Florida Senate - 2016 SENATOR AMENDMENT
Bill No. SB 460
Ì369986oÎ369986
LEGISLATIVE ACTION
Senate . House
Comm: RS .
02/29/2016 .
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Floor: PD/2R .
02/23/2016 12:41 PM .
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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 and medical cannabis.—
8 (1) DEFINITIONS.—As used in this section, the term:
9 (a) “Cannabis delivery device” means an object used,
10 intended for use, or designed for use in preparing, storing,
11 ingesting, inhaling, or otherwise introducing low-THC cannabis
12 or medical cannabis into the human body.
13 (b)(a) “Dispensing organization” means an organization
14 approved by the department to cultivate, process, transport, and
15 dispense low-THC cannabis or medical cannabis pursuant to this
16 section.
17 (c) “Independent testing laboratory” means a laboratory,
18 including the managers, employees, or contractors of the
19 laboratory, which has no direct or indirect interest in a
20 dispensing organization.
21 (d) “Legal representative” means the qualified patient’s
22 parent, legal guardian acting pursuant to a court’s
23 authorization as required under s. 744.3215(4), health care
24 surrogate acting pursuant to the qualified patient’s written
25 consent or a court’s authorization as required under s. 765.113,
26 or an individual who is authorized under a power of attorney to
27 make health care decisions on behalf of the qualified patient.
28 (e)(b) “Low-THC cannabis” means a plant of the genus
29 Cannabis, the dried flowers of which contain 0.8 percent or less
30 of tetrahydrocannabinol and more than 10 percent of cannabidiol
31 weight for weight; the seeds thereof; the resin extracted from
32 any part of such plant; or any compound, manufacture, salt,
33 derivative, mixture, or preparation of such plant or its seeds
34 or resin that is dispensed only from a dispensing organization.
35 (f) “Medical cannabis” means all parts of any plant of the
36 genus Cannabis, whether growing or not; the seeds thereof; the
37 resin extracted from any part of the plant; and every compound,
38 manufacture, sale, derivative, mixture, or preparation of the
39 plant or its seeds or resin that is dispensed only from a
40 dispensing organization for medical use by an eligible patient
41 as defined in s. 499.0295.
42 (g)(c) “Medical use” means administration of the ordered
43 amount of low-THC cannabis or medical cannabis. The term does
44 not include the:
45 1. Possession, use, or administration of low-THC cannabis
46 or medical cannabis by smoking.
47 2. The term also does not include the Transfer of low-THC
48 cannabis or medical cannabis to a person other than the
49 qualified patient for whom it was ordered or the qualified
50 patient’s legal representative on behalf of the qualified
51 patient.
52 3. Use or administration of low-THC cannabis or medical
53 cannabis:
54 a. On any form of public transportation.
55 b. In any public place.
56 c. In a qualified patient’s place of employment, if
57 restricted by his or her employer.
58 d. In a state correctional institution as defined in s.
59 944.02 or a correctional institution as defined in s. 944.241.
60 e. On the grounds of a preschool, primary school, or
61 secondary school.
62 f. On a school bus or in a vehicle, aircraft, or motorboat.
63 (h)(d) “Qualified patient” means a resident of this state
64 who has been added to the compassionate use registry by a
65 physician licensed under chapter 458 or chapter 459 to receive
66 low-THC cannabis or medical cannabis from a dispensing
67 organization.
68 (i)(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 ORDERING.—Effective January 1, 2015, A
72 physician is authorized to order licensed under chapter 458 or
73 chapter 459 who has examined and is treating a patient suffering
74 from cancer or a physical medical condition that chronically
75 produces symptoms of seizures or severe and persistent muscle
76 spasms may order for the patient’s medical use low-THC cannabis
77 to treat a qualified patient suffering from cancer or a physical
78 medical condition that chronically produces symptoms of seizures
79 or severe and persistent muscle spasms; order low-THC cannabis
80 such disease, disorder, or condition or to alleviate symptoms of
81 such disease, disorder, or condition, if no other satisfactory
82 alternative treatment options exist for the qualified that
83 patient; order medical cannabis to treat an eligible patient as
84 defined in s. 499.0295; or order a cannabis delivery device for
85 the medical use of low-THC cannabis or medical cannabis, only if
86 the physician and all of the following conditions apply:
87 (a) Holds an active, unrestricted license as a physician
88 under chapter 458 or an osteopathic physician under chapter 459;
89 (b) Has treated the patient for at least 3 months
90 immediately preceding the patient’s registration in the
91 compassionate use registry;
92 (c) Has successfully completed the course and examination
93 required under paragraph (4)(a);
94 (a) The patient is a permanent resident of this state.
