Florida Senate - 2016 SENATOR AMENDMENT
Bill No. CS/CS/CS/HB 307, 1st Eng.
Ì949118:Î949118
LEGISLATIVE ACTION
Senate . House
.
.
.
Floor: WD/2R .
03/04/2016 11:03 AM .
—————————————————————————————————————————————————————————————————
—————————————————————————————————————————————————————————————————
Senator Clemens moved the following:
1 Senate Amendment (with title amendment)
2
3 Delete lines 316 - 707
4 and insert:
5 (5) DUTIES AND POWERS OF THE DEPARTMENT.—By January 1,
6 2015, The department shall:
7 (a) The department shall create a secure, electronic, and
8 online compassionate use registry for the registration of
9 physicians and patients as provided under this section. The
10 registry must be accessible to law enforcement agencies and to a
11 dispensing organization in order to verify patient authorization
12 for low-THC cannabis and record the low-THC cannabis dispensed.
13 The registry must prevent an active registration of a patient by
14 multiple physicians.
15 (b)1. Beginning July 8, 2016, the department shall accept
16 applications for licensure as dispensing organizations. A
17 dispensing organization may be licensed to cultivate or process
18 low-THC cannabis or low-THC cannabis products or dispense low
19 THC cannabis or low-THC cannabis products through a dispensing
20 facility. A dispensing organization may be licensed to conduct
21 one or more of these activities. The department shall review
22 each application to determine whether the applicant meets the
23 criteria in subsection (6) and qualifies for licensure.
24 2. Within 10 days after receiving an application for
25 licensure, the department shall examine the application, notify
26 the applicant of any apparent errors or omissions, and request
27 any additional information the department is allowed by law to
28 require. An application for licensure must be filed with the
29 department no later than 5 p.m. on August 1, 2016, and all
30 applications must be complete no later than 5 p.m. on August 30,
31 2016.
32 3. Once licensed, applicants may operate in any region in
33 the state, but a dispensing organization licensed to cultivate
34 or process low-THC cannabis may not have cultivation or
35 processing facilities outside the region in which it is
36 licensed.
37 4. The department shall license a selected applicant unless
38 the applicant fails to pay the licensure fee within 10 days
39 after selection.
40 5. This section is exempt from s. 120.60(1) Authorize the
41 establishment of five dispensing organizations to ensure
42 reasonable statewide accessibility and availability as necessary
43 for patients registered in the compassionate use registry and
44 who are ordered low-THC cannabis under this section, one in each
45 of the following regions: northwest Florida, northeast Florida,
46 central Florida, southeast Florida, and southwest Florida.
47 (c) The department shall use develop an application form
48 that requires the applicant to state, as applicable:
49 1. Whether the application is for initial licensure or
50 renewal licensure;
51 2. Whether the application is for licensure as a
52 cultivator, processor, or dispenser of low-THC cannabis;
53 3. The name, the physical address, and the mailing address
54 of the applicant;
55 4. For a cultivating or processing license, the address
56 listed on the Department of Agriculture and Consumer Services
57 certificate of registration required in paragraph (6)(b);
58 5. The name, address, license number, and contact
59 information for the applicant’s medical director; and
60 6. All information required to be included by subsection
61 (6).
62 (d) The department shall and impose an initial application
63 fee of $10,000, an initial licensure fee of $25,000, and a
64 biennial renewal fee of $25,000 that is sufficient to cover the
65 costs of administering this section. An applicant for approval
66 as a dispensing organization must be able to demonstrate:
67 1. The technical and technological ability to cultivate and
68 produce low-THC cannabis. The applicant must possess a valid
69 certificate of registration issued by the Department of
70 Agriculture and Consumer Services pursuant to s. 581.131 that is
71 issued for the cultivation of more than 400,000 plants, be
72 operated by a nurseryman as defined in s. 581.011, and have been
73 operated as a registered nursery in this state for at least 30
74 continuous years.
75 2. The ability to secure the premises, resources, and
76 personnel necessary to operate as a dispensing organization.
77 3. The ability to maintain accountability of all raw
78 materials, finished products, and any byproducts to prevent
79 diversion or unlawful access to or possession of these
80 substances.
81 4. An infrastructure reasonably located to dispense low-THC
82 cannabis to registered patients statewide or regionally as
83 determined by the department.
