Florida Senate - 2015 COMMITTEE AMENDMENT
Bill No. CS for SB 7066
Ì429168JÎ429168
LEGISLATIVE ACTION
Senate . House
Comm: UNFAV .
04/09/2015 .
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The Committee on Rules (Soto) recommended 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 cannabis product
13 that is intended to have uniform character and quality, within
14 specified limits, and is produced at the same time from one or
15 more harvests.
16 (c) “Dispensing organization” means an applicant licensed
17 organization approved by the department to cultivate, process,
18 and dispense low-THC cannabis pursuant to this section.
19 (d) “Harvest” means a specifically identified and numbered
20 quantity of cannabis cultivated using the same herbicides,
21 pesticides, and fungicides and harvested at the same time from a
22 single facility.
23 (e)(b) “Low-THC Cannabis” means a plant of the genus
24 Cannabis, the dried flowers of which contain 0.8 percent or less
25 of tetrahydrocannabinol and more than 10 percent of cannabidiol
26 weight for weight; the seeds thereof; the resin extracted from
27 any part of such plant; or any compound, manufacture, salt,
28 derivative, mixture, or preparation of such plant or its seeds
29 or resin that is dispensed only from a dispensing organization.
30 (f) “Cannabis product” means any product derived from
31 cannabis, including the resin extracted from any part of such
32 plant or any compound, manufacture, salt, derivative, mixture,
33 or preparation of such plant or its seeds or resin which is
34 dispensed from a dispensing organization. Cannabis products
35 include, but are not limited to, oils, tinctures, creams,
36 encapsulations, and food products. All cannabis products must
37 maintain concentrations, weight for weight, of more than 10
38 percent of cannabidiol.
39 (g)(c) “Medical use” means administration of the ordered
40 amount of low-THC cannabis. The term does not include:
41 1. The possession, use, or administration by smoking;.
42 2. The term also does not include The transfer of low-THC
43 cannabis to a person other than the qualified patient for whom
44 it was ordered or the qualified patient’s legal representative
45 who is registered in the compassionate use registry on behalf of
46 the qualified patient; or.
47 3. The use or administration of cannabis or cannabis
48 products:
49 a. On any form of public transportation.
50 b. In any public place.
51 c. In a registered qualified patient’s place of work, if
52 restricted by his or her employer.
53 d. In a correctional facility.
54 e. On the grounds of any preschool, primary school, or
55 secondary school.
56 f. On a school bus.
57 (h)(d) “Qualified patient” means a resident of this state
58 who has been added to the compassionate use registry by a
59 physician licensed under chapter 458 or chapter 459 to receive
60 low-THC cannabis from a dispensing organization.
61 (i)(e) “Smoking” means burning or igniting a substance and
62 inhaling the smoke. Smoking does not include the use of a
63 vaporizer.
64 (2) PHYSICIAN ORDERING.—
65 (a) Effective January 1, 2015, A physician licensed under
66 chapter 458 or chapter 459 who has examined and is treating a
67 patient suffering from cancer, human immunodeficiency virus,
68 acquired immune deficiency syndrome, epilepsy, amyotrophic
69 lateral sclerosis, multiple sclerosis, Crohn’s disease,
70 Parkinson’s disease, paraplegia, quadriplegia, or terminal
71 illness a physical medical condition that chronically produces
72 symptoms of seizures or severe and persistent muscle spasms may
73 order for the patient’s medical use low-THC cannabis to treat
74 such disease, disorder, or condition; or to alleviate symptoms
75 of such disease, disorder, or condition;, or to alleviate
76 symptoms caused by a treatment for such disease, disorder, or
77 condition if no other satisfactory alternative treatment options
78 exist for that patient and all of the following conditions
79 apply:
80 1.(a) The patient is a permanent resident of this state.
81 2.(b) The physician determines that the risks of ordering
82 low-THC cannabis are reasonable in light of the potential
83 benefit for that patient. If a patient is younger than 18 years
84 of age, a second physician must concur with this determination,
85 and such determination must be documented in the patient’s
86 medical record.
87 3.(c) The physician registers the patient, the patient’s
88 legal representative if requested by the patient, and himself or
89 herself as the orderer of low-THC cannabis for the named patient
90 on the compassionate use registry maintained by the department
91 and updates the registry to reflect the contents of the order.
92 If the patient is a minor, the physician must register a legal
93 representative on the compassionate use registry. The physician
94 shall deactivate the patient’s registration when treatment is
95 discontinued.
96 4.(d) The physician maintains a patient treatment plan that
97 includes the dose, route of administration, planned duration,
98 and monitoring of the patient’s symptoms and other indicators of
99 tolerance or reaction to the low-THC cannabis.
100 5.(e) The physician submits the patient treatment plan, as
101 well as any other requested medical records, quarterly to the
102 University of Florida College of Pharmacy for research on the
103 safety and efficacy of low-THC cannabis on patients pursuant to
104 subsection (8).
105 6.(f) The physician obtains the voluntary informed consent
106 of the patient or the patient’s legal guardian to treatment with
107 low-THC cannabis after sufficiently explaining the current state
108 of knowledge in the medical community of the effectiveness of
109 treatment of the patient’s conditions or symptoms condition with
110 low-THC cannabis, the medically acceptable alternatives, and the
111 potential risks and side effects.
