Florida Senate - 2015 SENATOR AMENDMENT
Bill No. CS for CS for SB 7066
Ì274940)Î274940
LEGISLATIVE ACTION
Senate . House
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Senator Clemens moved the following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Section 381.986, Florida Statutes, is amended to
6 read:
7 381.986 Compassionate use of low-THC cannabis.—
8 (1) DEFINITIONS.—As used in this section, the term:
9 (a) “Applicant” means a person that has submitted an
10 application to the department for licensure or renewal as a
11 dispensing organization.
12 (b) “Batch” means a specific quantity of low-THC cannabis
13 product that is intended to have uniform character and quality,
14 within specified limits, and is produced at the same time from
15 one or more harvests.
16 (c) “Dispensing organization” means an applicant licensed
17 organization approved by the department to cultivate or ,
18 process low-THC cannabis, and or dispense low-THC cannabis
19 through a retail facility pursuant to this section.
20 (d) “Harvest” means a specifically identified and numbered
21 quantity of low-THC cannabis cultivated using the same
22 herbicides, pesticides, and fungicides and harvested at the same
23 time from a single facility.
24 (e) “Independent testing laboratory” means a laboratory,
25 and the managers, employees, or contractors of the laboratory,
26 which have no direct or indirect interest in a dispensing
27 organization.
28 (f)(b) “Low-THC cannabis” means a plant of the genus
29 Cannabis, the dried flowers of which contain 0.8 percent or less
30 of tetrahydrocannabinol and more than 10 percent of cannabidiol
31 weight for weight; the seeds thereof; the resin extracted from
32 any part of such plant; or any compound, manufacture, salt,
33 derivative, mixture, or preparation of such plant or its seeds
34 or resin that is dispensed only from a dispensing organization.
35 (g) “Low-THC cannabis product” means any product derived
36 from low-THC cannabis, including the resin extracted from any
37 part of such plant or any compound, manufacture, salt,
38 derivative, mixture, or preparation of such plant or its seeds
39 or resin which is dispensed from a dispensing organization. Low
40 THC cannabis products include, but are not limited to, oils,
41 tinctures, creams, encapsulations, and food products. Low-THC
42 cannabis food products may not include candy or similar
43 confectionary products that appeal to children. All low-THC
44 cannabis products must maintain concentrations, weight for
45 weight, of 0.8 percent or less of tetrahydrocannabinol and more
46 than 10 percent of cannabidiol.
47 (h)(c) “Medical use” means administration of the ordered
48 amount of low-THC cannabis. The term does not include:
49 1. The possession, use, or administration by smoking.
50 2. The term also does not include The transfer of low-THC
51 cannabis to a person other than the qualified patient for whom
52 it was ordered or the qualified patient’s legal representative
53 who is registered in the compassionate use registry on behalf of
54 the qualified patient.
55 3. The use or administration of low-THC cannabis or low-THC
56 cannabis products:
57 a. On any form of public transportation.
58 b. In any public place.
59 c. In a registered qualified patient’s place of work, if
60 restricted by his or her employer.
61 d. In a correctional facility.
62 e. On the grounds of any preschool, primary school, or
63 secondary school.
64 f. On a school bus.
65 (i)(d) “Qualified patient” means a resident of this state
66 who has been added to the compassionate use registry by a
67 physician licensed under chapter 458 or chapter 459 to receive
68 low-THC cannabis from a dispensing organization.
69 (j) “Retail facility” means a facility that is used by an
70 applicant licensed to dispense low-THC cannabis.
71 (k)(e) “Smoking” means burning or igniting a substance and
72 inhaling the smoke. Smoking does not include the use of a
73 vaporizer.
74 (2) PHYSICIAN ORDERING.—
75 (a) Effective January 1, 2015, A physician licensed under
76 chapter 458 or chapter 459 who has examined and is treating a
77 patient suffering from cancer, human immunodeficiency virus,
78 acquired immune deficiency syndrome, epilepsy, amyotrophic
79 lateral sclerosis, autism, multiple sclerosis, Crohn’s disease,
80 Parkinson’s disease, paraplegia, quadriplegia, or terminal
81 illness a physical medical condition that chronically produces
82 symptoms of seizures or severe and persistent muscle spasms may
83 order for the patient’s medical use low-THC cannabis to treat
84 such disease, disorder, or condition; or to alleviate symptoms
85 of such disease, disorder, or condition; or to alleviate
86 symptoms caused by a treatment for such disease, disorder, or
87 condition, if no other satisfactory alternative treatment
88 options exist for that patient and all of the following
89 conditions apply:
90 1.(a) The patient is a permanent resident of this state.
91 2.(b) The physician determines that the risks of ordering
92 low-THC cannabis are reasonable in light of the potential
93 benefit for that patient. If a patient is younger than 18 years
94 of age, a second physician must concur with this determination,
95 and such determination must be documented in the patient’s
96 medical record.
97 3.(c) The physician registers the patient, the patient’s
98 legal representative if requested by the patient, and himself or
99 herself as the orderer of low-THC cannabis for the named patient
100 on the compassionate use registry maintained by the department
101 and updates the registry to reflect the contents of the order.
