Florida Senate - 2015 SENATOR AMENDMENT
Bill No. CS for CS for SB 7066
Ì835218/Î835218
LEGISLATIVE ACTION
Senate . House
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Senator Bradley 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 an organization 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 organization
17 licensed approved by the department to cultivate, process, and
18 dispense low-THC cannabis pursuant to this section.
19 (d) “Harvest” means a specifically identified and numbered
20 quantity of low-THC cannabis cultivated using the same
21 herbicides, pesticides, and fungicides and harvested at the same
22 time from a single facility.
23 (e) “Independent testing laboratory” means a laboratory,
24 and the managers, employees, or contractors of the laboratory
25 which have no direct or indirect interest in a dispensing
26 organization.
27 (f)(b) “Low-THC cannabis” means a plant of the genus
28 Cannabis, the dried flowers of which contain 15 0.8 percent or
29 less of tetrahydrocannabinol and more than 10 percent of
30 cannabidiol weight for weight; the seeds thereof; the resin
31 extracted from any part of such plant; or any compound,
32 manufacture, salt, derivative, mixture, or preparation of such
33 plant or its seeds or resin that is dispensed only from a
34 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. All low
42 THC cannabis products must maintain concentrations, weight for
43 weight, of 15 percent or less of tetrahydrocannabinol and 10
44 percent cannabidiol.
45 (h)(c) “Medical use” means administration of the
46 recommended ordered amount of low-THC cannabis. The term does
47 not include:
48 1. The possession, use, or administration by smoking.
49 2. The term also does not include The transfer of low-THC
50 cannabis to a person other than the qualified patient for whom
51 it was recommended ordered or the qualified patient’s legal
52 representative who is registered in the compassionate use
53 registry on behalf of the qualified patient.
54 3. The use or administration of low-THC cannabis or low-THC
55 cannabis products:
56 a. On any form of public transportation.
57 b. In any public place.
58 c. In a registered qualified patient’s place of work, if
59 restricted by his or her employer.
60 d. In a correctional facility.
61 e. On the grounds of any preschool, primary school, or
62 secondary school.
63 f. On a school bus.
64 (i)(d) “Qualified patient” means a resident of this state
65 who has been added to the compassionate use registry by a
66 physician licensed under chapter 458 or chapter 459 to receive
67 low-THC cannabis from a dispensing organization.
68 (j)(e) “Smoking” means burning or igniting a substance and
69 inhaling the smoke. Smoking does not include the use of a
70 vaporizer.
71 (2) PHYSICIAN RECOMMENDING ORDERING.—
72 (a) Effective January 1, 2015, A physician licensed under
73 chapter 458 or chapter 459 who has examined and is treating a
74 patient suffering from cancer, human immunodeficiency virus,
75 acquired immune deficiency syndrome, epilepsy, amyotrophic
76 lateral sclerosis, autism, multiple sclerosis, Crohn’s disease,
77 Parkinson’s disease, paraplegia, quadriplegia, or terminal
78 illness a physical medical condition that chronically produces
79 symptoms of seizures or severe and persistent muscle spasms may
80 recommend order for the patient’s medical use low-THC cannabis
81 to treat such disease, disorder, or condition; or to alleviate
82 symptoms of such disease, disorder, or condition; or to
83 alleviate symptoms caused by a treatment for such disease,
84 disorder, or condition, if no other satisfactory alternative
85 treatment options exist for that patient and all of the
86 following conditions apply:
87 1.(a) The patient is a permanent resident of this state.
88 2.(b) The physician determines that the risks of
89 recommending ordering low-THC cannabis are reasonable in light
90 of the potential benefit for that patient. If a patient is
91 younger than 18 years of age, a second physician must concur
92 with this determination, and such determination must be
93 documented in the patient’s medical record.
94 3.(c) The physician registers the patient, the patient’s
95 legal representative if requested by the patient, and himself or
96 herself as the recommender orderer of low-THC cannabis for the
97 named patient on the compassionate use registry maintained by
98 the department and updates the registry to reflect the contents
99 of the recommendation order. If the patient is a minor, the
100 physician must register a legal representative on the
101 compassionate use registry. The physician shall deactivate the
102 patient’s registration when treatment is discontinued.
103 4.(d) The physician maintains a patient treatment plan that
104 includes the dose, route of administration, planned duration,
105 and monitoring of the patient’s symptoms and other indicators of
106 tolerance or reaction to the low-THC cannabis.
107 5.(e) The physician submits the patient treatment plan, as
108 well as any other requested medical records, biannually
109 quarterly to the University of Florida College of Pharmacy for
110 research on the safety and efficacy of low-THC cannabis on
111 patients pursuant to subsection (8).
112 6.(f) The physician obtains the voluntary informed consent
113 of the patient or the patient’s legal guardian to treatment with
114 low-THC cannabis after sufficiently explaining the current state
115 of knowledge in the medical community of the effectiveness of
116 treatment of the patient’s conditions or symptoms condition with
117 low-THC cannabis, the medically acceptable alternatives, and the
118 potential risks and side effects.
119 (b) A physician who improperly recommends low-THC cannabis
120 is subject to disciplinary action under the applicable practice
121 act and under s. 456.072(1)(k).
