Florida Senate - 2016 COMMITTEE AMENDMENT
Bill No. SB 460
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LEGISLATIVE ACTION
Senate . House
Comm: RCS .
02/29/2016 .
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The Committee on Rules (Galvano) recommended the following:
1 Senate Substitute for Amendment (369986) (with title
2 amendment)
3
4 Delete everything after the enacting clause
5 and insert:
6 Section 1. Section 381.986, Florida Statutes, is amended to
7 read:
8 381.986 Compassionate use of low-THC and medical cannabis.—
9 (1) DEFINITIONS.—As used in this section, the term:
10 (a) “Cannabis delivery device” means an object used,
11 intended for use, or designed for use in preparing, storing,
12 ingesting, inhaling, or otherwise introducing low-THC cannabis
13 or medical cannabis into the human body.
14 (b)(a) “Dispensing organization” means an organization
15 approved by the department to cultivate, process, transport, and
16 dispense low-THC cannabis or medical cannabis pursuant to this
17 section.
18 (c) “Independent testing laboratory” means a laboratory,
19 including the managers, employees, or contractors of the
20 laboratory, which has no direct or indirect interest in a
21 dispensing organization.
22 (d) “Legal representative” means the qualified patient’s
23 parent, legal guardian acting pursuant to a court’s
24 authorization as required under s. 744.3215(4), health care
25 surrogate acting pursuant to the qualified patient’s written
26 consent or a court’s authorization as required under s. 765.113,
27 or an individual who is authorized under a power of attorney to
28 make health care decisions on behalf of the qualified patient.
29 (e)(b) “Low-THC cannabis” means a plant of the genus
30 Cannabis, the dried flowers of which contain 0.8 percent or less
31 of tetrahydrocannabinol and more than 10 percent of cannabidiol
32 weight for weight; the seeds thereof; the resin extracted from
33 any part of such plant; or any compound, manufacture, salt,
34 derivative, mixture, or preparation of such plant or its seeds
35 or resin that is dispensed only from a dispensing organization.
36 (f) “Medical cannabis” means all parts of any plant of the
37 genus Cannabis, whether growing or not; the seeds thereof; the
38 resin extracted from any part of the plant; and every compound,
39 manufacture, sale, derivative, mixture, or preparation of the
40 plant or its seeds or resin that is dispensed only from a
41 dispensing organization for medical use by an eligible patient
42 as defined in s. 499.0295.
43 (g)(c) “Medical use” means administration of the ordered
44 amount of low-THC cannabis or medical cannabis. The term does
45 not include the:
46 1. Possession, use, or administration of low-THC cannabis
47 or medical cannabis by smoking.
48 2. The term also does not include the Transfer of low-THC
49 cannabis or medical cannabis to a person other than the
50 qualified patient for whom it was ordered or the qualified
51 patient’s legal representative on behalf of the qualified
52 patient.
53 3. Use or administration of low-THC cannabis or medical
54 cannabis:
55 a. On any form of public transportation.
56 b. In any public place.
57 c. In a qualified patient’s place of employment, if
58 restricted by his or her employer.
59 d. In a state correctional institution as defined in s.
60 944.02 or a correctional institution as defined in s. 944.241.
61 e. On the grounds of a preschool, primary school, or
62 secondary school.
63 f. On a school bus or in a vehicle, aircraft, or motorboat.
64 (h)(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 or medical cannabis from a dispensing
68 organization.
69 (i)(e) “Smoking” means burning or igniting a substance and
70 inhaling the smoke. Smoking does not include the use of a
71 vaporizer.
72 (2) PHYSICIAN ORDERING.—Effective January 1, 2015, A
73 physician is authorized to order licensed under chapter 458 or
74 chapter 459 who has examined and is treating a patient suffering
75 from cancer or a physical medical condition that chronically
76 produces symptoms of seizures or severe and persistent muscle
77 spasms may order for the patient’s medical use low-THC cannabis
78 to treat a qualified patient suffering from cancer or a physical
79 medical condition that chronically produces symptoms of seizures
80 or severe and persistent muscle spasms; order low-THC cannabis
81 such disease, disorder, or condition or to alleviate symptoms of
82 such disease, disorder, or condition, if no other satisfactory
83 alternative treatment options exist for the qualified that
84 patient; order medical cannabis to treat an eligible patient as
85 defined in s. 499.0295; or order a cannabis delivery device for
86 the medical use of low-THC cannabis or medical cannabis, only if
87 the physician and all of the following conditions apply:
88 (a) Holds an active, unrestricted license as a physician
89 under chapter 458 or an osteopathic physician under chapter 459;
90 (b) Has treated the patient for at least 3 months
91 immediately preceding the patient’s registration in the
92 compassionate use registry;
93 (c) Has successfully completed the course and examination
94 required under paragraph (4)(a);
95 (a) The patient is a permanent resident of this state.
96 (d)(b) Has determined The physician determines that the
97 risks of treating the patient with ordering low-THC cannabis or
98 medical cannabis are reasonable in light of the potential
99 benefit to the for that patient. If a patient is younger than 18
100 years of age, a second physician must concur with this
101 determination, and such determination must be documented in the
102 patient’s medical record;.
