Bill Text: FL S1758 | 2017 | Regular Session | Introduced
Bill Title: Medical Use of Marijuana
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2017-04-26 - Withdrawn from further consideration [S1758 Detail]
Download: Florida-2017-S1758-Introduced.html
Florida Senate - 2017 SB 1758 By Senator Grimsley 26-00705C-17 20171758__ 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 that a prior 13 order issued for low-THC cannabis or medical cannabis 14 is considered a physician certification under certain 15 circumstances; providing requirements for such orders; 16 revising criminal penalties; reducing the number of 17 hours of coursework required of physicians who issue 18 physician certifications; providing that physicians 19 who meet specified requirements are grandfathered for 20 the purpose of specified education requirements; 21 authorizing qualifying patients to designate 22 caregivers; requiring caregivers to meet specified 23 requirements; prohibiting a qualifying patient from 24 designating more than one caregiver at any given time; 25 providing exceptions; requiring the Department of 26 Health to register on the compassionate use registry a 27 caregiver and to issue him or her a caregiver 28 identification card if the caregiver meets certain 29 requirements; revising the list of entities that have 30 access to the compassionate use registry; requiring 31 the department to adopt rules by a specified date; 32 authorizing the department to charge a fee for 33 identification cards; requiring the department to 34 begin issuing identification cards to qualified 35 registrants by a specific date; providing requirements 36 for the identification cards; requiring the department 37 to register certain dispensing organizations as 38 medical marijuana treatment centers (MMTCs) by a 39 certain date; requiring the department to register 40 additional MMTCs in accordance with a specified 41 schedule; providing an exception to certain 42 registration requirements for certain applicants; 43 authorizing certain performance bonds to be used only 44 for reimbursement to the department for damages 45 incurred as a result of the MMTC’s failure to meet 46 certain requirements or department rules; deleting 47 obsolete provisions; revising the operational 48 requirements for MMTCs; authorizing the department to 49 waive certain requirements in the MMTC registration 50 application under specified circumstances; providing 51 requirements for MMTCs to grow, process, and dispense 52 marijuana; providing a contract option that requires 53 an independent testing laboratory to directly test an 54 MMTC’s marijuana final product; requiring that 55 marijuana receptacles be childproof; reducing the time 56 that samples are required to be retained; requiring 57 verification of patient and caregiver identification 58 cards, rather than registration cards, and amount and 59 type of marijuana before dispensing; requiring MMTC 60 compliance with certain standards in the production 61 and dispensing of edibles or food products; requiring 62 an MMTC to enter additional information into the 63 compassionate use registry; providing requirements to 64 ensure the safety and security of premises and 65 facilities of MMTCs, rather than dispensing 66 organizations, and the safe transport of marijuana; 67 requiring a vehicle transporting marijuana to be 68 legally parked under certain circumstances; revising 69 the department authority and responsibilities; 70 requiring the department to adopt rules relating to 71 ownership changes or changes in an owner’s investment 72 interest; authorizing the department to suspend, 73 revoke, or refuse to renew an MMTC’s registration if 74 the MMTC commits repeated violations that remain 75 uncured within a specified time limit; authorizing 76 emergency rulemaking procedures under certain 77 circumstances; prohibiting a municipality or county 78 from banning dispensing facilities; conforming 79 provisions to changes made by the act; providing 80 construction; authorizing certain institutes or state 81 universities to possess, test, transport, or dispose 82 of marijuana for research purposes; prohibiting a 83 person from offering or advertising services, and from 84 owning, operating, and maintaining certain facilities, 85 without registration; providing penalties including an 86 administrative fine imposed under certain 87 circumstances; prohibiting importation of marijuana; 88 authorizing exportation of marijuana and products 89 containing marijuana under certain circumstances; 90 amending ss. 381.987, 385.211, 499.0295, and 1004.441, 91 F.S.; conforming provisions to changes made by the 92 act; providing a directive to the Division of Law 93 Revision and Information; providing an effective date. 94 95 Be It Enacted by the Legislature of the State of Florida: 96 97 Section 1. Section 381.986, Florida Statutes, is amended to 98 read: 99 381.986 Compassionate use of marijuanalow-THC and medical100cannabis.— 101 (1) LEGISLATIVE INTENT.— 102 (a) It is the intent of the Legislature to implement s. 29, 103 Art. X of the State Constitution by creating a unified 104 regulatory structure within the framework of this section for 105 the acquisition, cultivation, possession, processing, transfer, 106 transportation, sale, distribution, and dispensing of marijuana, 107 products containing marijuana, related supplies, or educational 108 materials to qualifying patients or their caregivers. 109 (b) The Legislature intends that all rules adopted by the 110 Department of Health to implement this section be adopted 111 pursuant to s. 120.536(1) or s. 120.54. The Legislature intends 112 that the department use emergency rulemaking procedures pursuant 113 to s. 120.54(4) to adopt rules under this section if necessary 114 to meet any deadline for rulemaking established in s. 29, Art. X 115 of the State Constitution. 116 (c) Further, the Legislature intends that all registrations 117 for the purposes specified in paragraph (a) be issued solely in 118 accordance with the requirements of this section and all rules 119 adopted under this section. 120 (2) DEFINITIONS.—As used in this section, the term: 121 (a) “Caregiver” means a person who: 122 1. Is at least 21 years of age unless he or she is a close 123 relative of the qualifying patient; 124 2. Has agreed in writing to assist the qualifying patient 125 with the qualifying patient’s medical use of marijuana; and 126 3. Does not receive compensation, other than actual 127 expenses incurred, for assisting the qualifying patient with the 128 medical use of marijuana unless the caregiver is acting pursuant 129 to employment in a licensed facility“Cannabis delivery device”130means an object used, intended for use, or designed for use in131preparing, storing, ingesting, inhaling, or otherwise132introducing low-THC cannabis or medical cannabis into the human133body. 134 (b) “Close relative” means a spouse, parent, sibling, 135 grandparent, child, or grandchild, whether related by whole or 136 half blood, by marriage, or by adoption. 137 (c)(b)“Debilitating medical condition” means cancer, 138 epilepsy, glaucoma, a positive status for human immunodeficiency 139 virus, acquired immune deficiency syndrome, posttraumatic stress 140 disorder, amyotrophic lateral sclerosis, Crohn’s disease, 141 Parkinson’s disease, multiple sclerosis, a physical medical 142 condition that chronically produces symptoms of seizures or 143 severe and persistent muscle spasms, a terminal condition, or 144 other debilitating medical conditions of the same kind or class 145 as, or comparable to, those conditions enumerated in this 146 paragraph and for which a physician believes that the use of 147 marijuana would likely outweigh the potential health risks to a 148 patient“Dispensing organization” means an organization approved149by the department to cultivate, process, transport, and dispense150low-THC cannabis or medical cannabis pursuant to this section. 151 (d)(c)“Independent testing laboratory” means a laboratory, 152 including the managers, employees, or contractors of the 153 laboratory:,154 1. Which has no direct or indirect interest in a medical 155 marijuana treatment center; and 156 2. In which no medical marijuana treatment center has any 157 direct or indirect interestdispensing organization. 158 (e)(d)“Legal representative” means the qualifying 159qualifiedpatient’s parent, legal guardian acting pursuant to a 160 court’s authorization as required under s. 744.3215(4), health 161 care surrogate acting pursuant to the qualifyingqualified162 patient’s written consent or a court’s authorization as required 163 under s. 765.113, or an individual who is authorized under a 164 power of attorney to make health care decisions on behalf of the 165 qualifyingqualifiedpatient. 