Florida Senate - 2016 SENATOR AMENDMENT
Bill No. SB 460
Ì8117644Î811764
LEGISLATIVE ACTION
Senate . House
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Senator Clemens moved the following:
1 Senate Amendment to Amendment (369986) (with title
2 amendment)
3
4 Delete lines 215 - 596
5 and insert:
6 (5) DUTIES AND POWERS OF THE DEPARTMENT.—By January 1,
7 2015, The department shall:
8 (a) The department shall create a secure, electronic, and
9 online compassionate use registry for the registration of
10 physicians and patients as provided under this section. The
11 registry must be accessible to law enforcement agencies and to a
12 dispensing organization in order to verify patient authorization
13 for low-THC cannabis and record the low-THC cannabis dispensed.
14 The registry must prevent an active registration of a patient by
15 multiple physicians.
16 (b)1. Beginning July 8, 2016, the department shall accept
17 applications for licensure as dispensing organizations. A
18 dispensing organization may be licensed to cultivate or process
19 low-THC cannabis or low-THC cannabis products or dispense low
20 THC cannabis or low-THC cannabis products through a dispensing
21 facility. A dispensing organization may be licensed to conduct
22 one or more of these activities. The department shall review
23 each application to determine whether the applicant meets the
24 criteria in subsection (6) and qualifies for licensure.
25 2. Within 10 days after receiving an application for
26 licensure, the department shall examine the application, notify
27 the applicant of any apparent errors or omissions, and request
28 any additional information the department is allowed by law to
29 require. An application for licensure must be filed with the
30 department no later than 5 p.m. on August 1, 2016, and all
31 applications must be complete no later than 5 p.m. on August 30,
32 2016.
33 3. Once licensed, applicants may operate in any region in
34 the state, but a dispensing organization licensed to cultivate
35 or process low-THC cannabis may not have cultivation or
36 processing facilities outside the region in which it is
37 licensed.
38 4. The department shall license a selected applicant unless
39 the applicant fails to pay the licensure fee within 10 days
40 after selection.
41 5. This section is exempt from s. 120.60(1) Authorize the
42 establishment of five dispensing organizations to ensure
43 reasonable statewide accessibility and availability as necessary
44 for patients registered in the compassionate use registry and
45 who are ordered low-THC cannabis under this section, one in each
46 of the following regions: northwest Florida, northeast Florida,
47 central Florida, southeast Florida, and southwest Florida.
48 (c) The department shall use develop an application form
49 that requires the applicant to state, as applicable:
50 1. Whether the application is for initial licensure or
51 renewal licensure;
52 2. Whether the application is for licensure as a
53 cultivator, processor, or dispenser of low-THC cannabis;
54 3. The name, the physical address, and the mailing address
55 of the applicant;
56 4. For a cultivating or processing license, the address
57 listed on the Department of Agriculture and Consumer Services
58 certificate of registration required in paragraph (6)(b);
59 5. The name, address, license number, and contact
60 information for the applicant’s medical director; and
61 6. All information required to be included by subsection
62 (6).
63 (d) The department shall and impose an initial application
64 fee of $10,000, an initial licensure fee of $25,000, and a
65 biennial renewal fee of $25,000 that is sufficient to cover the
66 costs of administering this section. An applicant for approval
67 as a dispensing organization must be able to demonstrate:
68 1. The technical and technological ability to cultivate and
69 produce low-THC cannabis. The applicant must possess a valid
70 certificate of registration issued by the Department of
71 Agriculture and Consumer Services pursuant to s. 581.131 that is
72 issued for the cultivation of more than 400,000 plants, be
73 operated by a nurseryman as defined in s. 581.011, and have been
74 operated as a registered nursery in this state for at least 30
75 continuous years.
76 2. The ability to secure the premises, resources, and
77 personnel necessary to operate as a dispensing organization.
78 3. The ability to maintain accountability of all raw
79 materials, finished products, and any byproducts to prevent
80 diversion or unlawful access to or possession of these
81 substances.
82 4. An infrastructure reasonably located to dispense low-THC
83 cannabis to registered patients statewide or regionally as
84 determined by the department.
85 5. The financial ability to maintain operations for the
86 duration of the 2-year approval cycle, including the provision
87 of certified financials to the department. Upon approval, the
88 applicant must post a $5 million performance bond.