103 (e)(c) The physician Registers as the orderer of low-THC
104 cannabis or medical cannabis for the named patient on the
105 compassionate use registry maintained by the department and
106 updates the registry to reflect the contents of the order,
107 including the amount of low-THC cannabis or medical cannabis
108 that will provide the patient with not more than a 45-day supply
109 and a cannabis delivery device needed by the patient for the
110 medical use of low-THC cannabis or medical cannabis. The
111 physician must also update the registry within 7 days after any
112 change is made to the original order to reflect the change. The
113 physician shall deactivate the registration of the patient and
114 the patient’s legal representative patient’s registration when
115 treatment is discontinued;.
116 (f)(d) The physician Maintains a patient treatment plan
117 that includes the dose, route of administration, planned
118 duration, and monitoring of the patient’s symptoms and other
119 indicators of tolerance or reaction to the low-THC cannabis or
120 medical cannabis;.
121 (g)(e) The physician Submits the patient treatment plan
122 quarterly to the University of Florida College of Pharmacy for
123 research on the safety and efficacy of low-THC cannabis and
124 medical cannabis on patients;.
125 (h)(f) The physician Obtains the voluntary written informed
126 consent of the patient or the patient’s legal representative
127 guardian to treatment with low-THC cannabis after sufficiently
128 explaining the current state of knowledge in the medical
129 community of the effectiveness of treatment of the patient’s
130 condition with low-THC cannabis, the medically acceptable
131 alternatives, and the potential risks and side effects;
132 (i) Obtains written informed consent as defined in and
133 required under s. 499.0295, if the physician is ordering medical
134 cannabis for an eligible patient pursuant to that section; and
135 (j) Is not a medical director employed by a dispensing
136 organization.
137 (3) PENALTIES.—
138 (a) A physician commits a misdemeanor of the first degree,
139 punishable as provided in s. 775.082 or s. 775.083, if the
140 physician orders low-THC cannabis for a patient without a
141 reasonable belief that the patient is suffering from:
142 1. Cancer or a physical medical condition that chronically
143 produces symptoms of seizures or severe and persistent muscle
144 spasms that can be treated with low-THC cannabis; or
145 2. Symptoms of cancer or a physical medical condition that
146 chronically produces symptoms of seizures or severe and
147 persistent muscle spasms that can be alleviated with low-THC
148 cannabis.
149 (b) A physician commits a misdemeanor of the first degree,
150 punishable as provided in s. 775.082 or s. 775.083, if the
151 physician orders medical cannabis for a patient without a
152 reasonable belief that the patient has a terminal condition as
153 defined in s. 499.0295.
154 (c)(b) A Any person who fraudulently represents that he or
155 she has cancer, or a physical medical condition that chronically
156 produces symptoms of seizures or severe and persistent muscle
157 spasms, or a terminal condition to a physician for the purpose
158 of being ordered low-THC cannabis, medical cannabis, or a
159 cannabis delivery device by such physician commits a misdemeanor
160 of the first degree, punishable as provided in s. 775.082 or s.
161 775.083.
162 (d) An eligible patient as defined in s. 499.0295 who uses
163 medical cannabis, and such patient’s legal representative who
164 administers medical cannabis, in plain view of or in a place
165 open to the general public, on the grounds of a school, or in a
166 school bus, vehicle, aircraft, or motorboat, commits a
167 misdemeanor of the first degree, punishable as provided in s.
168 775.082 or s. 775.083.
169 (e) A physician who orders low-THC cannabis, medical
170 cannabis, or a cannabis delivery device and receives
171 compensation from a dispensing organization related to the
172 ordering of low-THC cannabis, medical cannabis, or a cannabis
173 delivery device is subject to disciplinary action under the
174 applicable practice act and s. 456.072(1)(n).
175 (4) PHYSICIAN EDUCATION.—
176 (a) Before ordering low-THC cannabis, medical cannabis, or
177 a cannabis delivery device for medical use by a patient in this
178 state, the appropriate board shall require the ordering
179 physician licensed under chapter 458 or chapter 459 to
180 successfully complete an 8-hour course and subsequent
181 examination offered by the Florida Medical Association or the
182 Florida Osteopathic Medical Association that encompasses the
183 clinical indications for the appropriate use of low-THC cannabis
184 and medical cannabis, the appropriate cannabis delivery devices
185 mechanisms, the contraindications for such use, and as well as
186 the relevant state and federal laws governing the ordering,
187 dispensing, and possessing of these substances and devices this
188 substance. The first course and examination shall be presented
189 by October 1, 2014, and shall be administered at least annually
190 thereafter. Successful completion of the course may be used by a
191 physician to satisfy 8 hours of the continuing medical education
192 requirements required by his or her respective board for
193 licensure renewal. This course may be offered in a distance
194 learning format.