112 (b) A physician who improperly orders cannabis is subject
113 to disciplinary action under the applicable practice act and
114 under s. 456.072(1)(k).
115 (3) PENALTIES.—
116 (a) A physician commits a misdemeanor of the first degree,
117 punishable as provided in s. 775.082 or s. 775.083, if the
118 physician orders low-THC cannabis for a patient without a
119 reasonable belief that the patient is suffering from at least
120 one of the conditions listed in subsection (2).:
121 1. Cancer or a physical medical condition that chronically
122 produces symptoms of seizures or severe and persistent muscle
123 spasms that can be treated with low-THC cannabis; or
124 2. Symptoms of cancer or a physical medical condition that
125 chronically produces symptoms of seizures or severe and
126 persistent muscle spasms that can be alleviated with low-THC
127 cannabis.
128 (b) Any person who fraudulently represents that he or she
129 has at least one condition listed in subsection (2) cancer or a
130 physical medical condition that chronically produces symptoms of
131 seizures or severe and persistent muscle spasms to a physician
132 for the purpose of being ordered low-THC cannabis by such
133 physician commits a misdemeanor of the first degree, punishable
134 as provided in s. 775.082 or s. 775.083.
135 (4) PHYSICIAN EDUCATION.—
136 (a) Before ordering low-THC cannabis for use by a patient
137 in this state, the appropriate board shall require the ordering
138 physician licensed under chapter 458 or chapter 459 to
139 successfully complete an 8-hour course and subsequent
140 examination offered by the Florida Medical Association or the
141 Florida Osteopathic Medical Association that encompasses the
142 clinical indications for the appropriate use of low-THC
143 cannabis, the appropriate delivery mechanisms, the
144 contraindications for such use, as well as the relevant state
145 and federal laws governing the ordering, dispensing, and
146 possessing of this substance. The first course and examination
147 shall be presented by October 1, 2014, and shall be administered
148 at least annually thereafter. Successful completion of the
149 course may be used by a physician to satisfy 8 hours of the
150 continuing medical education requirements required by his or her
151 respective board for licensure renewal. This course may be
152 offered in a distance learning format.
153 (b) The appropriate board shall require the medical
154 director of each dispensing organization approved under
155 subsection (5) to successfully complete a 2-hour course and
156 subsequent examination offered by the Florida Medical
157 Association or the Florida Osteopathic Medical Association that
158 encompasses appropriate safety procedures and knowledge of low
159 THC cannabis.
160 (c) Successful completion of the course and examination
161 specified in paragraph (a) is required for every physician who
162 orders low-THC cannabis each time such physician renews his or
163 her license. In addition, successful completion of the course
164 and examination specified in paragraph (b) is required for the
165 medical director of each dispensing organization each time such
166 physician renews his or her license.
167 (d) A physician who fails to comply with this subsection
168 and who orders low-THC cannabis may be subject to disciplinary
169 action under the applicable practice act and under s.
170 456.072(1)(k).
171 (5) DUTIES AND POWERS OF THE DEPARTMENT.—By January 1,
172 2015, The department shall:
173 (a) The department shall create a secure, electronic, and
174 online compassionate use registry for the registration of
175 physicians and patients as provided under this section. The
176 registry must be accessible to law enforcement agencies and to a
177 dispensing organization in order to verify patient authorization
178 for low-THC cannabis and record the low-THC cannabis dispensed.
179 The registry must prevent an active registration of a patient by
180 multiple physicians.
181 (b)1. Beginning 7 days after the effective date of this
182 act, the department shall accept applications for licensure as a
183 dispensing organization. The department shall review each
184 application to determine whether the applicant meets the
185 criteria in subsection (6) and qualifies for licensure.
186 2. Within 10 days after receiving an application for
187 licensure, the department shall examine the application, notify
188 the applicant of any apparent errors or omissions, and request
189 any additional information the department is allowed by law to
190 require. An application for licensure must be filed with the
191 department no later than 5 p.m. on the 30th day after the
192 effective date of this act, and all applications must be
193 complete no later than 5 p.m. on the 60th day after the
194 effective date of this act.
195 3. If fewer than 20 applicants meet the criteria specified
196 in subsection (6), the department shall, by the 75th day after
197 the effective date of this act, license each such applicant. If
198 more than 20 applicants meet these criteria, licensure shall be
199 determined by lottery.
200 4. Beginning March 15, 2016, and every 6 months thereafter,
201 if fewer than 20 dispensing organization licenses have been
202 issued in this state, the department may issue additional
203 licenses to qualified applicants up to the 20-organization
204 maximum. The department shall use the same timeframes as set
205 forth in subparagraphs 1.-3., beginning 75 days before the date
206 specified for issuing additional licenses. If the number of
207 qualified applicants under this subparagraph exceeds the number
208 of dispensing organization licenses available for issuance,
209 licensure shall be determined by lottery.
210 5. This section is exempt from s. 120.60 Authorize the
211 establishment of five dispensing organizations to ensure
212 reasonable statewide accessibility and availability as necessary
213 for patients registered in the compassionate use registry and
214 who are ordered low-THC cannabis under this section, one in each
215 of the following regions: northwest Florida, northeast Florida,
216 central Florida, southeast Florida, and southwest Florida.