84 5. The financial ability to maintain operations for the
85 duration of the 2-year approval cycle, including the provision
86 of certified financials to the department. Upon approval, the
87 applicant must post a $5 million performance bond.
88 6. That all owners and managers have been fingerprinted and
89 have successfully passed a level 2 background screening pursuant
90 to s. 435.04.
91 7. The employment of a medical director who is a physician
92 licensed under chapter 458 or chapter 459 to supervise the
93 activities of the dispensing organization.
94 (e) The department shall inspect each dispensing
95 organization’s properties, cultivation facilities, processing
96 facilities, or dispensing facilities according to its licensure
97 before they begin operations and at least once every 2 years
98 thereafter. The department may conduct additional announced or
99 unannounced inspections, including followup inspections, at
100 reasonable hours in order to ensure that such properties or
101 facilities maintain compliance with all applicable requirements
102 in subsections (6) and (7) and to ensure that the dispensing
103 organization has not committed any act that would endanger the
104 health, safety, or security of a qualified patient, a dispensing
105 organization staff member, or the community in which the
106 dispensing organization is located. Licensure under this section
107 constitutes permission for the department to enter and inspect
108 the premises or facilities of any dispensing organization. A
109 dispensing organization must make all facility premises,
110 equipment, documents, low-THC cannabis, and low-THC cannabis
111 products available, as applicable, to the department upon
112 inspection. The department may test any low-THC cannabis or low
113 THC cannabis product in order to ensure that it is safe for
114 human consumption and that it meets the requirements in this
115 section.
116 (f) The department may suspend or revoke a license, deny or
117 refuse to renew a license, or impose an administrative penalty
118 not to exceed $10,000 for the following acts or omissions:
119 1. Violating this section, s. 499.0295, or department rule.
120 2. Failing to maintain qualifications for licensure.
121 3. Endangering the health, safety, or security of a
122 qualified patient.
123 4. Improperly disclosing personal and confidential
124 information of a qualified patient.
125 5. Attempting to procure a license by bribery or fraudulent
126 misrepresentation.
127 6. Being convicted or found guilty of, or entering a plea
128 of nolo contendere to, regardless of adjudication, a crime in
129 any jurisdiction which directly relates to the business of a
130 dispensing organization.
131 7. Making or filing a report or record that the licensee
132 knows to be false.
133 8. Willfully failing to maintain a record required by this
134 section or department rule.
135 9. Willfully impeding or obstructing an employee or agent
136 of the department in the furtherance of his or her official
137 duties.
138 10. Engaging in fraud or deceit, negligence, incompetence,
139 or misconduct in the business practices of a licensee.
140 11. Making misleading, deceptive, or fraudulent
141 representations in or related to the business practices of a
142 licensee.
143 12. Having a license or the authority to engage in any
144 regulated profession, occupation, or business that is related to
145 the business practices of a dispensing organization revoked,
146 suspended, or otherwise acted against, including the denial of
147 licensure, by the licensing authority of any jurisdiction,
148 including its agencies or subdivisions, for a violation that
149 would constitute a violation under state law. A licensing
150 authority’s acceptance of a relinquishment of licensure or a
151 stipulation, consent order, or other settlement, offered in
152 response to or in anticipation of the filing of charges against
153 the license, shall be construed as an action against the
154 license.
155 13. Violating a lawful order of the department or an agency
156 of the state, or failing to comply with a lawfully issued
157 subpoena of the department or an agency of the state.
158 (g) The department shall create a permitting process for
159 all dispensing organization vehicles used for the transportation
160 of low-THC cannabis or low-THC cannabis products.
161 (h)(c) The department shall monitor physician registration
162 and ordering of low-THC cannabis for ordering practices that
163 could facilitate unlawful diversion or misuse of low-THC
164 cannabis and take disciplinary action as indicated.
165 (i)(d) The department shall adopt rules as necessary to
166 implement this section.
