92 which shall be maintained in the patient’s medical record. The 93 patient, or the patient’s parent or legal guardian if the 94 patient is a minor, must sign the informed consent acknowledging 95 that the qualified physician has sufficiently explained its 96 content. The qualified physician must use a standardized 97 informed consent form adopted in rule by the Board of Medicine 98 and the Board of Osteopathic Medicine, which must include, at a 99 minimum, information related to: 100 a. The Federal Government’s classification of marijuana as 101 a Schedule I controlled substance. 102 b. The approval and oversight status of marijuana by the 103 Food and Drug Administration. 104 c. The current state of research on the efficacy of 105 marijuana to treat the qualifying conditions set forth in this 106 section. 107 d. The potential for addiction. 108 e. The potential effect that marijuana may have on a 109 patient’s coordination, motor skills, and cognition, including a 110 warning against operating heavy machinery, operating a motor 111 vehicle, or engaging in activities that require a person to be 112 alert or respond quickly. 113 f. The potential side effects of marijuana use, including 114 the negative health risks associated with smoking marijuana. 115 g. The risks, benefits, and drug interactions of marijuana. 116 h. That the patient’s de-identified health information 117 contained in the physician certification and medical marijuana 118 use registry may be used for research purposes. 119 (b) If a qualified physician issues a physician 120 certification for a qualified patient diagnosed with a 121 qualifying medical condition pursuant to paragraph (2)(k), the 122 physician must submit the following to the applicable board 123 within 14 days after issuing the physician certification: 124 1. Documentation supporting the qualified physician’s 125 opinion that the medical condition is of the same kind or class 126 as the conditions in paragraphs (2)(a)-(j). 127 2. Documentation that establishes the efficacy of marijuana 128 as treatment for the condition. 129 3. Documentation supporting the qualified physician’s 130 opinion that the benefits of medical use of marijuana would 131 likely outweigh the potential health risks for the patient. 132 4. Any other documentation as required by board rule. 133 134 The department must submit such documentation to the Consortium 135Coalitionfor Medical Marijuana Clinical Outcomes Researchand136Educationestablished pursuant to s. 1004.4351. 137 (c) If a qualified physician determines that smoking is an 138 appropriate route of administration for a qualified patient, 139 other than a patient diagnosed with a terminal condition, the 140 qualified physician must submit the following documentation to 141 the applicable board: 142 1. A list of other routes of administration, if any, 143 certified by a qualified physician that the patient has tried, 144 the length of time the patient used such routes of 145 administration, and an assessment of the effectiveness of those 146 routes of administration in treating the qualified patient’s 147 qualifying condition. 148 2. Research documenting the effectiveness of smoking as a 149 route of administration to treat similarly situated patients 150 with the same qualifying condition as the qualified patient. 151 3. A statement signed by the qualified physician 152 documenting the qualified physician’s opinion that the benefits 153 of smoking marijuana for medical use outweigh the risks for the 154 qualified patient. 155 (d) A qualified physician may not issue a physician 156 certification for marijuana in a form for smoking to a patient 157 under 18 years of age unless the patient is diagnosed with a 158 terminal condition, the qualified physician determines that 159 smoking is the most effective route of administration for the 160 patient, and a second physician who is a board-certified 161 pediatrician concurs with such determination. Such determination 162 and concurrence must be documented in the patient’s medical 163 record and in the medical marijuana use registry. The certifying 164 physician must obtain the written informed consent of such 165 patient’s parent or legal guardian before issuing a physician 166 certification to the patient for marijuana in a form for 167 smoking. The qualified physician must use a standardized 168 informed consent form adopted in rule by the Board of Medicine 169 and the Board of Osteopathic Medicine which must include 170 information concerning the negative health effects of smoking 171 marijuana on persons under 18 years of age and an 172 acknowledgement that the qualified physician has sufficiently 173 explained the contents of the form. 174 (e) The Board of Medicine and the Board of Osteopathic 175 Medicine shall review the documentation submitted pursuant to 176 paragraph (c) and shall each, by July 1, 2021, adopt by rule 177 practice standards for the certification of smoking as a route 178 of administration. 179 (f)(c)A qualified physician may not issue a physician 180 certification for more than three 70-day supply limits of 181 marijuana or more than one 35-day supply limit of marijuana in a 182 form for smoking. The department shall quantify by rule a daily 183 dose amount with equivalent dose amounts for each allowable form 184 of marijuana dispensed by a medical marijuana treatment center. 185 The department shall use the daily dose amount to calculate a 186 70-day supply. 187 1. A qualified physician may request an exception to the 188 daily dose amount limit, the 35-day supply limit of marijuana in 189 a form for smoking, and the 4-ounce possession limit of 190 marijuana in a form for smoking established in paragraph 191 (14)(a). The request shall be made electronically on a form 192 adopted by the department in rule and must include, at a 193 minimum: 194 a. The qualified patient’s qualifying medical condition. 