217 (c) The department shall use develop an application form
218 that requires the applicant to state:
219 1. Whether the application is for initial licensure or
220 renewal licensure;
221 2. The name, the physical address, the mailing address, the
222 address listed on the Department of Agriculture and Consumer
223 Services certificate required in paragraph (6)(b), and the
224 contact information for the applicant and for the nursery that
225 holds the Department of Agriculture and Consumer Services
226 certificate, if different from the applicant;
227 3. The name, address, and contact information for the
228 operating nurseryman of the organization that holds the
229 Department of Agriculture and Consumer Services certificate;
230 4. The name, address, license number, and contact
231 information for the applicant’s medical director; and
232 5. All information required to be included by subsection
233 (6).
234 (d) The department shall and impose an initial application
235 fee of $50,000, an initial licensure fee of $125,000, and a
236 biennial renewal fee of $125,000 that is sufficient to cover the
237 costs of administering this section. An applicant for approval
238 as a dispensing organization must be able to demonstrate:
239 1. The technical and technological ability to cultivate and
240 produce low-THC cannabis. The applicant must possess a valid
241 certificate of registration issued by the Department of
242 Agriculture and Consumer Services pursuant to s. 581.131 that is
243 issued for the cultivation of more than 400,000 plants, be
244 operated by a nurseryman as defined in s. 581.011, and have been
245 operated as a registered nursery in this state for at least 30
246 continuous years.
247 2. The ability to secure the premises, resources, and
248 personnel necessary to operate as a dispensing organization.
249 3. The ability to maintain accountability of all raw
250 materials, finished products, and any byproducts to prevent
251 diversion or unlawful access to or possession of these
252 substances.
253 4. An infrastructure reasonably located to dispense low-THC
254 cannabis to registered patients statewide or regionally as
255 determined by the department.
256 5. The financial ability to maintain operations for the
257 duration of the 2-year approval cycle, including the provision
258 of certified financials to the department. Upon approval, the
259 applicant must post a $5 million performance bond.
260 6. That all owners and managers have been fingerprinted and
261 have successfully passed a level 2 background screening pursuant
262 to s. 435.04.
263 7. The employment of a medical director who is a physician
264 licensed under chapter 458 or chapter 459 to supervise the
265 activities of the dispensing organization.
266 (e) The department shall inspect each dispensing
267 organization’s properties, cultivation facilities, processing
268 facilities, and retail facilities before they begin operations
269 and at least once every 2 years thereafter. The department may
270 conduct additional announced or unannounced inspections,
271 including followup inspections, at reasonable hours in order to
272 ensure that such property and facilities maintain compliance
273 with all applicable requirements in subsections (6) and (7) and
274 to ensure that the dispensing organization has not committed any
275 other act that would endanger the health, safety, or security of
276 a qualified patient, dispensing organization staff, or the
277 community in which the dispensing organization is located.
278 Licensure under this section constitutes permission for the
279 department to enter and inspect the premises and facilities of
280 any dispensing organization. The department may inspect any
281 licensed dispensing organization, and a dispensing organization
282 must make all facility premises, equipment, documents, cannabis,
283 and cannabis products available to the department upon
284 inspection. The department may test any cannabis or cannabis
285 product in order to ensure that it is safe for human consumption
286 and that it meets the requirements in this section.
287 (f) The department may suspend or revoke a license, deny or
288 refuse to renew a license, or impose an administrative penalty
289 not to exceed $10,000 for the following acts or omissions:
290 1. A violation of this section or department rule.
291 2. Failing to maintain qualifications for licensure.
292 3. Endangering the health, safety, or security of a
293 qualified patient.
294 4. Improperly disclosing personal and confidential
295 information of the qualified patient.
296 5. Attempting to procure a license by bribery or fraudulent
297 misrepresentation.
298 6. Being convicted or found guilty of, or entering a plea
299 of nolo contendere to, regardless of adjudication, a crime in
300 any jurisdiction which directly relates to the business of a
301 dispensing organization.
302 7. Making or filing a report or record that the licensee
303 knows to be false.
304 8. Willfully failing to maintain a record required by this
305 section or rule of the department.
306 9. Willfully impeding or obstructing an employee or agent
307 of the department in the furtherance of his or her official
308 duties.
309 10. Engaging in fraud or deceit, negligence, incompetence,
310 or misconduct in the business practices of a dispensing
311 organization.
312 11. Making misleading, deceptive, or fraudulent
313 representations in or related to the business practices of a
314 dispensing organization.
315 12. Having a license or the authority to engage in any
316 regulated profession, occupation, or business that is related to
317 the business practices of a dispensing organization revoked,
318 suspended, or otherwise acted against, including the denial of
319 licensure, by the licensing authority of any jurisdiction,
320 including its agencies or subdivisions, for a violation that
321 would constitute a violation under state law. A licensing
322 authority’s acceptance of a relinquishment of licensure or a
323 stipulation, consent order, or other settlement, offered in
324 response to or in anticipation of the filing of charges against
325 the license, shall be construed as an action against the
326 license.
327 13. Violating a lawful order of the department or an agency
328 of the state, or failing to comply with a lawfully issued
329 subpoena of the department or an agency of the state.
