Florida Senate - 2015 (Proposed Bill) SPB 7066 FOR CONSIDERATION By the Committee on Regulated Industries 580-02582A-15 1 20157066pb 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, Page 1 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 20157066pb 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; requiring a dispensing Page 2 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 20157066pb 59 organization to provide the department with specified 60 updated information within a specified period; 61 authorizing a dispensing organization to transport 62 low-THC cannabis or low-THC cannabis products in 63 vehicles in certain circumstances; requiring such 64 vehicles to be operated by specified persons in 65 certain circumstances; requiring a fee for a vehicle 66 permit; requiring the signature of the designated 67 driver with a vehicle permit application; providing 68 for expiration of the permit in certain circumstances; 69 requiring the department to cancel a vehicle permit 70 upon the request of specified persons; providing that 71 the licensee authorizes the inspection and search of 72 his or her vehicle without a search warrant by 73 specified persons; requiring all low-THC cannabis and 74 low-THC cannabis products to be tested by an 75 independent testing laboratory before the dispensing 76 organization may dispense it; requiring the 77 independent testing laboratory to provide the lab 78 results to the dispensing organization for a specified 79 determination; requiring all low-THC cannabis and low- 80 THC cannabis products to be labeled with specified 81 information before dispensing; requiring the 82 University of Florida College of Pharmacy to establish 83 and maintain a specified safety and efficacy research 84 program; providing program requirements; requiring the 85 department to provide information from the 86 prescription drug monitoring program to the University 87 of Florida as needed; requiring the Agency for Health Page 3 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 20157066pb 88 Care Administration to provide access to specified 89 patient records under certain circumstances; 90 authorizing specified individuals to manufacture, 91 possess, sell, deliver, distribute, dispense, and 92 lawfully dispose of reasonable quantities of low-THC 93 cannabis; authorizing a licensed laboratory and its 94 employees to receive and possess low-THC cannabis in 95 certain circumstances; providing that specified rules 96 adopted by the department are exempt from the 97 requirement to be ratified by the Legislature; 98 amending s. 381.987, F.S.; requiring the department to 99 allow specified persons engaged in research to access 100 the compassionate use registry; amending s. 893.055, 101 F.S.; providing that persons engaged in research at 102 the University of Florida shall have access to 103 specified information; amending s. 893.0551, F.S.; 104 providing a specified public records exemption for 105 persons engaged in research at the University of 106 Florida; providing an effective date. 107 108 Be It Enacted by the Legislature of the State of Florida: 109 110 111 Section 1. Section 381.986, Florida Statutes, is amended to read: 112 381.986 Compassionate use of low-THC cannabis.— 113 (1) DEFINITIONS.—As used in this section, the term: 114 (a) “Applicant” means a person that has submitted an 115 application to the department for licensure or renewal as a 116 dispensing organization. Page 4 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 117 20157066pb (b) “Batch” means a specific quantity of low-THC cannabis 118 product that is intended to have uniform character and quality, 119 within specified limits, and is produced at the same time from 120 one or more harvests. 121 (c) “Dispensing organization” means an applicant licensed 122 organization approved by the department to cultivate, process, 123 and dispense low-THC cannabis pursuant to this section. 124 (d) “Harvest” means a specifically identified and numbered 125 quantity of low-THC cannabis cultivated using the same 126 herbicides, pesticides, and fungicides and harvested at the same 127 time from a single facility. 128 (e)(b) “Low-THC cannabis” means a plant of the genus 129 Cannabis, the dried flowers of which contain 0.8 percent or less 130 of tetrahydrocannabinol and more than 10 percent of cannabidiol 131 weight for weight; the seeds thereof; the resin extracted from 132 any part of such plant; or any compound, manufacture, salt, 133 derivative, mixture, or preparation of such plant or its seeds 134 or resin that is dispensed only from a dispensing organization. 135 (f) “Low-THC cannabis product” means any product derived 136 from low-THC cannabis, including the resin extracted from any 137 part of such plant or any compound, manufacture, salt, 138 derivative, mixture, or preparation of such plant or its seeds 139 or resin which is dispensed from a dispensing organization. Low- 140 THC cannabis products include, but are not limited to, oils, 141 tinctures, creams, encapsulations, and food products. All low- 142 THC cannabis products must maintain concentrations, weight for 143 weight, of 0.8 percent or less of tetrahydrocannabinol and more 144 than 10 percent of cannabidiol. 145 (g)(c) “Medical use” means administration of the ordered Page 5 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 146 20157066pb amount of low-THC cannabis. The term does not include: 147 1. The possession, use, or administration by smoking;. 