102 If the patient is a minor, the physician must register a legal
103 representative on the compassionate use registry. The physician
104 shall deactivate the patient’s registration when treatment is
105 discontinued.
106 4.(d) The physician maintains a patient treatment plan that
107 includes the dose, route of administration, planned duration,
108 and monitoring of the patient’s symptoms and other indicators of
109 tolerance or reaction to the low-THC cannabis.
110 5.(e) The physician submits the patient treatment plan, as
111 well as any other requested medical records, quarterly to the
112 University of Florida College of Pharmacy for research on the
113 safety and efficacy of low-THC cannabis on patients pursuant to
114 subsection (8).
115 6.(f) The physician obtains the voluntary informed consent
116 of the patient or the patient’s legal guardian to treatment with
117 low-THC cannabis after sufficiently explaining the current state
118 of knowledge in the medical community of the effectiveness of
119 treatment of the patient’s conditions or symptoms condition with
120 low-THC cannabis, the medically acceptable alternatives, and the
121 potential risks and side effects.
122 (b) A physician who improperly orders low-THC cannabis is
123 subject to disciplinary action under the applicable practice act
124 and under s. 456.072(1)(k).
125 (3) PENALTIES.—
126 (a) A physician commits a misdemeanor of the first degree,
127 punishable as provided in s. 775.082 or s. 775.083, if the
128 physician orders low-THC cannabis for a patient without a
129 reasonable belief that the patient is suffering from at least
130 one of the conditions listed in subsection (2).:
131 1. Cancer or a physical medical condition that chronically
132 produces symptoms of seizures or severe and persistent muscle
133 spasms that can be treated with low-THC cannabis; or
134 2. Symptoms of cancer or a physical medical condition that
135 chronically produces symptoms of seizures or severe and
136 persistent muscle spasms that can be alleviated with low-THC
137 cannabis.
138 (b) Any person who fraudulently represents that he or she
139 has at least one condition listed in subsection (2) cancer or a
140 physical medical condition that chronically produces symptoms of
141 seizures or severe and persistent muscle spasms to a physician
142 for the purpose of being ordered low-THC cannabis by such
143 physician commits a misdemeanor of the first degree, punishable
144 as provided in s. 775.082 or s. 775.083.
145 (4) PHYSICIAN EDUCATION.—
146 (a) Before ordering low-THC cannabis for use by a patient
147 in this state, the appropriate board shall require the ordering
148 physician licensed under chapter 458 or chapter 459 to
149 successfully complete an 8-hour course and subsequent
150 examination offered by the Florida Medical Association or the
151 Florida Osteopathic Medical Association that encompasses the
152 clinical indications for the appropriate use of low-THC
153 cannabis, the appropriate delivery mechanisms, the
154 contraindications for such use, as well as the relevant state
155 and federal laws governing the ordering, dispensing, and
156 possessing of this substance. The first course and examination
157 shall be presented by October 1, 2014, and shall be administered
158 at least annually thereafter. Successful completion of the
159 course may be used by a physician to satisfy 8 hours of the
160 continuing medical education requirements required by his or her
161 respective board for licensure renewal. This course may be
162 offered in a distance learning format.
163 (b) The appropriate board shall require the medical
164 director of each dispensing organization approved under
165 subsection (5) to successfully complete a 2-hour course and
166 subsequent examination offered by the Florida Medical
167 Association or the Florida Osteopathic Medical Association that
168 encompasses appropriate safety procedures and knowledge of low
169 THC cannabis.
170 (c) Successful completion of the course and examination
171 specified in paragraph (a) is required for every physician who
172 orders low-THC cannabis each time such physician renews his or
173 her license. In addition, successful completion of the course
174 and examination specified in paragraph (b) is required for the
175 medical director of each dispensing organization each time such
176 physician renews his or her license.
177 (d) A physician who fails to comply with this subsection
178 and who orders low-THC cannabis may be subject to disciplinary
179 action under the applicable practice act and under s.
180 456.072(1)(k).
181 (5) DUTIES AND POWERS OF THE DEPARTMENT.—By January 1,
182 2015, The department shall:
183 (a) The department shall create a secure, electronic, and
184 online compassionate use registry for the registration of
185 physicians and patients as provided under this section. The
186 registry must be accessible to law enforcement agencies and to a
187 dispensing organization in order to verify patient authorization
188 for low-THC cannabis and record the low-THC cannabis dispensed.
189 The registry must prevent an active registration of a patient by
190 multiple physicians.
191 (b)1. Beginning 7 days after the effective date of this
192 act, the department shall accept applications for licensure as a
193 dispensing organization. A dispensing organization may be
194 licensed to cultivate or process low-THC cannabis or dispense
195 low-THC cannabis through a retail facility. A dispensing
196 organization may be licensed to conduct one or more of these
197 activities. The department shall review each application to
198 determine whether the applicant meets the criteria in subsection
199 (6) and qualifies for licensure.
200 2. Within 10 days after receiving an application for
201 licensure, the department shall examine the application, notify
202 the applicant of any apparent errors or omissions, and request
203 any additional information the department is allowed by law to
204 require. An application for licensure must be filed with the
205 department no later than 5 p.m. on the 30th day after the
206 effective date of this act, and all applications must be
207 complete no later than 5 p.m. on the 60th day after the
208 effective date of this act.
