Florida Senate - 2015 COMMITTEE AMENDMENT
Bill No. CS for SB 7066
Ì481462&Î481462
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
04/09/2015 .
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The Committee on Rules (Richter) recommended the following:
1 Senate Amendment (with title amendment)
2
3 Delete lines 139 - 771
4 and insert:
5 (e) “Independent testing laboratory” means a laboratory,
6 and the managers, employees, or contractors of the laboratory,
7 which have no direct or indirect interest in a dispensing
8 organization.
9 (f)(b) “Low-THC cannabis” means a plant of the genus
10 Cannabis, the dried flowers of which contain 0.8 percent or less
11 of tetrahydrocannabinol and more than 10 percent of cannabidiol
12 weight for weight; the seeds thereof; the resin extracted from
13 any part of such plant; or any compound, manufacture, salt,
14 derivative, mixture, or preparation of such plant or its seeds
15 or resin that is dispensed only from a dispensing organization.
16 (g) “Low-THC cannabis product” means any product derived
17 from low-THC cannabis, including the resin extracted from any
18 part of such plant or any compound, manufacture, salt,
19 derivative, mixture, or preparation of such plant or its seeds
20 or resin which is dispensed from a dispensing organization. Low
21 THC cannabis products include, but are not limited to, oils,
22 tinctures, creams, encapsulations, and food products. Low-THC
23 cannabis food products may not include candy or similar
24 confectionary products that appeal to children. All low-THC
25 cannabis products must maintain concentrations, weight for
26 weight, of 0.8 percent or less of tetrahydrocannabinol and more
27 than 10 percent of cannabidiol.
28 (h)(c) “Medical use” means administration of the ordered
29 amount of low-THC cannabis. The term does not include:
30 1. The possession, use, or administration by smoking.
31 2. The term also does not include The transfer of low-THC
32 cannabis to a person other than the qualified patient for whom
33 it was ordered or the qualified patient’s legal representative
34 who is registered in the compassionate use registry on behalf of
35 the qualified patient.
36 3. The use or administration of low-THC cannabis or low-THC
37 cannabis products:
38 a. On any form of public transportation.
39 b. In any public place.
40 c. In a registered qualified patient’s place of work, if
41 restricted by his or her employer.
42 d. In a correctional facility.
43 e. On the grounds of any preschool, primary school, or
44 secondary school.
45 f. On a school bus.
46 (i)(d) “Qualified patient” means a resident of this state
47 who has been added to the compassionate use registry by a
48 physician licensed under chapter 458 or chapter 459 to receive
49 low-THC cannabis from a dispensing organization.
50 (j)(e) “Smoking” means burning or igniting a substance and
51 inhaling the smoke. Smoking does not include the use of a
52 vaporizer.
53 (2) PHYSICIAN ORDERING.—
54 (a) Effective January 1, 2015, A physician licensed under
55 chapter 458 or chapter 459 who has examined and is treating a
56 patient suffering from cancer, human immunodeficiency virus,
57 acquired immune deficiency syndrome, epilepsy, amyotrophic
58 lateral sclerosis, autism, multiple sclerosis, Crohn’s disease,
59 Parkinson’s disease, paraplegia, quadriplegia, or terminal
60 illness a physical medical condition that chronically produces
61 symptoms of seizures or severe and persistent muscle spasms may
62 order for the patient’s medical use low-THC cannabis to treat
63 such disease, disorder, or condition; or to alleviate symptoms
64 of such disease, disorder, or condition; or to alleviate
65 symptoms caused by a treatment for such disease, disorder, or
66 condition, if no other satisfactory alternative treatment
67 options exist for that patient and all of the following
68 conditions apply:
69 1.(a) The patient is a permanent resident of this state.
70 2.(b) The physician determines that the risks of ordering
71 low-THC cannabis are reasonable in light of the potential
72 benefit for that patient. If a patient is younger than 18 years
73 of age, a second physician must concur with this determination,
74 and such determination must be documented in the patient’s
75 medical record.
76 3.(c) The physician registers the patient, the patient’s
77 legal representative if requested by the patient, and himself or
78 herself as the orderer of low-THC cannabis for the named patient
79 on the compassionate use registry maintained by the department
80 and updates the registry to reflect the contents of the order.
81 If the patient is a minor, the physician must register a legal
82 representative on the compassionate use registry. The physician
83 shall deactivate the patient’s registration when treatment is
84 discontinued.
85 4.(d) The physician maintains a patient treatment plan that
86 includes the dose, route of administration, planned duration,
87 and monitoring of the patient’s symptoms and other indicators of
88 tolerance or reaction to the low-THC cannabis.