148 2. The term also does not include The transfer of low-THC 149 cannabis to a person other than the qualified patient for whom 150 it was ordered or the qualified patient’s legal representative 151 who is registered in the compassionate use registry on behalf of 152 the qualified patient; or. 153 3. The use or administration of medical-grade marijuana: 154 a. On any form of public transportation. 155 b. In any public place. 156 c. In a registered qualified patient’s place of work, if 157 restricted by his or her employer. 158 d. In a correctional facility. 159 e. On the grounds of any preschool, primary school, or 160 secondary school. 161 f. On a school bus. 162 (h)(d) “Qualified patient” means a resident of this state 163 who has been added to the compassionate use registry by a 164 physician licensed under chapter 458 or chapter 459 to receive 165 low-THC cannabis from a dispensing organization. 166 (i)(e) “Smoking” means burning or igniting a substance and 167 inhaling the smoke. Smoking does not include the use of a 168 vaporizer. 169 (2) PHYSICIAN ORDERING.— 170 (a) Effective January 1, 2015, A physician licensed under 171 chapter 458 or chapter 459 who has examined and is treating a 172 patient suffering from cancer, human immunodeficiency virus, 173 acquired immune deficiency syndrome, epilepsy, amyotrophic 174 lateral sclerosis, multiple sclerosis, Crohn’s disease, Page 6 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 20157066pb 175 Parkinson’s disease, paraplegia, quadriplegia, or terminal 176 illness a physical medical condition that chronically produces 177 symptoms of seizures or severe and persistent muscle spasms may 178 order for the patient’s medical use low-THC cannabis to treat 179 such disease, disorder, or condition; or to alleviate symptoms 180 of such disease, disorder, or condition;, or to alleviate 181 symptoms caused by a treatment for such disease, disorder, or 182 condition if no other satisfactory alternative treatment options 183 exist for that patient and all of the following conditions 184 apply: 185 1.(a) The patient is a permanent resident of this state. 186 2.(b) The physician determines that the risks of ordering 187 low-THC cannabis are reasonable in light of the potential 188 benefit for that patient. If a patient is younger than 18 years 189 of age, a second physician must concur with this determination, 190 and such determination must be documented in the patient’s 191 medical record. 192 3.(c) The physician registers the patient, the patient’s 193 legal representative if requested by the patient, and himself or 194 herself as the orderer of low-THC cannabis for the named patient 195 on the compassionate use registry maintained by the department 196 and updates the registry to reflect the contents of the order. 197 If the patient is a minor, the physician must register a legal 198 representative on the compassionate use registry. The physician 199 shall deactivate the patient’s registration when treatment is 200 discontinued. 201 4.(d) The physician maintains a patient treatment plan that 202 includes the dose, route of administration, planned duration, 203 and monitoring of the patient’s symptoms and other indicators of Page 7 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 204 205 20157066pb tolerance or reaction to the low-THC cannabis. 5.(e) The physician submits the patient treatment plan, as 206 well as any other requested medical records, quarterly to the 207 University of Florida College of Pharmacy for research on the 208 safety and efficacy of low-THC cannabis on patients pursuant to 209 subsection (8). 210 6.(f) The physician obtains the voluntary informed consent 211 of the patient or the patient’s legal guardian to treatment with 212 low-THC cannabis after sufficiently explaining the current state 213 of knowledge in the medical community of the effectiveness of 214 treatment of the patient’s conditions or symptoms condition with 215 low-THC cannabis, the medically acceptable alternatives, and the 216 potential risks and side effects. 217 (b) A physician who improperly orders low-THC cannabis is 218 subject to disciplinary action under the applicable practice act 219 and under s. 456.072(1)(k). 220 (3) PENALTIES.— 221 (a) A physician commits a misdemeanor of the first degree, 222 punishable as provided in s. 775.082 or s. 775.083, if the 223 physician orders low-THC cannabis for a patient without a 224 reasonable belief that the patient is suffering from at least 225 one of the conditions listed in subsection (2).: 226 1. Cancer or a physical medical condition that chronically 227 produces symptoms of seizures or severe and persistent muscle 228 spasms that can be treated with low-THC cannabis; or 229 2. Symptoms of cancer or a physical medical condition that 230 chronically produces symptoms of seizures or severe and 231 persistent muscle spasms that can be alleviated with low-THC 232 cannabis. Page 8 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 233 20157066pb (b) Any person who fraudulently represents that he or she 234 has at least one condition listed in subsection (2) cancer or a 235 physical medical condition that chronically produces symptoms of 236 seizures or severe and persistent muscle spasms to a physician 237 for the purpose of being ordered low-THC cannabis by such 238 physician commits a misdemeanor of the first degree, punishable 239 as provided in s. 775.082 or s. 775.083. 240 (4) PHYSICIAN EDUCATION.