209 3. Once licensed, applicants are authorized to operate in
210 any region in the state, but a dispensing organization licensed
211 to cultivate or process low-THC cannabis may not have
212 cultivation or processing facilities outside the region in which
213 it is licensed.
214 4. The department shall license a selected applicant unless
215 the applicant fails to pay the licensure fee within 10 days of
216 selection.
217 5. This section is exempt from s. 120.60(1) Authorize the
218 establishment of five dispensing organizations to ensure
219 reasonable statewide accessibility and availability as necessary
220 for patients registered in the compassionate use registry and
221 who are ordered low-THC cannabis under this section, one in each
222 of the following regions: northwest Florida, northeast Florida,
223 central Florida, southeast Florida, and southwest Florida.
224 (c) The department shall use develop an application form
225 that requires the applicant to state, as applicable:
226 1. Whether the application is for initial licensure or
227 renewal licensure;
228 2. Whether the application is for licensure as a
229 cultivator, processor, or dispenser of low-THC cannabis;
230 3. The name, the physical address, and the mailing address
231 of the applicant;
232 4. For a cultivating or processing license, the address
233 listed on the Department of Agriculture and Consumer Services
234 certificate required in paragraph (6)(b);
235 5. The name, address, license number, and contact
236 information for the applicant’s medical director; and
237 6. All information required to be included by subsection
238 (6).
239 (d) The department shall and impose an initial application
240 fee of $10,000, an initial licensure fee of $25,000, and a
241 biennial renewal fee of $25,000 that is sufficient to cover the
242 costs of administering this section. An applicant for approval
243 as a dispensing organization must be able to demonstrate:
244 1. The technical and technological ability to cultivate and
245 produce low-THC cannabis. The applicant must possess a valid
246 certificate of registration issued by the Department of
247 Agriculture and Consumer Services pursuant to s. 581.131 that is
248 issued for the cultivation of more than 400,000 plants, be
249 operated by a nurseryman as defined in s. 581.011, and have been
250 operated as a registered nursery in this state for at least 30
251 continuous years.
252 2. The ability to secure the premises, resources, and
253 personnel necessary to operate as a dispensing organization.
254 3. The ability to maintain accountability of all raw
255 materials, finished products, and any byproducts to prevent
256 diversion or unlawful access to or possession of these
257 substances.
258 4. An infrastructure reasonably located to dispense low-THC
259 cannabis to registered patients statewide or regionally as
260 determined by the department.
261 5. The financial ability to maintain operations for the
262 duration of the 2-year approval cycle, including the provision
263 of certified financials to the department. Upon approval, the
264 applicant must post a $5 million performance bond.
265 6. That all owners and managers have been fingerprinted and
266 have successfully passed a level 2 background screening pursuant
267 to s. 435.04.
268 7. The employment of a medical director who is a physician
269 licensed under chapter 458 or chapter 459 to supervise the
270 activities of the dispensing organization.
271 (e) The department shall inspect each dispensing
272 organization’s properties, cultivation facilities, processing
273 facilities, or retail facilities according to its licensure
274 before they begin operations and at least once every 2 years
275 thereafter. The department may conduct additional announced or
276 unannounced inspections, including followup inspections, at
277 reasonable hours in order to ensure that such properties or
278 facilities maintain compliance with all applicable requirements
279 in subsections (6) and (7) and to ensure that the dispensing
280 organization has not committed any act that would endanger the
281 health, safety, or security of a qualified patient, a dispensing
282 organization staff member, or the community in which the
283 dispensing organization is located. Licensure under this section
284 constitutes permission for the department to enter and inspect
285 the premises or facilities of any dispensing organization. A
286 dispensing organization must make all facility premises,
287 equipment, documents, low-THC cannabis, and low-THC cannabis
288 products available, as applicable, to the department upon
289 inspection. The department may test any low-THC cannabis or low
290 THC cannabis product in order to ensure that it is safe for
291 human consumption and that it meets the requirements in this
292 section.
293 (f) The department may suspend or revoke a license, deny or
294 refuse to renew a license, or impose an administrative penalty
295 not to exceed $10,000 for the following acts or omissions:
296 1. Violating this section or department rule.
297 2. Failing to maintain qualifications for licensure.
298 3. Endangering the health, safety, or security of a
299 qualified patient.
300 4. Improperly disclosing personal and confidential
301 information of a qualified patient.
302 5. Attempting to procure a license by bribery or fraudulent
303 misrepresentation.
304 6. Being convicted or found guilty of, or entering a plea
305 of nolo contendere to, regardless of adjudication, a crime in
306 any jurisdiction which directly relates to the business of a
307 dispensing organization.
308 7. Making or filing a report or record that the licensee
309 knows to be false.
310 8. Willfully failing to maintain a record required by this
311 section or department rule.
312 9. Willfully impeding or obstructing an employee or agent
313 of the department in the furtherance of his or her official
314 duties.
315 10. Engaging in fraud or deceit, negligence, incompetence,
316 or misconduct in the business practices of a dispensing
317 organization.