89 6. That all owners and managers have been fingerprinted and
90 have successfully passed a level 2 background screening pursuant
91 to s. 435.04.
92 7. The employment of a medical director who is a physician
93 licensed under chapter 458 or chapter 459 to supervise the
94 activities of the dispensing organization.
95 (e) The department shall inspect each dispensing
96 organization’s properties, cultivation facilities, processing
97 facilities, or dispensing facilities according to its licensure
98 before they begin operations and at least once every 2 years
99 thereafter. The department may conduct additional announced or
100 unannounced inspections, including followup inspections, at
101 reasonable hours in order to ensure that such properties or
102 facilities maintain compliance with all applicable requirements
103 in subsections (6) and (7) and to ensure that the dispensing
104 organization has not committed any act that would endanger the
105 health, safety, or security of a qualified patient, a dispensing
106 organization staff member, or the community in which the
107 dispensing organization is located. Licensure under this section
108 constitutes permission for the department to enter and inspect
109 the premises or facilities of any dispensing organization. A
110 dispensing organization must make all facility premises,
111 equipment, documents, low-THC cannabis, and low-THC cannabis
112 products available, as applicable, to the department upon
113 inspection. The department may test any low-THC cannabis or low
114 THC cannabis product in order to ensure that it is safe for
115 human consumption and that it meets the requirements in this
116 section.
117 (f) The department may suspend or revoke a license, deny or
118 refuse to renew a license, or impose an administrative penalty
119 not to exceed $10,000 for the following acts or omissions:
120 1. Violating this section, s. 499.0295, or department rule.
121 2. Failing to maintain qualifications for licensure.
122 3. Endangering the health, safety, or security of a
123 qualified patient.
124 4. Improperly disclosing personal and confidential
125 information of a qualified patient.
126 5. Attempting to procure a license by bribery or fraudulent
127 misrepresentation.
128 6. Being convicted or found guilty of, or entering a plea
129 of nolo contendere to, regardless of adjudication, a crime in
130 any jurisdiction which directly relates to the business of a
131 dispensing organization.
132 7. Making or filing a report or record that the licensee
133 knows to be false.
134 8. Willfully failing to maintain a record required by this
135 section or department rule.
136 9. Willfully impeding or obstructing an employee or agent
137 of the department in the furtherance of his or her official
138 duties.
139 10. Engaging in fraud or deceit, negligence, incompetence,
140 or misconduct in the business practices of a licensee.
141 11. Making misleading, deceptive, or fraudulent
142 representations in or related to the business practices of a
143 licensee.
144 12. Having a license or the authority to engage in any
145 regulated profession, occupation, or business that is related to
146 the business practices of a dispensing organization revoked,
147 suspended, or otherwise acted against, including the denial of
148 licensure, by the licensing authority of any jurisdiction,
149 including its agencies or subdivisions, for a violation that
150 would constitute a violation under state law. A licensing
151 authority’s acceptance of a relinquishment of licensure or a
152 stipulation, consent order, or other settlement, offered in
153 response to or in anticipation of the filing of charges against
154 the license, shall be construed as an action against the
155 license.
156 13. Violating a lawful order of the department or an agency
157 of the state, or failing to comply with a lawfully issued
158 subpoena of the department or an agency of the state.
159 (g) The department shall create a permitting process for
160 all dispensing organization vehicles used for the transportation
161 of low-THC cannabis or low-THC cannabis products.
162 (h)(c) The department shall monitor physician registration
163 and ordering of low-THC cannabis for ordering practices that
164 could facilitate unlawful diversion or misuse of low-THC
165 cannabis and take disciplinary action as indicated.
166 (i)(d) The department shall adopt rules as necessary to
167 implement this section.
168 (6) DISPENSING ORGANIZATION.—
169 (a) An applicant seeking licensure as a dispensing
170 organization, or the renewal of its license, must submit an
171 application to the department. An applicant may seek licensure
172 as a dispensing organization to cultivate, process, or dispense
173 low-THC cannabis. Each function of the dispensing organization
174 requires separate licensure; however, an applicant may seek
175 licensure for more than one function. The department must review
176 all applications for completeness, including an appropriate
177 inspection of the applicant’s property or facilities, as
178 applicable, to verify the authenticity of the information
179 provided in, or in connection with, the application. An
180 applicant authorizes the department to inspect his or her
181 property or facilities for licensure by applying under this
182 subsection.