330 (g) The department shall create a permitting process for
331 all dispensing organization vehicles used for the transportation
332 of cannabis or cannabis products.
333 (h)(c) The department shall monitor physician registration
334 and ordering of low-THC cannabis for ordering practices that
335 could facilitate unlawful diversion or misuse of low-THC
336 cannabis and take disciplinary action as indicated.
337 (i)(d) The department shall adopt rules as necessary to
338 implement this section.
339 (6) DISPENSING ORGANIZATION.—
340 (a) An applicant seeking licensure as a dispensing
341 organization, or the renewal of its license, must submit an
342 application to the department. The department must review all
343 applications for completeness, including an appropriate
344 inspection of the applicant’s property and facilities to verify
345 the authenticity of the information provided in, or in
346 connection with, the application. An applicant authorizes the
347 department to inspect his or her property and facilities for
348 licensure by applying under this subsection.
349 (b) In order to receive or maintain licensure as a
350 dispensing organization, an applicant must provide proof that:
351 1. The applicant, or a separate entity that is owned solely
352 by the same persons or entities in the same ratio as the
353 applicant, possesses a valid certificate of registration issued
354 by the Department of Agriculture and Consumer Services pursuant
355 to s. 581.131 for the cultivation of more than 400,000 plants,
356 is operated by a nurseryman as defined in s. 581.011, and has
357 been operated as a registered nursery in this state for at least
358 30 continuous years.
359 2. The personnel on staff or under contract for the
360 applicant have experience cultivating and introducing multiple
361 varieties of plants in this state, including plants that are not
362 native to Florida; experience with propagating plants; and
363 experience with genetic modification or breeding of plants.
364 3. The personnel on staff or under contract for the
365 applicant include at least one person who:
366 a. Has at least 5 years’ experience with United States
367 Department of Agriculture Good Agricultural Practices and Good
368 Handling Practices;
369 b. Has at least 5 years’ experience with United States Food
370 and Drug Administration Good Manufacturing Practices for food
371 production;
372 c. Has a doctorate degree in organic chemistry or
373 microbiology;
374 d. Has at least 5 years of experience with laboratory
375 procedures which includes analytical laboratory quality control
376 measures, chain of custody procedures, and analytical laboratory
377 methods;
378 e. Has experience with cannabis cultivation and processing,
379 including cannabis extraction techniques and producing cannabis
380 products;
381 f. Has experience and qualifications in chain of custody or
382 other tracking mechanisms;
383 g. Works solely on inventory control; and
384 h. Works solely for security purposes.
385 4. The persons who have a direct or indirect interest in
386 the dispensing organization and the applicant’s managers,
387 employees, and contractors who directly interact with cannabis
388 or cannabis products have been fingerprinted and have
389 successfully passed a level 2 background screening pursuant to
390 s. 435.04.
391 5. The applicant owns, or has at least a 2-year lease of,
392 all properties, facilities, and equipment necessary for the
393 cultivation and processing of cannabis. The applicant must
394 provide a detailed description of each facility and its
395 equipment, a cultivation and processing plan, and a detailed
396 floor plan. The description must include proof that:
397 a. The applicant is capable of sufficient cultivation and
398 processing to serve at least 15,000 patients with an assumed
399 daily use of 1,000 mg per patient per day of cannabis or
400 cannabis product;
401 b. The applicant has arranged for access to all utilities
402 and resources necessary to cultivate or process cannabis at each
403 listed facility; and
404 c. Each facility is secured and has theft-prevention
405 systems including an alarm system, cameras, and 24-hour security
406 personnel.
407 6. The applicant has diversion and tracking prevention
408 procedures, including:
409 a. A system for tracking material through cultivation,
410 processing, and dispensing, including the use of batch and
411 harvest numbers;
412 b. An inventory control system for cannabis and cannabis
413 products;
414 c. A vehicle tracking and security system; and
415 d. A cannabis waste-disposal plan.
416 7. The applicant has recordkeeping policies and procedures
417 in place.
418 8. The applicant has a facility emergency management plan.
419 9. The applicant has a plan for dispensing cannabis
420 throughout the state. This plan must include planned retail
421 facilities and a delivery plan for providing cannabis and
422 cannabis products to qualified patients who cannot travel to a
423 retail facility.
424 10. The applicant has financial documentation, including:
425 a. Documentation that demonstrates the applicant’s
426 financial ability to operate. If the applicant’s assets, credit,
427 and projected revenues meet or exceed projected liabilities and
428 expenses and the applicant provides independent evidence that
429 the funds necessary for startup costs, working capital, and
430 contingency financing exist and are available as needed, the
431 applicant has demonstrated the financial ability to operate.
432 Financial ability to operate must be documented by:
433 I. The applicant’s audited financial statements. If the
434 applicant is a newly formed entity and does not have a financial
435 history of business upon which audited financial statements may
436 be submitted, the applicant must provide audited financial
437 statements for the separate entity that is owned solely by the
438 same persons or entities in the same ratio as the applicant that
439 possesses the valid certificate of registration issued by the
440 Department of Agriculture and Consumer Services;
441 II. The applicant’s projected financial statements,
442 including a balance sheet, an income and expense statement, and
443 a statement of cash flow for the first 2 years of operation,
444 which provides evidence that the applicant has sufficient
445 assets, credit, and projected revenues to cover liabilities and
446 expenses; and
447 III. A statement of the applicant’s estimated startup costs
448 and sources of funds, including a break-even projection and
449 documentation demonstrating that the applicant has the ability
450 to fund all startup costs, working capital costs, and
451 contingency financing requirements.