195 b. The dosage and route of administration that was 196 insufficient to provide relief to the qualified patient. 197 c. A description of how the patient will benefit from an 198 increased amount. 199 d. The minimum daily dose amount of marijuana that would be 200 sufficient for the treatment of the qualified patient’s 201 qualifying medical condition. 202 2. A qualified physician must provide the qualified 203 patient’s records upon the request of the department. 204 3. The department shall approve or disapprove the request 205 within 14 days after receipt of the complete documentation 206 required by this paragraph. The request shall be deemed approved 207 if the department fails to act within this time period. 208 (g)(d)A qualified physician must evaluate an existing 209 qualified patient at least once every 30 weeks before issuing a 210 new physician certification. A physician must: 211 1. Determine if the patient still meets the requirements to 212 be issued a physician certification under paragraph (a). 213 2. Identify and document in the qualified patient’s medical 214 records whether the qualified patient experienced either of the 215 following related to the medical use of marijuana: 216 a. An adverse drug interaction with any prescription or 217 nonprescription medication; or 218 b. A reduction in the use of, or dependence on, other types 219 of controlled substances as defined in s. 893.02. 220 3. Submit a report with the findings required pursuant to 221 subparagraph 2. to the department. The department shall submit 222 such reports to the ConsortiumCoalitionfor Medical Marijuana 223 Clinical Outcomes Researchand Educationestablished pursuant to 224 s. 1004.4351. 225 (h)(e)An active order for low-THC cannabis or medical 226 cannabis issued pursuant to former s. 381.986, Florida Statutes 227 2016, and registered with the compassionate use registry before 228 June 23, 2017, is deemed a physician certification, and all 229 patients possessing such orders are deemed qualified patients 230 until the department begins issuing medical marijuana use 231 registry identification cards. 232 (i)(f)The department shall monitor physician registration 233 in the medical marijuana use registry and the issuance of 234 physician certifications for practices that could facilitate 235 unlawful diversion or misuse of marijuana or a marijuana 236 delivery device and shall take disciplinary action as 237 appropriate. 238 (j)(g)The Board of Medicine and the Board of Osteopathic 239 Medicine shall jointly create a physician certification pattern 240 review panel that shall review all physician certifications 241 submitted to the medical marijuana use registry. The panel shall 242 track and report the number of physician certifications and the 243 qualifying medical conditions, dosage, supply amount, and form 244 of marijuana certified. The panel shall report the data both by 245 individual qualified physician and in the aggregate, by county, 246 and statewide. The physician certification pattern review panel 247 shall, beginning January 1, 2018, submit an annual report of its 248 findings and recommendations to the Governor, the President of 249 the Senate, and the Speaker of the House of Representatives. 250 (k)(h)The department, the Board of Medicine, and the Board 251 of Osteopathic Medicine may adopt rules pursuant to ss. 252 120.536(1) and 120.54 to implement this subsection. 253 (6) CAREGIVERS.— 254 (c) A qualified patient may designate no more than one 255 caregiver to assist with the qualified patient’s medical use of 256 marijuana, unless: 257 1. The qualified patient is a minor and the designated 258 caregivers are parents or legal guardians of the qualified 259 patient; 260 2. The qualified patient is an adult who has an 261 intellectual or developmental disability that prevents the 262 patient from being able to protect or care for himself or 263 herself without assistance or supervision and the designated 264 caregivers are the parents or legal guardians of the qualified 265 patient;or266 3. The qualified patient is admitted to a hospice program; 267 or 268 4. The qualified patient is participating in a research 269 program in a teaching nursing home pursuant to s. 1004.4351. 270 (d) A caregiver may be registered in the medical marijuana 271 use registry as a designated caregiver for no more than one 272 qualified patient, unless: 273 1. The caregiver is a parent or legal guardian of more than 274 one minor who is a qualified patient; 275 2. The caregiver is a parent or legal guardian of more than 276 one adult who is a qualified patient and who has an intellectual 277 or developmental disability that prevents the patient from being 278 able to protect or care for himself or herself without 279 assistance or supervision;or280 3. All qualified patients the caregiver has agreed to 281 assist are admitted to a hospice program and have requested the 282 assistance of that caregiver with the medical use of marijuana; 283 the caregiver is an employee of the hospice; and the caregiver 284 provides personal care or other services directly to clients of 285 the hospice in the scope of that employment; or 286 4. All qualified patients the caregiver has agreed to 287 assist are participating in a research program in a teaching 288 nursing home pursuant to s. 1004.4351. 289 (8) MEDICAL MARIJUANA TREATMENT CENTERS.