Bill Text: FL S7066 | 2015 | Regular Session | Comm Sub
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Low-THC Cannabis
Spectrum: Committee Bill
Status: (Introduced - Dead) 2015-05-01 - Died on Calendar [S7066 Detail]
Download: Florida-2015-S7066-Comm_Sub.html
Bill Title: Low-THC Cannabis
Spectrum: Committee Bill
Status: (Introduced - Dead) 2015-05-01 - Died on Calendar [S7066 Detail]
Download: Florida-2015-S7066-Comm_Sub.html
Florida Senate - 2015 CS for SB 7066 By the Committees on Health Policy; and Regulated Industries 588-03206-15 20157066c1 1 A bill to be entitled 2 An act relating to low-THC cannabis; amending s. 3 381.986, F.S.; defining terms; revising the illnesses 4 and symptoms for which a physician may order a patient 5 the medical use of low-THC cannabis in certain 6 circumstances; providing that a physician who 7 improperly orders low-THC cannabis is subject to 8 specified disciplinary action; revising the duties of 9 the Department of Health; requiring the department to 10 create a secure, electronic, and online compassionate 11 use registry; requiring the department to begin to 12 accept applications for licensure as a dispensing 13 organization according to a specified application 14 process; requiring the department to review all 15 applications, notify applicants of deficient 16 applications, and request any additional information 17 within a specified period; requiring an application 18 for licensure to be filed and complete by specified 19 dates; providing for a lottery for licensure as a 20 dispensing organization in certain circumstances; 21 authorizing the department to issue additional 22 licenses to qualified applicants in certain 23 circumstances; providing an exemption for the 24 application process; requiring the department to use 25 an application form that requires specified 26 information from the applicant; requiring the 27 department to impose specified application fees; 28 requiring the department to inspect each dispensing 29 organization’s properties, cultivation facilities, 30 processing facilities, and retail facilities before 31 those facilities may operate; authorizing followup 32 inspections at reasonable hours; providing that 33 licensure constitutes permission for the department to 34 enter and inspect the premises and facilities of any 35 dispensing organization; authorizing the department to 36 inspect any licensed dispensing organization; 37 requiring dispensing organizations to make all 38 facility premises, equipment, documents, low-THC 39 cannabis, and low-THC cannabis products available to 40 the department upon inspection; authorizing the 41 department to test low-THC cannabis or low-THC 42 cannabis products; authorizing the department to 43 suspend or revoke a license, deny or refuse to renew a 44 license, or impose a maximum administrative penalty 45 for specified acts or omissions; requiring the 46 department to create a permitting process for vehicles 47 used for the transportation of low-THC cannabis or 48 low-THC cannabis products; authorizing the department 49 to adopt rules as necessary for implementation of 50 specified provisions and procedures, and to provide 51 specified guidance; providing procedures and 52 requirements for an applicant seeking licensure as a 53 dispensing organization or the renewal of its license; 54 requiring the dispensing organization to verify 55 specified information of specified persons in certain 56 circumstances; authorizing a dispensing organization 57 to have cultivation facilities, processing facilities, 58 and retail facilities; authorizing a retail facility 59 to be established in a municipality only after such an 60 ordinance has been created; authorizing a retail 61 facility to be established in the unincorporated areas 62 of a county only after such an ordinance has been 63 created; requiring retail facilities to have all 64 utilities and resources necessary to store and 65 dispense low-THC and low-THC cannabis products; 66 requiring retail facilities to be secured with 67 specified theft-prevention systems; requiring a 68 dispensing organization to provide the department with 69 specified updated information within a specified 70 period; authorizing a dispensing organization to 71 transport low-THC cannabis or low-THC cannabis 72 products in vehicles in certain circumstances; 73 requiring such vehicles to be operated by specified 74 persons in certain circumstances; requiring a fee for 75 a vehicle permit; requiring the signature of the 76 designated driver with a vehicle permit application; 77 providing for expiration of the permit in certain 78 circumstances; requiring the department to cancel a 79 vehicle permit upon the request of specified persons; 80 providing that the licensee authorizes the inspection 81 and search of his or her vehicle without a search 82 warrant by specified persons; requiring all low-THC 83 cannabis and low-THC cannabis products to be tested by 84 an independent testing laboratory before the 85 dispensing organization may dispense it; requiring the 86 independent testing laboratory to provide the lab 87 results to the dispensing organization for a specified 88 determination; requiring all low-THC cannabis and low 89 THC cannabis products to be labeled with specified 90 information before dispensing; requiring the 91 University of Florida College of Pharmacy to establish 92 and maintain a specified safety and efficacy research 93 program; providing program requirements; requiring the 94 department to provide information from the 95 prescription drug monitoring program to the University 96 of Florida as needed; requiring the Agency for Health 97 Care Administration to provide access to specified 98 patient records under certain circumstances; providing 99 that the act does not provide an exception to the 100 prohibition against driving under the influence; 101 authorizing specified individuals to manufacture, 102 possess, sell, deliver, distribute, dispense, and 