Florida Senate - 2015 SB 528 By Senator Brandes 22-00645A-15 1 2015528__ A bill to be entitled 2 An act relating to the medical use of marijuana; 3 creating s. 381.99, F.S.; providing a short title; 4 creating s. 381.991, F.S.; defining terms; creating s. 5 381.992, F.S.; allowing registered patients and 6 designated caregivers to purchase, acquire, and 7 possess medical-grade marijuana subject to specified 8 requirements; allowing a cultivation and processing 9 licensee, employee, or contractor to acquire, 10 cultivate, transport, and sell marijuana under certain 11 circumstances; allowing a retail licensee to purchase, 12 receive, possess, store, dispense, and deliver 13 marijuana under certain circumstances; allowing a 14 licensed laboratory to receive marijuana for 15 certification purposes; prohibiting certain actions 16 regarding the acquisition, possession, transfer, use, 17 and administration of marijuana; clarifying that a 18 person is prohibited from driving under the influence 19 of marijuana; creating s. 381.993, F.S.; specifying 20 registration requirements for a patient identification 21 card; allowing a qualified patient to designate a 22 caregiver subject to certain requirements; requiring 23 notification by the Department of Health of the denial 24 of a designated caregiver’s registration; requiring 25 the department to create certain patient registration 26 and certification forms for availability by a 27 specified date; requiring the department to update a 28 patient registry and issue an identification card 29 under certain circumstances within a specified Page 1 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 2015528__ 30 timeframe; specifying the requirements of the 31 identification card, including expiration and renewal 32 requirements; providing notification and return 33 requirements if the department removes the patient or 34 caregiver from the registry; creating s. 381.994, 35 F.S.; requiring the department to create an online 36 patient registry by a specified date subject to 37 certain requirements; creating s. 381.995, F.S.; 38 requiring the department to establish standards and 39 develop and accept licensure application forms for the 40 cultivation, processing, and sale of marijuana by a 41 specified date subject to certain requirements; 42 providing for an initial application fee, a licensure 43 fee, and a renewal fee for specified licenses; 44 requiring the department to issue certain licenses by 45 specified dates; specifying requirements for a 46 cultivation and processing license, including 47 expiration and renewal requirements; specifying 48 facility requirements for a cultivation and processing 49 licensee, including inspections and the issuance of 50 cultivation and processing facility licenses; allowing 51 a dispensing organization to use a contractor to 52 cultivate and process marijuana subject to certain 53 requirements; directing a dispensing organization or 54 contractor to destroy all marijuana byproducts under 55 certain conditions within a specified timeframe; 56 allowing a cultivation and processing licensee to 57 sell, transport, and deliver marijuana products under 58 certain circumstances; prohibiting the Department of Page 2 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 2015528__ 59 Health from licensing retail facilities in a county 60 unless the board of county commissioners for that 61 county determines by ordinance the number and location 62 of retail facilities subject to certain limitations; 63 specifying the application requirements for a retail 64 license; requiring the department to consider certain 65 factors when issuing retail licenses to encourage a 66 competitive marketplace; providing expiration and 67 renewal requirements for a retail license; requiring 68 inspection of a retail facility before dispensing 69 marijuana; providing dispensing requirements; allowing 70 retail licensees to contract with certain types of 71 carriers to deliver marijuana under certain 72 circumstances; prohibiting a licensee from advertising 73 marijuana products; specifying inspection, license, 74 and testing requirements for certain facilities; 75 requiring the department to create standards and 76 impose penalties for a dispensing organization subject 77 to certain restrictions; requiring the department to 78 maintain a public, online list of all licensed retail 79 facilities; creating s. 381.996, F.S.; providing 80 patient certification requirements relating to 81 qualified patients; requiring a physician to transfer 82 an order and update the registry subject to certain 83 requirements and time restraints; requiring physician 84 education; creating s. 381.997, F.S.; requiring 85 testing, certification, and reporting of results by an 86 independent laboratory before distribution or sale of 87 marijuana or marijuana products; providing package and Page 3 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 2015528__ 88 label requirements; requiring the department to 89 establish quality standards and testing procedures by 90 a certain date; creating s. 381.998, F.S.; providing 91 criminal penalties; creating s. 381.999, F.S.; 92 establishing that this act does not require or 93 restrict health insurance coverage for the purchase of 94 medical-grade marijuana; creating s. 381.9991, F.S.; 95 providing rulemaking authority; providing an effective 96 date. 97 98 Be It Enacted by the Legislature of the State of Florida: 99 100 101 102 103 104 105 106 107 Section 1. Section 381.99, Florida Statutes, is created to read: 381.99 Short title.—Sections 381.99-381.9991 may be cited as “The Florida Medical Marijuana Act.” Section 2. Section 381.991, Florida Statutes, is created to read: 381.991 Definitions.