195 (b) The appropriate board shall require the medical
196 director of each dispensing organization to hold an active,
197 unrestricted license as a physician under chapter 458 or as an
198 osteopathic physician under chapter 459 and approved under
199 subsection (5) to successfully complete a 2-hour course and
200 subsequent examination offered by the Florida Medical
201 Association or the Florida Osteopathic Medical Association that
202 encompasses appropriate safety procedures and knowledge of low
203 THC cannabis, medical cannabis, and cannabis delivery devices.
204 (c) Successful completion of the course and examination
205 specified in paragraph (a) is required for every physician who
206 orders low-THC cannabis, medical cannabis, or a cannabis
207 delivery device each time such physician renews his or her
208 license. In addition, successful completion of the course and
209 examination specified in paragraph (b) is required for the
210 medical director of each dispensing organization each time such
211 physician renews his or her license.
212 (d) A physician who fails to comply with this subsection
213 and who orders low-THC cannabis, medical cannabis, or a cannabis
214 delivery device may be subject to disciplinary action under the
215 applicable practice act and under s. 456.072(1)(k).
216 (5) DUTIES OF THE DEPARTMENT.—By January 1, 2015, The
217 department shall:
218 (a) Create and maintain a secure, electronic, and online
219 compassionate use registry for the registration of physicians,
220 and patients, and the legal representatives of patients as
221 provided under this section. The registry must be accessible to
222 law enforcement agencies and to a dispensing organization in
223 order to verify the authorization of a patient or a patient’s
224 legal representative to possess patient authorization for low
225 THC cannabis, medical cannabis, or a cannabis delivery device
226 and record the low-THC cannabis, medical cannabis, or cannabis
227 delivery device dispensed. The registry must prevent an active
228 registration of a patient by multiple physicians.
229 (b) Authorize the establishment of five dispensing
230 organizations to ensure reasonable statewide accessibility and
231 availability as necessary for patients registered in the
232 compassionate use registry and who are ordered low-THC cannabis,
233 medical cannabis, or a cannabis delivery device under this
234 section, one in each of the following regions: northwest
235 Florida, northeast Florida, central Florida, southeast Florida,
236 and southwest Florida. The department shall develop an
237 application form and impose an initial application and biennial
238 renewal fee that is sufficient to cover the costs of
239 administering this section. An applicant for approval as a
240 dispensing organization must be able to demonstrate:
241 1. The technical and technological ability to cultivate and
242 produce low-THC cannabis. The applicant must possess a valid
243 certificate of registration issued by the Department of
244 Agriculture and Consumer Services pursuant to s. 581.131 that is
245 issued for the cultivation of more than 400,000 plants, be
246 operated by a nurseryman as defined in s. 581.011, and have been
247 operated as a registered nursery in this state for at least 30
248 continuous years.
249 2. The ability to secure the premises, resources, and
250 personnel necessary to operate as a dispensing organization.
251 3. The ability to maintain accountability of all raw
252 materials, finished products, and any byproducts to prevent
253 diversion or unlawful access to or possession of these
254 substances.
255 4. An infrastructure reasonably located to dispense low-THC
256 cannabis to registered patients statewide or regionally as
257 determined by the department.
258 5. The financial ability to maintain operations for the
259 duration of the 2-year approval cycle, including the provision
260 of certified financials to the department. Upon approval, the
261 applicant must post a $5 million performance bond. However, upon
262 a dispensing organization’s serving at least 1,000 qualified
263 patients, the dispensing organization is only required to
264 maintain a $2 million performance bond.
265 6. That all owners and managers have been fingerprinted and
266 have successfully passed a level 2 background screening pursuant
267 to s. 435.04.
268 7. The employment of a medical director who is a physician
269 licensed under chapter 458 or chapter 459 to supervise the
270 activities of the dispensing organization.
271 (c) Upon the registration of 250,000 active qualified
272 patients in the compassionate use registry, approve three
273 dispensing organizations, which must meet the requirements of
274 subparagraphs (b)2.-7. and demonstrate the technical and
275 technological ability to cultivate and produce low-THC cannabis.
276 (d) Allow a dispensing organization to make a wholesale
277 purchase of low-THC cannabis or medical cannabis from, or a
278 distribution of low-THC cannabis or medical cannabis to, another
279 dispensing organization.
280 (e)(c) Monitor physician registration and ordering of low
281 THC cannabis, medical cannabis, or a cannabis delivery device
282 for ordering practices that could facilitate unlawful diversion
283 or misuse of low-THC cannabis, medical cannabis, or a cannabis
284 delivery device and take disciplinary action as indicated.
285 (d) Adopt rules necessary to implement this section.
286 (6) DISPENSING ORGANIZATION.—An approved dispensing
287 organization must, at all times, shall maintain compliance with
288 the criteria demonstrated for selection and approval as a
289 dispensing organization under subsection (5) and the criteria
290 required in this subsection at all times.
291 (a) When growing low-THC cannabis or medical cannabis, a
292 dispensing organization:
293 1. May use pesticides determined by the department, after
294 consultation with the Department of Agriculture and Consumer
295 Services, to be safely applied to plants intended for human
296 consumption, but may not use pesticides designated as
297 restricted-use pesticides pursuant to s. 487.042.
