Bill Text: FL S1666 | 2017 | Regular Session | Introduced
Bill Title: Medical Use of Marijuana
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Failed) 2017-05-05 - Died in Health Policy [S1666 Detail]
Download: Florida-2017-S1666-Introduced.html
Florida Senate - 2017 SB 1666 By Senator Braynon 35-01039-17 20171666__ 1 A bill to be entitled 2 An act relating to medical use of marijuana; amending 3 s. 381.986, F.S.; providing legislative intent; 4 defining, redefining, and deleting terms; authorizing 5 physicians to issue physician certifications to 6 specified patients for the provision of marijuana and 7 marijuana delivery devices; requiring physicians to 8 meet certain conditions to be authorized to issue and 9 make determinations in physician certifications; 10 requiring certain physicians to annually reexamine and 11 reassess patients and update patient information in 12 the compassionate use registry; providing requirements 13 for physician certification for patients who are non 14 Florida residents; providing that a prior order for 15 low-THC cannabis or medical cannabis issued is 16 considered a physician certification under certain 17 circumstances; providing requirements for such 18 certifications; revising criminal penalties; reducing 19 the number of hours of coursework required of 20 physicians who issue physician certifications; 21 providing that physicians who meet specified 22 requirements are grandfathered for the purpose of 23 specified education requirements; authorizing 24 qualifying patients over the age of 21 to designate or 25 remove caregivers; requiring caregivers to meet 26 specified requirements, including a 1-hour course on 27 the administration of marijuana; authorizing a 28 qualifying patient to designate only one caregiver at 29 any given time; providing exceptions; authorizing a 30 caregiver to assist only one qualifying patient at any 31 given time; providing exceptions; requiring the 32 Department of Health to register on the compassionate 33 use registry a caregiver and to issue him or her a 34 caregiver identification card if the caregiver meets 35 certain requirements; providing requirements for 36 assisting a qualifying patient who is under the age of 37 18; revising the list of entities that have access to 38 the compassionate use registry; requiring the 39 department to adopt rules by a specified date; 40 authorizing the department to charge a fee for 41 identification cards; requiring the department to 42 begin issuing identification cards to qualified 43 registrants by a specific date; providing requirements 44 for the identification cards; requiring the department 45 to register certain dispensing organizations as 46 medical marijuana treatment centers (MMTCs) by a 47 certain date; deleting provisions to conform to 48 changes made by the act; requiring the department to 49 register additional MMTCs in accordance with a 50 specified schedule; prohibiting an entity from being 51 issued more than one MMTC registration; requiring the 52 department to review the number of qualifying patients 53 every 6 months; limiting the number of MMTCs; 54 decreasing the required performance bond amount under 55 certain circumstances; requiring the department to 56 create a 30-minute educational program for qualifying 57 patients; revising the operational requirements for 58 MMTCs; authorizing the department to waive certain 59 requirements in the MMTC registration application 60 under specified circumstances; providing requirements 61 for MMTCs to grow, process, and dispense marijuana, 62 rather than requirements for dispensing organizations 63 to grow, process, and dispense low-THC cannabis or 64 medical cannabis; providing a contract option that 65 requires an independent testing laboratory to directly 66 test an MMTC’s marijuana final product; requiring that 67 marijuana receptacles be opaque, childproof, and 68 tamper-evident; reducing the time that samples are 69 required to be retained; requiring verification of 70 patient and caregiver identification cards, rather 71 than registration cards, and amount and type of 72 marijuana before dispensing; requiring compliance with 73 certain standards in the production and dispensing of 74 edibles or food products; requiring an MMTC to enter 75 additional information into the compassionate use 76 registry; providing requirements to ensure the safety 77 and security of premises and facilities of MMTCs, 78 rather than the safety and security of premises and 79 facilities of dispensing organizations; requiring an 80 MMTC to register all owners and employees with the 81 department; requiring an MMTC to present a floor plan 82 to the department; defining terms to provide criteria 83 on visitor access to MMTC areas; providing 84 requirements to ensure the safe and sanitary transport 85 of marijuana, rather than the safe transport of low 86 THC cannabis and medical cannabis; requiring a vehicle 87 transporting marijuana to be legally parked under 88 certain circumstances; revising the department’s 89 authority and responsibilities; requiring the 90 department to adopt rules relating to ownership 91 changes or changes in an owner’s investment interest; 92 conforming provisions to changes made by the act; 93 providing circumstances under which the department may 94 suspend, revoke, or refuse to renew an MMTC’s 95 registration; providing rulemaking authority; 96 authorizing an MMTC employee to administer marijuana 97 under certain circumstances; providing construction; 98 conforming provisions to changes made by the act; 99 providing that a physician who issues a physician 100 certification is immune to civil claims and claims for 101 medical malpractice under certain circumstances; 102 providing that a health insurance provider or a 103 governmental agency or authority is not required to 104 reimburse expenses related to the use of marijuana; 105 authorizing certain institutes or state universities 106 to possess, test, transport, or dispose of marijuana 107 for research purposes; prohibiting a person from 108 offering, advertising, or performing services, and 109 from owning, operating, and maintaining certain 110 facilities, without registration; providing penalties; 111 prohibiting the importation of marijuana; authorizing 112 the exportation of marijuana and products containing 113 marijuana under certain circumstances; providing 114 severability; amending ss. 381.987, 385.211, 499.0295, 115 and 1004.441, F.S.; conforming provisions to changes 116 made by the act; providing a directive to the Division 117 of Law Revision and Information; providing an 118 effective date. 119 120 Be It Enacted by the Legislature of the State of Florida: 121 122 Section 1. Section 381.986, Florida Statutes, is amended to 123 read: 124 381.986 Compassionate use of marijuanalow-THC and medical125cannabis.— 126 (1) LEGISLATIVE INTENT.— 127 (a) It is the intent of the Legislature to implement s. 29, 128 Art. X of the State Constitution by creating a unified 129 regulatory structure within the framework of this section for 130 the acquisition, cultivation, possession, processing, transfer, 131 transportation, sale, distribution, or dispensing of marijuana, 132 products containing marijuana, related supplies, or educational 133 materials to qualifying patients or their caregivers. 134 (b) The Legislature intends that all rules adopted by the 135 Department of Health to implement this section be adopted 136 pursuant to s. 120.536(1) or s. 120.54. The Legislature intends 137 that the department use emergency rulemaking procedures pursuant 138 to s. 120.54(4) to adopt rules under this section if necessary 139 to meet any deadline for rulemaking established in s. 29, Art. X 140 of the State Constitution. 141 (c) Further, the Legislature intends that all registrations 142 for the purposes specified in paragraph (a) be issued solely in 143 accordance with the requirements of this section and all rules 144 adopted under this section. 145 (2) DEFINITIONS.—As used in this section, the term: 146 (a) “Caregiver” means a person who: 147 1. Is at least 21 years old unless he or she is a close 148 relative of the qualifying patient and the patient demonstrates 149 a need for assistance with the medical use of marijuana; 150 2. Has agreed in writing to assist the qualifying patient 151 with the qualifying patient’s medical use of marijuana; and 152 3. Does not receive compensation, other than actual 153 expenses incurred, for assisting the qualifying patient with the 154 medical use of marijuana unless the caregiver is acting pursuant 155 to employment in a licensed facility“Cannabis delivery device”156means an object used, intended for use, or designed for use in157preparing, storing, ingesting, inhaling, or otherwise158introducing low-THC cannabis or medical cannabis into the human159body. 160 (b) “Close relative” means a spouse, parent, sibling, 161 grandparent, child, or grandchild, whether related by whole or 162 half blood, by marriage, or by adoption. 