—As used in ss. 381.991-381.9991 the term: 108 (1) “Allowed amount of medical-grade marijuana” means the 109 amount of medical-grade marijuana, or the equivalent amount in 110 processed form, which a physician may determine is necessary to 111 treat a registered patient’s qualifying condition or qualifying 112 symptom or symptoms for 30 days. 113 (2) “Batch” means a specifically identified quantity of 114 processed marijuana that is uniform in strain; cultivated using 115 the same herbicides, pesticides, and fungicides; and harvested 116 at the same time from a single licensed cultivation and Page 4 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 117 2015528__ processing facility. 118 (3) “Cultivation and processing facility” means a facility 119 licensed by the department for the cultivation of marijuana, the 120 processing of marijuana, or both. 121 (4) “Cultivation and processing license” means a license 122 issued by the department which authorizes the licensee to 123 cultivate or process, or to both cultivate and process, 124 marijuana at one or more cultivation and processing facilities. 125 (5) “Department” means the Department of Health. 126 (6) “Designated caregiver” means a person who is registered 127 with the department as the caregiver for one or more registered 128 patients. 129 (7) “Dispense” means the transfer or sale at a retail 130 facility of the allowed amount of medical-grade marijuana from a 131 dispensing organization to a registered patient or the patient’s 132 designated caregiver. 133 (8) “Dispensing organization” means an organization that 134 holds a cultivation and processing license, a retail license, or 135 both. 136 (9) “Identification card” means a card issued by the 137 department only to registered patients and designated 138 caregivers. 139 140 141 (10) “Marijuana” has the same meaning as the term “cannabis” in s. 893.02. (11) “Medical-grade marijuana” means marijuana that has 142 been tested in accordance with s. 381.997; meets the standards 143 established by the department for sale to registered patients; 144 and is packaged, labeled, and ready to be dispensed. 145 (12) “Medical marijuana patient registry” means an online Page 5 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 2015528__ 146 electronic registry created and maintained by the department to 147 store identifying information for all registered patients and 148 designated caregivers. 149 (13) “Medical use” means the acquisition, possession, 150 transportation, use, and administration of the allowed amount of 151 medical-grade marijuana. 152 (14) “Physician” means a physician who is licensed under 153 chapter 458 or chapter 459 and meets the requirements of s. 154 381.996(4). 155 (15) “Qualified patient” means a resident of this state who 156 has been certified by a physician and diagnosed as suffering 157 from: 158 (a) Cancer; 159 (b) Positive status for human immunodeficiency virus (HIV); 160 (c) Acquired immune deficiency syndrome (AIDS); 161 (d) Epilepsy; 162 (e) Amyotrophic lateral sclerosis (ALS); 163 (f) Multiple sclerosis; 164 (g) Crohn’s disease; 165 (h) Parkinson’s disease; or 166 (i) Any physical medical condition or treatment for a 167 medical condition that chronically produces one or more 168 qualifying symptoms. 169 (16) “Qualifying symptom” means: 170 (a) Cachexia or wasting syndrome; 171 (b) Severe and persistent pain; 172 (c) Severe and persistent nausea; 173 (d) Persistent seizures; or 174 (e) Severe and persistent muscle spasms. Page 6 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 175 2015528__ (17) “Registered patient” means a qualified patient who has 176 registered with the department and has been issued a medical 177 marijuana registry identification card. 178 (18) “Retail facility” means a facility licensed by the 179 department to dispense medical-grade marijuana to registered 180 patients and caregivers. 181 (19) “Retail license” means a license issued by the 182 department which authorizes the licensee to dispense medical- 183 grade marijuana to registered patients and caregivers from a 184 retail facility. 185 186 Section 3. Section 381.992, Florida Statutes, is created to read: 187 381.992 Medical-grade marijuana.— 188 (1) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 189 any other law, but subject to the requirements in ss. 381.991- 190 381.9991, a registered patient or his or her designated 191 caregiver may purchase, acquire, and possess up to the allowed 192 amount of medical-grade marijuana, including paraphernalia, for 193 that patient’s medical use. In order to maintain the protections 194 under this section, a registered patient or his or her 195 designated caregiver must demonstrate that: 196 (a) He or she is legally in possession of the medical-grade 197 marijuana, by producing his or her medical marijuana 198 identification card; and 199 (b) Any marijuana in his or her possession is within the 200 registered patient’s allowed amount of marijuana, by producing a 201 receipt from the dispensing organization. 202 (2) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 203 any other law, but subject to the requirements in ss. 381.991Page 7 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 2015528__ 204 381.9991, a cultivation and processing licensee and an employee 205 or contractor of a cultivation and processing licensee may 206 acquire, cultivate, and possess marijuana while on the property 207 of a cultivation and processing facility; may transport 208 marijuana between licensed facilities owned by the licensee; may 209 transport marijuana to independent laboratories for 210 certification as medical-grade marijuana; and may transport and 211 sell medical-grade marijuana to retail facilities. 