95 (d)(b) Has determined The physician determines that the
96 risks of treating the patient with ordering low-THC cannabis or
97 medical cannabis are reasonable in light of the potential
98 benefit to the for that patient. If a patient is younger than 18
99 years of age, a second physician must concur with this
100 determination, and such determination must be documented in the
101 patient’s medical record;.
102 (e)(c) The physician Registers as the orderer of low-THC
103 cannabis or medical cannabis for the named patient on the
104 compassionate use registry maintained by the department and
105 updates the registry to reflect the contents of the order,
106 including the amount of low-THC cannabis or medical cannabis
107 that will provide the patient with not more than a 45-day supply
108 and a cannabis delivery device needed by the patient for the
109 medical use of low-THC cannabis or medical cannabis. The
110 physician must also update the registry within 7 days after any
111 change is made to the original order to reflect the change. The
112 physician shall deactivate the registration of the patient and
113 the patient’s legal representative patient’s registration when
114 treatment is discontinued;.
115 (f)(d) The physician Maintains a patient treatment plan
116 that includes the dose, route of administration, planned
117 duration, and monitoring of the patient’s symptoms and other
118 indicators of tolerance or reaction to the low-THC cannabis or
119 medical cannabis;.
120 (g)(e) The physician Submits the patient treatment plan
121 quarterly to the University of Florida College of Pharmacy for
122 research on the safety and efficacy of low-THC cannabis and
123 medical cannabis on patients;.
124 (h)(f) The physician Obtains the voluntary written informed
125 consent of the patient or the patient’s legal representative
126 guardian to treatment with low-THC cannabis after sufficiently
127 explaining the current state of knowledge in the medical
128 community of the effectiveness of treatment of the patient’s
129 condition with low-THC cannabis, the medically acceptable
130 alternatives, and the potential risks and side effects;
131 (i) Obtains written informed consent as defined in and
132 required under s. 499.0295, if the physician is ordering medical
133 cannabis for an eligible patient pursuant to that section; and
134 (j) Is not a medical director employed by a dispensing
135 organization.
136 (3) PENALTIES.—
137 (a) A physician commits a misdemeanor of the first degree,
138 punishable as provided in s. 775.082 or s. 775.083, if the
139 physician orders low-THC cannabis for a patient without a
140 reasonable belief that the patient is suffering from:
141 1. Cancer or a physical medical condition that chronically
142 produces symptoms of seizures or severe and persistent muscle
143 spasms that can be treated with low-THC cannabis; or
144 2. Symptoms of cancer or a physical medical condition that
145 chronically produces symptoms of seizures or severe and
146 persistent muscle spasms that can be alleviated with low-THC
147 cannabis.
148 (b) A physician commits a misdemeanor of the first degree,
149 punishable as provided in s. 775.082 or s. 775.083, if the
150 physician orders medical cannabis for a patient without a
151 reasonable belief that the patient has a terminal condition as
152 defined in s. 499.0295.
153 (c)(b) A Any person who fraudulently represents that he or
154 she has cancer, or a physical medical condition that chronically
155 produces symptoms of seizures or severe and persistent muscle
156 spasms, or a terminal condition to a physician for the purpose
157 of being ordered low-THC cannabis, medical cannabis, or a
158 cannabis delivery device by such physician commits a misdemeanor
159 of the first degree, punishable as provided in s. 775.082 or s.
160 775.083.
161 (d) An eligible patient as defined in s. 499.0295 who uses
162 medical cannabis, and such patient’s legal representative who
163 administers medical cannabis, in plain view of or in a place
164 open to the general public, on the grounds of a school, or in a
165 school bus, vehicle, aircraft, or motorboat commits a
166 misdemeanor of the first degree, punishable as provided in s.
167 775.082 or s. 775.083.
168 (e) A physician who orders low-THC cannabis, medical
169 cannabis, or a cannabis delivery device and receives
170 compensation from a dispensing organization related to the
171 ordering of low-THC cannabis, medical cannabis, or a cannabis
172 delivery device is subject to disciplinary action under the
173 applicable practice act and s. 456.072(1)(n).