163 (c)(b)“Debilitating medical condition” means cancer, 164 epilepsy, glaucoma, a positive status for human immunodeficiency 165 virus, acquired immune deficiency syndrome, posttraumatic stress 166 disorder, amyotrophic lateral sclerosis, Crohn’s disease, 167 Parkinson’s disease, multiple sclerosis, a physical medical 168 condition that chronically produces symptoms of seizures or 169 severe and persistent muscle spasms, a terminal condition, or 170 any other debilitating medical condition of the same kind or 171 class as, or comparable to, those conditions enumerated in this 172 paragraph and for which a physician believes that the use of 173 medical cannabis would likely outweigh the potential health 174 risks to a patient“Dispensing organization” means an175organization approved by the department to cultivate, process,176transport, and dispense low-THC cannabis or medical cannabis177pursuant to this section. 178 (d)(c)“Independent testing laboratory” means a laboratory, 179 including the managers, employees, or contractors of the 180 laboratory:,181 1. Which has no direct or indirect interest in a medical 182 marijuana treatment center; and 183 2. In which no medical marijuana treatment center has any 184 direct or indirect interestdispensing organization. 185 (e)(d)“Legal representative” means the qualifying 186qualifiedpatient’s parent, legal guardian acting pursuant to a 187 court’s authorization as required under s. 744.3215(4), health 188 care surrogate acting pursuant to the qualifyingqualified189 patient’s written consent or a court’s authorization as required 190 under s. 765.113, or an individual who is authorized under a 191 power of attorney to make health care decisions on behalf of the 192 qualifyingqualifiedpatient. 193 (f)(e)“Low-THC cannabis” means a plant of the genus 194 Cannabis, the dried flowers of which contain 0.8 percent or less 195 of tetrahydrocannabinol and more than 10 percent of cannabidiol 196 weight for weight; the seeds thereof; the resin extracted from 197 any part of such plant; or any compound, manufacture, salt, 198 derivative, mixture, or preparation of such plant or its seeds 199 or resin that is dispensed only by a medical marijuana treatment 200 centerfrom a dispensing organization. 201 (g)(f)“Marijuana” has the same meaning as provided in s. 202 29, Art. X of the State Constitution“Medical cannabis” means203all parts of any plant of the genusCannabis, whether growing or204not; the seeds thereof; the resin extracted from any part of the205plant; and every compound, manufacture, sale, derivative,206mixture, or preparation of the plant or its seeds or resin that207is dispensed only from a dispensing organization for medical use208by an eligible patient as defined in s. 499.0295. 209 (h) “Marijuana delivery device” means an object used, 210 intended for use, or designed for use in preparing, storing, 211 ingesting, inhaling, or otherwise introducing marijuana or low 212 THC cannabis into the human body. 213 (i) “Medical marijuana treatment center” or “MMTC” has the 214 same meaning as provided in s. 29, Art. X of the State 215 Constitution. 216 (j)(g)“Medical use” has the same meaning as provided in s. 217 29, Art. X of the State Constitutionmeans administration of the218ordered amount of low-THC cannabis or medical cannabis. The term 219 does not includethe: 220 1. The possession, use, or administration of marijuanalow221THC cannabis or medical cannabisby smoking. As used in this 222 subparagraph, the term “smoking” means burning or igniting a 223 substance and inhaling the smoke. Smoking does not include the 224 use of a vaporizer. 225 2. The possession, use, or administration of marijuana that 226 is not purchased or acquired from a medical marijuana treatment 227 center. 228 3. The transfer of marijuanalow-THC cannabis or medical229cannabisto a person other than the qualifyingqualifiedpatient 230for whom it was orderedor the qualifyingqualifiedpatient’s 231 caregiverlegal representativeon behalf of the qualifying 232qualifiedpatient. 233 4.3.The use or administration of marijuanalow-THC234cannabis or medical cannabis: 235 a. On any form of public transportation. 236 b. In any public place. 237 c. In a qualifyingqualifiedpatient’s place of employment, 238 if restricted by his or her employer. 239 d. In a state correctional institution as defined in s. 240 944.02 or a correctional institution as defined in s. 944.241. 241 e. On the grounds of a preschool, primary school, or 242 secondary school. 243 f. On a school bus or in a vehicle, aircraft, or motorboat. 244 (k)(h)“Qualifying patient” has the same meaning as 245 provided in s. 29, Art. X of the State Constitution. The term 246 also includes eligible patients, as defined in s. 499.0295. A 247 patient is not a qualifying patient unless he or she is 248 registered with the department and has been issued a“Qualified249patient”means a resident of this state who has been added to250thecompassionate use registry identification cardby a251physician licensed under chapter 458 or chapter 459 to receive252low-THC cannabis or medical cannabis from a dispensing253organization. 254(i) “Smoking” means burning or igniting a substance and255inhaling the smoke. Smoking does not include the use of a256vaporizer.257 (3)(2)PHYSICIAN CERTIFICATIONORDERING.—A physician is 258 authorized to issue a physician certification for the provision 259 of marijuana and marijuana delivery devicesorder low-THC260cannabisto treat a qualified patient suffering from cancer or a261physical medical condition that chronically produces symptoms of262seizures or severe and persistent muscle spasms; order low-THC263cannabis to alleviate symptoms of such disease, disorder, or264condition, if no other satisfactory alternative treatment265options exist for the qualified patient; order medical cannabis266 to treat a qualifyingan eligiblepatientas defined in s.267499.0295; or order a cannabis delivery device for the medical268use of low-THC cannabis or medical cannabis,only if the 269 physician: 270 (a) Holds an active, unrestricted license as a physician 271 under chapter 458 or an osteopathic physician under chapter 459; 272 (b)Has treated the patient for at least 3 months273immediately preceding the patient’s registration in the274compassionate use registry;275(c)Has successfully completed the course and examination 276 required under paragraph (6)(a)(4)(a); 277 (c) Has conducted a physical examination and made a full 278 assessment of the medical history of the patient; 279 (d) Has determined that the medical use of marijuana would 280 likely outweigh the potential health risksof treating the281patient with low-THC cannabis or medical cannabis are reasonable282in light of the potential benefitto the patient. If a patient 283 is younger than 18 years of age, a second physician must concur 284 with this determination, and such determination must be 285 documented in the patient’s medical record; 286 (e) Registers as the patient’s physicianorderer of low-THC287cannabis or medical cannabis for the named patienton the 288 compassionate use registry maintained by the department and 289 updates the registry to reflectthe contents of the order,290includingthe amount of marijuana whichlow-THC cannabis or291medical cannabisthatwill provide the patient with not more 292 than a 90-day45-daysupply and any marijuanaacannabis293 delivery device needed by the patient for the medical use of 294 marijuanalow-THC cannabis or medical cannabis. A physician may 295 certify an amount greater than a 90-day supply of marijuana if 296 the physician has a reasonable belief that the patient will use 297 the additional marijuana in a medically appropriate way. The 298 physician mustalsoupdate the registry within 7 days after any 299 change is made to the physician certificationoriginalorder to 300 reflect the change. The physician shall deactivate the 301 registration of the patientand the patient’s legal302representativewhen the physician no longer recommends the 303 medical use of marijuana for the patienttreatment is304discontinued; 305 (f) At least annually, recertifies the qualifying patient 306 pursuant to this subsection. The physician must require that a 307 non-Florida resident be physically present during the initial 308 exam and all followup exams. Before being issued a physician 309 certification, a qualifying patient who is a non-Florida 310 resident must: 311 1. Affirm that his or her stay in this state is for at 312 least 30 days; 313 2. Provide proof that he or she holds a state-issued 314 identification card or certification in another state with a 315 medical marijuana program; or 316 3. Elect to wait 2 weeks after the date of receiving a 317 physician certification to obtain marijuana. A non-Florida 318 resident who elects to wait under this subparagraph may not be 319 issued a physician certification for marijuana for more than 6 320 months; and 321(g) Submits the patient treatment plan quarterly to the322University of Florida College of Pharmacy for research on the323safety and efficacy of low-THC cannabis and medical cannabis on324patients;325(h) Obtains the voluntary written informed consent of the326patient or the patient’s legal representative to treatment with327low-THC cannabis after sufficiently explaining the current state328of knowledge in the medical community of the effectiveness of329treatment of the patient’s condition with low-THC cannabis, the330medically acceptable alternatives, and the potential risks and331side effects;332(i) Obtains written informed consent as defined in and333required under s. 499.0295, if the physician is ordering medical334cannabis for an eligible patient pursuant to that section; and335 (g)(j)Is not a medical director employed by an MMTCa336dispensing organization. 337 (4)(3)GRANDFATHERING.