Bill Text: FL S0460 | 2016 | Regular Session | Comm Sub
Bill Title: Medical Use of Cannabis
Spectrum: Bipartisan Bill
Status: (Introduced - Dead) 2016-03-04 - Laid on Table, companion bill(s) passed, see CS for CS/CS/HB 307 and HB 1313 (Ch. 2016-123) [S0460 Detail]
Download: Florida-2016-S0460-Comm_Sub.html
Florida Senate - 2016 CS for SB 460
By the Committee on Rules; and Senators Bradley, Soto, Sobel,
and Hutson
595-04427D-16 2016460c1
1 A bill to be entitled
2 An act relating to the medical use of cannabis;
3 amending s. 381.986, F.S.; providing and revising
4 definitions; revising requirements for physicians
5 ordering low-THC cannabis, medical cannabis, or a
6 cannabis delivery device; revising the information a
7 physician must update on the registry; requiring a
8 physician to update the registry within a specified
9 timeframe; requiring a physician to obtain certain
10 written consent; providing that a physician commits a
11 misdemeanor of the first degree under certain
12 circumstances; providing that an eligible patient who
13 uses medical cannabis, and such patient’s legal
14 representative, who administers medical cannabis in
15 specified prohibited locations commits a misdemeanor
16 of the first degree; providing that a physician who
17 orders low-THC cannabis or medical cannabis and
18 receives related compensation from a dispensing
19 organization is subject to disciplinary action;
20 revising requirements relating to physician education;
21 providing that the appropriate board must require the
22 medical director of each dispensing organization to
23 hold a certain license; revising the information that
24 the Department of Health is required to include in its
25 online compassionate use registry; revising
26 performance bond requirements for certain dispensing
27 organizations; requiring the department to approve
28 three dispensing organizations, including specified
29 applicants, under certain circumstances; providing
30 requirements for the three dispensing organizations;
31 requiring the department to allow a dispensing
32 organization to make certain wholesale purchases from
33 or distributions to another dispensing organization;
34 revising standards to be met and maintained by
35 dispensing organizations; authorizing dispensing
36 organizations to use certain pesticides after
37 consultation with the Department of Agriculture and
38 Consumer Services; providing requirements for
39 dispensing organizations when they are growing and
40 processing low-THC cannabis or medical cannabis;
41 requiring dispensing organizations to inspect seeds
42 and growing plants for certain pests and perform
43 certain fumigation and treatment of plants; providing
44 that dispensing organizations may not dispense low-THC
45 cannabis and medical cannabis unless they meet certain
46 testing requirements; requiring dispensing
47 organizations to maintain certain records; requiring
48 dispensing organizations to contract with an
49 independent testing laboratory to perform certain
50 audits; providing packaging requirements for low-THC
51 and medical cannabis; requiring dispensing
52 organizations to retain certain samples for specified
53 purposes; providing delivery requirements for
54 dispensing organizations when dispensing low-THC
55 cannabis and medical cannabis; providing certain
56 safety and security requirements for dispensing
57 organizations; providing certain safety and security
58 requirements for the transport of low-THC cannabis and
59 medical cannabis; authorizing the department to
60 conduct certain inspections; providing inspection
61 requirements; authorizing the department to enter into
62 certain interagency agreements; requiring the
63 department to make certain information available on
64 its website; authorizing the department to establish a
65 system for issuing and renewing registration cards;
66 providing requirements for the registration cards;
67 authorizing the department to impose certain fines;
68 authorizing the department to suspend, revoke, or
69 refuse to renew a dispensing organization’s approval
70 under certain circumstances; requiring the department
71 to renew the dispensing organization biennially under
72 certain conditions; providing applicability;
73 authorizing an approved independent testing laboratory
74 to possess, test, transport, and lawfully dispose of
75 low-THC cannabis or medical cannabis by department
76 rule ; providing that a dispensing organization is
77 presumed to be registered with the department under
78 certain circumstances; providing that a person is not
79 exempt from prosecution for certain offenses and is
80 not relieved from certain requirements of law under
81 certain circumstances; amending s. 499.0295, F.S.;
82 revising definitions; authorizing certain
83 manufacturers to dispense cannabis delivery devices;
84 requiring the department to authorize certain
85 dispensing organizations or applicants to provide low
86 THC cannabis, medical cannabis, and cannabis delivery
87 devices to eligible patients; providing for dispensing
88 organizations or applicants meeting specified criteria
89 to be granted authorization to cultivate certain
90 cannabis and operate as dispensing organizations;
91 requiring the department to grant approval as a
92 dispensing organization to certain qualified
93 applicants by a specified date; authorizing two
94 dispensing organizations in the same region under
95 certain circumstances; authorizing the Department of
96 Health to enforce certain rules; providing
97 applicability; providing an effective date.
98
99 Be It Enacted by the Legislature of the State of Florida:
100
101 Section 1. Section 381.986, Florida Statutes, is amended to
102 read:
103 381.986 Compassionate use of low-THC and medical cannabis.—
104 (1) DEFINITIONS.—As used in this section, the term:
105 (a) “Cannabis delivery device” means an object used,
106 intended for use, or designed for use in preparing, storing,
107 ingesting, inhaling, or otherwise introducing low-THC cannabis
108 or medical cannabis into the human body.
