Bill Text: FL S0182 | 2019 | Regular Session | Enrolled
Bill Title: Medical Use of Marijuana
Spectrum: Bipartisan Bill
Status: (Passed) 2019-03-18 - Chapter No. 2019-1 [S0182 Detail]
Download: Florida-2019-S0182-Enrolled.html
ENROLLED 2019 Legislature CS for CS for CS for SB 182, 1st Engrossed 2019182er 1 2 An act relating to the medical use of marijuana; 3 amending s. 381.986, F.S.; redefining the term 4 “marijuana delivery device” to provide an exception to 5 the requirement that such devices must be purchased 6 from a medical marijuana treatment center for devices 7 that are intended for the medical use of marijuana by 8 smoking; redefining the term “medical use” to include 9 the possession, use, or administration of marijuana in 10 a form for smoking; conforming provisions to changes 11 made by the act; restricting the smoking of marijuana 12 in enclosed indoor workplaces; requiring a patient’s 13 informed consent form to include the negative health 14 risks associated with smoking marijuana; conforming a 15 provision to changes made by the act; requiring a 16 qualified physician to submit specified documentation 17 to the Board of Medicine and the Board of Osteopathic 18 Medicine upon determining that smoking is an 19 appropriate route of administration for a qualified 20 patient, other than a patient diagnosed with a 21 terminal condition; prohibiting a physician from 22 certifying a patient under 18 years of age to smoke 23 marijuana for medical use unless the patient is 24 diagnosed with a terminal condition and the physician 25 makes a certain determination in concurrence with a 26 second physician who is a pediatrician; requiring a 27 qualified physician to obtain the written informed 28 consent of such patient’s parent or legal guardian 29 before certifying the patient to smoke marijuana for 30 medical use; requiring the qualified physician to use 31 a certain informed consent form adopted in rule by the 32 boards; requiring the boards to review specified 33 documentation and adopt certain practice standards by 34 rule by a specified date; establishing a supply limit 35 for a physician certification for marijuana in a form 36 for smoking; authorizing a qualified physician to 37 request an exception to the supply limit and 38 possession limit for marijuana in a form for smoking; 39 authorizing more than one caregiver to assist with a 40 qualified patient’s medical use of marijuana if the 41 patient is participating in a certain research program 42 in a teaching nursing home; authorizing a caregiver to 43 be listed in the medical marijuana use registry as a 44 designated caregiver for qualified patients who are 45 participating in a certain research program in a 46 teaching nursing home; prohibiting a medical marijuana 47 treatment center that produces prerolled marijuana 48 cigarettes from using wrapping paper made with tobacco 49 or hemp; requiring that marijuana in a form for 50 smoking meet certain packaging and labeling 51 requirements; requiring the Department of Health to 52 adopt rules regulating the types, appearance, and 53 labeling of marijuana delivery devices; prohibiting a 54 medical marijuana treatment center from dispensing 55 more than a specified supply limit of marijuana in a 56 form for smoking; revising a provision prohibiting a 57 medical marijuana treatment center from dispensing or 58 selling specified products; establishing possession 59 limits on marijuana in a form for smoking for a 60 qualified patient; allowing marijuana delivery devices 61 to be purchased from a vendor other than a medical 62 marijuana treatment center; providing applicability; 63 amending s. 1004.4351, F.S.; renaming the Coalition 64 for Medical Marijuana Research and Education as the 65 Consortium for Medical Marijuana Clinical Outcomes 66 Research; establishing the consortium for a specified 67 purpose; renaming the Medical Marijuana Research and 68 Education Board as the Medical Marijuana Research 69 Board; requiring the board to direct the operations of 70 the consortium; providing membership of the board; 71 providing for the appointment of a consortium 72 director; providing duties of the consortium director; 73 requiring the board to annually adopt a plan for 74 medical marijuana research; requiring the plan to 75 include specified information; providing research 76 requirements for the plan; requiring the board to 77 award funds to members of the consortium; requiring 78 the board to collaborate with and authorizing the 79 board to award funds to teaching nursing homes for 80 certain research; requiring the board to issue an 81 annual report to the Governor and Legislature by a 82 specified date; requiring the department to submit 83 certain data sets to the board; amending s. 381.987, 84 F.S.; conforming provisions to changes made by the 85 act; providing appropriations; providing an effective 86 date. 87 88 Be It Enacted by the Legislature of the State of Florida: 89 90 Section 1. Paragraphs (g) and (j) of subsection (1), 91 subsection (4), paragraphs (c) and (d) of subsection (6), 92 paragraph (e) of subsection (8), subsection (14), and subsection 93 (15) of section 381.986, Florida Statutes, are amended to read: 94 381.986 Medical use of marijuana.— 95 (1) DEFINITIONS.—As used in this section, the term: 96 (g) “Marijuana delivery device” means an object used, 97 intended for use, or designed for use in preparing, storing, 98 ingesting, inhaling, or otherwise introducing marijuana into the 99 human body, and which is dispensed from a medical marijuana 100 treatment center for medical use by a qualified patient, except 101 that delivery devices intended for the medical use of marijuana 102 by smoking need not be dispensed from a medical marijuana 103 treatment center in order to qualify as marijuana delivery 104 devices. 105 (j) “Medical use” means the acquisition, possession, use, 106 delivery, transfer, or administration of marijuana authorized by 107 a physician certification. The term does not include: 108 1. Possession, use, or administration of marijuana that was 109 not purchased or acquired from a medical marijuana treatment 110 center. 111 2. Possession, use, or administration of marijuanain a112form for smoking,in the form of commercially produced food 113 items other than edibles,or of marijuana seedsor flower,114except for flower in a sealed, tamper-proof receptacle for115vaping. 116 3. Use or administration of any form or amount of marijuana 117 in a manner that is inconsistent with the qualified physician’s 118 directions or physician certification. 