—An order for low-THC cannabis or 338 medical cannabis issued pursuant to former s. 381.986, Florida 339 Statutes 2016, and registered with the compassionate use 340 registry on or before the effective date of this act shall be 341 considered a physician certification issued pursuant to this 342 section. The details and expiration date of such certification 343 must be identical to the details and expiration date of the 344 order as logged in the compassionate use registry. Until the 345 department begins issuing compassionate use registry 346 identification cards, all patients with such orders shall be 347 considered qualifying patients, notwithstanding the requirement 348 that a qualifying patient have a compassionate use registry 349 identification card. 350 (5) PENALTIES.— 351 (a) A physician commits a misdemeanor of the first degree, 352 punishable as provided in s. 775.082 or s. 775.083, if the 353 physician issues a physician certification for marijuana to 354orders low-THC cannabis fora patient without a reasonable 355 belief that the patient is suffering from a debilitating medical 356 condition:3571. Cancer or a physical medical condition that chronically358produces symptoms of seizures or severe and persistent muscle359spasms that can be treated with low-THC cannabis; or3602. Symptoms of cancer or a physical medical condition that361chronically produces symptoms of seizures or severe and362persistent muscle spasms that can be alleviated with low-THC363cannabis. 364 (b)A physician commits a misdemeanor of the first degree,365punishable as provided in s. 775.082 or s. 775.083, if the366physician orders medical cannabis for a patient without a367reasonable belief that the patient has a terminal condition as368defined in s. 499.0295.369(c)A person who fraudulently represents that he or she has 370 a debilitatingcancer, a physicalmedical conditionthat371chronically produces symptoms of seizures or severe and372persistent muscle spasms, or a terminal conditionto a physician 373 for the purpose of being issued a physician certification for 374 marijuanaordered low-THC cannabis, medical cannabis,or a 375 marijuanacannabisdelivery device by such physician commits a 376 misdemeanor of the first degree, punishable as provided in s. 377 775.082 or s. 775.083. 378 (c)(d)A qualifyingAn eligiblepatientas defined in s.379499.0295who uses marijuanamedical cannabis, and such patient’s 380 caregiverlegal representativewho administers marijuanamedical381cannabis, in plain view of or in a place open to the general 382 public, on the grounds of a place of educationschool, or in an 383 aircraft, a motorboat, a school bus, a train, or a vehicle,384aircraft, or motorboat,commits a misdemeanor of the first 385 degree, punishable as provided in s. 775.082 or s. 775.083. 386 (d) Except as provided in paragraph (c), a caregiver who 387 violates any provision of this section or applicable department 388 rule commits, upon the first offense, a misdemeanor of the 389 second degree, punishable as provided in s. 775.082 or s. 390 775.083, and, upon the second and subsequent offenses, a 391 misdemeanor of the first degree, punishable as provided in s. 392 775.082 or s. 775.083. 393 (e) A physician who issues a physician certification for 394 marijuanaorders low-THC cannabis, medical cannabis,or a 395 marijuanacannabisdelivery device and receives compensation 396 from an MMTCa dispensing organizationrelated to issuing the 397 physician certification for marijuanathe ordering of low-THC398cannabis, medical cannabis,or a marijuanacannabisdelivery 399 device is subject to disciplinary action under the applicable 400 practice act and s. 456.072(1)(n). 401 (6)(4)PHYSICIAN EDUCATION.— 402 (a) Before a physician may issue a physician certification 403 pursuant to subsection (3)ordering low-THC cannabis, medical404cannabis, or a cannabis delivery device for medical use by a405patient in this state, the appropriate board shall require the 406orderingphysician to successfully complete a 4-houran 8-hour407 course and subsequent examination offered by the Florida Medical 408 Association or the Florida Osteopathic Medical Association which 409thatencompasses the clinical indications for the appropriate 410 use of marijuanalow-THC cannabis and medical cannabis, the 411 appropriate marijuanacannabisdelivery devices, the 412 contraindications for such use, and the relevant state and 413 federal laws governing the issuance of physician certifications, 414 as well as theordering,dispensing,and possessing of these 415 substances and devices. The course and examination shall be 416 administered at least quarterlyannually. Successful completion 417 of the course may be used by a physician to satisfy 4 hours8418hoursof the continuing medical education requirements required 419 by his or her respective board for licensure renewal. This 420 course may be offered in a distance learning format. A physician 421 who has completed a 4-hour course and subsequent examination 422 offered by the Florida Medical Association or the Florida 423 Osteopathic Medical Association which encompasses the clinical 424 indications for the appropriate use of marijuana and who is 425 registered in the compassionate use registry on the effective 426 date of this act is deemed to meet the requirements of this 427 paragraph. 428 (b) The appropriate board shall require the medical 429 director of each MMTCdispensing organizationto hold an active, 430 unrestricted license as a physician under chapter 458 or as an 431 osteopathic physician under chapter 459 and successfully 432 complete a 2-hour course and subsequent examination offered by 433 the Florida Medical Association or the Florida Osteopathic 434 Medical Association whichthatencompasses appropriate safety 435 procedures and knowledge of marijuanalow-THC cannabis, medical436cannabis,and marijuanacannabisdelivery devices. 437 (c)Successful completion of the course and examination438specified in paragraph (a) is required for every physician who439orders low-THC cannabis, medical cannabis, or a cannabis440delivery device each time such physician renews his or her441license. In addition, successful completion of the course and442examination specified in paragraph (b) is required for the443medical director of each dispensing organization each time such444physician renews his or her license.445(d)A physician who fails to comply with this subsection 446 and who issues a physician certification for marijuanaorders447low-THC cannabis, medical cannabis,or a marijuanacannabis448 delivery device may be subject to disciplinary action under the 449 applicable practice act and under s. 456.072(1)(k). 450 (7) CAREGIVERS.— 451 (a) During the course of registration with the department 452 for inclusion on the compassionate use registry, or at any time 453 while registered, a qualifying patient over the age of 21 may 454 designate or remove an individual as his or her caregiver to 455 assist him or her with the medical use of marijuana. The 456 designated caregiver must pass a level 2 screening pursuant to 457 chapter 435 unless the patient is a close relative of the 458 caregiver and the patient demonstrates a need for assistance 459 with the medical use of marijuana. The department shall create a 460 1-hour course for caregivers and a subsequent examination that 461 encompass basic information on the procedure and administration 462 of marijuana. The department shall require the designated 463 caregiver to successfully complete the course and pass the 464 subsequent examination before registering an individual as a 465 caregiver. 466 (b) A qualifying patient may have only one designated 467 caregiver at any given time unless all of the qualifying 468 patient’s caregivers are his or her close relatives or legal 469 representatives. 470 (c) A caregiver may assist only one qualifying patient at 471 any given time unless: 472 1. All qualifying patients the caregiver is assisting are 473 close relatives of each other and the caregiver is the legal 474 representative of at least one of the patients; or 475 2. All qualifying patients the caregiver is assisting are 476 receiving hospice services, or are residents in the same 477 assisted living facility, nursing home, or other licensed 478 facility and have requested the assistance of that caregiver 479 with the medical use of marijuana; the caregiver is an employee 480 of the hospice or licensed facility; and the caregiver provides 481 personal care or services directly to clients of the hospice or 482 licensed facility as a part of his or her employment duties at 483 the hospice or licensed facility. 484 (d) The department must register a caregiver on the 485 compassionate use registry and issue him or her a caregiver 486 identification card if he or she: 487 1. Is designated by a qualifying patient, provides hospice 488 services to a qualifying patient, or is requested by a 489 qualifying patient in a licensed facility for assistance with 490 the medical use of marijuana; and 491 2. Meets all of the requirements of this subsection and 492 department rules. 493 (e) If a qualifying patient is under the age of 18, only a 494 parent, legal guardian, caregiver, or health care provider may 495 assist the patient in the purchasing and administering of 496 marijuana for medical use. A qualifying patient under the age of 497 18 may not purchase marijuana. 498 (8)(5)DUTIES OF THE DEPARTMENT.