166 (f)(e)“Low-THC cannabis” means a plant of the genus 167 Cannabis, the dried flowers of which contain 0.8 percent or less 168 of tetrahydrocannabinol and more than 10 percent of cannabidiol 169 weight for weight; the seeds thereof; the resin extracted from 170 any part of such plant; or any compound, manufacture, salt, 171 derivative, mixture, or preparation of such plant or its seeds 172 or resin that is dispensed only by a medical marijuana treatment 173 centerfrom a dispensing organization. 174 (g)(f)“Marijuana” has the same meaning as provided in s. 175 29, Art. X of the State Constitution“Medical cannabis” means176all parts of any plant of the genusCannabis, whether growing or177not; the seeds thereof; the resin extracted from any part of the178plant; and every compound, manufacture, sale, derivative,179mixture, or preparation of the plant or its seeds or resin that180is dispensed only from a dispensing organization for medical use181by an eligible patient as defined in s. 499.0295. 182 (h) “Marijuana delivery device” means an object used, 183 intended for use, or designed for use in preparing, storing, 184 ingesting, inhaling, or otherwise introducing marijuana or low 185 THC cannabis into the human body. 186 (i) “Medical marijuana treatment center” or “MMTC” has the 187 same meaning as provided in s. 29, Art. X of the State 188 Constitution. 189 (j)(g)“Medical use” has the same meaning as provided in s. 190 29, Art. X of the State Constitutionmeans administration of the191ordered amount of low-THC cannabis or medical cannabis. The term 192 does not includethe: 193 1. Thepossession,use,or administration of marijuanalow194THC cannabis or medical cannabisby smoking. As used in this 195 subparagraph, the term “smoking” means burning or igniting a 196 substance and inhaling the smoke. Smoking does not include the 197 use of a vaporizer. 198 2. The possession, use, or administration of marijuana that 199 is not purchased or acquired from a medical marijuana treatment 200 center. 201 3. The transfer of marijuanalow-THC cannabis or medical202cannabisto a person other than the qualifyingqualifiedpatient 203for whom it was orderedor the qualifyingqualifiedpatient’s 204 caregiverlegal representativeon behalf of the qualifying 205qualifiedpatient. 206 4.3.The use or administration of marijuanalow-THC207cannabis or medical cannabis: 208 a. On any form of public transportation. 209 b. In any public place. 210 c. In a qualifyingqualifiedpatient’s place of employment, 211 if restricted by his or her employer. 212 d. In a state correctional institution as defined in s. 213 944.02 or a correctional institution as defined in s. 944.241. 214 e. On the grounds of a preschool, primary school, or 215 secondary school. 216 f. On a school bus or in a vehicle, aircraft, or motorboat. 217 (k)(h)“Qualifying patient” has the same meaning as 218 provided in s. 29, Art. X of the State Constitution. The term 219 also includes eligible patients, as defined in s. 499.0295, and 220 patients who are issued a physician certification under 221 subsection (3). A patient is not a qualifying patient unless he 222 or she is registered with the department and has been issued a 223“Qualified patient”means a resident of this state who has been224added to thecompassionate use registry identification cardby a225physician licensed under chapter 458 or chapter 459 to receive226low-THC cannabis or medical cannabis from a dispensing227organization. 228(i) “Smoking” means burning or igniting a substance and229inhaling the smoke. Smoking does not include the use of a230vaporizer.231 (3)(2)PHYSICIAN CERTIFICATIONORDERING.—A physician is 232 authorized to issue a physician certification for the provision 233 of marijuana and marijuana delivery devicesorder low-THC234cannabisto treat a qualified patient suffering from cancer or a235physical medical condition that chronically produces symptoms of236seizures or severe and persistent muscle spasms; order low-THC237cannabis to alleviate symptoms of such disease, disorder, or238condition, if no other satisfactory alternative treatment239options exist for the qualified patient; order medical cannabis240 to treat a qualifyingan eligiblepatientas defined in s.241499.0295; or order a cannabis delivery device for the medical242use of low-THC cannabis or medical cannabis,only if the 243 physician: 244 (a) Holds an active, unrestricted license as a physician 245 under chapter 458 or an osteopathic physician under chapter 459; 246 (b)Has treated the patient for at least 3 months247immediately preceding the patient’s registration in the248compassionate use registry;249(c)Has successfully completed the course and examination 250 required under paragraph (6)(a)(4)(a); 251 (c) Has conducted a physical examination and made a full 252 assessment of the medical history of the patient; 253 (d) Has determined that the medical use of marijuana would 254 likely outweigh the potential health risksof treating the255patient with low-THC cannabis or medical cannabis are reasonable256in light of the potential benefitto the patient. If a patient257is younger than 18 years of age, a second physician must concur258with this determination, and such determination must be259documented in the patient’s medical record; 260 (e) Registers as the patient’s physicianorderer of low-THC261cannabis or medical cannabis for the named patienton the 262 compassionate use registry maintained by the department and 263 updates the registry to reflectthe contents of the order,264includingthe amount of marijuana whichlow-THC cannabis or265medical cannabisthatwill provide the patient with not more 266 than a 45-day supply and any marijuanaacannabisdelivery 267 device needed by the patient for the medical use of marijuana 268low-THC cannabis or medical cannabis. A physician may certify an 269 amount greater than a 45-day supply of marijuana if the 270 physician has a reasonable belief that the patient will use the 271 additional marijuana in a medically appropriate way. The 272 physician mustalsoupdate the registry within 7 days after any 273 change is made to the physician certificationoriginalorder to 274 reflect the change. The physician shall deactivate the 275 registration of the patientand the patient’s legal276representativewhen the physician no longer recommends the 277 medical use of marijuana for the patienttreatment is278discontinued; 279 (f) At least annually, recertifies the qualifying patient 280 pursuant to this subsectionMaintains a patient treatment plan281that includes the dose, route of administration, planned282duration, and monitoring of the patient’s symptoms and other283indicators of tolerance or reaction to the low-THC cannabis or284medical cannabis; and 285(g) Submits the patient treatment plan quarterly to the286University of Florida College of Pharmacy for research on the287safety and efficacy of low-THC cannabis and medical cannabis on288patients;289(h) Obtains the voluntary written informed consent of the290patient or the patient’s legal representative to treatment with291low-THC cannabis after sufficiently explaining the current state292of knowledge in the medical community of the effectiveness of293treatment of the patient’s condition with low-THC cannabis, the294medically acceptable alternatives, and the potential risks and295side effects;296(i) Obtains written informed consent as defined in and297required under s. 499.0295, if the physician is ordering medical298cannabis for an eligible patient pursuant to that section; and299 (g)(j)Is not a medical director employed by an MMTCa300dispensing organization. 301 (4)(3)GRANDFATHERING.—An order for low-THC cannabis or 302 medical cannabis issued pursuant to former s. 381.986, Florida 303 Statutes 2016, and registered with the compassionate use 304 registry on or before the effective date of this act shall be 305 considered a physician certification issued pursuant to this 306 section. The details and expiration date of such certification 307 must be identical to the details and expiration date of the 308 order as logged in the compassionate use registry. Until the 309 department begins issuing compassionate use registry 310 identification cards, all patients with such orders shall be 311 considered qualifying patients, notwithstanding the requirement 312 that a qualifying patient have a compassionate use registry 313 identification card. 314 (5) PENALTIES.— 315 (a) A physician commits a misdemeanor of the first degree, 316 punishable as provided in s. 775.082 or s. 775.083, if the 317 physician issues a physician certification for marijuana to 318orders low-THC cannabis fora patient without a reasonable 319 belief that the patient is suffering from a debilitating medical 320 condition:3211. Cancer or a physical medical condition that chronically322produces symptoms of seizures or severe and persistent muscle323spasms that can be treated with low-THC cannabis; or3242. Symptoms of cancer or a physical medical condition that325chronically produces symptoms of seizures or severe and326persistent muscle spasms that can be alleviated with low-THC327cannabis. 