109 (b)(a) “Dispensing organization” means an organization
110 approved by the department to cultivate, process, transport, and
111 dispense low-THC cannabis or medical cannabis pursuant to this
112 section.
113 (c) “Independent testing laboratory” means a laboratory,
114 including the managers, employees, or contractors of the
115 laboratory, which has no direct or indirect interest in a
116 dispensing organization.
117 (d) “Legal representative” means the qualified patient’s
118 parent, legal guardian acting pursuant to a court’s
119 authorization as required under s. 744.3215(4), health care
120 surrogate acting pursuant to the qualified patient’s written
121 consent or a court’s authorization as required under s. 765.113,
122 or an individual who is authorized under a power of attorney to
123 make health care decisions on behalf of the qualified patient.
124 (e)(b) “Low-THC cannabis” means a plant of the genus
125 Cannabis, the dried flowers of which contain 0.8 percent or less
126 of tetrahydrocannabinol and more than 10 percent of cannabidiol
127 weight for weight; the seeds thereof; the resin extracted from
128 any part of such plant; or any compound, manufacture, salt,
129 derivative, mixture, or preparation of such plant or its seeds
130 or resin that is dispensed only from a dispensing organization.
131 (f) “Medical cannabis” means all parts of any plant of the
132 genus Cannabis, whether growing or not; the seeds thereof; the
133 resin extracted from any part of the plant; and every compound,
134 manufacture, sale, derivative, mixture, or preparation of the
135 plant or its seeds or resin that is dispensed only from a
136 dispensing organization for medical use by an eligible patient
137 as defined in s. 499.0295.
138 (g)(c) “Medical use” means administration of the ordered
139 amount of low-THC cannabis or medical cannabis. The term does
140 not include the:
141 1. Possession, use, or administration of low-THC cannabis
142 or medical cannabis by smoking.
143 2. The term also does not include the Transfer of low-THC
144 cannabis or medical cannabis to a person other than the
145 qualified patient for whom it was ordered or the qualified
146 patient’s legal representative on behalf of the qualified
147 patient.
148 3. Use or administration of low-THC cannabis or medical
149 cannabis:
150 a. On any form of public transportation.
151 b. In any public place.
152 c. In a qualified patient’s place of employment, if
153 restricted by his or her employer.
154 d. In a state correctional institution as defined in s.
155 944.02 or a correctional institution as defined in s. 944.241.
156 e. On the grounds of a preschool, primary school, or
157 secondary school.
158 f. On a school bus or in a vehicle, aircraft, or motorboat.
159 (h)(d) “Qualified patient” means a resident of this state
160 who has been added to the compassionate use registry by a
161 physician licensed under chapter 458 or chapter 459 to receive
162 low-THC cannabis or medical cannabis from a dispensing
163 organization.
164 (i)(e) “Smoking” means burning or igniting a substance and
165 inhaling the smoke. Smoking does not include the use of a
166 vaporizer.
167 (2) PHYSICIAN ORDERING.—Effective January 1, 2015, A
168 physician is authorized to order licensed under chapter 458 or
169 chapter 459 who has examined and is treating a patient suffering
170 from cancer or a physical medical condition that chronically
171 produces symptoms of seizures or severe and persistent muscle
172 spasms may order for the patient’s medical use low-THC cannabis
173 to treat a qualified patient suffering from cancer or a physical
174 medical condition that chronically produces symptoms of seizures
175 or severe and persistent muscle spasms; order low-THC cannabis
176 such disease, disorder, or condition or to alleviate symptoms of
177 such disease, disorder, or condition, if no other satisfactory
178 alternative treatment options exist for the qualified that
179 patient; order medical cannabis to treat an eligible patient as
180 defined in s. 499.0295; or order a cannabis delivery device for
181 the medical use of low-THC cannabis or medical cannabis, only if
182 the physician and all of the following conditions apply:
183 (a) Holds an active, unrestricted license as a physician
184 under chapter 458 or an osteopathic physician under chapter 459;
185 (b) Has treated the patient for at least 3 months
186 immediately preceding the patient’s registration in the
187 compassionate use registry;
188 (c) Has successfully completed the course and examination
189 required under paragraph (4)(a);
190 (a) The patient is a permanent resident of this state.
191 (d)(b) Has determined The physician determines that the
192 risks of treating the patient with ordering low-THC cannabis or
193 medical cannabis are reasonable in light of the potential
194 benefit to the for that patient. If a patient is younger than 18
195 years of age, a second physician must concur with this
196 determination, and such determination must be documented in the
197 patient’s medical record;.
198 (e)(c) The physician Registers as the orderer of low-THC
199 cannabis or medical cannabis for the named patient on the
200 compassionate use registry maintained by the department and
201 updates the registry to reflect the contents of the order,
202 including the amount of low-THC cannabis or medical cannabis
203 that will provide the patient with not more than a 45-day supply
204 and a cannabis delivery device needed by the patient for the
205 medical use of low-THC cannabis or medical cannabis. The
206 physician must also update the registry within 7 days after any
207 change is made to the original order to reflect the change. The
208 physician shall deactivate the registration of the patient and
209 the patient’s legal representative patient’s registration when
210 treatment is discontinued;.