183 (b) In order to receive, maintain, or renew licensure as a
184 dispensing organization, an applicant must provide proof that:
185 1. For a cultivating or processing license, the applicant,
186 or a separate entity that is owned solely by the same persons or
187 entities in the same ratio as the applicant, possesses a valid
188 certificate of registration issued by the Department of
189 Agriculture and Consumer Services pursuant to s. 581.131 for the
190 cultivation of more than 400,000 plants.
191 2. For a cultivating or processing license, the personnel
192 on staff or under contract for the applicant have experience
193 cultivating and introducing multiple varieties of plants in this
194 state, including plants that are not native to Florida;
195 experience with propagating plants; and experience with genetic
196 modification or breeding of plants.
197 3. For a cultivating or processing license, the personnel
198 on staff or under contract for the applicant include at least
199 one person who:
200 a. Has at least 5 years’ experience with the United States
201 Department of Agriculture Good Agricultural Practices and Good
202 Handling Practices;
203 b. Has at least 5 years’ experience with the United States
204 Food and Drug Administration Current Good Manufacturing
205 Practices for food production;
206 c. Has a doctorate degree in organic chemistry or
207 microbiology;
208 d. Has at least 5 years’ of experience with laboratory
209 procedures which includes analytical laboratory quality control
210 measures, chain of custody procedures, and analytical laboratory
211 methods;
212 e. Has experience with cannabis cultivation and processing,
213 including cannabis extraction techniques and producing cannabis
214 products;
215 f. Has experience and qualifications in chain of custody or
216 other tracking mechanisms;
217 g. Works solely on inventory control; and
218 h. Works solely for security purposes.
219 4. The persons who have a direct or indirect interest in
220 any dispensing organization and the applicant’s managers,
221 employees, and contractors who directly interact with low-THC
222 cannabis or low-THC cannabis products have been fingerprinted
223 and have successfully passed a level 2 background screening
224 pursuant to s. 435.04.
225 5. For a cultivating or processing license, the applicant
226 owns, or has at least a 2-year lease of, all properties,
227 facilities, and equipment necessary for the cultivation and
228 processing of low-THC cannabis. The applicant must provide a
229 detailed description of each facility and its equipment, a
230 cultivation and processing plan, and a detailed floor plan. The
231 description must include proof that:
232 a. The applicant is capable of cultivating and processing
233 sufficient low-THC cannabis or low-THC cannabis product to serve
234 at least 15,000 patients with an assumed daily use of 1,000 mg
235 per patient per day of low-THC cannabis or low-THC cannabis
236 product;
237 b. The applicant has arranged for access to all utilities
238 and resources necessary to cultivate or process low-THC cannabis
239 at each listed facility; and
240 c. Each facility is secured and has theft-prevention
241 systems, including an alarm system, cameras, and 24-hour
242 security personnel.
243 6. The applicant has diversion and tracking prevention
244 procedures, as applicable, including:
245 a. A system for tracking low-THC material through
246 cultivation, processing, or dispensing, including the use of
247 batch and harvest numbers;
248 b. An inventory control system for low-THC cannabis and
249 low-THC cannabis products;
250 c. A vehicle tracking and security system; and
251 d. A cannabis waste disposal plan.
252 7. The applicant has recordkeeping policies and procedures
253 in place.
254 8. The applicant has a facility emergency management plan.
255 9. For a dispensing license, the applicant has a plan for
256 dispensing low-THC cannabis throughout the state. This plan must
257 include planned dispensing facilities and a delivery plan for
258 providing low-THC cannabis and low-THC cannabis products to
259 qualified patients who cannot travel to a dispensing facility.
260 10. The applicant has financial documentation, as
261 applicable, including:
262 a. Documentation that demonstrates the applicant’s
263 financial ability to operate. If the applicant’s assets, credit,
264 and projected revenues meet or exceed projected liabilities and
265 expenses and the applicant provides independent evidence that
266 the funds necessary for startup costs, working capital, and
267 contingency financing exist and are available as needed, the
268 applicant has demonstrated the financial ability to operate.
