Florida Senate - 2017 SB 1666
By Senator Braynon
35-01039-17 20171666__
1 A bill to be entitled
2 An act relating to medical use of marijuana; amending
3 s. 381.986, F.S.; providing legislative intent;
4 defining, redefining, and deleting terms; authorizing
5 physicians to issue physician certifications to
6 specified patients for the provision of marijuana and
7 marijuana delivery devices; requiring physicians to
8 meet certain conditions to be authorized to issue and
9 make determinations in physician certifications;
10 requiring certain physicians to annually reexamine and
11 reassess patients and update patient information in
12 the compassionate use registry; providing requirements
13 for physician certification for patients who are non
14 Florida residents; providing that a prior order for
15 low-THC cannabis or medical cannabis issued is
16 considered a physician certification under certain
17 circumstances; providing requirements for such
18 certifications; revising criminal penalties; reducing
19 the number of hours of coursework required of
20 physicians who issue physician certifications;
21 providing that physicians who meet specified
22 requirements are grandfathered for the purpose of
23 specified education requirements; authorizing
24 qualifying patients over the age of 21 to designate or
25 remove caregivers; requiring caregivers to meet
26 specified requirements, including a 1-hour course on
27 the administration of marijuana; authorizing a
28 qualifying patient to designate only one caregiver at
29 any given time; providing exceptions; authorizing a
30 caregiver to assist only one qualifying patient at any
31 given time; providing exceptions; requiring the
32 Department of Health to register on the compassionate
33 use registry a caregiver and to issue him or her a
34 caregiver identification card if the caregiver meets
35 certain requirements; providing requirements for
36 assisting a qualifying patient who is under the age of
37 18; revising the list of entities that have access to
38 the compassionate use registry; requiring the
39 department to adopt rules by a specified date;
40 authorizing the department to charge a fee for
41 identification cards; requiring the department to
42 begin issuing identification cards to qualified
43 registrants by a specific date; providing requirements
44 for the identification cards; requiring the department
45 to register certain dispensing organizations as
46 medical marijuana treatment centers (MMTCs) by a
47 certain date; deleting provisions to conform to
48 changes made by the act; requiring the department to
49 register additional MMTCs in accordance with a
50 specified schedule; prohibiting an entity from being
51 issued more than one MMTC registration; requiring the
52 department to review the number of qualifying patients
53 every 6 months; limiting the number of MMTCs;
54 decreasing the required performance bond amount under
55 certain circumstances; requiring the department to
56 create a 30-minute educational program for qualifying
57 patients; revising the operational requirements for
58 MMTCs; authorizing the department to waive certain
59 requirements in the MMTC registration application
60 under specified circumstances; providing requirements
61 for MMTCs to grow, process, and dispense marijuana,
62 rather than requirements for dispensing organizations
63 to grow, process, and dispense low-THC cannabis or
64 medical cannabis; providing a contract option that
65 requires an independent testing laboratory to directly
66 test an MMTC’s marijuana final product; requiring that
67 marijuana receptacles be opaque, childproof, and
68 tamper-evident; reducing the time that samples are
69 required to be retained; requiring verification of
70 patient and caregiver identification cards, rather
71 than registration cards, and amount and type of
72 marijuana before dispensing; requiring compliance with
73 certain standards in the production and dispensing of
74 edibles or food products; requiring an MMTC to enter
75 additional information into the compassionate use
76 registry; providing requirements to ensure the safety
77 and security of premises and facilities of MMTCs,
78 rather than the safety and security of premises and
79 facilities of dispensing organizations; requiring an
80 MMTC to register all owners and employees with the
81 department; requiring an MMTC to present a floor plan
82 to the department; defining terms to provide criteria
83 on visitor access to MMTC areas; providing
84 requirements to ensure the safe and sanitary transport
85 of marijuana, rather than the safe transport of low
86 THC cannabis and medical cannabis; requiring a vehicle
87 transporting marijuana to be legally parked under
88 certain circumstances; revising the department’s
89 authority and responsibilities; requiring the
90 department to adopt rules relating to ownership
91 changes or changes in an owner’s investment interest;
92 conforming provisions to changes made by the act;
93 providing circumstances under which the department may
94 suspend, revoke, or refuse to renew an MMTC’s
95 registration; providing rulemaking authority;
96 authorizing an MMTC employee to administer marijuana
97 under certain circumstances; providing construction;
98 conforming provisions to changes made by the act;
99 providing that a physician who issues a physician
100 certification is immune to civil claims and claims for
101 medical malpractice under certain circumstances;
102 providing that a health insurance provider or a
103 governmental agency or authority is not required to
104 reimburse expenses related to the use of marijuana;
105 authorizing certain institutes or state universities
106 to possess, test, transport, or dispose of marijuana
107 for research purposes; prohibiting a person from
108 offering, advertising, or performing services, and
109 from owning, operating, and maintaining certain
110 facilities, without registration; providing penalties;
111 prohibiting the importation of marijuana; authorizing
112 the exportation of marijuana and products containing
113 marijuana under certain circumstances; providing
114 severability; amending ss. 381.987, 385.211, 499.0295,
115 and 1004.441, F.S.; conforming provisions to changes
116 made by the act; providing a directive to the Division
117 of Law Revision and Information; providing an
118 effective date.