— 290 (e) A licensed medical marijuana treatment center shall 291 cultivate, process, transport, and dispense marijuana for 292 medical use. A licensed medical marijuana treatment center may 293 not contract for services directly related to the cultivation, 294 processing, and dispensing of marijuana or marijuana delivery 295 devices, except that a medical marijuana treatment center 296 licensed pursuant to subparagraph (a)1. may contract with a 297 single entity for the cultivation, processing, transporting, and 298 dispensing of marijuana and marijuana delivery devices. A 299 licensed medical marijuana treatment center must, at all times, 300 maintain compliance with the criteria demonstrated and 301 representations made in the initial application and the criteria 302 established in this subsection. Upon request, the department may 303 grant a medical marijuana treatment center a variance from the 304 representations made in the initial application. Consideration 305 of such a request shall be based upon the individual facts and 306 circumstances surrounding the request. A variance may not be 307 granted unless the requesting medical marijuana treatment center 308 can demonstrate to the department that it has a proposed 309 alternative to the specific representation made in its 310 application which fulfills the same or a similar purpose as the 311 specific representation in a way that the department can 312 reasonably determine will not be a lower standard than the 313 specific representation in the application. A variance may not 314 be granted from the requirements in subparagraph 2. and 315 subparagraphs (b)1. and 2. 316 1. A licensed medical marijuana treatment center may 317 transfer ownership to an individual or entity who meets the 318 requirements of this section. A publicly traded corporation or 319 publicly traded company that meets the requirements of this 320 section is not precluded from ownership of a medical marijuana 321 treatment center. To accommodate a change in ownership: 322 a. The licensed medical marijuana treatment center shall 323 notify the department in writing at least 60 days before the 324 anticipated date of the change of ownership. 325 b. The individual or entity applying for initial licensure 326 due to a change of ownership must submit an application that 327 must be received by the department at least 60 days before the 328 date of change of ownership. 329 c. Upon receipt of an application for a license, the 330 department shall examine the application and, within 30 days 331 after receipt, notify the applicant in writing of any apparent 332 errors or omissions and request any additional information 333 required. 334 d. Requested information omitted from an application for 335 licensure must be filed with the department within 21 days after 336 the department’s request for omitted information or the 337 application shall be deemed incomplete and shall be withdrawn 338 from further consideration and the fees shall be forfeited. 339 340 Within 30 days after the receipt of a complete application, the 341 department shall approve or deny the application. 342 2. A medical marijuana treatment center, and any individual 343 or entity who directly or indirectly owns, controls, or holds 344 with power to vote 5 percent or more of the voting shares of a 345 medical marijuana treatment center, may not acquire direct or 346 indirect ownership or control of any voting shares or other form 347 of ownership of any other medical marijuana treatment center. 348 3. A medical marijuana treatment center may not enter into 349 any form of profit-sharing arrangement with the property owner 350 or lessor of any of its facilities where cultivation, 351 processing, storing, or dispensing of marijuana and marijuana 352 delivery devices occurs. 353 4. All employees of a medical marijuana treatment center 354 must be 21 years of age or older and have passed a background 355 screening pursuant to subsection (9). 356 5. Each medical marijuana treatment center must adopt and 357 enforce policies and procedures to ensure employees and 358 volunteers receive training on the legal requirements to 359 dispense marijuana to qualified patients. 360 6. When growing marijuana, a medical marijuana treatment 361 center: 362 a. May use pesticides determined by the department, after 363 consultation with the Department of Agriculture and Consumer 364 Services, to be safely applied to plants intended for human 365 consumption, but may not use pesticides designated as 366 restricted-use pesticides pursuant to s. 487.042. 367 b. Must grow marijuana within an enclosed structure and in 368 a room separate from any other plant. 369 c. Must inspect seeds and growing plants for plant pests 370 that endanger or threaten the horticultural and agricultural 371 interests of the state in accordance with chapter 581 and any 372 rules adopted thereunder. 373 d. Must perform fumigation or treatment of plants, or 374 remove and destroy infested or infected plants, in accordance 375 with chapter 581 and any rules adopted thereunder. 376 7. Each medical marijuana treatment center must produce and 377 make available for purchase at least one low-THC cannabis 378 product. 379 8. A medical marijuana treatment center that produces 380 edibles must hold a permit to operate as a food establishment 381 pursuant to chapter 500, the Florida Food Safety Act, and must 382 comply with all the requirements for food establishments 383 pursuant to chapter 500 and any rules adopted thereunder. 384 Edibles may not contain more than 200 milligrams of 385 tetrahydrocannabinol, and a single serving portion of an edible 386 may not exceed 10 milligrams of tetrahydrocannabinol. Edibles 387 may have a potency variance of no greater than 15 percent. 388 Edibles may not be attractive to children; be manufactured in 389 the shape of humans, cartoons, or animals; be manufactured in a 390 form that bears any reasonable resemblance to products available 391 for consumption as commercially available candy; or contain any 392 color additives. To discourage consumption of edibles by 393 children, the department shall determine by rule any shapes, 394 forms, and ingredients allowed and prohibited for edibles. 395 Medical marijuana treatment centers may not begin processing or 396 dispensing edibles until after the effective date of the rule. 397 The department shall also adopt sanitation rules providing the 398 standards and requirements for the storage, display, or 399 dispensing of edibles. 