—The department shall: 499 (a) Create and maintain a secure, electronic, and online 500 compassionate use registry for the registration of physicians, 501 qualifying patients, and caregiversthe legal representatives of502patientsas provided under this section. The registry must be 503 accessible to: 504 1. Physicians licensed under chapter 458 or chapter 459, to 505 ensure proper care for patients requesting physician 506 certifications; 507 2. Practitioners licensed to prescribe prescription drugs, 508 to ensure proper care for patients before prescribing 509 medications that may interact with the medical use of marijuana; 510 3. Law enforcement agencies, only for the purpose of 511 verifying the authorization of a qualifying patient or a 512 qualifying patient’s caregiver to possess marijuana or a 513 marijuana delivery device; and 514 4. MMTCs,to a dispensing organizationto verify the 515 authorization of a qualifying patient or a qualifying patient’s 516 caregiverlegal representativeto possess marijuanalow-THC517cannabis, medical cannabis,or a marijuanacannabisdelivery 518 device and to record the marijuanalow-THC cannabis, medical519cannabis,or marijuanacannabisdelivery device dispensed. The 520 registry must preventanactive registration of a qualifying 521 patient by multiple physicians. 522 (b) By July 3, 2017, adopt rules, pursuant to s. 120.536(1) 523 or s. 120.54, establishing procedures for the issuance, annual 524 renewal, suspension, and revocation of compassionate use 525 registry identification cards for qualifying patients and 526 caregivers who are residents of this state. The department may 527 use emergency rulemaking procedures pursuant to s. 120.54(4) to 528 adopt rules under this section as necessary to ensure that rules 529 are adopted on or before July 3, 2017. The department may charge 530 a reasonable fee associated with the issuance and renewal of 531 patient and caregiver identification cards. By October 3, 2017, 532 the department shall begin issuing identification cards to adult 533 patients who are residents of this state and who have a 534 physician certification that meets the requirements of 535 subsection (3); minor patients who are residents of this state 536 and who have a physician certification that meets the 537 requirements of subsection (3) and the written consent of a 538 parent or legal guardian; and caregivers registered pursuant to 539 subsection (7). Patient and caregiver identification cards must 540 be resistant to counterfeiting and tampering and must include at 541 least the following: 542 1. The name, address, and date of birth of the patient or 543 caregiver, as appropriate; 544 2. Designation of the cardholder as a patient or caregiver; 545 3. A unique numeric identifier for the patient or caregiver 546 which is matched to the identifier used for such person in the 547 department’s compassionate use registry. A caregiver’s numeric 548 identifier and file in the compassionate use registry must be 549 linked to the file of the patient or patients the caregiver is 550 assisting so that the caregiver’s status may be verified for 551 each patient individually; 552 4. The expiration date, which must be 1 year after the date 553 of issuance of the identification card or the date treatment 554 ends as provided in the patient’s physician certification, 555 whichever occurs first; and 556 5. For a caregiver who is assisting three or fewer 557 qualifying patients, the name and unique numeric identifier, or 558 the names and unique numeric identifiers, of the qualifying 559 patient, or the qualifying patients, that the caregiver is 560 assisting. 561 (c) Deem a dispensing organization approved under s. 2, 562 chapter 2014-157, Laws of Florida, or s. 3, chapter 2016-123, 563 Laws of Florida, before June 1, 2017, to meet the requirements 564 for approval as an MMTC under this section. The department shall 565 presume such dispensing organization to be registered with the 566 department as an MMTC and shall authorize such dispensing 567 organization to acquire, cultivate, possess, or process 568 marijuana or products containing marijuana, including developing 569 related products such as food, tinctures, aerosols, oils, or 570 ointments, for sale to qualifying patients and their caregivers; 571 or to transfer, transport, sell, distribute, or dispense 572 marijuana, products containing marijuana, related supplies, and 573 educational materials to qualifying patients or their 574 caregivers. If holding a valid certificate of registration by 575 the Department of Agriculture and Consumer Services pursuant to 576 s. 581.131 is not required for the renewal of the registration 577 approval, the Department of Health shall renew the approval of 578 such dispensing organization as an MMTC biennially upon payment 579 by the dispensing organization of the biennial renewal fee 580Authorize the establishment of five dispensing organizations to581ensure reasonable statewide accessibility and availability as582necessary for patients registered in the compassionate use583registry and who are ordered low-THC cannabis, medical cannabis,584or a cannabis delivery device under this section, one in each of585the following regions: northwest Florida, northeast Florida,586central Florida, southeast Florida, and southwest Florida. 587 (d) Register 10 additional MMTCs before October 3, 2017, 588 including, but not limited to, 1 applicant per occurrence which 589 is a recognized class member of Pigford v. Glickman, 185 F.R.D. 590 82 (D.D.C. 1999), or In re Black Farmers Litig., 856 F. Supp. 2d 591 1 (D.D.C. 2011), and which is a member of the Black Farmers and 592 Agriculturalists Association. All applicants must meet the 593 requirements in this subsection and in subsection (9) and be an 594 entity registered to do business in this state for at least 5 595 consecutive years as of the date of the application. Upon the 596 registration of every additional 25,000 active qualified 597 patients in the compassionate use registry after January 1, 598 2018, the department shall register 4 additional MMTCs. 599 1. An entity may not be issued more than 1 registration. 600 2. The department shall review the number of qualifying 601 patients every 6 months. 602 3. The department may not register more than 1 MMTC for 603 every 10 pharmacies licensed in this state. 604 (e)The department shallDevelop an application form for 605 registration as an MMTC and impose an initial application and 606 biennial renewal fee that is sufficient to cover the costs of 607 administering this section. To be registered as an MMTC, theAn608 applicantfor approval as a dispensing organizationmust be able 609 to demonstrate: 610 1. The technical and technological ability to cultivate and 611 produce marijuanalow-THC cannabis. The applicant must possess a 612 valid certificate of registration issued by the Department of 613 Agriculture and Consumer Services pursuant to s. 581.131that is614issuedfor the cultivation of more than 400,000 plants, be 615 operated by a nurseryman as defined in s. 581.011, and have been 616 operated as a registered nursery in this state for at least 30 617 continuous years. 618 2. The ability to secure the premises, resources, and 619 personnel necessary to operate as an MMTCa dispensing620organization. 621 3. The ability to maintain accountability of all raw 622 materials, finished products, and any byproducts to prevent 623 diversion or unlawful access to or possession of these 624 substances. 625 4. An infrastructure reasonably located to dispense 626 marijuanalow-THC cannabisto registered qualifying patients 627 statewideor regionally as determined by the department. 628 5. The financial ability to maintain operations for the 629 duration of the 2-year approval cycle, including the provision 630 of certified financials to the department. Upon approval, the 631 applicant must post a $5 million performance bond. However, upon 632 an MMTC’sa dispensing organization’sserving at least 1,000 633 qualifyingqualifiedpatients, the dispensing organization is 634onlyrequired to maintain only a $1$2million performance bond, 635 to apply retroactively to all registrations. 636 6. That all owners with a 5 percent or greater share and 637 all managers have been fingerprinted and have successfully 638 passed a level 2 background screening pursuant to s. 435.04. 639 7. The employment of a medical director to supervise the 640 activities of the MMTCdispensing organization. 641(c) Upon the registration of 250,000 active qualified642patients in the compassionate use registry, approve three643dispensing organizations, including, but not limited to, an644applicant that is a recognized class member ofPigford v.645Glickman, 185 F.R.D. 82 (D.D.C. 1999), orIn Re Black Farmers646Litig., 856 F. Supp. 2d 1 (D.D.C. 2011), and a member of the647Black Farmers and Agriculturalists Association, which must meet648the requirements of subparagraphs (b)2.-7. and demonstrate the649technical and technological ability to cultivate and produce650low-THC cannabis.651 (f)(d)Allow an MMTCa dispensing organizationto make a 652 wholesale purchase of marijuanalow-THC cannabis or medical653cannabisfrom, or a distribution of marijuanalow-THC cannabis654or medical cannabisto, another MMTCdispensing organization. 