167 (6) DISPENSING ORGANIZATION.—
168 (a) An applicant seeking licensure as a dispensing
169 organization, or the renewal of its license, must submit an
170 application to the department. An applicant may seek licensure
171 as a dispensing organization to cultivate, process, or dispense
172 low-THC cannabis. Each function of the dispensing organization
173 requires separate licensure; however, an applicant may seek
174 licensure for more than one function. The department must review
175 all applications for completeness, including an appropriate
176 inspection of the applicant’s property or facilities, as
177 applicable, to verify the authenticity of the information
178 provided in, or in connection with, the application. An
179 applicant authorizes the department to inspect his or her
180 property or facilities for licensure by applying under this
181 subsection.
182 (b) In order to receive, maintain, or renew licensure as a
183 dispensing organization, an applicant must provide proof that:
184 1. For a cultivating or processing license, the applicant,
185 or a separate entity that is owned solely by the same persons or
186 entities in the same ratio as the applicant, possesses a valid
187 certificate of registration issued by the Department of
188 Agriculture and Consumer Services pursuant to s. 581.131 for the
189 cultivation of more than 400,000 plants.
190 2. For a cultivating or processing license, the personnel
191 on staff or under contract for the applicant have experience
192 cultivating and introducing multiple varieties of plants in this
193 state, including plants that are not native to Florida;
194 experience with propagating plants; and experience with genetic
195 modification or breeding of plants.
196 3. For a cultivating or processing license, the personnel
197 on staff or under contract for the applicant include at least
198 one person who:
199 a. Has at least 5 years’ experience with the United States
200 Department of Agriculture Good Agricultural Practices and Good
201 Handling Practices;
202 b. Has at least 5 years’ experience with the United States
203 Food and Drug Administration Current Good Manufacturing
204 Practices for food production;
205 c. Has a doctorate degree in organic chemistry or
206 microbiology;
207 d. Has at least 5 years’ of experience with laboratory
208 procedures which includes analytical laboratory quality control
209 measures, chain of custody procedures, and analytical laboratory
210 methods;
211 e. Has experience with cannabis cultivation and processing,
212 including cannabis extraction techniques and producing cannabis
213 products;
214 f. Has experience and qualifications in chain of custody or
215 other tracking mechanisms;
216 g. Works solely on inventory control; and
217 h. Works solely for security purposes.
218 4. The persons who have a direct or indirect interest in
219 any dispensing organization and the applicant’s managers,
220 employees, and contractors who directly interact with low-THC
221 cannabis or low-THC cannabis products have been fingerprinted
222 and have successfully passed a level 2 background screening
223 pursuant to s. 435.04.
224 5. For a cultivating or processing license, the applicant
225 owns, or has at least a 2-year lease of, all properties,
226 facilities, and equipment necessary for the cultivation and
227 processing of low-THC cannabis. The applicant must provide a
228 detailed description of each facility and its equipment, a
229 cultivation and processing plan, and a detailed floor plan. The
230 description must include proof that:
231 a. The applicant is capable of cultivating and processing
232 sufficient low-THC cannabis or low-THC cannabis product to serve
233 at least 15,000 patients with an assumed daily use of 1,000 mg
234 per patient per day of low-THC cannabis or low-THC cannabis
235 product;
236 b. The applicant has arranged for access to all utilities
237 and resources necessary to cultivate or process low-THC cannabis
238 at each listed facility; and
239 c. Each facility is secured and has theft-prevention
240 systems, including an alarm system, cameras, and 24-hour
241 security personnel.
242 6. The applicant has diversion and tracking prevention
243 procedures, as applicable, including:
244 a. A system for tracking low-THC material through
245 cultivation, processing, or dispensing, including the use of
246 batch and harvest numbers;
247 b. An inventory control system for low-THC cannabis and
248 low-THC cannabis products;
249 c. A vehicle tracking and security system; and
250 d. A cannabis waste disposal plan.
251 7. The applicant has recordkeeping policies and procedures
252 in place.
253 8. The applicant has a facility emergency management plan.
254 9. For a dispensing license, the applicant has a plan for
255 dispensing low-THC cannabis throughout the state. This plan must
256 include planned dispensing facilities and a delivery plan for
257 providing low-THC cannabis and low-THC cannabis products to
258 qualified patients who cannot travel to a dispensing facility.