119
120 Be It Enacted by the Legislature of the State of Florida:
121
122 Section 1. Section 381.986, Florida Statutes, is amended to
123 read:
124 381.986 Compassionate use of marijuana low-THC and medical
125 cannabis.—
126 (1) LEGISLATIVE INTENT.—
127 (a) It is the intent of the Legislature to implement s. 29,
128 Art. X of the State Constitution by creating a unified
129 regulatory structure within the framework of this section for
130 the acquisition, cultivation, possession, processing, transfer,
131 transportation, sale, distribution, or dispensing of marijuana,
132 products containing marijuana, related supplies, or educational
133 materials to qualifying patients or their caregivers.
134 (b) The Legislature intends that all rules adopted by the
135 Department of Health to implement this section be adopted
136 pursuant to s. 120.536(1) or s. 120.54. The Legislature intends
137 that the department use emergency rulemaking procedures pursuant
138 to s. 120.54(4) to adopt rules under this section if necessary
139 to meet any deadline for rulemaking established in s. 29, Art. X
140 of the State Constitution.
141 (c) Further, the Legislature intends that all registrations
142 for the purposes specified in paragraph (a) be issued solely in
143 accordance with the requirements of this section and all rules
144 adopted under this section.
145 (2) DEFINITIONS.—As used in this section, the term:
146 (a) “Caregiver” means a person who:
147 1. Is at least 21 years old unless he or she is a close
148 relative of the qualifying patient and the patient demonstrates
149 a need for assistance with the medical use of marijuana;
150 2. Has agreed in writing to assist the qualifying patient
151 with the qualifying patient’s medical use of marijuana; and
152 3. Does not receive compensation, other than actual
153 expenses incurred, for assisting the qualifying patient with the
154 medical use of marijuana unless the caregiver is acting pursuant
155 to employment in a licensed facility “Cannabis delivery device”
156 means an object used, intended for use, or designed for use in
157 preparing, storing, ingesting, inhaling, or otherwise
158 introducing low-THC cannabis or medical cannabis into the human
159 body.
160 (b) “Close relative” means a spouse, parent, sibling,
161 grandparent, child, or grandchild, whether related by whole or
162 half blood, by marriage, or by adoption.
163 (c)(b) “Debilitating medical condition” means cancer,
164 epilepsy, glaucoma, a positive status for human immunodeficiency
165 virus, acquired immune deficiency syndrome, posttraumatic stress
166 disorder, amyotrophic lateral sclerosis, Crohn’s disease,
167 Parkinson’s disease, multiple sclerosis, a physical medical
168 condition that chronically produces symptoms of seizures or
169 severe and persistent muscle spasms, a terminal condition, or
170 any other debilitating medical condition of the same kind or
171 class as, or comparable to, those conditions enumerated in this
172 paragraph and for which a physician believes that the use of
173 medical cannabis would likely outweigh the potential health
174 risks to a patient “Dispensing organization” means an
175 organization approved by the department to cultivate, process,
176 transport, and dispense low-THC cannabis or medical cannabis
177 pursuant to this section.
178 (d)(c) “Independent testing laboratory” means a laboratory,
179 including the managers, employees, or contractors of the
180 laboratory:,
181 1. Which has no direct or indirect interest in a medical
182 marijuana treatment center; and
183 2. In which no medical marijuana treatment center has any
184 direct or indirect interest dispensing organization.
