Bill Text: FL S1388 | 2017 | Regular Session | Introduced
Bill Title: Medical Cannabis
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2017-05-01 - Withdrawn from further consideration [S1388 Detail]
Download: Florida-2017-S1388-Introduced.html
Florida Senate - 2017 SB 1388 By Senator Artiles 40-01186-17 20171388__ 1 A bill to be entitled 2 An act relating to medical cannabis; amending s. 3 381.986, F.S.; defining, redefining, and deleting 4 terms; authorizing physicians to issue physician 5 certifications for medical cannabis or cannabis 6 delivery devices, instead of ordering low-THC 7 cannabis, for patients suffering from a debilitating 8 medical condition; authorizing physicians to make 9 specific determinations in certifications; requiring 10 physicians to meet certain conditions to be authorized 11 to issue such physician certifications; providing 12 criminal penalties; deleting provisions requiring 13 successful completion of a specified course and 14 examination by a physician who orders low-THC cannabis 15 and by a medical director of a dispensing 16 organization; requiring the Department of Health to 17 register medical marijuana treatment centers, rather 18 than to authorize the establishment of dispensing 19 organizations; requiring the department to register 20 additional medical marijuana treatment centers under 21 certain circumstances; requiring the department to 22 authorize the establishment of medical marijuana 23 testing facilities; prohibiting a medical marijuana 24 testing facility from being owned by certain persons; 25 providing rulemaking authority; conforming provisions 26 to changes made by the act; deleting provisions 27 relating to the department’s issuance of registration 28 cards for patients and their legal representatives; 29 requiring the department to establish a quality 30 control program that requires medical cannabis to be 31 tested by a medical marijuana testing facility; 32 requiring medical marijuana treatment centers to 33 submit samples of medical cannabis to a medical 34 marijuana testing facility; providing testing 35 specifications; requiring retention of testing 36 records; providing rulemaking authority; conforming 37 provisions to changes made by the act; amending ss. 38 381.987, 385.211, 499.0295, 893.02, and 1004.441, 39 F.S.; conforming provisions to changes made by the 40 act; providing an effective date. 41 42 Be It Enacted by the Legislature of the State of Florida: 43 44 Section 1. Section 381.986, Florida Statutes, is amended to 45 read: 46 381.986 Compassionate use oflow-THC andmedical cannabis.— 47 (1) DEFINITIONS.—As used in this section, the term: 48 (a) “Cannabis delivery device” means an object used, 49 intended for use, or designed for use in preparing, storing, 50 ingesting, inhaling, or otherwise introducinglow-THC cannabis51ormedical cannabis into the human body. 52 (b) “Caregiver” means a person who is at least 21 years 53 old, who has agreed to assist with a qualifying patient’s 54 medical use of marijuana, and who has obtained a valid caregiver 55 identification card issued by the department. 56 (c) “Debilitating medical condition” means cancer, 57 epilepsy, glaucoma, positive status for human immunodeficiency 58 virus (HIV), acquired immune deficiency syndrome (AIDS), 59 posttraumatic stress disorder (PTSD), amyotrophic lateral 60 sclerosis (ALS), Crohn’s disease, Parkinson’s disease, multiple 61 sclerosis, or other debilitating medical conditions of the same 62 kind or class as or comparable to those enumerated and for which 63 a physician believes that the medical use of marijuana would 64 likely outweigh the potential health risks for a patient 65“Dispensing organization” means an organization approved by the66department to cultivate, process, transport, and dispense low67THC cannabis or medical cannabis pursuant to this section. 68(c) “Independent testing laboratory” means a laboratory,69including the managers, employees, or contractors of the70laboratory, which has no direct or indirect interest in a71dispensing organization.72(d) “Legal representative” means the qualified patient’s73parent, legal guardian acting pursuant to a court’s74authorization as required under s. 744.3215(4), health care75surrogate acting pursuant to the qualified patient’s written76consent or a court’s authorization as required under s. 765.113,77or an individual who is authorized under a power of attorney to78make health care decisions on behalf of the qualified patient.79(e) “Low-THC cannabis” means a plant of the genusCannabis,80the dried flowers of which contain 0.8 percent or less of81tetrahydrocannabinol and more than 10 percent of cannabidiol82weight for weight; the seeds thereof; the resin extracted from83any part of such plant; or any compound, manufacture, salt,84derivative, mixture, or preparation of such plant or its seeds85or resin that is dispensed only from a dispensing organization.86 (d)(f)“Medical cannabis” means all parts of any plant of 87 the genus Cannabis, whether growing or not; the seeds thereof; 88 the resin extracted from any part of the plant; and every 89 compound, manufacture, sale, derivative, mixture, or preparation 90 of the plant or its seeds or resin that is dispensed only from a 91 medical marijuana treatment centerdispensing organizationfor 92 medical use by a qualifyingan eligiblepatientas defined in s.93499.0295. 94 (e) “Medical marijuana treatment center” or “MMTC” means an 95 entity that is registered with the department and that: 96 1. Acquires, cultivates, possesses, or processes marijuana 97 or products containing marijuana, including developing related 98 products such as food, tinctures, aerosols, oils, or ointments, 99 for sale to qualifying patients or their caregivers; or 100 2. Transfers, transports, sells, distributes, or dispenses 101 marijuana, products containing marijuana, related supplies, or 102 educational materials to qualifying patients or their 103 caregivers. 104 (f) “Medical marijuana testing facility” means an entity 105 that is licensed by the department and that is certified by the 106 department, or by an accredited, third-party laboratory 107 certification body that meets department standards, to obtain, 108 transport, store, analyze, and dispose of samples of medical 109 cannabis for the purpose of certifying the safety and potency of 110 medical cannabis. 