318 11. Making misleading, deceptive, or fraudulent
319 representations in or related to the business practices of a
320 dispensing organization.
321 12. Having a license or the authority to engage in any
322 regulated profession, occupation, or business that is related to
323 the business practices of a dispensing organization revoked,
324 suspended, or otherwise acted against, including the denial of
325 licensure, by the licensing authority of any jurisdiction,
326 including its agencies or subdivisions, for a violation that
327 would constitute a violation under state law. A licensing
328 authority’s acceptance of a relinquishment of licensure or a
329 stipulation, consent order, or other settlement, offered in
330 response to or in anticipation of the filing of charges against
331 the license, shall be construed as an action against the
332 license.
333 13. Violating a lawful order of the department or an agency
334 of the state, or failing to comply with a lawfully issued
335 subpoena of the department or an agency of the state.
336 (g) The department shall create a permitting process for
337 all dispensing organization vehicles used for the transportation
338 of low-THC cannabis or low-THC cannabis products.
339 (h)(c) The department shall monitor physician registration
340 and ordering of low-THC cannabis for ordering practices that
341 could facilitate unlawful diversion or misuse of low-THC
342 cannabis and take disciplinary action as indicated.
343 (i)(d) The department shall adopt rules as necessary to
344 implement this section.
345 (6) DISPENSING ORGANIZATION.—
346 (a) An applicant seeking licensure as a dispensing
347 organization, or the renewal of its license, must submit an
348 application to the department. An applicant may seek licensure
349 as a dispensing organization to cultivate, process, or dispense
350 low-THC cannabis. Each function of the dispensing organization
351 requires separate licensure; however, an applicant may seek
352 licensure for more than one function. The department must review
353 all applications for completeness, including an appropriate
354 inspection of the applicant’s property or facilities, as
355 applicable, to verify the authenticity of the information
356 provided in, or in connection with, the application. An
357 applicant authorizes the department to inspect his or her
358 property or facilities for licensure by applying under this
359 subsection.
360 (b) In order to receive or maintain licensure as a
361 dispensing organization, an applicant must provide proof that:
362 1. For a cultivating or processing license, the applicant,
363 or a separate entity that is owned solely by the same persons or
364 entities in the same ratio as the applicant, possesses a valid
365 certificate of registration issued by the Department of
366 Agriculture and Consumer Services pursuant to s. 581.131 for the
367 cultivation of more than 400,000 plants.
368 2. For a cultivating or processing license, the personnel
369 on staff or under contract for the applicant have experience
370 cultivating and introducing multiple varieties of plants in this
371 state, including plants that are not native to Florida;
372 experience with propagating plants; and experience with genetic
373 modification or breeding of plants.
374 3. For a cultivating or processing license, the personnel
375 on staff or under contract for the applicant include at least
376 one person who:
377 a. Has at least 5 years’ experience with United States
378 Department of Agriculture Good Agricultural Practices and Good
379 Handling Practices;
380 b. Has at least 5 years’ experience with United States Food
381 and Drug Administration Good Manufacturing Practices for food
382 production;
383 c. Has a doctorate degree in organic chemistry or
384 microbiology;
385 d. Has at least 5 years’ of experience with laboratory
386 procedures which includes analytical laboratory quality control
387 measures, chain of custody procedures, and analytical laboratory
388 methods;
389 e. Has experience with cannabis cultivation and processing,
390 including cannabis extraction techniques and producing cannabis
391 products;
392 f. Has experience and qualifications in chain of custody or
393 other tracking mechanisms;
394 g. Works solely on inventory control; and
395 h. Works solely for security purposes.
396 4. The persons who have a direct or indirect interest in
397 any dispensing organization and the applicant’s managers,
398 employees, and contractors who directly interact with low-THC
399 cannabis or low-THC cannabis products have been fingerprinted
400 and have successfully passed a level 2 background screening
401 pursuant to s. 435.04.
402 5. For a cultivating or processing license, the applicant
403 owns, or has at least a 2-year lease of, all properties,
404 facilities, and equipment necessary for the cultivation and
405 processing of low-THC cannabis. The applicant must provide a
406 detailed description of each facility and its equipment, a
407 cultivation and processing plan, and a detailed floor plan. The
408 description must include proof that:
409 a. The applicant is capable of sufficient cultivation and
410 processing to serve at least 15,000 patients with an assumed
411 daily use of 1,000 mg per patient per day of low-THC cannabis or
412 low-THC cannabis product;
413 b. The applicant has arranged for access to all utilities
414 and resources necessary to cultivate or process low-THC cannabis
415 at each listed facility; and
416 c. Each facility is secured and has theft-prevention
417 systems including an alarm system, cameras, and 24-hour security
418 personnel.
419 6. The applicant has diversion and tracking prevention
420 procedures, as applicable, including:
421 a. A system for tracking low-THC material through
422 cultivation, processing, or dispensing, including the use of
423 batch and harvest numbers;
424 b. An inventory control system for low-THC cannabis and
425 low-THC cannabis products;
426 c. A vehicle tracking and security system; and
427 d. A cannabis waste-disposal plan.