103 lawfully dispose of reasonable quantities of low-THC 104 cannabis; authorizing a licensed laboratory and its 105 employees to receive and possess low-THC cannabis in 106 certain circumstances; providing that specified rules 107 adopted by the department are exempt from the 108 requirement to be ratified by the Legislature; 109 amending s. 381.987, F.S.; requiring the department to 110 allow specified persons engaged in research to access 111 the compassionate use registry; amending s. 893.055, 112 F.S.; providing that persons engaged in research at 113 the University of Florida shall have access to 114 specified information; amending s. 893.0551, F.S.; 115 providing a specified public records exemption for 116 persons engaged in research at the University of 117 Florida; providing an effective date. 118 119 Be It Enacted by the Legislature of the State of Florida: 120 121 Section 1. Section 381.986, Florida Statutes, is amended to 122 read: 123 381.986 Compassionate use of low-THC cannabis.— 124 (1) DEFINITIONS.—As used in this section, the term: 125 (a) “Applicant” means a person that has submitted an 126 application to the department for licensure or renewal as a 127 dispensing organization. 128 (b) “Batch” means a specific quantity of low-THC cannabis 129 product that is intended to have uniform character and quality, 130 within specified limits, and is produced at the same time from 131 one or more harvests. 132 (c) “Dispensing organization” means an applicant licensed 133organization approvedby the department to cultivate, process, 134 and dispense low-THC cannabis pursuant to this section. 135 (d) “Harvest” means a specifically identified and numbered 136 quantity of low-THC cannabis cultivated using the same 137 herbicides, pesticides, and fungicides and harvested at the same 138 time from a single facility. 139 (e)(b)“Low-THC cannabis” means a plant of the genus 140 Cannabis, the dried flowers of which contain 0.8 percent or less 141 of tetrahydrocannabinol and more than 10 percent of cannabidiol 142 weight for weight; the seeds thereof; the resin extracted from 143 any part of such plant; or any compound, manufacture, salt, 144 derivative, mixture, or preparation of such plant or its seeds 145 or resin that is dispensed only from a dispensing organization. 146 (f) “Low-THC cannabis product” means any product derived 147 from low-THC cannabis, including the resin extracted from any 148 part of such plant or any compound, manufacture, salt, 149 derivative, mixture, or preparation of such plant or its seeds 150 or resin which is dispensed from a dispensing organization. Low 151 THC cannabis products include, but are not limited to, oils, 152 tinctures, creams, encapsulations, and food products. All low 153 THC cannabis products must maintain concentrations, weight for 154 weight, of 0.8 percent or less of tetrahydrocannabinol and more 155 than 10 percent of cannabidiol. 156 (g)(c)“Medical use” means administration of the ordered 157 amount of low-THC cannabis. The term does not include: 158 1. The possession, use, or administration by smoking;.159 2.The term also does not includeThe transfer of low-THC 160 cannabis to a person other than the qualified patient for whom 161 it was ordered or the qualified patient’s legal representative 162 who is registered in the compassionate use registry on behalf of 163 the qualified patient; or.164 3. The use or administration of low-THC cannabis or low-THC 165 cannabis products: 166 a. On any form of public transportation. 167 b. In any public place. 168 c. In a registered qualified patient’s place of work, if 169 restricted by his or her employer. 170 d. In a correctional facility. 171 e. On the grounds of any preschool, primary school, or 172 secondary school. 173 f. On a school bus. 174 (h)(d)“Qualified patient” means a resident of this state 175 who has been added to the compassionate use registry by a 176 physician licensed under chapter 458 or chapter 459 to receive 177 low-THC cannabis from a dispensing organization. 178 (i)(e)“Smoking” means burning or igniting a substance and 179 inhaling the smoke. Smoking does not include the use of a 180 vaporizer. 181 (2) PHYSICIAN ORDERING.— 182 (a)Effective January 1, 2015,A physician licensed under 183 chapter 458 or chapter 459 who has examined and is treating a 184 patient suffering from cancer, human immunodeficiency virus, 185 acquired immune deficiency syndrome, epilepsy, amyotrophic 186 lateral sclerosis, multiple sclerosis, Crohn’s disease, 187 Parkinson’s disease, paraplegia, quadriplegia, or terminal 188 illnessa physical medical condition that chronically produces189symptoms of seizures or severe and persistent muscle spasmsmay 190 order for the patient’s medical use low-THC cannabis to treat 191 such disease, disorder, or condition;orto alleviate symptoms 192 of such disease, disorder, or condition;,or to alleviate 193 symptoms caused by a treatment for such disease, disorder, or 194 condition if no other satisfactory alternative treatment options 195 exist for that patient and all of the followingconditions196 apply: 197 1.(a)The patient is a permanent resident of this state. 198 2.(b)The physician determines that the risks of ordering 199 low-THC cannabis are reasonable in light of the potential 200 benefit for that patient. If a patient is younger than 18 years 201 of age, a second physician must concur with this determination, 202 and such determination must be documented in the patient’s 203 medical record. 204 3.(c)The physician registers the patient, the patient’s 205 legal representative if requested by the patient, and himself or 206 herself as the orderer of low-THC cannabis for the named patient 207 on the compassionate use registry maintained by the department 208 and updates the registry to reflect the contents of the order. 209 If the patient is a minor, the physician must register a legal 210 representative on the compassionate use registry. The physician 211 shall deactivate the patient’s registration when treatment is 212 discontinued. 