174 (4) PHYSICIAN EDUCATION.—
175 (a) Before ordering low-THC cannabis, medical cannabis, or
176 a cannabis delivery device for medical use by a patient in this
177 state, the appropriate board shall require the ordering
178 physician licensed under chapter 458 or chapter 459 to
179 successfully complete an 8-hour course and subsequent
180 examination offered by the Florida Medical Association or the
181 Florida Osteopathic Medical Association that encompasses the
182 clinical indications for the appropriate use of low-THC cannabis
183 and medical cannabis, the appropriate cannabis delivery devices
184 mechanisms, the contraindications for such use, and as well as
185 the relevant state and federal laws governing the ordering,
186 dispensing, and possessing of these substances and devices this
187 substance. The first course and examination shall be presented
188 by October 1, 2014, and shall be administered at least annually
189 thereafter. Successful completion of the course may be used by a
190 physician to satisfy 8 hours of the continuing medical education
191 requirements required by his or her respective board for
192 licensure renewal. This course may be offered in a distance
193 learning format.
194 (b) The appropriate board shall require the medical
195 director of each dispensing organization to hold an active,
196 unrestricted license as a physician under chapter 458 or as an
197 osteopathic physician under chapter 459 and approved under
198 subsection (5) to successfully complete a 2-hour course and
199 subsequent examination offered by the Florida Medical
200 Association or the Florida Osteopathic Medical Association that
201 encompasses appropriate safety procedures and knowledge of low
202 THC cannabis, medical cannabis, and cannabis delivery devices.
203 (c) Successful completion of the course and examination
204 specified in paragraph (a) is required for every physician who
205 orders low-THC cannabis, medical cannabis, or a cannabis
206 delivery device each time such physician renews his or her
207 license. In addition, successful completion of the course and
208 examination specified in paragraph (b) is required for the
209 medical director of each dispensing organization each time such
210 physician renews his or her license.
211 (d) A physician who fails to comply with this subsection
212 and who orders low-THC cannabis, medical cannabis, or a cannabis
213 delivery device may be subject to disciplinary action under the
214 applicable practice act and under s. 456.072(1)(k).
215 (5) DUTIES OF THE DEPARTMENT.—By January 1, 2015, The
216 department shall:
217 (a) Create and maintain a secure, electronic, and online
218 compassionate use registry for the registration of physicians,
219 and patients, and the legal representatives of patients as
220 provided under this section. The registry must be accessible to
221 law enforcement agencies and to a dispensing organization in
222 order to verify the authorization of a patient or a patient’s
223 legal representative to possess patient authorization for low
224 THC cannabis, medical cannabis, or a cannabis delivery device
225 and record the low-THC cannabis, medical cannabis, or cannabis
226 delivery device dispensed. The registry must prevent an active
227 registration of a patient by multiple physicians.
228 (b) Authorize the establishment of five dispensing
229 organizations to ensure reasonable statewide accessibility and
230 availability as necessary for patients registered in the
231 compassionate use registry and who are ordered low-THC cannabis,
232 medical cannabis, or a cannabis delivery device under this
233 section, one in each of the following regions: northwest
234 Florida, northeast Florida, central Florida, southeast Florida,
235 and southwest Florida. The department shall develop an
236 application form and impose an initial application and biennial
237 renewal fee that is sufficient to cover the costs of
238 administering this section. An applicant for approval as a
239 dispensing organization must be able to demonstrate:
240 1. The technical and technological ability to cultivate and
241 produce low-THC cannabis. The applicant must possess a valid
242 certificate of registration issued by the Department of
243 Agriculture and Consumer Services pursuant to s. 581.131 that is
244 issued for the cultivation of more than 400,000 plants, be
245 operated by a nurseryman as defined in s. 581.011, and have been
246 operated as a registered nursery in this state for at least 30
247 continuous years.
248 2. The ability to secure the premises, resources, and
249 personnel necessary to operate as a dispensing organization.
250 3. The ability to maintain accountability of all raw
251 materials, finished products, and any byproducts to prevent
252 diversion or unlawful access to or possession of these
253 substances.
254 4. An infrastructure reasonably located to dispense low-THC
255 cannabis to registered patients statewide or regionally as
256 determined by the department.
257 5. The financial ability to maintain operations for the
258 duration of the 2-year approval cycle, including the provision
259 of certified financials to the department. Upon approval, the
260 applicant must post a $5 million performance bond. However, upon
261 a dispensing organization’s serving at least 1,000 qualified
262 patients, the dispensing organization is only required to
263 maintain a $2 million performance bond.
264 6. That all owners and managers have been fingerprinted and
265 have successfully passed a level 2 background screening pursuant
266 to s. 435.04.
267 7. The employment of a medical director who is a physician
268 licensed under chapter 458 or chapter 459 to supervise the
269 activities of the dispensing organization.
270 (c) Upon the registration of 250,000 qualified patients in
271 the compassionate use registry, approve three additional
272 dispensing organizations, which must meet the requirements of
273 subparagraphs (b)2.-7. for such approval.