298 2. Must grow low-THC cannabis or medical cannabis within an
299 enclosed structure and in a room separate from any other plant.
300 3. Must inspect seeds and growing plants for plant pests
301 that endanger or threaten the horticultural and agricultural
302 interests of the state, notify the Department of Agriculture and
303 Consumer Services within 10 calendar days after a determination
304 that a plant is infested or infected by such plant pest, and
305 implement and maintain phytosanitary policies and procedures.
306 4. Must perform fumigation or treatment of plants, or the
307 removal and destruction of infested or infected plants, in
308 accordance with chapter 581 and any rules adopted thereunder.
309 (b) When processing low-THC cannabis or medical cannabis, a
310 dispensing organization must:
311 1. Process the low-THC cannabis or medical cannabis within
312 an enclosed structure and in a room separate from other plants
313 or products.
314 2. Test the processed low-THC cannabis and medical cannabis
315 before they are dispensed. Results must be verified and signed
316 by two dispensing organization employees. Before dispensing low
317 THC cannabis, the dispensing organization must determine that
318 the test results indicate that the low-THC cannabis meets the
319 definition of low-THC cannabis and, for medical cannabis and
320 low-THC cannabis, that all medical cannabis and low-THC cannabis
321 is safe for human consumption and free from contaminants that
322 are unsafe for human consumption. The dispensing organization
323 must retain records of all testing and samples of each
324 homogenous batch of cannabis and low-THC cannabis for at least 9
325 months. The dispensing organization must contract with an
326 independent testing laboratory to perform audits on the
327 dispensing organization’s standard operating procedures, testing
328 records, and samples and provide the results to the department
329 to confirm that the low-THC cannabis or medical cannabis meets
330 the requirements of this section and that the medical cannabis
331 and low-THC cannabis is safe for human consumption.
332 3. Package the low-THC cannabis or medical cannabis in
333 compliance with the United States Poison Prevention Packaging
334 Act of 1970, 15 U.S.C. ss. 1471 et seq.
335 4. Package the low-THC cannabis or medical cannabis in a
336 receptacle that has a firmly affixed and legible label stating
337 the following information:
338 a. A statement that the low-THC cannabis or medical
339 cannabis meets the requirements of subparagraph 2.;
340 b. The name of the dispensing organization from which the
341 medical cannabis or low-THC cannabis originates; and
342 c. The batch number and harvest number from which the
343 medical cannabis or low-THC cannabis originates.
344 5. Reserve two processed samples from each batch and retain
345 such samples for at least 9 months for the purpose of testing
346 pursuant to the audit required under subparagraph 2.
347 (c) When dispensing low-THC cannabis, medical cannabis, or
348 a cannabis delivery device, a dispensing organization:
349 1. May not dispense more than a 45-day supply of low-THC
350 cannabis or medical cannabis to a patient or the patient’s legal
351 representative.
352 2. Must have the dispensing organization’s employee who
353 dispenses the low-THC cannabis, medical cannabis, or a cannabis
354 delivery device enter into the compassionate use registry his or
355 her name or unique employee identifier.
356 3. Must verify in the compassionate use registry that a
357 physician has ordered the low-THC cannabis, medical cannabis, or
358 a specific type of a cannabis delivery device for the patient.
359 4. May not dispense or sell any other type of cannabis,
360 alcohol, or illicit drug-related product, including pipes,
361 bongs, or wrapping papers, other than a physician-ordered
362 cannabis delivery device required for the medical use of low-THC
363 cannabis or medical cannabis, while dispensing low-THC cannabis
364 or medical cannabis.
365 5. Must Before dispensing low-THC cannabis to a qualified
366 patient, the dispensing organization shall verify that the
367 patient has an active registration in the compassionate use
368 registry, the patient or patient’s legal representative holds a
369 valid and active registration card, the order presented matches
370 the order contents as recorded in the registry, and the order
371 has not already been filled.
372 6. Must, upon dispensing the low-THC cannabis, medical
373 cannabis, or cannabis delivery device, the dispensing
374 organization shall record in the registry the date, time,
375 quantity, and form of low-THC cannabis or medical cannabis
376 dispensed and the type of cannabis delivery device dispensed.
377 (d) To ensure the safety and security of its premises and
378 any off-site storage facilities, and to maintain adequate
379 controls against the diversion, theft, and loss of low-THC
380 cannabis, medical cannabis, or cannabis delivery devices, a
381 dispensing organization shall:
382 1.a. Maintain a fully operational security alarm system
383 that secures all entry points and perimeter windows and is
384 equipped with motion detectors; pressure switches; and duress,
385 panic, and hold-up alarms; or
386 b. Maintain a video surveillance system that records
387 continuously 24 hours each day and meets at least one of the
388 following criteria:
389 (I) Cameras are fixed in a place that allows for the clear
390 identification of persons and activities in controlled areas of
391 the premises. Controlled areas include grow rooms, processing
392 rooms, storage rooms, disposal rooms or areas, and point-of-sale
393 rooms;
394 (II) Cameras are fixed in entrances and exits to the
395 premises, which shall record from both indoor and outdoor, or
396 ingress and egress, vantage points;
397 (III) Recorded images must clearly and accurately display
398 the time and date; or
399 (IV) Retain video surveillance recordings for a minimum of
400 45 days or longer upon the request of a law enforcement agency.