89 5.(e) The physician submits the patient treatment plan, as
90 well as any other requested medical records, quarterly to the
91 University of Florida College of Pharmacy for research on the
92 safety and efficacy of low-THC cannabis on patients pursuant to
93 subsection (8).
94 6.(f) The physician obtains the voluntary informed consent
95 of the patient or the patient’s legal guardian to treatment with
96 low-THC cannabis after sufficiently explaining the current state
97 of knowledge in the medical community of the effectiveness of
98 treatment of the patient’s conditions or symptoms condition with
99 low-THC cannabis, the medically acceptable alternatives, and the
100 potential risks and side effects.
101 (b) A physician who improperly orders low-THC cannabis is
102 subject to disciplinary action under the applicable practice act
103 and under s. 456.072(1)(k).
104 (3) PENALTIES.—
105 (a) A physician commits a misdemeanor of the first degree,
106 punishable as provided in s. 775.082 or s. 775.083, if the
107 physician orders low-THC cannabis for a patient without a
108 reasonable belief that the patient is suffering from at least
109 one of the conditions listed in subsection (2).:
110 1. Cancer or a physical medical condition that chronically
111 produces symptoms of seizures or severe and persistent muscle
112 spasms that can be treated with low-THC cannabis; or
113 2. Symptoms of cancer or a physical medical condition that
114 chronically produces symptoms of seizures or severe and
115 persistent muscle spasms that can be alleviated with low-THC
116 cannabis.
117 (b) Any person who fraudulently represents that he or she
118 has at least one condition listed in subsection (2) cancer or a
119 physical medical condition that chronically produces symptoms of
120 seizures or severe and persistent muscle spasms to a physician
121 for the purpose of being ordered low-THC cannabis by such
122 physician commits a misdemeanor of the first degree, punishable
123 as provided in s. 775.082 or s. 775.083.
124 (4) PHYSICIAN EDUCATION.—
125 (a) Before ordering low-THC cannabis for use by a patient
126 in this state, the appropriate board shall require the ordering
127 physician licensed under chapter 458 or chapter 459 to
128 successfully complete an 8-hour course and subsequent
129 examination offered by the Florida Medical Association or the
130 Florida Osteopathic Medical Association that encompasses the
131 clinical indications for the appropriate use of low-THC
132 cannabis, the appropriate delivery mechanisms, the
133 contraindications for such use, as well as the relevant state
134 and federal laws governing the ordering, dispensing, and
135 possessing of this substance. The first course and examination
136 shall be presented by October 1, 2014, and shall be administered
137 at least annually thereafter. Successful completion of the
138 course may be used by a physician to satisfy 8 hours of the
139 continuing medical education requirements required by his or her
140 respective board for licensure renewal. This course may be
141 offered in a distance learning format.
142 (b) The appropriate board shall require the medical
143 director of each dispensing organization approved under
144 subsection (5) to successfully complete a 2-hour course and
145 subsequent examination offered by the Florida Medical
146 Association or the Florida Osteopathic Medical Association that
147 encompasses appropriate safety procedures and knowledge of low
148 THC cannabis.
149 (c) Successful completion of the course and examination
150 specified in paragraph (a) is required for every physician who
151 orders low-THC cannabis each time such physician renews his or
152 her license. In addition, successful completion of the course
153 and examination specified in paragraph (b) is required for the
154 medical director of each dispensing organization each time such
155 physician renews his or her license.
156 (d) A physician who fails to comply with this subsection
157 and who orders low-THC cannabis may be subject to disciplinary
158 action under the applicable practice act and under s.
159 456.072(1)(k).
160 (5) DUTIES AND POWERS OF THE DEPARTMENT.—By January 1,
161 2015, The department shall:
162 (a) The department shall create a secure, electronic, and
163 online compassionate use registry for the registration of
164 physicians and patients as provided under this section. The
165 registry must be accessible to law enforcement agencies and to a
166 dispensing organization in order to verify patient authorization
167 for low-THC cannabis and record the low-THC cannabis dispensed.
168 The registry must prevent an active registration of a patient by
169 multiple physicians.
170 (b)1. Beginning 7 days after the effective date of this
171 act, the department shall accept applications for licensure as a
172 dispensing organization. The department shall review each
173 application to determine whether the applicant meets the
174 criteria in subsection (6) and qualifies for licensure.
175 2. Within 10 days after receiving an application for
176 licensure, the department shall examine the application, notify
177 the applicant of any apparent errors or omissions, and request
178 any additional information the department is allowed by law to
179 require. An application for licensure must be filed with the
180 department no later than 5 p.m. on the 30th day after the
181 effective date of this act, and all applications must be
182 complete no later than 5 p.m. on the 60th day after the
183 effective date of this act.