122 (3) PENALTIES.—
123 (a) A physician commits a misdemeanor of the first degree,
124 punishable as provided in s. 775.082 or s. 775.083, if the
125 physician recommends orders low-THC cannabis for a patient
126 without a reasonable belief that the patient is suffering from
127 at least one of the conditions listed in subsection (2).:
128 1. Cancer or a physical medical condition that chronically
129 produces symptoms of seizures or severe and persistent muscle
130 spasms that can be treated with low-THC cannabis; or
131 2. Symptoms of cancer or a physical medical condition that
132 chronically produces symptoms of seizures or severe and
133 persistent muscle spasms that can be alleviated with low-THC
134 cannabis.
135 (b) Any person who fraudulently represents that he or she
136 has at least one condition listed in subsection (2) cancer or a
137 physical medical condition that chronically produces symptoms of
138 seizures or severe and persistent muscle spasms to a physician
139 for the purpose of being recommended ordered low-THC cannabis by
140 such physician commits a misdemeanor of the first degree,
141 punishable as provided in s. 775.082 or s. 775.083.
142 (4) PHYSICIAN EDUCATION.—
143 (a) Before recommending ordering low-THC cannabis for use
144 by a patient in this state, the appropriate board shall require
145 the recommending ordering physician licensed under chapter 458
146 or chapter 459 to successfully complete an 8-hour course and
147 subsequent examination offered by the Florida Medical
148 Association or the Florida Osteopathic Medical Association that
149 encompasses the clinical indications for the appropriate use of
150 low-THC cannabis, the appropriate delivery mechanisms, the
151 contraindications for such use, as well as the relevant state
152 and federal laws governing the recommending ordering,
153 dispensing, and possessing of this substance. The first course
154 and examination shall be presented by October 1, 2014, and shall
155 be administered at least four times annually thereafter.
156 Successful completion of the course may be used by a physician
157 to satisfy 8 hours of the continuing medical education
158 requirements required by his or her respective board for
159 licensure renewal. This course may be offered in a distance
160 learning format.
161 (b) The appropriate board shall require the medical
162 director of each dispensing organization approved under
163 subsection (5) to successfully complete a 2-hour course and
164 subsequent examination offered by the Florida Medical
165 Association or the Florida Osteopathic Medical Association that
166 encompasses appropriate safety procedures and knowledge of low
167 THC cannabis.
168 (c) Successful completion of the course and examination
169 specified in paragraph (a) is required for every physician who
170 recommends orders low-THC cannabis each time such physician
171 renews his or her license. In addition, successful completion of
172 the course and examination specified in paragraph (b) is
173 required for the medical director of each dispensing
174 organization each time such physician renews his or her license.
175 (d) A physician who fails to comply with this subsection
176 and who recommends orders low-THC cannabis may be subject to
177 disciplinary action under the applicable practice act and under
178 s. 456.072(1)(k).
179 (5) DUTIES AND POWERS OF THE DEPARTMENT.—By January 1,
180 2015, The department shall:
181 (a) The department shall create a secure, electronic, and
182 online compassionate use registry for the registration of
183 physicians and patients as provided under this section. The
184 registry must be accessible to law enforcement agencies and to a
185 dispensing organization in order to verify patient authorization
186 for low-THC cannabis and record the low-THC cannabis dispensed.
187 The registry must prevent an active registration of a patient by
188 multiple physicians.
189 (b)1. Beginning 7 days after the effective date of this
190 act, the department shall accept applications for licensure as a
191 dispensing organization. The department shall review each
192 application to determine whether the applicant meets the
193 criteria in subsection (6) and qualifies for licensure.
194 2. Within 10 days after receiving an application for
195 licensure, the department shall examine the application, notify
196 the applicant of any apparent errors or omissions, and request
197 any additional information the department is allowed by law to
198 require. An application for licensure must be filed with the
199 department no later than 5 p.m. on the 45th day after the
200 effective date of this act, and all applications must be
201 complete no later than 5 p.m. on the 75th day after the
202 effective date of this act.
203 3. The applications shall be reviewed and scored by a
204 selection committee composed of:
205 a. The Director of the Office of Compassionate Use within
206 the department.
207 b. A member of the Florida Medical Association appointed by
208 the president of the association.
209 c. A member of the Drug Policy Institute at the University
210 of Florida appointed by the president of the University of
211 Florida.
212 4. Before the 90th day after the effective date of this
213 act, the department shall select, based on the scoring of merit
214 based applications, the two highest-scoring applicants in each
215 of the state’s five water management districts which meet the
216 criteria for licensure specified in subsection (6).
217 a. The scorecards of the selection committee members shall
218 be combined to generate an aggregate score for each application.
219 If a tie aggregate score occurs, the winner shall be the
220 applicant that has the highest number of points on the
221 aggregated scorecard attributable to the operating nurseryman’s
222 cultivation experience. If a tie remains after consideration of
223 such points, the winner shall be the applicant that has the
224 highest number of points on the aggregated scorecard
225 attributable to the applicant’s experience in processing
226 cannabis.
227 b. Each qualified nursery may submit one application in the
228 region listed as its primary location on its certificate of
229 registration with the Department of Agriculture and Consumer
230 Services as of the date this act takes effect.
231 5. After the department has selected 10 dispensing
232 organizations pursuant to subparagraph 4., the department shall
233 select, based on the scoring of the merit-based applications,
234 the next 5 highest-scoring applicants statewide which meet the
235 criteria for licensure specified in subsection (6). A tie shall
236 be resolved as specified in sub-subparagraph 4.a. An applicant
237 selected under this subparagraph after being licensed by the
238 department may operate as a dispensing organization in any
239 region of the state, but may not have cultivation or processing
240 facilities outside the region in which it is licensed.