211 (f)(d) The physician Maintains a patient treatment plan
212 that includes the dose, route of administration, planned
213 duration, and monitoring of the patient’s symptoms and other
214 indicators of tolerance or reaction to the low-THC cannabis or
215 medical cannabis;.
216 (g)(e) The physician Submits the patient treatment plan
217 quarterly to the University of Florida College of Pharmacy for
218 research on the safety and efficacy of low-THC cannabis and
219 medical cannabis on patients;.
220 (h)(f) The physician Obtains the voluntary written informed
221 consent of the patient or the patient’s legal representative
222 guardian to treatment with low-THC cannabis after sufficiently
223 explaining the current state of knowledge in the medical
224 community of the effectiveness of treatment of the patient’s
225 condition with low-THC cannabis, the medically acceptable
226 alternatives, and the potential risks and side effects;
227 (i) Obtains written informed consent as defined in and
228 required under s. 499.0295, if the physician is ordering medical
229 cannabis for an eligible patient pursuant to that section; and
230 (j) Is not a medical director employed by a dispensing
231 organization.
232 (3) PENALTIES.—
233 (a) A physician commits a misdemeanor of the first degree,
234 punishable as provided in s. 775.082 or s. 775.083, if the
235 physician orders low-THC cannabis for a patient without a
236 reasonable belief that the patient is suffering from:
237 1. Cancer or a physical medical condition that chronically
238 produces symptoms of seizures or severe and persistent muscle
239 spasms that can be treated with low-THC cannabis; or
240 2. Symptoms of cancer or a physical medical condition that
241 chronically produces symptoms of seizures or severe and
242 persistent muscle spasms that can be alleviated with low-THC
243 cannabis.
244 (b) A physician commits a misdemeanor of the first degree,
245 punishable as provided in s. 775.082 or s. 775.083, if the
246 physician orders medical cannabis for a patient without a
247 reasonable belief that the patient has a terminal condition as
248 defined in s. 499.0295.
249 (c)(b) A Any person who fraudulently represents that he or
250 she has cancer, or a physical medical condition that chronically
251 produces symptoms of seizures or severe and persistent muscle
252 spasms, or a terminal condition to a physician for the purpose
253 of being ordered low-THC cannabis, medical cannabis, or a
254 cannabis delivery device by such physician commits a misdemeanor
255 of the first degree, punishable as provided in s. 775.082 or s.
256 775.083.
257 (d) An eligible patient as defined in s. 499.0295 who uses
258 medical cannabis, and such patient’s legal representative who
259 administers medical cannabis, in plain view of or in a place
260 open to the general public, on the grounds of a school, or in a
261 school bus, vehicle, aircraft, or motorboat, commits a
262 misdemeanor of the first degree, punishable as provided in s.
263 775.082 or s. 775.083.
264 (e) A physician who orders low-THC cannabis, medical
265 cannabis, or a cannabis delivery device and receives
266 compensation from a dispensing organization related to the
267 ordering of low-THC cannabis, medical cannabis, or a cannabis
268 delivery device is subject to disciplinary action under the
269 applicable practice act and s. 456.072(1)(n).
270 (4) PHYSICIAN EDUCATION.—
271 (a) Before ordering low-THC cannabis, medical cannabis, or
272 a cannabis delivery device for medical use by a patient in this
273 state, the appropriate board shall require the ordering
274 physician licensed under chapter 458 or chapter 459 to
275 successfully complete an 8-hour course and subsequent
276 examination offered by the Florida Medical Association or the
277 Florida Osteopathic Medical Association that encompasses the
278 clinical indications for the appropriate use of low-THC cannabis
279 and medical cannabis, the appropriate cannabis delivery devices
280 mechanisms, the contraindications for such use, and as well as
281 the relevant state and federal laws governing the ordering,
282 dispensing, and possessing of these substances and devices this
283 substance. The first course and examination shall be presented
284 by October 1, 2014, and shall be administered at least annually
285 thereafter. Successful completion of the course may be used by a
286 physician to satisfy 8 hours of the continuing medical education
287 requirements required by his or her respective board for
288 licensure renewal. This course may be offered in a distance
289 learning format.
290 (b) The appropriate board shall require the medical
291 director of each dispensing organization to hold an active,
292 unrestricted license as a physician under chapter 458 or as an
293 osteopathic physician under chapter 459 and approved under
294 subsection (5) to successfully complete a 2-hour course and
295 subsequent examination offered by the Florida Medical
296 Association or the Florida Osteopathic Medical Association that
297 encompasses appropriate safety procedures and knowledge of low
298 THC cannabis, medical cannabis, and cannabis delivery devices.
299 (c) Successful completion of the course and examination
300 specified in paragraph (a) is required for every physician who
301 orders low-THC cannabis, medical cannabis, or a cannabis
302 delivery device each time such physician renews his or her
303 license. In addition, successful completion of the course and
304 examination specified in paragraph (b) is required for the
305 medical director of each dispensing organization each time such
306 physician renews his or her license.