111 (g) “Medical use” means the acquisition, transportation, 112 possession, use, or administration of an amount of medical 113 cannabis in accordance with department rules, or of related 114 supplies, by a qualifying patient or a caregiver for use for the 115 treatment of a debilitating medical condition of the qualifying 116 patientadministration of the ordered amount of low-THC cannabis117or medical cannabis.The term does not include the:1181. Possession, use, or administration of low-THC cannabis119or medical cannabis by smoking.1202. Transfer of low-THC cannabis or medical cannabis to a121person other than the qualified patient for whom it was ordered122or the qualified patient’s legal representative on behalf of the123qualified patient.1243. Use or administration of low-THC cannabis or medical125cannabis:126a. On any form of public transportation.127b. In any public place.128c. In a qualified patient’s place of employment, if129restricted by his or her employer.130d. In a state correctional institution as defined in s.131944.02 or a correctional institution as defined in s. 944.241.132e. On the grounds of a preschool, primary school, or133secondary school.134f. On a school bus or in a vehicle, aircraft, or motorboat.135 (h) “Person” means a natural person, partnership, 136 association, company, corporation, limited liability company, or 137 organization. The term does not include a governmental 138 organization. 139 (i)(h)“Qualifying patient” means a person who has been 140 diagnosed to have a debilitating medical condition and who has a 141 physician certification and a valid qualifying patient 142 identification card“Qualified patient” means a resident of this143state who has been added to the compassionate use registry by a144physician licensed under chapter 458 or chapter 459 to receive145low-THC cannabis or medical cannabis from a dispensing146organization. 147(i) “Smoking” means burning or igniting a substance and148inhaling the smoke. Smoking does not include the use of a149vaporizer.150 (2) PHYSICIAN CERTIFICATIONORDERING.—A physician is 151 authorized to issue a physician certification for medicalorder152low-THCcannabis or a cannabis delivery device to treat a 153 qualifyingqualifiedpatient suffering from a debilitating 154cancer or a physicalmedical conditionthat chronically produces155symptoms of seizures or severe and persistent muscle spasms;156order low-THC cannabis to alleviate symptoms of such disease,157disorder, or condition, if no other satisfactory alternative158treatment options exist for the qualified patient; order medical159cannabis to treat an eligible patient as defined in s. 499.0295;160or order a cannabis delivery device for themedicaluse oflow161THC cannabis ormedical cannabis,only if the physician: 162 (a) Holds an active, unrestricted license as a physician 163 under chapter 458 or an osteopathic physician under chapter 459; 164 (b) Has treated the patient for at least 3 months 165 immediately preceding the patient’s registration in the 166 compassionate use registry; 167 (c) Has successfully completed the course and examination 168 required under paragraph (4)(a); 169 (d) Has determined that the risks of treating the patient 170 withlow-THC cannabis ormedical cannabis are reasonable in 171 light of the potential benefit to the patient. If a patient is 172 younger than 18 years of age, a second physician must concur 173 with this determination, and such determination must be 174 documented in the patient’s medical record; 175 (e) Registers as the patient’s physicianorderer oflow-THC176cannabis ormedical cannabis for the named patienton the 177 compassionate use registry maintained by the department and 178 updates the registry to reflect the contents of the order of 179 medical cannabis, including the amount oflow-THC cannabis or180 medical cannabis whichthatwill provide the patient with not 181 more than a 45-day supply and a cannabis delivery device needed 182 by the patient for the medical use oflow-THC cannabis or183 medical cannabis. The physician must also update the registry 184 within 7 days after any change is made to the original order to 185 reflect the change. The physician shall deactivate the 186 registration of the patient and the patient’s caregiverlegal187representativewhen the physician no longer recommends the 188 medical use of marijuana for the patienttreatment is189discontinued; 190 (f) Maintains a patient treatment plan that includes the 191 dose, route of administration, planned duration, and monitoring 192 of the patient’s symptoms and other indicators of tolerance or 193 reaction to thelow-THC cannabis ormedical cannabis; 194 (g) Submits the patient treatment plan quarterly to the 195 University of Florida College of Pharmacy for research on the 196 safety and efficacy oflow-THC cannabis andmedical cannabis on 197 patients; 198 (h) Obtains the voluntary written informed consent of the 199 patient or the patient’s caregiverlegal representativeto 200 treatment with medicallow-THCcannabis after sufficiently 201 explaining the current state of knowledge in the medical 202 community of the effectiveness of treatment of the patient’s 203 condition with medicallow-THCcannabis, the medically 204 acceptable alternatives, and the potential risks and side 205 effects; 206(i) Obtains written informed consent as defined in and207required under s. 499.0295, if the physician is ordering medical208cannabis for an eligible patient pursuant to that section; and209 (i)(j)Is not a medical director employed by an MMTCa210dispensing organization. 211 (3) PENALTIES.— 212 (a) A physician commits a misdemeanor of the first degree, 213 punishable as provided in s. 775.082 or s. 775.083, if the 214 physician issues a physician certification for medicalorders215low-THCcannabis or a cannabis delivery device for a patient 216 without a reasonable belief that the patient is suffering from a 217 debilitating medical condition:2181. Cancer or a physical medical condition that chronically219produces symptoms of seizures or severe and persistent muscle220spasms that can be treated with low-THC cannabis; or2212. Symptoms of cancer or a physical medical condition that222chronically produces symptoms of seizures or severe and223persistent muscle spasms that can be alleviated with low-THC224cannabis.225(b) A physician commits a misdemeanor of the first degree,226punishable as provided in s. 775.082 or s. 775.083, if the227physician orders medical cannabis for a patient without a228reasonable belief that the patient has a terminal condition as229defined in s. 499.0295. 230 (b)(c)A person who fraudulently represents that he or she 231 has a debilitating medicalcancer, a physical medical condition232that chronically produces symptoms of seizures or severe and233persistent muscle spasms, or a terminalcondition to a physician 234 for the purpose of being issued a physician certification for 235orderedlow-THC cannabis,medical cannabis,or a cannabis 236 delivery device by such physician commits a misdemeanor of the 237 first degree, punishable as provided in s. 775.082 or s. 238 775.083. 