401 2. Ensure that the organization’s outdoor premises have
402 sufficient lighting from dusk until dawn.
403 3. Establish and maintain a tracking system approved by the
404 department that traces the low-THC cannabis or medical cannabis
405 from seed to sale. The tracking system shall include
406 notification of key events as determined by the department,
407 including when cannabis seeds are planted, when cannabis plants
408 are harvested and destroyed, and when low-THC cannabis or
409 medical cannabis is transported, sold, stolen, diverted, or
410 lost.
411 4. Not dispense from its premises low-THC cannabis, medical
412 cannabis, or a cannabis delivery device between the hours of 9
413 p.m. and 7 a.m., but may perform all other operations and
414 deliver low-THC cannabis and medical cannabis to qualified
415 patients 24 hours each day.
416 5. Store low-THC cannabis or medical cannabis in a secured,
417 locked room or a vault.
418 6. Require at least two of its employees, or two employees
419 of a security agency with whom it contracts, to be on the
420 premises at all times.
421 7. Require each employee to wear a photo identification
422 badge at all times while on the premises.
423 8. Require each visitor to wear a visitor’s pass at all
424 times while on the premises.
425 9. Implement an alcohol and drug-free workplace policy.
426 10. Report to local law enforcement within 24 hours after
427 it is notified or becomes aware of the theft, diversion, or loss
428 of low-THC cannabis or medical cannabis.
429 (e) To ensure the safe transport of low-THC cannabis or
430 medical cannabis to dispensing organization facilities,
431 independent testing laboratories, or patients, the dispensing
432 organization must:
433 1. Maintain a transportation manifest, which must be
434 retained for at least 1 year.
435 2. Ensure only vehicles in good working order are used to
436 transport low-THC cannabis or medical cannabis.
437 3. Lock low-THC cannabis or medical cannabis in a separate
438 compartment or container within the vehicle.
439 4. Require at least two persons to be in a vehicle
440 transporting low-THC cannabis or medical cannabis, and require
441 at least one person to remain in the vehicle while the low-THC
442 cannabis or medical cannabis is being delivered.
443 5. Provide specific safety and security training to
444 employees transporting or delivering low-THC cannabis or medical
445 cannabis.
446 (7) DEPARTMENT AUTHORITY AND RESPONSIBILITIES.—
447 (a) The department may conduct announced or unannounced
448 inspections of dispensing organizations to determine compliance
449 with this section or rules adopted pursuant to this section.
450 (b) The department shall inspect a dispensing organization
451 upon complaint or notice provided to the department that the
452 dispensing organization has dispensed low-THC cannabis or
453 medical cannabis containing any mold, bacteria, or other
454 contaminant that may cause or has caused an adverse effect to
455 human health or the environment.
456 (c) The department shall conduct at least a biennial
457 inspection of each dispensing organization to evaluate the
458 dispensing organization’s records, personnel, equipment,
459 processes, security measures, sanitation practices, and quality
460 assurance practices.
461 (d) The department may enter into interagency agreements
462 with the Department of Agriculture and Consumer Services, the
463 Department of Business and Professional Regulation, the
464 Department of Transportation, the Department of Highway Safety
465 and Motor Vehicles, and the Agency for Health Care
466 Administration, and such agencies are authorized to enter into
467 an interagency agreement with the department, to conduct
468 inspections or perform other responsibilities assigned to the
469 department under this section.
470 (e) The department must make a list of all approved
471 dispensing organizations and qualified ordering physicians and
472 medical directors publicly available on its website.
473 (f) The department may establish a system for issuing and
474 renewing registration cards for patients and their legal
475 representatives, establish the circumstances under which the
476 cards may be revoked by or must be returned to the department,
477 and establish fees to implement such system. The department must
478 require, at a minimum, the registration cards to:
479 1. Provide the name, address, and date of birth of the
480 patient or legal representative.
481 2. Have a full-face, passport-type, color photograph of the
482 patient or legal representative taken within the 90 days
483 immediately preceding registration.
484 3. Identify whether the cardholder is a patient or legal
485 representative.
486 4. List a unique numeric identifier for the patient or
487 legal representative that is matched to the identifier used for
488 such person in the department’s compassionate use registry.
489 5. Provide the expiration date, which shall be 1 year after
490 the date of the physician’s initial order of low-THC cannabis or
491 medical cannabis.
492 6. For the legal representative, provide the name and
493 unique numeric identifier of the patient that the legal
494 representative is assisting.
495 7. Be resistant to counterfeiting or tampering.