307 (d) A physician who fails to comply with this subsection
308 and who orders low-THC cannabis, medical cannabis, or a cannabis
309 delivery device may be subject to disciplinary action under the
310 applicable practice act and under s. 456.072(1)(k).
311 (5) DUTIES OF THE DEPARTMENT.—By January 1, 2015, The
312 department shall:
313 (a) Create and maintain a secure, electronic, and online
314 compassionate use registry for the registration of physicians,
315 and patients, and the legal representatives of patients as
316 provided under this section. The registry must be accessible to
317 law enforcement agencies and to a dispensing organization in
318 order to verify the authorization of a patient or a patient’s
319 legal representative to possess patient authorization for low
320 THC cannabis, medical cannabis, or a cannabis delivery device
321 and record the low-THC cannabis, medical cannabis, or cannabis
322 delivery device dispensed. The registry must prevent an active
323 registration of a patient by multiple physicians.
324 (b) Authorize the establishment of five dispensing
325 organizations to ensure reasonable statewide accessibility and
326 availability as necessary for patients registered in the
327 compassionate use registry and who are ordered low-THC cannabis,
328 medical cannabis, or a cannabis delivery device under this
329 section, one in each of the following regions: northwest
330 Florida, northeast Florida, central Florida, southeast Florida,
331 and southwest Florida. The department shall develop an
332 application form and impose an initial application and biennial
333 renewal fee that is sufficient to cover the costs of
334 administering this section. An applicant for approval as a
335 dispensing organization must be able to demonstrate:
336 1. The technical and technological ability to cultivate and
337 produce low-THC cannabis. The applicant must possess a valid
338 certificate of registration issued by the Department of
339 Agriculture and Consumer Services pursuant to s. 581.131 that is
340 issued for the cultivation of more than 400,000 plants, be
341 operated by a nurseryman as defined in s. 581.011, and have been
342 operated as a registered nursery in this state for at least 30
343 continuous years.
344 2. The ability to secure the premises, resources, and
345 personnel necessary to operate as a dispensing organization.
346 3. The ability to maintain accountability of all raw
347 materials, finished products, and any byproducts to prevent
348 diversion or unlawful access to or possession of these
349 substances.
350 4. An infrastructure reasonably located to dispense low-THC
351 cannabis to registered patients statewide or regionally as
352 determined by the department.
353 5. The financial ability to maintain operations for the
354 duration of the 2-year approval cycle, including the provision
355 of certified financials to the department. Upon approval, the
356 applicant must post a $5 million performance bond. However, upon
357 a dispensing organization’s serving at least 1,000 qualified
358 patients, the dispensing organization is only required to
359 maintain a $2 million performance bond.
360 6. That all owners and managers have been fingerprinted and
361 have successfully passed a level 2 background screening pursuant
362 to s. 435.04.
363 7. The employment of a medical director who is a physician
364 licensed under chapter 458 or chapter 459 to supervise the
365 activities of the dispensing organization.
366 (c) Upon the registration of 250,000 active qualified
367 patients in the compassionate use registry, approve three
368 dispensing organizations, including, but not limited to, an
369 applicant that is a recognized class member of Pigford v.
370 Glickman, 185 F.R.D. 82 (D.D.C. 1999) or In Re Black Farmers
371 Litig., 856 F. Supp. 2d 1 (D.D.C. 2011) and a member of the
372 Black Farmers and Agriculturalists Association, which must meet
373 the requirements of subparagraphs (b)2.-7. and demonstrate the
374 technical and technological ability to cultivate and produce
375 low-THC cannabis.
376 (d) Allow a dispensing organization to make a wholesale
377 purchase of low-THC cannabis or medical cannabis from, or a
378 distribution of low-THC cannabis or medical cannabis to, another
379 dispensing organization.
380 (e)(c) Monitor physician registration and ordering of low
381 THC cannabis, medical cannabis, or a cannabis delivery device
382 for ordering practices that could facilitate unlawful diversion
383 or misuse of low-THC cannabis, medical cannabis, or a cannabis
384 delivery device and take disciplinary action as indicated.
385 (d) Adopt rules necessary to implement this section.
386 (6) DISPENSING ORGANIZATION.—An approved dispensing
387 organization must, at all times, shall maintain compliance with
388 the criteria demonstrated for selection and approval as a
389 dispensing organization under subsection (5) and the criteria
390 required in this subsection at all times.
391 (a) When growing low-THC cannabis or medical cannabis, a
392 dispensing organization:
393 1. May use pesticides determined by the department, after
394 consultation with the Department of Agriculture and Consumer
395 Services, to be safely applied to plants intended for human
396 consumption, but may not use pesticides designated as
397 restricted-use pesticides pursuant to s. 487.042.
398 2. Must grow low-THC cannabis or medical cannabis within an
399 enclosed structure and in a room separate from any other plant.
400 3. Must inspect seeds and growing plants for plant pests
401 that endanger or threaten the horticultural and agricultural
402 interests of the state, notify the Department of Agriculture and
403 Consumer Services within 10 calendar days after a determination
404 that a plant is infested or infected by such plant pest, and
405 implement and maintain phytosanitary policies and procedures.