269 Financial ability to operate must be documented by:
270 I. The applicant’s audited financial statements. If the
271 applicant is a newly formed entity and does not have a financial
272 history of business upon which audited financial statements may
273 be submitted, the applicant must provide audited financial
274 statements for the separate entity that is owned solely by the
275 same persons or entities in the same ratio as the applicant;
276 II. The applicant’s projected financial statements,
277 including a balance sheet, an income and expense statement, and
278 a statement of cash flow for the first 2 years of operation,
279 which provide evidence that the applicant has sufficient assets,
280 credit, and projected revenues to cover liabilities and
281 expenses; and
282 III. A statement of the applicant’s estimated startup costs
283 and sources of funds, including a break-even projection and
284 documentation demonstrating that the applicant has the ability
285 to fund all startup costs, working capital costs, and
286 contingency financing requirements.
287
288 All documents required under this sub-subparagraph shall be
289 prepared in accordance with generally accepted accounting
290 principles and signed by a certified public accountant. The
291 statements required by sub-sub-subparagraphs II. and III. may be
292 presented as a compilation;
293 b. A list of all subsidiaries of the applicant;
294 c. A list of all lawsuits pending and completed within the
295 past 7 years of which the applicant was a party; and
296 d. Proof of a $1 million performance and compliance bond,
297 or other equivalent means of security deemed equivalent by the
298 department, such as an irrevocable letter of credit or a deposit
299 in a trust account or financial institution, payable to the
300 department, which must be posted once the applicant is approved
301 as a dispensing organization. The purpose of the bond is to
302 secure payment of any administrative penalties imposed by the
303 department and any fees and costs incurred by the department
304 regarding the dispensing organization license, such as the
305 dispensing organization failing to pay 30 days after the fine or
306 costs become final. The department may make a claim against such
307 bond or security until 1 year after the dispensing
308 organization’s license ceases to be valid or until 60 days after
309 any administrative or legal proceeding authorized in this
310 section involving the dispensing organization concludes,
311 including any appeal, whichever occurs later.
312 11. The employment of a medical director who is a physician
313 licensed under chapter 458 or chapter 459 to supervise the
314 activities of the dispensing organization.
315 (c) An approved dispensing organization shall maintain
316 compliance with the criteria in paragraphs (b), (d), and (e) and
317 subsection (7) demonstrated for selection and approval as a
318 dispensing organization under subsection (5) at all times.
319 Before dispensing low-THC cannabis or low-THC cannabis products
320 to a qualified patient or to the qualified patient’s legal
321 representative, the dispensing organization shall verify the
322 identity of the qualified patient or the qualified patient’s
323 legal representative by requiring the qualified patient or the
324 qualified patient’s legal representative to produce a
325 government-issued identification card and shall verify that the
326 qualified patient and the qualified patient’s legal
327 representative have has an active registration in the
328 compassionate use registry, that the order presented matches the
329 order contents as recorded in the registry, and that the order
330 has not already been filled. Upon dispensing the low-THC
331 cannabis or low-THC cannabis products, the dispensing
332 organization shall record in the registry the date, time,
333 quantity, and form of low-THC cannabis dispensed.
334 (d)1. A dispensing organization may have cultivation
335 facilities, processing facilities, or dispensing facilities.
336 2. A municipality must determine by ordinance the criteria
337 for the number and location of, and other permitting
338 requirements for, all dispensing facilities located within its
339 municipal boundaries. A dispensing facility may be established
340 in a municipality only after such an ordinance has been created.
341 A county must determine by ordinance the criteria for the
342 number, location, and other permitting requirements for all
343 dispensing facilities located within the unincorporated areas of
344 that county. A dispensing facility may be established in the
345 unincorporated areas of a county only after such an ordinance
346 has been created. Dispensing facilities must have all utilities
347 and resources necessary to store and dispense low-THC cannabis
348 and low-THC cannabis products. Dispensing facilities must be
349 secured and have theft-prevention systems, including an alarm
350 system, cameras, and 24-hour security personnel. Dispensing
351 facilities may not sell, or contract for the sale of, anything
352 other than low-THC cannabis or low-THC cannabis products on the
353 property of the dispensing facilities. Before a dispensing
354 facility may dispense low-THC cannabis or a low-THC cannabis
355 product, the dispensing organization must have a computer
356 network compliant with the federal Health Insurance Portability
357 and Accountability Act of 1996 which can access and upload data
358 to the compassionate use registry and which shall be used by all
359 dispensing facilities.