274 (d) Allow a dispensing organization to make a wholesale
275 purchase of low-THC cannabis or medical cannabis from, or a
276 distribution of low-THC cannabis or medical cannabis to, another
277 dispensing organization.
278 (e)(c) Monitor physician registration and ordering of low
279 THC cannabis, medical cannabis, or a cannabis delivery device
280 for ordering practices that could facilitate unlawful diversion
281 or misuse of low-THC cannabis, medical cannabis, or a cannabis
282 delivery device and take disciplinary action as indicated.
283 (d) Adopt rules necessary to implement this section.
284 (6) DISPENSING ORGANIZATION.—An approved dispensing
285 organization must, at all times, shall maintain compliance with
286 the criteria demonstrated for selection and approval as a
287 dispensing organization under subsection (5) and the criteria
288 required in this subsection at all times.
289 (a) When growing low-THC cannabis or medical cannabis, a
290 dispensing organization:
291 1. May use pesticides determined by the department, after
292 consultation with the Department of Agriculture and Consumer
293 Services, to be safely applied to plants intended for human
294 consumption, but may not use pesticides designated as
295 restricted-use pesticides pursuant to s. 487.042.
296 2. Must grow and process low-THC cannabis or medical
297 cannabis within an enclosed structure and in a room separate
298 from any other plant.
299 3. Must inspect seeds and growing plants for plant pests
300 that endanger or threaten the horticultural and agricultural
301 interests of the state, notify the Department of Agriculture and
302 Consumer Services within 10 calendar days after a determination
303 that a plant is infested or infected by such plant pest, and
304 implement and maintain phytosanitary policies and procedures.
305 4. Must perform fumigation or treatment of plants, or the
306 removal and destruction of infested or infected plants, in
307 accordance with chapter 581 and any rules adopted thereunder.
308 (b) When processing low-THC cannabis or medical cannabis, a
309 dispensing organization must:
310 1. Process the low-THC cannabis or medical cannabis in an
311 enclosure separate from other plants or products.
312 2. Test the processed low-THC cannabis and medical cannabis
313 before they are dispensed. Results must be verified and signed
314 by two dispensing organization employees. Before dispensing low
315 THC cannabis, the dispensing organization must determine that
316 the test results indicate that the low-THC cannabis meets the
317 definition of low-THC cannabis and, for medical cannabis and
318 low-THC cannabis, that all medical cannabis and low-THC cannabis
319 is safe for human consumption and free from contaminants that
320 are unsafe for human consumption. The dispensing organization
321 must retain records of all testing and samples of each
322 homogenous batch of cannabis and low-THC cannabis for at least 9
323 months. The dispensing organization must contract with an
324 independent testing laboratory to perform audits on the
325 dispensing organization’s standard operating procedures, testing
326 records, and samples and provide the results to the department
327 to confirm that the low-THC cannabis or medical cannabis meets
328 the requirements of this section and that the medical cannabis
329 and low-THC cannabis is safe for human consumption.
330 3. Package the low-THC cannabis or medical cannabis in
331 compliance with the United States Poison Prevention Packaging
332 Act of 1970, 15 U.S.C. ss. 1471 et seq.
333 4. Package the low-THC cannabis or medical cannabis in a
334 receptacle that has a firmly affixed and legible label stating
335 the following information:
336 a. A statement that the low-THC cannabis or medical
337 cannabis meets the requirements of subparagraph 2.;
338 b. The name of the dispensing organization from which the
339 medical cannabis or low-THC cannabis originates; and
340 c. The batch number and harvest number from which the
341 medical cannabis or low-THC cannabis originates.
342 5. Reserve two processed samples from each batch and retain
343 such samples for at least 9 months for the purpose of testing
344 pursuant to the audit required under subparagraph 2.
345 (c) When dispensing low-THC cannabis, medical cannabis, or
346 a cannabis delivery device, a dispensing organization:
347 1. May not dispense more than a 45-day supply of low-THC
348 cannabis or medical cannabis to a patient or the patient’s legal
349 representative.
350 2. Must have the dispensing organization’s employee who
351 dispenses the low-THC cannabis, medical cannabis, or a cannabis
352 delivery device enter into the compassionate use registry his or
353 her name or unique employee identifier.
354 3. Must verify in the compassionate use registry that a
355 physician has ordered the low-THC cannabis, medical cannabis, or
356 a specific type of a cannabis delivery device for the patient.
357 4. May not dispense or sell any other type of cannabis,
358 alcohol, or illicit drug-related product, including pipes,
359 bongs, or wrapping papers, other than a physician-ordered
360 cannabis delivery device required for the medical use of low-THC
361 cannabis or medical cannabis, while dispensing low-THC cannabis
362 or medical cannabis.