184 3. Prior to the 75th day after the effective date of this
185 act, the department shall select by lottery two applicants who
186 meet the criteria in subsection (6) in each of the following
187 regions:
188 a. Northwest Florida, consisting of Bay, Calhoun, Escambia,
189 Franklin, Gadsden, Gulf, Holmes, Jackson, Jefferson, Leon,
190 Liberty, Madison, Santa Rosa, Okaloosa, Taylor, Wakulla, Walton,
191 and Washington counties.
192 b. Northeast Florida, consisting of Alachua, Baker,
193 Bradford, Clay, Columbia, Dixie, Duval, Flagler, Gilchrist,
194 Hamilton, Lafayette, Levy, Marion, Nassau, Putnam, St. Johns,
195 Suwannee, and Union counties.
196 c. Central Florida, consisting of Brevard, Citrus, Hardee,
197 Hernando, Hillsborough, Indian River, Lake, Orange, Osceola,
198 Pasco, Pinellas, Polk, Seminole, St. Lucie, Sumter, and Volusia
199 counties.
200 d. Southwest Florida, consisting of Charlotte, Collier,
201 DeSoto, Glades, Hendry, Highlands, Lee, Manatee, Okeechobee, and
202 Sarasota counties.
203 e. Southeast Florida, consisting of Broward, Miami-Dade,
204 Martin, Monroe, and Palm Beach counties.
205 4. After the department has selected by lottery the 10
206 dispensing organizations pursuant to subparagraph 3., the
207 department shall select by lottery 10 more applicants who meet
208 the criteria in subsection (6) for licensure. Once licensed,
209 those applicants are authorized to operate in any region in the
210 state, but a dispensing organization may not have cultivation or
211 processing facilities outside the region in which it is
212 licensed.
213 5. The department shall license an applicant selected
214 pursuant to subparagraph 3. or subparagraph 4. unless the
215 applicant fails to pay the licensure fee within 10 days of
216 selection. If a selected applicant fails to timely pay the
217 licensure fee, the department shall select by lottery another
218 applicant from the existing pool of eligible applicants.
219 6. If the department revokes a license or denies the
220 renewal of a license pursuant to paragraph (f), the department
221 shall conduct a new lottery using the selection process outlined
222 in this paragraph. The selection process must begin 24 hours
223 after such revocation or denial.
224 7. If the department does not have a sufficient pool of
225 qualified applicants to issue 2 licenses in each region, or to
226 license 10 dispensing organizations pursuant to subparagraph 4.,
227 the department shall conduct a lottery using the process in this
228 paragraph every 6 months until each region has 2 licensed
229 dispensing organizations and 10 additional dispensing
230 organizations are licensed, totaling 20 licensed dispensing
231 organizations in this state.
232 8. This section is exempt from s. 120.60(1) Authorize the
233 establishment of five dispensing organizations to ensure
234 reasonable statewide accessibility and availability as necessary
235 for patients registered in the compassionate use registry and
236 who are ordered low-THC cannabis under this section, one in each
237 of the following regions: northwest Florida, northeast Florida,
238 central Florida, southeast Florida, and southwest Florida.
239 (c) The department shall use develop an application form
240 that requires the applicant to state:
241 1. Whether the application is for initial licensure or
242 renewal licensure;
243 2. The name, the physical address, the mailing address, the
244 address listed on the Department of Agriculture and Consumer
245 Services certificate required in paragraph (6)(b), and the
246 contact information for the applicant and for the nursery that
247 holds the Department of Agriculture and Consumer Services
248 certificate, if different from the applicant;
249 3. The name, address, and contact information for the
250 operating nurseryman of the organization that holds the
251 Department of Agriculture and Consumer Services certificate;
252 4. The name, address, license number, and contact
253 information for the applicant’s medical director; and
254 5. All information required to be included by subsection
255 (6).
256 (d) The department shall and impose an initial application
257 fee of $50,000, an initial licensure fee of $125,000, and a
258 biennial renewal fee of $125,000 that is sufficient to cover the
259 costs of administering this section. An applicant for approval
260 as a dispensing organization must be able to demonstrate:
261 1. The technical and technological ability to cultivate and
262 produce low-THC cannabis. The applicant must possess a valid
263 certificate of registration issued by the Department of
264 Agriculture and Consumer Services pursuant to s. 581.131 that is
265 issued for the cultivation of more than 400,000 plants, be
266 operated by a nurseryman as defined in s. 581.011, and have been
267 operated as a registered nursery in this state for at least 30
268 continuous years.
269 2. The ability to secure the premises, resources, and
270 personnel necessary to operate as a dispensing organization.
271 3. The ability to maintain accountability of all raw
272 materials, finished products, and any byproducts to prevent
273 diversion or unlawful access to or possession of these
274 substances.
275 4. An infrastructure reasonably located to dispense low-THC
276 cannabis to registered patients statewide or regionally as
277 determined by the department.