360 (e) Within 15 days after such information becoming
361 available, a dispensing organization must provide the department
362 with updated information, as applicable, including:
363 1. The location and a detailed description of any new or
364 proposed facility.
365 2. The updated contact information, including electronic
366 and voice communication, for all dispensing organization
367 facilities.
368 3. The registration information for any vehicle used for
369 the transportation of low-THC cannabis and low-THC cannabis
370 products, including confirmation that all such vehicles have
371 tracking and security systems.
372 4. A plan for the recall of any or all low-THC cannabis or
373 low-THC cannabis products.
374 (f)1. A dispensing organization may transport low-THC
375 cannabis or low-THC cannabis products in a vehicle departing
376 from its place of business only in a vehicle that is owned or
377 leased by the licensee or by a person designated by the
378 dispensing organization, and for which a valid vehicle permit
379 has been issued for such vehicle by the department.
380 2. A vehicle owned or leased by the dispensing
381 organization, or by a person designated by the dispensing
382 organization and approved by the department, must be operated by
383 a person designated by the dispensing organization and approved
384 by the department when transporting low-THC cannabis or low-THC
385 products from the licensee’s place of business.
386 3. A vehicle permit may be obtained by a dispensing
387 organization upon application and payment of a fee of $5 per
388 vehicle to the department. The signature of the person
389 designated by the dispensing organization to drive the vehicle
390 must be included on the vehicle permit application. Such permit
391 remains valid and does not expire unless the licensee or any
392 person designated by the dispensing organization disposes of his
393 or her vehicle, or the licensee’s license is transferred,
394 canceled, not renewed, or is revoked by the department,
395 whichever occurs first. The department shall cancel a vehicle
396 permit upon request of the licensee or owner of the vehicle.
397 4. By acceptance of a license issued under this section,
398 the licensee agrees that the permitted vehicle is, at all times
399 it is being used to transport low-THC cannabis or low-THC
400 cannabis products, subject to inspection and search without a
401 search warrant by authorized employees of the department,
402 sheriffs, deputy sheriffs, police officers, or other law
403 enforcement officers to determine that the licensee is
404 transporting such products in compliance with this section.
405 (7) TESTING AND LABELING OF LOW-THC CANNABIS.—
406 (a) All low-THC cannabis and low-THC cannabis products must
407 be tested by an independent testing laboratory before the
408 dispensing organization may dispense them. The independent
409 testing laboratory shall provide the dispensing organization
410 with lab results. Before dispensing, the dispensing organization
411 must determine that the lab results indicate that the low-THC
412 cannabis or low-THC cannabis product meets the definition of
413 low-THC cannabis or low-THC cannabis product, is safe for human
414 consumption, and is free from harmful contaminants.
415 (b) All low-THC cannabis and low-THC cannabis products must
416 be labeled before dispensing. The label must include, at a
417 minimum:
418 1. A statement that the low-THC cannabis or low-THC
419 cannabis product meets the requirements in paragraph (a);
420 2. The name of the independent testing laboratory that
421 tested the low-THC cannabis or low-THC cannabis product;
422 3. The name of the cultivation and processing facility
423 where the low-THC cannabis or low-THC cannabis product
424 originates; and
425 4. The batch number and harvest number from which the low
426 THC cannabis or low-THC cannabis product originates.
427 (8) SAFETY AND EFFICACY RESEARCH FOR LOW-THC CANNABIS.—The
428 University of Florida College of Pharmacy shall establish and
429 maintain a safety and efficacy research program for the use of
430 low-THC cannabis or low-THC cannabis products to treat
431 qualifying conditions and symptoms. The program must include a
432 fully integrated electronic information system for the broad
433 monitoring of health outcomes and safety signal detection. The
434 electronic information system must include information from the
435 compassionate use registry; provider reports, including
436 treatment plans, adverse event reports, and treatment
437 discontinuation reports; patient reports of adverse impacts;
438 event-triggered interviews and medical chart reviews performed
439 by the University of Florida clinical research staff;
440 information from external databases, including Medicaid billing
441 reports and information in the prescription drug monitoring
442 database for registered patients; and all other medical reports
443 required by the University of Florida to conduct the research
444 required by this subsection. The department must provide access
445 to information from the compassionate use registry and the
446 prescription drug monitoring database, established in s.