406 4. Must perform fumigation or treatment of plants, or the
407 removal and destruction of infested or infected plants, in
408 accordance with chapter 581 and any rules adopted thereunder.
409 (b) When processing low-THC cannabis or medical cannabis, a
410 dispensing organization must:
411 1. Process the low-THC cannabis or medical cannabis within
412 an enclosed structure and in a room separate from other plants
413 or products.
414 2. Test the processed low-THC cannabis and medical cannabis
415 before they are dispensed. Results must be verified and signed
416 by two dispensing organization employees. Before dispensing low
417 THC cannabis, the dispensing organization must determine that
418 the test results indicate that the low-THC cannabis meets the
419 definition of low-THC cannabis and, for medical cannabis and
420 low-THC cannabis, that all medical cannabis and low-THC cannabis
421 is safe for human consumption and free from contaminants that
422 are unsafe for human consumption. The dispensing organization
423 must retain records of all testing and samples of each
424 homogenous batch of cannabis and low-THC cannabis for at least 9
425 months. The dispensing organization must contract with an
426 independent testing laboratory to perform audits on the
427 dispensing organization’s standard operating procedures, testing
428 records, and samples and provide the results to the department
429 to confirm that the low-THC cannabis or medical cannabis meets
430 the requirements of this section and that the medical cannabis
431 and low-THC cannabis is safe for human consumption.
432 3. Package the low-THC cannabis or medical cannabis in
433 compliance with the United States Poison Prevention Packaging
434 Act of 1970, 15 U.S.C. ss. 1471 et seq.
435 4. Package the low-THC cannabis or medical cannabis in a
436 receptacle that has a firmly affixed and legible label stating
437 the following information:
438 a. A statement that the low-THC cannabis or medical
439 cannabis meets the requirements of subparagraph 2.;
440 b. The name of the dispensing organization from which the
441 medical cannabis or low-THC cannabis originates; and
442 c. The batch number and harvest number from which the
443 medical cannabis or low-THC cannabis originates.
444 5. Reserve two processed samples from each batch and retain
445 such samples for at least 9 months for the purpose of testing
446 pursuant to the audit required under subparagraph 2.
447 (c) When dispensing low-THC cannabis, medical cannabis, or
448 a cannabis delivery device, a dispensing organization:
449 1. May not dispense more than a 45-day supply of low-THC
450 cannabis or medical cannabis to a patient or the patient’s legal
451 representative.
452 2. Must have the dispensing organization’s employee who
453 dispenses the low-THC cannabis, medical cannabis, or a cannabis
454 delivery device enter into the compassionate use registry his or
455 her name or unique employee identifier.
456 3. Must verify in the compassionate use registry that a
457 physician has ordered the low-THC cannabis, medical cannabis, or
458 a specific type of a cannabis delivery device for the patient.
459 4. May not dispense or sell any other type of cannabis,
460 alcohol, or illicit drug-related product, including pipes,
461 bongs, or wrapping papers, other than a physician-ordered
462 cannabis delivery device required for the medical use of low-THC
463 cannabis or medical cannabis, while dispensing low-THC cannabis
464 or medical cannabis.
465 5. Must Before dispensing low-THC cannabis to a qualified
466 patient, the dispensing organization shall verify that the
467 patient has an active registration in the compassionate use
468 registry, the patient or patient’s legal representative holds a
469 valid and active registration card, the order presented matches
470 the order contents as recorded in the registry, and the order
471 has not already been filled.
472 6. Must, upon dispensing the low-THC cannabis, medical
473 cannabis, or cannabis delivery device, the dispensing
474 organization shall record in the registry the date, time,
475 quantity, and form of low-THC cannabis or medical cannabis
476 dispensed and the type of cannabis delivery device dispensed.
477 (d) To ensure the safety and security of its premises and
478 any off-site storage facilities, and to maintain adequate
479 controls against the diversion, theft, and loss of low-THC
480 cannabis, medical cannabis, or cannabis delivery devices, a
481 dispensing organization shall:
482 1.a. Maintain a fully operational security alarm system
483 that secures all entry points and perimeter windows and is
484 equipped with motion detectors; pressure switches; and duress,
485 panic, and hold-up alarms; or
486 b. Maintain a video surveillance system that records
487 continuously 24 hours each day and meets at least one of the
488 following criteria:
489 (I) Cameras are fixed in a place that allows for the clear
490 identification of persons and activities in controlled areas of
491 the premises. Controlled areas include grow rooms, processing
492 rooms, storage rooms, disposal rooms or areas, and point-of-sale
493 rooms;
494 (II) Cameras are fixed in entrances and exits to the
495 premises, which shall record from both indoor and outdoor, or
496 ingress and egress, vantage points;
497 (III) Recorded images must clearly and accurately display
498 the time and date; or
499 (IV) Retain video surveillance recordings for a minimum of
500 45 days or longer upon the request of a law enforcement agency.
501 2. Ensure that the organization’s outdoor premises have
502 sufficient lighting from dusk until dawn.