428 7. The applicant has recordkeeping policies and procedures
429 in place.
430 8. The applicant has a facility emergency management plan.
431 9. For a dispensing license, the applicant has a plan for
432 dispensing low-THC cannabis throughout the state. This plan must
433 include planned retail facilities and a delivery plan for
434 providing low-THC cannabis and low-THC cannabis products to
435 qualified patients who cannot travel to a retail facility.
436 10. The applicant has financial documentation, as
437 applicable, including:
438 a. Documentation that demonstrates the applicant’s
439 financial ability to operate. If the applicant’s assets, credit,
440 and projected revenues meet or exceed projected liabilities and
441 expenses and the applicant provides independent evidence that
442 the funds necessary for startup costs, working capital, and
443 contingency financing exist and are available as needed, the
444 applicant has demonstrated the financial ability to operate.
445 Financial ability to operate must be documented by:
446 I. The applicant’s audited financial statements. If the
447 applicant is a newly formed entity and does not have a financial
448 history of business upon which audited financial statements may
449 be submitted, the applicant must provide audited financial
450 statements for the separate entity that is owned solely by the
451 same persons or entities in the same ratio as the applicant;
452 II. The applicant’s projected financial statements,
453 including a balance sheet, an income and expense statement, and
454 a statement of cash flow for the first 2 years of operation,
455 which provides evidence that the applicant has sufficient
456 assets, credit, and projected revenues to cover liabilities and
457 expenses; and
458 III. A statement of the applicant’s estimated startup costs
459 and sources of funds, including a break-even projection and
460 documentation demonstrating that the applicant has the ability
461 to fund all startup costs, working capital costs, and
462 contingency financing requirements.
463
464 All documents required under this sub-subparagraph shall be
465 prepared in accordance with generally accepted accounting
466 principles and signed by a certified public accountant. The
467 statements required by sub-sub-subparagraphs II. and III. may be
468 presented as a compilation;
469 b. A list of all subsidiaries of the applicant;
470 c. A list of all lawsuits pending and completed within the
471 past 7 years of which the applicant was a party; and
472 d. Proof of a $1 million performance and compliance bond,
473 or other equivalent means of security deemed equivalent by the
474 department, such as an irrevocable letter of credit or a deposit
475 in a trust account or financial institution, payable to the
476 department, which must be posted once the applicant is approved
477 as a dispensing organization. The purpose of the bond is to
478 secure payment of any administrative penalties imposed by the
479 department and any fees and costs incurred by the department
480 regarding the dispensing organization license, such as the
481 dispensing organization failing to pay 30 days after the fine or
482 costs become final. The department may make a claim against such
483 bond or security until 1 year after the dispensing
484 organization’s license ceases to be valid or until 60 days after
485 any administrative or legal proceeding authorized in this
486 section involving the dispensing organization concludes,
487 including any appeal, whichever occurs later.
488 11. The employment of a medical director who is a physician
489 licensed under chapter 458 or chapter 459 to supervise the
490 activities of the dispensing organization.
491 (c) An approved dispensing organization shall maintain
492 compliance with the criteria in paragraphs (b), (d), and (e) and
493 subsection (7) demonstrated for selection and approval as a
494 dispensing organization under subsection (5) at all times.
495 Before dispensing low-THC cannabis or low-THC cannabis products
496 to a qualified patient or to the qualified patient’s legal
497 representative, the dispensing organization shall verify the
498 identity of the qualified patient or the qualified patient’s
499 legal representative by requiring the qualified patient or the
500 qualified patient’s legal representative to produce a
501 government-issued identification card and shall verify that the
502 qualified patient and the qualified patient’s legal
503 representative have has an active registration in the
504 compassionate use registry, that the order presented matches the
505 order contents as recorded in the registry, and that the order
506 has not already been filled. Upon dispensing the low-THC
507 cannabis, the dispensing organization shall record in the
508 registry the date, time, quantity, and form of low-THC cannabis
509 dispensed.
510 (d) A dispensing organization may have cultivation
511 facilities, processing facilities, or retail facilities.
512 1. All matters regarding the location of cultivation
513 facilities and processing facilities are preempted to the state.
514 Cultivation facilities and processing facilities must be closed
515 to the public, and low-THC cannabis may not be dispensed on the
516 premises of such facilities.
517 2. A municipality must determine by ordinance the criteria
518 for the number and location of, and other permitting
519 requirements for, all retail facilities located within its
520 municipal boundaries. A retail facility may be established in a
521 municipality only after such an ordinance has been created. A
522 county must determine by ordinance the criteria for the number,
523 location, and other permitting requirements for all retail
524 facilities located within the unincorporated areas of that
525 county. A retail facility may be established in the
526 unincorporated areas of a county only after such an ordinance
527 has been created. Retail facilities must have all utilities and
528 resources necessary to store and dispense low-THC cannabis and
529 low-THC cannabis products. Retail facilities must be secured and
530 have theft-prevention systems, including an alarm system,
531 cameras, and 24-hour security personnel. Retail facilities may
532 not sell, or contract for the sale of, anything other than low
533 THC cannabis or low-THC cannabis products on the property of the
534 retail facility. Before a retail facility may dispense low-THC
535 cannabis or a low-THC cannabis product, the dispensing
536 organization must have a computer network compliant with the
537 federal Health Insurance Portability and Accountability Act of
538 1996 which is able to access and upload data to the
539 compassionate use registry and which shall be used by all retail
540 facilities.