241 6. The department shall license an applicant selected
242 pursuant to subparagraph 4. or subparagraph 5. unless the
243 applicant fails to pay the licensure fee within 20 days of
244 selection.
245 7.a. An unsuccessful applicant may contest the final
246 selection of applicants by filing a written petition with the
247 State Surgeon General within 5 days after the final selection
248 occurs. Within 10 days after receipt of the petition, the State
249 Surgeon General shall review and issue a final determination
250 regarding the contested selection.
251 b. An unsuccessful applicant may appeal the State Surgeon
252 General’s final determination to the circuit court within 10
253 days after issuance of the final determination by filing a
254 complaint, together with the fees prescribed in chapter 28, with
255 the clerk of the circuit court. The complaint must set forth the
256 grounds on which the petitioner requests that the final
257 selection of applicants be set aside.
258 c. Grounds for contesting the selection process are:
259 (I) Misconduct, fraud, or corruption by any member of the
260 selection committee.
261 (II) The ineligibility of a successful applicant.
262 (III) Proof that a member of the selection committee
263 accepted or intended to accept a bribe or reward in money,
264 property, or any other thing of value for the purpose of
265 influencing the selection of applicants.
266 d. A petitioner under sub-subparagraph b. is entitled to an
267 immediate hearing. However, the court in its discretion may
268 limit the time for taking testimony.
269 e. The issuance of a license may not be stayed by the
270 department or the Division of Administrative Hearings during the
271 pendency of any judicial review proceedings under this
272 subparagraph.
273 f. A court may grant a stay or an injunction in an action
274 relating to the denial of a license only if a bond is posted by
275 the petitioner seeking a stay or injunction and the court finds
276 that:
277 (I) The petitioner has a substantial likelihood of success
278 on the merits;
279 (II) The threatened harm or injury to the petitioner
280 clearly outweighs any possible injury to a qualified patient
281 occasioned by granting the stay or injunction; and
282 (III) It is in the public interest to grant the stay or
283 injunction.
284 g. A proceeding pursuant to this subparagraph is the
285 exclusive means to contest or appeal the final selection of
286 applicants. Chapter 120 does not apply to this subparagraph
287 Authorize the establishment of five dispensing organizations to
288 ensure reasonable statewide accessibility and availability as
289 necessary for patients registered in the compassionate use
290 registry and who are ordered low-THC cannabis under this
291 section, one in each of the following regions: northwest
292 Florida, northeast Florida, central Florida, southeast Florida,
293 and southwest Florida.
294 8. The timeframes specified in s. 120.60(1) does not apply
295 to this paragraph.
296 (c) The department shall use develop an application form
297 that requires the applicant to state:
298 1. Whether the application is for initial licensure or
299 renewal licensure;
300 2. The name, the physical address, the mailing address, the
301 address listed on the Department of Agriculture and Consumer
302 Services certificate required in paragraph (6)(b), and the
303 contact information for the applicant and for the nursery that
304 holds the Department of Agriculture and Consumer Services
305 certificate, if different from the applicant;
306 3. The name, address, and contact information for the
307 operating nurseryman of the organization that holds the
308 Department of Agriculture and Consumer Services certificate;
309 4. The name, address, license number, and contact
310 information for the applicant’s medical director; and
311 5. All information required to be included by subsection
312 (6).
313 (d) The department shall and impose an initial application
314 fee of $50,000, an initial licensure fee of $125,000, and a
315 biennial renewal fee of $125,000 that is sufficient to cover the
316 costs of administering this section. An applicant for approval
317 as a dispensing organization must be able to demonstrate:
318 1. The technical and technological ability to cultivate and
319 produce low-THC cannabis. The applicant must possess a valid
320 certificate of registration issued by the Department of
321 Agriculture and Consumer Services pursuant to s. 581.131 that is
322 issued for the cultivation of more than 400,000 plants, be
323 operated by a nurseryman as defined in s. 581.011, and have been
324 operated as a registered nursery in this state for at least 30
325 continuous years.
326 2. The ability to secure the premises, resources, and
327 personnel necessary to operate as a dispensing organization.
328 3. The ability to maintain accountability of all raw
329 materials, finished products, and any byproducts to prevent
330 diversion or unlawful access to or possession of these
331 substances.
332 4. An infrastructure reasonably located to dispense low-THC
333 cannabis to registered patients statewide or regionally as
334 determined by the department.
335 5. The financial ability to maintain operations for the
336 duration of the 2-year approval cycle, including the provision
337 of certified financials to the department. Upon approval, the
338 applicant must post a $5 million performance bond.
339 6. That all owners and managers have been fingerprinted and
340 have successfully passed a level 2 background screening pursuant
341 to s. 435.04.
342 7. The employment of a medical director who is a physician
343 licensed under chapter 458 or chapter 459 to supervise the
344 activities of the dispensing organization.
345 (e) The department may inspect each dispensing
346 organization’s properties, cultivation facilities, processing
347 facilities, and retail facilities before and after the
348 organization begins operations. The department may conduct
349 announced or unannounced inspections, including followup
350 inspections, at reasonable hours in order to ensure that such
351 property and facilities maintain compliance with all applicable
352 requirements in subsections (6) and (7) and to ensure that the
353 dispensing organization has not committed any other act that
354 would endanger the health, safety, or security of a qualified
355 patient, dispensing organization staff, or the community in
356 which the dispensing organization is located. Licensure under
357 this section constitutes permission for the department to enter
358 and inspect the premises and facilities of any dispensing
359 organization. The department may inspect any licensed dispensing
360 organization, and a dispensing organization must make all
361 facility premises, equipment, documents, low-THC cannabis, and
362 low-THC cannabis products available to the department upon
363 inspection. The department may test any low-THC cannabis or low
364 THC cannabis product in order to ensure that it is safe for
365 human consumption and that it meets the requirements in this
366 section.