278 5. The financial ability to maintain operations for the
279 duration of the 2-year approval cycle, including the provision
280 of certified financials to the department. Upon approval, the
281 applicant must post a $5 million performance bond.
282 6. That all owners and managers have been fingerprinted and
283 have successfully passed a level 2 background screening pursuant
284 to s. 435.04.
285 7. The employment of a medical director who is a physician
286 licensed under chapter 458 or chapter 459 to supervise the
287 activities of the dispensing organization.
288 (e) The department shall inspect each dispensing
289 organization’s properties, cultivation facilities, processing
290 facilities, and retail facilities before they begin operations
291 and at least once every 2 years thereafter. The department may
292 conduct additional announced or unannounced inspections,
293 including followup inspections, at reasonable hours in order to
294 ensure that such property and facilities maintain compliance
295 with all applicable requirements in subsections (6) and (7) and
296 to ensure that the dispensing organization has not committed any
297 other act that would endanger the health, safety, or security of
298 a qualified patient, dispensing organization staff, or the
299 community in which the dispensing organization is located.
300 Licensure under this section constitutes permission for the
301 department to enter and inspect the premises and facilities of
302 any dispensing organization. The department may inspect any
303 licensed dispensing organization, and a dispensing organization
304 must make all facility premises, equipment, documents, low-THC
305 cannabis, and low-THC cannabis products available to the
306 department upon inspection. The department may test any low-THC
307 cannabis or low-THC cannabis product in order to ensure that it
308 is safe for human consumption and that it meets the requirements
309 in this section.
310 (f) The department may suspend or revoke a license, deny or
311 refuse to renew a license, or impose an administrative penalty
312 not to exceed $10,000 for the following acts or omissions:
313 1. A violation of this section or department rule.
314 2. Failing to maintain qualifications for licensure.
315 3. Endangering the health, safety, or security of a
316 qualified patient.
317 4. Improperly disclosing personal and confidential
318 information of the qualified patient.
319 5. Attempting to procure a license by bribery or fraudulent
320 misrepresentation.
321 6. Being convicted or found guilty of, or entering a plea
322 of nolo contendere to, regardless of adjudication, a crime in
323 any jurisdiction which directly relates to the business of a
324 dispensing organization.
325 7. Making or filing a report or record that the licensee
326 knows to be false.
327 8. Willfully failing to maintain a record required by this
328 section or rule of the department.
329 9. Willfully impeding or obstructing an employee or agent
330 of the department in the furtherance of his or her official
331 duties.
332 10. Engaging in fraud or deceit, negligence, incompetence,
333 or misconduct in the business practices of a dispensing
334 organization.
335 11. Making misleading, deceptive, or fraudulent
336 representations in or related to the business practices of a
337 dispensing organization.
338 12. Having a license or the authority to engage in any
339 regulated profession, occupation, or business that is related to
340 the business practices of a dispensing organization revoked,
341 suspended, or otherwise acted against, including the denial of
342 licensure, by the licensing authority of any jurisdiction,
343 including its agencies or subdivisions, for a violation that
344 would constitute a violation under state law. A licensing
345 authority’s acceptance of a relinquishment of licensure or a
346 stipulation, consent order, or other settlement, offered in
347 response to or in anticipation of the filing of charges against
348 the license, shall be construed as an action against the
349 license.
350 13. Violating a lawful order of the department or an agency
351 of the state, or failing to comply with a lawfully issued
352 subpoena of the department or an agency of the state.
353 (g) The department shall create a permitting process for
354 all dispensing organization vehicles used for the transportation
355 of low-THC cannabis or low-THC cannabis products.
356 (h)(c) The department shall monitor physician registration
357 and ordering of low-THC cannabis for ordering practices that
358 could facilitate unlawful diversion or misuse of low-THC
359 cannabis and take disciplinary action as indicated.
360 (i)(d) The department shall adopt rules as necessary to
361 implement this section.
362 (6) DISPENSING ORGANIZATION.—
363 (a) An applicant seeking licensure as a dispensing
364 organization, or the renewal of its license, must submit an
365 application to the department. The department must review all
366 applications for completeness, including an appropriate
367 inspection of the applicant’s property and facilities to verify
368 the authenticity of the information provided in, or in
369 connection with, the application. An applicant authorizes the
370 department to inspect his or her property and facilities for
371 licensure by applying under this subsection.
372 (b) In order to receive or maintain licensure as a
373 dispensing organization, an applicant must provide proof that:
374 1. The applicant, or a separate entity that is owned solely
375 by the same persons or entities in the same ratio as the
376 applicant, possesses a valid certificate of registration issued
377 by the Department of Agriculture and Consumer Services pursuant
378 to s. 581.131 for the cultivation of more than 400,000 plants,
379 is operated by a nurseryman as defined in s. 581.011, and has
380 been operated as a registered nursery in this state for at least
381 30 continuous years.