185 (e)(d) “Legal representative” means the qualifying
186 qualified patient’s parent, legal guardian acting pursuant to a
187 court’s authorization as required under s. 744.3215(4), health
188 care surrogate acting pursuant to the qualifying qualified
189 patient’s written consent or a court’s authorization as required
190 under s. 765.113, or an individual who is authorized under a
191 power of attorney to make health care decisions on behalf of the
192 qualifying qualified patient.
193 (f)(e) “Low-THC cannabis” means a plant of the genus
194 Cannabis, the dried flowers of which contain 0.8 percent or less
195 of tetrahydrocannabinol and more than 10 percent of cannabidiol
196 weight for weight; the seeds thereof; the resin extracted from
197 any part of such plant; or any compound, manufacture, salt,
198 derivative, mixture, or preparation of such plant or its seeds
199 or resin that is dispensed only by a medical marijuana treatment
200 center from a dispensing organization.
201 (g)(f) “Marijuana” has the same meaning as provided in s.
202 29, Art. X of the State Constitution “Medical cannabis” means
203 all parts of any plant of the genus Cannabis, whether growing or
204 not; the seeds thereof; the resin extracted from any part of the
205 plant; and every compound, manufacture, sale, derivative,
206 mixture, or preparation of the plant or its seeds or resin that
207 is dispensed only from a dispensing organization for medical use
208 by an eligible patient as defined in s. 499.0295.
209 (h) “Marijuana delivery device” means an object used,
210 intended for use, or designed for use in preparing, storing,
211 ingesting, inhaling, or otherwise introducing marijuana or low
212 THC cannabis into the human body.
213 (i) “Medical marijuana treatment center” or “MMTC” has the
214 same meaning as provided in s. 29, Art. X of the State
215 Constitution.
216 (j)(g) “Medical use” has the same meaning as provided in s.
217 29, Art. X of the State Constitution means administration of the
218 ordered amount of low-THC cannabis or medical cannabis. The term
219 does not include the:
220 1. The possession, use, or administration of marijuana low
221 THC cannabis or medical cannabis by smoking. As used in this
222 subparagraph, the term “smoking” means burning or igniting a
223 substance and inhaling the smoke. Smoking does not include the
224 use of a vaporizer.
225 2. The possession, use, or administration of marijuana that
226 is not purchased or acquired from a medical marijuana treatment
227 center.
228 3. The transfer of marijuana low-THC cannabis or medical
229 cannabis to a person other than the qualifying qualified patient
230 for whom it was ordered or the qualifying qualified patient’s
231 caregiver legal representative on behalf of the qualifying
232 qualified patient.
233 4.3. The use or administration of marijuana low-THC
234 cannabis or medical cannabis:
235 a. On any form of public transportation.
236 b. In any public place.
237 c. In a qualifying qualified patient’s place of employment,
238 if restricted by his or her employer.
239 d. In a state correctional institution as defined in s.
240 944.02 or a correctional institution as defined in s. 944.241.
241 e. On the grounds of a preschool, primary school, or
242 secondary school.
243 f. On a school bus or in a vehicle, aircraft, or motorboat.
244 (k)(h) “Qualifying patient” has the same meaning as
245 provided in s. 29, Art. X of the State Constitution. The term
246 also includes eligible patients, as defined in s. 499.0295. A
247 patient is not a qualifying patient unless he or she is
248 registered with the department and has been issued a “Qualified
249 patient” means a resident of this state who has been added to
250 the compassionate use registry identification card by a
251 physician licensed under chapter 458 or chapter 459 to receive
252 low-THC cannabis or medical cannabis from a dispensing
253 organization.
254 (i) “Smoking” means burning or igniting a substance and
255 inhaling the smoke. Smoking does not include the use of a
256 vaporizer.
257 (3)(2) PHYSICIAN CERTIFICATION ORDERING.—A physician is
258 authorized to issue a physician certification for the provision
259 of marijuana and marijuana delivery devices order low-THC
260 cannabis to treat a qualified patient suffering from cancer or a
261 physical medical condition that chronically produces symptoms of
262 seizures or severe and persistent muscle spasms; order low-THC
263 cannabis to alleviate symptoms of such disease, disorder, or
264 condition, if no other satisfactory alternative treatment
265 options exist for the qualified patient; order medical cannabis
266 to treat a qualifying an eligible patient as defined in s.