328 (b)A physician commits a misdemeanor of the first degree,329punishable as provided in s. 775.082 or s. 775.083, if the330physician orders medical cannabis for a patient without a331reasonable belief that the patient has a terminal condition as332defined in s. 499.0295.333(c)A person who fraudulently represents that he or she has 334 a debilitatingcancer, a physicalmedical conditionthat335chronically produces symptoms of seizures or severe and336persistent muscle spasms, or a terminal conditionto a physician 337 for the purpose of being issued a physician certification for 338 marijuanaordered low-THC cannabis, medical cannabis,or a 339 marijuanacannabisdelivery device by such physician commits a 340 misdemeanor of the first degree, punishable as provided in s. 341 775.082 or s. 775.083. 342 (c)(d)A qualifyingAn eligiblepatientas defined in s.343499.0295who uses marijuanamedical cannabis, and such patient’s 344 caregiverlegal representativewho administers marijuanamedical345cannabis, in plain view of or in a place open to the general 346 public, on the grounds of a place of educationschool, or in an 347 aircraft, a motorboat, a school bus, a train, or a vehicle,348aircraft, or motorboat,commits a misdemeanor of the first 349 degree, punishable as provided in s. 775.082 or s. 775.083. 350 (d) Except as provided in paragraph (c), a caregiver who 351 violates any provision of this section or applicable department 352 rule commits, upon the first offense, a misdemeanor of the 353 second degree, punishable as provided in s. 775.082 or s. 354 775.083, and, upon the second and subsequent offenses, a 355 misdemeanor of the first degree, punishable as provided in s. 356 775.082 or s. 775.083. 357 (e) A physician who issues a physician certification for 358 marijuanaorders low-THC cannabis, medical cannabis,or a 359 marijuanacannabisdelivery device and receives compensation 360 from an MMTCa dispensing organizationrelated to issuing the 361 physician certification for marijuanathe ordering of low-THC362cannabis, medical cannabis,or a marijuanacannabisdelivery 363 device is subject to disciplinary action under the applicable 364 practice act and s. 456.072(1)(n). 365 (6)(4)PHYSICIAN EDUCATION.— 366 (a) Before a physician may issue a physician certification 367 pursuant to subsection (3)ordering low-THC cannabis, medical368cannabis, or a cannabis delivery device for medical use by a369patient in this state, the appropriate board shall require the 370 ordering physician to successfully complete a 4-houran 8-hour371 course and subsequent examination offered by the Florida Medical 372 Association or the Florida Osteopathic Medical Association which 373thatencompasses the clinical indications for the appropriate 374 use of marijuanalow-THC cannabis and medical cannabis, the 375 appropriate marijuanacannabisdelivery devices, the 376 contraindications for such use, and the relevant state and 377 federal laws governing the issuance of physician certifications, 378 as well as theordering,dispensing,and possessing of these 379 substances and devices. The course and examination shall be 380 administered at least quarterlyannually. Successful completion 381 of the course may be used by a physician to satisfy 4 hours8382hoursof the continuing medical educationrequirementsrequired 383 by his or her respective board for licensure renewal. This 384 course may be offered in a distance learning format. A physician 385 who has completed an 8-hour course and subsequent examination 386 offered by the Florida Medical Association or the Florida 387 Osteopathic Medical Association which encompasses the clinical 388 indications for the appropriate use of marijuana and who is 389 registered in the compassionate use registry on the effective 390 date of this act is deemed to meet the requirements of this 391 paragraph. 392 (b) The appropriate board shall require the medical 393 director of each MMTCdispensing organizationto hold an active, 394 unrestricted license as a physician under chapter 458 or as an 395 osteopathic physician under chapter 459 and successfully 396 complete a 2-hour course and subsequent examination offered by 397 the Florida Medical Association or the Florida Osteopathic 398 Medical Association whichthatencompasses appropriate safety 399 procedures and knowledge of marijuanalow-THC cannabis, medical400cannabis,and marijuanacannabisdelivery devices. 401 (c)Successful completion of the course and examination402specified in paragraph (a) is required for every physician who403orders low-THC cannabis, medical cannabis, or a cannabis404delivery device each time such physician renews his or her405license. In addition, successful completion of the course and406examination specified in paragraph (b) is required for the407medical director of each dispensing organization each time such408physician renews his or her license.409(d)A physician who fails to comply with this subsection 410 and who issues a physician certification for marijuanaorders411low-THC cannabis, medical cannabis,or a marijuanacannabis412 delivery device may be subject to disciplinary action under the 413 applicable practice act and under s. 456.072(1)(k). 414 (7) CAREGIVERS.— 415 (a) During the course of registration with the department 416 for inclusion on the compassionate use registry, or at any time 417 while registered, a qualifying patient may designate an 418 individual as his or her caregiver to assist him or her with the 419 medical use of marijuana. The designated caregiver must pass a 420 level 2 screening pursuant to chapter 435 unless the patient is 421 a close relative of the caregiver. 422 (b) A qualifying patient may have only one designated 423 caregiver at any given time unless all of the qualifying 424 patient’s caregivers are his or her close relatives or legal 425 representatives. 426 (c) A caregiver may assist only one qualifying patient at 427 any given time unless: 428 1. All qualifying patients the caregiver is assisting are 429 close relatives of each other and the caregiver is the legal 430 representative of at least one of the patients; or 431 2. All qualifying patients the caregiver is assisting are 432 receiving hospice services, or are residents in the same 433 assisted living facility, nursing home, or other licensed 434 facility and have requested the assistance of that caregiver 435 with the medical use of marijuana; the caregiver is an employee 436 of the hospice or licensed facility; and the caregiver provides 437 personal care or services directly to clients of the hospice or 438 licensed facility as a part of his or her employment duties at 439 the hospice or licensed facility. 440 (d) The department must register a caregiver on the 441 compassionate use registry and issue him or her a caregiver 442 identification card if he or she: 443 1. Is designated by a qualifying patient, provides hospice 444 services to a qualifying patient, or is requested by a 445 qualifying patient in a licensed facility for assistance with 446 the medical use of marijuana; and 447 2. Meets all of the requirements of this subsection and 448 department rules. 449 (8)(5)DUTIES OF THE DEPARTMENT.—The department shall: 450 (a) Create and maintain a secure, electronic, and online 451 compassionate use registry for the registration of physicians, 452 qualifying patients, and caregiversthe legal representatives of453patientsas provided under this section. The registry must be 454 accessible to: 455 1. Physicians licensed under chapter 458 or chapter 459, to 456 ensure proper care for patients requesting physician 457 certifications; 458 2. Practitioners licensed to prescribe prescription drugs, 459 to ensure proper care for patients before prescribing 460 medications that may interact with the medical use of marijuana; 461 3. Law enforcement agencies, to verify the authorization of 462 a qualifying patient or a qualifying patient’s caregiver to 463 possess marijuana or a marijuana delivery device; and 464 4. MMTCs,to a dispensing organizationto verify the 465 authorization of a qualifying patient or a qualifying patient’s 466 caregiverlegal representativeto possess marijuanalow-THC467cannabis, medical cannabis,or a marijuanacannabisdelivery 468 device and to record the marijuanalow-THC cannabis, medical469cannabis,or marijuanacannabisdelivery device dispensed. The 470 registry must preventanactive registration of a qualifying 471 patient by multiple physicians. 