382 2. The personnel on staff or under contract for the
383 applicant have experience cultivating and introducing multiple
384 varieties of plants in this state, including plants that are not
385 native to Florida; experience with propagating plants; and
386 experience with genetic modification or breeding of plants.
387 3. The personnel on staff or under contract for the
388 applicant include at least one person who:
389 a. Has at least 5 years’ experience with United States
390 Department of Agriculture Good Agricultural Practices and Good
391 Handling Practices;
392 b. Has at least 5 years’ experience with United States Food
393 and Drug Administration Good Manufacturing Practices for food
394 production;
395 c. Has a doctorate degree in organic chemistry or
396 microbiology;
397 d. Has at least 5 years’ of experience with laboratory
398 procedures which includes analytical laboratory quality control
399 measures, chain of custody procedures, and analytical laboratory
400 methods;
401 e. Has experience with cannabis cultivation and processing,
402 including cannabis extraction techniques and producing cannabis
403 products;
404 f. Has experience and qualifications in chain of custody or
405 other tracking mechanisms;
406 g. Works solely on inventory control; and
407 h. Works solely for security purposes.
408 4. The persons who have a direct or indirect interest in
409 the dispensing organization and the applicant’s managers,
410 employees, and contractors who directly interact with low-THC
411 cannabis or low-THC cannabis products have been fingerprinted
412 and have successfully passed a level 2 background screening
413 pursuant to s. 435.04.
414 5. The applicant owns, or has at least a 2-year lease of,
415 all properties, facilities, and equipment necessary for the
416 cultivation and processing of low-THC cannabis. The applicant
417 must provide a detailed description of each facility and its
418 equipment, a cultivation and processing plan, and a detailed
419 floor plan. The description must include proof that:
420 a. The applicant is capable of sufficient cultivation and
421 processing to serve at least 15,000 patients with an assumed
422 daily use of 1,000 mg per patient per day of low-THC cannabis or
423 low-THC cannabis product;
424 b. The applicant has arranged for access to all utilities
425 and resources necessary to cultivate or process low-THC cannabis
426 at each listed facility; and
427 c. Each facility is secured and has theft-prevention
428 systems including an alarm system, cameras, and 24-hour security
429 personnel.
430 6. The applicant has diversion and tracking prevention
431 procedures, including:
432 a. A system for tracking low-THC material through
433 cultivation, processing, and dispensing, including the use of
434 batch and harvest numbers;
435 b. An inventory control system for low-THC cannabis and
436 low-THC cannabis products;
437 c. A vehicle tracking and security system; and
438 d. A cannabis waste-disposal plan.
439 7. The applicant has recordkeeping policies and procedures
440 in place.
441 8. The applicant has a facility emergency management plan.
442 9. The applicant has a plan for dispensing low-THC cannabis
443 throughout the state. This plan must include planned retail
444 facilities and a delivery plan for providing low-THC cannabis
445 and low-THC cannabis products to qualified patients who cannot
446 travel to a retail facility.
447 10. The applicant has financial documentation, including:
448 a. Documentation that demonstrates the applicant’s
449 financial ability to operate. If the applicant’s assets, credit,
450 and projected revenues meet or exceed projected liabilities and
451 expenses and the applicant provides independent evidence that
452 the funds necessary for startup costs, working capital, and
453 contingency financing exist and are available as needed, the
454 applicant has demonstrated the financial ability to operate.
455 Financial ability to operate must be documented by:
456 I. The applicant’s audited financial statements. If the
457 applicant is a newly formed entity and does not have a financial
458 history of business upon which audited financial statements may
459 be submitted, the applicant must provide audited financial
460 statements for the separate entity that is owned solely by the
461 same persons or entities in the same ratio as the applicant that
462 possesses the valid certificate of registration issued by the
463 Department of Agriculture and Consumer Services;
464 II. The applicant’s projected financial statements,
465 including a balance sheet, an income and expense statement, and
466 a statement of cash flow for the first 2 years of operation,
467 which provides evidence that the applicant has sufficient
468 assets, credit, and projected revenues to cover liabilities and
469 expenses; and
470 III. A statement of the applicant’s estimated startup costs
471 and sources of funds, including a break-even projection and
472 documentation demonstrating that the applicant has the ability
473 to fund all startup costs, working capital costs, and
474 contingency financing requirements.
475
476 All documents required under this sub-subparagraph shall be
477 prepared in accordance with generally accepted accounting
478 principles and signed by a certified public accountant. The
479 statements required by sub-sub-subparagraphs II. and III. may be
480 presented as a compilation.