213 4.(d)The physician maintains a patient treatment plan that 214 includes the dose, route of administration, planned duration, 215 and monitoring of the patient’s symptoms and other indicators of 216 tolerance or reaction to the low-THC cannabis. 217 5.(e)The physician submits the patient treatment plan, as 218 well as any other requested medical records, quarterly to the 219 University of Florida College of Pharmacy for research on the 220 safety and efficacy of low-THC cannabis on patients pursuant to 221 subsection (8). 222 6.(f)The physician obtains the voluntary informed consent 223 of the patient or the patient’s legal guardian to treatment with 224 low-THC cannabis after sufficiently explaining the current state 225 of knowledge in the medical community of the effectiveness of 226 treatment of the patient’s conditions or symptomsconditionwith 227 low-THC cannabis, the medically acceptable alternatives, and the 228 potential risks and side effects. 229 (b) A physician who improperly orders low-THC cannabis is 230 subject to disciplinary action under the applicable practice act 231 and under s. 456.072(1)(k). 232 (3) PENALTIES.— 233 (a) A physician commits a misdemeanor of the first degree, 234 punishable as provided in s. 775.082 or s. 775.083, if the 235 physician orders low-THC cannabis for a patient without a 236 reasonable belief that the patient is suffering from at least 237 one of the conditions listed in subsection (2).:2381. Cancer or a physical medical condition that chronically239produces symptoms of seizures or severe and persistent muscle240spasms that can be treated with low-THC cannabis; or2412. Symptoms of cancer or a physical medical condition that242chronically produces symptoms of seizures or severe and243persistent muscle spasms that can be alleviated with low-THC244cannabis.245 (b) Any person who fraudulently represents that he or she 246 has at least one condition listed in subsection (2)cancer or a247physical medical condition that chronically produces symptoms of248seizures or severe and persistent muscle spasmsto a physician 249 for the purpose of being ordered low-THC cannabis by such 250 physician commits a misdemeanor of the first degree, punishable 251 as provided in s. 775.082 or s. 775.083. 252 (4) PHYSICIAN EDUCATION.— 253 (a) Before ordering low-THC cannabis for use by a patient 254 in this state, the appropriate board shall require the ordering 255 physician licensed under chapter 458 or chapter 459 to 256 successfully complete an 8-hour course and subsequent 257 examination offered by the Florida Medical Association or the 258 Florida Osteopathic Medical Association that encompasses the 259 clinical indications for the appropriate use of low-THC 260 cannabis, the appropriate delivery mechanisms, the 261 contraindications for such use, as well as the relevant state 262 and federal laws governing the ordering, dispensing, and 263 possessing of this substance. The first course and examination 264 shall be presented by October 1, 2014, and shall be administered 265 at least annually thereafter. Successful completion of the 266 course may be used by a physician to satisfy 8 hours of the 267 continuing medical education requirements required by his or her 268 respective board for licensure renewal. This course may be 269 offered in a distance learning format. 270 (b) The appropriate board shall require the medical 271 director of each dispensing organization approved under 272 subsection (5) to successfully complete a 2-hour course and 273 subsequent examination offered by the Florida Medical 274 Association or the Florida Osteopathic Medical Association that 275 encompasses appropriate safety procedures and knowledge of low 276 THC cannabis. 277 (c) Successful completion of the course and examination 278 specified in paragraph (a) is required for every physician who 279 orders low-THC cannabis each time such physician renews his or 280 her license. In addition, successful completion of the course 281 and examination specified in paragraph (b) is required for the 282 medical director of each dispensing organization each time such 283 physician renews his or her license. 284 (d) A physician who fails to comply with this subsection 285 and who orders low-THC cannabis may be subject to disciplinary 286 action under the applicable practice act and under s. 287 456.072(1)(k). 288 (5) DUTIES AND POWERS OF THE DEPARTMENT.—By January 1,2892015,The department shall:290 (a) The department shall create a secure, electronic, and 291 online compassionate use registry for the registration of 292 physicians and patients as provided under this section. The 293 registry must be accessible to law enforcement agencies and to a 294 dispensing organization in order to verify patient authorization 295 for low-THC cannabis and record the low-THC cannabis dispensed. 296 The registry must prevent an active registration of a patient by 297 multiple physicians. 298 (b)1. Beginning 7 days after the effective date of this 299 act, the department shall accept applications for licensure as a 300 dispensing organization. The department shall review each 301 application to determine whether the applicant meets the 302 criteria in subsection (6) and qualifies for licensure. 303 2. Within 10 days after receiving an application for 304 licensure, the department shall examine the application, notify 305 the applicant of any apparent errors or omissions, and request 306 any additional information the department is allowed by law to 307 require. An application for licensure must be filed with the 308 department no later than 5 p.m. on the 30th day after the 309 effective date of this act, and all applications must be 310 complete no later than 5 p.m. on the 60th day after the 311 effective date of this act. 312 3. If fewer than 20 applicants meet the criteria specified 313 in subsection (6), the department shall, by the 75th day after 314 the effective date of this act, license each such applicant. If 315 more than 20 applicants meet these criteria, licensure shall be 316 determined by lottery. 