452
453 All documents required under this sub-subparagraph shall be
454 prepared in accordance with generally accepted accounting
455 principles and signed by a certified public accountant. The
456 statements required by sub-sub-subparagraph II. and III. may be
457 presented as a compilation.
458 b. A list of all subsidiaries of the applicant;
459 c. A list of all lawsuits pending and completed within the
460 past 7 years of which the applicant was a party; and
461 d. Proof of a $1 million performance and compliance bond,
462 or other equivalent means of security deemed equivalent by the
463 department, such as an irrevocable letter of credit or a deposit
464 in a trust account or financial institution, payable to the
465 department, which must be posted once the applicant is approved
466 as a dispensing organization. The purpose of the bond is to
467 secure payment of any administrative penalties imposed by the
468 department and any fees and costs incurred by the department
469 regarding the dispensing organization license, such as the
470 dispensing organization failing to pay 30 days after the fine or
471 costs become final. The department may make a claim against such
472 bond or security until 1 year after the dispensing
473 organization’s license ceases to be valid or until 60 days after
474 any administrative or legal proceeding authorized in this
475 section involving the dispensing organization concludes,
476 including any appeal, whichever occurs later.
477 11. The employment of a medical director who is a physician
478 licensed under chapter 458 or chapter 459 to supervise the
479 activities of the dispensing organization.
480 (c) An approved dispensing organization shall maintain
481 compliance with the criteria in paragraphs (b), (d), and (e) and
482 subsection (7) demonstrated for selection and approval as a
483 dispensing organization under subsection (5) at all times.
484 Before dispensing low-THC cannabis or cannabis products to a
485 qualified patient or to the qualified patient’s legal
486 representative, the dispensing organization shall verify the
487 identity of the qualified patient or the qualified patient’s
488 legal representative by requiring the qualified patient or the
489 qualified patient’s legal representative to produce a
490 government-issued identification card and shall verify that the
491 qualified patient and the qualified patient’s legal
492 representative have has an active registration in the
493 compassionate use registry, that the order presented matches the
494 order contents as recorded in the registry, and that the order
495 has not already been filled. Upon dispensing the low-THC
496 cannabis, the dispensing organization shall record in the
497 registry the date, time, quantity, and form of low-THC cannabis
498 dispensed.
499 (d) A dispensing organization may have cultivation
500 facilities, processing facilities, and retail facilities.
501 1. All matters regarding the location of cultivation
502 facilities and processing facilities are preempted to the state.
503 Cultivation facilities and processing facilities must be closed
504 to the public, and cannabis may not be dispensed on the premises
505 of such facilities.
506 2. A municipality must determine by ordinance the criteria
507 for the number, location, and other permitting requirements for
508 all retail facilities located within its municipal boundaries. A
509 retail facility may be established in a municipality only after
510 such an ordinance has been created. A county must determine by
511 ordinance the criteria for the number, location, and other
512 permitting requirements for all retail facilities located within
513 the unincorporated areas of that county. A retail facility may
514 be established in the unincorporated areas of a county only
515 after such an ordinance has been created. Retail facilities must
516 have all utilities and resources necessary to store and dispense
517 cannabis and cannabis products. Retail facilities must be
518 secured and have theft-prevention systems, including an alarm
519 system, cameras, and 24-hour security personnel. Retail
520 facilities may not sell, or contract for the sale of, anything
521 other than cannabis or cannabis products on the property of the
522 retail facility. Before a retail facility may dispense cannabis
523 or a cannabis product, the dispensing organization must have a
524 computer network compliant with the federal Health Insurance
525 Portability and Accountability Act of 1996 which is able to
526 access and upload data to the compassionate use registry and
527 which shall be used by all retail facilities.
528 (e) Within 15 days of such information becoming available,
529 a dispensing organization must provide the department with
530 updated information, as applicable, including:
531 1. The location and a detailed description of any new or
532 proposed facilities.
533 2. The updated contact information, including electronic
534 and voice communication, for all dispensing organization
535 facilities.
536 3. The registration information for any vehicles used for
537 the transportation of cannabis and cannabis product, including
538 confirmation that all such vehicles have tracking and security
539 systems.
540 4. A plan for the recall of any or all cannabis or cannabis
541 product.
542 (f)1. A dispensing organization may transport cannabis or
543 cannabis products in vehicles departing from their places of
544 business only in vehicles that are owned or leased by the
545 licensee or by a person designated by the dispensing
546 organization, and for which a valid vehicle permit has been
547 issued for such vehicle by the department.
548 2. A vehicle owned or leased by the dispensing organization
549 or a person designated by the dispensing organization and
550 approved by the department must be operated by such person when
551 transporting cannabis or products from the licensee’s place of
552 business.