503 3. Establish and maintain a tracking system approved by the
504 department that traces the low-THC cannabis or medical cannabis
505 from seed to sale. The tracking system shall include
506 notification of key events as determined by the department,
507 including when cannabis seeds are planted, when cannabis plants
508 are harvested and destroyed, and when low-THC cannabis or
509 medical cannabis is transported, sold, stolen, diverted, or
510 lost.
511 4. Not dispense from its premises low-THC cannabis, medical
512 cannabis, or a cannabis delivery device between the hours of 9
513 p.m. and 7 a.m., but may perform all other operations and
514 deliver low-THC cannabis and medical cannabis to qualified
515 patients 24 hours each day.
516 5. Store low-THC cannabis or medical cannabis in a secured,
517 locked room or a vault.
518 6. Require at least two of its employees, or two employees
519 of a security agency with whom it contracts, to be on the
520 premises at all times.
521 7. Require each employee to wear a photo identification
522 badge at all times while on the premises.
523 8. Require each visitor to wear a visitor’s pass at all
524 times while on the premises.
525 9. Implement an alcohol and drug-free workplace policy.
526 10. Report to local law enforcement within 24 hours after
527 it is notified or becomes aware of the theft, diversion, or loss
528 of low-THC cannabis or medical cannabis.
529 (e) To ensure the safe transport of low-THC cannabis or
530 medical cannabis to dispensing organization facilities,
531 independent testing laboratories, or patients, the dispensing
532 organization must:
533 1. Maintain a transportation manifest, which must be
534 retained for at least 1 year.
535 2. Ensure only vehicles in good working order are used to
536 transport low-THC cannabis or medical cannabis.
537 3. Lock low-THC cannabis or medical cannabis in a separate
538 compartment or container within the vehicle.
539 4. Require at least two persons to be in a vehicle
540 transporting low-THC cannabis or medical cannabis, and require
541 at least one person to remain in the vehicle while the low-THC
542 cannabis or medical cannabis is being delivered.
543 5. Provide specific safety and security training to
544 employees transporting or delivering low-THC cannabis or medical
545 cannabis.
546 (7) DEPARTMENT AUTHORITY AND RESPONSIBILITIES.—
547 (a) The department may conduct announced or unannounced
548 inspections of dispensing organizations to determine compliance
549 with this section or rules adopted pursuant to this section.
550 (b) The department shall inspect a dispensing organization
551 upon complaint or notice provided to the department that the
552 dispensing organization has dispensed low-THC cannabis or
553 medical cannabis containing any mold, bacteria, or other
554 contaminant that may cause or has caused an adverse effect to
555 human health or the environment.
556 (c) The department shall conduct at least a biennial
557 inspection of each dispensing organization to evaluate the
558 dispensing organization’s records, personnel, equipment,
559 processes, security measures, sanitation practices, and quality
560 assurance practices.
561 (d) The department may enter into interagency agreements
562 with the Department of Agriculture and Consumer Services, the
563 Department of Business and Professional Regulation, the
564 Department of Transportation, the Department of Highway Safety
565 and Motor Vehicles, and the Agency for Health Care
566 Administration, and such agencies are authorized to enter into
567 an interagency agreement with the department, to conduct
568 inspections or perform other responsibilities assigned to the
569 department under this section.
570 (e) The department must make a list of all approved
571 dispensing organizations and qualified ordering physicians and
572 medical directors publicly available on its website.
573 (f) The department may establish a system for issuing and
574 renewing registration cards for patients and their legal
575 representatives, establish the circumstances under which the
576 cards may be revoked by or must be returned to the department,
577 and establish fees to implement such system. The department must
578 require, at a minimum, the registration cards to:
579 1. Provide the name, address, and date of birth of the
580 patient or legal representative.
581 2. Have a full-face, passport-type, color photograph of the
582 patient or legal representative taken within the 90 days
583 immediately preceding registration.
584 3. Identify whether the cardholder is a patient or legal
585 representative.
586 4. List a unique numeric identifier for the patient or
587 legal representative that is matched to the identifier used for
588 such person in the department’s compassionate use registry.
589 5. Provide the expiration date, which shall be 1 year after
590 the date of the physician’s initial order of low-THC cannabis or
591 medical cannabis.
592 6. For the legal representative, provide the name and
593 unique numeric identifier of the patient that the legal
594 representative is assisting.
595 7. Be resistant to counterfeiting or tampering.
596 (g) The department may impose reasonable fines not to
597 exceed $10,000 on a dispensing organization for any of the
598 following violations:
599 1. Violating this section, s. 499.0295, or department rule.
600 2. Failing to maintain qualifications for approval.
601 3. Endangering the health, safety, or security of a
602 qualified patient.
603 4. Improperly disclosing personal and confidential
604 information of the qualified patient.
605 5. Attempting to procure dispensing organization approval
606 by bribery, fraudulent misrepresentation, or extortion.
607 6. Being convicted or found guilty of, or entering a plea
608 of guilty or nolo contendere to, regardless of adjudication, a
609 crime in any jurisdiction which directly relates to the business
610 of a dispensing organization.