496 (g) The department may impose reasonable fines not to
497 exceed $10,000 on a dispensing organization for any of the
498 following violations:
499 1. Violating this section, s. 499.0295, or department rule.
500 2. Failing to maintain qualifications for approval.
501 3. Endangering the health, safety, or security of a
502 qualified patient.
503 4. Improperly disclosing personal and confidential
504 information of the qualified patient.
505 5. Attempting to procure dispensing organization approval
506 by bribery, fraudulent misrepresentation, or extortion.
507 6. Being convicted or found guilty of, or entering a plea
508 of guilty or nolo contendere to, regardless of adjudication, a
509 crime in any jurisdiction which directly relates to the business
510 of a dispensing organization.
511 7. Making or filing a report or record that the dispensing
512 organization knows to be false.
513 8. Willfully failing to maintain a record required by this
514 section or department rule.
515 9. Willfully impeding or obstructing an employee or agent
516 of the department in the furtherance of his or her official
517 duties.
518 10. Engaging in fraud or deceit, negligence, incompetence,
519 or misconduct in the business practices of a dispensing
520 organization.
521 11. Making misleading, deceptive, or fraudulent
522 representations in or related to the business practices of a
523 dispensing organization.
524 12. Having a license or the authority to engage in any
525 regulated profession, occupation, or business that is related to
526 the business practices of a dispensing organization suspended,
527 revoked, or otherwise acted against by the licensing authority
528 of any jurisdiction, including its agencies or subdivisions, for
529 a violation that would constitute a violation under Florida law.
530 13. Violating a lawful order of the department or an agency
531 of the state, or failing to comply with a lawfully issued
532 subpoena of the department or an agency of the state.
533 (h) The department may suspend, revoke, or refuse to renew
534 a dispensing organization’s approval if a dispensing
535 organization commits any of the violations in paragraph (g).
536 (i) The department shall renew the approval of a dispensing
537 organization biennially if the dispensing organization meets the
538 requirements of this section and pays the biennial renewal fee.
539 (j) The department may adopt rules necessary to implement
540 this section.
541 (8) PREEMPTION.—
542 (a) All matters regarding the regulation of the cultivation
543 and processing of medical cannabis or low-THC cannabis by
544 dispensing organizations are preempted to the state.
545 (b) A municipality may determine by ordinance the criteria
546 for the number and location of, and other permitting
547 requirements that do not conflict with state law or department
548 rule for, dispensing facilities of dispensing organizations
549 located within its municipal boundaries. A county may determine
550 by ordinance the criteria for the number, location, and other
551 permitting requirements that do not conflict with state law or
552 department rule for all dispensing facilities of dispensing
553 organizations located within the unincorporated areas of that
554 county.
555 (9)(7) EXCEPTIONS TO OTHER LAWS.—
556 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
557 any other provision of law, but subject to the requirements of
558 this section, a qualified patient and the qualified patient’s
559 legal representative may purchase and possess for the patient’s
560 medical use up to the amount of low-THC cannabis or medical
561 cannabis ordered for the patient, but not more than a 45-day
562 supply, and a cannabis delivery device ordered for the patient.
563 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
564 any other provision of law, but subject to the requirements of
565 this section, an approved dispensing organization and its
566 owners, managers, and employees may manufacture, possess, sell,
567 deliver, distribute, dispense, and lawfully dispose of
568 reasonable quantities, as established by department rule, of
569 low-THC cannabis, medical cannabis, or a cannabis delivery
570 device. For purposes of this subsection, the terms
571 “manufacture,” “possession,” “deliver,” “distribute,” and
572 “dispense” have the same meanings as provided in s. 893.02.
573 (c) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
574 any other provision of law, but subject to the requirements of
575 this section, an approved independent testing laboratory may
576 possess, test, transport, and lawfully dispose of low-THC
577 cannabis or medical cannabis as provided by department rule.
578 (d)(c) An approved dispensing organization and its owners,
579 managers, and employees are not subject to licensure or
580 regulation under chapter 465 or chapter 499 for manufacturing,
581 possessing, selling, delivering, distributing, dispensing, or
582 lawfully disposing of reasonable quantities, as established by
583 department rule, of low-THC cannabis, medical cannabis, or a
584 cannabis delivery device.
585 (e) An approved dispensing organization that continues to
586 meet the requirements for approval is presumed to be registered
587 with the department and to meet the regulations adopted by the
588 department or its successor agency for the purpose of dispensing
589 medical cannabis or low-THC cannabis under Florida law.
590 Additionally, the authority provided to a dispensing
591 organization in s. 499.0295 does not impair the approval of a
592 dispensing organization.
593 (f) This subsection does not preclude a person from being
594 prosecuted for a criminal offense related to impairment or
595 intoxication resulting from the medical use of low-THC cannabis
596 or medical cannabis or relieve a person from any requirement
597 under law to submit to a breath, blood, urine, or other test to
598 detect the presence of a controlled substance.