259 10. The applicant has financial documentation, as
260 applicable, including:
261 a. Documentation that demonstrates the applicant’s
262 financial ability to operate. If the applicant’s assets, credit,
263 and projected revenues meet or exceed projected liabilities and
264 expenses and the applicant provides independent evidence that
265 the funds necessary for startup costs, working capital, and
266 contingency financing exist and are available as needed, the
267 applicant has demonstrated the financial ability to operate.
268 Financial ability to operate must be documented by:
269 I. The applicant’s audited financial statements. If the
270 applicant is a newly formed entity and does not have a financial
271 history of business upon which audited financial statements may
272 be submitted, the applicant must provide audited financial
273 statements for the separate entity that is owned solely by the
274 same persons or entities in the same ratio as the applicant;
275 II. The applicant’s projected financial statements,
276 including a balance sheet, an income and expense statement, and
277 a statement of cash flow for the first 2 years of operation,
278 which provide evidence that the applicant has sufficient assets,
279 credit, and projected revenues to cover liabilities and
280 expenses; and
281 III. A statement of the applicant’s estimated startup costs
282 and sources of funds, including a break-even projection and
283 documentation demonstrating that the applicant has the ability
284 to fund all startup costs, working capital costs, and
285 contingency financing requirements.
286
287 All documents required under this sub-subparagraph shall be
288 prepared in accordance with generally accepted accounting
289 principles and signed by a certified public accountant. The
290 statements required by sub-sub-subparagraphs II. and III. may be
291 presented as a compilation;
292 b. A list of all subsidiaries of the applicant;
293 c. A list of all lawsuits pending and completed within the
294 past 7 years of which the applicant was a party; and
295 d. Proof of a $1 million performance and compliance bond,
296 or other equivalent means of security deemed equivalent by the
297 department, such as an irrevocable letter of credit or a deposit
298 in a trust account or financial institution, payable to the
299 department, which must be posted once the applicant is approved
300 as a dispensing organization. The purpose of the bond is to
301 secure payment of any administrative penalties imposed by the
302 department and any fees and costs incurred by the department
303 regarding the dispensing organization license, such as the
304 dispensing organization failing to pay 30 days after the fine or
305 costs become final. The department may make a claim against such
306 bond or security until 1 year after the dispensing
307 organization’s license ceases to be valid or until 60 days after
308 any administrative or legal proceeding authorized in this
309 section involving the dispensing organization concludes,
310 including any appeal, whichever occurs later.
311 11. The employment of a medical director who is a physician
312 licensed under chapter 458 or chapter 459 to supervise the
313 activities of the dispensing organization.
314 (c) An approved dispensing organization shall maintain
315 compliance with the criteria in paragraphs (b), (d), and (e) and
316 subsection (7) demonstrated for selection and approval as a
317 dispensing organization under subsection (5) at all times.
318 Before dispensing low-THC cannabis or low-THC cannabis products
319 to a qualified patient or to the qualified patient’s legal
320 representative, the dispensing organization shall verify the
321 identity of the qualified patient or the qualified patient’s
322 legal representative by requiring the qualified patient or the
323 qualified patient’s legal representative to produce a
324 government-issued identification card and shall verify that the
325 qualified patient and the qualified patient’s legal
326 representative have has an active registration in the
327 compassionate use registry, that the order presented matches the
328 order contents as recorded in the registry, and that the order
329 has not already been filled. Upon dispensing the low-THC
330 cannabis or low-THC cannabis products, the dispensing
331 organization shall record in the registry the date, time,
332 quantity, and form of low-THC cannabis dispensed.
333 (d)1. A dispensing organization may have cultivation
334 facilities, processing facilities, or dispensing facilities.
335 2. A municipality must determine by ordinance the criteria
336 for the number and location of, and other permitting
337 requirements for, all dispensing facilities located within its
338 municipal boundaries. A dispensing facility may be established
339 in a municipality only after such an ordinance has been created.
340 A county must determine by ordinance the criteria for the
341 number, location, and other permitting requirements for all
342 dispensing facilities located within the unincorporated areas of
343 that county. A dispensing facility may be established in the
344 unincorporated areas of a county only after such an ordinance
345 has been created. Dispensing facilities must have all utilities
346 and resources necessary to store and dispense low-THC cannabis
347 and low-THC cannabis products. Dispensing facilities must be
348 secured and have theft-prevention systems, including an alarm
349 system, cameras, and 24-hour security personnel. Dispensing
350 facilities may not sell, or contract for the sale of, anything
351 other than low-THC cannabis or low-THC cannabis products on the
352 property of the dispensing facilities. Before a dispensing
353 facility may dispense low-THC cannabis or a low-THC cannabis
354 product, the dispensing organization must have a computer
355 network compliant with the federal Health Insurance Portability
356 and Accountability Act of 1996 which can access and upload data
357 to the compassionate use registry and which shall be used by all
358 dispensing facilities.