367 (f)1. Subject to subparagraph 2., the department may impose
368 an administrative penalty not to exceed $10,000 for each of the
369 following violations:
370 a. Violating this section or department rule.
371 b. Failing to maintain qualifications for licensure.
372 c. Endangering the health, safety, or security of a
373 qualified patient.
374 d. Improperly disclosing personal and confidential
375 information of the qualified patient.
376 e. Attempting to procure a license by bribery or fraudulent
377 misrepresentation.
378 f. Being convicted or found guilty of, or entering a plea
379 of nolo contendere to, regardless of adjudication, a crime in
380 any jurisdiction which directly relates to the business of a
381 dispensing organization.
382 g. Making or filing a report or record that the licensee
383 knows to be false.
384 h. Willfully failing to maintain a record required by this
385 section or rule of the department.
386 i. Willfully impeding or obstructing an employee or agent
387 of the department in the furtherance of his or her official
388 duties.
389 j. Engaging in fraud or deceit, negligence, incompetence,
390 or misconduct in the business practices of a dispensing
391 organization.
392 k. Making misleading, deceptive, or fraudulent
393 representations in or related to the business practices of a
394 dispensing organization.
395 l. Having a license or the authority to engage in any
396 regulated profession, occupation, or business that is related to
397 the business practices of a dispensing organization revoked,
398 suspended, or otherwise acted against, including the denial of
399 licensure, by the licensing authority of any jurisdiction,
400 including its agencies or subdivisions, for a violation that
401 would constitute a violation under state law. A licensing
402 authority’s acceptance of a relinquishment of licensure or a
403 stipulation, consent order, or other settlement, offered in
404 response to or in anticipation of the filing of charges against
405 the license, shall be construed as an action against the
406 license.
407 m. Violating a lawful order of the department or an agency
408 of the state, or failing to comply with a lawfully issued
409 subpoena of the department or an agency of the state.
410 2. Prior to imposing an administrative penalty under this
411 paragraph, the department shall provide to the dispensing
412 organization notice of the alleged violation and allow 20
413 business days for the dispensing organization to take corrective
414 action to cure the alleged violation and, if applicable, to
415 implement corrective action to prevent a future violation. If
416 the dispensing organization takes appropriate corrective action
417 to cure the alleged violation and, if applicable, takes
418 appropriate corrective action to prevent a future violation, the
419 violation shall be deemed cured and an administrative penalty
420 may not be imposed. If the violation is not cured, the
421 department may impose an administrative penalty on the
422 dispensing organization and may suspend, revoke, deny, or refuse
423 to renew the license of the dispensing organization.
424 (g) The department shall create a permitting process for
425 all dispensing organization vehicles used for the transportation
426 of low-THC cannabis or low-THC cannabis products.
427 (h)(c) The department shall monitor physician registration
428 and recommendation ordering of low-THC cannabis for
429 recommendation ordering practices that could facilitate unlawful
430 diversion or misuse of low-THC cannabis and take disciplinary
431 action as indicated.
432 (i)(d) The department shall adopt rules as necessary to
433 implement this section; however, the application process
434 specified under paragraph (b) to award licenses shall not be
435 contingent upon rules being first adopted.
436 (6) DISPENSING ORGANIZATION.—
437 (a) An applicant seeking licensure as a dispensing
438 organization, or the renewal of its license, must submit an
439 application to the department. The department must review all
440 applications for completeness, including any department
441 requested inspection of the applicant’s property and facilities
442 to verify the authenticity of the information provided in, or in
443 connection with, the application. An applicant authorizes the
444 department to inspect its property and facilities for licensure
445 by applying under this subsection.
446 (b) In order to receive or maintain licensure as a
447 dispensing organization, an applicant must provide proof that
448 the applicant, or a separate entity that is owned solely by the
449 same persons or entities in the same ratio as the applicant:
450 1. Possesses a valid certificate of registration issued by
451 the Department of Agriculture and Consumer Services pursuant to
452 s. 581.131 for the cultivation of more than 400,000 plants, is
453 operated by a nurseryman as defined in s. 581.011, and has
454 operated as a registered nursery in this state as the same
455 corporate entity, or the legal successor of such entity by
456 merger or acquisition, for at least 30 continuous years as
457 verified by registrations from both the Division of Corporations
458 of the Department of State and the Department of Agriculture and
459 Consumer Services; or
460 2. Is a recognized class member of Pigford v. Glickman, 182
461 F.R.D. 82 (D.D.C. 1999) or In re Black Farmers Litig., 856 F.
462 Supp. 2d 1 (D.D.C. 2011), possesses a valid certificate of
463 registration issued by the Department of Agriculture and
464 Consumer Services pursuant to s. 581.131 for the cultivation of
465 more than 100,000 plants, and has operated as a registered
466 nursery in this state as the same corporate entity, or the legal
467 successor of such entity by merger or acquisition, for at least
468 10 continuous years as verified by registrations from both the
469 Division of Corporations of the Department of State and the
470 Department of Agriculture and Consumer Services.
471
472 An applicant or a separate entity under this paragraph must be
473 capable of obtaining a zoning permit that authorizes the
474 cultivation of low-THC cannabis in the municipality or county
475 listed on the applicant’s or entity’s certificate of
476 registration with the Department of Agriculture and Consumer
477 Services where the cultivation activities are proposed to occur.
478 (c) Each applicant for a license must provide proof that:
479 1. The applicant’s nurseryman as defined in s. 581.011 has
480 experience cultivating and propagating multiple varieties of
481 mature, finished, nonnative plants in this state and mature,
482 finished, potted herbs as evidenced by crop insurance reports or
483 invoices or bills of sale.