317 4. Beginning March 15, 2016, and every 6 months thereafter, 318 if fewer than 20 dispensing organization licenses have been 319 issued in this state, the department may issue additional 320 licenses to qualified applicants up to the 20-organization 321 maximum. The department shall use the same timeframes as set 322 forth in subparagraphs 1.-3., beginning 75 days before the date 323 specified for issuing additional licenses. If the number of 324 qualified applicants under this subparagraph exceeds the number 325 of dispensing organization licenses available for issuance, 326 licensure shall be determined by lottery. 327 5. This section is exempt from s. 120.60Authorize the328establishment of five dispensing organizations to ensure329reasonable statewide accessibility and availability as necessary330for patients registered in the compassionate use registry and331who are ordered low-THC cannabis under this section,one in each332of the following regions: northwest Florida, northeast Florida,333central Florida, southeast Florida, and southwest Florida. 334 (c) The department shall usedevelopan application form 335 that requires the applicant to state: 336 1. Whether the application is for initial licensure or 337 renewal licensure; 338 2. The name, the physical address, the mailing address, the 339 address listed on the Department of Agriculture and Consumer 340 Services certificate required in paragraph (6)(b), and the 341 contact information for the applicant and for the nursery that 342 holds the Department of Agriculture and Consumer Services 343 certificate, if different from the applicant; 344 3. The name, address, and contact information for the 345 operating nurseryman of the organization that holds the 346 Department of Agriculture and Consumer Services certificate; 347 4. The name, address, license number, and contact 348 information for the applicant’s medical director; and 349 5. All information required to be included by subsection 350 (6). 351 (d) The department shallandimpose an initial application 352 fee of $50,000, an initial licensure fee of $125,000, and a 353 biennial renewal fee of $125,000that is sufficient to cover the354costs of administering this section.An applicant for approval355as a dispensing organization must be able to demonstrate:3561. The technical and technological ability to cultivate and357produce low-THC cannabis. The applicant must possess a valid358certificate of registration issued by the Department of359Agriculture and Consumer Services pursuant to s. 581.131 that is360issued for the cultivation of more than 400,000 plants, be361operated by a nurseryman as defined in s. 581.011, and have been362operated as a registered nursery in this state for at least 30363continuous years.3642. The ability to secure the premises, resources, and365personnel necessary to operate as a dispensing organization.3663. The ability to maintain accountability of all raw367materials, finished products, and any byproducts to prevent368diversion or unlawful access to or possession of these369substances.3704. An infrastructure reasonably located to dispense low-THC371cannabis to registered patients statewide or regionally as372determined by the department.3735. The financial ability to maintain operations for the374duration of the 2-year approval cycle, including the provision375of certified financials to the department. Upon approval, the376applicant must post a $5 million performance bond.3776. That all owners and managers have been fingerprinted and378have successfully passed a level 2 background screening pursuant379to s. 435.04.3807. The employment of a medical director who is a physician381licensed under chapter 458 or chapter 459 to supervise the382activities of the dispensing organization.383 (e) The department shall inspect each dispensing 384 organization’s properties, cultivation facilities, processing 385 facilities, and retail facilities before they begin operations 386 and at least once every 2 years thereafter. The department may 387 conduct additional announced or unannounced inspections, 388 including followup inspections, at reasonable hours in order to 389 ensure that such property and facilities maintain compliance 390 with all applicable requirements in subsections (6) and (7) and 391 to ensure that the dispensing organization has not committed any 392 other act that would endanger the health, safety, or security of 393 a qualified patient, dispensing organization staff, or the 394 community in which the dispensing organization is located. 395 Licensure under this section constitutes permission for the 396 department to enter and inspect the premises and facilities of 397 any dispensing organization. The department may inspect any 398 licensed dispensing organization, and a dispensing organization 399 must make all facility premises, equipment, documents, low-THC 400 cannabis, and low-THC cannabis products available to the 401 department upon inspection. The department may test any low-THC 402 cannabis or low-THC cannabis product in order to ensure that it 403 is safe for human consumption and that it meets the requirements 404 in this section. 405 (f) The department may suspend or revoke a license, deny or 406 refuse to renew a license, or impose an administrative penalty 407 not to exceed $10,000 for the following acts or omissions: 408 1. A violation of this section or department rule. 409 2. Failing to maintain qualifications for licensure. 410 3. Endangering the health, safety, or security of a 411 qualified patient. 412 4. Improperly disclosing personal and confidential 413 information of the qualified patient. 414 5. Attempting to procure a license by bribery or fraudulent 415 misrepresentation. 