400 9. Within 12 months after licensure, a medical marijuana 401 treatment center must demonstrate to the department that all of 402 its processing facilities have passed a Food Safety Good 403 Manufacturing Practices, such as Global Food Safety Initiative 404 or equivalent, inspection by a nationally accredited certifying 405 body. A medical marijuana treatment center must immediately stop 406 processing at any facility which fails to pass this inspection 407 until it demonstrates to the department that such facility has 408 met this requirement. 409 10. A medical marijuana treatment center that produces 410 prerolled marijuana cigarettes may not use wrapping paper made 411 with tobacco or hemp. 412 11.10.When processing marijuana, a medical marijuana 413 treatment center must: 414 a. Process the marijuana within an enclosed structure and 415 in a room separate from other plants or products. 416 b. Comply with department rules when processing marijuana 417 with hydrocarbon solvents or other solvents or gases exhibiting 418 potential toxicity to humans. The department shall determine by 419 rule the requirements for medical marijuana treatment centers to 420 use such solvents or gases exhibiting potential toxicity to 421 humans. 422 c. Comply with federal and state laws and regulations and 423 department rules for solid and liquid wastes. The department 424 shall determine by rule procedures for the storage, handling, 425 transportation, management, and disposal of solid and liquid 426 waste generated during marijuana production and processing. The 427 Department of Environmental Protection shall assist the 428 department in developing such rules. 429 d. Test the processed marijuana using a medical marijuana 430 testing laboratory before it is dispensed. Results must be 431 verified and signed by two medical marijuana treatment center 432 employees. Before dispensing, the medical marijuana treatment 433 center must determine that the test results indicate that low 434 THC cannabis meets the definition of low-THC cannabis, the 435 concentration of tetrahydrocannabinol meets the potency 436 requirements of this section, the labeling of the concentration 437 of tetrahydrocannabinol and cannabidiol is accurate, and all 438 marijuana is safe for human consumption and free from 439 contaminants that are unsafe for human consumption. The 440 department shall determine by rule which contaminants must be 441 tested for and the maximum levels of each contaminant which are 442 safe for human consumption. The Department of Agriculture and 443 Consumer Services shall assist the department in developing the 444 testing requirements for contaminants that are unsafe for human 445 consumption in edibles. The department shall also determine by 446 rule the procedures for the treatment of marijuana that fails to 447 meet the testing requirements of this section, s. 381.988, or 448 department rule. The department may select a random sample from 449 edibles available for purchase in a dispensing facility which 450 shall be tested by the department to determine that the edible 451 meets the potency requirements of this section, is safe for 452 human consumption, and the labeling of the tetrahydrocannabinol 453 and cannabidiol concentration is accurate. A medical marijuana 454 treatment center may not require payment from the department for 455 the sample. A medical marijuana treatment center must recall 456 edibles, including all edibles made from the same batch of 457 marijuana, which fail to meet the potency requirements of this 458 section, which are unsafe for human consumption, or for which 459 the labeling of the tetrahydrocannabinol and cannabidiol 460 concentration is inaccurate. The medical marijuana treatment 461 center must retain records of all testing and samples of each 462 homogenous batch of marijuana for at least 9 months. The medical 463 marijuana treatment center must contract with a marijuana 464 testing laboratory to perform audits on the medical marijuana 465 treatment center’s standard operating procedures, testing 466 records, and samples and provide the results to the department 467 to confirm that the marijuana or low-THC cannabis meets the 468 requirements of this section and that the marijuana or low-THC 469 cannabis is safe for human consumption. A medical marijuana 470 treatment center shall reserve two processed samples from each 471 batch and retain such samples for at least 9 months for the 472 purpose of such audits. A medical marijuana treatment center may 473 use a laboratory that has not been certified by the department 474 under s. 381.988 until such time as at least one laboratory 475 holds the required certification, but in no event later than 476 July 1, 2018. 477 e. Package the marijuana in compliance with the United 478 States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss. 479 1471 et seq. 480 f. Package the marijuana in a receptacle that has a firmly 481 affixed and legible label stating the following information: 482 (I) The marijuana or low-THC cannabis meets the 483 requirements of sub-subparagraph d. 484 (II) The name of the medical marijuana treatment center 485 from which the marijuana originates. 486 (III) The batch number and harvest number from which the 487 marijuana originates and the date dispensed. 488 (IV) The name of the physician who issued the physician 489 certification. 490 (V) The name of the patient. 491 (VI) The product name, if applicable, and dosage form, 492 including concentration of tetrahydrocannabinol and cannabidiol. 493 The product name may not contain wording commonly associated 494 with products marketed by or to children. 495 (VII) The recommended dose. 496 (VIII) A warning that it is illegal to transfer medical 497 marijuana to another person. 498 (IX) A marijuana universal symbol developed by the 499 department. 500 12.11.The medical marijuana treatment center shall include 501 in each package a patient package insert with information on the 502 specific product dispensed related to: 503 a. Clinical pharmacology. 