363 5. Must Before dispensing low-THC cannabis to a qualified
364 patient, the dispensing organization shall verify that the
365 patient has an active registration in the compassionate use
366 registry, the patient or patient’s legal representative holds a
367 valid and active registration card, the order presented matches
368 the order contents as recorded in the registry, and the order
369 has not already been filled.
370 6. Must, upon dispensing the low-THC cannabis, medical
371 cannabis, or cannabis delivery device, the dispensing
372 organization shall record in the registry the date, time,
373 quantity, and form of low-THC cannabis or medical cannabis
374 dispensed and the type of cannabis delivery device dispensed.
375 (d) To ensure the safety and security of its premises and
376 any off-site storage facilities, and to maintain adequate
377 controls against the diversion, theft, and loss of low-THC
378 cannabis, medical cannabis, or cannabis delivery devices, a
379 dispensing organization shall:
380 1.a. Maintain a fully operational security alarm system
381 that secures all entry points and perimeter windows and is
382 equipped with motion detectors; pressure switches; and duress,
383 panic, and hold-up alarms; or
384 b. Maintain a video surveillance system that records
385 continuously 24 hours each day and meets at least one of the
386 following criteria:
387 (I) Cameras are fixed in a place that allows for the clear
388 identification of persons and activities in controlled areas of
389 the premises. Controlled areas include grow rooms, processing
390 rooms, storage rooms, disposal rooms or areas, and point-of-sale
391 rooms;
392 (II) Cameras are fixed in entrances and exits to the
393 premises, which shall record from both indoor and outdoor, or
394 ingress and egress, vantage points;
395 (III) Recorded images must clearly and accurately display
396 the time and date; or
397 (IV) Retain video surveillance recordings for a minimum of
398 45 days or longer upon the request of a law enforcement agency.
399 2. Ensure that the organization’s outdoor premises have
400 sufficient lighting from dusk until dawn.
401 3. Establish and maintain a tracking system approved by the
402 department that traces the low-THC cannabis or medical cannabis
403 from seed to sale. The tracking system shall include
404 notification of key events as determined by the department,
405 including when cannabis seeds are planted, when cannabis plants
406 are harvested and destroyed, and when low-THC cannabis or
407 medical cannabis is transported, sold, stolen, diverted, or
408 lost.
409 4. Not dispense from its premises low-THC cannabis, medical
410 cannabis, or a cannabis delivery device between the hours of 9
411 p.m. and 7 a.m., but may perform all other operations and
412 deliver low-THC cannabis and medical cannabis to qualified
413 patients 24 hours each day.
414 5. Store low-THC cannabis or medical cannabis in a secured,
415 locked room or a vault.
416 6. Require at least two of its employees, or two employees
417 of a security agency with whom it contracts, to be on the
418 premises at all times.
419 7. Require each employee to wear a photo identification
420 badge at all times while on the premises.
421 8. Require each visitor to wear a visitor’s pass at all
422 times while on the premises.
423 9. Implement an alcohol and drug-free workplace policy.
424 10. Report to local law enforcement within 24 hours after
425 it is notified or becomes aware of the theft, diversion, or loss
426 of low-THC cannabis or medical cannabis.
427 (e) To ensure the safe transport of low-THC cannabis or
428 medical cannabis to dispensing organization facilities,
429 independent testing laboratories, or patients, the dispensing
430 organization must:
431 1. Maintain a transportation manifest, which must be
432 retained for at least 1 year.
433 2. Ensure only vehicles in good working order are used to
434 transport low-THC cannabis or medical cannabis.
435 3. Lock low-THC cannabis or medical cannabis in a separate
436 compartment or container within the vehicle.
437 4. Require at least two persons to be in a vehicle
438 transporting low-THC cannabis or medical cannabis, and require
439 at least one person to remain in the vehicle while the low-THC
440 cannabis or medical cannabis is being delivered.
441 5. Provide specific safety and security training to
442 employees transporting or delivering low-THC cannabis or medical
443 cannabis.
444 (7) DEPARTMENT AUTHORITY AND RESPONSIBILITIES.—
445 (a) The department may conduct announced or unannounced
446 inspections of dispensing organizations to determine compliance
447 with this section or rules adopted pursuant to this section.
448 (b) The department shall inspect a dispensing organization
449 upon complaint or notice provided to the department that the
450 dispensing organization has dispensed low-THC cannabis or
451 medical cannabis containing any mold, bacteria, or other
452 contaminant that may cause or has caused an adverse effect to
453 human health or the environment.