212 (3) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 213 any other law, but subject to the requirements in ss. 381.991- 214 381.9991, a retail licensee and an employee of a retail licensee 215 may purchase and receive medical-grade marijuana from a 216 cultivation and processing licensee or its employee or 217 contractor; may possess, store, and hold medical-grade marijuana 218 for retail sale; and may dispense the allowed amount of medical- 219 grade marijuana to a registered patient or designated caregiver 220 at a retail facility. A retail licensee and an employee or 221 contractor of a retail licensee may deliver medical-grade 222 marijuana to the residence of a registered patient. 223 (4) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or 224 any other law, but subject to the requirements in ss. 381.991- 225 381.9991, a licensed laboratory and an employee of an 226 independent testing laboratory may receive and possess marijuana 227 for the sole purpose of testing the marijuana for certification 228 as medical-grade marijuana. 229 (5) This section does not authorize: 230 (a) The acquisition, purchase, transportation, use, 231 possession, or administration of any type of marijuana other 232 than medical-grade marijuana by a registered patient or Page 8 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 233 234 2015528__ designated caregiver. (b) The use of medical-grade marijuana by anyone other than 235 the registered patient for whom the medical-grade marijuana was 236 ordered. 237 (c) The transfer or administration of medical-grade 238 marijuana to anyone other than the registered patient for whom 239 the medical-grade marijuana was ordered. 240 (d) The acquisition or purchase of medical-grade marijuana 241 by a registered patient or designated caregiver from an entity 242 other than a dispensing organization that has a retail license. 243 (e) A registered patient or designated caregiver to 244 transfer medical-grade marijuana to a person other than the 245 patient for whom the medical-grade marijuana was ordered or to 246 any entity except for the purpose of returning unused medical- 247 grade marijuana to a dispensing organization. 248 (f) The use or administration of medical-grade marijuana: 249 1. On any form of public transportation. 250 2. In any public place. 251 3. In a registered patient’s place of work, if restricted 252 253 254 by his or her employer. (g) The possession, use, or administration of medical-grade marijuana: 255 1. In a correctional facility; 256 2. On the grounds of any preschool, primary school, or 257 secondary school; or 258 3. On a school bus. 259 (6) This section does not exempt any person from the 260 prohibition against driving under the influence provided in s. 261 316.193. Page 9 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 262 263 264 265 266 267 2015528__ Section 4. Section 381.993, Florida Statutes, is created to read: 381.993 Medical marijuana patient and designated caregiver registration.— (1) In order to register for an identification card, a qualified patient must submit to the department: 268 (a) A patient registration form; 269 (b) Proof of Florida residency; and 270 (c) A passport-style photograph taken within the previous 271 272 90 days. (2) For a qualified patient to be registered and to receive 273 an identification card, a physician must submit a patient- 274 certification form directly to the department which includes: 275 (a) Certification by the physician that the patient suffers 276 from one or more qualifying conditions or symptoms specified in 277 s. 381.991(15); and 278 (b) Unless the patient suffers from a condition listed in 279 s. 381.991(15)(a)-(i), certification that in that physician’s 280 good faith medical judgment the patient has exhausted all other 281 reasonable medical treatments for those symptoms. 282 (3) If a qualified patient is under 21 years of age, a 283 second physician must also submit a patient-certification form 284 that meets the requirements of paragraphs (2)(a) and 2(b). 285 286 287 (4) The patient-certification form may be submitted through the department website. (5) A qualified patient may, at initial registration or 288 while a registered patient, designate a caregiver to assist him 289 or her with the medical use of medical-grade marijuana. A 290 designated caregiver must be at least 21 years of age and must Page 10 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 2015528__ 291 meet the background screening requirements in s. 408.809 unless 292 the caregiver is assisting only his or her own spouse, parents, 293 children, or siblings. A designated caregiver may not be 294 registered to assist more than one patient at any given time 295 unless: 296 297 298 299 300 (a) All of the caregiver’s registered patients are the caregiver’s parents, siblings, or children; (b) All of the caregiver’s registered patients are first degree relations to each other who share a residence; and (c) All of the caregiver’s registered patients reside in an 301 assisted living facility, nursing home, or other such facility 302 and the caregiver is an employee of that facility. 303 (6) If the department determines, for any reason, that a 304 caregiver designated by a registered patient may not assist that 305 patient, the department must notify that patient of the denial 306 of the designated caregiver’s registration. 307 (7) The department must create a registration form and a 308 patient-certification form and make the forms available to the 309 public by January 1, 2016. The registration form must require 310 the patient to include, at a minimum, the information required 311 to be on the patient’s identification card and on his or her 312 designated caregiver’s identification card if the patient is 313 designating a caregiver. 