447 893.055, as needed by the University of Florida to conduct
448 research under this subsection. The Agency for Health Care
449 Administration must provide access to registered patient
450 Medicaid records, to the extent allowed under federal law, as
451 needed by the University of Florida to conduct research under
452 this subsection.
453 (9) PERSONS WITH INTEREST IN THE DISPENSING ORGANIZATION.
454 The persons who have direct or indirect interest in the
455 dispensing organization and the dispensing organization’s
456 managers, employees, and contractors who directly interact with
457 low-THC cannabis or low-THC cannabis products may not make
458 recommendations, offer prescriptions, or provide medical advice
459 to qualified patients.
460 (10) DEPARTMENT AUTHORITY AND RESPONSIBILITIES.—
461 (a) The department may conduct announced or unannounced
462 inspections of dispensing organizations to determine compliance
463 with this section or rules adopted pursuant to this section.
464 (b) The department shall inspect a dispensing organization
465 upon complaint or notice provided to the department that the
466 dispensing organization has dispensed low-THC cannabis or low
467 THC cannabis products containing any mold, bacteria, or other
468 contaminant that may cause or has caused an adverse effect to
469 human health or the environment.
470 (c) The department shall conduct at least a biennial
471 inspection of each dispensing organization to evaluate the
472 dispensing organization’s records, personnel, equipment,
473 processes, security measures, sanitation practices, and quality
474 assurance practices.
475 (d) The department may enter into interagency agreements
476 with the Department of Agriculture and Consumer Services, the
477 Department of Business and Professional Regulation, the
478 Department of Transportation, the Department of Highway Safety
479 and Motor Vehicles, and the Agency for Health Care
480 Administration, and such agencies are authorized to enter into
481 an interagency agreement with the department, to conduct
482 inspections or perform other responsibilities assigned to the
483 department under this section.
484 (e) The department must make a list of all approved
485 dispensing organizations and qualified ordering physicians and
486 medical directors publicly available on its website.
487 (f) The department may establish a system for issuing and
488 renewing registration cards for qualified patients and their
489 legal representatives, establish the circumstances under which
490 the cards may be revoked by or must be returned to the
491 department, and establish fees to implement such system. The
492 department must require, at a minimum, the registration cards
493 to:
494 1. Provide the name, address, and date of birth of the
495 qualified patient or legal representative.
496 2. Have a full-face, passport-type, color photograph of the
497 qualified patient or legal representative taken within the 90
498 days immediately preceding registration.
499 3. Identify whether the cardholder is a qualified patient
500 or legal representative.
501 4. List a unique numeric identifier for the qualified
502 patient or legal representative which is matched to the
503 identifier used for such person in the department’s
504 compassionate use registry.
505 5. Provide the expiration date, which shall be 1 year after
506 the date of the physician’s initial order of low-THC cannabis.
507 6. For the legal representative, provide the name and
508 unique numeric identifier of the qualified patient that the
509 legal representative is assisting.
510 7. Be resistant to counterfeiting or tampering.
511 (g) The department may suspend, revoke, or refuse to renew
512 a dispensing organization’s approval if a dispensing
513 organization commits any of the violations in paragraph (g).
514 (h) The department shall renew the approval of a dispensing
515 organization biennially if the dispensing organization meets the
516 requirements of this section and pays the biennial renewal fee.
517 (i) The department may adopt rules necessary to implement
518 this section.
519 (11) PREEMPTION.—
520 (a) All matters regarding the regulation of the cultivation
521 and processing of medical cannabis or low-THC cannabis by
522 dispensing organizations are preempted to the state.