553 3. A vehicle permit may be obtained by a dispensing
554 organization upon application and payment of a fee of $5 per
555 vehicle to the department. The signature of the person
556 designated by the dispensing organization to drive the vehicle
557 must be included on the vehicle permit application. Such permit
558 remains valid and does not expire unless the licensee or any
559 person designated by the dispensing organization disposes of his
560 or her vehicle, or the licensee’s license is transferred,
561 canceled, not renewed, or is revoked by the department,
562 whichever occurs first. The department shall cancel a vehicle
563 permit upon request of the licensee or owner of the vehicle.
564 4. By acceptance of a license issued under this section,
565 the licensee agrees that the licensed vehicle is, at all times
566 it is being used to transport cannabis or cannabis products,
567 subject to inspection and search without a search warrant by
568 authorized employees of the department, sheriffs, deputy
569 sheriffs, police officers, or other law enforcement officers to
570 determine that the licensee is transporting such products in
571 compliance with this section.
572 (7) TESTING AND LABELING OF CANNABIS.—
573 (a) All cannabis and cannabis products must be tested by an
574 independent testing laboratory before the dispensing
575 organization may dispense them. The independent testing
576 laboratory shall provide the dispensing organization with lab
577 results. Before dispensing, the dispensing organization must
578 determine that the lab results indicate that the cannabis or
579 cannabis product meets the definition of cannabis or cannabis
580 product, is safe for human consumption, and is free from harmful
581 contaminants.
582 (b) All cannabis and cannabis products must be labeled
583 before dispensing. The label must include, at a minimum:
584 1. A statement that the cannabis or cannabis product meets
585 the requirements in paragraph (a);
586 2. The name of the independent testing laboratory that
587 tested the cannabis or cannabis product;
588 3. The name of the cultivation and processing facility
589 where the cannabis or cannabis product originates; and
590 4. The batch number and harvest number from which the
591 cannabis or cannabis product originates.
592 (8) SAFETY AND EFFICACY RESEARCH FOR CANNABIS.—The
593 University of Florida College of Pharmacy must establish and
594 maintain a safety and efficacy research program for the use of
595 cannabis or cannabis products to treat qualifying conditions and
596 symptoms. The program must include a fully integrated electronic
597 information system for the broad monitoring of health outcomes
598 and safety signal detection. The electronic information system
599 must include information from the compassionate use registry;
600 provider reports, including treatment plans, adverse event
601 reports, and treatment discontinuation reports; patient reports
602 of adverse impacts; event-triggered interviews and medical chart
603 reviews performed by University of Florida clinical research
604 staff; information from external databases, including Medicaid
605 billing reports and information in the prescription drug
606 monitoring database for registered patients; and all other
607 medical reports required by the University of Florida to conduct
608 the research required by this subsection. The department must
609 provide access to information from the compassionate use
610 registry and the prescription drug monitoring database,
611 established in s. 893.055, as needed by the University of
612 Florida to conduct research under this subsection. The Agency
613 for Health Care Administration must provide access to registered
614 patient Medicaid records, to the extent allowed under federal
615 law, as needed by the University of Florida to conduct research
616 under this subsection.
617 (9)(7) EXCEPTIONS TO OTHER LAWS.—
618 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
619 any other provision of law, but subject to the requirements of
620 this section, a qualified patient and the qualified patient’s
621 legal representative who is registered with the department on
622 the compassionate use registry may purchase and possess for the
623 patient’s medical use up to the amount of low-THC cannabis
624 ordered for the patient. Nothing in this section exempts any
625 person from the prohibition against driving under the influence
626 provided in s. 316.193.
627 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
628 any other provision of law, but subject to the requirements of
629 this section, an approved dispensing organization and its
630 owners, managers, and employees and the owners, managers, and
631 employees of contractors who have direct contact with cannabis
632 or cannabis product may manufacture, possess, sell, deliver,
633 distribute, dispense, and lawfully dispose of reasonable
634 quantities, as established by department rule, of low-THC
635 cannabis. For purposes of this subsection, the terms
636 “manufacture,” “possession,” “deliver,” “distribute,” and
637 “dispense” have the same meanings as provided in s. 893.02.
638 (c) An approved dispensing organization and its owners,
639 managers, and employees are not subject to licensure or
640 regulation under chapter 465 or chapter 499 for manufacturing,
641 possessing, selling, delivering, distributing, dispensing, or
642 lawfully disposing of reasonable quantities, as established by
643 department rule, of low-THC cannabis.
644 (d) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
645 any other law, but subject to the requirements of this section,
646 a licensed laboratory and its employees may receive and possess
647 cannabis for the sole purpose of testing the cannabis to ensure
648 compliance with this section.
649 (10) Rules adopted by the department under this section are
650 exempt from the requirement that they be ratified by the
651 Legislature pursuant to s. 120.541(3).
652 Section 2. Subsections (1) and (2) and paragraphs (b) and
653 (c) of subsection (3) of section 381.987, Florida Statutes, are
654 amended, and paragraph (g) is added to subsection (3) of that
655 section, to read:
656 381.987 Public records exemption for personal identifying
657 information in the compassionate use registry.—
658 (1) A patient’s personal identifying information held by
659 the department in the compassionate use registry established
660 under s. 381.986, including, but not limited to, the patient’s
661 name, address, telephone number, and government-issued
662 identification number, and all information pertaining to the
663 physician’s order for low-THC cannabis and the dispensing
664 thereof are confidential and exempt from s. 119.07(1) and s.