314 (8) Beginning on July 1, 2016, when the department receives 315 a registration form, the supporting patient-certification form, 316 and proof of the patient’s residency, the department must, 317 within 14 days: 318 319 (a) Enter the qualified patient’s and his or her designated caregiver’s information into the medical marijuana patient Page 11 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 320 2015528__ registry; and 321 (b) Issue an identification card to the qualified patient 322 and to that patient’s designated caregiver, if applicable. The 323 department is not required to issue an additional identification 324 card to a designated caregiver who already possesses a valid 325 identification card when that caregiver becomes registered as 326 the caregiver for additional registered patients unless the 327 required information has changed. The expiration date for a 328 designated caregiver’s identification card must coincide with 329 the last occurring expiration date on the identification card of 330 the patient the caregiver is registered to assist. 331 (9) Identification cards issued to registered patients and 332 designated caregivers must be resistant to counterfeiting and 333 include, but not be limited to, all of the following 334 information: 335 (a) The person’s full legal name. 336 (b) The person’s photograph. 337 (c) A randomly assigned identification number. 338 (d) The expiration date of the identification card. 339 (10) Except as provided in paragraph (8)(b), patient and 340 caregiver identification cards expire 1 year after the date they 341 are issued. In order to renew an identification card, a 342 qualified patient must submit proof of continued residency and a 343 physician must certify to the department: 344 (a) That he or she has examined the patient during the 345 course of the patient’s treatment with medical-grade marijuana; 346 347 348 (b) That the patient suffers from one or more qualifying symptoms or conditions; (c) That, except for patients suffering from the conditions Page 12 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 2015528__ 349 listed in s. 381.991(15)(a)-(i), in the physician’s good faith 350 medical judgment, there are no reasonable alternative medical 351 options for the relief of such symptom or symptoms; 352 (d) That, in the physician’s good faith medical judgment, 353 the use of medical-grade marijuana gives the patient some relief 354 from his or her symptoms; and 355 356 357 (e) The allowed amount of medical-grade marijuana that the physician orders for the patient’s use. (11) Should the department become aware of information that 358 would disqualify a patient or caregiver from being registered, 359 the department must notify that person of the change in his or 360 her status as follows: 361 (a) For registered patients, the department must give 362 notice at least 30 days before removing that patient from the 363 registry. The patient must return all medical-grade marijuana, 364 medical-grade marijuana products, and his or her identification 365 card to a retail facility within 30 days after receiving such 366 notice. A dispensing organization must notify the department 367 within 24 hours after it has received such a return. Such 368 notification may be submitted electronically. 369 (b) For designated caregivers, the department must give 370 notice to the registered patient and the designated caregiver at 371 least 15 days before removing a caregiver from the registry. The 372 caregiver must return his or her identification card to a retail 373 facility within 15 days after receiving such notice. A 374 dispensing organization must notify the department within 24 375 hours after it has received such a return. Such notification may 376 be submitted electronically. 377 Section 5. Section 381.994, Florida Statutes, is created to Page 13 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 378 2015528__ read: 379 381.994 Electronic medical marijuana patient registry.— 380 (1) By July 1, 2016, the department must create a secure, 381 online, electronic medical marijuana patient registry containing 382 a file for each registered patient and caregiver and for each 383 certifying physician consisting of, but not limited to, all of 384 the following: 385 (a) For patients and caregivers: 386 1. His or her full legal name; 387 2. His or her photograph; 388 3. The randomly assigned identification number on his or 389 her identification card; and 390 4. The expiration date of the identification card. 391 (b) For physicians, the physician’s full legal name and 392 license number. 393 (c) For a registered patient: 394 1. The full legal name of his or her designated caregiver, 395 if any; 396 397 398 399 2. His or her allowed amount of medical-grade marijuana; and 3. The concentration ranges of specified cannabinoids, if any, ordered by the patient’s certifying physician. 400 (d) For a designated caregiver: 401 1. The full legal name or names of all registered patients 402 403 404 405 406 whom the caregiver is registered to assist; 2. The allowed amount of medical-grade marijuana for each patient the caregiver is registered to assist; and 3. The concentration ranges of specified cannabinoids, if any, ordered by the certifying physician for each respective Page 14 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 407 408 2015528__ patient the caregiver is registered to assist. (e) The date and time of dispensing, and the allowed amount 409 of medical-grade marijuana dispensed, for each of that 410 registered patient’s or caregiver’s transactions with the 411 dispensing organization. 