541 (e) Within 15 days after such information becoming
542 available, a dispensing organization must provide the department
543 with updated information, as applicable, including:
544 1. The location and a detailed description of any new or
545 proposed facilities.
546 2. The updated contact information, including electronic
547 and voice communication, for all dispensing organization
548 facilities.
549 3. The registration information for any vehicles used for
550 the transportation of low-THC cannabis and low-THC cannabis
551 products, including confirmation that all such vehicles have
552 tracking and security systems.
553 4. A plan for the recall of any or all low-THC cannabis or
554 low-THC cannabis products.
555 (f)1. A dispensing organization may transport low-THC
556 cannabis or low-THC cannabis products in vehicles departing from
557 their places of business only in vehicles that are owned or
558 leased by the licensee or by a person designated by the
559 dispensing organization, and for which a valid vehicle permit
560 has been issued for such vehicle by the department.
561 2. A vehicle owned or leased by the dispensing organization
562 or a person designated by the dispensing organization and
563 approved by the department must be operated by such person when
564 transporting low-THC cannabis or low-THC products from the
565 licensee’s place of business.
566 3. A vehicle permit may be obtained by a dispensing
567 organization upon application and payment of a fee of $5 per
568 vehicle to the department. The signature of the person
569 designated by the dispensing organization to drive the vehicle
570 must be included on the vehicle permit application. Such permit
571 remains valid and does not expire unless the licensee or any
572 person designated by the dispensing organization disposes of his
573 or her vehicle, or the licensee’s license is transferred,
574 canceled, not renewed, or is revoked by the department,
575 whichever occurs first. The department shall cancel a vehicle
576 permit upon request of the licensee or owner of the vehicle.
577 4. By acceptance of a license issued under this section,
578 the licensee agrees that the licensed vehicle is, at all times
579 it is being used to transport low-THC cannabis or low-THC
580 cannabis products, subject to inspection and search without a
581 search warrant by authorized employees of the department,
582 sheriffs, deputy sheriffs, police officers, or other law
583 enforcement officers to determine that the licensee is
584 transporting such products in compliance with this section.
585 (7) TESTING AND LABELING OF LOW-THC CANNABIS.—
586 (a) All low-THC cannabis and low-THC cannabis products must
587 be tested by an independent testing laboratory before the
588 dispensing organization may dispense them. The independent
589 testing laboratory shall provide the dispensing organization
590 with lab results. Before dispensing, the dispensing organization
591 must determine that the lab results indicate that the low-THC
592 cannabis or low-THC cannabis product meets the definition of
593 low-THC cannabis or low-THC cannabis product, is safe for human
594 consumption, and is free from harmful contaminants.
595 (b) All low-THC cannabis and low-THC cannabis products must
596 be labeled before dispensing. The label must include, at a
597 minimum:
598 1. A statement that the low-THC cannabis or low-THC
599 cannabis product meets the requirements in paragraph (a);
600 2. The name of the independent testing laboratory that
601 tested the low-THC cannabis or low-THC cannabis product;
602 3. The name of the cultivation and processing facility
603 where the low-THC cannabis or low-THC cannabis product
604 originates; and
605 4. The batch number and harvest number from which the low
606 THC cannabis or low-THC cannabis product originates.
607 (8) SAFETY AND EFFICACY RESEARCH FOR LOW-THC CANNABIS.—The
608 University of Florida College of Pharmacy shall establish and
609 maintain a safety and efficacy research program for the use of
610 low-THC cannabis or low-THC cannabis products to treat
611 qualifying conditions and symptoms. The program must include a
612 fully integrated electronic information system for the broad
613 monitoring of health outcomes and safety signal detection. The
614 electronic information system must include information from the
615 compassionate use registry; provider reports, including
616 treatment plans, adverse event reports, and treatment
617 discontinuation reports; patient reports of adverse impacts;
618 event-triggered interviews and medical chart reviews performed
619 by University of Florida clinical research staff; information
620 from external databases, including Medicaid billing reports and
621 information in the prescription drug monitoring database for
622 registered patients; and all other medical reports required by
623 the University of Florida to conduct the research required by
624 this subsection. The department must provide access to
625 information from the compassionate use registry and the
626 prescription drug monitoring database, established in s.
627 893.055, as needed by the University of Florida to conduct
628 research under this subsection. The Agency for Health Care
629 Administration must provide access to registered patient
630 Medicaid records, to the extent allowed under federal law, as
631 needed by the University of Florida to conduct research under
632 this subsection.
633 (9) The persons who have direct or indirect interest in the
634 dispensing organization and the dispensing organization’s
635 managers, employees, and contractors who directly interact with
636 low-THC cannabis or low-THC cannabis products are prohibited
637 from making recommendations, offering prescriptions, or
638 providing medical advice to qualified patients.