665 24(a), Art. I of the State Constitution.
666 (2) A physician’s identifying information held by the
667 department in the compassionate use registry established under
668 s. 381.986, including, but not limited to, the physician’s name,
669 address, telephone number, government-issued identification
670 number, and Drug Enforcement Administration number, and all
671 information pertaining to the physician’s order for low-THC
672 cannabis and the dispensing thereof are confidential and exempt
673 from s. 119.07(1) and s. 24(a), Art. I of the State
674 Constitution.
675 (3) The department shall allow access to the registry,
676 including access to confidential and exempt information, to:
677 (b) A dispensing organization approved by the department
678 pursuant to s. 381.986 which is attempting to verify the
679 authenticity of a physician’s order for low-THC cannabis,
680 including whether the order had been previously filled and
681 whether the order was written for the person attempting to have
682 it filled.
683 (c) A physician who has written an order for low-THC
684 cannabis for the purpose of monitoring the patient’s use of such
685 cannabis or for the purpose of determining, before issuing an
686 order for low-THC cannabis, whether another physician has
687 ordered the patient’s use of low-THC cannabis. The physician may
688 access the confidential and exempt information only for the
689 patient for whom he or she has ordered or is determining whether
690 to order the use of low-THC cannabis pursuant to s. 381.986.
691 (g) Persons engaged in research at the University of
692 Florida pursuant to s. 381.986(8).
693 Section 3. Subsection (1) of section 385.211, Florida
694 Statutes, is amended to read:
695 385.211 Refractory and intractable epilepsy treatment and
696 research at recognized medical centers.—
697 (1) As used in this section, the term “low-THC cannabis”
698 means “low-THC cannabis” as defined in s. 381.986 that is
699 dispensed only from a dispensing organization as defined in s.
700 381.986.
701 Section 4. Subsection (3) of section 893.02, Florida
702 Statutes, is amended to read:
703 893.02 Definitions.—The following words and phrases as used
704 in this chapter shall have the following meanings, unless the
705 context otherwise requires:
706 (3) “Cannabis” means all parts of any plant of the genus
707 Cannabis, whether growing or not; the seeds thereof; the resin
708 extracted from any part of the plant; and every compound,
709 manufacture, salt, derivative, mixture, or preparation of the
710 plant or its seeds or resin. The term does not include “low-THC
711 cannabis,” as defined in s. 381.986, if manufactured, possessed,
712 sold, purchased, delivered, distributed, or dispensed, in
713 conformance with s. 381.986.
714 Section 5. Paragraph (b) of subsection (7) of section
715 893.055, Florida Statutes, is amended to read:
716 893.055 Prescription drug monitoring program.—
717 (7)
718 (b) A pharmacy, prescriber, or dispenser shall have access
719 to information in the prescription drug monitoring program’s
720 database which relates to a patient of that pharmacy,
721 prescriber, or dispenser in a manner established by the
722 department as needed for the purpose of reviewing the patient’s
723 controlled substance prescription history. Persons engaged in
724 research at the University of Florida pursuant to s. 381.986(8)
725 shall have access to information in the prescription drug
726 monitoring program’s database which relates to qualified
727 patients as defined in s. 381.986(1) for the purpose of
728 conducting such research. Other access to the program’s database
729 shall be limited to the program’s manager and to the designated
730 program and support staff, who may act only at the direction of
731 the program manager or, in the absence of the program manager,
732 as authorized. Access by the program manager or such designated
733 staff is for prescription drug program management only or for
734 management of the program’s database and its system in support
735 of the requirements of this section and in furtherance of the
736 prescription drug monitoring program. Confidential and exempt
737 information in the database shall be released only as provided
738 in paragraph (c) and s. 893.0551. The program manager,
739 designated program and support staff who act at the direction of
740 or in the absence of the program manager, and any individual who
741 has similar access regarding the management of the database from
742 the prescription drug monitoring program shall submit
743 fingerprints to the department for background screening. The
744 department shall follow the procedure established by the
745 Department of Law Enforcement to request a statewide criminal
746 history record check and to request that the Department of Law
747 Enforcement forward the fingerprints to the Federal Bureau of
748 Investigation for a national criminal history record check.
749 Section 6. Paragraph (h) is added to subsection (3) of
750 section 893.0551, Florida Statutes, to read:
751 893.0551 Public records exemption for the prescription drug
752 monitoring program.—
753 (3) The department shall disclose such confidential and
754 exempt information to the following persons or entities upon
755 request and after using a verification process to ensure the
756 legitimacy of the request as provided in s. 893.055:
757 (h) Persons engaged in research at the University of
758 Florida pursuant to s. 381.986(8).
759 Section 7. Subsection (1) of section 1004.441, Florida
760 Statutes, is amended to read:
761 1004.441 Refractory and intractable epilepsy treatment and
762 research.—
763 (1) As used in this section, the term “low-THC cannabis”
764 means “low-THC cannabis” as defined in s. 381.986 that is
765 dispensed only from a dispensing organization as defined in s.
766 381.986.