454 (c) The department shall conduct at least a biennial
455 inspection of each dispensing organization to evaluate the
456 dispensing organization’s records, personnel, equipment,
457 processes, security measures, sanitation practices, and quality
458 assurance practices.
459 (d) The department may enter into interagency agreements
460 with the Department of Agriculture and Consumer Services, the
461 Department of Business and Professional Regulation, the
462 Department of Transportation, the Department of Highway Safety
463 and Motor Vehicles, and the Agency for Health Care
464 Administration, and such agencies are authorized to enter into
465 an interagency agreement with the department, to conduct
466 inspections or perform other responsibilities assigned to the
467 department under this section.
468 (e) The department must make a list of all approved
469 dispensing organizations and qualified ordering physicians and
470 medical directors publicly available on its website.
471 (f) The department may establish a system for issuing and
472 renewing registration cards for patients and their legal
473 representatives, establish the circumstances under which the
474 cards may be revoked by or must be returned to the department,
475 and establish fees to implement such system. The department must
476 require, at a minimum, the registration cards to:
477 1. Provide the name, address, and date of birth of the
478 patient or legal representative.
479 2. Have a full-face, passport-type, color photograph of the
480 patient or legal representative taken within the 90 days
481 immediately preceding registration.
482 3. Identify whether the cardholder is a patient or legal
483 representative.
484 4. List a unique numeric identifier for the patient or
485 legal representative that is matched to the identifier used for
486 such person in the department’s compassionate use registry.
487 5. Provide the expiration date, which shall be 1 year after
488 the date of the physician’s initial order of low-THC cannabis or
489 medical cannabis.
490 6. For the legal representative, provide the name and
491 unique numeric identifier of the patient that the legal
492 representative is assisting.
493 7. Be resistant to counterfeiting or tampering.
494 (g) The department may impose reasonable fines not to
495 exceed $10,000 on a dispensing organization for any of the
496 following violations:
497 1. Violating this section, s. 499.0295, or department rule.
498 2. Failing to maintain qualifications for approval.
499 3. Endangering the health, safety, or security of a
500 qualified patient.
501 4. Improperly disclosing personal and confidential
502 information of the qualified patient.
503 5. Attempting to procure dispensing organization approval
504 by bribery, fraudulent misrepresentation, or extortion.
505 6. Being convicted or found guilty of, or entering a plea
506 of guilty or nolo contendere to, regardless of adjudication, a
507 crime in any jurisdiction which directly relates to the business
508 of a dispensing organization.
509 7. Making or filing a report or record that the dispensing
510 organization knows to be false.
511 8. Willfully failing to maintain a record required by this
512 section or department rule.
513 9. Willfully impeding or obstructing an employee or agent
514 of the department in the furtherance of his or her official
515 duties.
516 10. Engaging in fraud or deceit, negligence, incompetence,
517 or misconduct in the business practices of a dispensing
518 organization.
519 11. Making misleading, deceptive, or fraudulent
520 representations in or related to the business practices of a
521 dispensing organization.
522 12. Having a license or the authority to engage in any
523 regulated profession, occupation, or business that is related to
524 the business practices of a dispensing organization suspended,
525 revoked, or otherwise acted against by the licensing authority
526 of any jurisdiction, including its agencies or subdivisions, for
527 a violation that would constitute a violation under Florida law.
528 13. Violating a lawful order of the department or an agency
529 of the state, or failing to comply with a lawfully issued
530 subpoena of the department or an agency of the state.
531 (h) The department may suspend, revoke, or refuse to renew
532 a dispensing organization’s approval if a dispensing
533 organization commits any of the violations in paragraph (g).
534 (i) The department shall renew the approval of a dispensing
535 organization biennially if the dispensing organization meets the
536 requirements of this section and pays the biennial renewal fee.
537 (j) The department may adopt rules necessary to implement
538 this section.
539 (8) PREEMPTION.—
540 (a) All matters regarding the regulation of the cultivation
541 and processing of medical cannabis or low-THC cannabis by
542 dispensing organizations are preempted to the state.
543 (b) A municipality may determine by ordinance the criteria
544 for the number and location of, and other permitting
545 requirements that do not conflict with state law or department
546 rule for, dispensing facilities of dispensing organizations
547 located within its municipal boundaries. A county may determine
548 by ordinance the criteria for the number, location, and other
549 permitting requirements that do not conflict with state law or
550 department rule for all dispensing facilities of dispensing
551 organizations located within the unincorporated areas of that
552 county.