639 (10)(7) EXCEPTIONS TO OTHER LAWS.—
640 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
641 any other provision of law, but subject to the requirements of
642 this section, a qualified patient and the qualified patient’s
643 legal representative who is registered with the department on
644 the compassionate use registry may purchase and possess for the
645 patient’s medical use up to the amount of low-THC cannabis
646 ordered for the patient. Nothing in this section exempts any
647 person from the prohibition against driving under the influence
648 provided in s. 316.193.
649 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
650 any other provision of law, but subject to the requirements of
651 this section, an approved dispensing organization and its
652 owners, managers, and employees and the owners, managers, and
653 employees of contractors who have direct contact with low-THC
654 cannabis or low-THC cannabis product may manufacture, possess,
655 sell, deliver, distribute, dispense, and lawfully dispose of
656 reasonable quantities, as established by department rule, of
657 low-THC cannabis in accordance with their licensure. For
658 purposes of this subsection, the terms “manufacture,”
659 “possession,” “deliver,” “distribute,” and “dispense” have the
660 same meanings as provided in s. 893.02.
661 (c) An approved dispensing organization and its owners,
662 managers, and employees are not subject to licensure or
663 regulation under chapter 465 or chapter 499 for manufacturing,
664 possessing, selling, delivering, distributing, dispensing, or
665 lawfully disposing of reasonable quantities, as established by
666 department rule, of low-THC cannabis.
667 (d) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
668 any other law, but subject to the requirements of this section,
669 a licensed laboratory and its employees may receive and possess
670 low-THC cannabis for the sole purpose of testing the low-THC
671 cannabis to ensure compliance with this section.
672 (11) Rules adopted by the department under this section are
673 exempt from the requirement that they be ratified by the
674 Legislature pursuant to s. 120.541(3).
675 Section 2. Paragraph (g) is added to subsection (3) of
676 section 381.987, Florida Statutes, to read:
677 381.987 Public records exemption for personal identifying
678 information in the compassionate use registry.—
679 (3) The department shall allow access to the registry,
680 including access to confidential and exempt information, to:
681 (g) Persons engaged in research at the University of
682 Florida pursuant to s. 381.986(8).
683 Section 3. Paragraph (b) of subsection (7) of section
684 893.055, Florida Statutes, is amended to read:
685 893.055 Prescription drug monitoring program.—
686 (7)
687 (b) A pharmacy, prescriber, or dispenser shall have access
688 to information in the prescription drug monitoring program’s
689 database which relates to a patient of that pharmacy,
690 prescriber, or dispenser in a manner established by the
691 department as needed for the purpose of reviewing the patient’s
692 controlled substance prescription history. Persons engaged in
693 research at the University of Florida pursuant to s. 381.986(8)
694 shall have access to information in the prescription drug
695 monitoring program’s database which relates to qualified
696 patients as defined in s. 381.986(1) for the purpose of
697 conducting such research. Other access to the program’s database
698 shall be limited to the program’s manager and to the designated
699 program and support staff, who may act only at the direction of
700 the program manager or, in the absence of the program manager,
701 as authorized. Access by the program manager or such designated
702 staff is for prescription drug program management only or for
703 management of the program’s database and its system in support
704 of the requirements of this section and in furtherance of the
705 prescription drug monitoring program. Confidential and exempt
706 information in the database shall be released only as provided
707 in paragraph (c) and s. 893.0551. The program manager,
708 designated program and support staff who act at the direction of
709 or in the absence of the program manager, and any individual who
710 has similar access regarding the management of the database from
711 the prescription drug monitoring program shall submit
712 fingerprints to the department for background screening. The
713 department shall follow the procedure established by the
714 Department of Law Enforcement to request a statewide criminal
715 history record check and to request that the Department of Law
716 Enforcement forward the fingerprints to the Federal Bureau of
717 Investigation for a national criminal history record check.
718 Section 4. Paragraph (h) is added to subsection (3) of
719 section 893.0551, Florida Statutes, to read:
720 893.0551 Public records exemption for the prescription drug
721 monitoring program.—
722 (3) The department shall disclose such confidential and
723 exempt information to the following persons or entities upon
724 request and after using a verification process to ensure the
725 legitimacy of the request as provided in s. 893.055:
726 (h) Persons engaged in research at the University of
727 Florida pursuant to s. 381.986(8).
728 Section 5. The Division of Law Revision and Information is
729 directed to replace the phrase “the effective date of this act”
730 wherever it occurs in this act with the date the act becomes a
731 law.