484 2. The applicant’s personnel on staff or under contract
485 include at least one person who:
486 a. Has experience with laboratory procedures which includes
487 analytical laboratory quality control measures, chain of custody
488 procedures, and analytical laboratory methods;
489 b. Has experience with cannabis cultivation and processing,
490 in a state or nationally regulated market, including cannabis
491 extraction techniques and producing cannabis products;
492 c. Has experience and qualifications in chain of custody or
493 other tracking mechanisms; and
494 d. Works solely for security purposes.
495 3. Each owner who has a 10 percent or greater interest in
496 the dispensing organization and the applicant’s managers,
497 employees, and contractors who directly interact with low-THC
498 cannabis or low-THC cannabis products have been fingerprinted
499 and have successfully passed a level 2 background screening
500 pursuant to s. 435.04.
501 4. The applicant owns, has at least a 2-year lease of, or
502 has an option to lease or own, all proposed properties,
503 facilities, and equipment necessary for the cultivation and
504 processing of low-THC cannabis. The applicant must provide a
505 detailed description of each proposed facility and its
506 equipment, a cultivation and processing plan, and a detailed
507 floor plan. The description must include proof that each
508 facility is secured and has theft-prevention systems including
509 an alarm system, cameras, and security personnel.
510 5. The applicant has diversion and tracking prevention
511 procedures, including:
512 a. A system for tracking low-THC material through
513 cultivation, processing, and dispensing, including the use of
514 batch and harvest numbers;
515 b. An inventory control system for low-THC cannabis and
516 low-THC cannabis products;
517 c. A vehicle tracking and security system; and
518 d. A cannabis waste-disposal plan.
519 6. The applicant has recordkeeping policies and procedures
520 in place.
521 7. The applicant has a facility emergency management plan.
522 8. The applicant has the financial ability to operate as
523 demonstrated by $4 million in escrowed funds or the equivalent
524 of $4 million in pledged assets, securities, or irrevocable
525 letters of credit.
526 9. The applicant has a $1 million performance and
527 compliance bond, or other equivalent means of security, such as
528 an irrevocable letter of credit, pledged securities, or a
529 deposit in a trust account or financial institution, payable to
530 the department, which must be posted once the applicant is
531 approved as a dispensing organization. The purpose of the bond
532 is to secure payment of any administrative penalties imposed by
533 the department. The department may make a claim against such
534 bond or security until 1 year after the dispensing
535 organization’s license ceases to be valid or until 60 days after
536 any administrative or legal proceeding authorized in this
537 section involving the dispensing organization concludes,
538 including any appeal, whichever occurs later.
539 10. The applicant employs or contracts a medical director
540 who is a Florida resident and a physician licensed under chapter
541 458 or chapter 459 to supervise the activities of the dispensing
542 organization.
543
544 Each applicant that submits a complete application shall be
545 reviewed and scored by the reviewers under paragraph (5)(b)
546 based on the degree to which the applicant meets and exceeds the
547 criteria specified in this paragraph.
548 (d) The license of a dispensing organization shall be
549 renewed by the department biennially if the dispensing
550 organization meets the requirements of paragraphs (b) and (c),
551 pays the biennial renewal fee, and, if applicable, has cured
552 each violation alleged under paragraph (5)(f).
553 (e) An approved dispensing organization shall maintain
554 compliance with the criteria in paragraphs (b), (c), and (f) and
555 subsection (7) demonstrated for selection and approval as a
556 dispensing organization under subsection (5) at all times.
557 Before dispensing low-THC cannabis or low-THC cannabis products
558 to a qualified patient or to the qualified patient’s legal
559 representative, the dispensing organization shall verify the
560 identity of the qualified patient or the qualified patient’s
561 legal representative by requiring the qualified patient or the
562 qualified patient’s legal representative to produce a
563 government-issued identification card and shall verify that the
564 qualified patient and the qualified patient’s legal
565 representative have has an active registration in the
566 compassionate use registry, that the recommendation order
567 presented matches the recommended order contents as recorded in
568 the registry, and that the recommendation order has not already
569 been filled. Upon dispensing the low-THC cannabis, the
570 dispensing organization shall record in the registry the date,
571 time, quantity, and form of low-THC cannabis dispensed.
572 (f) A dispensing organization may have cultivation
573 facilities, processing facilities, and retail facilities.
574 1. The cultivation facilities and processing facilities
575 must be closed to the public.
576 2. A municipality may determine by ordinance the criteria
577 for the number and location of, and other permitting
578 requirements for, all cultivation, processing, and retail
579 facilities located within its municipal boundaries. A county may
580 determine by ordinance the criteria for the number, location,
581 and other permitting requirements for all cultivation,
582 processing, and retail facilities located within the
583 unincorporated areas of that county. Retail facilities must have
584 all utilities and resources necessary to store and dispense low
585 THC cannabis and low-THC cannabis products. Retail facilities
586 must be secured and have theft-prevention systems, including an
587 alarm system, cameras, and 24-hour security personnel. Before a
588 retail facility may dispense low-THC cannabis or a low-THC
589 cannabis product, the dispensing organization must have a
590 computer network compliant with the federal Health Insurance
591 Portability and Accountability Act of 1996 which is able to
592 access and upload data to the compassionate use registry and
593 which shall be used by all retail facilities.