239 (c)(d)A qualifyingAn eligiblepatientas defined in s.240499.0295who uses medical cannabis, and such patient’s caregiver 241legal representativewho administers medical cannabis, in plain 242 view of or in a place open to the general public, on the grounds 243 of a school, or in a school bus, vehicle, aircraft, or 244 motorboat, commits a misdemeanor of the first degree, punishable 245 as provided in s. 775.082 or s. 775.083. 246 (d)(e)A physician who issues a physician certification for 247orderslow-THC cannabis,medical cannabis,or a cannabis 248 delivery device and receives compensation from an MMTCa249dispensing organizationrelated to the ordering oflow-THC250cannabis,medical cannabis,or a cannabis delivery device is 251 subject to disciplinary action under the applicable practice act 252 and s. 456.072(1)(n). 253 (4) PHYSICIAN EDUCATION.— 254 (a) Before a physician may issue a physician certification 255 fororderinglow-THC cannabis,medical cannabis,or a cannabis 256 delivery device for medical use by a patient in this state, the 257 appropriate board shall require theorderingphysician to 258 successfully complete an 8-hour course and subsequent 259 examination offered by the Florida Medical Association or the 260 Florida Osteopathic Medical Association whichthatencompasses 261 the clinical indications for the appropriate use oflow-THC262cannabis andmedical cannabis, the appropriate cannabis delivery 263 devices, the contraindications for such use, and the relevant 264 state and federal laws governing the issuance of physician 265 certificationsordering, as well as the dispensing,and 266 possessing of these substances and devices. The course and 267 examination shall be administered at least annually. Successful 268 completion of the course may be used by a physician to satisfy 8 269 hours of the continuing medical education requirements required 270 by his or her respective board for licensure renewal. This 271 course may be offered in a distance learning format. 272 (b) The appropriate board shall require the medical 273 director of each MMTCdispensing organizationto hold an active, 274 unrestricted license as a physician under chapter 458 or as an 275 osteopathic physician under chapter 459 and successfully 276 complete a 2-hour course and subsequent examination offered by 277 the Florida Medical Association or the Florida Osteopathic 278 Medical Association whichthatencompasses appropriate safety 279 procedures and knowledge oflow-THC cannabis,medical cannabis,280 and cannabis delivery devices. 281(c) Successful completion of the course and examination282specified in paragraph (a) is required for every physician who283orders low-THC cannabis, medical cannabis, or a cannabis284delivery device each time such physician renews his or her285license. In addition, successful completion of the course and286examination specified in paragraph (b) is required for the287medical director of each dispensing organization each time such288physician renews his or her license.289 (c)(d)A physician who fails to comply with this subsection 290 and who issues a physician certification fororderslow-THC291cannabis,medical cannabis,or a cannabis delivery device may be 292 subject to disciplinary action under the applicable practice act 293 and under s. 456.072(1)(k). 294 (5) DUTIES OF THE DEPARTMENT.—The department shall: 295 (a) Create and maintain a secure, electronic, and online 296 compassionate use registry for the registration of physicians, 297 patients, and caregiversthe legal representativesof patients 298 as provided under this section. The registry must be accessible 299 to law enforcement agencies and to MMTCsa dispensing300organizationto verify the authorization of a patient or a 301 patient’s caregiverlegal representativeto possesslow-THC302cannabis,medical cannabis,or a cannabis delivery device and 303 record thelow-THC cannabis,medical cannabis,or cannabis 304 delivery device dispensed. The registry must prevent an active 305 registration of a patient by multiple physicians. 306 (b) Within 6 months after the registration of 250,000 307 active qualifying patients in the compassionate use registry, 308 register five additional MMTCs, including, but not limited to, 309 an applicant that is a recognized class member of Pigford v. 310 Glickman, 185 F.R.D. 82 (D.D.C. 1999), or In re Black Farmers 311 Litig., 856 F. Supp. 2d 1 (D.D.C. 2011), and that is a member of 312 the Black Farmers and Agriculturalists Association. 313 Additionally, the department must register an additional five 314 MMTCs within 6 months after the registration of each of the 315 following totals of the number of patients in the compassionate 316 use registry: 350,000 qualifying patients; 400,000 qualifying 317 patients; 500,000 qualifying patients; and then the registration 318 of each additional 100,000 qualifying patients above 500,000, if 319 a sufficient number of MMTC applicants meet the registration 320 requirements established in this section and by department rule 321Authorize the establishment of five dispensing organizations to322ensure reasonable statewide accessibility and availability as323necessary for patients registered in the compassionate use324registry and who are ordered low-THC cannabis, medical cannabis,325or a cannabis delivery device under this section, one in each of326the following regions: northwest Florida, northeast Florida,327central Florida, southeast Florida, and southwest Florida. The 328 department shall develop an application form and impose an 329 initial application and biennial renewal fee that is sufficient 330 to cover the costs of administering this section. An applicant 331 for approval as an MMTCadispensing organizationmust be able 332 to demonstrate: 333 1. The technical and technological ability to cultivate and 334 produce medicallow-THCcannabis.The applicant must possess a335valid certificate of registration issued by the Department of336Agriculture and Consumer Services pursuant to s. 581.131 that is337issued for the cultivation of more than 400,000 plants, be338operated by a nurseryman as defined in s. 581.011, and have been339operated as a registered nursery in this state for at least 30340continuous years.341 2. The ability to secure the premises, resources, and 342 personnel necessary to operate as an MMTCadispensing343organization. 