599 Section 2. Subsections (2) and (3) of section 499.0295,
600 Florida Statutes, are amended to read:
601 499.0295 Experimental treatments for terminal conditions.—
602 (2) As used in this section, the term:
603 (a) “Dispensing organization” means an organization
604 approved by the Department of Health under s. 381.986(5) to
605 cultivate, process, transport, and dispense low-THC cannabis,
606 medical cannabis, and cannabis delivery devices.
607 (b)(a) “Eligible patient” means a person who:
608 1. Has a terminal condition that is attested to by the
609 patient’s physician and confirmed by a second independent
610 evaluation by a board-certified physician in an appropriate
611 specialty for that condition;
612 2. Has considered all other treatment options for the
613 terminal condition currently approved by the United States Food
614 and Drug Administration;
615 3. Has given written informed consent for the use of an
616 investigational drug, biological product, or device; and
617 4. Has documentation from his or her treating physician
618 that the patient meets the requirements of this paragraph.
619 (c)(b) “Investigational drug, biological product, or
620 device” means:
621 1. A drug, biological product, or device that has
622 successfully completed phase 1 of a clinical trial but has not
623 been approved for general use by the United States Food and Drug
624 Administration and remains under investigation in a clinical
625 trial approved by the United States Food and Drug
626 Administration; or
627 2. Medical cannabis that is manufactured and sold by a
628 dispensing organization.
629 (d)(c) “Terminal condition” means a progressive disease or
630 medical or surgical condition that causes significant functional
631 impairment, is not considered by a treating physician to be
632 reversible even with the administration of available treatment
633 options currently approved by the United States Food and Drug
634 Administration, and, without the administration of life
635 sustaining procedures, will result in death within 1 year after
636 diagnosis if the condition runs its normal course.
637 (e)(d) “Written informed consent” means a document that is
638 signed by a patient, a parent of a minor patient, a court
639 appointed guardian for a patient, or a health care surrogate
640 designated by a patient and includes:
641 1. An explanation of the currently approved products and
642 treatments for the patient’s terminal condition.
643 2. An attestation that the patient concurs with his or her
644 physician in believing that all currently approved products and
645 treatments are unlikely to prolong the patient’s life.
646 3. Identification of the specific investigational drug,
647 biological product, or device that the patient is seeking to
648 use.
649 4. A realistic description of the most likely outcomes of
650 using the investigational drug, biological product, or device.
651 The description shall include the possibility that new,
652 unanticipated, different, or worse symptoms might result and
653 death could be hastened by the proposed treatment. The
654 description shall be based on the physician’s knowledge of the
655 proposed treatment for the patient’s terminal condition.
656 5. A statement that the patient’s health plan or third
657 party administrator and physician are not obligated to pay for
658 care or treatment consequent to the use of the investigational
659 drug, biological product, or device unless required to do so by
660 law or contract.
661 6. A statement that the patient’s eligibility for hospice
662 care may be withdrawn if the patient begins treatment with the
663 investigational drug, biological product, or device and that
664 hospice care may be reinstated if the treatment ends and the
665 patient meets hospice eligibility requirements.
666 7. A statement that the patient understands he or she is
667 liable for all expenses consequent to the use of the
668 investigational drug, biological product, or device and that
669 liability extends to the patient’s estate, unless a contract
670 between the patient and the manufacturer of the investigational
671 drug, biological product, or device states otherwise.
672 (3) Upon the request of an eligible patient, a manufacturer
673 may, or upon a physician’s order pursuant to s. 381.986, a
674 dispensing organization may:
675 (a) Make its investigational drug, biological product, or
676 device available under this section.
677 (b) Provide an investigational drug, biological product, or
678 device, or cannabis delivery device as defined in s. 381.986 to
679 an eligible patient without receiving compensation.
680 (c) Require an eligible patient to pay the costs of, or the
681 costs associated with, the manufacture of the investigational
682 drug, biological product, or device, or cannabis delivery device
683 as defined in s. 381.986.
684 Section 3. (1) Notwithstanding s. 381.986(5)(b), Florida
685 Statutes, a dispensing organization that receives notice from
686 the Department of Health that it is approved as a region’s
687 dispensing organization, posts a $5 million performance bond in
688 compliance with rule 64-4.002(5)(e), Florida Administrative
689 Code, meets the requirements of and requests cultivation
690 authorization pursuant to rule 64-4.005(2), Florida
691 Administrative Code, and expends at least $100,000 to fulfill
692 its legal obligations as a dispensing organization; or any
693 applicant that received the highest aggregate score through the
694 department’s evaluation process, notwithstanding any prior
695 determination by the department that the applicant failed to
696 meet the requirements of s. 381.986, Florida Statutes, must be
697 granted cultivation authorization by the department and is
698 approved to operate as a dispensing organization for the full
699 term of its original approval and all subsequent renewals
700 pursuant to s. 381.986, Florida Statutes. Any applicant that
701 qualifies under this subsection that has not previously been
702 approved as a dispensing organization by the department must be
703 given approval as a dispensing organization by the department
704 within 10 days before the effective date of this act, and within
705 10 days after receiving such approval must comply with the bond
706 requirement in rule 64-4.002(5)(e), Florida Administrative Code,
707 and must comply with all other applicable requirements of rule
708 64-4, Florida Administrative Code.