119 4. Transfer of marijuana to a person other than the 120 qualified patient for whom it was authorized or the qualified 121 patient’s caregiver on behalf of the qualified patient. 122 5. Use or administration of marijuana in the following 123 locations: 124 a. On any form of public transportation, except for low-THC 125 cannabis not in a form for smoking. 126 b. In any public place, except for low-THC cannabis not in 127 a form for smoking. 128 c. In a qualified patient’s place of employment, except 129 when permitted by his or her employer. 130 d. In a state correctional institution, as defined in s. 131 944.02, or a correctional institution, as defined in s. 944.241. 132 e. On the grounds of a preschool, primary school, or 133 secondary school, except as provided in s. 1006.062. 134 f. In a school bus, a vehicle, an aircraft, or a motorboat, 135 except for low-THC cannabis not in a form for smoking. 136 6. The smoking of marijuana in an enclosed indoor workplace 137 as defined in s. 386.203(5). 138 (4) PHYSICIAN CERTIFICATION.— 139 (a) A qualified physician may issue a physician 140 certification only if the qualified physician: 141 1. Conducted a physical examination while physically 142 present in the same room as the patient and a full assessment of 143 the medical history of the patient. 144 2. Diagnosed the patient with at least one qualifying 145 medical condition. 146 3. Determined that the medical use of marijuana would 147 likely outweigh the potential health risks for the patient, and 148 such determination must be documented in the patient’s medical 149 record. If a patient is younger than 18 years of age, a second 150 physician must concur with this determination, and such 151 concurrence must be documented in the patient’s medical record. 152 4. Determined whether the patient is pregnant and 153 documented such determination in the patient’s medical record. A 154 physician may not issue a physician certification, except for 155 low-THC cannabis, to a patient who is pregnant. 156 5. Reviewed the patient’s controlled drug prescription 157 history in the prescription drug monitoring program database 158 established pursuant to s. 893.055. 159 6. Reviews the medical marijuana use registry and confirmed 160 that the patient does not have an active physician certification 161 from another qualified physician. 162 7. Registers as the issuer of the physician certification 163 for the named qualified patient on the medical marijuana use 164 registry in an electronic manner determined by the department, 165 and: 166 a. Enters into the registry the contents of the physician 167 certification, including the patient’s qualifying condition and 168 the dosage not to exceed the daily dose amount determined by the 169 department, the amount and forms of marijuana authorized for the 170 patient, and any types of marijuana delivery devices needed by 171 the patient for the medical use of marijuana. 172 b. Updates the registry within 7 days after any change is 173 made to the original physician certification to reflect such 174 change. 175 c. Deactivates the registration of the qualified patient 176 and the patient’s caregiver when the physician no longer 177 recommends the medical use of marijuana for the patient. 178 8. Obtains the voluntary and informed written consent of 179 the patient for medical use of marijuana each time the qualified 180 physician issues a physician certification for the patient, 181 which shall be maintained in the patient’s medical record. The 182 patient, or the patient’s parent or legal guardian if the 183 patient is a minor, must sign the informed consent acknowledging 184 that the qualified physician has sufficiently explained its 185 content. The qualified physician must use a standardized 186 informed consent form adopted in rule by the Board of Medicine 187 and the Board of Osteopathic Medicine, which must include, at a 188 minimum, information related to: 189 a. The Federal Government’s classification of marijuana as 190 a Schedule I controlled substance. 191 b. The approval and oversight status of marijuana by the 192 Food and Drug Administration. 193 c. The current state of research on the efficacy of 194 marijuana to treat the qualifying conditions set forth in this 195 section. 196 d. The potential for addiction. 197 e. The potential effect that marijuana may have on a 198 patient’s coordination, motor skills, and cognition, including a 199 warning against operating heavy machinery, operating a motor 200 vehicle, or engaging in activities that require a person to be 201 alert or respond quickly. 202 f. The potential side effects of marijuana use, including 203 the negative health risks associated with smoking marijuana. 204 g. The risks, benefits, and drug interactions of marijuana. 205 h. That the patient’s de-identified health information 206 contained in the physician certification and medical marijuana 207 use registry may be used for research purposes. 208 (b) If a qualified physician issues a physician 209 certification for a qualified patient diagnosed with a 210 qualifying medical condition pursuant to paragraph (2)(k), the 211 physician must submit the following to the applicable board 212 within 14 days after issuing the physician certification: 213 1. Documentation supporting the qualified physician’s 214 opinion that the medical condition is of the same kind or class 215 as the conditions in paragraphs (2)(a)-(j). 216 2. Documentation that establishes the efficacy of marijuana 217 as treatment for the condition. 218 3. Documentation supporting the qualified physician’s 219 opinion that the benefits of medical use of marijuana would 220 likely outweigh the potential health risks for the patient. 221 4. Any other documentation as required by board rule. 222 223 The department must submit such documentation to the Consortium 224Coalitionfor Medical Marijuana Clinical Outcomes Researchand225Educationestablished pursuant to s. 1004.4351. 226 (c) If a qualified physician determines that smoking is an 227 appropriate route of administration for a qualified patient, 228 other than a patient diagnosed with a terminal condition, the 229 qualified physician must submit the following documentation to 230 the applicable board: 231 1. A list of other routes of administration, if any, 232 certified by a qualified physician that the patient has tried, 233 the length of time the patient used such routes of 234 administration, and an assessment of the effectiveness of those 235 routes of administration in treating the qualified patient’s 236 qualifying condition. 