504 b. Indications and use. 505 c. Dosage and administration. 506 d. Dosage forms and strengths. 507 e. Contraindications. 508 f. Warnings and precautions. 509 g. Adverse reactions. 510 13. In addition to the packaging and labeling requirements 511 specified in subparagraphs 11. and 12., marijuana in a form for 512 smoking must be packaged in a sealed receptacle with a legible 513 and prominent warning to keep away from children and a warning 514 that states marijuana smoke contains carcinogens and may 515 negatively affect health. Such receptacles for marijuana in a 516 form for smoking must be plain, opaque, and white without 517 depictions of the product or images other than the medical 518 marijuana treatment center’s department-approved logo and the 519 marijuana universal symbol. 520 14. The department shall adopt rules to regulate the types, 521 appearance, and labeling of marijuana delivery devices dispensed 522 from a medical marijuana treatment center. The rules must 523 require marijuana delivery devices to have an appearance 524 consistent with medical use. 525 15.12.Each edible shall be individually sealed in plain, 526 opaque wrapping marked only with the marijuana universal symbol. 527 Where practical, each edible shall be marked with the marijuana 528 universal symbol. In addition to the packaging and labeling 529 requirements in subparagraphs 11. and 12.10. and 11., edible 530 receptacles must be plain, opaque, and white without depictions 531 of the product or images other than the medical marijuana 532 treatment center’s department-approved logo and the marijuana 533 universal symbol. The receptacle must also include a list all of 534 the edible’s ingredients, storage instructions, an expiration 535 date, a legible and prominent warning to keep away from children 536 and pets, and a warning that the edible has not been produced or 537 inspected pursuant to federal food safety laws. 538 16.13.When dispensing marijuana or a marijuana delivery 539 device, a medical marijuana treatment center: 540 a. May dispense any active, valid order for low-THC 541 cannabis, medical cannabis and cannabis delivery devices issued 542 pursuant to former s. 381.986, Florida Statutes 2016, which was 543 entered into the medical marijuana use registry before July 1, 544 2017. 545 b. May not dispense more than a 70-day supply of marijuana 546 within any 70-day period to a qualified patient or caregiver. 547 May not dispense more than one 35-day supply of marijuana in a 548 form for smoking within any 35-day period to a qualified patient 549 or caregiver. A 35-day supply of marijuana in a form for smoking 550 may not exceed 2.5 ounces unless an exception to this amount is 551 approved by the department pursuant to paragraph (4)(f). 552 c. Must have the medical marijuana treatment center’s 553 employee who dispenses the marijuana or a marijuana delivery 554 device enter into the medical marijuana use registry his or her 555 name or unique employee identifier. 556 d. Must verify that the qualified patient and the 557 caregiver, if applicable, each have an active registration in 558 the medical marijuana use registry and an active and valid 559 medical marijuana use registry identification card, the amount 560 and type of marijuana dispensed matches the physician 561 certification in the medical marijuana use registry for that 562 qualified patient, and the physician certification has not 563 already been filled. 564 e. May not dispense marijuana to a qualified patient who is 565 younger than 18 years of age. If the qualified patient is 566 younger than 18 years of age, marijuana may only be dispensed to 567 the qualified patient’s caregiver. 568 f. May not dispense or sell any other type of cannabis, 569 alcohol, or illicit drug-related product, including pipes,570bongs,or wrapping papers made with tobacco or hemp, other than 571 a marijuana delivery device required for the medical use of 572 marijuana and which is specified in a physician certification. 573 g. Must, upon dispensing the marijuana or marijuana 574 delivery device, record in the registry the date, time, 575 quantity, and form of marijuana dispensed; the type of marijuana 576 delivery device dispensed; and the name and medical marijuana 577 use registry identification number of the qualified patient or 578 caregiver to whom the marijuana delivery device was dispensed. 579 h. Must ensure that patient records are not visible to 580 anyone other than the qualified patient, his or her caregiver, 581 and authorized medical marijuana treatment center employees. 582 (14) EXCEPTIONS TO OTHER LAWS.— 583 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 584 any other provision of law, but subject to the requirements of 585 this section, a qualified patient and the qualified patient’s 586 caregiver may purchase from a medical marijuana treatment center 587 for the patient’s medical use a marijuana delivery device and up 588 to the amount of marijuana authorized in the physician 589 certification, but may not possess more than a 70-day supply of 590 marijuana, or the greater of 4 ounces of marijuana in a form for 591 smoking or an amount of marijuana in a form for smoking approved 592 by the department pursuant to paragraph (4)(f), at any given 593 time and all marijuana purchased must remain in its original 594 packaging. 595 (b) Notwithstanding paragraph (a), s. 893.13, s. 893.135, 596 s. 893.147, or any other provision of law, a qualified patient 597 and the qualified patient’s caregiver may purchase and possess a 598 marijuana delivery device intended for the medical use of 599 marijuana by smoking from a vendor other than a medical 600 marijuana treatment center. 