472 (b) By July 3, 2017, adopt rules, pursuant to s. 120.536(1) 473 or s. 120.54, establishing procedures for the issuance, annual 474 renewal, suspension, and revocation of compassionate use 475 registry identification cards for qualifying patients and 476 caregivers who are residents of this state. The department may 477 use emergency rulemaking procedures pursuant to s. 120.54(4) to 478 adopt rules under this section as necessary to ensure that rules 479 are adopted on or before July 3, 2017. The department may charge 480 a reasonable fee associated with the issuance and renewal of 481 patient and caregiver identification cards. By October 3, 2017, 482 the department shall begin issuing identification cards to adult 483 patients who are residents of this state and who have a 484 physician certification that meets the requirements of 485 subsection (3); minor patients who are residents of this state 486 and who have a physician certification that meets the 487 requirements of subsection (3) and the written consent of a 488 parent or legal guardian; and caregivers registered pursuant to 489 subsection (7). Patient and caregiver identification cards must 490 be resistant to counterfeiting and tampering and must include at 491 least the following: 492 1. The name, address, and date of birth of the patient or 493 caregiver, as appropriate; 494 2. Designation of the cardholder as a patient or caregiver; 495 3. A unique numeric identifier for the patient or caregiver 496 which is matched to the identifier used for such person in the 497 department’s compassionate use registry. A caregiver’s numeric 498 identifier and file in the compassionate use registry must be 499 linked to the file of the patient or patients the caregiver is 500 assisting so that the caregiver’s status may be verified for 501 each patient individually; 502 4. The expiration date, which must be 1 year after the date 503 of issuance of the identification card or the date treatment 504 ends as provided in the patient’s physician certification, 505 whichever occurs first; and 506 5. For a caregiver who is assisting three or fewer 507 qualifying patients, the names and unique numeric identifiers of 508 the qualifying patient or patients that the caregiver is 509 assisting. 510 (c) Deem a dispensing organization approved under s. 2, 511 chapter 2014-157, Laws of Florida, or s. 3, chapter 2016-123, 512 Laws of Florida, before June 1, 2017, to meet the requirements 513 for approval as an MMTC under this section. The department shall 514 presume such dispensing organization to be registered with the 515 department as an MMTC and shall authorize such dispensing 516 organization to acquire, cultivate, possess, and process 517 marijuana or products containing marijuana, including developing 518 related products such as food, tinctures, aerosols, oils, or 519 ointments, for sale to qualifying patients and their caregivers; 520 and to transfer, transport, sell, distribute, or dispense 521 marijuana, products containing marijuana, related supplies, and 522 educational materials to qualifying patients or their 523 caregivers. The department must renew the registration of such 524 dispensing organization as an MMTC biennially upon the 525 dispensing organization’s payment of the biennial renewal fee, 526 unless the dispensing organization is required to hold a valid 527 certificate of registration from the Department of Agriculture 528 and Consumer Services pursuant to s. 581.131 and fails to 529 maintain such registrationAuthorize the establishment of five530dispensing organizations to ensure reasonable statewide531accessibility and availability as necessary for patients532registered in the compassionate use registry and who are ordered533low-THC cannabis, medical cannabis, or a cannabis delivery534device under this section, one in each of the following regions:535northwest Florida, northeast Florida, central Florida, southeast536Florida, and southwest Florida. 537 (d) Within 6 months after the registration of each 538 occurrence of 250,000 active qualifying patients in the 539 compassionate use registry, begin the application process for 540 registering three additional MMTCs, including, but not limited 541 to, one applicant per occurrence which is a recognized class 542 member of Pigford v. Glickman, 185 F.R.D. 82 (D.D.C. 1999), or 543 In re Black Farmers Litig., 856 F. Supp. 2d 1 (D.D.C. 2011), and 544 which is a member of the Black Farmers and Agriculturalists 545 Association. Each applicant must meet the requirements in this 546 subsection and in subsection (9) and be an entity registered to 547 do business in this state for at least 5 consecutive years as of 548 the date of the application. Notwithstanding any other 549 provisions of this subsection, applicants who are recognized 550 class members of Pigford v. Glickman, 185 F.R.D. 82 (D.D.C. 551 1999), or In re Black Farmers Litig., 856 F. Supp. 2d 1 (D.D.C. 552 2011), and which are members of the Black Farmers and 553 Agriculturalists Association need not have been operated as a 554 registered nursery in this state for at least 30 continuous 555 years. 556 (e)The department shallDevelop an application form for 557 registration as an MMTC and impose an initial application and 558 biennial renewal fee that is sufficient to cover the costs of 559 administering this section. To be registered as an MMTC, theAn560 applicantfor approval as a dispensing organizationmust be able 561 to demonstrate: 562 1. The technical and technological ability to cultivate and 563 produce marijuanalow-THC cannabis. The applicant must possess a 564 valid certificate of registration issued by the Department of 565 Agriculture and Consumer Services pursuant to s. 581.131that is566issuedfor the cultivation of more than 400,000 plants, be 567 operated by a nurseryman as defined in s. 581.011, and have been 568 operated as a registered nursery in this state for at least 30 569 continuous years. 570 2. The ability to secure the premises, resources, and 571 personnel necessary to operate as an MMTCa dispensing572organization. 573 3. The ability to maintain accountability of all raw 574 materials, finished products, and any byproducts to prevent 575 diversion or unlawful access to or possession of these 576 substances. 577 4. An infrastructure reasonably located to dispense 578 marijuanalow-THC cannabisto registered qualifying patients 579 statewideor regionally as determined by the department. 580 5. The financial ability to maintain operations for the 581 duration of the 2-year approval cycle, including the provision 582 of certified financials to the department. Upon approval, the 583 applicant must post a $5 million performance bond. However, upon 584 an MMTC’sa dispensing organization’sserving at least 1,000 585 qualifyingqualifiedpatients, the MMTCdispensing organization586 isonlyrequired to maintain only a $2 million performance bond. 587 A performance bond posted under this subparagraph may be used 588 only for reimbursement to the department for any damages 589 incurred by the department as a result of an MMTC’s failure to 590 perform its obligations under this section or department rules. 591 Such damages include: 592 a. All costs and expenses incurred by the department to 593 nonrenew or revoke the applicant’s registration for cause and to 594 register a replacement MMTC; and 595 b. All costs and expenses incurred by qualifying patients 596 for transportation and delivery of marijuana which would not 597 have been incurred but for the revocation of the applicant’s 598 registration, if claims for such costs and expenses are 599 submitted to the department. 600 6. That all owners with a 5 percent or greater share in the 601 applicant and managers have been fingerprinted and have 602 successfully passed a level 2 background screening pursuant to 603 s. 435.04. 604 7. The employment of a medical director to supervise the 605 activities of the MMTCdispensing organization. 606(c) Upon the registration of 250,000 active qualified607patients in the compassionate use registry, approve three608dispensing organizations, including, but not limited to, an609applicant that is a recognized class member ofPigford v.610Glickman, 185 F.R.D. 82 (D.D.C. 1999), orIn Re Black Farmers611Litig., 856 F. Supp. 2d 1 (D.D.C. 2011), and a member of the612Black Farmers and Agriculturalists Association, which must meet613the requirements of subparagraphs (b)2.-7. and demonstrate the614technical and technological ability to cultivate and produce615low-THC cannabis.616 (f)(d)Allow an MMTCa dispensing organizationto make a 617 wholesale purchase of marijuanalow-THC cannabis or medical618cannabisfrom, or a distribution of marijuanalow-THC cannabis619or medical cannabisto, another MMTCdispensing organization. 