611 7. Making or filing a report or record that the dispensing
612 organization knows to be false.
613 8. Willfully failing to maintain a record required by this
614 section or department rule.
615 9. Willfully impeding or obstructing an employee or agent
616 of the department in the furtherance of his or her official
617 duties.
618 10. Engaging in fraud or deceit, negligence, incompetence,
619 or misconduct in the business practices of a dispensing
620 organization.
621 11. Making misleading, deceptive, or fraudulent
622 representations in or related to the business practices of a
623 dispensing organization.
624 12. Having a license or the authority to engage in any
625 regulated profession, occupation, or business that is related to
626 the business practices of a dispensing organization suspended,
627 revoked, or otherwise acted against by the licensing authority
628 of any jurisdiction, including its agencies or subdivisions, for
629 a violation that would constitute a violation under Florida law.
630 13. Violating a lawful order of the department or an agency
631 of the state, or failing to comply with a lawfully issued
632 subpoena of the department or an agency of the state.
633 (h) The department may suspend, revoke, or refuse to renew
634 a dispensing organization’s approval if a dispensing
635 organization commits any of the violations in paragraph (g).
636 (i) The department shall renew the approval of a dispensing
637 organization biennially if the dispensing organization meets the
638 requirements of this section and pays the biennial renewal fee.
639 (j) The department may adopt rules necessary to implement
640 this section.
641 (8) PREEMPTION.—
642 (a) All matters regarding the regulation of the cultivation
643 and processing of medical cannabis or low-THC cannabis by
644 dispensing organizations are preempted to the state.
645 (b) A municipality may determine by ordinance the criteria
646 for the number and location of, and other permitting
647 requirements that do not conflict with state law or department
648 rule for, dispensing facilities of dispensing organizations
649 located within its municipal boundaries. A county may determine
650 by ordinance the criteria for the number, location, and other
651 permitting requirements that do not conflict with state law or
652 department rule for all dispensing facilities of dispensing
653 organizations located within the unincorporated areas of that
654 county.
655 (9)(7) EXCEPTIONS TO OTHER LAWS.—
656 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
657 any other provision of law, but subject to the requirements of
658 this section, a qualified patient and the qualified patient’s
659 legal representative may purchase and possess for the patient’s
660 medical use up to the amount of low-THC cannabis or medical
661 cannabis ordered for the patient, but not more than a 45-day
662 supply, and a cannabis delivery device ordered for the patient.
663 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
664 any other provision of law, but subject to the requirements of
665 this section, an approved dispensing organization and its
666 owners, managers, and employees may manufacture, possess, sell,
667 deliver, distribute, dispense, and lawfully dispose of
668 reasonable quantities, as established by department rule, of
669 low-THC cannabis, medical cannabis, or a cannabis delivery
670 device. For purposes of this subsection, the terms
671 “manufacture,” “possession,” “deliver,” “distribute,” and
672 “dispense” have the same meanings as provided in s. 893.02.
673 (c) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
674 any other provision of law, but subject to the requirements of
675 this section, an approved independent testing laboratory may
676 possess, test, transport, and lawfully dispose of low-THC
677 cannabis or medical cannabis as provided by department rule.
678 (d)(c) An approved dispensing organization and its owners,
679 managers, and employees are not subject to licensure or
680 regulation under chapter 465 or chapter 499 for manufacturing,
681 possessing, selling, delivering, distributing, dispensing, or
682 lawfully disposing of reasonable quantities, as established by
683 department rule, of low-THC cannabis, medical cannabis, or a
684 cannabis delivery device.
685 (e) An approved dispensing organization that continues to
686 meet the requirements for approval is presumed to be registered
687 with the department and to meet the regulations adopted by the
688 department or its successor agency for the purpose of dispensing
689 medical cannabis or low-THC cannabis under Florida law.
690 Additionally, the authority provided to a dispensing
691 organization in s. 499.0295 does not impair the approval of a
692 dispensing organization.
693 (f) This subsection does not exempt a person from
694 prosecution for a criminal offense related to impairment or
695 intoxication resulting from the medical use of low-THC cannabis
696 or medical cannabis or relieve a person from any requirement
697 under law to submit to a breath, blood, urine, or other test to
698 detect the presence of a controlled substance.
699 Section 2. Subsections (2) and (3) of section 499.0295,
700 Florida Statutes, are amended to read:
701 499.0295 Experimental treatments for terminal conditions.—
702 (2) As used in this section, the term:
703 (a) “Dispensing organization” means an organization
704 approved by the Department of Health under s. 381.986(5) to
705 cultivate, process, transport, and dispense low-THC cannabis,
706 medical cannabis, and cannabis delivery devices.
707 (b)(a) “Eligible patient” means a person who:
708 1. Has a terminal condition that is attested to by the
709 patient’s physician and confirmed by a second independent
710 evaluation by a board-certified physician in an appropriate
711 specialty for that condition;
712 2. Has considered all other treatment options for the
713 terminal condition currently approved by the United States Food
714 and Drug Administration;
715 3. Has given written informed consent for the use of an
716 investigational drug, biological product, or device; and
717 4. Has documentation from his or her treating physician
718 that the patient meets the requirements of this paragraph.