601 (c)(b)Notwithstanding s. 893.13, s. 893.135, s. 893.147, 602 or any other provision of law, but subject to the requirements 603 of this section, an approved medical marijuana treatment center 604 and its owners, managers, and employees may manufacture, 605 possess, sell, deliver, distribute, dispense, and lawfully 606 dispose of marijuana or a marijuana delivery device as provided 607 in this section, s. 381.988, and by department rule. For the 608 purposes of this subsection, the terms “manufacture,” 609 “possession,” “deliver,” “distribute,” and “dispense” have the 610 same meanings as provided in s. 893.02. 611 (d)(c)Notwithstanding s. 893.13, s. 893.135, s. 893.147, 612 or any other provision of law, but subject to the requirements 613 of this section, a certified marijuana testing laboratory, 614 including an employee of a certified marijuana testing 615 laboratory acting within the scope of his or her employment, may 616 acquire, possess, test, transport, and lawfully dispose of 617 marijuana as provided in this section, in s. 381.988, and by 618 department rule. 619 (e)(d)A licensed medical marijuana treatment center and 620 its owners, managers, and employees are not subject to licensure 621 or regulation under chapter 465 or chapter 499 for 622 manufacturing, possessing, selling, delivering, distributing, 623 dispensing, or lawfully disposing of marijuana or a marijuana 624 delivery device, as provided in this section, in s. 381.988, and 625 by department rule. 626 (f)(e)This subsection does not exempt a person from 627 prosecution for a criminal offense related to impairment or 628 intoxication resulting from the medical use of marijuana or 629 relieve a person from any requirement under law to submit to a 630 breath, blood, urine, or other test to detect the presence of a 631 controlled substance. 632 (g)(f)Notwithstanding s. 893.13, s. 893.135, s. 893.147, 633 or any other provision of law, but subject to the requirements 634 of this section and pursuant to policies and procedures 635 established pursuant to s. 1006.62(8), school personnel may 636 possess marijuana that is obtained for medical use pursuant to 637 this section by a student who is a qualified patient. 638 (h)(g)Notwithstanding s. 893.13, s. 893.135, s. 893.147, 639 or any other provision of law, but subject to the requirements 640 of this section, a research institute established by a public 641 postsecondary educational institution, such as the H. Lee 642 Moffitt Cancer Center and Research Institute, Inc., established 643 under s. 1004.43, or a state university that has achieved the 644 preeminent state research university designation under s. 645 1001.7065 may possess, test, transport, and lawfully dispose of 646 marijuana for research purposes as provided by this section. 647 (15) APPLICABILITY.— 648 (a) This section does not limit the ability of an employer 649 to establish, continue, or enforce a drug-free workplace program 650 or policy. 651 (b) This section does not require an employer to 652 accommodate the medical use of marijuana in any workplace or any 653 employee working while under the influence of marijuana. 654 (c) This section does not create a cause of action against 655 an employer for wrongful discharge or discrimination. 656 (d) This section does not impair the ability of any party 657 to restrict or limit smoking or vaping marijuana on his or her 658 private property. 659 (e) This section does not prohibit the medical use of 660 marijuana or a caregiver assisting with the medical use of 661 marijuana in a nursing home facility licensed under part II of 662 chapter 400, a hospice facility licensed under part IV of 663 chapter 400, or an assisted living facility licensed under part 664 I of chapter 429, if the medical use of marijuana is not 665 prohibited in the facility’s policies. 666 (f) Marijuana, as defined in this section, is not 667 reimbursable under chapter 440. 668 Section 2. Section 1004.4351, Florida Statutes, is amended 669 to read: 670 1004.4351 Medical marijuana researchand education.— 671 (1) SHORT TITLE.—This section shall be known and may be 672 cited as the “Medical Marijuana Researchand EducationAct.” 673 (2) LEGISLATIVE FINDINGS.—The Legislature finds that: 674 (a) The present state of knowledge concerning the use of 675 marijuana to alleviate pain and treat illnesses is limited 676 because permission to perform clinical studies on marijuana is 677 difficult to obtain, with access to research-grade marijuana so 678 restricted that little or no unbiased studies have been 679 performed. 680 (b) Under the State Constitution, marijuana is available 681 for the treatment of certain debilitating medical conditions. 682 (c) Additional clinical studies are needed to ensure that 683 the residents of this state obtain the correct dosing, 684 formulation, route, modality, frequency, quantity, and quality 685 of marijuana for specific illnesses. 686 (d) An effective medical marijuana researchand education687 program would mobilize the scientific, educational,and medical 688 resources that presently exist in this state to determine the 689 appropriate and best use of marijuana to treat illness. 690 (3) DEFINITIONS.—As used in this section, the term: 691 (a) “Board” means the Medical Marijuana Researchand692EducationBoard. 693 (b) “Consortium”“Coalition”means the ConsortiumCoalition694 for Medical Marijuana Clinical Outcomes Researchand Education. 695 (c) “Marijuana” has the same meaning as provided in s. 29, 696 Art. X of the State Constitution. 697 (4) CONSORTIUMCOALITIONFOR MEDICAL MARIJUANA CLINICAL 698 OUTCOMES RESEARCHAND EDUCATION.