359 (e) Within 15 days after such information becoming
360 available, a dispensing organization must provide the department
361 with updated information, as applicable, including:
362 1. The location and a detailed description of any new or
363 proposed facility.
364 2. The updated contact information, including electronic
365 and voice communication, for all dispensing organization
366 facilities.
367 3. The registration information for any vehicle used for
368 the transportation of low-THC cannabis and low-THC cannabis
369 products, including confirmation that all such vehicles have
370 tracking and security systems.
371 4. A plan for the recall of any or all low-THC cannabis or
372 low-THC cannabis products.
373 (f)1. A dispensing organization may transport low-THC
374 cannabis or low-THC cannabis products in a vehicle departing
375 from its place of business only in a vehicle that is owned or
376 leased by the licensee or by a person designated by the
377 dispensing organization, and for which a valid vehicle permit
378 has been issued for such vehicle by the department.
379 2. A vehicle owned or leased by the dispensing
380 organization, or by a person designated by the dispensing
381 organization and approved by the department, must be operated by
382 a person designated by the dispensing organization and approved
383 by the department when transporting low-THC cannabis or low-THC
384 products from the licensee’s place of business.
385 3. A vehicle permit may be obtained by a dispensing
386 organization upon application and payment of a fee of $5 per
387 vehicle to the department. The signature of the person
388 designated by the dispensing organization to drive the vehicle
389 must be included on the vehicle permit application. Such permit
390 remains valid and does not expire unless the licensee or any
391 person designated by the dispensing organization disposes of his
392 or her vehicle, or the licensee’s license is transferred,
393 canceled, not renewed, or is revoked by the department,
394 whichever occurs first. The department shall cancel a vehicle
395 permit upon request of the licensee or owner of the vehicle.
396 4. By acceptance of a license issued under this section,
397 the licensee agrees that the permitted vehicle is, at all times
398 it is being used to transport low-THC cannabis or low-THC
399 cannabis products, subject to inspection and search without a
400 search warrant by authorized employees of the department,
401 sheriffs, deputy sheriffs, police officers, or other law
402 enforcement officers to determine that the licensee is
403 transporting such products in compliance with this section.
404 (7) TESTING AND LABELING OF LOW-THC CANNABIS.—
405 (a) All low-THC cannabis and low-THC cannabis products must
406 be tested by an independent testing laboratory before the
407 dispensing organization may dispense them. The independent
408 testing laboratory shall provide the dispensing organization
409 with lab results. Before dispensing, the dispensing organization
410 must determine that the lab results indicate that the low-THC
411 cannabis or low-THC cannabis product meets the definition of
412 low-THC cannabis or low-THC cannabis product, is safe for human
413 consumption, and is free from harmful contaminants.
414 (b) All low-THC cannabis and low-THC cannabis products must
415 be labeled before dispensing. The label must include, at a
416 minimum:
417 1. A statement that the low-THC cannabis or low-THC
418 cannabis product meets the requirements in paragraph (a);
419 2. The name of the independent testing laboratory that
420 tested the low-THC cannabis or low-THC cannabis product;
421 3. The name of the cultivation and processing facility
422 where the low-THC cannabis or low-THC cannabis product
423 originates; and
424 4. The batch number and harvest number from which the low
425 THC cannabis or low-THC cannabis product originates.
426 (8) SAFETY AND EFFICACY RESEARCH FOR LOW-THC CANNABIS.—The
427 University of Florida College of Pharmacy shall establish and
428 maintain a safety and efficacy research program for the use of
429 low-THC cannabis or low-THC cannabis products to treat
430 qualifying conditions and symptoms. The program must include a
431 fully integrated electronic information system for the broad
432 monitoring of health outcomes and safety signal detection. The
433 electronic information system must include information from the
434 compassionate use registry; provider reports, including
435 treatment plans, adverse event reports, and treatment
436 discontinuation reports; patient reports of adverse impacts;
437 event-triggered interviews and medical chart reviews performed
438 by the University of Florida clinical research staff;
439 information from external databases, including Medicaid billing
440 reports and information in the prescription drug monitoring
441 database for registered patients; and all other medical reports
442 required by the University of Florida to conduct the research
443 required by this subsection. The department must provide access
444 to information from the compassionate use registry and the
445 prescription drug monitoring database, established in s.