655 (g)(e)Monitor physician registration in the compassionate 656 use registry and the issuance of physician certifications 657 pursuant to subsection (3)and ordering of low-THC cannabis,658medical cannabis, or a cannabis delivery deviceforordering659 practices that could facilitate unlawful diversion or misuse of 660 marijuanalow-THC cannabis, medical cannabis,or a marijuana 661cannabisdelivery device and take disciplinary action as 662 indicated. 663 (h) Create a 30-minute educational program for qualifying 664 patients on the responsible use of marijuana. The program must 665 address the safe consumption of edible marijuana products and 666 keeping the patient’s marijuana from children and unauthorized 667 users. 668 (9)(6)MEDICAL MARIJUANA TREATMENT CENTERSDISPENSING669ORGANIZATION.—In order to be an MMTC, an entity must register 670 with the department. An MMTCAn approved dispensing organization671 must, at all times, maintain compliance withthe criteria672demonstrated for selection and approval as a dispensing673organization under subsection (5) andthe criteria required in 674 this subsection and all representations made to the department 675 in the MMTC’s application for registration. Upon request, the 676 department may grant an MMTC one or more variances from the 677 representations made in the MMTC’s application. Consideration of 678 such a variance shall be based upon the facts and circumstances 679 surrounding the request. A variance may not be granted unless 680 the requesting MMTC can demonstrate to the department that it 681 has a proposed alternative to the specific representation made 682 in its application which fulfills the same or a similar purpose 683 as the specific representation in a way that the department can 684 reasonably determine will not be a lower standard than the 685 specific representation in the application. An MMTC is not 686 required to obtain a variance for deviations from the MMTC’s 687 application for registration which do not materially affect the 688 MMTC’s operations or the quality of the marijuana dispensed by 689 the MMTC or for deviations from the MMTC’s application which are 690 needed to conform to current statutes or rules. 691 (a) When growing marijuanalow-THC cannabis or medical692cannabis, an MMTCa dispensing organization: 693 1. May use pesticides determined by the department, after 694 consultation with the Department of Agriculture and Consumer 695 Services, to be safely applied to plants intended for human 696 consumption, but may not use pesticides designated as 697 restricted-use pesticides pursuant to s. 487.042. 698 2. Must grow marijuanalow-THC cannabis or medical cannabis699 within an enclosed structureand in a room separate from any700other plant. 701 3. Must inspect seeds and growing plants for plant pests 702 that endanger or threaten the horticultural and agricultural 703 interests of the state, notify the Department of Agriculture and 704 Consumer Services within 10 calendar days after a determination 705 that a plant is infested or infected by such plant pest, and 706 implement and maintain phytosanitary policies and procedures. 707 4. Must perform fumigation or treatment of plants, or the 708 removal and destruction of infested or infected plants, in 709 accordance with chapter 581 and any rules adopted thereunder. 710 (b) When processing marijuana, an MMTClow-THC cannabis or711medical cannabis, a dispensing organizationmust: 712 1. Follow health and safety standards established by the 713 department. The department shall require the use of food grade 714 solvents, equipment, and procedures in the processing of 715 marijuana to ensure safe consumption. 716 2. Process the marijuanalow-THC cannabis or medical717cannabiswithin an enclosed structure and in a room separate 718 from other plants or products. 719 3.2.Test the processed marijuanalow-THC cannabis and720medical cannabisbefore it isthey aredispensed. Results must 721 be verified and signed by two MMTCdispensing organization722 employees. Before dispensing marijuanalow-THC cannabis, the 723 MMTCdispensing organizationmust determine that the marijuana 724test results indicate that the low-THC cannabismeets the725definition of low-THC cannabis and, for medical cannabis and726low-THC cannabis, that all medical cannabis and low-THC cannabis727 is safe for human consumptionand free from contaminants that728are unsafe for human consumption. The MMTCdispensing729organizationmust retain records of all testing and samples of 730 each homogenous batch of marijuanacannabis and low-THC cannabis731 for at least 69months. The MMTCdispensing organizationmust 732 contract with an independent testing laboratory to: 733 a. Perform audits on the MMTC’sdispensing organization’s734 standard operating procedures, testing records, and samples and 735 provide the results to the department to confirm that the 736 marijuanalow-THC cannabis or medical cannabismeets the 737 requirements of this section and that the marijuanamedical738cannabis and low-THC cannabisis safe for human consumption; or 739 b. Directly test the marijuana final product to ensure that 740 it meets the requirements of this section and is safe for human 741 consumption before it is dispensed or distributed. 742 4.3.Directly package the marijuanalow-THC cannabis or743medical cannabisin compliance with the United States Poison 744 Prevention Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq. 745 5.4.Package the marijuanalow-THC cannabis or medical746cannabisin an opaque, childproof, and tamper-evidenta747 receptacle that has a firmly affixed and legible label stating 748 the following information: 749 a. A statement that the marijuanalow-THC cannabis or750medical cannabismeets the requirements of subparagraphs 1., 751subparagraph2. and 3.; 752 b. The name of the MMTCdispensing organizationfrom which 753 the marijuanamedical cannabis or low-THC cannabisoriginates 754 and the MMTC’s registration number;and755 c. The batch number and harvest number from which the 756 marijuanamedical cannabis or low-THC cannabisoriginates; 757 d. A universal symbol indicating that marijuana is 758 contained in the package; and 759 e. Warning statements. 760 6.5.Reserve two processed samples from each batch and 761 retain such samples for at least 69months for the purpose of 762 testing pursuant to the audit required under subparagraph 3.2.763 (c) When dispensing marijuanalow-THC cannabis, medical764cannabis,or a marijuanacannabisdelivery device, an MMTCa765dispensing organization: 766 1. May not dispense more than thea 45-daysupply of 767 marijuanalow-THC cannabis or medical cannabisto a qualifying 768 patient or the qualifying patient’s caregiver which is indicated 769 on the qualifying patient’s physician certificationlegal770representative. 771 2. Must ensure thathavethedispensing organization’s772 employee who dispenses the marijuanalow-THC cannabis, medical773cannabis,or a marijuanacannabisdelivery device entersenter774 into the compassionate use registry his or her name or unique 775 employee identifier. 776 3. Must verify that the qualifying patient and the 777 caregiver, if applicable, both have an active and valid 778 compassionate use registry identification card and that the 779 amount and type of marijuana dispensed match the physician’s 780 certification in the compassionate use registry for that 781 qualifying patientthat a physician has ordered the low-THC782cannabis, medical cannabis, or a specific type of a cannabis783delivery device for the patient. 784 4. May not dispense or sell any other type of cannabis, 785 alcohol, or illicit drug-related product, including pipes, 786 bongs, or wrapping papers, other than aphysician-ordered787 marijuanacannabisdelivery device required for the medical use 788 of marijuana which is specified in the physician certification. 789 An MMTC may produce and dispense marijuana as an edible or food 790 product but may not produce such items in a format designed to 791 be attractive to children. In addition to the requirements of 792 this section and department rule, food products produced by an 793 MMTC must meet all food safety standards established in state 794 and federal law, including, but not limited to, the 795 identification of the serving size and the amount of 796 tetrahydrocannabinol in each servinglow-THC cannabis or medical797cannabis, while dispensing low-THC cannabis or medical cannabis. 7985. Must verify that the patient has an active registration799in the compassionate use registry, the patient or patient’s800legal representative holds a valid and active registration card,801the order presented matches the order contents as recorded in802the registry, and the order has not already been filled.803 5.6.Must, upon dispensing the marijuanalow-THC cannabis,804medical cannabis,or marijuanacannabisdelivery device, record 805 in the registry the date, time, quantity, and form of marijuana 806low-THC cannabis or medical cannabisdispensed;andthe type of 807 marijuanacannabisdelivery device dispensed; and the name and 808 compassionate use registry numeric identifier of the qualifying 809 patient or caregiver to whom the marijuana delivery device was 810 dispensed. 