481 b. A list of all subsidiaries of the applicant;
482 c. A list of all lawsuits pending and completed within the
483 past 7 years of which the applicant was a party; and
484 d. Proof of a $1 million performance and compliance bond,
485 or other equivalent means of security deemed equivalent by the
486 department, such as an irrevocable letter of credit or a deposit
487 in a trust account or financial institution, payable to the
488 department, which must be posted once the applicant is approved
489 as a dispensing organization. The purpose of the bond is to
490 secure payment of any administrative penalties imposed by the
491 department and any fees and costs incurred by the department
492 regarding the dispensing organization license, such as the
493 dispensing organization failing to pay 30 days after the fine or
494 costs become final. The department may make a claim against such
495 bond or security until 1 year after the dispensing
496 organization’s license ceases to be valid or until 60 days after
497 any administrative or legal proceeding authorized in this
498 section involving the dispensing organization concludes,
499 including any appeal, whichever occurs later.
500 11. The employment of a medical director who is a physician
501 licensed under chapter 458 or chapter 459 to supervise the
502 activities of the dispensing organization.
503 (c) An approved dispensing organization shall maintain
504 compliance with the criteria in paragraphs (b), (d), and (e) and
505 subsection (7) demonstrated for selection and approval as a
506 dispensing organization under subsection (5) at all times.
507 Before dispensing low-THC cannabis or low-THC cannabis products
508 to a qualified patient or to the qualified patient’s legal
509 representative, the dispensing organization shall verify the
510 identity of the qualified patient or the qualified patient’s
511 legal representative by requiring the qualified patient or the
512 qualified patient’s legal representative to produce a
513 government-issued identification card and shall verify that the
514 qualified patient and the qualified patient’s legal
515 representative have has an active registration in the
516 compassionate use registry, that the order presented matches the
517 order contents as recorded in the registry, and that the order
518 has not already been filled. Upon dispensing the low-THC
519 cannabis, the dispensing organization shall record in the
520 registry the date, time, quantity, and form of low-THC cannabis
521 dispensed.
522 (d) A dispensing organization may have cultivation
523 facilities, processing facilities, and retail facilities.
524 1. All matters regarding the location of cultivation
525 facilities and processing facilities are preempted to the state.
526 Cultivation facilities and processing facilities must be closed
527 to the public, and low-THC cannabis may not be dispensed on the
528 premises of such facilities.
529 2. A municipality must determine by ordinance the criteria
530 for the number and location of, and other permitting
531 requirements for, all retail facilities located within its
532 municipal boundaries. A retail facility may be established in a
533 municipality only after such an ordinance has been created. A
534 county must determine by ordinance the criteria for the number,
535 location, and other permitting requirements for all retail
536 facilities located within the unincorporated areas of that
537 county. A retail facility may be established in the
538 unincorporated areas of a county only after such an ordinance
539 has been created. Retail facilities must have all utilities and
540 resources necessary to store and dispense low-THC cannabis and
541 low-THC cannabis products. Retail facilities must be secured and
542 have theft-prevention systems, including an alarm system,
543 cameras, and 24-hour security personnel. Retail facilities may
544 not sell, or contract for the sale of, anything other than low
545 THC cannabis or low-THC cannabis products on the property of the
546 retail facility. Before a retail facility may dispense low-THC
547 cannabis or a low-THC cannabis product, the dispensing
548 organization must have a computer network compliant with the
549 federal Health Insurance Portability and Accountability Act of
550 1996 which is able to access and upload data to the
551 compassionate use registry and which shall be used by all retail
552 facilities.
553 (e) Within 15 days of such information becoming available,
554 a dispensing organization must provide the department with
555 updated information, as applicable, including:
556 1. The location and a detailed description of any new or
557 proposed facilities.
558 2. The updated contact information, including electronic
559 and voice communication, for all dispensing organization
560 facilities.
561 3. The registration information for any vehicles used for
562 the transportation of low-THC cannabis and low-THC cannabis
563 products, including confirmation that all such vehicles have
564 tracking and security systems.
565 4. A plan for the recall of any or all low-THC cannabis or
566 low-THC cannabis products.
567 (f)1. A dispensing organization may transport low-THC
568 cannabis or low-THC cannabis products in vehicles departing from
569 their places of business only in vehicles that are owned or
570 leased by the licensee or by a person designated by the
571 dispensing organization, and for which a valid vehicle permit
572 has been issued for such vehicle by the department.
573 2. A vehicle owned or leased by the dispensing organization
574 or a person designated by the dispensing organization and
575 approved by the department must be operated by such person when
576 transporting low-THC cannabis or low-THC products from the
577 licensee’s place of business.