412 (2) The registry must be able to: 413 (a) Be accessed by a retail licensee or employee to verify 414 the authenticity of a patient identification card, to verify the 415 allowed amount and any specified type of medical-grade marijuana 416 ordered by his or her physician, and to determine the prior 417 dates on which and times at which medical-grade marijuana was 418 dispensed to the patient and the amount dispensed on each 419 occasion; 420 421 422 (b) Accept in real time the original and updated orders for medical-grade marijuana from certifying physicians; (c) Be accessed by law enforcement agencies in order to 423 verify patient or caregiver authorization for possession of an 424 allowed amount of medical-grade marijuana; and 425 (d) Accept and post initial and updated information to each 426 registered patient’s file from the dispensing organization that 427 shows the date, time, and amount of medical-grade marijuana 428 dispensed to that patient at the point of sale. 429 430 Section 6. Section 381.995, Florida Statutes, is created to read: 431 381.995 Dispensing organizations.— 432 (1) By January 1, 2016, the department shall establish 433 operating standards for the cultivation, processing, packaging, 434 and labeling of marijuana, establish standards for the sale of 435 medical-grade marijuana, develop licensure application forms for Page 15 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 2015528__ 436 cultivation and processing licenses and retail licenses, make 437 such forms available to the public, establish procedures and 438 requirements for cultivation facility licenses and renewals and 439 processing facility licenses and renewals, and begin accepting 440 applications for licensure. The department may charge an initial 441 application fee of up to $100,000 for cultivation and processing 442 licenses and up to $10,000 for retail licenses, a licensure fee, 443 and a license renewal fee as necessary to pay for all expenses 444 incurred by the department in administering this section. 445 (2) The department must begin issuing cultivation and 446 processing licenses by March 1, 2016, and retail licenses by 447 July 1, 2016. 448 449 450 451 (3) The department may issue a cultivation and processing license to an applicant who provides: (a) A completed cultivation and processing license application form; 452 (b) The initial application fee; 453 (c) The legal name of the applicant; 454 (d) The physical address of each location where marijuana 455 456 457 458 will be cultivated and processed; (e) The name, address, and date of birth of each principal officer and board member, if applicable; (f) The name, address, and date of birth of each of the 459 applicant’s current employees who will participate in the 460 operations of the dispensing organization; 461 (g) Proof that all principals and employees of the 462 applicant have passed a level 2 background screening pursuant to 463 chapter 435 within the prior year; 464 (h) Proof of an established infrastructure or the ability Page 16 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 2015528__ 465 to establish an infrastructure in a reasonable amount of time 466 designed to cultivate, process, test, package, and label 467 marijuana and to deliver medical-grade marijuana to retail 468 facilities throughout the state; 469 (i) Proof that the applicant possesses the technical and 470 technological ability to cultivate and process medical-grade 471 marijuana; 472 (j) Proof of operating procedures designed to secure and 473 maintain accountability for all marijuana and marijuana-related 474 byproducts it may possess; 475 476 477 478 479 (k) Proof of the financial ability to maintain operations for the duration of the license; (l) Proof of at least $1 million of hazard and liability insurance for each cultivation and processing facility; and (m) A $5 million performance and compliance bond, to be 480 forfeited if the licensee fails to maintain its license for the 481 duration of the licensure period or fails to comply with the 482 substantive requirements of this subsection and applicable 483 agency rules for the duration of the licensure period. 484 (4) A cultivation and processing license expires 2 years 485 after the date it is issued. The licensee must apply for a 486 renewed license before the expiration date. In order to receive 487 a renewed license, a cultivation and processing licensee must 488 demonstrate continued compliance with the requirements in 489 subsection (3) and have no outstanding substantial violations of 490 the standards established by the department for the cultivation, 491 processing, packaging, and labeling of marijuana and medical- 492 grade marijuana. 493 (5) A cultivation and processing licensee may cultivate Page 17 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 2015528__ 494 marijuana at one or more facilities only if each facility used 495 for cultivation has been inspected by the department and issued 496 a cultivation facility license. A cultivation and processing 497 licensee may process marijuana at one or more processing 498 facilities only if each facility used for processing has been 499 inspected by the department and issued a processing facility 500 license. A cultivation and processing licensee may cultivate and 501 process marijuana at the same facility only if that facility has 502 been inspected by the department and issued both a cultivation 503 facility license and a processing facility license. Each 504 cultivation and processing facility must be secure and closed to 505 the public and may not be located within 1,000 feet of an 506 existing public or private elementary or secondary school, a 507 child care facility licensed under s. 402.302, or a licensed 508 service provider offering substance abuse services. The 509 department may establish by rule additional security and zoning 510 requirements for cultivation and processing facilities. All 511 matters regarding the licensure and regulation of cultivation 512 and processing facilities, including the location of such 513 facilities, are preempted to the state. 