811 (d) To ensure the safety and security of its premises and 812 any off-site storage facilities,and to maintain adequate 813 controls against the diversion, theft, and loss of marijuana 814low-THC cannabis, medical cannabis,or marijuanacannabis815 delivery devices, an MMTCa dispensing organizationshall: 816 1.a. Maintain a fully operational security alarm system 817 that secures all entry points and perimeter windows and is 818 equipped with motion detectors; pressure switches; and duress, 819 panic, and hold-up alarms; or 820 b. Maintain a video surveillance system that records 821 continuously 24 hours each day and meets at least one of the 822 following criteria: 823 (I) Cameras are fixed in a place that allows for the clear 824 identification of persons and activities in controlled areas of 825 the premises. Controlled areas include grow rooms, processing 826 rooms, storage rooms, disposal rooms or areas, and point-of-sale 827 rooms; 828 (II) Cameras are fixed in entrances and exits to the 829 premises, which shall record from both indoor and outdoor, or 830 ingress and egress, vantage points; 831 (III) Recorded images must clearly and accurately display 832 the time and date; or 833 (IV) Retain video surveillance recordings for a minimum of 834 45 days or longer upon the request of a law enforcement agency. 835 2. Ensure that the MMTC’sorganization’soutdoor premises 836 have sufficient lighting from dusk until dawn. 837 3. Establish and maintain a tracking system approved by the 838 department whichthattraces the marijuanalow-THC cannabis or839medical cannabisfrom seed to sale. The tracking system must 840shallinclude notification of key events as determined by the 841 department, including when marijuanacannabisseeds are planted, 842 when marijuanacannabisplants are harvested and destroyed, and 843 when marijuanalow-THC cannabis or medical cannabisis 844 transported, sold, stolen, diverted, or lost. 845 4. Not dispense from its premises marijuanalow-THC846cannabis, medical cannabis,or a marijuanacannabisdelivery 847 device between the hours of 9 p.m. and 7 a.m., but may perform 848 all other operations and deliver marijuanalow-THC cannabis and849medical cannabisto qualifyingqualifiedpatients 24 hours each 850 day. 851 5. Store marijuanalow-THC cannabis or medical cannabisin 852 a secured, locked room or a vault. 853 6. Require at least two of its employees, or two employees 854 of a security agency with whom it contracts, to be on the 855 premises of any cultivation or processing facilities at all 856 times. 857 7. Require each employee or contractor to wear a photo 858 identification badge at all times while on the premises. 859 8. Require each visitor to wear a visitor’s pass at all 860 times while on the premises. 861 9. Implement an alcohol and drug-free workplace policy. 862 10. Report to local law enforcement within 24 hours after 863 it is notified or becomes aware of the theft, diversion, or loss 864 of marijuanalow-THC cannabis or medical cannabis. 865 11. Register all MMTC owners and employees with the 866 department. 867 12. Present a floor plan to the department which designates 868 each area of the facility as a “limited access area,” 869 “restricted access area,” or “general access area.” As used in 870 this subparagraph, the term: 871 a. “Limited access area” means the area within an MMTC 872 where marijuana is cultivated, processed, stored, packaged, and 873 sold to other MMTCs. This area is accessible only to employees 874 and visitors escorted by an employee. 875 b. “Restricted access area” means the area within an MMTC 876 where marijuana is sold to qualifying patients and caregivers. 877 This area is accessible only to employees, qualifying patients, 878 and caregivers and to visitors escorted by an employee. 879 Individuals admitted into a restricted access area must provide 880 a photo identification as required by the department. 881 c. “General access area” means the area within an MMTC 882 where marijuana is not grown, cultivated, processed, stored, 883 packaged, processed for sale, or sold. This area is accessible 884 to visitors. 885 (e) To ensure the safe and sanitary transport of marijuana 886low-THC cannabis or medical cannabisto MMTCdispensing887organizationfacilities, independent testing laboratories, or 888 qualifying patients, the MMTCdispensing organizationmust: 889 1. Maintain a transportation manifest, which must be 890 retained for at least 1 year. 891 2. Ensure only vehicles in good working order are used to 892 transport marijuanalow-THC cannabis or medical cannabis. 893 3. Lock marijuanalow-THC cannabis or medical cannabisin a 894 separate compartment or container within the vehicle. 895 4. Require at least two persons to be in a vehicle 896 transporting marijuanalow-THC cannabis or medical cannabis, and 897 require at least one person to remain in the vehicle while the 898 marijuanalow-THC cannabis or medical cannabisis being 899 delivered. 900 5. Ensure that any vehicle transporting marijuana to a 901 qualifying patient or caregiver is legally parked while 902 marijuana is being delivered to the qualifying patient or 903 caregiver. 904 6.5.Provide specific safety and security training to 905 employees transporting or delivering marijuanalow-THC cannabis906or medical cannabis. 907 (10)(7)DEPARTMENT AUTHORITY AND RESPONSIBILITIES.— 908 (a) The department may conduct announced or unannounced 909 inspections of MMTCsdispensing organizationsto determine 910 compliance with this section or rules adopted pursuant to this 911 section. 912 (b) The department shall inspect an MMTCa dispensing913organizationupon complaint or notice provided to the department 914 that the MMTCdispensing organizationhas dispensed marijuana 915low-THC cannabis or medical cannabiscontaining any mold, 916 bacteria, or other contaminant at a level that may cause or has 917 caused an adverse effect to human health or the environment. 918 (c) The department shall conduct at least a biennial 919 inspection of each MMTCdispensing organizationto evaluate the 920 MMTC’sdispensing organization’srecords, personnel, equipment, 921 processes, security measures, sanitation practices, and quality 922 assurance practices. 923 (d) The department shall adopt by rule a process for 924 approving changes in MMTC ownership or a change in an MMTC 925 owner’s investment interest of 5 percent or more. This process 926 must include specific criteria for the approval or denial of an 927 application for change of ownership or a change in investment 928 interest and procedures for screening applicants’ criminal and 929 financial histories. 930 (e) The department may enter into interagency agreements 931 with the Department of Agriculture and Consumer Services, the 932 Department of Business and Professional Regulation, the 933 Department of Law Enforcement, the Department of Transportation, 934 the Department of Highway Safety and Motor Vehicles, and the 935 Agency for Health Care Administration, and such agencies are 936 authorized to enter into an interagency agreement with the 937 department, to conduct inspections or perform other 938 responsibilities assigned to the department under this section. 939 (f)(e)The department must make a list of all approved 940 MMTCs,dispensing organizationsandqualified ordering941 physicians who are qualified to issue physician certifications, 942 and medical directors of MMTCs publicly available on its 943 website. 944(f) The department may establish a system for issuing and945renewing registration cards for patients and their legal946representatives, establish the circumstances under which the947cards may be revoked by or must be returned to the department,948and establish fees to implement such system. The department must949require, at a minimum, the registration cards to:9501. Provide the name, address, and date of birth of the951patient or legal representative.9522. Have a full-face, passport-type, color photograph of the953patient or legal representative taken within the 90 days954immediately preceding registration.9553. Identify whether the cardholder is a patient or legal956representative.9574. List a unique numeric identifier for the patient or958legal representative that is matched to the identifier used for959such person in the department’s compassionate use registry.9605. Provide the expiration date, whichshallbe 1 year after961the date of the physician’s initial order of low-THC cannabis or962medical cannabis.9636. For the legal representative, provide the name and964unique numeric identifier of the patient that the legal965representative is assisting.9667. Be resistant to counterfeiting or tampering.967 (g) The department may impose reasonable fines not to 968 exceed $10,000 on an MMTCa dispensing organizationfor any of 969 the following violations: 970 1. Violating this section, s. 499.0295, or department rule. 971 2. Failing to maintain qualifications registration with the 972 departmentfor approval. 973 3. Endangering the health, safety, or security of a 974 qualifyingqualifiedpatient. 975 4. Improperly disclosing personal and confidential 976 information of a qualifyingthe qualifiedpatient. 977 5. Attempting to procure MMTC registration with the 978 departmentdispensing organization approvalby bribery, 979 fraudulent misrepresentation, or extortion. 980 6. Any owner or manager of the MMTC being convicted or 981 found guilty of, or entering a plea of guilty or nolo contendere 982 to, regardless of adjudication, a crime in any jurisdiction 983 which directly relates to the business of an MMTCa dispensing984organization. 985 7. Making or filing a report or record that the MMTC 986dispensing organizationknows to be false. 