267 499.0295; or order a cannabis delivery device for the medical
268 use of low-THC cannabis or medical cannabis, only if the
269 physician:
270 (a) Holds an active, unrestricted license as a physician
271 under chapter 458 or an osteopathic physician under chapter 459;
272 (b) Has treated the patient for at least 3 months
273 immediately preceding the patient’s registration in the
274 compassionate use registry;
275 (c) Has successfully completed the course and examination
276 required under paragraph (6)(a) (4)(a);
277 (c) Has conducted a physical examination and made a full
278 assessment of the medical history of the patient;
279 (d) Has determined that the medical use of marijuana would
280 likely outweigh the potential health risks of treating the
281 patient with low-THC cannabis or medical cannabis are reasonable
282 in light of the potential benefit to the patient. If a patient
283 is younger than 18 years of age, a second physician must concur
284 with this determination, and such determination must be
285 documented in the patient’s medical record;
286 (e) Registers as the patient’s physician orderer of low-THC
287 cannabis or medical cannabis for the named patient on the
288 compassionate use registry maintained by the department and
289 updates the registry to reflect the contents of the order,
290 including the amount of marijuana which low-THC cannabis or
291 medical cannabis that will provide the patient with not more
292 than a 90-day 45-day supply and any marijuana a cannabis
293 delivery device needed by the patient for the medical use of
294 marijuana low-THC cannabis or medical cannabis. A physician may
295 certify an amount greater than a 90-day supply of marijuana if
296 the physician has a reasonable belief that the patient will use
297 the additional marijuana in a medically appropriate way. The
298 physician must also update the registry within 7 days after any
299 change is made to the physician certification original order to
300 reflect the change. The physician shall deactivate the
301 registration of the patient and the patient’s legal
302 representative when the physician no longer recommends the
303 medical use of marijuana for the patient treatment is
304 discontinued;
305 (f) At least annually, recertifies the qualifying patient
306 pursuant to this subsection. The physician must require that a
307 non-Florida resident be physically present during the initial
308 exam and all followup exams. Before being issued a physician
309 certification, a qualifying patient who is a non-Florida
310 resident must:
311 1. Affirm that his or her stay in this state is for at
312 least 30 days;
313 2. Provide proof that he or she holds a state-issued
314 identification card or certification in another state with a
315 medical marijuana program; or
316 3. Elect to wait 2 weeks after the date of receiving a
317 physician certification to obtain marijuana. A non-Florida
318 resident who elects to wait under this subparagraph may not be
319 issued a physician certification for marijuana for more than 6
320 months; and
321 (g) Submits the patient treatment plan quarterly to the
322 University of Florida College of Pharmacy for research on the
323 safety and efficacy of low-THC cannabis and medical cannabis on
324 patients;
325 (h) Obtains the voluntary written informed consent of the
326 patient or the patient’s legal representative to treatment with
327 low-THC cannabis after sufficiently explaining the current state
328 of knowledge in the medical community of the effectiveness of
329 treatment of the patient’s condition with low-THC cannabis, the
330 medically acceptable alternatives, and the potential risks and
331 side effects;
332 (i) Obtains written informed consent as defined in and
333 required under s. 499.0295, if the physician is ordering medical
334 cannabis for an eligible patient pursuant to that section; and
335 (g)(j) Is not a medical director employed by an MMTC a
336 dispensing organization.
337 (4)(3) GRANDFATHERING.—An order for low-THC cannabis or
338 medical cannabis issued pursuant to former s. 381.986, Florida
339 Statutes 2016, and registered with the compassionate use
340 registry on or before the effective date of this act shall be
341 considered a physician certification issued pursuant to this
342 section. The details and expiration date of such certification
343 must be identical to the details and expiration date of the
344 order as logged in the compassionate use registry. Until the
345 department begins issuing compassionate use registry
346 identification cards, all patients with such orders shall be
347 considered qualifying patients, notwithstanding the requirement
348 that a qualifying patient have a compassionate use registry
349 identification card.
350 (5) PENALTIES.—
351 (a) A physician commits a misdemeanor of the first degree,
352 punishable as provided in s. 775.082 or s. 775.083, if the
353 physician issues a physician certification for marijuana to
354 orders low-THC cannabis for a patient without a reasonable
355 belief that the patient is suffering from a debilitating medical
356 condition:
357 1. Cancer or a physical medical condition that chronically
358 produces symptoms of seizures or severe and persistent muscle
359 spasms that can be treated with low-THC cannabis; or
360 2. Symptoms of cancer or a physical medical condition that
361 chronically produces symptoms of seizures or severe and
362 persistent muscle spasms that can be alleviated with low-THC
363 cannabis.