767 Section 8. This act shall take effect upon becoming a law.
768
769 ================= T I T L E A M E N D M E N T ================
770 And the title is amended as follows:
771 Delete everything before the enacting clause
772 and insert:
773 A bill to be entitled
774 An act relating to cannabis; amending s. 381.986,
775 F.S.; defining terms; revising the illnesses and
776 symptoms for which a physician may order a patient the
777 medical use of cannabis in certain circumstances;
778 providing that a physician who improperly orders
779 cannabis is subject to specified disciplinary action;
780 revising the duties of the Department of Health;
781 requiring the department to create a secure,
782 electronic, and online compassionate use registry;
783 requiring the department to begin to accept
784 applications for licensure as a dispensing
785 organization according to a specified application
786 process; requiring the department to review all
787 applications, notify applicants of deficient
788 applications, and request any additional information
789 within a specified period; requiring an application
790 for licensure to be filed and complete by specified
791 dates; providing for a lottery for licensure as a
792 dispensing organization in certain circumstances;
793 authorizing the department to issue additional
794 licenses to qualified applicants in certain
795 circumstances; providing an exemption for the
796 application process; requiring the department to use
797 an application form that requires specified
798 information from the applicant; requiring the
799 department to impose specified application fees;
800 requiring the department to inspect each dispensing
801 organization’s properties, cultivation facilities,
802 processing facilities, and retail facilities before
803 those facilities may operate; authorizing followup
804 inspections at reasonable hours; providing that
805 licensure constitutes permission for the department to
806 enter and inspect the premises and facilities of any
807 dispensing organization; authorizing the department to
808 inspect any licensed dispensing organization;
809 requiring dispensing organizations to make all
810 facility premises, equipment, documents, cannabis, and
811 cannabis products available to the department upon
812 inspection; authorizing the department to test
813 cannabis or cannabis products; authorizing the
814 department to suspend or revoke a license, deny or
815 refuse to renew a license, or impose a maximum
816 administrative penalty for specified acts or
817 omissions; requiring the department to create a
818 permitting process for vehicles used for the
819 transportation of cannabis or cannabis products;
820 authorizing the department to adopt rules as necessary
821 for implementation of specified provisions and
822 procedures, and to provide specified guidance;
823 providing procedures and requirements for an applicant
824 seeking licensure as a dispensing organization or the
825 renewal of its license; requiring the dispensing
826 organization to verify specified information of
827 specified persons in certain circumstances;
828 authorizing a dispensing organization to have
829 cultivation facilities, processing facilities, and
830 retail facilities; authorizing a retail facility to be
831 established in a municipality only after such an
832 ordinance has been created; authorizing a retail
833 facility to be established in the unincorporated areas
834 of a county only after such an ordinance has been
835 created; requiring retail facilities to have all
836 utilities and resources necessary to store and
837 dispense and cannabis products; requiring retail
838 facilities to be secured with specified theft
839 prevention systems; requiring a dispensing
840 organization to provide the department with specified
841 updated information within a specified period;
842 authorizing a dispensing organization to transport
843 cannabis or cannabis products in vehicles in certain
844 circumstances; requiring such vehicles to be operated
845 by specified persons in certain circumstances;
846 requiring a fee for a vehicle permit; requiring the
847 signature of the designated driver with a vehicle
848 permit application; providing for expiration of the
849 permit in certain circumstances; requiring the
850 department to cancel a vehicle permit upon the request
851 of specified persons; providing that the licensee
852 authorizes the inspection and search of his or her
853 vehicle without a search warrant by specified persons;
854 requiring all cannabis and cannabis products to be
855 tested by an independent testing laboratory before the
856 dispensing organization may dispense it; requiring the
857 independent testing laboratory to provide the lab
858 results to the dispensing organization for a specified
859 determination; requiring all cannabis and cannabis
860 products to be labeled with specified information
861 before dispensing; requiring the University of Florida
862 College of Pharmacy to establish and maintain a
863 specified safety and efficacy research program;
864 providing program requirements; requiring the
865 department to provide information from the
866 prescription drug monitoring program to the University
867 of Florida as needed; requiring the Agency for Health
868 Care Administration to provide access to specified
869 patient records under certain circumstances; providing
870 that the act does not provide an exception to the
871 prohibition against driving under the influence;
872 authorizing specified individuals to manufacture,
873 possess, sell, deliver, distribute, dispense, and
874 lawfully dispose of reasonable quantities of cannabis;
875 authorizing a licensed laboratory and its employees to
876 receive and possess cannabis in certain circumstances;
877 providing that specified rules adopted by the
878 department are exempt from the requirement to be
879 ratified by the Legislature; amending s. 381.987,
880 F.S.; conforming provisions to changes made by the
881 act; requiring the department to allow specified
882 persons engaged in research to access the
883 compassionate use registry; amending ss. 385.221 and
884 893.02, F.S.; conforming provisions to changes made by
885 the act; amending s. 893.055, F.S.; providing that
886 persons engaged in research at the University of
887 Florida shall have access to specified information;
888 amending s. 893.0551, F.S.; providing a specified
889 public records exemption for persons engaged in
890 research at the University of Florida; amending s.
891 1004.441, F.S.; conforming provisions to changes made
892 by the act; providing an effective date.