620 (g)(e)Monitor physician registration in the compassionate 621 use registry and the issuance of physician certifications 622 pursuant to subsection (3)and ordering of low-THC cannabis,623medical cannabis, or a cannabis delivery deviceforordering624 practices that could facilitate unlawful diversion or misuse of 625 marijuanalow-THC cannabis, medical cannabis,or a marijuana 626cannabisdelivery device and take disciplinary action as 627 indicated. 628 (9)(6)MEDICAL MARIJUANA TREATMENT CENTERSDISPENSING629ORGANIZATION.—In order to be an MMTC, an entity must register 630 with the department. An MMTCAn approved dispensing organization631 must, at all times, maintain compliance withthe criteria632demonstrated for selection and approval as a dispensing633organization under subsection (5) andthe criteria required in 634 this subsection and all representations made to the department 635 in the MMTC’s application for registration. Upon request, the 636 department may grant an MMTC one or more variances from the 637 representations made in the MMTC’s application. Consideration of 638 such a variance shall be based upon the facts and circumstances 639 surrounding the request. A variance may not be granted unless 640 the requesting MMTC can demonstrate to the department that it 641 has a proposed alternative to the specific representation made 642 in its application which fulfills the same or a similar purpose 643 as the specific representation in a way that the department can 644 reasonably determine will not be a lower standard than the 645 specific representation in the application. An MMTC is not 646 required to obtain a variance for deviations from the MMTC’s 647 application for registration which do not materially affect the 648 MMTC’s operations or the quality of the marijuana dispensed by 649 the MMTC or for deviations from the MMTC’s application which are 650 needed to conform to current statutes or rules. 651 (a) When growing marijuanalow-THC cannabis or medical652cannabis, an MMTCa dispensing organization: 653 1. May use pesticides determined by the department, after 654 consultation with the Department of Agriculture and Consumer 655 Services, to be safely applied to plants intended for human 656 consumption, but may not use pesticides designated as 657 restricted-use pesticides pursuant to s. 487.042. 658 2. Must grow marijuanalow-THC cannabis or medical cannabis659 within an enclosed structureand in a room separate from any660other plant. 661 3. Must inspect seeds and growing plants for plant pests 662 that endanger or threaten the horticultural and agricultural 663 interests of the state, notify the Department of Agriculture and 664 Consumer Services within 10 calendar days after a determination 665 that a plant is infested or infected by such plant pest, and 666 implement and maintain phytosanitary policies and procedures. 667 4. Must perform fumigation or treatment of plants, or the 668 removal and destruction of infested or infected plants, in 669 accordance with chapter 581 and any rules adopted thereunder. 670 (b) When processing marijuana, an MMTClow-THC cannabis or671medical cannabis, a dispensing organizationmust: 672 1. Process the marijuanalow-THC cannabis or medical673cannabiswithin an enclosed structureand in a room separate674from other plants or products. 675 2. Test the processed marijuanalow-THC cannabis and676medical cannabisbefore it isthey aredispensed. Results must 677 be verified and signed by two MMTCdispensing organization678 employees. Before dispensing marijuanalow-THC cannabis, the 679 MMTCdispensing organizationmust determine that the marijuana 680test results indicate that the low-THC cannabismeets the681definition of low-THC cannabis and, for medical cannabis and682low-THC cannabis, that all medical cannabis and low-THC cannabis683 is safe for human consumptionand free from contaminants that684are unsafe for human consumption. The MMTCdispensing685organizationmust retain records of all testing and samples of 686 each homogenous batch of marijuanacannabis and low-THC cannabis687 for at least 69months. The MMTCdispensing organizationmust 688 contract with an independent testing laboratory to: 689 a. Perform audits on the MMTC’sdispensing organization’s690 standard operating procedures, testing records, and samples and 691 provide the results to the department to confirm that the 692 marijuanalow-THC cannabis or medical cannabismeets the 693 requirements of this section and that the marijuanamedical694cannabis and low-THC cannabisis safe for human consumption; or 695 b. Directly test the marijuana final product to ensure that 696 it meets the requirements of this section and is safe for human 697 consumption before it is dispensed or distributed. 698 3. Package the marijuanalow-THC cannabis or medical699cannabisin compliance with the United States Poison Prevention 700 Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq. 701 4. Package the marijuanalow-THC cannabis or medical702cannabisin a childproof receptacle that has a firmly affixed 703 and legible label stating the following information: 704 a. A statement that the marijuanalow-THC cannabis or705medical cannabismeets the requirements of subparagraph 2.; 706 b. The name of the MMTCdispensing organizationfrom which 707 the marijuanamedical cannabis or low-THC cannabisoriginates; 708 and 709 c. The batch number and harvest number from which the 710 marijuanamedical cannabis or low-THC cannabisoriginates. 711 5. Reserve two processed samples from each batch and retain 712 such samples for at least 69months for the purpose of testing 713 pursuant to the audit required under subparagraph 2. 714 (c) When dispensing marijuanalow-THC cannabis, medical715cannabis,or a marijuanacannabisdelivery device, an MMTCa716dispensing organization: 717 1. May not dispense more than thea 45-daysupply of 718 marijuanalow-THC cannabis or medical cannabisto a qualifying 719 patient or the qualifying patient’s caregiver which is indicated 720 on the qualifying patient’s physician certificationlegal721representative. 722 2. Must ensure thathavethedispensing organization’s723 employee who dispenses the marijuanalow-THC cannabis, medical724cannabis,or marijuanaacannabisdelivery device entersenter725 into the compassionate use registry his or her name or unique 726 employee identifier. 727 3. Must verify that the qualifying patient and the 728 caregiver, if applicable, both have an active and valid 729 compassionate use registry identification card and that the 730 amount and type of marijuana dispensed match the physician’s 731 certification in the compassionate use registry for that 732 qualifying patientthat a physician has ordered the low-THC733cannabis, medical cannabis, or a specific type of a cannabis734delivery device for the patient. 735 4. May not dispense or sell any other type of marijuana 736cannabis, alcohol, or illicit drug-related product, including 737 pipes, bongs, or wrapping papers, other than a marijuana 738physician-orderedcannabisdelivery device required for the 739 medical use of marijuana which is specified in the physician 740 certification. An MMTC may produce and dispense marijuana as an 741 edible or food product but may not produce such items in a 742 format designed to be attractive to children. In addition to the 743 requirements of this section and department rule, food products 744 produced by an MMTC must meet all food safety standards 745 established in state and federal law, including, but not limited 746 to, the identification of the serving size and the amount of 747 tetrahydrocannabinol in each servinglow-THC cannabis or medical748cannabis, while dispensing low-THC cannabis or medical cannabis. 7495. Must verify that the patient has an active registration750in the compassionate use registry, the patient or patient’s751legal representative holds a valid and active registration card,752the order presented matches the order contents as recorded in753the registry, and the order has not already been filled.754 5.6.Must, upon dispensing the marijuanalow-THC cannabis,755medical cannabis,or marijuanacannabisdelivery device, record 756 in the registry the date, time, quantity, and form of marijuana 757low-THC cannabis or medical cannabisdispensed;andthe type of 758 marijuanacannabisdelivery device dispensed; and the name and 759 compassionate use registry numeric identifier of the qualifying 760 patient or caregiver to whom the marijuana or marijuana delivery 761 device was dispensed. 