237 2. Research documenting the effectiveness of smoking as a 238 route of administration to treat similarly situated patients 239 with the same qualifying condition as the qualified patient. 240 3. A statement signed by the qualified physician 241 documenting the qualified physician’s opinion that the benefits 242 of smoking marijuana for medical use outweigh the risks for the 243 qualified patient. 244 (d) A qualified physician may not issue a physician 245 certification for marijuana in a form for smoking to a patient 246 under 18 years of age unless the patient is diagnosed with a 247 terminal condition, the qualified physician determines that 248 smoking is the most effective route of administration for the 249 patient, and a second physician who is a board-certified 250 pediatrician concurs with such determination. Such determination 251 and concurrence must be documented in the patient’s medical 252 record and in the medical marijuana use registry. The certifying 253 physician must obtain the written informed consent of such 254 patient’s parent or legal guardian before issuing a physician 255 certification to the patient for marijuana in a form for 256 smoking. The qualified physician must use a standardized 257 informed consent form adopted in rule by the Board of Medicine 258 and the Board of Osteopathic Medicine which must include 259 information concerning the negative health effects of smoking 260 marijuana on persons under 18 years of age and an 261 acknowledgement that the qualified physician has sufficiently 262 explained the contents of the form. 263 (e) The Board of Medicine and the Board of Osteopathic 264 Medicine shall review the documentation submitted pursuant to 265 paragraph (c) and shall each, by July 1, 2021, adopt by rule 266 practice standards for the certification of smoking as a route 267 of administration. 268 (f)(c)A qualified physician may not issue a physician 269 certification for more than three 70-day supply limits of 270 marijuana or more than six 35-day supply limits of marijuana in 271 a form for smoking. The department shall quantify by rule a 272 daily dose amount with equivalent dose amounts for each 273 allowable form of marijuana dispensed by a medical marijuana 274 treatment center. The department shall use the daily dose amount 275 to calculate a 70-day supply. 276 1. A qualified physician may request an exception to the 277 daily dose amount limit, the 35-day supply limit of marijuana in 278 a form for smoking, and the 4-ounce possession limit of 279 marijuana in a form for smoking established in paragraph 280 (14)(a). The request shall be made electronically on a form 281 adopted by the department in rule and must include, at a 282 minimum: 283 a. The qualified patient’s qualifying medical condition. 284 b. The dosage and route of administration that was 285 insufficient to provide relief to the qualified patient. 286 c. A description of how the patient will benefit from an 287 increased amount. 288 d. The minimum daily dose amount of marijuana that would be 289 sufficient for the treatment of the qualified patient’s 290 qualifying medical condition. 291 2. A qualified physician must provide the qualified 292 patient’s records upon the request of the department. 293 3. The department shall approve or disapprove the request 294 within 14 days after receipt of the complete documentation 295 required by this paragraph. The request shall be deemed approved 296 if the department fails to act within this time period. 297 (g)(d)A qualified physician must evaluate an existing 298 qualified patient at least once every 30 weeks before issuing a 299 new physician certification. A physician must: 300 1. Determine if the patient still meets the requirements to 301 be issued a physician certification under paragraph (a). 302 2. Identify and document in the qualified patient’s medical 303 records whether the qualified patient experienced either of the 304 following related to the medical use of marijuana: 305 a. An adverse drug interaction with any prescription or 306 nonprescription medication; or 307 b. A reduction in the use of, or dependence on, other types 308 of controlled substances as defined in s. 893.02. 309 3. Submit a report with the findings required pursuant to 310 subparagraph 2. to the department. The department shall submit 311 such reports to the ConsortiumCoalitionfor Medical Marijuana 312 Clinical Outcomes Researchand Educationestablished pursuant to 313 s. 1004.4351. 314 (h)(e)An active order for low-THC cannabis or medical 315 cannabis issued pursuant to former s. 381.986, Florida Statutes 316 2016, and registered with the compassionate use registry before 317 June 23, 2017, is deemed a physician certification, and all 318 patients possessing such orders are deemed qualified patients 319 until the department begins issuing medical marijuana use 320 registry identification cards. 321 (i)(f)The department shall monitor physician registration 322 in the medical marijuana use registry and the issuance of 323 physician certifications for practices that could facilitate 324 unlawful diversion or misuse of marijuana or a marijuana 325 delivery device and shall take disciplinary action as 326 appropriate. 327 (j)(g)The Board of Medicine and the Board of Osteopathic 328 Medicine shall jointly create a physician certification pattern 329 review panel that shall review all physician certifications 330 submitted to the medical marijuana use registry. The panel shall 331 track and report the number of physician certifications and the 332 qualifying medical conditions, dosage, supply amount, and form 333 of marijuana certified. The panel shall report the data both by 334 individual qualified physician and in the aggregate, by county, 335 and statewide. The physician certification pattern review panel 336 shall, beginning January 1, 2018, submit an annual report of its 337 findings and recommendations to the Governor, the President of 338 the Senate, and the Speaker of the House of Representatives. 339 (k)(h)The department, the Board of Medicine, and the Board 340 of Osteopathic Medicine may adopt rules pursuant to ss. 341 120.536(1) and 120.54 to implement this subsection. 342 (6) CAREGIVERS.— 343 (c) A qualified patient may designate no more than one 344 caregiver to assist with the qualified patient’s medical use of 345 marijuana, unless: 346 1. The qualified patient is a minor and the designated 347 caregivers are parents or legal guardians of the qualified 348 patient; 349 2. The qualified patient is an adult who has an 350 intellectual or developmental disability that prevents the 351 patient from being able to protect or care for himself or 352 herself without assistance or supervision and the designated 353 caregivers are the parents or legal guardians of the qualified 354 patient;or355 3. The qualified patient is admitted to a hospice program; 356 or 357 4. The qualified patient is participating in a research 358 program in a teaching nursing home pursuant to s. 1004.4351. 