364 (b) A physician commits a misdemeanor of the first degree,
365 punishable as provided in s. 775.082 or s. 775.083, if the
366 physician orders medical cannabis for a patient without a
367 reasonable belief that the patient has a terminal condition as
368 defined in s. 499.0295.
369 (c) A person who fraudulently represents that he or she has
370 a debilitating cancer, a physical medical condition that
371 chronically produces symptoms of seizures or severe and
372 persistent muscle spasms, or a terminal condition to a physician
373 for the purpose of being issued a physician certification for
374 marijuana ordered low-THC cannabis, medical cannabis, or a
375 marijuana cannabis delivery device by such physician commits a
376 misdemeanor of the first degree, punishable as provided in s.
377 775.082 or s. 775.083.
378 (c)(d) A qualifying An eligible patient as defined in s.
379 499.0295 who uses marijuana medical cannabis, and such patient’s
380 caregiver legal representative who administers marijuana medical
381 cannabis, in plain view of or in a place open to the general
382 public, on the grounds of a place of education school, or in an
383 aircraft, a motorboat, a school bus, a train, or a vehicle,
384 aircraft, or motorboat, commits a misdemeanor of the first
385 degree, punishable as provided in s. 775.082 or s. 775.083.
386 (d) Except as provided in paragraph (c), a caregiver who
387 violates any provision of this section or applicable department
388 rule commits, upon the first offense, a misdemeanor of the
389 second degree, punishable as provided in s. 775.082 or s.
390 775.083, and, upon the second and subsequent offenses, a
391 misdemeanor of the first degree, punishable as provided in s.
392 775.082 or s. 775.083.
393 (e) A physician who issues a physician certification for
394 marijuana orders low-THC cannabis, medical cannabis, or a
395 marijuana cannabis delivery device and receives compensation
396 from an MMTC a dispensing organization related to issuing the
397 physician certification for marijuana the ordering of low-THC
398 cannabis, medical cannabis, or a marijuana cannabis delivery
399 device is subject to disciplinary action under the applicable
400 practice act and s. 456.072(1)(n).
401 (6)(4) PHYSICIAN EDUCATION.—
402 (a) Before a physician may issue a physician certification
403 pursuant to subsection (3) ordering low-THC cannabis, medical
404 cannabis, or a cannabis delivery device for medical use by a
405 patient in this state, the appropriate board shall require the
406 ordering physician to successfully complete a 4-hour an 8-hour
407 course and subsequent examination offered by the Florida Medical
408 Association or the Florida Osteopathic Medical Association which
409 that encompasses the clinical indications for the appropriate
410 use of marijuana low-THC cannabis and medical cannabis, the
411 appropriate marijuana cannabis delivery devices, the
412 contraindications for such use, and the relevant state and
413 federal laws governing the issuance of physician certifications,
414 as well as the ordering, dispensing, and possessing of these
415 substances and devices. The course and examination shall be
416 administered at least quarterly annually. Successful completion
417 of the course may be used by a physician to satisfy 4 hours 8
418 hours of the continuing medical education requirements required
419 by his or her respective board for licensure renewal. This
420 course may be offered in a distance learning format. A physician
421 who has completed a 4-hour course and subsequent examination
422 offered by the Florida Medical Association or the Florida
423 Osteopathic Medical Association which encompasses the clinical
424 indications for the appropriate use of marijuana and who is
425 registered in the compassionate use registry on the effective
426 date of this act is deemed to meet the requirements of this
427 paragraph.
428 (b) The appropriate board shall require the medical
429 director of each MMTC dispensing organization to hold an active,
430 unrestricted license as a physician under chapter 458 or as an
431 osteopathic physician under chapter 459 and successfully
432 complete a 2-hour course and subsequent examination offered by
433 the Florida Medical Association or the Florida Osteopathic
434 Medical Association which that encompasses appropriate safety
435 procedures and knowledge of marijuana low-THC cannabis, medical
436 cannabis, and marijuana cannabis delivery devices.