— 241 (a) Before ordering low-THC cannabis for use by a patient 242 in this state, the appropriate board shall require the ordering 243 physician licensed under chapter 458 or chapter 459 to 244 successfully complete an 8-hour course and subsequent 245 examination offered by the Florida Medical Association or the 246 Florida Osteopathic Medical Association that encompasses the 247 clinical indications for the appropriate use of low-THC 248 cannabis, the appropriate delivery mechanisms, the 249 contraindications for such use, as well as the relevant state 250 and federal laws governing the ordering, dispensing, and 251 possessing of this substance. The first course and examination 252 shall be presented by October 1, 2014, and shall be administered 253 at least annually thereafter. Successful completion of the 254 course may be used by a physician to satisfy 8 hours of the 255 continuing medical education requirements required by his or her 256 respective board for licensure renewal. This course may be 257 offered in a distance learning format. 258 (b) The appropriate board shall require the medical 259 director of each dispensing organization approved under 260 subsection (5) to successfully complete a 2-hour course and 261 subsequent examination offered by the Florida Medical Page 9 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 20157066pb 262 Association or the Florida Osteopathic Medical Association that 263 encompasses appropriate safety procedures and knowledge of low- 264 THC cannabis. 265 (c) Successful completion of the course and examination 266 specified in paragraph (a) is required for every physician who 267 orders low-THC cannabis each time such physician renews his or 268 her license. In addition, successful completion of the course 269 and examination specified in paragraph (b) is required for the 270 medical director of each dispensing organization each time such 271 physician renews his or her license. 272 (d) A physician who fails to comply with this subsection 273 and who orders low-THC cannabis may be subject to disciplinary 274 action under the applicable practice act and under s. 275 456.072(1)(k). 276 277 278 (5) DUTIES AND POWERS OF THE DEPARTMENT.—By January 1, 2015, The department shall: (a) The department shall create a secure, electronic, and 279 online compassionate use registry for the registration of 280 physicians and patients as provided under this section. The 281 registry must be accessible to law enforcement agencies and to a 282 dispensing organization in order to verify patient authorization 283 for low-THC cannabis and record the low-THC cannabis dispensed. 284 The registry must prevent an active registration of a patient by 285 multiple physicians. 286 (b)1. Beginning 7 days after the effective date of this 287 act, the department shall accept applications for licensure as a 288 dispensing organization. The department shall review each 289 application to determine whether the applicant meets the 290 criteria in subsection (6) and qualifies for licensure. Page 10 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 291 20157066pb 2. Within 10 days after receiving an application for 292 licensure, the department shall examine the application, notify 293 the applicant of any apparent errors or omissions, and request 294 any additional information the department is allowed by law to 295 require. An application for licensure must be filed with the 296 department no later than 5 p.m. on the 30th day after the 297 effective date of this act, and all applications must be 298 complete no later than 5 p.m. on the 60th day after the 299 effective date of this act. 300 3. If fewer than 20 applicants meet the criteria specified 301 in subsection (6), the department shall, by the 75th day after 302 the effective date of this act, license each such applicant. If 303 more than 20 applicants meet these criteria, licensure shall be 304 determined by lottery. 305 4. Beginning March 15, 2016, and every 6 months thereafter, 306 if fewer than 20 dispensing organization licenses have been 307 issued in this state, the department may issue additional 308 licenses to qualified applicants up to the 20-organization 309 maximum. If the number of qualified applicants under this 310 subparagraph exceeds the number of dispensing organization 311 licenses available for issuance, licensure shall be determined 312 by lottery. 313 5. This section is exempt from s. 120.60 Authorize the 314 establishment of five dispensing organizations to ensure 315 reasonable statewide accessibility and availability as necessary 316 for patients registered in the compassionate use registry and 317 who are ordered low-THC cannabis under this section, one in each 318 of the following regions: northwest Florida, northeast Florida, 319 central Florida, southeast Florida, and southwest Florida. Page 11 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 320 321 (c) The department shall use develop an application form that requires the applicant to state: 322 323 20157066pb 1. Whether the application is for initial licensure or renewal licensure; 324 2. The name, the physical address, the mailing address, the 325 address listed on the Department of Agriculture and Consumer 326 Services certificate required in paragraph (6)(b), and the 327 contact information for the applicant and for the nursery that 328 holds the Department of Agriculture and Consumer Services 329 certificate, if different from the applicant; 330 3. The name, address, and contact information for the 331 operating nurseryman of the organization that holds the 332 Department of Agriculture and Consumer Services certificate; 333 334 4. The name, address, license number, and contact information for the applicant’s medical director; and 335 336 337 5. All information required to be included by subsection (6). (d) The department shall and impose an initial application 338 fee of $50,000, an initial licensure fee of $125,000, and a 339 biennial renewal fee of $125,000 that is sufficient to cover the 340 costs of administering this section. An applicant for approval 341 as a dispensing organization must be able to demonstrate: 342 1. The technical and technological ability to cultivate and 343 produce low-THC cannabis. The applicant must possess a valid 344 certificate of registration issued by the Department of 345 Agriculture and Consumer Services pursuant to s. 581.131 that is 346 issued for the cultivation of more than 400,000 plants, be 347 operated by a nurseryman as defined in s. 581.011, and have been 348 operated as a registered nursery in this state for at least 30 Page 12 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 349 350 351 352 20157066pb continuous years. 