359 (d) A caregiver may be registered in the medical marijuana 360 use registry as a designated caregiver for no more than one 361 qualified patient, unless: 362 1. The caregiver is a parent or legal guardian of more than 363 one minor who is a qualified patient; 364 2. The caregiver is a parent or legal guardian of more than 365 one adult who is a qualified patient and who has an intellectual 366 or developmental disability that prevents the patient from being 367 able to protect or care for himself or herself without 368 assistance or supervision;or369 3. All qualified patients the caregiver has agreed to 370 assist are admitted to a hospice program and have requested the 371 assistance of that caregiver with the medical use of marijuana; 372 the caregiver is an employee of the hospice; and the caregiver 373 provides personal care or other services directly to clients of 374 the hospice in the scope of that employment; or 375 4. All qualified patients the caregiver has agreed to 376 assist are participating in a research program in a teaching 377 nursing home pursuant to s. 1004.4351. 378 (8) MEDICAL MARIJUANA TREATMENT CENTERS.— 379 (e) A licensed medical marijuana treatment center shall 380 cultivate, process, transport, and dispense marijuana for 381 medical use. A licensed medical marijuana treatment center may 382 not contract for services directly related to the cultivation, 383 processing, and dispensing of marijuana or marijuana delivery 384 devices, except that a medical marijuana treatment center 385 licensed pursuant to subparagraph (a)1. may contract with a 386 single entity for the cultivation, processing, transporting, and 387 dispensing of marijuana and marijuana delivery devices. A 388 licensed medical marijuana treatment center must, at all times, 389 maintain compliance with the criteria demonstrated and 390 representations made in the initial application and the criteria 391 established in this subsection. Upon request, the department may 392 grant a medical marijuana treatment center a variance from the 393 representations made in the initial application. Consideration 394 of such a request shall be based upon the individual facts and 395 circumstances surrounding the request. A variance may not be 396 granted unless the requesting medical marijuana treatment center 397 can demonstrate to the department that it has a proposed 398 alternative to the specific representation made in its 399 application which fulfills the same or a similar purpose as the 400 specific representation in a way that the department can 401 reasonably determine will not be a lower standard than the 402 specific representation in the application. A variance may not 403 be granted from the requirements in subparagraph 2. and 404 subparagraphs (b)1. and 2. 405 1. A licensed medical marijuana treatment center may 406 transfer ownership to an individual or entity who meets the 407 requirements of this section. A publicly traded corporation or 408 publicly traded company that meets the requirements of this 409 section is not precluded from ownership of a medical marijuana 410 treatment center. To accommodate a change in ownership: 411 a. The licensed medical marijuana treatment center shall 412 notify the department in writing at least 60 days before the 413 anticipated date of the change of ownership. 414 b. The individual or entity applying for initial licensure 415 due to a change of ownership must submit an application that 416 must be received by the department at least 60 days before the 417 date of change of ownership. 418 c. Upon receipt of an application for a license, the 419 department shall examine the application and, within 30 days 420 after receipt, notify the applicant in writing of any apparent 421 errors or omissions and request any additional information 422 required. 423 d. Requested information omitted from an application for 424 licensure must be filed with the department within 21 days after 425 the department’s request for omitted information or the 426 application shall be deemed incomplete and shall be withdrawn 427 from further consideration and the fees shall be forfeited. 428 429 Within 30 days after the receipt of a complete application, the 430 department shall approve or deny the application. 431 2. A medical marijuana treatment center, and any individual 432 or entity who directly or indirectly owns, controls, or holds 433 with power to vote 5 percent or more of the voting shares of a 434 medical marijuana treatment center, may not acquire direct or 435 indirect ownership or control of any voting shares or other form 436 of ownership of any other medical marijuana treatment center. 437 3. A medical marijuana treatment center may not enter into 438 any form of profit-sharing arrangement with the property owner 439 or lessor of any of its facilities where cultivation, 440 processing, storing, or dispensing of marijuana and marijuana 441 delivery devices occurs. 442 4. All employees of a medical marijuana treatment center 443 must be 21 years of age or older and have passed a background 444 screening pursuant to subsection (9). 445 5. Each medical marijuana treatment center must adopt and 446 enforce policies and procedures to ensure employees and 447 volunteers receive training on the legal requirements to 448 dispense marijuana to qualified patients. 449 6. When growing marijuana, a medical marijuana treatment 450 center: 451 a. May use pesticides determined by the department, after 452 consultation with the Department of Agriculture and Consumer 453 Services, to be safely applied to plants intended for human 454 consumption, but may not use pesticides designated as 455 restricted-use pesticides pursuant to s. 487.042. 456 b. Must grow marijuana within an enclosed structure and in 457 a room separate from any other plant. 458 c. Must inspect seeds and growing plants for plant pests 459 that endanger or threaten the horticultural and agricultural 460 interests of the state in accordance with chapter 581 and any 461 rules adopted thereunder. 462 d. Must perform fumigation or treatment of plants, or 463 remove and destroy infested or infected plants, in accordance 464 with chapter 581 and any rules adopted thereunder. 465 7. Each medical marijuana treatment center must produce and 466 make available for purchase at least one low-THC cannabis 467 product. 