416 6. Being convicted or found guilty of, or entering a plea 417 of nolo contendere to, regardless of adjudication, a crime in 418 any jurisdiction which directly relates to the business of a 419 dispensing organization. 420 7. Making or filing a report or record that the licensee 421 knows to be false. 422 8. Willfully failing to maintain a record required by this 423 section or rule of the department. 424 9. Willfully impeding or obstructing an employee or agent 425 of the department in the furtherance of his or her official 426 duties. 427 10. Engaging in fraud or deceit, negligence, incompetence, 428 or misconduct in the business practices of a dispensing 429 organization. 430 11. Making misleading, deceptive, or fraudulent 431 representations in or related to the business practices of a 432 dispensing organization. 433 12. Having a license or the authority to engage in any 434 regulated profession, occupation, or business that is related to 435 the business practices of a dispensing organization revoked, 436 suspended, or otherwise acted against, including the denial of 437 licensure, by the licensing authority of any jurisdiction, 438 including its agencies or subdivisions, for a violation that 439 would constitute a violation under state law. A licensing 440 authority’s acceptance of a relinquishment of licensure or a 441 stipulation, consent order, or other settlement, offered in 442 response to or in anticipation of the filing of charges against 443 the license, shall be construed as an action against the 444 license. 445 13. Violating a lawful order of the department or an agency 446 of the state, or failing to comply with a lawfully issued 447 subpoena of the department or an agency of the state. 448 (g) The department shall create a permitting process for 449 all dispensing organization vehicles used for the transportation 450 of low-THC cannabis or low-THC cannabis products. 451 (h)(c)The department shall monitor physician registration 452 and ordering of low-THC cannabis for ordering practices that 453 could facilitate unlawful diversion or misuse of low-THC 454 cannabis and take disciplinary action as indicated. 455 (i)(d)The department shall adopt rules as necessary to 456 implement this section. 457 (6) DISPENSING ORGANIZATION.— 458 (a) An applicant seeking licensure as a dispensing 459 organization, or the renewal of its license, must submit an 460 application to the department. The department must review all 461 applications for completeness, including an appropriate 462 inspection of the applicant’s property and facilities to verify 463 the authenticity of the information provided in, or in 464 connection with, the application. An applicant authorizes the 465 department to inspect his or her property and facilities for 466 licensure by applying under this subsection. 467 (b) In order to receive or maintain licensure as a 468 dispensing organization, an applicant must provide proof that: 469 1. The applicant, or a separate entity that is owned solely 470 by the same persons or entities in the same ratio as the 471 applicant, possesses a valid certificate of registration issued 472 by the Department of Agriculture and Consumer Services pursuant 473 to s. 581.131 for the cultivation of more than 400,000 plants, 474 is operated by a nurseryman as defined in s. 581.011, and has 475 been operated as a registered nursery in this state for at least 476 30 continuous years. 477 2. The personnel on staff or under contract for the 478 applicant have experience cultivating and introducing multiple 479 varieties of plants in this state, including plants that are not 480 native to Florida; experience with propagating plants; and 481 experience with genetic modification or breeding of plants. 482 3. The personnel on staff or under contract for the 483 applicant include at least one person who: 484 a. Has at least 5 years’ experience with United States 485 Department of Agriculture Good Agricultural Practices and Good 486 Handling Practices; 487 b. Has at least 5 years’ experience with United States Food 488 and Drug Administration Good Manufacturing Practices for food 489 production; 490 c. Has a doctorate degree in organic chemistry or 491 microbiology; 492 d. Has at least 5 years of experience with laboratory 493 procedures which includes analytical laboratory quality control 494 measures, chain of custody procedures, and analytical laboratory 495 methods; 496 e. Has experience with cannabis cultivation and processing, 497 including cannabis extraction techniques and producing cannabis 498 products; 499 f. Has experience and qualifications in chain of custody or 500 other tracking mechanisms; 501 g. Works solely on inventory control; and 502 h. Works solely for security purposes. 503 4. The persons who have a direct or indirect interest in 504 the dispensing organization and the applicant’s managers, 505 employees, and contractors who directly interact with low-THC 506 cannabis or low-THC cannabis products have been fingerprinted 507 and have successfully passed a level 2 background screening 508 pursuant to s. 435.04. 509 5. The applicant owns, or has at least a 2-year lease of, 510 all properties, facilities, and equipment necessary for the 511 cultivation and processing of low-THC cannabis. The applicant 512 must provide a detailed description of each facility and its 513 equipment, a cultivation and processing plan, and a detailed 514 floor plan. The description must include proof that: 515 a. The applicant is capable of sufficient cultivation and 516 processing to serve at least 15,000 patients with an assumed 517 daily use of 1,000 mg per patient per day of low-THC cannabis or 518 low-THC cannabis product; 519 b. The applicant has arranged for access to all utilities 520 and resources necessary to cultivate or process low-THC cannabis 521 at each listed facility; and 522 c. Each facility is secured and has theft-prevention 523 systems including an alarm system, cameras, and 24-hour security 524 personnel. 