2. The ability to secure the premises, resources, and personnel necessary to operate as a dispensing organization. 3. The ability to maintain accountability of all raw 353 materials, finished products, and any byproducts to prevent 354 diversion or unlawful access to or possession of these 355 substances. 356 4. An infrastructure reasonably located to dispense low-THC 357 cannabis to registered patients statewide or regionally as 358 determined by the department. 359 5. The financial ability to maintain operations for the 360 duration of the 2-year approval cycle, including the provision 361 of certified financials to the department. Upon approval, the 362 applicant must post a $5 million performance bond. 363 6. That all owners and managers have been fingerprinted and 364 have successfully passed a level 2 background screening pursuant 365 to s. 435.04. 366 7. The employment of a medical director who is a physician 367 licensed under chapter 458 or chapter 459 to supervise the 368 activities of the dispensing organization. 369 (e) The department shall inspect each dispensing 370 organization’s properties, cultivation facilities, processing 371 facilities, and retail facilities before they begin operations 372 and at least once every 2 years thereafter. The department may 373 conduct additional announced or unannounced inspections, 374 including followup inspections, at reasonable hours in order to 375 ensure that such property and facilities maintain compliance 376 with all applicable requirements in subsections (6) and (7) and 377 to ensure that the dispensing organization has not committed any Page 13 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 20157066pb 378 other act that would endanger the health, safety, or security of 379 a qualified patient, dispensing organization staff, or the 380 community in which the dispensing organization is located. 381 Licensure under this section constitutes permission for the 382 department to enter and inspect the premises and facilities of 383 any dispensing organization. The department may inspect any 384 licensed dispensing organization, and a dispensing organization 385 must make all facility premises, equipment, documents, low-THC 386 cannabis, and low-THC cannabis products available to the 387 department upon inspection. The department may test any low-THC 388 cannabis or low-THC cannabis product in order to ensure that it 389 is safe for human consumption and that it meets the requirements 390 in this section. 391 (f) The department may suspend or revoke a license, deny or 392 refuse to renew a license, or impose an administrative penalty 393 not to exceed $10,000 for the following acts or omissions: 394 1. A violation of this section or department rule. 395 2. Failing to maintain qualifications for licensure. 396 3. Endangering the health, safety, or security of a 397 398 399 400 401 402 qualified patient. 4. Improperly disclosing personal and confidential information of the qualified patient. 5. Attempting to procure a license by bribery or fraudulent misrepresentation. 6. Being convicted or found guilty of, or entering a plea 403 of nolo contendere to, regardless of adjudication, a crime in 404 any jurisdiction which directly relates to the business of a 405 dispensing organization. 406 7. Making or filing a report or record that the licensee Page 14 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 407 408 409 410 20157066pb knows to be false. 8. Willfully failing to maintain a record required by this section or rule of the department. 9. Willfully impeding or obstructing an employee or agent 411 of the department in the furtherance of his or her official 412 duties. 413 10. Engaging in fraud or deceit, negligence, incompetence, 414 or misconduct in the business practices of a dispensing 415 organization. 416 11. Making misleading, deceptive, or fraudulent 417 representations in or related to the business practices of a 418 dispensing organization. 419 12. Having a license or the authority to engage in any 420 regulated profession, occupation, or business that is related to 421 the business practices of a dispensing organization revoked, 422 suspended, or otherwise acted against, including the denial of 423 licensure, by the licensing authority of any jurisdiction, 424 including its agencies or subdivisions, for a violation that 425 would constitute a violation under state law. A licensing 426 authority’s acceptance of a relinquishment of licensure or a 427 stipulation, consent order, or other settlement, offered in 428 response to or in anticipation of the filing of charges against 429 the license, shall be construed as an action against the 430 license. 431 13. Violating a lawful order of the department or an agency 432 of the state, or failing to comply with a lawfully issued 433 subpoena of the department or an agency of the state. 