594 (g) Within 15 days after such information becoming
595 available, a dispensing organization must provide the department
596 with updated information, as applicable, including:
597 1. The location and a detailed description of any new or
598 proposed facilities.
599 2. The updated contact information, including electronic
600 and voice communication, for all dispensing organization
601 facilities.
602 3. The registration information for any vehicles used for
603 the transportation of low-THC cannabis and low-THC cannabis
604 products, including confirmation that all such vehicles have
605 tracking and security systems.
606 4. A plan for the recall of any or all low-THC cannabis or
607 low-THC cannabis products.
608 (h)1. A dispensing organization or a contractor of the
609 organization may transport low-THC cannabis or low-THC cannabis
610 products in vehicles departing from their places of business
611 only in vehicles that are owned or leased by the licensee or by
612 a person or contractor designated by the dispensing
613 organization, and for which a valid vehicle permit has been
614 issued for such vehicle by the department.
615 2. A vehicle owned or leased by the dispensing organization
616 or a person or contractor designated by the dispensing
617 organization and approved by the department must be operated by
618 such person when transporting low-THC cannabis or low-THC
619 products from the licensee’s place of business.
620 3. A vehicle permit may be obtained by a dispensing
621 organization upon application and payment of a fee of $5 per
622 vehicle to the department. The signature of the person
623 designated by the dispensing organization to drive the vehicle
624 must be included on the vehicle permit application. Such permit
625 remains valid and does not expire unless the licensee or any
626 person designated by the dispensing organization disposes of his
627 or her vehicle, or the licensee’s license is transferred,
628 canceled, not renewed, or is revoked by the department,
629 whichever occurs first. The department shall cancel a vehicle
630 permit upon request of the licensee or owner of the vehicle.
631 4. By acceptance of a license issued under this section,
632 the licensee agrees that the licensed vehicle is, at all times
633 it is being used to transport low-THC cannabis or low-THC
634 cannabis products, subject to inspection and search without a
635 search warrant by authorized employees of the department,
636 sheriffs, deputy sheriffs, police officers, or other law
637 enforcement officers to determine that the licensee is
638 transporting such products in compliance with this section.
639 (i) A dispensing organization may wholesale low-THC
640 cannabis or a low-THC cannabis product to another licensed
641 dispensing organization.
642 (7) TESTING AND LABELING OF LOW-THC CANNABIS.—
643 (a) All low-THC cannabis and low-THC cannabis products must
644 be tested by an independent testing laboratory before the
645 dispensing organization may dispense them. The independent
646 testing laboratory shall provide the dispensing organization
647 with lab results. Before dispensing, the dispensing organization
648 must determine that the lab results indicate that the low-THC
649 cannabis or low-THC cannabis product meets the definition of
650 low-THC cannabis or low-THC cannabis product, is safe for human
651 consumption, and is free from contaminants that are unsafe for
652 human consumption.
653 (b) All low-THC cannabis and low-THC cannabis products must
654 be labeled before dispensing. The label must include, at a
655 minimum:
656 1. A statement that the low-THC cannabis or low-THC
657 cannabis product meets the requirements in paragraph (a);
658 2. The name of the independent testing laboratory that
659 tested the low-THC cannabis or low-THC cannabis product;
660 3. The name of the cultivation and processing facility
661 where the low-THC cannabis or low-THC cannabis product
662 originates; and
663 4. The batch number and harvest number from which the low
664 THC cannabis or low-THC cannabis product originates.
665 (8) SAFETY AND EFFICACY RESEARCH FOR LOW-THC CANNABIS.—The
666 University of Florida College of Pharmacy shall establish and
667 maintain a safety and efficacy research program for the use of
668 low-THC cannabis or low-THC cannabis products to treat
669 qualifying conditions and symptoms. The program must include a
670 fully integrated electronic information system for the broad
671 monitoring of health outcomes and safety signal detection. The
672 electronic information system must include information from the
673 compassionate use registry; provider reports, including
674 treatment plans, adverse event reports, and treatment
675 discontinuation reports; patient reports of adverse impacts;
676 event-triggered interviews and medical chart reviews performed
677 by University of Florida clinical research staff; information
678 from external databases, including Medicaid billing reports and
679 information in the prescription drug monitoring database for
680 registered patients; and all other medical reports required by
681 the University of Florida to conduct the research required by
682 this subsection. The department must provide access to
683 information from the compassionate use registry and the
684 prescription drug monitoring database, established in s.
685 893.055, as needed by the University of Florida to conduct
686 research under this subsection. The Agency for Health Care
687 Administration must provide access to registered patient
688 Medicaid records, to the extent allowed under federal law, as
689 needed by the University of Florida to conduct research under
690 this subsection.
691 (9) The persons who have direct or indirect interest in the
692 dispensing organization and the dispensing organization’s
693 managers, employees, and contractors who directly interact with
694 low-THC cannabis or low-THC cannabis products are prohibited
695 from making recommendations, offering prescriptions, or
696 providing medical advice to qualified patients.