468 8. A medical marijuana treatment center that produces 469 edibles must hold a permit to operate as a food establishment 470 pursuant to chapter 500, the Florida Food Safety Act, and must 471 comply with all the requirements for food establishments 472 pursuant to chapter 500 and any rules adopted thereunder. 473 Edibles may not contain more than 200 milligrams of 474 tetrahydrocannabinol, and a single serving portion of an edible 475 may not exceed 10 milligrams of tetrahydrocannabinol. Edibles 476 may have a potency variance of no greater than 15 percent. 477 Edibles may not be attractive to children; be manufactured in 478 the shape of humans, cartoons, or animals; be manufactured in a 479 form that bears any reasonable resemblance to products available 480 for consumption as commercially available candy; or contain any 481 color additives. To discourage consumption of edibles by 482 children, the department shall determine by rule any shapes, 483 forms, and ingredients allowed and prohibited for edibles. 484 Medical marijuana treatment centers may not begin processing or 485 dispensing edibles until after the effective date of the rule. 486 The department shall also adopt sanitation rules providing the 487 standards and requirements for the storage, display, or 488 dispensing of edibles. 489 9. Within 12 months after licensure, a medical marijuana 490 treatment center must demonstrate to the department that all of 491 its processing facilities have passed a Food Safety Good 492 Manufacturing Practices, such as Global Food Safety Initiative 493 or equivalent, inspection by a nationally accredited certifying 494 body. A medical marijuana treatment center must immediately stop 495 processing at any facility which fails to pass this inspection 496 until it demonstrates to the department that such facility has 497 met this requirement. 498 10. A medical marijuana treatment center that produces 499 prerolled marijuana cigarettes may not use wrapping paper made 500 with tobacco or hemp. 501 11.10.When processing marijuana, a medical marijuana 502 treatment center must: 503 a. Process the marijuana within an enclosed structure and 504 in a room separate from other plants or products. 505 b. Comply with department rules when processing marijuana 506 with hydrocarbon solvents or other solvents or gases exhibiting 507 potential toxicity to humans. The department shall determine by 508 rule the requirements for medical marijuana treatment centers to 509 use such solvents or gases exhibiting potential toxicity to 510 humans. 511 c. Comply with federal and state laws and regulations and 512 department rules for solid and liquid wastes. The department 513 shall determine by rule procedures for the storage, handling, 514 transportation, management, and disposal of solid and liquid 515 waste generated during marijuana production and processing. The 516 Department of Environmental Protection shall assist the 517 department in developing such rules. 518 d. Test the processed marijuana using a medical marijuana 519 testing laboratory before it is dispensed. Results must be 520 verified and signed by two medical marijuana treatment center 521 employees. Before dispensing, the medical marijuana treatment 522 center must determine that the test results indicate that low 523 THC cannabis meets the definition of low-THC cannabis, the 524 concentration of tetrahydrocannabinol meets the potency 525 requirements of this section, the labeling of the concentration 526 of tetrahydrocannabinol and cannabidiol is accurate, and all 527 marijuana is safe for human consumption and free from 528 contaminants that are unsafe for human consumption. The 529 department shall determine by rule which contaminants must be 530 tested for and the maximum levels of each contaminant which are 531 safe for human consumption. The Department of Agriculture and 532 Consumer Services shall assist the department in developing the 533 testing requirements for contaminants that are unsafe for human 534 consumption in edibles. The department shall also determine by 535 rule the procedures for the treatment of marijuana that fails to 536 meet the testing requirements of this section, s. 381.988, or 537 department rule. The department may select a random sample from 538 edibles available for purchase in a dispensing facility which 539 shall be tested by the department to determine that the edible 540 meets the potency requirements of this section, is safe for 541 human consumption, and the labeling of the tetrahydrocannabinol 542 and cannabidiol concentration is accurate. A medical marijuana 543 treatment center may not require payment from the department for 544 the sample. A medical marijuana treatment center must recall 545 edibles, including all edibles made from the same batch of 546 marijuana, which fail to meet the potency requirements of this 547 section, which are unsafe for human consumption, or for which 548 the labeling of the tetrahydrocannabinol and cannabidiol 549 concentration is inaccurate. The medical marijuana treatment 550 center must retain records of all testing and samples of each 551 homogenous batch of marijuana for at least 9 months. The medical 552 marijuana treatment center must contract with a marijuana 553 testing laboratory to perform audits on the medical marijuana 554 treatment center’s standard operating procedures, testing 555 records, and samples and provide the results to the department 556 to confirm that the marijuana or low-THC cannabis meets the 557 requirements of this section and that the marijuana or low-THC 558 cannabis is safe for human consumption. A medical marijuana 559 treatment center shall reserve two processed samples from each 560 batch and retain such samples for at least 9 months for the 561 purpose of such audits. A medical marijuana treatment center may 562 use a laboratory that has not been certified by the department 563 under s. 381.988 until such time as at least one laboratory 564 holds the required certification, but in no event later than 565 July 1, 2018. 566 e. Package the marijuana in compliance with the United 567 States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss. 568 1471 et seq. 569 f. Package the marijuana in a receptacle that has a firmly 570 affixed and legible label stating the following information: 571 (I) The marijuana or low-THC cannabis meets the 572 requirements of sub-subparagraph d. 573 (II) The name of the medical marijuana treatment center 574 from which the marijuana originates. 575 (III) The batch number and harvest number from which the 576 marijuana originates and the date dispensed. 