— 699 (a) There is established within a state university 700 designated by the Board of Governorsthe H. Lee Moffitt Cancer701Center and Research Institute, Inc.,the ConsortiumCoalition702 for Medical Marijuana Clinical Outcomes Research which shall 703 consist of public and private universitiesand Education. The 704 purpose of the consortiumcoalitionis to conduct rigorous 705 scientific research and, provide education,disseminate such 706 research, and guide policy for the adoption of a statewide707policy on ordering and dosing practices for the medical use of708marijuana. The coalition shall be physically located at the H.709Lee Moffitt Cancer Center and Research Institute, Inc. 710 (b) The Medical Marijuana Researchand EducationBoard is 711 established to direct the operations of the consortium 712coalition. The board shall be composed ofsevenmembers 713 representing each participating university appointed by the 714 president of each participating universitythe chief executive715officer of the H. Lee Moffitt Cancer Center and Research716Institute, Inc. Board members must have experience in a variety 717 of scientific and medical fields, including, but not limited to, 718 oncology, neurology, psychology, pediatrics, nutrition, and 719 addiction. Members shall be appointed to 4-year terms and may be 720 reappointed to serve additional terms. The chair shall be 721 elected by the board from among its members to serve a 2-year 722 term. The board shall meet at least semiannually at the call of 723 the chair or, in his or her absence or incapacity, the vice 724 chair. Four members constitute a quorum. A majority vote of the 725 members present is required for all actions of the board. The 726 board may prescribe, amend, and repeal a charter governing the 727 manner in which it conducts its business. A board member shall 728 serve without compensation but is entitled to be reimbursed for 729 travel expenses by the consortiumcoalitionor the organization 730 he or she represents in accordance with s. 112.061. 731 (c) The consortiumcoalitionshall be administered by a 732coalitiondirector, who shall be appointed by and serve at the 733 pleasure of the board. Thecoalitiondirector shall, subject to 734 the approval of the board: 735 1. Propose a budget for the consortiumcoalition. 736 2. Foster the collaboration of scientists, researchers, and 737 other appropriate personnel in accordance with the consortium’s 738coalition’scharter. 739 3. Engage individuals in public and private university 740 programs relevant to the consortium’s work to participate in the 741 consortium. 742 4.3.Identify and prioritize the research to be conducted 743 by the consortiumcoalition. 744 5.4.Prepare a plan for medical marijuana researchthe745Medical Marijuana Research and Education Planfor submission to 746 the board. 747 6.5.Apply for grants to obtain funding for research 748 conducted by the consortiumcoalition. 749 7.6.Perform other duties as determined by the board. 750(d) The board shall advise the Board of Governors, the751State Surgeon General, the Governor, and the Legislature with752respect to medical marijuana research and education in this753state. The board shall explore methods of implementing and754enforcing medical marijuana laws in relation to cancer control,755research, treatment, and education.756 (d)(e)The board shall annually adopt a plan for medical 757 marijuana research. The plan must organize a program of research 758 that contributes to the body of scientific knowledge on the 759 effects of the medical use of marijuana and informs both policy 760 and medical practice related to the treatment of debilitating 761 medical conditions with marijuana. Research much include 762 tracking clinical outcomes, certification standards, dosing 763 standards, routes of administration, efficacy, and side effects. 764 Research must also include the study of the effects of smoking 765 marijuana to treat debilitating medical conditions. The board 766 must award funds to members of the consortium and to perform 767 research consistent with the plan. The board may also award 768 funds to teaching nursing homes, as defined in s. 430.08, for 769 research on medical use of marijuana to alleviate conditions 770 related to chronic disease and aging, known as the “Medical771Marijuana Research and Education Plan,” which must be in772accordance with state law and coordinate with existing programs773in this state. The plan must include recommendations for the774coordination and integration of medical, pharmacological,775nursing, paramedical, community, and other resources connected776with the treatment of debilitating medical conditions; research777related to the treatment of such medical conditions; and778education. 779 (e)(f)By February 15 of each year, the board shall issue a 780 report to the Governor, the President of the Senate, and the 781 Speaker of the House of Representatives on research projects, 782 research findings, community outreach initiatives, and future 783 plans for the consortiumcoalition. 784 (f)(g)Beginning August 1, 2019January 15, 2018, and 785 quarterly thereafter, the Department of Health shall submit to 786 the board a data set that includes, for each patient registered 787 in the medical marijuana use registry, the patient’s qualifying 788 medical condition and the daily dose amount, routes of 789 administration, and forms of marijuana certified for the 790 patient. The department shall also provide the board with such 791 data for all patients registered in the medical marijuana use 792 registry before August 1, 2019. 793(5)RESPONSIBILITIES OF THE H. LEE MOFFITT CANCER CENTER794AND RESEARCH INSTITUTE, INC.—The H. Lee Moffitt Cancer Center795and Research Institute, Inc., shall allocate staff and provide796information and assistance, as the coalition’s budget permits,797to assist the board in fulfilling its responsibilities.798 Section 3. Paragraph (h) of subsection (2) and paragraph 799 (b) of subsection (3) of section 381.987, Florida Statutes, are 800 amended to read: 801 381.987 Public records exemption for personal identifying 802 information relating to medical marijuana held by the 803 department.— 804 (2) The department shall allow access to the confidential 805 and exempt information in the medical marijuana use registry to: 806 (h) The ConsortiumCoalitionfor Medical Marijuana Clinical 807 Outcomes Researchand Educationestablished in s. 1004.4351(4). 