344 3. The ability to maintain accountability of all raw 345 materials, finished products, and any byproducts to prevent 346 diversion or unlawful access to or possession of these 347 substances. 348 4. An infrastructure reasonably located to dispense medical 349low-THCcannabis to qualifyingregisteredpatients statewide or 350 regionally as determined by the department. 351 5. The financial ability to maintain operations for the 352 duration of the 2-year approval cycle, including the provision 353 of certified financials to the department. Upon approval, the 354 applicant must post a $5 million performance bond. However, upon 355adispensing organization’sserving at least 1,000 qualifying 356qualifiedpatients, the MMTCdispensing organizationisonly357 required to maintain only a $2 million performance bond. 358 6. That all owners and managers have been fingerprinted and 359 have successfully passed a level 2 background screening pursuant 360 to s. 435.04. 361 7. The employment of a medical director to supervise the 362 activities of the MMTCdispensing organization. 363(c)Upon the registration of 250,000 active qualified364patients in the compassionate use registry, approve three365dispensing organizations, including, but not limited to, an366applicant that is a recognized class member ofPigford v.367Glickman, 185 F.R.D. 82 (D.D.C. 1999), orIn Re Black Farmers368Litig., 856 F. Supp. 2d 1 (D.D.C. 2011), and a member of the369Black Farmers and Agriculturalists Association, which must meet370the requirements of subparagraphs (b)2.-7. and demonstrate the371technical and technological ability to cultivate and produce372low-THC cannabis.373 (c)(d)Allow an MMTCadispensing organizationto make a 374 wholesale purchase oflow-THC cannabis ormedical cannabis from, 375 or a distribution oflow-THC cannabis ormedical cannabis to, 376 another MMTCdispensing organization. 377 (d)(e)Monitor physician registration in the compassionate 378 use registry and the issuance of physician certifications 379ordering of low-THCcannabis, medical cannabis, or a cannabis380delivery device for ordering practicesthat could facilitate 381 unlawful diversion or misuse oflow-THC cannabis,medical 382 cannabis,or a cannabis delivery device and take disciplinary 383 action as indicated. 384 (e) Authorize the establishment of medical marijuana 385 testing facilities to ensure that all medical cannabis is tested 386 for potency and contaminants in accordance with the department’s 387 quality control program. A medical marijuana testing facility 388 may collect and accept samples of, and possess, store, 389 transport, and test medical cannabis. A medical marijuana 390 testing facility may not be owned by a person who also possesses 391 an ownership interest in an MMTC. 392 1. The department shall develop regulations concerning 393 medical marijuana testing facility license requirements, 394 suitability, and processes; develop an application form for a 395 medical marijuana testing facility license; and impose an 396 initial application fee and a biennial renewal fee sufficient to 397 cover the costs of administering this section. 398 2. In addition to licensure, a medical marijuana testing 399 facility must be certified to perform all required tests by the 400 department or by an accredited, third-party laboratory 401 certification body that meets department standards. The 402 department shall establish reasonable rules for the 403 certification and operation of medical marijuana testing 404 facilities. Rules for certification must, at a minimum, address 405 standards relating to: 406 a. Personnel qualifications; 407 b. Equipment and methodology; 408 c. Proficiency testing; 409 d. Tracking; 410 e. Sampling; 411 f. Chain of custody; 412 g. Record and sample retention; 413 h. Reporting; 414 i. Audit and inspection; and 415 j. Security. 416 3. The department shall suspend or reduce any mandatory 417 testing requirement specified in its quality control program if 418 the number of licensed and certified medical marijuana testing 419 facilities is insufficient to process the tests necessary to 420 meet the current and anticipated market for MMTCs. 421 4. A medical marijuana testing facility may accept only 422 samples composed of medical cannabis which are obtained from a 423 sample source approved by the department, including an MMTC, a 424 researcher affiliated with an accredited university or research 425 hospital, a qualifying patient, a caregiver, and any entity 426 authorized by the department. 427 (6) MEDICAL MARIJUANA TREATMENT CENTERSDISPENSING428ORGANIZATION.—An approved MMTCdispensing organizationmust, at 429 all times, maintain compliance with the criteria demonstrated 430 for selection and approval as an MMTCadispensing organization431 under subsection (5) and the criteria required in this 432 subsection. 433 (a) When growinglow-THC cannabis ormedical cannabis, an 434 MMTCadispensing organization: 435 1. May use pesticides determined by the department, after 436 consultation with the Department of Agriculture and Consumer 437 Services, to be safely applied to plants intended for human 438 consumption, but may not use pesticides designated as 439 restricted-use pesticides pursuant to s. 487.042. 440 2. Must growlow-THC cannabis ormedical cannabis within an 441 enclosed structure and in a room separate from any other plant. 442 3. Must inspect seeds and growing plants for plant pests 443 that endanger or threaten the horticultural and agricultural 444 interests of the state, notify the Department of Agriculture and 445 Consumer Services within 10 calendar days after a determination 446 that a plant is infested or infected by such plant pest, and 447 implement and maintain phytosanitary policies and procedures. 448 4. Must perform fumigation or treatment of plants, or the 449 removal and destruction of infested or infected plants, in 450 accordance with chapter 581 and any rules adopted thereunder. 