987 8. Willfully failing to maintain a record required by this 988 section or department rule. 989 9. Willfully impeding or obstructing an employee or agent 990 of the department in the furtherance of his or her official 991 duties. 992 10. Engaging in fraud or deceit, negligence, incompetence, 993 or misconduct in the business practices of an MMTCa dispensing994organization. 995 11. Making misleading, deceptive, or fraudulent 996 representations in or related to the business practices of an 997 MMTCa dispensing organization. 998 12. Having a license or the authority to engage in any 999 regulated profession, occupation, or business that is related to 1000 the business practices of an MMTCadispensing organization1001 suspended, revoked, or otherwise acted against by the licensing 1002 authority of any jurisdiction, including its agencies or 1003 subdivisions, for a violation that would constitute a violation 1004 under Florida law. 1005 13. Violating a lawful order of the department or an agency 1006 of the state, or failing to comply with a lawfully issued 1007 subpoena of the department or an agency of the state. 1008 (h) The department may suspend, revoke, or refuse to renew 1009 an MMTC’s registration with the departmenta dispensing1010organization’sapprovalif the MMTCa dispensing organization1011 commits repeated violations specifiedany of the violationsin 1012 paragraph (g) which remain uncured after 30 days’ notice from 1013 the department. The department may not suspend, revoke, or 1014 refuse to renew an MMTC’s registration due to an uncured 1015 violation if the MMTC begins taking action to cure the violation 1016 within 30 days after receiving a notice of the violation from 1017 the department and such action is pursuant to a corrective 1018 action plan filed by the MMTC with the department or if the MMTC 1019 takes reasonable steps to ensure that a future violation of a 1020 similar nature does not occur. 1021 (i) The department shall renew an MMTC’s registration with 1022 the departmentthe approval ofa dispensing organization1023 biennially if the MMTCdispensing organizationmeets the 1024 requirements of this section and pays the biennial renewal fee. 1025 (j) The department may adopt rules necessary to implement 1026 this section pursuant to s. 120.536(1) or s. 120.54. The 1027 department may use emergency rulemaking procedures pursuant to 1028 s. 120.54(4) to adopt rules under this section if necessary to 1029 meet any deadline for rulemaking established in s. 29, Art. X of 1030 the State Constitution. 1031 (k) The department may adopt rules authorizing an MMTC to 1032 have specified employees administer marijuana. Marijuana may be 1033 administered only at an MMTC that is registered with the 1034 department as an administration facility. 1035 (11)(8)PREEMPTION.— 1036 (a) All matters regarding the regulation of the cultivation 1037 and processing of marijuanamedical cannabis or low-THC cannabis1038 by MMTCsdispensing organizationsare preempted to the state. 1039 (b) A municipality may determine by ordinance the criteria 1040 for the number and location of, and other permitting 1041 requirements that do not conflict with state law or department 1042 rule for, dispensing facilities of MMTCsdispensing1043organizationslocated within its municipal boundaries. A county 1044 may determine by ordinance the criteria for the number, 1045 location, and other permitting requirements that do not conflict 1046 with state law or department rule for all dispensing facilities 1047 of MMTCsdispensing organizationslocated within the 1048 unincorporated areas of that county. This section does not 1049 preempt any law or ordinance of any county or municipality which 1050 imposes restrictions on the location of an MMTC if the law or 1051 ordinance does not unreasonably interfere with the availability 1052 of marijuana to qualifying patients. 1053 (12)(9)EXCEPTIONS TO OTHER LAWS.— 1054 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 1055 any other provision of law, but subject to the requirements of 1056 this section, a qualifyingqualifiedpatient, or a caregiver who 1057 has obtained a valid compassionate use registry identification 1058 card from the department,and the qualified patient’s legal1059representativemay purchase from an MMTC and possess for the 1060 qualifying patient’s medical use, up to the amount of marijuana 1061 in the physician certificationlow-THC cannabis or medical1062cannabis ordered for the patient, but not more than a 90-day451063daysupply, except as provided in (3)(e), and a marijuana 1064cannabisdelivery device specified in the physician 1065 certificationorderedfor the qualifying patient. 1066 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 1067 any other provision of law, but subject to the requirements of 1068 this section, an MMTCan approveddispensingorganizationand 1069 its owners, managers, contractors, and employees may 1070 manufacture, possess, sell, deliver, distribute, dispense, and 1071 lawfully dispose of reasonable quantities, as established by 1072 department rule, of marijuanalow-THC cannabis,medical1073cannabis,or a marijuanacannabisdelivery device. As used in 1074For purposes ofthis subsection, the terms “manufacture,” 1075 “possession,” “deliver,” “distribute,” and “dispense” have the 1076 same meanings as provided in s. 893.02. 1077 (c) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 1078 any other provision of law, but subject to the requirements of 1079 this section, an approved independent testing laboratory may 1080 possess, test, transport, and lawfully dispose of marijuanalow1081THC cannabis ormedical cannabisas provided by department rule. 1082 (d) An MMTCapproveddispensing organizationand its 1083 owners, managers, contractors, and employees are not subject to 1084 licensure or regulation under chapter 465 or chapter 499 for 1085 manufacturing, possessing, selling, delivering, distributing, 1086 dispensing, or lawfully disposing of reasonable quantities, as 1087 established by department rule, of marijuanalow-THC cannabis,1088medical cannabis,or a marijuanacannabisdelivery device. 1089 (e) Exercise by an MMTC ofAn approveddispensing1090organizationthat continues to meet the requirements for1091approvalis presumed to be registered with the department and to1092meet the regulations adopted by the department or its successor1093agency for the purpose of dispensingmedical cannabisor low-THC1094cannabis under Florida law. Additionally,the authority provided 1095 to a dispensing organization in s. 499.0295 does not impair its 1096 registration with the departmenttheapprovalof adispensing1097organization. 1098 (f) This subsection does not exempt a person from 1099 prosecution for a criminal offense related to impairment or 1100 intoxication resulting from the medical use of marijuanalow-THC1101cannabis ormedical cannabisor relieve a person from any 1102 requirement under law to submit to a breath, blood, urine, or 1103 other test to detect the presence of a controlled substance. 1104 (g) This section does not affect or repeal laws relating to 1105 negligence or professional malpractice on the part of a 1106 caregiver, a physician, or an MMTC or its agents and employees. 1107 However, a physician who issues a physician certification and 1108 who fully complies with the requirements of this section is 1109 immune from liability in civil actions and claims for medical 1110 malpractice. 1111 (h) This section does not require a health insurance 1112 provider or a governmental agency or authority to reimburse a 1113 person for expenses related to the use of marijuana. 1114 (i) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 1115 any other provision of law, but subject to the requirements of 1116 this section, a research institute established by a public 1117 postsecondary educational institution, such as the H. Lee 1118 Moffitt Cancer Center and Research Institute established in s. 1119 1004.43, or a state university that has achieved the preeminent 1120 state research university designation pursuant to s. 1001.7065, 1121 may possess, test, transport, and lawfully dispose of marijuana 1122 for research purposes as provided by department rule. 1123 (13) PROHIBITED ACTIVITIES.— 1124 (a) A person or entity may not offer or advertise services 1125 as an MMTC without registering as an MMTC with the department. 1126 An MMTC may not advertise or hold out to the public that it 1127 holds a registration for other than that for which it actually 1128 holds the registration. 1129 (b) The ownership, operation, or maintenance of an 1130 unauthorized dispensing organization or entity or the 1131 performance of a service that requires registration without 1132 proper registration is a violation of this section. The 1133 department or any state attorney may, in addition to other 1134 remedies provided in this section, bring an action for an 1135 injunction to restrain any unauthorized activity or to enjoin 1136 the future operation or maintenance of the unauthorized 1137 dispensing organization or entity or the performance of any 1138 service in violation of this section, until compliance with this 1139 section and department rules has been demonstrated to the 1140 satisfaction of the department. 1141 (c) If after receiving notification from the department, 1142 such person, organization, or entity fails to cease operation, 1143 the person, organization, or entity is subject to penalties as 1144 prescribed by this section. Each day of continued operation is a 1145 separate offense. 