525 6. The applicant has diversion and tracking prevention 526 procedures, including: 527 a. A system for tracking low-THC material through 528 cultivation, processing, and dispensing, including the use of 529 batch and harvest numbers; 530 b. An inventory control system for low-THC cannabis and 531 low-THC cannabis products; 532 c. A vehicle tracking and security system; and 533 d. A cannabis waste-disposal plan. 534 7. The applicant has recordkeeping policies and procedures 535 in place. 536 8. The applicant has a facility emergency management plan. 537 9. The applicant has a plan for dispensing low-THC cannabis 538 throughout the state. This plan must include planned retail 539 facilities and a delivery plan for providing low-THC cannabis 540 and low-THC cannabis products to qualified patients who cannot 541 travel to a retail facility. 542 10. The applicant has financial documentation, including: 543 a. Documentation that demonstrates the applicant’s 544 financial ability to operate. If the applicant’s assets, credit, 545 and projected revenues meet or exceed projected liabilities and 546 expenses and the applicant provides independent evidence that 547 the funds necessary for startup costs, working capital, and 548 contingency financing exist and are available as needed, the 549 applicant has demonstrated the financial ability to operate. 550 Financial ability to operate must be documented by: 551 I. The applicant’s audited financial statements. If the 552 applicant is a newly formed entity and does not have a financial 553 history of business upon which audited financial statements may 554 be submitted, the applicant must provide audited financial 555 statements for the separate entity that is owned solely by the 556 same persons or entities in the same ratio as the applicant that 557 possesses the valid certificate of registration issued by the 558 Department of Agriculture and Consumer Services; 559 II. The applicant’s projected financial statements, 560 including a balance sheet, an income and expense statement, and 561 a statement of cash flow for the first 2 years of operation, 562 which provides evidence that the applicant has sufficient 563 assets, credit, and projected revenues to cover liabilities and 564 expenses; and 565 III. A statement of the applicant’s estimated startup costs 566 and sources of funds, including a break-even projection and 567 documentation demonstrating that the applicant has the ability 568 to fund all startup costs, working capital costs, and 569 contingency financing requirements. 570 571 All documents required under this sub-subparagraph shall be 572 prepared in accordance with generally accepted accounting 573 principles and signed by a certified public accountant. The 574 statements required by sub-sub-subparagraph II. and III. may be 575 presented as a compilation. 576 b. A list of all subsidiaries of the applicant; 577 c. A list of all lawsuits pending and completed within the 578 past 7 years of which the applicant was a party; and 579 d. Proof of a $1 million performance and compliance bond, 580 or other equivalent means of security deemed equivalent by the 581 department, such as an irrevocable letter of credit or a deposit 582 in a trust account or financial institution, payable to the 583 department, which must be posted once the applicant is approved 584 as a dispensing organization. The purpose of the bond is to 585 secure payment of any administrative penalties imposed by the 586 department and any fees and costs incurred by the department 587 regarding the dispensing organization license, such as the 588 dispensing organization failing to pay 30 days after the fine or 589 costs become final. The department may make a claim against such 590 bond or security until 1 year after the dispensing 591 organization’s license ceases to be valid or until 60 days after 592 any administrative or legal proceeding authorized in this 593 section involving the dispensing organization concludes, 594 including any appeal, whichever occurs later. 595 11. The employment of a medical director who is a physician 596 licensed under chapter 458 or chapter 459 to supervise the 597 activities of the dispensing organization. 598 (c) An approved dispensing organization shall maintain 599 compliance with the criteria in paragraphs (b), (d), and (e) and 600 subsection (7)demonstrated for selection and approval as a601dispensing organization under subsection (5)at all times. 602 Before dispensing low-THC cannabis or low-THC cannabis products 603 to a qualified patient or to the qualified patient’s legal 604 representative, the dispensing organization shall verify the 605 identity of the qualified patient or the qualified patient’s 606 legal representative by requiring the qualified patient or the 607 qualified patient’s legal representative to produce a 608 government-issued identification card and shall verify that the 609 qualified patient and the qualified patient’s legal 610 representative havehasan active registration in the 611 compassionate use registry, that the order presented matches the 612 order contents as recorded in the registry, and that the order 613 has not already been filled. Upon dispensing the low-THC 614 cannabis, the dispensing organization shall record in the 615 registry the date, time, quantity, and form of low-THC cannabis 616 dispensed. 617 (d) A dispensing organization may have cultivation 618 facilities, processing facilities, and retail facilities. 619 1. All matters regarding the location of cultivation 620 facilities and processing facilities are preempted to the state. 621 Cultivation facilities and processing facilities must be closed 622 to the public, and low-THC cannabis may not be dispensed on the 623 premises of such facilities. 