697 (10)(7) EXCEPTIONS TO OTHER LAWS.—
698 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
699 any other provision of law, but subject to the requirements of
700 this section, a qualified patient and the qualified patient’s
701 legal representative who is registered with the department on
702 the compassionate use registry may purchase and possess for the
703 patient’s medical use up to the amount of low-THC cannabis
704 recommended ordered for the patient. The patient or patient’s
705 representative may purchase, consume, or possess only low-THC
706 cannabis that has been produced by a dispensing organization
707 licensed under this section. Nothing in this section exempts any
708 person from the prohibition against driving under the influence
709 provided in s. 316.193.
710 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
711 any other provision of law, but subject to the requirements of
712 this section, an approved dispensing organization and its
713 owners, managers, and employees and the owners, managers, and
714 employees of contractors who have direct contact with low-THC
715 cannabis or low-THC cannabis product may manufacture, possess,
716 sell, deliver, distribute, dispense, and lawfully dispose of
717 reasonable quantities, as established by department rule, of
718 low-THC cannabis. For purposes of this subsection, the terms
719 “manufacture,” “possession,” “deliver,” “distribute,” and
720 “dispense” have the same meanings as provided in s. 893.02.
721 (c) An approved dispensing organization and its owners,
722 managers, and employees, and contractors are not subject to
723 licensure or regulation under chapter 465 or chapter 499 for
724 manufacturing, possessing, selling, delivering, distributing,
725 dispensing, or lawfully disposing of reasonable quantities, as
726 established by department rule, of low-THC cannabis.
727 (d) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
728 any other law, but subject to the requirements of this section,
729 an independent testing laboratory and its employees may receive
730 and possess low-THC cannabis for the sole purpose of testing the
731 low-THC cannabis to ensure compliance with this section.
732 Section 2. Paragraph (g) is added to subsection (3) of
733 section 381.987, Florida Statutes, to read:
734 381.987 Public records exemption for personal identifying
735 information in the compassionate use registry.—
736 (3) The department shall allow access to the registry,
737 including access to confidential and exempt information, to:
738 (g) Persons engaged in research at the University of
739 Florida pursuant to s. 381.986(8).
740 Section 3. Paragraph (b) of subsection (7) of section
741 893.055, Florida Statutes, is amended to read:
742 893.055 Prescription drug monitoring program.—
743 (7)
744 (b) A pharmacy, prescriber, or dispenser shall have access
745 to information in the prescription drug monitoring program’s
746 database which relates to a patient of that pharmacy,
747 prescriber, or dispenser in a manner established by the
748 department as needed for the purpose of reviewing the patient’s
749 controlled substance prescription history. Persons engaged in
750 research at the University of Florida pursuant to s. 381.986(8)
751 shall have access to information in the prescription drug
752 monitoring program’s database which relates to qualified
753 patients as defined in s. 381.986(1) for the purpose of
754 conducting such research. Other access to the program’s database
755 shall be limited to the program’s manager and to the designated
756 program and support staff, who may act only at the direction of
757 the program manager or, in the absence of the program manager,
758 as authorized. Access by the program manager or such designated
759 staff is for prescription drug program management only or for
760 management of the program’s database and its system in support
761 of the requirements of this section and in furtherance of the
762 prescription drug monitoring program. Confidential and exempt
763 information in the database shall be released only as provided
764 in paragraph (c) and s. 893.0551. The program manager,
765 designated program and support staff who act at the direction of
766 or in the absence of the program manager, and any individual who
767 has similar access regarding the management of the database from
768 the prescription drug monitoring program shall submit
769 fingerprints to the department for background screening. The
770 department shall follow the procedure established by the
771 Department of Law Enforcement to request a statewide criminal
772 history record check and to request that the Department of Law
773 Enforcement forward the fingerprints to the Federal Bureau of
774 Investigation for a national criminal history record check.
775 Section 4. Paragraph (h) is added to subsection (3) of
776 section 893.0551, Florida Statutes, to read:
777 893.0551 Public records exemption for the prescription drug
778 monitoring program.—
779 (3) The department shall disclose such confidential and
780 exempt information to the following persons or entities upon
781 request and after using a verification process to ensure the
782 legitimacy of the request as provided in s. 893.055:
783 (h) Persons engaged in research at the University of
784 Florida pursuant to s. 381.986(8).
785 Section 5. If an application for licensure as a dispensing
786 organization was submitted to the Department of Health before
787 the effective date of this act, the department shall within 7
788 days after the effective date of this act examine the
789 application and notify the applicant if the application does not
790 comply with s. 381.986, Florida Statutes. The department shall
791 allow an applicant to correct and refile its application in
792 compliance with the deadlines specified in s. 381.986(5),
793 Florida Statutes.
794 Section 6. This act shall take effect upon becoming a law.
795
796 ================= T I T L E A M E N D M E N T ================
797 And the title is amended as follows:
798 Delete everything before the enacting clause
799 and insert:
800 A bill to be entitled
801 An act relating to low-THC cannabis; amending s.
802 381.986, F.S.; defining and redefining terms; revising
803 the illnesses and symptoms for which a physician may
804 recommend for the patient’s medical use low-THC
805 cannabis; revising requirements applicable to such
806 recommendations; providing that a physician who
807 improperly recommends low-THC cannabis is subject to
808 specified disciplinary action; providing that a
809 physician who recommends low-THC cannabis without a
810 specified reasonable belief is subject to certain
811 criminal penalties; providing that a patient who
812 fraudulently misrepresents a condition to obtain low
813 THC cannabis is subject to certain criminal penalties;
814 requiring specified physician education to be offered
815 by the Florida Medical Association or Florida
816 Osteopathic Medical Association a certain number of
817 times annually; revising the duties of the Department
818 of Health; requiring the department to create a
819 secure, electronic, and online compassionate use
820 registry; requiring the department to begin accepting
821 applications for licensure as a dispensing
822 organization within a certain period according to a
823 specified application process; requiring applications
824 to be reviewed and scored by a selection committee;
825 specifying the composition of the committee; requiring
826 the department to select a specified number of
827 applicants based on certain criteria for licensure as
828 dispensing organizations in certain regions of the
829 state and statewide; authorizing certain applicants to
830 operate as a dispensing organization in any region of
831 the state, but prohibiting such organization from
832 having cultivation or processing facilities outside
833 the region in which it is licensed; requiring the
834 department to license selected applicants unless the
835 applicant fails to pay the licensure fee within a
836 specified period; providing a process for an
837 unsuccessful applicant to contest and appeal the
838 department’s final selection of applicants; providing
839 that ch. 120, F.S., does not apply to such process;
840 providing that certain timeframes do not apply to the
841 application and licensure process; requiring the
842 department to use an application form requiring
843 specified information; requiring the department to
844 impose certain application, licensure, and renewal
845 fees; authorizing the department to inspect each
846 dispensing organization’s properties, cultivation
847 facilities, processing facilities, and retail
848 facilities before and after those facilities begin
849 operations; requiring dispensing organizations to make
850 all facility premises, equipment, documents, low-THC
851 cannabis, and low-THC cannabis products available to
852 the department upon inspection; authorizing the
853 department to test low-THC cannabis or low-THC
854 cannabis products; authorizing the department to
855 impose an administrative penalty and take other
856 specified administrative action against the license of
857 a dispensing organization based on specified
858 violations if the dispensing organization fails to
859 cure a violation after being providing certain notice
860 and an opportunity to cure; requiring the department
861 to create a permitting process for vehicles used for
862 the transportation of low-THC cannabis or low-THC
863 cannabis products; requiring the department to adopt
864 rules as necessary for implementation of the section;
865 specifying that the award of certain licenses is not
866 contingent on such rules being first adopted;
867 providing procedures and requirements for an applicant
868 seeking licensure as a dispensing organization and for
869 the renewal and maintenance of such license; requiring
870 the dispensing organization to verify specified
871 information of specified persons in certain
872 circumstances; authorizing a dispensing organization
873 to have cultivation facilities, processing facilities,
874 and retail facilities; authorizing a municipality and
875 county to determine by ordinance the number and
876 location of, and other permitting requirements for,
877 all cultivation, processing, and retail facilities
878 located within its respective boundaries; specifying
879 requirements for retail facilities; requiring a
880 dispensing organization to provide the department with
881 certain updated information within a specified period;
882 authorizing a dispensing organization or contractor to
883 transport low-THC cannabis or low-THC cannabis
884 products in vehicles in certain circumstances;
885 requiring such vehicles to be operated by specified
886 persons in certain circumstances; requiring a fee for
887 a vehicle permit; requiring the signature of the
888 designated driver with a vehicle permit application;
889 providing for expiration of the permit in certain
890 circumstances; requiring the department to cancel a
891 vehicle permit upon the request of specified persons;
892 providing that the licensee authorizes the inspection
893 and search of his or her vehicle without a search
894 warrant by specified persons; requiring all low-THC
895 cannabis and low-THC cannabis products to be tested by
896 an independent testing laboratory before the
897 dispensing organization may dispense it; requiring the
898 independent testing laboratory to provide the lab
899 results to the dispensing organization for a specified
900 determination; requiring all low-THC cannabis and low
901 THC cannabis products to be labeled with specified
902 information before dispensing; requiring the
903 University of Florida College of Pharmacy to establish
904 and maintain a specified safety and efficacy research
905 program; providing program requirements; requiring the
906 department to provide information from the
907 prescription drug monitoring program to the University
908 of Florida as needed; requiring the Agency for Health
909 Care Administration to provide access to specified
910 patient records under certain circumstances;
911 prohibiting persons who have direct or indirect
912 interest in a dispensing organization and the
913 dispensing organization’s managers, employees, and
914 contractors who directly interact with low-THC
915 cannabis and low-THC cannabis products from making
916 recommendations, offering prescriptions, or providing
917 medical advice to qualified patients; providing that
918 the act does not provide an exception to the
919 prohibition against driving under the influence;
920 authorizing specified individuals to manufacture,
921 possess, sell, deliver, distribute, dispense, and
922 lawfully dispose of reasonable quantities of low-THC
923 cannabis; authorizing a laboratory and its employees
924 to receive and possess low-THC cannabis in certain
925 circumstances; amending s. 381.987, F.S.; requiring
926 the department to allow specified persons engaged in
927 research to access the compassionate use registry;
928 amending s. 893.055, F.S.; providing that persons
929 engaged in research at the University of Florida shall
930 have access to specified information; amending s.
931 893.0551, F.S.; authorizing certain persons engaged in
932 research at the University of Florida to have access
933 to specified information in the prescription drug
934 monitoring program’s database; requiring the
935 Department of Health to provide notice to certain
936 applicants for licensure as a dispensing organization
937 if their applications do not comply with specified
938 law; requiring the department to allow such applicant
939 to correct and refile its application; providing an
940 effective date.