762 (d) To ensure the safety and security of its premises and 763 any off-site storage facilities,and to maintain adequate 764 controls against the diversion, theft, and loss of marijuana 765low-THC cannabis, medical cannabis,or marijuanacannabis766 delivery devices, an MMTCa dispensing organizationshall: 767 1.a. Maintain a fully operational security alarm system 768 that secures all entry points and perimeter windows and is 769 equipped with motion detectors; pressure switches; and duress, 770 panic, and hold-up alarms; or 771 b. Maintain a video surveillance system that records 772 continuously 24 hours each day and meets at least one of the 773 following criteria: 774 (I) Cameras are fixed in a place that allows for the clear 775 identification of persons and activities in controlled areas of 776 the premises. Controlled areas include grow rooms, processing 777 rooms, storage rooms, disposal rooms or areas, and point-of-sale 778 rooms; 779 (II) Cameras are fixed in entrances and exits to the 780 premises, which shall record from both indoor and outdoor, or 781 ingress and egress, vantage points; 782 (III) Recorded images must clearly and accurately display 783 the time and date; or 784 (IV) Retain video surveillance recordings for a minimum of 785 45 days or longer upon the request of a law enforcement agency. 786 2. Ensure that the MMTC’sorganization’soutdoor premises 787 have sufficient lighting from dusk until dawn. 788 3. Establish and maintain a tracking system approved by the 789 department whichthattraces the marijuanalow-THC cannabis or790medical cannabisfrom seed to sale. The tracking system must 791shallinclude notification of key events as determined by the 792 department, including when marijuanacannabisseeds are planted, 793 when marijuanacannabisplants are harvested and destroyed, and 794 when marijuanalow-THC cannabis or medical cannabisis 795 transported, sold, stolen, diverted, or lost. 796 4. Not dispense from its premises marijuanalow-THC797cannabis, medical cannabis,or a marijuanacannabisdelivery 798 device between the hours of 9 p.m. and 7 a.m., but may perform 799 all other operations and deliver marijuanalow-THC cannabis and800medical cannabisto qualifyingqualifiedpatients 24 hours each 801 day. 802 5. Store marijuanalow-THC cannabis or medical cannabisin 803 a secured, locked room or a vault. 804 6. Require at least two of its employees, or two employees 805 of a security agency with whom it contracts, to be on the 806 premises of any cultivation or processing facilities at all 807 times. 808 7. Require each employee or contractor to wear a photo 809 identification badge at all times while on the premises. 810 8. Require each visitor to wear a visitor’s pass at all 811 times while on the premises. 812 9. Implement an alcohol and drug-free workplace policy. 813 10. Report to local law enforcement within 24 hours after 814 it is notified or becomes aware of the theft, diversion, or loss 815 of marijuanalow-THC cannabis or medical cannabis. 816 (e) To ensure the safe transport of marijuanalow-THC817cannabis or medical cannabisto MMTCdispensing organization818 facilities, independent testing laboratories, or qualifying 819 patients, the MMTCdispensing organizationmust: 820 1. Maintain a transportation manifest, which must be 821 retained for at least 1 year. 822 2. Ensure only vehicles in good working order are used to 823 transport marijuanalow-THC cannabis or medical cannabis. 824 3. Lock marijuanalow-THC cannabis or medical cannabisin a 825 separate compartment or container within the vehicle. 826 4. Require at least two persons to be in a vehicle 827 transporting marijuanalow-THC cannabis or medical cannabis, and 828 require at least one person to remain in the vehicle while the 829 marijuanalow-THC cannabis or medical cannabisis being 830 delivered. 831 5. Ensure that any vehicle transporting marijuana to a 832 qualifying patient or caregiver is legally parked while 833 marijuana is being delivered to the qualifying patient or 834 caregiver. 835 6.5.Provide specific safety and security training to 836 employees transporting or delivering marijuanalow-THC cannabis837or medical cannabis. 838 (10)(7)DEPARTMENT AUTHORITY AND RESPONSIBILITIES.— 839 (a) The department may conduct announced or unannounced 840 inspections of MMTCsdispensing organizationsto determine 841 compliance with this section or rules adopted pursuant to this 842 section. 843 (b) The department shall inspect an MMTCa dispensing844organizationupon complaint or notice provided to the department 845 that the MMTCdispensing organizationhas dispensed marijuana 846low-THC cannabis or medical cannabiscontaining any mold, 847 bacteria, or other contaminant at a level that may cause or has 848 caused an adverse effect to human health or the environment. 849 (c) The department shall conduct at least a biennial 850 inspection of each MMTCdispensing organizationto evaluate the 851 MMTC’sdispensing organization’srecords, personnel, equipment, 852 processes, security measures, sanitation practices, and quality 853 assurance practices. 854 (d) The department shall adopt by rule a process for 855 approving changes in MMTC ownership or a change in an MMTC 856 owner’s investment interest of 5 percent or more. This process 857 shall be limited to verifying compliance with subparagraph 858 (8)(e)6. 859 (e) The department may enter into interagency agreements 860 with the Department of Agriculture and Consumer Services, the 861 Department of Business and Professional Regulation, the 862 Department of Law Enforcement, the Department of Transportation, 863 the Department of Highway Safety and Motor Vehicles, and the 864 Agency for Health Care Administration, and such agencies are 865 authorized to enter into an interagency agreement with the 866 department, to conduct inspections or perform other 867 responsibilities assigned to the department under this section. 868 (f)(e)The department must make a list of all approved 869 MMTCs,dispensing organizationsandqualified ordering870 physicians who are qualified to issue physician certifications, 871 and medical directors of MMTCs publicly available on its 872 website. 873(f) The department may establish a system for issuing and874renewing registration cards for patients and their legal875representatives, establish the circumstances under which the876cards may be revoked by or must be returned to the department,877and establish fees to implement such system. The department must878require, at a minimum, the registration cards to:8791. Provide the name, address, and date of birth of the880patient or legal representative.8812. Have a full-face, passport-type, color photograph of the882patient or legal representative taken within the 90 days883immediately preceding registration.8843. Identify whether the cardholder is a patient or legal885representative.8864. List a unique numeric identifier for the patient or887legal representative that is matched to the identifier used for888such person in the department’s compassionate use registry.8895. Provide the expiration date, which shall be 1 year after890the date of the physician’s initial order of low-THC cannabis or891medical cannabis.8926. For the legal representative, provide the name and893unique numeric identifier of the patient that the legal894representative is assisting.8957. Be resistant to counterfeiting or tampering.896 (g) The department may impose reasonable fines not to 897 exceed $10,000 on an MMTCa dispensing organizationfor any of 898 the following violations: 899 1. Violating this section, s. 499.0295, or department rule. 900 2. Failing to maintain qualifications for registration with 901 the departmentapproval. 902 3. Endangering the health, safety, or security of a 903 qualifyingqualifiedpatient. 904 4. Improperly disclosing personal and confidential 905 information of a qualifyingthe qualifiedpatient. 906 5. Attempting to procure MMTC registration with the 907 departmentdispensing organization approvalby bribery, 908 fraudulent misrepresentation, or extortion. 909 6. Any owner or manager of the MMTC being convicted or 910 found guilty of, or entering a plea of guilty or nolo contendere 911 to, regardless of adjudication, a crime in any jurisdiction 912 which directly relates to the business of an MMTCa dispensing913organization. 914 7. Making or filing a report or record that the MMTC 915dispensing organizationknows to be false. 916 8. Willfully failing to maintain a record required by this 917 section or department rule. 918 9. Willfully impeding or obstructing an employee or agent 919 of the department in the furtherance of his or her official 920 duties. 921 10. Engaging in fraud or deceit, negligence, incompetence, 922 or misconduct in the business practices of an MMTCa dispensing923organization. 924 11. Making misleading, deceptive, or fraudulent 925 representations in or related to the business practices of an 926 MMTCa dispensing organization. 