451 (b) Before transferring medical cannabis to other licensed 452 premises or selling or transferring medical cannabis to a 453 qualifying patient or caregiver, an MMTCWhen processing low-THC454cannabis or medical cannabis, a dispensing organizationmust: 455 1. Have theProcess the low-THC cannabis or medical456cannabis within an enclosed structure and in a room separate457from other plants or products.4582.Test the processed low-THC cannabis andmedical cannabis 459 tested by a medical marijuana testing facility to ensure it 460 meets the standards established by the department’s quality 461 control program before it isthey aredispensed in accordance 462 with department rule.Results must be verified and signed by two463dispensing organization employees. Before dispensing low-THC464cannabis, the dispensing organization must determine that the465test results indicate that the low-THC cannabis meets the466definition of low-THC cannabis and, for medical cannabis and467low-THC cannabis, that all medical cannabis and low-THC cannabis468is safe for human consumption and free from contaminants that469are unsafe for human consumption. The dispensing organization470must retain records of all testing and samples of each471homogenous batch of cannabis and low-THC cannabis for at least 9472months. The dispensing organization must contract with an473independent testing laboratory to perform audits on the474dispensing organization’s standard operating procedures, testing475records, and samples and provide the results to the department476to confirm that the low-THC cannabis or medical cannabis meets477the requirements of this section and that the medical cannabis478and low-THC cannabis is safe for human consumption.479 2.3.Package thelow-THC cannabis ormedical cannabis in 480 compliance with the United States Poison Prevention Packaging 481 Act of 1970, 15 U.S.C. ss. 1471 et seq. 482 3.4.Package thelow-THC cannabis ormedical cannabis in a 483 receptacle that has a firmly affixed and legible label stating 484 the following information, and any other information required by 485 department rule: 486 a. A statement that thelow-THC cannabis ormedical 487 cannabis meets the requirements of subparagraph 1.2.; 488 b. The name of the medical marijuana treatment center 489dispensing organizationfrom which the medical cannabisor low490THC cannabisoriginates; and 491 c. The batch number, lot number, or other unique 492 identificationand harvestnumber from which the medical 493 cannabisor low-THC cannabisoriginates. 4945. Reserve two processed samples from each batch and retain495such samples for at least 9 months for the purpose of testing496pursuant to the audit required under subparagraph 2.497 (c) When dispensinglow-THC cannabis,medical cannabis,or 498 a cannabis delivery device, an MMTCa dispensing organization: 499 1. May not dispense more than a 45-day supply oflow-THC500cannabis ormedical cannabis to a patient or the patient’s 501 caregiverlegal representative. 502 2. Must have the MMTC’sdispensing organization’semployee 503 who dispenses thelow-THC cannabis,medical cannabis,or a 504 cannabis delivery device enter into the compassionate use 505 registry his or her name or unique employee identifier. 506 3. Must verify in the compassionate use registry that a 507 physician has ordered thelow-THC cannabis,medical cannabis,or 508 a specific type of a cannabis delivery device for the patient. 509 4. May not dispense or sell any other type of cannabis, 510 alcohol, or illicit drug-related product, including pipes, 511 bongs, or wrapping papers, other than a physician-ordered 512 cannabis delivery device required for the medical use oflow-THC513cannabis ormedical cannabis, while dispensinglow-THC cannabis514ormedical cannabis. 515 5. Must verify that the patient has an active registration 516 in the compassionate use registry, the patient or patient’s 517 caregiverlegal representativeholds a valid and active 518 identificationregistrationcard, the order presented matches 519 the order contents as recorded in the registry, and the order 520 has not already been filled. 521 6. Must, upon dispensing thelow-THC cannabis,medical 522 cannabis,or cannabis delivery device, record in the registry 523 the date, time, quantity, and form oflow-THC cannabis or524 medical cannabis dispensed and the type of cannabis delivery 525 device dispensed. 526 (d) To ensure the safety and security of its premises and 527 any off-site storage facilities, and to maintain adequate 528 controls against the diversion, theft, and loss oflow-THC529cannabis,medical cannabis,or cannabis delivery devices, an 530 MMTCa dispensing organizationshall: 531 1.a. Maintain a fully operational security alarm system 532 that secures all entry points and perimeter windows and is 533 equipped with motion detectors; pressure switches; and duress, 534 panic, and hold-up alarms; or 535 b. Maintain a video surveillance system that records 536 continuously 24 hours each day and meets at least one of the 537 following criteria: 538 (I) Cameras are fixed in a place that allows for the clear 539 identification of persons and activities in controlled areas of 540 the premises. Controlled areas include grow rooms, processing 541 rooms, storage rooms, disposal rooms or areas, and point-of-sale 542 rooms; 543 (II) Cameras are fixed in entrances and exits to the 544 premises, which shall record from both indoor and outdoor, or 545 ingress and egress, vantage points; 546 (III) Recorded images must clearly and accurately display 547 the time and date; or 548 (IV) Retain video surveillance recordings for a minimum of 549 45 days or longer upon the request of a law enforcement agency. 550 2. Ensure that the MMTC’sorganization’soutdoor premises 551 have sufficient lighting from dusk until dawn. 552 3. Establish and maintain a tracking system approved by the 553 department whichthattraces thelow-THC cannabis ormedical 554 cannabis from seed to sale. The tracking system mustshall555 include notification of key events as determined by the 556 department, including when cannabis seeds are planted, when 557 cannabis plants are harvested and destroyed, and whenlow-THC558cannabis ormedical cannabis is transported, sold, stolen, 559 diverted, or lost. 560 4. Not dispense from its premiseslow-THC cannabis,medical 561 cannabis,or a cannabis delivery device between the hours of 9 562 p.m. and 7 a.m., but may perform all other operations and 563 deliverlow-THC cannabis andmedical cannabis to qualifying 564qualifiedpatients 24 hours each day. 565 5. Storelow-THC cannabis ormedical cannabis in a secured, 566 locked room or a vault. 567 6. Require at least two of its employees, or two employees 568 of a security agency with whom it contracts, to be on the 569 premises at all times. 570 7. Require each employee to wear a photo identification 571 badge at all times while on the premises. 572 8. Require each visitor to wear a visitor’s pass at all 573 times while on the premises. 574 9. Implement an alcohol and drug-free workplace policy. 575 10. Report to local law enforcement within 24 hours after 576 it is notified or becomes aware of the theft, diversion, or loss 577 oflow-THC cannabis ormedical cannabis. 