514 (6) Before beginning cultivation or processing at a 515 facility, that facility must be inspected and licensed as a 516 cultivation facility, a processing facility, or both by the 517 department. A cultivation and processing licensee may cultivate 518 and process marijuana only for the purpose of producing medical- 519 grade marijuana and may do so only at a licensed cultivation and 520 processing facility. Such processing may include, but is not 521 limited to, processing marijuana into medical-grade marijuana 522 and processing medical-grade marijuana into various forms Page 18 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 2015528__ 523 including, but not limited to, topical applications, oils, and 524 food products for a registered patient’s use. A dispensing 525 organization may use a contractor to cultivate the marijuana, to 526 process marijuana into medical-grade marijuana, or to process 527 the medical-grade marijuana into other forms, but the dispensing 528 organization is responsible for all of the operations performed 529 by each contractor relating to the cultivation and processing of 530 marijuana and the physical possession of all marijuana and 531 medical-grade marijuana. All work done by a contractor must be 532 performed at a licensed cultivation and processing facility. All 533 marijuana byproducts that are unable to be processed or 534 reprocessed into medical-grade marijuana must be destroyed by 535 the dispensing organization or its contractor within 48 hours 536 after processing is completed. 537 (7) A cultivation and processing licensee may transport, or 538 contract to have transported, marijuana and marijuana products 539 to independent testing laboratories to be tested and certified 540 as medical-grade marijuana. 541 (8) A cultivation and processing licensee may sell, 542 transport, and deliver medical-grade marijuana and medical-grade 543 marijuana products to retail licensees throughout the state. 544 (9) The department may not license any retail facilities in 545 a county unless the board of county commissioners for that 546 county determines by ordinance the number and location of any 547 retail facilities that may be located within that county. A 548 retail facility may not be located on the same property as a 549 facility licensed for cultivation or processing of marijuana or 550 within 1,000 feet of an existing public or private elementary or 551 secondary school, a child care facility licensed under s. Page 19 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 2015528__ 552 402.302, or a licensed service provider that offers substance 553 abuse services. 554 555 (10) An applicant for a retail license must provide the department with at least all of the following: 556 (a) A completed retail license application form. 557 (b) The initial application fee. 558 (c) The full legal name of the applicant. 559 (d) The physical address of the retail facility where 560 561 562 563 564 565 marijuana will be dispensed. (e) Identifying information for all other current or previous retail licenses held by the applicant. (f) The name, address, and date of birth for each of the applicant’s principal officers and board members. (g) The name, address, and date of birth of each of the 566 applicant’s current employees who will participate in the 567 operations of the dispensing organization. 568 (h) Proof that all principals and employees of the 569 applicant have passed a level 2 background screening pursuant to 570 chapter 435 within the prior year. 571 (i) Proof of an established infrastructure or the ability 572 to establish an infrastructure in a reasonable amount of time 573 which is designed to receive medical-grade marijuana from 574 cultivation and processing facilities, the ability to maintain 575 the security of the retail facility to prevent theft or 576 diversion of any medical marijuana product received, the ability 577 to correctly dispense the allowed amount and specified type of 578 medical-grade marijuana to a registered patient or his or her 579 designated caregiver pursuant to a physician’s order, the 580 ability to check the medical marijuana patient registry, and the Page 20 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 2015528__ 581 ability to electronically update the medical marijuana patient 582 registry with dispensing information. 583 (j) Proof of operating procedures designed to secure and 584 maintain accountability for all medical-grade marijuana and 585 products that it may receive and possess. 586 587 588 589 590 (k) Proof of the financial ability to maintain operations for the duration of the license. (l) Proof of at least $500,000 of hazard and liability insurance for each license. (m) A $1 million performance and compliance bond, for each 591 license, to be forfeited if the licensee fails to maintain the 592 license for the duration of the licensure period or fails to 593 comply with the requirements of this subsection for the duration 594 of the licensure period. 595 (11) The department may issue multiple retail licenses to a 596 single qualified entity; however, to encourage a competitive 597 marketplace, when multiple entities have applied for a license 598 in the same county, in addition to the qualifications of each 599 applicant, the department shall consider the number of retail 600 licenses currently held by each applicant and the number of 601 separate entities that hold retail licenses within the same 602 geographic area. 603 (12) A retail license expires 2 years after the date it is 604 issued. The retail licensee must reapply for renewed licensure 605 before the expiration date. In order to qualify for a renewed 606 license, a retail licensee must meet all the requirements for 607 initial licensure and have no outstanding substantial violations 608 of the applicable standards established by the department. 