808 (3) The department shall allow access to the confidential 809 and exempt information pertaining to the physician certification 810 for marijuana and the dispensing thereof, whether in the 811 registry or otherwise held by the department, to: 812 (b) The ConsortiumCoalitionfor Medical Marijuana Clinical 813 Outcomes Researchand Educationpursuant to s. 381.986 for the 814 purpose of conducting research regarding the medical use of 815 marijuana. 816 Section 4. (1) For the 2019-2020 fiscal year, the sum of 817 $1.5 million in recurring funds is appropriated from the General 818 Revenue Fund to the Board of Governors for the Consortium for 819 Medical Marijuana Clinical Outcomes Research established under 820 s. 1004.4351, Florida Statutes. 821 (2) For the 2018-2019 fiscal year, the sum of $391,333 in 822 nonrecurring funds is appropriated from the Grants and Donations 823 Trust Fund to the Department of Health for the purpose of 824 implementing the requirements of this act. 825 (3) For the 2019-2020 fiscal year, the sum of $705,331 in 826 recurring funds is appropriated from the Grants and Donations 827 Trust Fund to the Department of Health for the purpose of 828 implementing the requirements of this act. 829 Section 5. This act shall take effect upon becoming a law. 830 831 ================= T I T L E A M E N D M E N T ================ 832 And the title is amended as follows: 833 Delete everything before the enacting clause 834 and insert: 835 A bill to be entitled 836 An act relating to the medical use of marijuana; 837 amending s. 381.986, F.S.; redefining the term 838 “marijuana delivery device” to eliminate the 839 requirement that such devices must be purchased from a 840 medical marijuana treatment center; redefining the 841 term “medical use” to include the possession, use, or 842 administration of marijuana in a form for smoking; 843 conforming provisions to changes made by the act; 844 restricting the smoking of marijuana in enclosed 845 indoor workplaces; requiring a patient’s informed 846 consent form to include the negative health risks 847 associated with smoking marijuana; conforming a 848 provision to changes made by the act; requiring a 849 qualified physician to submit specified documentation 850 to the Board of Medicine and the Board of Osteopathic 851 Medicine upon determining that smoking is an 852 appropriate route of administration for a qualified 853 patient, other than a patient diagnosed with a 854 terminal condition; prohibiting a physician from 855 certifying a patient under 18 years of age to smoke 856 marijuana for medical use unless the patient is 857 diagnosed with a terminal condition and the physician 858 makes a certain determination in concurrence with a 859 second physician who is a pediatrician; requiring a 860 qualified physician to obtain the written informed 861 consent of the such patient’s parent or legal guardian 862 before certifying the patient to smoke marijuana for 863 medical use; requiring the qualified physician to use 864 a certain informed consent form adopted in rule by the 865 boards; requiring the boards to review specified 866 documentation and adopt certain practice standards by 867 rule by a specified date; establishing a supply limit 868 for a physician certification for marijuana in a form 869 for smoking; authorizing a qualified physician to 870 request an exception to the supply limit and 871 possession limit for marijuana in a form for smoking; 872 authorizing more than one caregiver to assist with a 873 qualified patient’s medical use of marijuana if the 874 patient is participating in a certain research program 875 in a teaching nursing home; authorizing a caregiver to 876 be listed in the medical marijuana use registry as a 877 designated caregiver for qualified patients who are 878 participating in a certain research program in a 879 teaching nursing home; prohibiting a medical marijuana 880 treatment center that produces prerolled marijuana 881 cigarettes from using wrapping paper made with tobacco 882 or hemp; requiring that marijuana in a form for 883 smoking meet certain packaging and labeling 884 requirements; requiring the Department of Health to 885 adopt rules regulating the types, appearance, and 886 labeling of marijuana delivery devices; prohibiting a 887 medical marijuana treatment center from dispensing 888 more than a specified supply limit of marijuana in a 889 form for smoking; revising a provision prohibiting a 890 medical marijuana treatment center from dispensing or 891 selling specified products; establishing possession 892 limits on marijuana in a form for smoking for a 893 qualified patient; allowing marijuana delivery devices 894 to be purchased from a vendor other than a medical 895 marijuana treatment center; providing applicability; 896 amending s. 1004.4351, F.S.; renaming the Coalition 897 for Medical Marijuana Research and Education as the 898 Consortium for Medical Marijuana Clinical Outcomes 899 Research; establishing the consortium for a specified 900 purpose; renaming the Medical Marijuana Research and 901 Education Board as the Medical Marijuana Research 902 Board; requiring the board to direct the operations of 903 the consortium; providing membership of the board; 904 providing for the appointment of a consortium 905 director; providing duties of the consortium director; 906 requiring the board to annually adopt a plan for 907 medical marijuana research; requiring the plan to 908 include specified information; providing research 909 requirements for the plan; requiring the board to 910 award funds to members of the consortium; authorizing 911 the board to award funds to teaching nursing homes for 912 certain research; requiring the board to issue an 913 annual report to the Governor and Legislature by a 914 specified date; requiring the department to submit 915 certain data sets to the board; amending s. 381.987, 916 F.S.; conforming provisions to changes made by the 917 act; providing appropriations; providing an effective 918 date.