578 3. A vehicle permit may be obtained by a dispensing
579 organization upon application and payment of a fee of $5 per
580 vehicle to the department. The signature of the person
581 designated by the dispensing organization to drive the vehicle
582 must be included on the vehicle permit application. Such permit
583 remains valid and does not expire unless the licensee or any
584 person designated by the dispensing organization disposes of his
585 or her vehicle, or the licensee’s license is transferred,
586 canceled, not renewed, or is revoked by the department,
587 whichever occurs first. The department shall cancel a vehicle
588 permit upon request of the licensee or owner of the vehicle.
589 4. By acceptance of a license issued under this section,
590 the licensee agrees that the licensed vehicle is, at all times
591 it is being used to transport low-THC cannabis or low-THC
592 cannabis products, subject to inspection and search without a
593 search warrant by authorized employees of the department,
594 sheriffs, deputy sheriffs, police officers, or other law
595 enforcement officers to determine that the licensee is
596 transporting such products in compliance with this section.
597 (7) TESTING AND LABELING OF LOW-THC CANNABIS.—
598 (a) All low-THC cannabis and low-THC cannabis products must
599 be tested by an independent testing laboratory before the
600 dispensing organization may dispense them. The independent
601 testing laboratory shall provide the dispensing organization
602 with lab results. Before dispensing, the dispensing organization
603 must determine that the lab results indicate that the low-THC
604 cannabis or low-THC cannabis product meets the definition of
605 low-THC cannabis or low-THC cannabis product, is safe for human
606 consumption, and is free from harmful contaminants.
607 (b) All low-THC cannabis and low-THC cannabis products must
608 be labeled before dispensing. The label must include, at a
609 minimum:
610 1. A statement that the low-THC cannabis or low-THC
611 cannabis product meets the requirements in paragraph (a);
612 2. The name of the independent testing laboratory that
613 tested the low-THC cannabis or low-THC cannabis product;
614 3. The name of the cultivation and processing facility
615 where the low-THC cannabis or low-THC cannabis product
616 originates; and
617 4. The batch number and harvest number from which the low
618 THC cannabis or low-THC cannabis product originates.
619 (8) SAFETY AND EFFICACY RESEARCH FOR LOW-THC CANNABIS.—The
620 University of Florida College of Pharmacy shall establish and
621 maintain a safety and efficacy research program for the use of
622 low-THC cannabis or low-THC cannabis products to treat
623 qualifying conditions and symptoms. The program must include a
624 fully integrated electronic information system for the broad
625 monitoring of health outcomes and safety signal detection. The
626 electronic information system must include information from the
627 compassionate use registry; provider reports, including
628 treatment plans, adverse event reports, and treatment
629 discontinuation reports; patient reports of adverse impacts;
630 event-triggered interviews and medical chart reviews performed
631 by University of Florida clinical research staff; information
632 from external databases, including Medicaid billing reports and
633 information in the prescription drug monitoring database for
634 registered patients; and all other medical reports required by
635 the University of Florida to conduct the research required by
636 this subsection. The department must provide access to
637 information from the compassionate use registry and the
638 prescription drug monitoring database, established in s.
639 893.055, as needed by the University of Florida to conduct
640 research under this subsection. The Agency for Health Care
641 Administration must provide access to registered patient
642 Medicaid records, to the extent allowed under federal law, as
643 needed by the University of Florida to conduct research under
644 this subsection.
645 (9) The persons who have direct or indirect interest in the
646 dispensing organization and the dispensing organization’s
647 managers, employees, and contractors who directly interact with
648 low-THC cannabis or low-THC cannabis products are prohibited
649 from making recommendations, offering prescriptions, or
650 providing medical advice to qualified patients.
651 (10)(7) EXCEPTIONS TO OTHER LAWS.—
652 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
653 any other provision of law, but subject to the requirements of
654 this section, a qualified patient and the qualified patient’s
655 legal representative who is registered with the department on
656 the compassionate use registry may purchase and possess for the
657 patient’s medical use up to the amount of low-THC cannabis
658 ordered for the patient. Nothing in this section exempts any
659 person from the prohibition against driving under the influence
660 provided in s. 316.193.
661 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
662 any other provision of law, but subject to the requirements of
663 this section, an approved dispensing organization and its
664 owners, managers, and employees and the owners, managers, and
665 employees of contractors who have direct contact with low-THC
666 cannabis or low-THC cannabis product may manufacture, possess,
667 sell, deliver, distribute, dispense, and lawfully dispose of
668 reasonable quantities, as established by department rule, of
669 low-THC cannabis. For purposes of this subsection, the terms
670 “manufacture,” “possession,” “deliver,” “distribute,” and
671 “dispense” have the same meanings as provided in s. 893.02.