578 (e) To ensure the safe transport oflow-THC cannabisor579 medical cannabis to medical marijuana testing facilities, MMTCs, 580 caregiversdispensing organization facilities, independent581testing laboratories, or qualifying patients, an MMTC or medical 582 marijuana testing facility that transports medical cannabisthe583dispensing organizationmust: 584 1. Maintain a transportation manifest, which must be 585 retained for at least 1 year. 586 2. Ensure only vehicles in good working order are used to 587 transportlow-THC cannabis ormedical cannabis. 588 3. Locklow-THC cannabis ormedical cannabis in a separate 589 compartment or container within the vehicle. 590 4. Require at least two persons to be in a vehicle 591 transportinglow-THC cannabis ormedical cannabis, and require 592 at least one person to remain in the vehicle while thelow-THC593cannabis ormedical cannabis is being delivered. 594 5. Provide specific safety and security training to 595 employees transporting or deliveringlow-THC cannabis ormedical 596 cannabis. 597 (7) DEPARTMENT AUTHORITY AND RESPONSIBILITIES.— 598 (a) The department may conduct announced or unannounced 599 inspections of MMTCsdispensing organizationsto determine 600 compliance with this section or rules adopted pursuant to this 601 section. 602 (b) The department shall inspect an MMTCa dispensing603organizationupon complaint or notice provided to the department 604 that the MMTCdispensing organizationhas dispensedlow-THC605cannabis ormedical cannabis containing any mold, bacteria, or 606 other contaminant that may cause or has caused an adverse effect 607 to human health or the environment. 608 (c) The department shall conduct at least a biennial 609 inspection of each MMTCdispensing organizationto evaluate the 610 MMTC’sdispensing organization’srecords, personnel, equipment, 611 processes, security measures, sanitation practices, and quality 612 assurance practices. 613 (d) The department may enter into interagency agreements 614 with the Department of Agriculture and Consumer Services, the 615 Department of Business and Professional Regulation, the 616 Department of Transportation, the Department of Highway Safety 617 and Motor Vehicles, and the Agency for Health Care 618 Administration, and such agencies are authorized to enter into 619 an interagency agreement with the department, to conduct 620 inspections or perform other responsibilities assigned to the 621 department under this section. 622 (e) The department must make a list of all approved MMTCs, 623 physicians who aredispensing organizationsandqualified to 624 issue physician certifications,ordering physiciansand medical 625 directors of MMTCs publicly available on its website. 626(f) The department may establish a system for issuing and627renewing registration cards for patients and their legal628representatives, establish the circumstances under which the629cards may be revoked by or must be returned to the department,630and establish fees to implement such system. The department must631require, at a minimum, the registration cards to:6321. Provide the name, address, and date of birth of the633patient or legal representative.6342. Have a full-face, passport-type, color photograph of the635patient or legal representative taken within the 90 days636immediately preceding registration.6373. Identify whether the cardholder is a patient or legal638representative.6394. List a unique numeric identifier for the patient or640legal representative that is matched to the identifier used for641such person in the department’s compassionate use registry.6425. Provide the expiration date, which shall be 1 year after643the date of the physician’s initial order of low-THC cannabis or644medical cannabis.6456. For the legal representative, provide the name and646unique numeric identifier of the patient that the legal647representative is assisting.6487. Be resistant to counterfeiting or tampering.649 (f)(g)The department may impose reasonable fines not to 650 exceed $10,000 on an MMTCa dispensing organizationfor any of 651 the following violations: 652 1. Violating this section, s. 499.0295, or department rule. 653 2. Failing to maintain qualifications for approval. 654 3. Endangering the health, safety, or security of a 655 qualifyingqualifiedpatient. 656 4. Improperly disclosing personal and confidential 657 information of the qualifyingqualifiedpatient. 658 5. Attempting to procure MMTCdispensing organization659 approval by bribery, fraudulent misrepresentation, or extortion. 660 6. Being convicted or found guilty of, or entering a plea 661 of guilty or nolo contendere to, regardless of adjudication, a 662 crime in any jurisdiction which directly relates to the business 663 of an MMTCa dispensing organization. 664 7. Making or filing a report or record that the MMTC 665dispensing organizationknows to be false. 666 8. Willfully failing to maintain a record required by this 667 section or department rule. 668 9. Willfully impeding or obstructing an employee or agent 669 of the department in the furtherance of his or her official 670 duties. 671 10. Engaging in fraud or deceit, negligence, incompetence, 672 or misconduct in the business practices of an MMTCa dispensing673organization. 674 11. Making misleading, deceptive, or fraudulent 675 representations in or related to the business practices of an 676 MMTCa dispensing organization. 677 12. Having a license or the authority to engage in any 678 regulated profession, occupation, or business that is related to 679 the business practices of an MMTCa dispensing organization680 suspended, revoked, or otherwise acted against by the licensing 681 authority of any jurisdiction, including its agencies or 682 subdivisions, for a violation that would constitute a violation 683 under Florida law. 684 13. Violating a lawful order of the department or an agency 685 of the state, or failing to comply with a lawfully issued 686 subpoena of the department or an agency of the state. 687 (g)(h)The department may suspend, revoke, or refuse to 688 renew thea dispensing organization’sapproval of an MMTC if the 689 MMTCa dispensing organizationcommits any of the violations in 690 paragraph (f)(g). 691 (h)(i)The department shall renew the approval of an MMTCa692dispensing organizationbiennially if the MMTCdispensing693organizationmeets the requirements of this section and pays the 694 biennial renewal fee. 695 (i)1. The department shall establish a quality control 696 program requiring medical cannabis to be tested by a medical 697 marijuana testing facility for potency and contaminants before 698 sale to qualifying patients and caregivers. 