709 (2) If an organization that does not meet the criteria of
710 subsection (1) receives a final determination from the Division
711 of Administrative Hearings, the Department of Health, or a court
712 of competent jurisdiction that it was entitled to be a
713 dispensing organization under s. 381.986, Florida Statutes, and
714 applicable rules, such organization and an organization that
715 meets the criteria of subsection (1) shall both be dispensing
716 organizations in the same region. During the operations of any
717 dispensing organization that meets the criteria in this section,
718 the Department of Health may enforce rule 64-4.005, Florida
719 Administrative Code, as filed on June 17, 2015.
720 (3) This section does not apply to s. 381.986 (5)(c),
721 Florida Statutes.
722 Section 4. This act shall take effect upon becoming a law.
723
724 ================= T I T L E A M E N D M E N T ================
725 And the title is amended as follows:
726 Delete everything before the enacting clause
727 and insert:
728 A bill to be entitled
729 An act relating to the medical use of cannabis;
730 amending s. 381.986, F.S.; providing and revising
731 definitions; revising requirements for physicians
732 ordering low-THC cannabis, medical cannabis, or a
733 cannabis delivery device; revising the information a
734 physician must update on the registry; requiring a
735 physician to update the registry within a specified
736 timeframe; requiring a physician to obtain certain
737 written consent; providing that a physician commits a
738 misdemeanor of the first degree under certain
739 circumstances; providing that an eligible patient who
740 uses medical cannabis and such patient’s legal
741 representative who administers medical cannabis in
742 specified locations commits a misdemeanor of the first
743 degree; providing that a physician who orders low-THC
744 cannabis or medical cannabis and receives related
745 compensation from a dispensing organization is subject
746 to disciplinary action; revising requirements relating
747 to physician education; providing that the appropriate
748 board must require the medical director of each
749 dispensing organization to hold a certain license;
750 revising the information that the Department of Health
751 is required to include in its online compassionate use
752 registry; revising performance bond requirements for
753 certain dispensing organizations; requiring the
754 department to approve three dispensing organizations
755 under certain circumstances; providing requirements
756 for the three dispensing organizations; requiring the
757 department to allow a dispensing organization to make
758 certain wholesale purchases from or distributions to
759 another dispensing organization; revising standards to
760 be met and maintained by dispensing organizations;
761 authorizing dispensing organizations to use certain
762 pesticides after consultation with the Department of
763 Agriculture and Consumer Services; providing
764 requirements for dispensing organizations when they
765 are growing and processing low-THC cannabis or medical
766 cannabis; requiring dispensing organizations to
767 inspect seeds and growing plants for certain pests and
768 perform certain fumigation and treatment of plants;
769 providing that dispensing organizations may not
770 dispense low-THC cannabis and medical cannabis unless
771 they meet certain testing requirements; requiring
772 dispensing organizations to maintain certain records;
773 requiring dispensing organizations to contract with an
774 independent testing laboratory to perform certain
775 audits; providing packaging requirements for low-THC
776 or medical cannabis; requiring dispensing
777 organizations to retain certain samples for specified
778 purposes; providing delivery requirements when
779 dispensing low-THC cannabis and medical cannabis;
780 providing certain safety and security requirements for
781 dispensing organizations; providing certain safety and
782 security requirements for transporting low-THC
783 cannabis and medical cannabis; authorizing the
784 department to conduct certain inspections; providing
785 inspection requirements; authorizing the department to
786 enter into certain interagency agreements; requiring
787 the department to make certain information available
788 on its website; authorizing the department to
789 establish a system for issuing and renewing
790 registration cards; providing requirements for the
791 registration cards; authorizing the department to
792 impose certain fines; authorizing the department to
793 suspend, revoke, or refuse to renew a dispensing
794 organization’s approval under certain circumstances;
795 requiring the department to renew the dispensing
796 organization biennially under certain conditions;
797 providing applicability; authorizing an approved
798 independent testing laboratory to possess, test,
799 transport, and lawfully dispose of low-THC cannabis or
800 medical cannabis by department rule ; providing that a
801 dispensing organization is presumed to be registered
802 with the department under certain circumstances;
803 providing that a person is not precluded from certain
804 criminal offenses under certain circumstances;
805 amending s. 499.0295, F.S.; revising definitions;
806 authorizing certain manufacturers to dispense cannabis
807 delivery devices; requiring the department to
808 authorize certain dispensing organizations or
809 applicants to provide low-THC cannabis, medical
810 cannabis, and cannabis delivery devices to eligible
811 patients; providing for dispensing organizations or
812 applicants meeting specified criteria to be granted
813 authorization to cultivate certain cannabis and
814 operate as dispensing organizations; requiring the
815 department to grant approval as a dispensing
816 organization by a specified date; authorizing two
817 dispensing organizations in the same region under
818 certain circumstances; authorizing the Department of
819 Health to enforce certain rules; providing
820 applicability; providing an effective date.