609 (13) Before beginning to dispense, each retail facility Page 21 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 2015528__ 610 must be inspected by the department. Retail licensees may 611 dispense the allowed amount of medical-grade marijuana to a 612 registered patient or the patient’s designated caregiver only if 613 the dispensing organization’s employee: 614 (a) Verifies the authenticity of the patient’s or 615 caregiver’s identification card with the medical marijuana 616 patient registry; 617 618 (b) Verifies the physician’s order for medical-grade marijuana with the medical marijuana patient registry; 619 (c) Determines that the registered patient has not been 620 dispensed the allowed amount of marijuana within the previous 30 621 days; 622 (d) Issues the registered patient or the patient’s 623 caregiver a receipt that details the date and time of 624 dispensing, the amount of medical-grade marijuana dispensed, and 625 the person to whom the medical-grade marijuana was dispensed; 626 and 627 (e) Updates the medical marijuana patient registry with the 628 date and time of dispensing and the amount and type of medical- 629 grade marijuana being dispensed to the registered patient before 630 dispensing to that patient or that patient’s designated 631 caregiver. 632 (14) Retail licensees may contract with licensed and bonded 633 carriers to transport medical-grade marijuana and medical-grade 634 marijuana products between properties owned by the licensee and 635 to deliver it to the residence of a registered patient. 636 637 638 (15) A licensee under the Florida Medical Marijuana Act may not advertise its marijuana products. (16) The department must inspect and license each Page 22 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 2015528__ 639 dispensing organization’s cultivation and processing facilities 640 and retail facilities before those facilities begin operations. 641 The department must also inspect each licensed facility at least 642 once every 2 years. The department may also conduct additional 643 announced or unannounced inspections at reasonable hours in 644 order to ensure that such facilities meet the standards set by 645 the department. The department may test any marijuana, marijuana 646 product, medical-grade marijuana, or medical-grade marijuana 647 product in order to ensure that such marijuana, marijuana 648 product, medical-grade marijuana, or medical-grade marijuana 649 product meets the standards established by the department. The 650 department may, by interagency agreement with the Department of 651 Business and Professional Regulation or with the Department of 652 Agriculture and Consumer Services, perform joint inspections of 653 such facilities with those agencies. 654 (17) The department must create a schedule of violations in 655 rule in order to impose reasonable fines not to exceed $10,000 656 on a dispensing organization. In determining the amount of the 657 fine to be levied for a violation, the department shall 658 consider: 659 (a) The severity of the violation; 660 (b) Any actions taken by the dispensing organization to 661 correct the violation or to remedy complaints; and 662 (c) Any previous violations. 663 (18) The department may suspend, revoke, or refuse to renew 664 the license of a dispensing organization or of an individual 665 facility for violations of the standards established by the 666 department. 667 (19) The department shall maintain a publicly available, Page 23 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 2015528__ 668 easily accessible list on its website of all licensed retail 669 facilities. 670 671 Section 7. Section 381.996, Florida Statutes, is created to read: 672 381.996 Patient certification.— 673 (1) A physician may certify a patient to the department as 674 675 676 677 a qualified patient if: (a) The physician has seen the patient on a regular basis for a period of at least 3 months; (b) The physician certifies that, in his or her good faith 678 medical judgment, the patient chronically suffers from one or 679 more of the qualifying conditions or symptoms; and 680 (c) For patients who do not suffer from a condition listed 681 in s. 381.991(15)(a)-(i), the physician certifies that in his or 682 her good faith medical judgment the patient has exhausted all 683 other reasonably available medical treatments for any of the 684 patient’s qualifying symptoms. 685 (2) After certifying a patient, the physician must 686 electronically transfer an original order for medical-grade 687 marijuana for that patient to the medical marijuana patient 688 registry. Such order must include, at a minimum, the allowed 689 amount of medical-grade marijuana and the concentration ranges 690 for individual cannabinoids, if any. The physician must also 691 update the registry with any changes in the specifications of 692 his or her order for that patient within 7 days. 693 (3) If the physician becomes aware that alternative 694 treatments are available, that the patient no longer suffers 695 from his or her qualifying condition or symptom, or if the 696 physician’s order for the allowed amount of medical marijuana Page 24 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 2015528__ 697 changes for that patient, the physician must update the registry 698 with the new information within 7 