434 435 (g) The department shall create a permitting process for all dispensing organization vehicles used for the transportation Page 15 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 436 437 20157066pb of low-THC cannabis or low-THC cannabis products. (h)(c) The department shall monitor physician registration 438 and ordering of low-THC cannabis for ordering practices that 439 could facilitate unlawful diversion or misuse of low-THC 440 cannabis and take disciplinary action as indicated. 441 442 (i)(d) The department shall adopt rules as necessary to implement this section. 443 (6) DISPENSING ORGANIZATION.— 444 (a) An applicant seeking licensure as a dispensing 445 organization, or the renewal of its license, must submit an 446 application to the department. The department must review all 447 applications for completeness, including an appropriate 448 inspection of the applicant’s property and facilities to verify 449 the authenticity of the information provided in, or in 450 connection with, the application. An applicant authorizes the 451 department to inspect his or her property and facilities for 452 licensure by applying under this subsection. 453 454 455 (b) In order to receive or maintain licensure as a dispensing organization, an applicant must provide proof that: 1. The applicant, or a separate entity that is owned solely 456 by the same persons or entities in the same ratio as the 457 applicant, possesses a valid certificate of registration issued 458 by the Department of Agriculture and Consumer Services pursuant 459 to s. 581.131 for the cultivation of more than 400,000 plants, 460 the applicant’s land is operated by a nurseryman as defined in 461 s. 581.011, and the land has been operated as a registered 462 nursery in this state for at least 30 continuous years. 463 464 2. The personnel on staff or under contract for the applicant have experience cultivating and introducing multiple Page 16 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 20157066pb 465 varieties of plants in this state, including plants that are not 466 native to Florida; experience with propagating plants; and 467 experience with genetic modification or breeding of plants. 468 469 470 3. The personnel on staff or under contract for the applicant include at least one person who: a. Has at least 5 years’ experience with United States 471 Department of Agriculture Good Agricultural Practices and Good 472 Handling Practices; 473 b. Has at least 5 years’ experience with United States Food 474 and Drug Administration Good Manufacturing Practices for food 475 production; 476 477 c. Has a doctorate degree in organic chemistry or microbiology; 478 d. Has at least 5 years of experience with laboratory 479 procedures which includes analytical laboratory quality control 480 measures, chain of custody procedures, and analytical laboratory 481 methods; 482 e. Has experience with cannabis cultivation and processing, 483 including cannabis extraction techniques and producing cannabis 484 products; 485 486 f. Has experience and qualifications in chain of custody or other tracking mechanisms; 487 g. Works solely on inventory control; and 488 h. Works solely for security purposes. 489 4. The persons who have a direct or indirect interest in 490 the dispensing organization and the applicant’s managers, 491 employees, and contractors who directly interact with low-THC 492 cannabis or low-THC cannabis products have been fingerprinted 493 and have successfully passed a level 2 background screening Page 17 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 494 495 20157066pb pursuant to s. 435.04. 5. The applicant owns, or has at least a 2-year lease of, 496 all properties, facilities, and equipment necessary for the 497 cultivation and processing of low-THC cannabis. The applicant 498 must provide a detailed description of each facility and its 499 equipment, a cultivation and processing plan, and a detailed 500 floor plan. The description must include proof that: 501 a. The applicant is capable of sufficient cultivation and 502 processing to serve at least 15,000 patients with an assumed 503 daily use of 1,000 mg per patient per day of low-THC cannabis or 504 low-THC cannabis product; 505 b. The applicant has arranged for access to all utilities 506 and resources necessary to cultivate or process low-THC cannabis 507 at each listed facility; and 508 c. Each facility is secured and has theft-prevention 509 systems including an alarm system, cameras, and 24-hour security 510 personnel. 511 512 513 6. The applicant has diversion and tracking prevention procedures, including: a. A system for tracking low-THC material through 514 cultivation, processing, and dispensing, including the use of 515 batch and harvest numbers; 516 517 b. An inventory control system for low-THC cannabis and low-THC cannabis products; 518 c. A vehicle tracking and security system; and 519 d. A cannabis waste-disposal plan. 520 7. The applicant has recordkeeping policies and procedures 521 522 in place. 8. The applicant has a facility emergency management plan. Page 18 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 523 20157066pb 9. The applicant has a plan for dispensing low-THC cannabis 524 throughout the state. This plan must include planned retail 525 facilities and a delivery plan for providing low-THC cannabis 526 and low-THC cannabis products to qualified patients who cannot 527 travel to a retail facility. 528 10. The applicant has financial documentation, including: 529 a. Documentation that demonstrates the applicant’s 530 financial ability to operate. If the applicant’s assets, credit, 531 and projected revenues meet or exceed projected liabilities and 532 expenses and the applicant provides independent evidence that 533 the funds necessary for startup costs, working capital, and 534 contingency financing exist and are available as needed, the 535 applicant has demonstrated the financial ability to operate. 