732 Section 6. This act shall take effect upon becoming a law.
733
734 ================= T I T L E A M E N D M E N T ================
735 And the title is amended as follows:
736 Delete everything before the enacting clause
737 and insert:
738 A bill to be entitled
739 An act relating to low-THC cannabis; amending s.
740 381.986, F.S.; defining terms; revising the illnesses
741 and symptoms for which a physician may order a patient
742 the medical use of low-THC cannabis in certain
743 circumstances; providing that a physician who
744 improperly orders low-THC cannabis is subject to
745 specified disciplinary action; revising the duties of
746 the Department of Health; requiring the department to
747 create a secure, electronic, and online compassionate
748 use registry; requiring the department to begin to
749 accept applications for licensure as a dispensing
750 organization according to a specified application
751 process; authorizing a dispensing organization to be
752 licensed to cultivate, to process, or to dispense low
753 THC cannabis; requiring the department to review all
754 applications, notify applicants of deficient
755 applications, and request any additional information
756 within a specified period; requiring an application
757 for licensure to be filed and complete by specified
758 dates; authorizing licensed applicants to operate in
759 any region of the state; prohibiting a dispensing
760 organization licensed to cultivate or process low-THC
761 cannabis from having cultivation or processing
762 facilities outside the region in which it is licensed;
763 requiring licensure fees to be paid within a specified
764 timeframe; providing an exemption for the application
765 process; requiring the department to use an
766 application form that requires specified information
767 from the applicant; requiring the department to impose
768 specified application fees; requiring the department
769 to inspect each dispensing organization’s properties,
770 cultivation facilities, processing facilities, or
771 retail facilities before those facilities may operate;
772 authorizing followup inspections at reasonable hours;
773 providing that licensure constitutes permission for
774 the department to enter and inspect the premises or
775 facilities of any dispensing organization; authorizing
776 the department to inspect any licensed dispensing
777 organization; requiring dispensing organizations to
778 make all facility premises, equipment, documents, low
779 THC cannabis, and low-THC cannabis products, as
780 applicable, available to the department upon
781 inspection; authorizing the department to test low-THC
782 cannabis or low-THC cannabis products; authorizing the
783 department to suspend or revoke a license, deny or
784 refuse to renew a license, or impose a maximum
785 administrative penalty for specified acts or
786 omissions; requiring the department to create a
787 permitting process for vehicles used for the
788 transportation of low-THC cannabis or low-THC cannabis
789 products; requiring the department to adopt rules as
790 necessary for implementation of specified provisions
791 and procedures, and to provide specified guidance;
792 providing procedures and requirements for an applicant
793 seeking licensure as a dispensing organization or the
794 renewal of its license; requiring the dispensing
795 organization to verify specified information of
796 specified persons in certain circumstances;
797 authorizing a dispensing organization to have
798 cultivation facilities, processing facilities, or
799 retail facilities; authorizing a retail facility to be
800 established in a municipality only after such an
801 ordinance has been created; authorizing a retail
802 facility to be established in the unincorporated areas
803 of a county only after such an ordinance has been
804 created; requiring retail facilities to have all
805 utilities and resources necessary to store and
806 dispense low-THC and low-THC cannabis products;
807 requiring retail facilities to be secured with
808 specified theft-prevention systems; requiring a
809 dispensing organization to provide the department with
810 specified updated information within a specified
811 period; authorizing a dispensing organization to
812 transport low-THC cannabis or low-THC cannabis
813 products in vehicles in certain circumstances;
814 requiring such vehicles to be operated by specified
815 persons in certain circumstances; requiring a fee for
816 a vehicle permit; requiring the signature of the
817 designated driver with a vehicle permit application;
818 providing for expiration of the permit in certain
819 circumstances; requiring the department to cancel a
820 vehicle permit upon the request of specified persons;
821 providing that the licensee authorizes the inspection
822 and search of his or her vehicle without a search
823 warrant by specified persons; requiring all low-THC
824 cannabis and low-THC cannabis products to be tested by
825 an independent testing laboratory before the
826 dispensing organization may dispense it; requiring the
827 independent testing laboratory to provide the lab
828 results to the dispensing organization for a specified
829 determination; requiring all low-THC cannabis and low
830 THC cannabis products to be labeled with specified
831 information before dispensing; requiring the
832 University of Florida College of Pharmacy to establish
833 and maintain a specified safety and efficacy research
834 program; providing program requirements; requiring the
835 department to provide information from the
836 prescription drug monitoring program to the University
837 of Florida as needed; requiring the Agency for Health
838 Care Administration to provide access to specified
839 patient records under certain circumstances;
840 prohibiting persons who have direct or indirect
841 interest in a dispensing organization and the
842 dispensing organization’s managers, employees, and
843 contractors who directly interact with low-THC
844 cannabis and low-THC cannabis products from making
845 recommendations, offering prescriptions, or providing
846 medical advice to qualified patients; providing that
847 the act does not provide an exception to the
848 prohibition against driving under the influence;
849 authorizing specified individuals to manufacture,
850 possess, sell, deliver, distribute, dispense, and
851 lawfully dispose of reasonable quantities of low-THC
852 cannabis according to their licensure; authorizing a
853 licensed laboratory and its employees to receive and
854 possess low-THC cannabis in certain circumstances;
855 providing that specified rules adopted by the
856 department are exempt from the requirement to be
857 ratified by the Legislature; amending s. 381.987,
858 F.S.; requiring the department to allow specified
859 persons engaged in research to access the
860 compassionate use registry; amending s. 893.055, F.S.;
861 providing that persons engaged in research at the
862 University of Florida shall have access to specified
863 information; amending s. 893.0551, F.S.; providing a
864 specified public records exemption for persons engaged
865 in research at the University of Florida; providing a
866 directive to the Division of Law Revision and
867 Information; providing an effective date.