927 12. Having a license or the authority to engage in any 928 regulated profession, occupation, or business that is related to 929 the business practices of an MMTCadispensing organization930 suspended, revoked, or otherwise acted against by the licensing 931 authority of any jurisdiction, including its agencies or 932 subdivisions, for a violation that would constitute a violation 933 under Florida law. 934 13. Violating a lawful order of the department or an agency 935 of the state, or failing to comply with a lawfully issued 936 subpoena of the department or an agency of the state. 937 (h) The department may suspend, revoke, or refuse to renew 938 an MMTC’s registration with the departmenta dispensing939organization’sapprovalif the MMTCa dispensing organization940 commits repeated violations specifiedany of the violationsin 941 paragraph (g) which remain uncured after 30 days’ notice from 942 the department. The department may not suspend, revoke, or 943 refuse to renew an MMTC’s registration due to an uncured 944 violation if the MMTC begins taking action to cure the violation 945 within 30 days after receiving a notice of the violation from 946 the department and such action is pursuant to a corrective 947 action plan filed by the MMTC with the department or if the MMTC 948 takes reasonable steps to ensure that a future violation of a 949 similar nature does not occur. 950 (i) The department shall renew an MMTC’s registration with 951 the departmentthe approval ofa dispensing organization952 biennially if the MMTCdispensing organizationmeets the 953 requirements of this section and pays the biennial renewal fee. 954 (j) The department may adopt rules necessary to implement 955 this section pursuant to s. 120.536(1) or s. 120.54. The 956 department may use emergency rulemaking procedures pursuant to 957 s. 120.54(4) to adopt rules under this section if necessary to 958 meet any deadline for rulemaking established in s. 29, Art. X of 959 the State Constitution. 960 (11)(8)PREEMPTION.— 961 (a) All matters regarding the regulation of the cultivation 962 and processing of marijuanamedical cannabis or low-THC cannabis963 by MMTCsdispensing organizationsare preempted to the state. 964 (b) A municipality may determine by ordinance the criteria 965 for the number and location of, and other permitting 966 requirements that do not conflict with state law or department 967 rule for, dispensing facilities of MMTCsdispensing968organizationslocated within its municipal boundaries. A county 969 may determine by ordinance the criteria for the number, 970 location, and other permitting requirements that do not conflict 971 with state law or department rule for all dispensing facilities 972 of MMTCsdispensing organizationslocated within the 973 unincorporated areas of that county. A municipality or a county 974 may not ban dispensing facilities within its boundaries or enact 975 zoning or other such ordinances that would have the effect of 976 banning dispensing facilities within its boundaries. 977 (12)(9)EXCEPTIONS TO OTHER LAWS.— 978 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 979 any other provision of law, but subject to the requirements of 980 this section, a qualifyingqualifiedpatient, or a caregiver who 981 has obtained a valid compassionate use registry identification 982 card from the department,and the qualified patient’s legal983representativemay purchase from an MMTC and possess for the 984 qualifying patient’s medical use up to the amount of marijuana 985 in the physician’s certificationlow-THC cannabis or medical986cannabis ordered for the patient, but not more than a 45-day 987 supply, except as provided in (3)(e), and a marijuanacannabis988 delivery device specified in the physician’s certification 989orderedfor the qualifying patient. 990 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 991 any other provision of law, but subject to the requirements of 992 this section, an MMTCan approveddispensingorganizationand 993 its owners, managers, and employees may manufacture, possess, 994 sell, deliver, distribute, dispense, and lawfully dispose of 995 reasonable quantities, as established by department rule, of 996 marijuanalow-THC cannabis,medical cannabis,or a marijuana 997cannabisdelivery device. As used inFor purposes ofthis 998 subsection, the terms “manufacture,” “possession,” “deliver,” 999 “distribute,” and “dispense” have the same meanings as provided 1000 in s. 893.02. 1001 (c) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 1002 any other provision of law, but subject to the requirements of 1003 this section, an approved independent testing laboratory may 1004 possess, test, transport, and lawfully dispose of marijuanalow1005THC cannabis ormedical cannabisas provided by department rule. 1006 (d) An MMTCapproveddispensing organizationand its 1007 owners, managers, and employees are not subject to licensure or 1008 regulation under chapter 465 or chapter 499 for manufacturing, 1009 possessing, selling, delivering, distributing, dispensing, or 1010 lawfully disposing of reasonable quantities, as established by 1011 department rule, of marijuanalow-THC cannabis,medical1012cannabis,or a marijuanacannabisdelivery device. 1013 (e) Exercise by an MMTC ofAn approveddispensing1014organizationthat continues to meet the requirements for1015approvalis presumed to be registered with the department and to1016meet the regulations adopted by the department or its successor1017agency for the purpose of dispensingmedical cannabisor low-THC1018cannabis under Florida law. Additionally,the authority provided 1019 to a dispensing organization in s. 499.0295 does not impair its 1020 registration with the departmenttheapprovalof adispensing1021organization. 1022 (f) This subsection does not exempt a person from 1023 prosecution for a criminal offense related to impairment or 1024 intoxication resulting from the medical use of marijuanalow-THC1025cannabis ormedical cannabisor relieve a person from any 1026 requirement under law to submit to a breath, blood, urine, or 1027 other test to detect the presence of a controlled substance. 1028 (g) This section does not affect or repeal laws relating to 1029 negligence or professional malpractice on the part of a 1030 caregiver, a physician, or an MMTC or its agents and employees. 1031 (h) This section does not require a health insurance 1032 provider or a governmental agency or authority to reimburse a 1033 person for expenses related to the use of marijuana. 1034 (i) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 1035 any other provision of law, but subject to the requirements of 1036 this section, a research institute established by a public 1037 postsecondary educational institution, such as the H. Lee 1038 Moffitt Cancer Center and Research Institute established in s. 1039 1004.43, or a state university that has achieved the preeminent 1040 state research university designation pursuant to s. 1001.7065, 1041 may possess, test, transport, and lawfully dispose of marijuana 1042 for research purposes as provided by department rule. 1043 (13) PROHIBITED ACTIVITIES.— 1044 (a) A person or entity may not offer or advertise services 1045 as an MMTC without registering as an MMTC with the department. 1046 An MMTC may not advertise or hold out to the public that it 1047 holds a registration for other than that for which it actually 1048 holds the license. 1049 (b) The operation or maintenance of an unauthorized 1050 dispensing organization or entity or the performance of a 1051 service that requires registration without proper registration 1052 is a violation of this section. The department or any state 1053 attorney may, in addition to other remedies provided in this 1054 section, bring an action for an injunction to restrain any 1055 unauthorized activity or to enjoin the future operation or 1056 maintenance of the unauthorized dispensing organization or 1057 entity or the performance of any service in violation of this 1058 section until compliance with this section and department rules 1059 has been demonstrated to the satisfaction of the department. 1060 (c) If after receiving notification from the department, 1061 such person or entity fails to cease operation, the department 1062 may impose an administrative fine of up to $10,000 per 1063 violation, in addition to other penalties as prescribed by this 1064 section or applicable criminal law. In addition, the department 1065 may assess reasonable investigative and legal costs for 1066 prosecution of the violation against the person or entity. Each 1067 day of continued operation is a separate offense. 1068 (14) IMPORTATION AND EXPORTATION OF MARIJUANA.— 1069 (a) Marijuana may not be imported from outside this state. 1070 (b) Marijuana and products containing marijuana which are 1071 cultivated and produced in accordance with this section may be 1072 exported as authorized by federal law and the laws of the states 1073 or countries to which they are exported. 