536 Financial ability to operate must be documented by: 537 I. The applicant’s audited financial statements. If the 538 applicant is a newly formed entity and does not have a financial 539 history of business upon which audited financial statements may 540 be submitted, the applicant must provide audited financial 541 statements for the separate entity that is owned solely by the 542 same persons or entities in the same ratio as the applicant that 543 possesses the valid certificate of registration issued by the 544 Department of Agriculture and Consumer Services; 545 II. The applicant’s projected financial statements, 546 including a balance sheet, an income and expense statement, and 547 a statement of cash flow for the first 2 years of operation, 548 which provides evidence that the applicant has sufficient 549 assets, credit, and projected revenues to cover liabilities and 550 expenses; and 551 III. A statement of the applicant’s estimated startup costs Page 19 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 20157066pb 552 and sources of funds, including a break-even projection and 553 documentation demonstrating that the applicant has the ability 554 to fund all startup costs, working capital costs, and 555 contingency financing requirements. 556 557 All documents required under this sub-subparagraph shall be 558 prepared in accordance with generally accepted accounting 559 principles and signed by a certified public accountant. The 560 statements required by sub-sub-subparagraph II. and III. may be 561 presented as a compilation. 562 b. A list of all subsidiaries of the applicant; 563 c. A list of all lawsuits pending and completed within the 564 past 7 years of which the applicant was a party; and 565 d. Proof of a $1 million performance and compliance bond, 566 or other equivalent means of security deemed equivalent by the 567 department, such as an irrevocable letter of credit or a deposit 568 in a trust account or financial institution, payable to the 569 department, which must be posted once the applicant is approved 570 as a dispensing organization. The purpose of the bond is to 571 secure payment of any administrative penalties imposed by the 572 department and any fees and costs incurred by the department 573 regarding the dispensing organization license, such as the 574 dispensing organization failing to pay 30 days after the fine or 575 costs become final. The department may make a claim against such 576 bond or security until 1 year after the dispensing 577 organization’s license ceases to be valid or until 60 days after 578 any administrative or legal proceeding authorized in this 579 section involving the dispensing organization concludes, 580 including any appeal, whichever occurs later. Page 20 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 581 20157066pb 11. The employment of a medical director who is a physician 582 licensed under chapter 458 or chapter 459 to supervise the 583 activities of the dispensing organization. 584 (c) An approved dispensing organization shall maintain 585 compliance with the criteria in paragraphs (b), (d), and (e) and 586 subsection (7) demonstrated for selection and approval as a 587 dispensing organization under subsection (5) at all times. 588 Before dispensing low-THC cannabis or low-THC cannabis products 589 to a qualified patient or to the qualified patient’s legal 590 representative, the dispensing organization shall verify the 591 identity of the qualified patient or the qualified patient’s 592 legal representative by requiring the qualified patient or the 593 qualified patient’s legal representative to produce a 594 government-issued identification card and shall verify that the 595 qualified patient and the qualified patient’s legal 596 representative have has an active registration in the 597 compassionate use registry, that the order presented matches the 598 order contents as recorded in the registry, and that the order 599 has not already been filled. Upon dispensing the low-THC 600 cannabis, the dispensing organization shall record in the 601 registry the date, time, quantity, and form of low-THC cannabis 602 dispensed. 603 (d) A dispensing organization may have cultivation 604 facilities, processing facilities, and retail facilities. 605 1. All matters regarding the location of cultivation 606 facilities and processing facilities are preempted to the state. 607 Cultivation facilities and processing facilities must be closed 608 to the public, and low-THC cannabis may not be dispensed on the 609 premises of such facilities. Page 21 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 610 20157066pb 2. A county must determine by ordinance the criteria for 611 the number, location, and other permitting requirements for all 612 retail facilities located within that county. A retail facility 613 may be established in a county only after such an ordinance has 614 been created. Retail facilities must meet the requirements in 615 subparagraphs (b)5. and (b)7. Retail facilities may not sell, or 616 contract for the sale of, anything other than low-THC cannabis 617 or low-THC cannabis products on the property of the retail 618 facility. Before a retail facility may dispense low-THC cannabis 619 or a low-THC cannabis product, the dispensing organization must 620 have a computer network compliant with the federal Health 621 Insurance Portability and Accountability Act of 1996 which is 622 able to access and upload data to the compassionate use registry 623 and which shall be used by all retail facilities. 