446 893.055, as needed by the University of Florida to conduct
447 research under this subsection. The Agency for Health Care
448 Administration must provide access to registered patient
449 Medicaid records, to the extent allowed under federal law, as
450 needed by the University of Florida to conduct research under
451 this subsection.
452 (9) PERSONS WITH INTEREST IN THE DISPENSING ORGANIZATION.
453 The persons who have direct or indirect interest in the
454 dispensing organization and the dispensing organization’s
455 managers, employees, and contractors who directly interact with
456 low-THC cannabis or low-THC cannabis products may not make
457 recommendations, offer prescriptions, or provide medical advice
458 to qualified patients.
459 (10) DEPARTMENT AUTHORITY AND RESPONSIBILITIES.—
460 (a) The department may conduct announced or unannounced
461 inspections of dispensing organizations to determine compliance
462 with this section or rules adopted pursuant to this section.
463 (b) The department shall inspect a dispensing organization
464 upon complaint or notice provided to the department that the
465 dispensing organization has dispensed low-THC cannabis or low
466 THC cannabis products containing any mold, bacteria, or other
467 contaminant that may cause or has caused an adverse effect to
468 human health or the environment.
469 (c) The department shall conduct at least a biennial
470 inspection of each dispensing organization to evaluate the
471 dispensing organization’s records, personnel, equipment,
472 processes, security measures, sanitation practices, and quality
473 assurance practices.
474 (d) The department may enter into interagency agreements
475 with the Department of Agriculture and Consumer Services, the
476 Department of Business and Professional Regulation, the
477 Department of Transportation, the Department of Highway Safety
478 and Motor Vehicles, and the Agency for Health Care
479 Administration, and such agencies are authorized to enter into
480 an interagency agreement with the department, to conduct
481 inspections or perform other responsibilities assigned to the
482 department under this section.
483 (e) The department must make a list of all approved
484 dispensing organizations and qualified ordering physicians and
485 medical directors publicly available on its website.
486 (f) The department may establish a system for issuing and
487 renewing registration cards for qualified patients and their
488 legal representatives, establish the circumstances under which
489 the cards may be revoked by or must be returned to the
490 department, and establish fees to implement such system. The
491 department must require, at a minimum, the registration cards
492 to:
493 1. Provide the name, address, and date of birth of the
494 qualified patient or legal representative.
495 2. Have a full-face, passport-type, color photograph of the
496 qualified patient or legal representative taken within the 90
497 days immediately preceding registration.
498 3. Identify whether the cardholder is a qualified patient
499 or legal representative.
500 4. List a unique numeric identifier for the qualified
501 patient or legal representative which is matched to the
502 identifier used for such person in the department’s
503 compassionate use registry.
504 5. Provide the expiration date, which shall be 1 year after
505 the date of the physician’s initial order of low-THC cannabis.
506 6. For the legal representative, provide the name and
507 unique numeric identifier of the qualified patient that the
508 legal representative is assisting.
509 7. Be resistant to counterfeiting or tampering.
510 (g) The department may suspend, revoke, or refuse to renew
511 a dispensing organization’s approval if a dispensing
512 organization commits any of the violations in paragraph (g).
513 (h) The department shall renew the approval of a dispensing
514 organization biennially if the dispensing organization meets the
515 requirements of this section and pays the biennial renewal fee.
516 (i) The department may adopt rules necessary to implement
517 this section.
518 (11) PREEMPTION.—
519 (a) All matters regarding the regulation of the cultivation
520 and processing of medical cannabis or low-THC cannabis by
521 dispensing organizations are preempted to the state.