days. 699 (4) In order to qualify to issue patient certifications for 700 medical-grade marijuana, and before ordering medical-grade 701 marijuana for any patient, a physician must successfully 702 complete an 8-hour course and subsequent examination offered by 703 the Florida Medical Association or the Florida Osteopathic 704 Medical Association, as appropriate, which encompasses the 705 clinical indications for the appropriate use of medical-grade 706 marijuana, the appropriate delivery mechanisms, the 707 contraindications of the use of medical-grade marijuana, and the 708 relevant state and federal laws governing ordering, dispensing, 709 and possession. The appropriate boards shall offer the first 710 course and examination by October 1, 2015, and shall administer 711 them at least annually thereafter. Successful completion of the 712 course may be used by a physician to satisfy 8 hours of the 713 continuing medical education requirements imposed by his or her 714 respective board for licensure renewal. This course may be 715 offered in a distance-learning format. Successful completion of 716 the course and examination is required for every physician who 717 orders medical-grade marijuana each time such physician renews 718 his or her license. 719 720 Section 8. Section 381.997, Florida Statutes, is created to read: 721 381.997 Medical-grade marijuana testing and labeling.— 722 (1) A cultivation and processing licensee may not 723 distribute or sell medical-grade marijuana or product to a 724 retail licensee unless the batch of origin of that marijuana or 725 product has been tested by an independent testing laboratory and Page 25 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 2015528__ 726 the cultivation and processing licensee has received test 727 results from that laboratory which certify that the batch meets 728 the quality standards established by the department. 729 (2) When testing a batch of marijuana or product a testing 730 laboratory must, at a minimum, test for unsafe contaminants and 731 for presence and concentration of individual cannabinoids. 732 (3) Each testing laboratory must report its findings for 733 each batch tested to the cultivation and processing licensee 734 from which the batch originated and to the department. Such 735 findings must include, at a minimum, the license number or 736 numbers of the processing and cultivation facility from which 737 the batch originated, the size and batch number of the batch 738 tested, the types of tests performed on the batch, and the 739 results of each test. 740 (4) Before distribution or sale to a retail licensee, any 741 medical-grade marijuana that meets department testing standards 742 must be packaged in a child-resistant container and labeled with 743 at least the name and license number of the cultivation and 744 processing licensee, the license number of the facility or 745 facilities where the batch was harvested and processed, the 746 harvest or production batch number, the concentration range of 747 each individual cannabinoid present at testing, and any other 748 labeling requirements established in Florida or federal law or 749 rules for that form of the product. For the purposes of this 750 subsection, any oil-based extraction meant for direct 751 consumption in small quantities as a supplement need not be 752 labeled as a food product. 753 754 (5) Before sale to a registered patient or caregiver, a retail licensee must affix an additional label to each product Page 26 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 755 756 2015528__ that includes the licensee’s name and license number. (6) By January 1, 2016, the department must establish 757 standards for quality and testing procedures and for maximum 758 levels of unsafe contaminants. The department must also create a 759 list of individual cannabinoids that must be tested for, 760 concentrations that are considered significant for those 761 cannabinoids, and varying ranges of concentrations for each 762 cannabinoid upon which a physician may base his or her order for 763 a patient’s use of a specific strain of medical-grade marijuana. 764 Section 9. Section 381.998, Florida Statutes, is created to 765 read: 766 381.998 Penalties.— 767 (1) A physician commits a misdemeanor of the first degree, 768 punishable as provided in s. 775.082 or s. 775.083, if he or she 769 orders medical-grade marijuana for a patient without a 770 reasonable belief that the patient is suffering from a condition 771 or symptom listed in s. 381.991(15) or s. 381.991(16). 772 (2) A person who fraudulently represents that he or she has 773 a medical condition or symptom listed in s. 381.991(15) or s. 774 381.991(16) for the purpose of being ordered medical-grade 775 marijuana by such physician commits a misdemeanor of the first 776 degree, punishable as provided in s. 775.082 or s. 775.083. 777 778 Section 10. Section 381.999, Florida Statutes, is created to read: 779 381.999 Insurance.—The Florida Medical Marijuana Act does 780 not require a governmental, private, or other health insurance 781 provider or health care services plan to cover a claim for 782 reimbursement for the purchase of medical-grade marijuana nor 783 does it restrict such coverage. Page 27 of 28 CODING: Words stricken are deletions; words underlined are additions. Florida Senate - 2015 SB 528 22-00645A-15 784 785 2015528__ Section 11. Section 381.9991, Florida Statutes, is created to read: 786 381.9991 Rulemaking Authority.-The department may adopt 787 rules related to health, safety, and welfare as necessary to 788 implement this act. 789 Section 12. This act shall take effect July 1, 2015. Page 28 of 28 CODING: Words stricken are deletions; words underlined are additions.