523 (b) A municipality may determine by ordinance the criteria
524 for the number and location of, and other permitting
525 requirements that do not conflict with state law or department
526 rule for, dispensing facilities of dispensing organizations
527 located within its municipal boundaries. A county may determine
528 by ordinance the criteria for the number, location, and other
529 permitting requirements that do not conflict with state law or
530 department rule for all dispensing facilities of dispensing
531 organizations located within the unincorporated areas of that
532 county.
533 (12)(7) EXCEPTIONS TO OTHER LAWS.—
534 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
535 any other provision of law, but subject to the requirements of
536 this section, a qualified patient and the qualified patient’s
537 legal representative who is registered with the department on
538 the compassionate use registry may purchase and possess for the
539 patient’s medical use up to the amount of low-THC cannabis or
540 medical cannabis ordered for the patient, but not more than a
541 45-day supply, and a cannabis delivery device ordered for the
542 patient. This section does not exempt any person from the
543 prohibition against driving under the influence provided in s.
544 316.193.
545 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
546 any other provision of law, but subject to the requirements of
547 this section, an approved dispensing organization and its
548 owners, managers, and employees, and the owners, managers, and
549 employees of contractors who have direct contact with low-THC
550 cannabis or low-THC cannabis products may manufacture, possess,
551 sell, deliver, distribute, dispense, and lawfully dispose of
552 reasonable quantities, as established by department rule, of
553 low-THC cannabis or low-THC cannabis products in accordance with
554 their licensure. For purposes of this subsection, the terms
555 “manufacture,” “possession,” “deliver,” “distribute,” and
556 “dispense” have the same meanings as provided in s. 893.02.
557 (c) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
558 any other law, but subject to the requirements of this section,
559 an approved independent testing laboratory may possess, test,
560 transport, and lawfully dispose of low-THC cannabis or medical
561 cannabis as provided by department rule.
562 (d)(c) An approved dispensing organization and its owners,
563 managers, and employees are not subject to licensure or
564 regulation under chapter 465 or chapter 499 for manufacturing,
565 possessing, selling, delivering, distributing, dispensing, or
566 lawfully disposing of reasonable quantities, as established by
567 department rule, of low-THC cannabis.
568 (e) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
569 any other law, but subject to the requirements of this section,
570 a licensed laboratory and its employees may receive and possess
571 low-THC cannabis or low-THC cannabis products for the sole
572 purpose of testing the low-THC cannabis or low-THC cannabis
573 products to ensure compliance with this section.
574 (f) A dispensing organization that continues to meet the
575 requirements for approval is presumed to be registered with the
576 department and to meet the regulations adopted by the department
577 or its successor agency for the purpose of dispensing medical
578 cannabis or low-THC cannabis under state law. Additionally, the
579 authority provided to a dispensing organization in s. 499.0295
580 does not impair the approval of a dispensing organization.
581 (g) This subsection does not preclude a person from being
582 prosecuted for a criminal offense related to impairment or
583 intoxication resulting from the medical use of low-THC cannabis
584 or medical cannabis or relieve a person from any requirement
585 under law to submit to a breath, blood, urine, or other test to
586 detect the presence of a controlled substance.
587 (13) RULES.—Rules adopted by the department under this
588 section are exempt from the requirement that they be ratified by
589 the Legislature pursuant to s. 120.541(3).