1146 (14) IMPORTATION AND EXPORTATION OF MARIJUANA.— 1147 (a) Marijuana may not be imported from outside this state. 1148 (b) Marijuana and products containing marijuana which are 1149 cultivated and produced in accordance with this section may be 1150 exported as authorized by federal law and the laws of the states 1151 or countries to which they are exported. 1152 (15) SEVERABILITY CLAUSE.—If any provision of this section 1153 or its application to any person or circumstance is held 1154 invalid, the invalidity does not affect other provisions or 1155 applications of this section which can be given effect without 1156 the invalid provision or application, and to this end the 1157 provisions of this section are severable. 1158 Section 2. Subsections (1) and (2) of section 381.987, 1159 Florida Statutes, are amended, and paragraphs (b) and (c) of 1160 subsection (3) of that section are amended, to read: 1161 381.987 Public records exemption for personal identifying 1162 information in the compassionate use registry.— 1163 (1) A patient’s personal identifying information held by 1164 the department in the compassionate use registry established 1165 under s. 381.986, including, but not limited to, the patient’s 1166 name, address, telephone number, and government-issued 1167 identification number, and all information pertaining to the 1168 physician certificationphysician’s orderfor marijuanalow-THC1169cannabisand the dispensing thereof are confidential and exempt 1170 from s. 119.07(1) and s. 24(a), Art. I of the State 1171 Constitution. 1172 (2) A physician’s identifying information held by the 1173 department in the compassionate use registry established under 1174 s. 381.986, including, but not limited to, the physician’s name, 1175 address, telephone number, government-issued identification 1176 number, and Drug Enforcement Administration number, and all 1177 information pertaining to the physician certification 1178physician’s orderfor marijuanalow-THCcannabisand the 1179 dispensing thereof are confidential and exempt from s. 119.07(1) 1180 and s. 24(a), Art. I of the State Constitution. 1181 (3) The department shall allow access to the registry, 1182 including access to confidential and exempt information, to: 1183 (b) A medical marijuana treatment centerdispensing1184organizationapproved by the department pursuant to s. 381.986 1185 which is attempting to verify the authenticity of a physician 1186 certificationphysician’sorderfor marijuanalow-THC cannabis, 1187 including whether the physician certification order had been 1188 previously filled and whether the physician certification order 1189 was written for the person attempting to have it filled. 1190 (c) A physician who has issued a physician certification 1191written an orderfor marijuanalow-THCcannabisfor the purpose 1192 of monitoring the patient’s use of such cannabis or for the 1193 purpose of determining, before issuing an order for marijuana 1194low-THCcannabis, whether another physician has ordered the 1195 patient’s use of marijuanalow-THCcannabis. The physician may 1196 access the confidential and exempt information only for the 1197 patient for whom he or she has ordered or is determining whether 1198 to order the use of marijuanalow-THCcannabispursuant to s. 1199 381.986. 1200 Section 3. Subsection (1) of section 385.211, Florida 1201 Statutes, is amended to read: 1202 385.211 Refractory and intractable epilepsy treatment and 1203 research at recognized medical centers.— 1204 (1) As used in this section, the term “low-THC cannabis” 1205 means “low-THC cannabis” as defined in s. 381.986 whichthatis 1206 dispensed only from a medical marijuana treatment center 1207dispensing organizationas defined in s. 381.986. 1208 Section 4. Subsections (2) and (3) of section 499.0295, 1209 Florida Statutes, are amended to read: 1210 499.0295 Experimental treatments for terminal conditions.— 1211 (2) As used in this section, the term: 1212(a) “Dispensing organization” means an organization1213approved by the Department of Health under s. 381.986(5) to1214cultivate, process, transport, and dispense low-THC cannabis,1215medical cannabis, and cannabis delivery devices.1216 (a)(b)“Eligible patient” means a person who: 1217 1. Has a terminal condition that is attested to by the 1218 patient’s physician and confirmed by a second independent 1219 evaluation by a board-certified physician in an appropriate 1220 specialty for that condition; 1221 2. Has considered all other treatment options for the 1222 terminal condition currently approved by the United States Food 1223 and Drug Administration; 1224 3. Has given written informed consent for the use of an 1225 investigational drug, biological product, or device; and 1226 4. Has documentation from his or her treating physician 1227 that the patient meets the requirements of this paragraph. 1228 (b)(c)“Investigational drug, biological product, or 1229 device” means:12301.a drug, biological product, or device that has 1231 successfully completed phase 1 of a clinical trial but has not 1232 been approved for general use by the United States Food and Drug 1233 Administration and remains under investigation in a clinical 1234 trial approved by the United States Food and Drug 1235 Administration; or12362. Medical cannabis that is manufactured and sold by a1237dispensing organization. 1238 (c)(d)“Terminal condition” means a progressive disease or 1239 medical or surgical condition that causes significant functional 1240 impairment, is not considered by a treating physician to be 1241 reversible even with the administration of available treatment 1242 options currently approved by the United States Food and Drug 1243 Administration, and, without the administration of life 1244 sustaining procedures, will result in death within 1 year after 1245 diagnosis if the condition runs its normal course. 1246 (d)(e)“Written informed consent” means a document that is 1247 signed by a patient, a parent of a minor patient, a court 1248 appointed guardian for a patient, or a health care surrogate 1249 designated by a patient and includes: 1250 1. An explanation of the currently approved products and 1251 treatments for the patient’s terminal condition. 1252 2. An attestation that the patient concurs with his or her 1253 physician in believing that all currently approved products and 1254 treatments are unlikely to prolong the patient’s life. 1255 3. Identification of the specific investigational drug, 1256 biological product, or device that the patient is seeking to 1257 use. 1258 4. A realistic description of the most likely outcomes of 1259 using the investigational drug, biological product, or device. 1260 The description shall include the possibility that new, 1261 unanticipated, different, or worse symptoms might result and 1262 death could be hastened by the proposed treatment. The 1263 description shall be based on the physician’s knowledge of the 1264 proposed treatment for the patient’s terminal condition. 1265 5. A statement that the patient’s health plan or third 1266 party administrator and physician are not obligated to pay for 1267 care or treatment consequent to the use of the investigational 1268 drug, biological product, or device unless required to do so by 1269 law or contract. 1270 6. A statement that the patient’s eligibility for hospice 1271 care may be withdrawn if the patient begins treatment with the 1272 investigational drug, biological product, or device and that 1273 hospice care may be reinstated if the treatment ends and the 1274 patient meets hospice eligibility requirements. 1275 7. A statement that the patient understands he or she is 1276 liable for all expenses consequent to the use of the 1277 investigational drug, biological product, or device and that 1278 liability extends to the patient’s estate, unless a contract 1279 between the patient and the manufacturer of the investigational 1280 drug, biological product, or device states otherwise. 1281 (3) Upon the request of an eligible patient, a manufacturer 1282 may, or, upon the issuance of a physician certificationa1283physician’s orderpursuant to s. 381.986, an MMTCadispensing1284organizationmay: 1285 (a) Make its investigational drug, biological product, or 1286 device available under this section. 1287 (b) Provide an investigational drug, biological product, 1288 device, or cannabis delivery device as defined in s. 381.986 to 1289 an eligible patient without receiving compensation. 1290 (c) Require an eligible patient to pay the costs of, or the 1291 costs associated with, the manufacture of the investigational 1292 drug, biological product, device, or cannabis delivery device as 1293 defined in s. 381.986. 1294 Section 5. Subsection (1) of section 1004.441, Florida 1295 Statutes, is amended to read: 1296 1004.441 Refractory and intractable epilepsy treatment and 1297 research.— 1298 (1) As used in this section, the term “low-THC cannabis” 1299 means “low-THC cannabis” as defined in s. 381.986 whichthatis 1300 dispensed only from a medical marijuana treatment center 1301dispensing organizationas defined in s. 381.986. 1302 Section 6. The Division of Law Revision and Information is 1303 directed to replace the phrase “the effective date of this act” 1304 wherever it occurs in this act with the date the act becomes a 1305 law. 1306 Section 7. This act shall take effect upon becoming a law.