553 (9)(7) EXCEPTIONS TO OTHER LAWS.—
554 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
555 any other provision of law, but subject to the requirements of
556 this section, a qualified patient and the qualified patient’s
557 legal representative may purchase and possess for the patient’s
558 medical use up to the amount of low-THC cannabis or medical
559 cannabis ordered for the patient, but not more than a 45-day
560 supply, and a cannabis delivery device ordered for the patient.
561 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
562 any other provision of law, but subject to the requirements of
563 this section, an approved dispensing organization and its
564 owners, managers, and employees may manufacture, possess, sell,
565 deliver, distribute, dispense, and lawfully dispose of
566 reasonable quantities, as established by department rule, of
567 low-THC cannabis, medical cannabis, or a cannabis delivery
568 device. For purposes of this subsection, the terms
569 “manufacture,” “possession,” “deliver,” “distribute,” and
570 “dispense” have the same meanings as provided in s. 893.02.
571 (c) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
572 any other provision of law, but subject to the requirements of
573 this section, an approved independent testing laboratory may
574 possess, test, transport, and lawfully dispose of low-THC
575 cannabis or medical cannabis as provided by department rule.
576 (d)(c) An approved dispensing organization and its owners,
577 managers, and employees are not subject to licensure or
578 regulation under chapter 465 or chapter 499 for manufacturing,
579 possessing, selling, delivering, distributing, dispensing, or
580 lawfully disposing of reasonable quantities, as established by
581 department rule, of low-THC cannabis, medical cannabis, or a
582 cannabis delivery device.
583 (e) An approved dispensing organization that continues to
584 meet the requirements for approval is presumed to be registered
585 with the department and to meet the regulations adopted by the
586 department or its successor agency for the purpose of dispensing
587 medical cannabis or low-THC cannabis under state law.
588 Additionally, the authority provided to a dispensing
589 organization in s. 499.0295 does not impair the approval of a
590 dispensing organization.
591 (f) This subsection does not preclude a person from being
592 prosecuted for a criminal offense related to impairment or
593 intoxication resulting from the medical use of low-THC cannabis
594 or medical cannabis or relieve a person from any requirement
595 under law to submit to a breath, blood, urine, or other test to
596 detect the presence of a controlled substance.
597 Section 2. Subsections (2) and (3) of section 499.0295,
598 Florida Statutes, are amended to read:
599 499.0295 Experimental treatments for terminal conditions.—
600 (2) As used in this section, the term:
601 (a) “Dispensing organization” means an organization
602 approved by the Department of Health under s. 381.986(5) to
603 cultivate, process, transport, and dispense low-THC cannabis,
604 medical cannabis, and cannabis delivery devices.
605 (b)(a) “Eligible patient” means a person who:
606 1. Has a terminal condition that is attested to by the
607 patient’s physician and confirmed by a second independent
608 evaluation by a board-certified physician in an appropriate
609 specialty for that condition;
610 2. Has considered all other treatment options for the
611 terminal condition currently approved by the United States Food
612 and Drug Administration;
613 3. Has given written informed consent for the use of an
614 investigational drug, biological product, or device; and
615 4. Has documentation from his or her treating physician
616 that the patient meets the requirements of this paragraph.
617 (c)(b) “Investigational drug, biological product, or
618 device” means:
619 1. A drug, biological product, or device that has
620 successfully completed phase 1 of a clinical trial but has not
621 been approved for general use by the United States Food and Drug
622 Administration and remains under investigation in a clinical
623 trial approved by the United States Food and Drug
624 Administration; or
625 2. Medical cannabis that is manufactured and sold by a
626 dispensing organization.
627 (d)(c) “Terminal condition” means a progressive disease or
628 medical or surgical condition that causes significant functional
629 impairment, is not considered by a treating physician to be
630 reversible even with the administration of available treatment
631 options currently approved by the United States Food and Drug
632 Administration, and, without the administration of life
633 sustaining procedures, will result in death within 1 year after
634 diagnosis if the condition runs its normal course.
635 (e)(d) “Written informed consent” means a document that is
636 signed by a patient, a parent of a minor patient, a court
637 appointed guardian for a patient, or a health care surrogate
638 designated by a patient and includes:
639 1. An explanation of the currently approved products and
640 treatments for the patient’s terminal condition.
641 2. An attestation that the patient concurs with his or her
642 physician in believing that all currently approved products and
643 treatments are unlikely to prolong the patient’s life.
644 3. Identification of the specific investigational drug,
645 biological product, or device that the patient is seeking to
646 use.
647 4. A realistic description of the most likely outcomes of
648 using the investigational drug, biological product, or device.