672 (c) An approved dispensing organization and its owners,
673 managers, and employees are not subject to licensure or
674 regulation under chapter 465 or chapter 499 for manufacturing,
675 possessing, selling, delivering, distributing, dispensing, or
676 lawfully disposing of reasonable quantities, as established by
677 department rule, of low-THC cannabis.
678 (d) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
679 any other law, but subject to the requirements of this section,
680 a licensed laboratory and its employees may receive and possess
681 low-THC cannabis for the sole purpose of testing the low-THC
682 cannabis to ensure compliance with this section.
683 (11) Rules adopted by the department under this section are
684
685 ================= T I T L E A M E N D M E N T ================
686 And the title is amended as follows:
687 Delete lines 19 - 98
688 and insert:
689 dates; requiring the department to select two
690 applicants in specified regions for licensure as a
691 dispensing organization; requiring the department to
692 issue 10 additional licenses to qualified applicants
693 by lottery; authorizing applicants to operate in any
694 region of the state; prohibiting a dispensing
695 organization from having cultivation or processing
696 facilities outside the region in which it is licensed;
697 requiring the department to select by lottery another
698 applicant in certain circumstances; requiring the
699 department to conduct a new lottery after the
700 revocation or the denial of renewal of a license;
701 requiring the department to conduct a lottery at
702 specified intervals if there are available dispensing
703 organization licenses; providing an exemption for the
704 application process; requiring the department to use
705 an application form that requires specified
706 information from the applicant; requiring the
707 department to impose specified application fees;
708 requiring the department to inspect each dispensing
709 organization’s properties, cultivation facilities,
710 processing facilities, and retail facilities before
711 those facilities may operate; authorizing followup
712 inspections at reasonable hours; providing that
713 licensure constitutes permission for the department to
714 enter and inspect the premises and facilities of any
715 dispensing organization; authorizing the department to
716 inspect any licensed dispensing organization;
717 requiring dispensing organizations to make all
718 facility premises, equipment, documents, low-THC
719 cannabis, and low-THC cannabis products available to
720 the department upon inspection; authorizing the
721 department to test low-THC cannabis or low-THC
722 cannabis products; authorizing the department to
723 suspend or revoke a license, deny or refuse to renew a
724 license, or impose a maximum administrative penalty
725 for specified acts or omissions; requiring the
726 department to create a permitting process for vehicles
727 used for the transportation of low-THC cannabis or
728 low-THC cannabis products; authorizing the department
729 to adopt rules as necessary for implementation of
730 specified provisions and procedures, and to provide
731 specified guidance; providing procedures and
732 requirements for an applicant seeking licensure as a
733 dispensing organization or the renewal of its license;
734 requiring the dispensing organization to verify
735 specified information of specified persons in certain
736 circumstances; authorizing a dispensing organization
737 to have cultivation facilities, processing facilities,
738 and retail facilities; authorizing a retail facility
739 to be established in a municipality only after such an
740 ordinance has been created; authorizing a retail
741 facility to be established in the unincorporated areas
742 of a county only after such an ordinance has been
743 created; requiring retail facilities to have all
744 utilities and resources necessary to store and
745 dispense low-THC and low-THC cannabis products;
746 requiring retail facilities to be secured with
747 specified theft-prevention systems; requiring a
748 dispensing organization to provide the department with
749 specified updated information within a specified
750 period; authorizing a dispensing organization to
751 transport low-THC cannabis or low-THC cannabis
752 products in vehicles in certain circumstances;
753 requiring such vehicles to be operated by specified
754 persons in certain circumstances; requiring a fee for
755 a vehicle permit; requiring the signature of the
756 designated driver with a vehicle permit application;
757 providing for expiration of the permit in certain
758 circumstances; requiring the department to cancel a
759 vehicle permit upon the request of specified persons;
760 providing that the licensee authorizes the inspection
761 and search of his or her vehicle without a search
762 warrant by specified persons; requiring all low-THC
763 cannabis and low-THC cannabis products to be tested by
764 an independent testing laboratory before the
765 dispensing organization may dispense it; requiring the
766 independent testing laboratory to provide the lab
767 results to the dispensing organization for a specified
768 determination; requiring all low-THC cannabis and low
769 THC cannabis products to be labeled with specified
770 information before dispensing; requiring the
771 University of Florida College of Pharmacy to establish
772 and maintain a specified safety and efficacy research
773 program; providing program requirements; requiring the
774 department to provide information from the
775 prescription drug monitoring program to the University
776 of Florida as needed; requiring the Agency for Health
777 Care Administration to provide access to specified
778 patient records under certain circumstances;
779 prohibiting persons who have direct or indirect
780 interest in a dispensing organization and the
781 dispensing organization’s managers, employees, and
782 contractors who directly interact with low-THC
783 cannabis and low-THC cannabis products from making
784 recommendations, offering prescriptions, or providing
785 medical advice to qualified patients; providing