577 (IV) The name of the physician who issued the physician 578 certification. 579 (V) The name of the patient. 580 (VI) The product name, if applicable, and dosage form, 581 including concentration of tetrahydrocannabinol and cannabidiol. 582 The product name may not contain wording commonly associated 583 with products marketed by or to children. 584 (VII) The recommended dose. 585 (VIII) A warning that it is illegal to transfer medical 586 marijuana to another person. 587 (IX) A marijuana universal symbol developed by the 588 department. 589 12.11.The medical marijuana treatment center shall include 590 in each package a patient package insert with information on the 591 specific product dispensed related to: 592 a. Clinical pharmacology. 593 b. Indications and use. 594 c. Dosage and administration. 595 d. Dosage forms and strengths. 596 e. Contraindications. 597 f. Warnings and precautions. 598 g. Adverse reactions. 599 13. In addition to the packaging and labeling requirements 600 specified in subparagraphs 11. and 12., marijuana in a form for 601 smoking must be packaged in a sealed receptacle with a legible 602 and prominent warning to keep away from children and a warning 603 that states marijuana smoke contains carcinogens and may 604 negatively affect health. Such receptacles for marijuana in a 605 form for smoking must be plain, opaque, and white without 606 depictions of the product or images other than the medical 607 marijuana treatment center’s department-approved logo and the 608 marijuana universal symbol. 609 14. The department shall adopt rules to regulate the types, 610 appearance, and labeling of marijuana delivery devices dispensed 611 from a medical marijuana treatment center. The rules must 612 require marijuana delivery devices to have an appearance 613 consistent with medical use. 614 15.12.Each edible shall be individually sealed in plain, 615 opaque wrapping marked only with the marijuana universal symbol. 616 Where practical, each edible shall be marked with the marijuana 617 universal symbol. In addition to the packaging and labeling 618 requirements in subparagraphs 11. and 12.10. and 11., edible 619 receptacles must be plain, opaque, and white without depictions 620 of the product or images other than the medical marijuana 621 treatment center’s department-approved logo and the marijuana 622 universal symbol. The receptacle must also include a list all of 623 the edible’s ingredients, storage instructions, an expiration 624 date, a legible and prominent warning to keep away from children 625 and pets, and a warning that the edible has not been produced or 626 inspected pursuant to federal food safety laws. 627 16.13.When dispensing marijuana or a marijuana delivery 628 device, a medical marijuana treatment center: 629 a. May dispense any active, valid order for low-THC 630 cannabis, medical cannabis and cannabis delivery devices issued 631 pursuant to former s. 381.986, Florida Statutes 2016, which was 632 entered into the medical marijuana use registry before July 1, 633 2017. 634 b. May not dispense more than a 70-day supply of marijuana 635 within any 70-day period to a qualified patient or caregiver. 636 May not dispense more than one 35-day supply of marijuana in a 637 form for smoking within any 35-day period to a qualified patient 638 or caregiver. A 35-day supply of marijuana in a form for smoking 639 may not exceed 2.5 ounces unless an exception to this amount is 640 approved by the department pursuant to paragraph (4)(f). 641 c. Must have the medical marijuana treatment center’s 642 employee who dispenses the marijuana or a marijuana delivery 643 device enter into the medical marijuana use registry his or her 644 name or unique employee identifier. 645 d. Must verify that the qualified patient and the 646 caregiver, if applicable, each have an active registration in 647 the medical marijuana use registry and an active and valid 648 medical marijuana use registry identification card, the amount 649 and type of marijuana dispensed matches the physician 650 certification in the medical marijuana use registry for that 651 qualified patient, and the physician certification has not 652 already been filled. 653 e. May not dispense marijuana to a qualified patient who is 654 younger than 18 years of age. If the qualified patient is 655 younger than 18 years of age, marijuana may only be dispensed to 656 the qualified patient’s caregiver. 657 f. May not dispense or sell any other type of cannabis, 658 alcohol, or illicit drug-related product, including pipes,659bongs,or wrapping papers made with tobacco or hemp, other than 660 a marijuana delivery device required for the medical use of 661 marijuana and which is specified in a physician certification. 662 g. Must, upon dispensing the marijuana or marijuana 663 delivery device, record in the registry the date, time, 664 quantity, and form of marijuana dispensed; the type of marijuana 665 delivery device dispensed; and the name and medical marijuana 666 use registry identification number of the qualified patient or 667 caregiver to whom the marijuana delivery device was dispensed. 668 h. Must ensure that patient records are not visible to 669 anyone other than the qualified patient, his or her caregiver, 670 and authorized medical marijuana treatment center employees. 671 (14) EXCEPTIONS TO OTHER LAWS.— 672 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 673 any other provision of law, but subject to the requirements of 674 this section, a qualified patient and the qualified patient’s 675 caregiver may purchase from a medical marijuana treatment center 676 for the patient’s medical use a marijuana delivery device and up 677 to the amount of marijuana authorized in the physician 678 certification, but may not possess more than a 70-day supply of 679 marijuana, or the greater of 4 ounces of marijuana in a form for 680 smoking or an amount of marijuana in a form for smoking approved 681 by the department pursuant to paragraph (4)(f), at any given 682 time and all marijuana purchased must remain in its original 683 packaging. 684 (b) Notwithstanding paragraph (a), s. 893.13, s. 893.135, 685 s. 893.147, or any other provision of law, a qualified patient 686 and the qualified patient’s caregiver may purchase and possess a 687 marijuana delivery device intended for the medical use of 688 marijuana by smoking from a vendor other than a medical 689 marijuana treatment center. 