624 (e) Within 15 days of such information becoming available, 625 a dispensing organization must provide the department with 626 updated information, as applicable, including: 627 628 629 1. The location and a detailed description of any new or proposed facilities. 2. The updated contact information, including electronic 630 and voice communication, for all dispensing organization 631 facilities. 632 3. The registration information for any vehicles used for 633 the transportation of low-THC cannabis and low-THC cannabis 634 product, including confirmation that all such vehicles have 635 tracking and security systems. 636 637 638 4. A plan for the recall of any or all low-THC cannabis or low-THC cannabis product. (f)1. A dispensing organization may transport low-THC Page 22 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 20157066pb 639 cannabis or low-THC cannabis products in vehicles departing from 640 their places of business only in vehicles that are owned or 641 leased by the licensee or by a person designated by the 642 dispensing organization, and for which a valid vehicle permit 643 has been issued for such vehicle by the department. 644 2. A vehicle owned or leased by the dispensing organization 645 or a person designated by the dispensing organization and 646 approved by the department must be operated by such person when 647 transporting low-THC cannabis or low-THC products from the 648 licensee’s place of business. 649 3. A vehicle permit may be obtained by a dispensing 650 organization upon application and payment of a fee of $5 per 651 vehicle to the department. The signature of the person 652 designated by the dispensing organization to drive the vehicle 653 must be included on the vehicle permit application. Such permit 654 remains valid and does not expire unless the licensee or any 655 person designated by the dispensing organization disposes of his 656 or her vehicle, or the licensee’s license is transferred, 657 canceled, not renewed, or is revoked by the department, 658 whichever occurs first. The department shall cancel a vehicle 659 permit upon request of the licensee or owner of the vehicle. 660 4. By acceptance of a license issued under this section, 661 the licensee agrees that the licensed vehicle is, at all times 662 it is being used to transport low-THC cannabis or low-THC 663 cannabis products, subject to inspection and search without a 664 search warrant by authorized employees of the department, 665 sheriffs, deputy sheriffs, or police officers to determine that 666 the licensee is transporting such products in compliance with 667 this section. Page 23 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 20157066pb 668 (7) TESTING AND LABELING OF LOW-THC CANNABIS.— 669 (a) All low-THC cannabis and low-THC cannabis products must 670 be tested by an independent testing laboratory before the 671 dispensing organization may dispense them. The independent 672 testing laboratory shall provide the dispensing organization 673 with lab results. Before dispensing, the dispensing organization 674 must determine that the lab results indicate that the low-THC 675 cannabis or low-THC cannabis product meets the definition of 676 low-THC cannabis or low-THC cannabis product, is safe for human 677 consumption, and is free from harmful contaminants. 678 (b) All low-THC cannabis and low-THC cannabis products must 679 be labeled before dispensing. The label must include, at a 680 minimum: 681 682 683 684 685 1. A statement that the low-THC cannabis or low-THC cannabis product meets the requirements in paragraph (a); 2. The name of the independent testing laboratory that tested the low-THC cannabis or low-THC cannabis product; 3. The name of the cultivation and processing facility 686 where the low-THC cannabis or low-THC cannabis product 687 originates; and 688 689 690 4. The batch number and harvest number from which the lowTHC cannabis or low-THC cannabis product originates. (8) SAFETY AND EFFICACY RESEARCH FOR LOW-THC CANNABIS.—The 691 University of Florida College of Pharmacy must establish and 692 maintain a safety and efficacy research program for the use of 693 low-THC cannabis or low-THC cannabis products to treat 694 qualifying conditions and symptoms. The program must include a 695 fully integrated electronic information system for the broad 696 monitoring of health outcomes and safety signal detection. The Page 24 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 20157066pb 697 electronic information system must include information from the 698 compassionate use registry; provider reports, including 699 treatment plans, adverse event reports, and treatment 700 discontinuation reports; patient reports of adverse impacts; 701 event-triggered interviews and medical chart reviews performed 702 by University of Florida clinical research staff; information 703 from external databases, including Medicaid billing reports and 704 information in the prescription drug monitoring database for 705 registered patients; and all other medical reports required by 706 the University of Florida to conduct the research required by 707 this subsection. The department must provide access to 708 information from the compassionate use registry and the 709 prescription drug monitoring database, established in s. 710 893.055, as needed by the University of Florida to conduct 711 research under this subsection. The Agency for Health Care 712 Administration must provide access to registered patient 713 Medicaid records, to the extent allowed under federal law, as 714 needed by the University of Florida to conduct research under 715 this subsection. 