624 2. A municipality must determine by ordinance the criteria 625 for the number, location, and other permitting requirements for 626 all retail facilities located within its municipal boundaries. A 627 retail facility may be established in a municipality only after 628 such an ordinance has been created. A county must determine by 629 ordinance the criteria for the number, location, and other 630 permitting requirements for all retail facilities located within 631 the unincorporated areas of that county. A retail facility may 632 be established in the unincorporated areas of a county only 633 after such an ordinance has been created. Retail facilities must 634 have all utilities and resources necessary to store and dispense 635 low-THC cannabis and low-THC cannabis products. Retail 636 facilities must be secured and have theft-prevention systems, 637 including an alarm system, cameras, and 24-hour security 638 personnel. Retail facilities may not sell, or contract for the 639 sale of, anything other than low-THC cannabis or low-THC 640 cannabis products on the property of the retail facility. Before 641 a retail facility may dispense low-THC cannabis or a low-THC 642 cannabis product, the dispensing organization must have a 643 computer network compliant with the federal Health Insurance 644 Portability and Accountability Act of 1996 which is able to 645 access and upload data to the compassionate use registry and 646 which shall be used by all retail facilities. 647 (e) Within 15 days of such information becoming available, 648 a dispensing organization must provide the department with 649 updated information, as applicable, including: 650 1. The location and a detailed description of any new or 651 proposed facilities. 652 2. The updated contact information, including electronic 653 and voice communication, for all dispensing organization 654 facilities. 655 3. The registration information for any vehicles used for 656 the transportation of low-THC cannabis and low-THC cannabis 657 product, including confirmation that all such vehicles have 658 tracking and security systems. 659 4. A plan for the recall of any or all low-THC cannabis or 660 low-THC cannabis product. 661 (f)1. A dispensing organization may transport low-THC 662 cannabis or low-THC cannabis products in vehicles departing from 663 their places of business only in vehicles that are owned or 664 leased by the licensee or by a person designated by the 665 dispensing organization, and for which a valid vehicle permit 666 has been issued for such vehicle by the department. 667 2. A vehicle owned or leased by the dispensing organization 668 or a person designated by the dispensing organization and 669 approved by the department must be operated by such person when 670 transporting low-THC cannabis or low-THC products from the 671 licensee’s place of business. 672 3. A vehicle permit may be obtained by a dispensing 673 organization upon application and payment of a fee of $5 per 674 vehicle to the department. The signature of the person 675 designated by the dispensing organization to drive the vehicle 676 must be included on the vehicle permit application. Such permit 677 remains valid and does not expire unless the licensee or any 678 person designated by the dispensing organization disposes of his 679 or her vehicle, or the licensee’s license is transferred, 680 canceled, not renewed, or is revoked by the department, 681 whichever occurs first. The department shall cancel a vehicle 682 permit upon request of the licensee or owner of the vehicle. 683 4. By acceptance of a license issued under this section, 684 the licensee agrees that the licensed vehicle is, at all times 685 it is being used to transport low-THC cannabis or low-THC 686 cannabis products, subject to inspection and search without a 687 search warrant by authorized employees of the department, 688 sheriffs, deputy sheriffs, police officers, or other law 689 enforcement officers to determine that the licensee is 690 transporting such products in compliance with this section. 691 (7) TESTING AND LABELING OF LOW-THC CANNABIS.— 692 (a) All low-THC cannabis and low-THC cannabis products must 693 be tested by an independent testing laboratory before the 694 dispensing organization may dispense them. The independent 695 testing laboratory shall provide the dispensing organization 696 with lab results. Before dispensing, the dispensing organization 697 must determine that the lab results indicate that the low-THC 698 cannabis or low-THC cannabis product meets the definition of 699 low-THC cannabis or low-THC cannabis product, is safe for human 700 consumption, and is free from harmful contaminants. 701 (b) All low-THC cannabis and low-THC cannabis products must 702 be labeled before dispensing. The label must include, at a 703 minimum: 704 1. A statement that the low-THC cannabis or low-THC 705 cannabis product meets the requirements in paragraph (a); 706 2. The name of the independent testing laboratory that 707 tested the low-THC cannabis or low-THC cannabis product; 708 3. The name of the cultivation and processing facility 709 where the low-THC cannabis or low-THC cannabis product 710 originates; and 711 4. The batch number and harvest number from which the low 712 THC cannabis or low-THC cannabis product originates. 713 (8) SAFETY AND EFFICACY RESEARCH FOR LOW-THC CANNABIS.—The 714 University of Florida College of Pharmacy must establish and 715 maintain a safety and efficacy research program for the use of 716 low-THC cannabis or low-THC cannabis products to treat 717 qualifying conditions and symptoms. The program must include a 718 fully integrated electronic information system for the broad 719 monitoring of health outcomes and safety signal detection. The 720 electronic information system must include information from the 721 compassionate use registry; provider reports, including 722 treatment plans, adverse event reports, and treatment 723 discontinuation reports; patient reports of adverse impacts; 724 event-triggered interviews and medical chart reviews performed 725 by University of Florida clinical research staff; information 726 from external databases, including Medicaid billing reports and 727 information in the prescription drug monitoring database for 728 registered patients; and all other medical reports required by 729 the University of Florida to conduct the research required by 730 this subsection. The department must provide access to 731 information from the compassionate use registry and the 732 prescription drug monitoring database, established in s. 733 893.055, as needed by the University of Florida to conduct 734 research under this subsection. The Agency for Health Care 735 Administration must provide access to registered patient 736 Medicaid records, to the extent allowed under federal law, as 737 needed by the University of Florida to conduct research under 738 this subsection. 