690 (c)(b)Notwithstanding s. 893.13, s. 893.135, s. 893.147, 691 or any other provision of law, but subject to the requirements 692 of this section, an approved medical marijuana treatment center 693 and its owners, managers, and employees may manufacture, 694 possess, sell, deliver, distribute, dispense, and lawfully 695 dispose of marijuana or a marijuana delivery device as provided 696 in this section, s. 381.988, and by department rule. For the 697 purposes of this subsection, the terms “manufacture,” 698 “possession,” “deliver,” “distribute,” and “dispense” have the 699 same meanings as provided in s. 893.02. 700 (d)(c)Notwithstanding s. 893.13, s. 893.135, s. 893.147, 701 or any other provision of law, but subject to the requirements 702 of this section, a certified marijuana testing laboratory, 703 including an employee of a certified marijuana testing 704 laboratory acting within the scope of his or her employment, may 705 acquire, possess, test, transport, and lawfully dispose of 706 marijuana as provided in this section, in s. 381.988, and by 707 department rule. 708 (e)(d)A licensed medical marijuana treatment center and 709 its owners, managers, and employees are not subject to licensure 710 or regulation under chapter 465 or chapter 499 for 711 manufacturing, possessing, selling, delivering, distributing, 712 dispensing, or lawfully disposing of marijuana or a marijuana 713 delivery device, as provided in this section, in s. 381.988, and 714 by department rule. 715 (f)(e)This subsection does not exempt a person from 716 prosecution for a criminal offense related to impairment or 717 intoxication resulting from the medical use of marijuana or 718 relieve a person from any requirement under law to submit to a 719 breath, blood, urine, or other test to detect the presence of a 720 controlled substance. 721 (g)(f)Notwithstanding s. 893.13, s. 893.135, s. 893.147, 722 or any other provision of law, but subject to the requirements 723 of this section and pursuant to policies and procedures 724 established pursuant to s. 1006.62(8), school personnel may 725 possess marijuana that is obtained for medical use pursuant to 726 this section by a student who is a qualified patient. 727 (h)(g)Notwithstanding s. 893.13, s. 893.135, s. 893.147, 728 or any other provision of law, but subject to the requirements 729 of this section, a research institute established by a public 730 postsecondary educational institution, such as the H. Lee 731 Moffitt Cancer Center and Research Institute, Inc., established 732 under s. 1004.43, or a state university that has achieved the 733 preeminent state research university designation under s. 734 1001.7065 may possess, test, transport, and lawfully dispose of 735 marijuana for research purposes as provided by this section. 736 (15) APPLICABILITY.— 737 (a) This section does not limit the ability of an employer 738 to establish, continue, or enforce a drug-free workplace program 739 or policy. 740 (b) This section does not require an employer to 741 accommodate the medical use of marijuana in any workplace or any 742 employee working while under the influence of marijuana. 743 (c) This section does not create a cause of action against 744 an employer for wrongful discharge or discrimination. 745 (d) This section does not impair the ability of any party 746 to restrict or limit smoking or vaping marijuana on his or her 747 private property. 748 (e) This section does not prohibit the medical use of 749 marijuana or a caregiver assisting with the medical use of 750 marijuana in a nursing home facility licensed under part II of 751 chapter 400, a hospice facility licensed under part IV of 752 chapter 400, or an assisted living facility licensed under part 753 I of chapter 429, if the medical use of marijuana is not 754 prohibited in the facility’s policies. 755 (f) Marijuana, as defined in this section, is not 756 reimbursable under chapter 440. 757 Section 2. Section 1004.4351, Florida Statutes, is amended 758 to read: 759 1004.4351 Medical marijuana researchand education.— 760 (1) SHORT TITLE.—This section shall be known and may be 761 cited as the “Medical Marijuana Researchand EducationAct.” 762 (2) LEGISLATIVE FINDINGS.—The Legislature finds that: 763 (a) The present state of knowledge concerning the use of 764 marijuana to alleviate pain and treat illnesses is limited 765 because permission to perform clinical studies on marijuana is 766 difficult to obtain, with access to research-grade marijuana so 767 restricted that little or no unbiased studies have been 768 performed. 769 (b) Under the State Constitution, marijuana is available 770 for the treatment of certain debilitating medical conditions. 771 (c) Additional clinical studies are needed to ensure that 772 the residents of this state obtain the correct dosing, 773 formulation, route, modality, frequency, quantity, and quality 774 of marijuana for specific illnesses. 775 (d) An effective medical marijuana researchand education776 program would mobilize the scientific, educational,and medical 777 resources that presently exist in this state to determine the 778 appropriate and best use of marijuana to treat illness. 779 (3) DEFINITIONS.—As used in this section, the term: 780 (a) “Board” means the Medical Marijuana Researchand781EducationBoard. 782 (b) “Consortium”“Coalition”means the ConsortiumCoalition783 for Medical Marijuana Clinical Outcomes Researchand Education. 784 (c) “Marijuana” has the same meaning as provided in s. 29, 785 Art. X of the State Constitution. 786 (4) CONSORTIUMCOALITIONFOR MEDICAL MARIJUANA CLINICAL 787 OUTCOMES RESEARCHAND EDUCATION.— 788 (a) There is established within a state university 789 designated by the Board of Governorsthe H. Lee Moffitt Cancer790Center and Research Institute, Inc.,the ConsortiumCoalition791 for Medical Marijuana Clinical Outcomes Research which shall 792 consist of public and private universitiesand Education. The 793 purpose of the consortiumcoalitionis to conduct rigorous 794 scientific research and, provide education,disseminate such 795 research, and guide policy for the adoption of a statewide796policy on ordering and dosing practices for the medical use of797marijuana. The coalition shall be physically located at the H.798Lee Moffitt Cancer Center and Research Institute, Inc. 799 (b) The Medical Marijuana Researchand EducationBoard is 800 established to direct the operations of the consortium 801coalition. The board shall be composed ofsevenmembers 802 representing each participating university appointed by the 803 president of each participating universitythe chief executive804officer of the H. Lee Moffitt Cancer Center and Research805Institute, Inc. Board members must have experience in a variety 806 of scientific and medical fields, including, but not limited to, 807 oncology, neurology, psychology, pediatrics, nutrition, and 808 addiction. Members shall be appointed to 4-year terms and may be 809 reappointed to serve additional terms. The chair shall be 810 elected by the board from among its members to serve a 2-year 811 term. The board shall meet at least semiannually at the call of 812 the chair or, in his or her absence or incapacity, the vice 813 chair. Four members constitute a quorum. A majority vote of the 814 members present is required for all actions of the board. The 815 board may prescribe, amend, and repeal a charter governing the 816 manner in which it conducts its business. A board member shall 817 serve without compensation but is entitled to be reimbursed for 818 travel expenses by the consortiumcoalitionor the organization 819 he or she represents in accordance with s. 112.061. 