522 (b) A municipality may determine by ordinance the criteria
523 for the number and location of, and other permitting
524 requirements that do not conflict with state law or department
525 rule for, dispensing facilities of dispensing organizations
526 located within its municipal boundaries. A county may determine
527 by ordinance the criteria for the number, location, and other
528 permitting requirements that do not conflict with state law or
529 department rule for all dispensing facilities of dispensing
530 organizations located within the unincorporated areas of that
531 county.
532 (12)(7) EXCEPTIONS TO OTHER LAWS.—
533 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
534 any other provision of law, but subject to the requirements of
535 this section, a qualified patient and the qualified patient’s
536 legal representative who is registered with the department on
537 the compassionate use registry may purchase and possess for the
538 patient’s medical use up to the amount of low-THC cannabis or
539 medical cannabis ordered for the patient, but not more than a
540 45-day supply, and a cannabis delivery device ordered for the
541 patient. This section does not exempt any person from the
542 prohibition against driving under the influence provided in s.
543 316.193.
544 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
545 any other provision of law, but subject to the requirements of
546 this section, an approved dispensing organization and its
547 owners, managers, and employees, and the owners, managers, and
548 employees of contractors who have direct contact with low-THC
549 cannabis or low-THC cannabis products may manufacture, possess,
550 sell, deliver, distribute, dispense, and lawfully dispose of
551 reasonable quantities, as established by department rule, of
552 low-THC cannabis or low-THC cannabis products in accordance with
553 their licensure. For purposes of this subsection, the terms
554 “manufacture,” “possession,” “deliver,” “distribute,” and
555 “dispense” have the same meanings as provided in s. 893.02.
556 (c) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
557 any other law, but subject to the requirements of this section,
558 an approved independent testing laboratory may possess, test,
559 transport, and lawfully dispose of low-THC cannabis or medical
560 cannabis as provided by department rule.
561 (d)(c) An approved dispensing organization and its owners,
562 managers, and employees are not subject to licensure or
563 regulation under chapter 465 or chapter 499 for manufacturing,
564 possessing, selling, delivering, distributing, dispensing, or
565 lawfully disposing of reasonable quantities, as established by
566 department rule, of low-THC cannabis.
567 (e) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
568 any other law, but subject to the requirements of this section,
569 a licensed laboratory and its employees may receive and possess
570 low-THC cannabis or low-THC cannabis products for the sole
571 purpose of testing the low-THC cannabis or low-THC cannabis
572 products to ensure compliance with this section.
573 (f) A dispensing organization that continues to meet the
574 requirements for approval is presumed to be registered with the
575 department and to meet the regulations adopted by the department
576 or its successor agency for the purpose of dispensing medical
577 cannabis or low-THC cannabis under state law. Additionally, the
578 authority provided to a dispensing organization in s. 499.0295
579 does not impair the approval of a dispensing organization.
580 (g) This subsection does not preclude a person from being
581 prosecuted for a criminal offense related to impairment or
582 intoxication resulting from the medical use of low-THC cannabis
583 or medical cannabis or relieve a person from any requirement
584 under law to submit to a breath, blood, urine, or other test to
585 detect the presence of a controlled substance.
586 (13) RULES.—Rules adopted by the department under this
587 section are exempt from the requirement that they be ratified by
588 the Legislature pursuant to s. 120.541(3).