699 a. The quality control program must require MMTCs to submit 700 samples from each batch or lot of medical cannabis harvested or 701 manufactured to a medical marijuana testing facility for testing 702 to ensure, at a minimum, that the labeling of the potency of 703 tetrahydrocannabinol and all other marketed cannabinoids or 704 terpenes is accurate and that the medical cannabis dispensed to 705 qualifying patients is safe for human consumption. 706 b. All samples submitted for testing to satisfy a test 707 required under the quality control program must be collected by 708 the medical marijuana testing facility or its certified agent in 709 accordance with department rules. 710 c. An MMTC must maintain records of all tests conducted on 711 medical cannabis, including the results of each test and any 712 additional information as required by the department. 713 2. The department shall adopt all rules necessary to create 714 and oversee the quality control program, which must include, at 715 a minimum: 716 a. Permissible levels of variation in potency labeling and 717 standards requiring tetrahydrocannabinol in edible medical 718 cannabis products to be distributed homogenously throughout the 719 product; 720 b. Permissible levels of contaminants and mandatory testing 721 for contaminants to confirm that the tested medical cannabis is 722 safe for human consumption, which must include, but is not 723 limited to, testing for microbiological impurity, residual 724 solvents, and pesticide residues; 725 c. The destruction of medical cannabis determined to be 726 inaccurately labeled or unsafe for human consumption after the 727 MMTC has an opportunity to take remedial action; 728 d. The collection, storage, handling, recording, and 729 destruction of samples of medical cannabis by medical marijuana 730 testing facilities; and 731 e. Security, inventory tracking, and record retention. 732 (j) The department may adopt rules necessary to implement 733 and administer this section. 734 (8) PREEMPTION.— 735 (a) All matters regarding the regulation of the cultivation 736 and processing of medical cannabisor low-THC cannabisby MMTCs 737dispensing organizationsare preempted to the state. 738 (b) A municipality may determine by ordinance the criteria 739 for the number and location of, and other permitting 740 requirements that do not conflict with state law or department 741 rule for, dispensing facilities of MMTCsdispensing742organizationslocated within its municipal boundaries. A county 743 may determine by ordinance the criteria for the number, 744 location, and other permitting requirements that do not conflict 745 with state law or department rule for all dispensing facilities 746 of MMTCsdispensing organizationslocated within the 747 unincorporated areas of that county. 748 (9) EXCEPTIONS TO OTHER LAWS.— 749 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 750 any other provision of law, but subject to the requirements of 751 this section, a qualifyingqualifiedpatient or a caregiverand752thequalifiedpatient’s legal representativemay purchase and 753 possess for the qualifying patient’s medical use up to the 754 amount oflow-THC cannabis ormedical cannabis ordered for the 755 patient, but not more than a 45-day supply, and a cannabis 756 delivery device ordered for the patient. 757 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 758 any other provision of law, but subject to the requirements of 759 this section, an MMTCan approved dispensing organizationand 760 its owners, managers, and employees may manufacture, possess, 761 sell, deliver, distribute, dispense, and lawfully dispose of 762 reasonable quantities, as established by department rule, of 763low-THC cannabis,medical cannabis,or a cannabis delivery 764 device. As used inFor purposes ofthis subsection, the terms 765 “manufacture,” “possession,” “deliver,” “distribute,” and 766 “dispense” have the same meanings as provided in s. 893.02. 767 (c) Notwithstandings. 893.13, s. 893.135, s. 893.147, or768 any other provision of law, but subject to the requirements of 769 this section, a medical marijuana testing facilityan approved770independent testing laboratorymay possess, test, transport, and 771 lawfully dispose oflow-THC cannabis ormedical cannabis as 772 provided by department rule. 773 (d) An approved MMTCdispensing organizationand its 774 owners, managers, and employees are not subject to licensure or 775 regulation under chapter 465 or chapter 499 for manufacturing, 776 possessing, selling, delivering, distributing, dispensing, or 777 lawfully disposing of reasonable quantities, as established by 778 department rule, oflow-THC cannabis,medical cannabis,or a 779 cannabis delivery device. 780 (e) An approved MMTCdispensing organizationthat continues 781 to meet the requirements for approval is presumed to be 782 registered with the department and to meet the regulations 783 adopted by the department or its successor agency for the 784 purpose of dispensing medical cannabisor low-THC cannabisunder 785 Florida law. Additionally, the authority provided to an MMTCa786dispensing organizationin s. 499.0295 does not impair its 787 registration with the departmentthe approval of a dispensing788organization. 789 (f) This subsection does not exempt a person from 790 prosecution for a criminal offense related to impairment or 791 intoxication resulting from the medical use oflow-THC cannabis792ormedical cannabis or relieve a person from any requirement 793 under law to submit to a breath, blood, urine, or other test to 794 detect the presence of a controlled substance. 795 Section 2. Subsections (1) and (2) of section 381.987, 796 Florida Statutes, are amended, and paragraphs (b) and (c) of 797 subsection (3) of that section are amended, to read: 798 381.987 Public records exemption for personal identifying 799 information in the compassionate use registry.— 800 (1) A patient’s personal identifying information held by 801 the department in the compassionate use registry established 802 under s. 381.986, including, but not limited to, the patient’s 803 name, address, telephone number, and government-issued 804 identification number, and all information pertaining to the 805 physician certificationphysician’s orderfor medicallow-THC806 cannabis and the dispensing thereof are confidential and exempt 807 from s. 119.07(1) and s. 24(a), Art. I of the State 808 Constitution. 809 (2) A physician’s identifying information held by the 810 department in the compassionate use registry established under 811 s. 381.986, including, but not limited to, the physician’s name, 812 address, telephone number, government-issued identification 813 number, and Drug Enforcement Administration number, and all 814 information pertaining to the physician certification 815physician’s orderfor medicallow-THCcannabis and the 816 dispensing thereof are confidential and exempt from s. 119.07(1) 817 and s. 24(a), Art. I of the State Constitution. 