820 (c) The consortiumcoalitionshall be administered by a 821coalitiondirector, who shall be appointed by and serve at the 822 pleasure of the board. Thecoalitiondirector shall, subject to 823 the approval of the board: 824 1. Propose a budget for the consortiumcoalition. 825 2. Foster the collaboration of scientists, researchers, and 826 other appropriate personnel in accordance with the consortium’s 827coalition’scharter. 828 3. Engage individuals in public and private university 829 programs relevant to the consortium’s work to participate in the 830 consortium. 831 4.3.Identify and prioritize the research to be conducted 832 by the consortiumcoalition. 833 5.4.Prepare a plan for medical marijuana researchthe834Medical Marijuana Research and Education Planfor submission to 835 the board. 836 6.5.Apply for grants to obtain funding for research 837 conducted by the consortiumcoalition. 838 7.6.Perform other duties as determined by the board. 839(d) The board shall advise the Board of Governors, the840State Surgeon General, the Governor, and the Legislature with841respect to medical marijuana research and education in this842state. The board shall explore methods of implementing and843enforcing medical marijuana laws in relation to cancer control,844research, treatment, and education.845 (d)(e)The board shall annually adopt a plan for medical 846 marijuana research. The plan must organize a program of research 847 that contributes to the body of scientific knowledge on the 848 effects of the medical use of marijuana and informs both policy 849 and medical practice related to the treatment of debilitating 850 medical conditions with marijuana. Research must include 851 tracking clinical outcomes, certification standards, dosing 852 standards, routes of administration, efficacy, and side effects. 853 Research must also include the study of the effects of smoking 854 marijuana to treat debilitating medical conditions. The board 855 must award funds to members of the consortium and to perform 856 research consistent with the plan. The board shall collaborate 857 with and may award funds to teaching nursing homes, as defined 858 in s. 430.08, for research on medical use of marijuana to 859 alleviate conditions related to chronic disease and aging, known860as the “Medical Marijuana Research and Education Plan,” which861must be in accordance with state law and coordinate with862existing programs in this state. The plan must include863recommendations for the coordination and integration of medical,864pharmacological, nursing, paramedical, community, and other865resources connected with the treatment of debilitating medical866conditions; research related to the treatment of such medical867conditions; and education. 868 (e)(f)By February 15 of each year, the board shall issue a 869 report to the Governor, the President of the Senate, and the 870 Speaker of the House of Representatives on research projects, 871 research findings, community outreach initiatives, and future 872 plans for the consortiumcoalition. 873 (f)(g)Beginning August 1, 2019January 15, 2018, and 874 quarterly thereafter, the Department of Health shall submit to 875 the board a data set that includes, for each patient registered 876 in the medical marijuana use registry, the patient’s qualifying 877 medical condition and the daily dose amount, routes of 878 administration, and forms of marijuana certified for the 879 patient. The department shall also provide the board with such 880 data for all patients registered in the medical marijuana use 881 registry before August 1, 2019. 882(5)RESPONSIBILITIES OF THE H. LEE MOFFITT CANCER CENTER883AND RESEARCH INSTITUTE, INC.—The H. Lee Moffitt Cancer Center884and Research Institute, Inc., shall allocate staff and provide885information and assistance, as the coalition’s budget permits,886to assist the board in fulfilling its responsibilities.887 Section 3. Paragraph (h) of subsection (2) and paragraph 888 (b) of subsection (3) of section 381.987, Florida Statutes, are 889 amended to read: 890 381.987 Public records exemption for personal identifying 891 information relating to medical marijuana held by the 892 department.— 893 (2) The department shall allow access to the confidential 894 and exempt information in the medical marijuana use registry to: 895 (h) The ConsortiumCoalitionfor Medical Marijuana Clinical 896 Outcomes Researchand Educationestablished in s. 1004.4351(4). 897 (3) The department shall allow access to the confidential 898 and exempt information pertaining to the physician certification 899 for marijuana and the dispensing thereof, whether in the 900 registry or otherwise held by the department, to: 901 (b) The ConsortiumCoalitionfor Medical Marijuana Clinical 902 Outcomes Researchand Educationpursuant to s. 381.986 for the 903 purpose of conducting research regarding the medical use of 904 marijuana. 905 Section 4. (1) For the 2019-2020 fiscal year, the sum of 906 $1.5 million in recurring funds is appropriated from the General 907 Revenue Fund to the Board of Governors for the Consortium for 908 Medical Marijuana Clinical Outcomes Research established under 909 s. 1004.4351, Florida Statutes. 910 (2) For the 2018-2019 fiscal year, the sum of $391,333 in 911 nonrecurring funds is appropriated from the Grants and Donations 912 Trust Fund to the Department of Health for the purpose of 913 implementing the requirements of this act. 914 (3) For the 2019-2020 fiscal year, the sum of $705,331 in 915 recurring funds is appropriated from the Grants and Donations 916 Trust Fund to the Department of Health for the purpose of 917 implementing the requirements of this act. 918 Section 5. This act shall take effect upon becoming a law.