1074 Section 2. Subsections (1) and (2) of section 381.987, 1075 Florida Statutes, are amended, and paragraphs (b) and (c) of 1076 subsection (3) of that section are amended, to read: 1077 381.987 Public records exemption for personal identifying 1078 information in the compassionate use registry.— 1079 (1) A patient’s personal identifying information held by 1080 the department in the compassionate use registry established 1081 under s. 381.986, including, but not limited to, the patient’s 1082 name, address, telephone number, and government-issued 1083 identification number, and all information pertaining to the 1084 physician certificationphysician’s orderfor marijuanalow-THC1085cannabisand the dispensing thereof are confidential and exempt 1086 from s. 119.07(1) and s. 24(a), Art. I of the State 1087 Constitution. 1088 (2) A physician’s identifying information held by the 1089 department in the compassionate use registry established under 1090 s. 381.986, including, but not limited to, the physician’s name, 1091 address, telephone number, government-issued identification 1092 number, and Drug Enforcement Administration number, and all 1093 information pertaining to the physician certification 1094physician’s orderfor marijuanalow-THCcannabisand the 1095 dispensing thereof are confidential and exempt from s. 119.07(1) 1096 and s. 24(a), Art. I of the State Constitution. 1097 (3) The department shall allow access to the registry, 1098 including access to confidential and exempt information, to: 1099 (b) A medical marijuana treatment centerdispensing1100organizationapproved by the department pursuant to s. 381.986 1101 which is attempting to verify the authenticity of a physician 1102 certificationphysician’sorderfor marijuanalow-THC cannabis, 1103 including whether the physician certificationorderhad been 1104 previously filled and whether the physician certificationorder1105 was written for the person attempting to have it filled. 1106 (c) A physician who has issued a physician certification 1107written an orderfor marijuanalow-THCcannabisfor the purpose 1108 of monitoring the patient’s use of such cannabis or for the 1109 purpose of determining, before issuing an order for marijuana 1110low-THCcannabis, whether another physician has ordered the 1111 patient’s use of marijuanalow-THCcannabis. The physician may 1112 access the confidential and exempt information only for the 1113 patient for whom he or she has ordered or is determining whether 1114 to order the use of marijuanalow-THCcannabispursuant to s. 1115 381.986. 1116 Section 3. Subsection (1) of section 385.211, Florida 1117 Statutes, is amended to read: 1118 385.211 Refractory and intractable epilepsy treatment and 1119 research at recognized medical centers.— 1120 (1) As used in this section, the term “low-THC cannabis” 1121 means “low-THC cannabis” as defined in s. 381.986 whichthatis 1122 dispensed only from a medical marijuana treatment center 1123dispensing organizationas defined in s. 381.986. 1124 Section 4. Subsections (2) and (3) of section 499.0295, 1125 Florida Statutes, are amended to read: 1126 499.0295 Experimental treatments for terminal conditions.— 1127 (2) As used in this section, the term: 1128(a) “Dispensing organization” means an organization1129approved by the Department of Health under s. 381.986(5) to1130cultivate, process, transport, and dispense low-THC cannabis,1131medical cannabis, and cannabis delivery devices.1132 (a)(b)“Eligible patient” means a person who: 1133 1. Has a terminal condition that is attested to by the 1134 patient’s physician and confirmed by a second independent 1135 evaluation by a board-certified physician in an appropriate 1136 specialty for that condition; 1137 2. Has considered all other treatment options for the 1138 terminal condition currently approved by the United States Food 1139 and Drug Administration; 1140 3. Has given written informed consent for the use of an 1141 investigational drug, biological product, or device; and 1142 4. Has documentation from his or her treating physician 1143 that the patient meets the requirements of this paragraph. 1144 (b)(c)“Investigational drug, biological product, or 1145 device” means:11461.a drug, biological product, or device that has 1147 successfully completed phase 1 of a clinical trial but has not 1148 been approved for general use by the United States Food and Drug 1149 Administration and remains under investigation in a clinical 1150 trial approved by the United States Food and Drug 1151 Administration; or11522. Medical cannabis that is manufactured and sold by a1153dispensing organization. 1154 (c)(d)“Terminal condition” means a progressive disease or 1155 medical or surgical condition that causes significant functional 1156 impairment, is not considered by a treating physician to be 1157 reversible even with the administration of available treatment 1158 options currently approved by the United States Food and Drug 1159 Administration, and, without the administration of life 1160 sustaining procedures, will result in death within 1 year after 1161 diagnosis if the condition runs its normal course. 1162 (d)(e)“Written informed consent” means a document that is 1163 signed by a patient, a parent of a minor patient, a court 1164 appointed guardian for a patient, or a health care surrogate 1165 designated by a patient and includes: 1166 1. An explanation of the currently approved products and 1167 treatments for the patient’s terminal condition. 1168 2. An attestation that the patient concurs with his or her 1169 physician in believing that all currently approved products and 1170 treatments are unlikely to prolong the patient’s life. 1171 3. Identification of the specific investigational drug, 1172 biological product, or device that the patient is seeking to 1173 use. 1174 4. A realistic description of the most likely outcomes of 1175 using the investigational drug, biological product, or device. 1176 The description shall include the possibility that new, 1177 unanticipated, different, or worse symptoms might result and 1178 death could be hastened by the proposed treatment. The 1179 description shall be based on the physician’s knowledge of the 1180 proposed treatment for the patient’s terminal condition. 1181 5. A statement that the patient’s health plan or third 1182 party administrator and physician are not obligated to pay for 1183 care or treatment consequent to the use of the investigational 1184 drug, biological product, or device unless required to do so by 1185 law or contract. 1186 6. A statement that the patient’s eligibility for hospice 1187 care may be withdrawn if the patient begins treatment with the 1188 investigational drug, biological product, or device and that 1189 hospice care may be reinstated if the treatment ends and the 1190 patient meets hospice eligibility requirements. 1191 7. A statement that the patient understands he or she is 1192 liable for all expenses consequent to the use of the 1193 investigational drug, biological product, or device and that 1194 liability extends to the patient’s estate, unless a contract 1195 between the patient and the manufacturer of the investigational 1196 drug, biological product, or device states otherwise. 1197 (3) Upon the request of an eligible patient, a manufacturer 1198 may, or, upon the issuance of a physician certificationa1199physician’s orderpursuant to s. 381.986, an MMTCadispensing1200organizationmay: 1201 (a) Make its investigational drug, biological product, or 1202 device available under this section. 1203 (b) Provide an investigational drug, biological product, 1204 device, or marijuanacannabisdelivery device as defined in s. 1205 381.986 to an eligible patient without receiving compensation. 1206 (c) Require an eligible patient to pay the costs of, or the 1207 costs associated with, the manufacture of the investigational 1208 drug, biological product, device, or marijuanacannabisdelivery 1209 device as defined in s. 381.986. 1210 Section 5. Subsection (1) of section 1004.441, Florida 1211 Statutes, is amended to read: 1212 1004.441 Refractory and intractable epilepsy treatment and 1213 research.— 1214 (1) As used in this section, the term “low-THC cannabis” 1215 means “low-THC cannabis” as defined in s. 381.986 whichthatis 1216 dispensed only from a medical marijuana treatment center 1217dispensing organizationas defined in s. 381.986. 1218 Section 6. The Division of Law Revision and Information is 1219 directed to replace the phrase “the effective date of this act” 1220 wherever it occurs in this act with the date the act becomes a 1221 law. 1222 Section 7. This act shall take effect upon becoming a law.