818 (3) The department shall allow access to the registry, 819 including access to confidential and exempt information, to: 820 (b) A medical marijuana treatment centerdispensing821organizationapproved by the department pursuant to s. 381.986 822 which is attempting to verify the authenticity of a physician 823 certificationphysician’sorderfor medicallow-THCcannabis, 824 including whether the physician certificationorderhad been 825 previously filled and whether the physician certificationorder826 was written for the person attempting to have it filled. 827 (c) A physician who has issued a physician certification 828written an orderfor medicallow-THCcannabis for the purpose of 829 monitoring the patient’s use of such cannabis or for the purpose 830 of determining, before issuing an order for medicallow-THC831 cannabis, whether another physician has ordered the patient’s 832 use of medicallow-THCcannabis. The physician may access the 833 confidential and exempt information only for the patient for 834 whom he or she has ordered or is determining whether to order 835 the use of medicallow-THCcannabis pursuant to s. 381.986. 836 Section 3. Section 385.211, Florida Statutes, is amended to 837 read: 838 385.211 Refractory and intractable epilepsy treatment and 839 research at recognized medical centers.— 840 (1) As used in this section, the term “medical cannabis” 841 has the same meaning“low-THC cannabis”means“low-THC cannabis”842 asdefinedin s. 381.986that is dispensed only froma843dispensing organizationas defined in s. 381.986. 844 (2) Notwithstanding chapter 893, medical centers recognized 845 pursuant to s. 381.925, or an academic medical research 846 institution legally affiliated with a licensed children’s 847 specialty hospital as defined in s. 395.002(28) whichthat848 contracts with the Department of Health, may conduct research on 849 cannabidiol and medicallow-THCcannabis. This research may 850 include, but is not limited to, the agricultural development, 851 production, clinical research, and use of liquid medical 852 derivatives of cannabidiol and medicallow-THCcannabis for the 853 treatment for refractory or intractable epilepsy. The authority 854 for recognized medical centers to conduct this research is 855 derived from 21 C.F.R. parts 312 and 316. Current state or 856 privately obtained research funds may be used to support the 857 activities described in this section. 858 Section 4. Present paragraphs (b) and (c) of subsection (2) 859 of section 499.0295, Florida Statutes, are redesignated as 860 paragraphs (a) and (b), respectively, present paragraphs (a) and 861 (c) of that subsection are amended, a new paragraph (c) is added 862 to that subsection, and subsection (3) of that section is 863 amended, to read: 864 499.0295 Experimental treatments for terminal conditions.— 865 (2) As used in this section, the term: 866(a) “Dispensing organization” means an organization867approved by the Department of Health under s. 381.986(5) to868cultivate, process, transport, and dispense low-THC cannabis,869medical cannabis, and cannabis delivery devices.870 (b)(c)“Investigational drug, biological product, or 871 device” means: 872 1. A drug, biological product, or device that has 873 successfully completed phase 1 of a clinical trial but has not 874 been approved for general use by the United States Food and Drug 875 Administration and remains under investigation in a clinical 876 trial approved by the United States Food and Drug 877 Administration; or 878 2. Medical cannabis that is manufactured and sold by an 879 MMTCadispensing organization. 880 (c) “Medical marijuana treatment center” or “MMTC” means an 881 organization registered with the Department of Health under s. 882 381.986. 883 (3) Upon the request of an eligible patient, a manufacturer 884 may, or, upon the issuance of a physician certificationa885physician’s orderpursuant to s. 381.986, an MMTCadispensing886organizationmay: 887 (a) Make its investigational drug, biological product, or 888 device available under this section. 889 (b) Provide an investigational drug, biological product, 890 device, or cannabis delivery device as defined in s. 381.986 to 891 an eligible patient without receiving compensation. 892 (c) Require an eligible patient to pay the costs of, or the 893 costs associated with, the manufacture of the investigational 894 drug, biological product, device, or cannabis delivery device as 895 defined in s. 381.986. 896 Section 5. Subsection (3) of section 893.02, Florida 897 Statutes, is amended to read: 898 893.02 Definitions.—The following words and phrases as used 899 in this chapter shall have the following meanings, unless the 900 context otherwise requires: 901 (3) “Cannabis” means all parts of any plant of the genus 902 Cannabis, whether growing or not; the seeds thereof; the resin 903 extracted from any part of the plant; and every compound, 904 manufacture, salt, derivative, mixture, or preparation of the 905 plant or its seeds or resin. The term does not include “medical 906 cannabis,”“low-THC cannabis,”as defined in s. 381.986, if 907 manufactured, possessed, sold, purchased, delivered, 908 distributed, or dispensed, in conformance with s. 381.986. 909 Section 6. Section 1004.441, Florida Statutes, is amended 910 to read: 911 1004.441 Refractory and intractable epilepsy treatment and 912 research.— 913 (1) As used in this section, the term “medical cannabis” 914 has the same meaning“low-THC cannabis”means“low-THC cannabis”915 asdefinedin s. 381.986that is dispensed only froma916dispensing organizationas defined in s. 381.986. 917 (2) Notwithstanding chapter 893, state universities with 918 both medical and agricultural research programs, including those 919 that have satellite campuses or research agreements with other 920 similar institutions, may conduct research on cannabidiol and 921 medicallow-THCcannabis. This research may include, but is not 922 limited to, the agricultural development, production, clinical 923 research, and use of liquid medical derivatives of cannabidiol 924 and medicallow-THCcannabis for the treatment for refractory or 925 intractable epilepsy. The authority for state universities to 926 conduct this research is derived from 21 C.F.R. parts 312 and 927 316. Current state or privately obtained research funds may be 928 used to support the activities authorized by this section. 929 Section 7. This act shall take effect July 1, 2017.