716 (9)(7) EXCEPTIONS TO OTHER LAWS.— 717 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 718 any other provision of law, but subject to the requirements of 719 this section, a qualified patient and the qualified patient’s 720 legal representative who is registered with the department on 721 the compassionate use registry may purchase and possess for the 722 patient’s medical use up to the amount of low-THC cannabis 723 ordered for the patient. 724 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 725 any other provision of law, but subject to the requirements of Page 25 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 20157066pb 726 this section, an approved dispensing organization and its 727 owners, managers, and employees and the owners, managers, and 728 employees of contractors who have direct contact with low-THC 729 cannabis or low-THC cannabis product may manufacture, possess, 730 sell, deliver, distribute, dispense, and lawfully dispose of 731 reasonable quantities, as established by department rule, of 732 low-THC cannabis. For purposes of this subsection, the terms 733 “manufacture,” “possession,” “deliver,” “distribute,” and 734 “dispense” have the same meanings as provided in s. 893.02. 735 (c) An approved dispensing organization and its owners, 736 managers, and employees are not subject to licensure or 737 regulation under chapter 465 or chapter 499 for manufacturing, 738 possessing, selling, delivering, distributing, dispensing, or 739 lawfully disposing of reasonable quantities, as established by 740 department rule, of low-THC cannabis. 741 (d) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 742 any other law, but subject to the requirements of this section, 743 a licensed laboratory and its employees may receive and possess 744 low-THC cannabis for the sole purpose of testing the low-THC 745 cannabis to ensure compliance with this section. 746 (10) Rules adopted by the department under this section are 747 exempt from the requirement that they be ratified by the 748 Legislature pursuant to s. 120.541(3). 749 750 751 752 753 754 Section 2. Paragraph (g) is added to subsection (3) of section 381.987, Florida Statutes, to read: 381.987 Public records exemption for personal identifying information in the compassionate use registry.— (3) The department shall allow access to the registry, including access to confidential and exempt information, to: Page 26 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 755 756 757 758 20157066pb (g) Persons engaged in research at the University of Florida pursuant to s. 381.986(8). Section 3. Paragraph (b) of subsection (7) of section 893.055, Florida Statutes, is amended to read: 759 893.055 Prescription drug monitoring program.— 760 (7) 761 (b) A pharmacy, prescriber, or dispenser shall have access 762 to information in the prescription drug monitoring program’s 763 database which relates to a patient of that pharmacy, 764 prescriber, or dispenser in a manner established by the 765 department as needed for the purpose of reviewing the patient’s 766 controlled substance prescription history. Persons engaged in 767 research at the University of Florida pursuant to s. 381.986(8) 768 shall have access to information in the prescription drug 769 monitoring program’s database which relates to qualified 770 patients as defined in s. 381.986(1) for the purpose of 771 conducting such research. Other access to the program’s database 772 shall be limited to the program’s manager and to the designated 773 program and support staff, who may act only at the direction of 774 the program manager or, in the absence of the program manager, 775 as authorized. Access by the program manager or such designated 776 staff is for prescription drug program management only or for 777 management of the program’s database and its system in support 778 of the requirements of this section and in furtherance of the 779 prescription drug monitoring program. Confidential and exempt 780 information in the database shall be released only as provided 781 in paragraph (c) and s. 893.0551. The program manager, 782 designated program and support staff who act at the direction of 783 or in the absence of the program manager, and any individual who Page 27 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 (Proposed Bill) SPB 7066 580-02582A-15 20157066pb 784 has similar access regarding the management of the database from 785 the prescription drug monitoring program shall submit 786 fingerprints to the department for background screening. The 787 department shall follow the procedure established by the 788 Department of Law Enforcement to request a statewide criminal 789 history record check and to request that the Department of Law 790 Enforcement forward the fingerprints to the Federal Bureau of 791 Investigation for a national criminal history record check. 792 Section 4. Paragraph (h) is added to subsection (3) of 793 794 795 section 893.0551, Florida Statutes, to read: 893.0551 Public records exemption for the prescription drug monitoring program.— 796 (3) The department shall disclose such confidential and 797 exempt information to the following persons or entities upon 798 request and after using a verification process to ensure the 799 legitimacy of the request as provided in s. 893.055: 800 801 802 (h) Persons engaged in research at the University of Florida pursuant to s. 381.986(8). Section 5. This act shall take effect upon becoming a law. Page 28 of 28 CODING: Words stricken are deletions; words underlined are additions.