739 (9)(7)EXCEPTIONS TO OTHER LAWS.— 740 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 741 any otherprovision oflaw, but subject to the requirements of 742 this section, a qualified patient and the qualified patient’s 743 legal representative who is registered with the department on 744 the compassionate use registry may purchase and possess for the 745 patient’s medical use up to the amount of low-THC cannabis 746 ordered for the patient. Nothing in this section exempts any 747 person from the prohibition against driving under the influence 748 provided in s. 316.193. 749 (b) 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, an approved dispensing organization and its 752 owners, managers,andemployees and the owners, managers, and 753 employees of contractors who have direct contact with low-THC 754 cannabis or low-THC cannabis product may manufacture, possess, 755 sell, deliver, distribute, dispense, and lawfully dispose of 756 reasonable quantities, as established by department rule, of 757 low-THC cannabis. For purposes of this subsection, the terms 758 “manufacture,” “possession,” “deliver,” “distribute,” and 759 “dispense” have the same meanings as provided in s. 893.02. 760 (c) An approved dispensing organization and its owners, 761 managers, and employees are not subject to licensure or 762 regulation under chapter 465 or chapter 499 for manufacturing, 763 possessing, selling, delivering, distributing, dispensing, or 764 lawfully disposing of reasonable quantities, as established by 765 department rule, of low-THC cannabis. 766 (d) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 767 any other law, but subject to the requirements of this section, 768 a licensed laboratory and its employees may receive and possess 769 low-THC cannabis for the sole purpose of testing the low-THC 770 cannabis to ensure compliance with this section. 771 (10) Rules adopted by the department under this section are 772 exempt from the requirement that they be ratified by the 773 Legislature pursuant to s. 120.541(3). 774 Section 2. Paragraph (g) is added to subsection (3) of 775 section 381.987, Florida Statutes, to read: 776 381.987 Public records exemption for personal identifying 777 information in the compassionate use registry.— 778 (3) The department shall allow access to the registry, 779 including access to confidential and exempt information, to: 780 (g) Persons engaged in research at the University of 781 Florida pursuant to s. 381.986(8). 782 Section 3. Paragraph (b) of subsection (7) of section 783 893.055, Florida Statutes, is amended to read: 784 893.055 Prescription drug monitoring program.— 785 (7) 786 (b) A pharmacy, prescriber, or dispenser shall have access 787 to information in the prescription drug monitoring program’s 788 database which relates to a patient of that pharmacy, 789 prescriber, or dispenser in a manner established by the 790 department as needed for the purpose of reviewing the patient’s 791 controlled substance prescription history. Persons engaged in 792 research at the University of Florida pursuant to s. 381.986(8) 793 shall have access to information in the prescription drug 794 monitoring program’s database which relates to qualified 795 patients as defined in s. 381.986(1) for the purpose of 796 conducting such research. Other access to the program’s database 797 shall be limited to the program’s manager and to the designated 798 program and support staff, who may act only at the direction of 799 the program manager or, in the absence of the program manager, 800 as authorized. Access by the program manager or such designated 801 staff is for prescription drug program management only or for 802 management of the program’s database and its system in support 803 of the requirements of this section and in furtherance of the 804 prescription drug monitoring program. Confidential and exempt 805 information in the database shall be released only as provided 806 in paragraph (c) and s. 893.0551. The program manager, 807 designated program and support staff who act at the direction of 808 or in the absence of the program manager, and any individual who 809 has similar access regarding the management of the database from 810 the prescription drug monitoring program shall submit 811 fingerprints to the department for background screening. The 812 department shall follow the procedure established by the 813 Department of Law Enforcement to request a statewide criminal 814 history record check and to request that the Department of Law 815 Enforcement forward the fingerprints to the Federal Bureau of 816 Investigation for a national criminal history record check. 817 Section 4. Paragraph (h) is added to subsection (3) of 818 section 893.0551, Florida Statutes, to read: 819 893.0551 Public records exemption for the prescription drug 820 monitoring program.— 821 (3) The department shall disclose such confidential and 822 exempt information to the following persons or entities upon 823 request and after using a verification process to ensure the 824 legitimacy of the request as provided in s. 893.055: 825 (h) Persons engaged in research at the University of 826 Florida pursuant to s. 381.986(8). 827 Section 5. This act shall take effect upon becoming a law.