719 (c)(b) “Investigational drug, biological product, or
720 device” means:
721 1. A drug, biological product, or device that has
722 successfully completed phase 1 of a clinical trial but has not
723 been approved for general use by the United States Food and Drug
724 Administration and remains under investigation in a clinical
725 trial approved by the United States Food and Drug
726 Administration; or
727 2. Medical cannabis that is manufactured and sold by a
728 dispensing organization.
729 (d)(c) “Terminal condition” means a progressive disease or
730 medical or surgical condition that causes significant functional
731 impairment, is not considered by a treating physician to be
732 reversible even with the administration of available treatment
733 options currently approved by the United States Food and Drug
734 Administration, and, without the administration of life
735 sustaining procedures, will result in death within 1 year after
736 diagnosis if the condition runs its normal course.
737 (e)(d) “Written informed consent” means a document that is
738 signed by a patient, a parent of a minor patient, a court
739 appointed guardian for a patient, or a health care surrogate
740 designated by a patient and includes:
741 1. An explanation of the currently approved products and
742 treatments for the patient’s terminal condition.
743 2. An attestation that the patient concurs with his or her
744 physician in believing that all currently approved products and
745 treatments are unlikely to prolong the patient’s life.
746 3. Identification of the specific investigational drug,
747 biological product, or device that the patient is seeking to
748 use.
749 4. A realistic description of the most likely outcomes of
750 using the investigational drug, biological product, or device.
751 The description shall include the possibility that new,
752 unanticipated, different, or worse symptoms might result and
753 death could be hastened by the proposed treatment. The
754 description shall be based on the physician’s knowledge of the
755 proposed treatment for the patient’s terminal condition.
756 5. A statement that the patient’s health plan or third
757 party administrator and physician are not obligated to pay for
758 care or treatment consequent to the use of the investigational
759 drug, biological product, or device unless required to do so by
760 law or contract.
761 6. A statement that the patient’s eligibility for hospice
762 care may be withdrawn if the patient begins treatment with the
763 investigational drug, biological product, or device and that
764 hospice care may be reinstated if the treatment ends and the
765 patient meets hospice eligibility requirements.
766 7. A statement that the patient understands he or she is
767 liable for all expenses consequent to the use of the
768 investigational drug, biological product, or device and that
769 liability extends to the patient’s estate, unless a contract
770 between the patient and the manufacturer of the investigational
771 drug, biological product, or device states otherwise.
772 (3) Upon the request of an eligible patient, a manufacturer
773 may, or upon a physician’s order pursuant to s. 381.986, a
774 dispensing organization may:
775 (a) Make its investigational drug, biological product, or
776 device available under this section.
777 (b) Provide an investigational drug, biological product, or
778 device, or cannabis delivery device as defined in s. 381.986 to
779 an eligible patient without receiving compensation.
780 (c) Require an eligible patient to pay the costs of, or the
781 costs associated with, the manufacture of the investigational
782 drug, biological product, or device, or cannabis delivery device
783 as defined in s. 381.986.
784 Section 3. (1) Notwithstanding s. 381.986(5)(b), Florida
785 Statutes, a dispensing organization that receives notice from
786 the Department of Health that it is approved as a region’s
787 dispensing organization, posts a $5 million performance bond in
788 compliance with rule 64-4.002(5)(e), Florida Administrative
789 Code, meets the requirements of and requests cultivation
790 authorization pursuant to rule 64-4.005(2), Florida
791 Administrative Code, and expends at least $100,000 to fulfill
792 its legal obligations as a dispensing organization; or any
793 applicant that received the highest aggregate score through the
794 department’s evaluation process, notwithstanding any prior
795 determination by the department that the applicant failed to
796 meet the requirements of s. 381.986, Florida Statutes, must be
797 granted cultivation authorization by the department and is
798 approved to operate as a dispensing organization for the full
799 term of its original approval and all subsequent renewals
800 pursuant to s. 381.986, Florida Statutes. Any applicant that
801 qualifies under this subsection which has not previously been
802 approved as a dispensing organization by the department must be
803 given approval as a dispensing organization by the department
804 within 10 days before the effective date of this act, and within
805 10 days after receiving such approval must comply with the bond
806 requirement in rule 64-4.002(5)(e), Florida Administrative Code,
807 and must comply with all other applicable requirements of rule
808 64-4, Florida Administrative Code.
809 (2) If an organization that does not meet the criteria of
810 subsection (1) receives a final determination from the Division
811 of Administrative Hearings, the Department of Health, or a court
812 of competent jurisdiction that it was entitled to be a
813 dispensing organization under s. 381.986, Florida Statutes, and
814 applicable rules, such organization and an organization that
815 meets the criteria of subsection (1) shall both be dispensing
816 organizations in the same region. During the operations of any
817 dispensing organization that meets the criteria in this section,
818 the Department of Health may enforce rule 64-4.005, Florida
819 Administrative Code, as filed on June 17, 2015.
820 (3) This section does not apply to s. 381.986 (5)(c),
821 Florida Statutes.
822 Section 4. This act shall take effect upon becoming a law.