590
591 ================= T I T L E A M E N D M E N T ================
592 And the title is amended as follows:
593 Delete lines 722 - 734
594 and insert:
595 to physician education; requiring the department to
596 accept applications for licensure as dispensing
597 organizations according to a specified application
598 process; authorizing a dispensing organization to be
599 licensed to cultivate, to process, or to dispense low
600 THC cannabis; requiring the department to review all
601 applications, notify applicants of deficient
602 applications, and request any additional information
603 within a specified period; requiring an application
604 for licensure to be filed and complete by specified
605 dates; authorizing licensed applicants to operate in
606 any region of the state; prohibiting a dispensing
607 organization licensed to cultivate or process low-THC
608 cannabis from having cultivation or processing
609 facilities outside the region in which it is licensed;
610 requiring licensure fees to be paid within a specified
611 timeframe; providing an exemption for the application
612 process; requiring the department to use an
613 application form that requires specified information
614 from the applicant; specifying application fees,
615 licensure fees, and renewal fees; requiring the
616 department to inspect each dispensing organization’s
617 properties, cultivation facilities, processing
618 facilities, or dispensing facilities before those
619 facilities may operate; authorizing followup
620 inspections at reasonable hours; providing that
621 licensure constitutes permission for the department to
622 enter and inspect the premises or facilities of any
623 dispensing organization; requiring dispensing
624 organizations to make all facility premises,
625 equipment, documents, low-THC cannabis, and low-THC
626 cannabis products, as applicable, available to the
627 department upon inspection; authorizing the department
628 to test low-THC cannabis or low-THC cannabis products;
629 authorizing the department to suspend or revoke a
630 license, deny or refuse to renew a license, or impose
631 a maximum administrative penalty for specified acts or
632 omissions; requiring the department to create a
633 permitting process for vehicles used for the
634 transportation of low-THC cannabis or low-THC cannabis
635 products; providing procedures and requirements for an
636 applicant seeking licensure as a dispensing
637 organization or the renewal of its license; requiring
638 the dispensing organization to verify specified
639 information of specified persons in certain
640 circumstances; authorizing a dispensing organization
641 to have cultivation facilities, processing facilities,
642 or dispensing facilities; providing that all matters
643 regarding the location of cultivation facilities and
644 processing facilities are preempted to the state;
645 providing requirements for cultivation facilities and
646 processing facilities; requiring a municipality to
647 determine by ordinance specified criteria related to
648 dispensing facilities; authorizing a dispensing
649 facility to be established in a municipality only
650 after such an ordinance has been created; authorizing
651 a dispensing facility to be established in the
652 unincorporated areas of a county only after such an
653 ordinance has been created; requiring dispensing
654 facilities to have all utilities and resources
655 necessary to store and dispense low-THC and low-THC
656 cannabis products; requiring dispensing facilities to
657 be secured with specified theft-prevention systems;
658 requiring a dispensing organization to provide the
659 department with specified updated information within a
660 specified period; authorizing a dispensing
661 organization to transport low-THC cannabis or low-THC
662 cannabis products in vehicles in certain
663 circumstances; requiring such vehicles to be operated
664 by specified persons in certain circumstances;
665 requiring a fee for a vehicle permit; requiring the
666 signature of the designated driver with a vehicle
667 permit application; providing for expiration of the
668 permit in certain circumstances; requiring the
669 department to cancel a vehicle permit upon the request
670 of specified persons; providing that the licensee
671 authorizes the inspection and search of his or her
672 vehicle without a search warrant by specified persons;
673 requiring all low-THC cannabis and low-THC cannabis
674 products to be tested by an independent testing
675 laboratory before the dispensing organization may
676 dispense them; requiring the independent testing
677 laboratory to provide the lab results to the
678 dispensing organization for a specified determination;
679 requiring all low-THC cannabis and low-THC cannabis
680 products to be labeled with specified information
681 before dispensing; requiring the University of Florida
682 College of Pharmacy to establish and maintain a
683 specified safety and efficacy research program;
684 providing program requirements; requiring the
685 department to provide access to information from the
686 compassionate use registry and the prescription drug
687 monitoring program database to the University of
688 Florida as needed; requiring the Agency for Health
689 Care Administration to provide access to specified
690 patient records under certain circumstances;
691 prohibiting persons who have direct or indirect
692 interest in a dispensing organization and the
693 dispensing organization’s managers, employees, and
694 contractors who directly interact with low-THC
695 cannabis and low-THC cannabis products from making
696 recommendations, offering prescriptions, or providing
697 medical advice to qualified patients; revising duties
698 and responsibilities of the department; providing that
699 certain matters are preempted to the state;
700 authorizing a municipality to determine by ordinance
701 certain criteria relating to dispensing organizations;
702 providing that the act does not provide an exception
703 to the prohibition against driving under the
704 influence; authorizing specified individuals to
705 manufacture, possess, sell, deliver, distribute,
706 dispense, and lawfully dispose of reasonable
707 quantities of low-THC cannabis according to their
708 licensure; authorizing a licensed laboratory and its
709 employees to receive and possess low-THC cannabis in
710 certain circumstances; providing applicability;
711 providing that specified rules adopted by the
712 department are exempt from the requirement to be
713 ratified by the Legislature; amending s. 499.0295,