649 The description shall include the possibility that new,
650 unanticipated, different, or worse symptoms might result and
651 death could be hastened by the proposed treatment. The
652 description shall be based on the physician’s knowledge of the
653 proposed treatment for the patient’s terminal condition.
654 5. A statement that the patient’s health plan or third
655 party administrator and physician are not obligated to pay for
656 care or treatment consequent to the use of the investigational
657 drug, biological product, or device unless required to do so by
658 law or contract.
659 6. A statement that the patient’s eligibility for hospice
660 care may be withdrawn if the patient begins treatment with the
661 investigational drug, biological product, or device and that
662 hospice care may be reinstated if the treatment ends and the
663 patient meets hospice eligibility requirements.
664 7. A statement that the patient understands he or she is
665 liable for all expenses consequent to the use of the
666 investigational drug, biological product, or device and that
667 liability extends to the patient’s estate, unless a contract
668 between the patient and the manufacturer of the investigational
669 drug, biological product, or device states otherwise.
670 (3) Upon the request of an eligible patient, a manufacturer
671 may, or upon a physician’s order pursuant to s. 381.986, a
672 dispensing organization may:
673 (a) Make its investigational drug, biological product, or
674 device available under this section.
675 (b) Provide an investigational drug, biological product, or
676 device, or cannabis delivery device as defined in s. 381.986 to
677 an eligible patient without receiving compensation.
678 (c) Require an eligible patient to pay the costs of, or the
679 costs associated with, the manufacture of the investigational
680 drug, biological product, or device, or cannabis delivery device
681 as defined in s. 381.986.
682 Section 3. (1) Notwithstanding s. 381.986(5)(b), Florida
683 Statutes, a dispensing organization that receives notice from
684 the Department of Health that it is approved as a region’s
685 dispensing organization; posts a $5 million performance bond in
686 compliance with rule 64-4.002(5)(e), Florida Administrative
687 Code; meets the requirements of and requests cultivation
688 authorization pursuant to rule 64-4.005(2), Florida
689 Administrative Code; and expends at least $100,000 to fulfill
690 its legal obligations as a dispensing organization shall be
691 granted cultivation authorization by the Department of Health
692 and is authorized to operate as a dispensing organization for
693 the full term of its original approval and all subsequent
694 renewals pursuant to s. 381.986, Florida Statutes.
695 (2) An action taken before or after the effective date of
696 this section by the Division of Administrative Hearings, the
697 Department of Health, or a court of competent jurisdiction which
698 has the effect of approving, pursuant to s. 381.986(5)(b),
699 Florida Statutes, a dispensing organization that does not meet
700 the criteria of subsection (1) does not impair an authorization
701 granted pursuant to subsection (1) to a dispensing organization
702 meeting the criteria of subsection (1). During the operations of
703 any dispensing organization that meets the criteria of
704 subsection (1), the Department of Health may enforce rule 64
705 4.005, Florida Administrative Code, as filed on June 17, 2015.
706 Section 4. This act shall take effect upon becoming a law.
707
708 ================= T I T L E A M E N D M E N T ================
709 And the title is amended as follows:
710 Delete everything before the enacting clause
711 and insert:
712 A bill to be entitled
713 An act relating to the medical use of cannabis;
714 amending s. 381.986, F.S.; providing and revising
715 definitions; revising requirements for physicians
716 ordering low-THC cannabis; providing requirements for
717 physicians ordering medical cannabis; providing
718 penalties; providing that a physician who orders low
719 THC cannabis or medical cannabis and receives related
720 compensation from a dispensing organization is subject
721 to disciplinary action; revising requirements relating
722 to physician education; requiring the Department of
723 Health to include legal representative information in
724 its online compassionate use registry; revising
725 requirements for dispensing organizations; revising
726 duties and responsibilities of the department;
727 revising standards to be met and maintained by
728 dispensing organizations; authorizing an independent
729 testing laboratory and its employees to possess, test,
730 transport, and lawfully dispose of low-THC cannabis or
731 medical cannabis under certain circumstances;
732 exempting an approved dispensing organization and
733 related persons from the Florida Drug and Cosmetic
734 Act; providing applicability; amending s. 499.0295,
735 F.S.; defining the term “dispensing organization”;
736 revising the definition of the term “investigational
737 drug, biological product, or device”; authorizing
738 certain manufacturers to dispense cannabis delivery
739 devices; authorizing certain dispensing organizations
740 to provide low-THC cannabis, medical cannabis, and
741 cannabis delivery devices to eligible patients;
742 providing for dispensing organizations meeting
743 specified criteria to be granted authorization to
744 cultivate certain cannabis and operate as dispensing
745 organizations; providing applicability; providing an
746 effective date.