589
590 ================= T I T L E A M E N D M E N T ================
591 And the title is amended as follows:
592 Delete lines 21 - 81
593 and insert:
594 requiring the department to accept applications for
595 licensure as dispensing organizations according to a
596 specified application process; authorizing a
597 dispensing organization to be licensed to cultivate,
598 to process, or to dispense low-THC cannabis; requiring
599 the department to review all applications, notify
600 applicants of deficient applications, and request any
601 additional information within a specified period;
602 requiring an application for licensure to be filed and
603 complete by specified dates; authorizing licensed
604 applicants to operate in any region of the state;
605 prohibiting a dispensing organization licensed to
606 cultivate or process low-THC cannabis from having
607 cultivation or processing facilities outside the
608 region in which it is licensed; requiring licensure
609 fees to be paid within a specified timeframe;
610 providing an exemption for the application process;
611 requiring the department to use an application form
612 that requires specified information from the
613 applicant; specifying application fees, licensure
614 fees, and renewal fees; requiring the department to
615 inspect each dispensing organization’s properties,
616 cultivation facilities, processing facilities, or
617 dispensing facilities before those facilities may
618 operate; authorizing followup inspections at
619 reasonable hours; providing that licensure constitutes
620 permission for the department to enter and inspect the
621 premises or facilities of any dispensing organization;
622 requiring dispensing organizations to make all
623 facility premises, equipment, documents, low-THC
624 cannabis, and low-THC cannabis products, as
625 applicable, available to the department upon
626 inspection; authorizing the department to test low-THC
627 cannabis or low-THC cannabis products; authorizing the
628 department to suspend or revoke a license, deny or
629 refuse to renew a license, or impose an administrative
630 penalty for specified acts or omissions; requiring the
631 department to create a permitting process for vehicles
632 used for the transportation of low-THC cannabis or
633 low-THC cannabis products; providing procedures and
634 requirements for an applicant seeking licensure as a
635 dispensing organization or the renewal of its license;
636 requiring the dispensing organization to verify
637 specified information of specified persons in certain
638 circumstances; authorizing a dispensing organization
639 to have cultivation facilities, processing facilities,
640 or dispensing facilities; providing that all matters
641 regarding the location of cultivation facilities and
642 processing facilities are preempted to the state;
643 providing requirements for cultivation facilities and
644 processing facilities; requiring a municipality to
645 determine by ordinance specified criteria related to
646 dispensing facilities; authorizing a dispensing
647 facility to be established in a municipality only
648 after such an ordinance has been created; authorizing
649 a dispensing facility to be established in the
650 unincorporated areas of a county only after such an
651 ordinance has been created; requiring dispensing
652 facilities to have all utilities and resources
653 necessary to store and dispense low-THC and low-THC
654 cannabis products; requiring dispensing facilities to
655 be secured with specified theft-prevention systems;
656 requiring a dispensing organization to provide the
657 department with specified updated information within a
658 specified period; authorizing a dispensing
659 organization to transport low-THC cannabis or low-THC
660 cannabis products in vehicles in certain
661 circumstances; requiring such vehicles to be operated
662 by specified persons in certain circumstances;
663 requiring a fee for a vehicle permit; requiring the
664 signature of the designated driver with a vehicle
665 permit application; providing for expiration of the
666 permit in certain circumstances; requiring the
667 department to cancel a vehicle permit upon the request
668 of specified persons; providing that the licensee
669 authorizes the inspection and search of his or her
670 vehicle without a search warrant by specified persons;
671 requiring all low-THC cannabis and low-THC cannabis
672 products to be tested by an independent testing
673 laboratory before the dispensing organization may
674 dispense them; requiring the independent testing
675 laboratory to provide the lab results to the
676 dispensing organization for a specified determination;
677 requiring all low-THC cannabis and low-THC cannabis
678 products to be labeled with specified information
679 before dispensing; requiring the University of Florida
680 College of Pharmacy to establish and maintain a
681 specified safety and efficacy research program;
682 providing program requirements; requiring the
683 department to provide access to information from the
684 compassionate use registry and the prescription drug
685 monitoring program database to the University of
686 Florida as needed; requiring the Agency for Health
687 Care Administration to provide access to specified
688 patient records under certain circumstances;
689 prohibiting persons who have direct or indirect
690 interest in a dispensing organization and the
691 dispensing organization’s managers, employees, and
692 contractors who directly interact with low-THC
693 cannabis and low-THC cannabis products from making
694 recommendations, offering prescriptions, or providing
695 medical advice to qualified patients; revising duties
696 and responsibilities of the department; providing that
697 certain matters are preempted to the state;
698 authorizing a municipality to determine by ordinance
699 certain criteria relating to dispensing organizations;
700 providing that the act does not provide an exception
701 to the prohibition against driving under the
702 influence; authorizing specified individuals to
703 manufacture, possess, sell, deliver, distribute,
704 dispense, and lawfully dispose of reasonable
705 quantities of low-THC cannabis according to their
706 licensure; authorizing a licensed laboratory and its
707 employees to receive and possess low-THC cannabis in
708 certain circumstances; providing applicability;
709 providing that specified rules adopted by the
710 department are exempt from the requirement to be
711 ratified by the Legislature; amending s. 499.0295,
712 F.S.;