437 (c) Successful completion of the course and examination
438 specified in paragraph (a) is required for every physician who
439 orders low-THC cannabis, medical cannabis, or a cannabis
440 delivery device each time such physician renews his or her
441 license. In addition, successful completion of the course and
442 examination specified in paragraph (b) is required for the
443 medical director of each dispensing organization each time such
444 physician renews his or her license.
445 (d) A physician who fails to comply with this subsection
446 and who issues a physician certification for marijuana orders
447 low-THC cannabis, medical cannabis, or a marijuana cannabis
448 delivery device may be subject to disciplinary action under the
449 applicable practice act and under s. 456.072(1)(k).
450 (7) CAREGIVERS.—
451 (a) During the course of registration with the department
452 for inclusion on the compassionate use registry, or at any time
453 while registered, a qualifying patient over the age of 21 may
454 designate or remove an individual as his or her caregiver to
455 assist him or her with the medical use of marijuana. The
456 designated caregiver must pass a level 2 screening pursuant to
457 chapter 435 unless the patient is a close relative of the
458 caregiver and the patient demonstrates a need for assistance
459 with the medical use of marijuana. The department shall create a
460 1-hour course for caregivers and a subsequent examination that
461 encompass basic information on the procedure and administration
462 of marijuana. The department shall require the designated
463 caregiver to successfully complete the course and pass the
464 subsequent examination before registering an individual as a
465 caregiver.
466 (b) A qualifying patient may have only one designated
467 caregiver at any given time unless all of the qualifying
468 patient’s caregivers are his or her close relatives or legal
469 representatives.
470 (c) A caregiver may assist only one qualifying patient at
471 any given time unless:
472 1. All qualifying patients the caregiver is assisting are
473 close relatives of each other and the caregiver is the legal
474 representative of at least one of the patients; or
475 2. All qualifying patients the caregiver is assisting are
476 receiving hospice services, or are residents in the same
477 assisted living facility, nursing home, or other licensed
478 facility and have requested the assistance of that caregiver
479 with the medical use of marijuana; the caregiver is an employee
480 of the hospice or licensed facility; and the caregiver provides
481 personal care or services directly to clients of the hospice or
482 licensed facility as a part of his or her employment duties at
483 the hospice or licensed facility.
484 (d) The department must register a caregiver on the
485 compassionate use registry and issue him or her a caregiver
486 identification card if he or she:
487 1. Is designated by a qualifying patient, provides hospice
488 services to a qualifying patient, or is requested by a
489 qualifying patient in a licensed facility for assistance with
490 the medical use of marijuana; and
491 2. Meets all of the requirements of this subsection and
492 department rules.
493 (e) If a qualifying patient is under the age of 18, only a
494 parent, legal guardian, caregiver, or health care provider may
495 assist the patient in the purchasing and administering of
496 marijuana for medical use. A qualifying patient under the age of
497 18 may not purchase marijuana.
498 (8)(5) DUTIES OF THE DEPARTMENT.—The department shall:
499 (a) Create and maintain a secure, electronic, and online
500 compassionate use registry for the registration of physicians,
501 qualifying patients, and caregivers the legal representatives of
502 patients as provided under this section. The registry must be
503 accessible to:
504 1. Physicians licensed under chapter 458 or chapter 459, to
505 ensure proper care for patients requesting physician
506 certifications;
507 2. Practitioners licensed to prescribe prescription drugs,
508 to ensure proper care for patients before prescribing
509 medications that may interact with the medical use of marijuana;
510 3. Law enforcement agencies, only for the purpose of
511 verifying the authorization of a qualifying patient or a
512 qualifying patient’s caregiver to possess marijuana or a
513 marijuana delivery device; and
514 4. MMTCs, to a dispensing organization to verify the
515 authorization of a qualifying patient or a qualifying patient’s
516 caregiver legal representative to possess marijuana low-THC
517 cannabis, medical cannabis, or a marijuana cannabis delivery
518 device and to record the marijuana low-THC cannabis, medical
519 cannabis, or marijuana cannabis delivery device dispensed. The
520 registry must prevent an active registration of a qualifying
521 patient by multiple physicians.
522 (b) By July 3, 2017, adopt rules, pursuant to s. 120.536(1)
523 or s. 120.54, establishing procedures for the issuance, annual
524 renewal, suspension, and revocation of compassionate use
525 registry identification cards for qualifying patients and
526 caregivers who are residents of this state. The department may
527 use emergency rulemaking procedures pursuant to s. 120.54(4) to
528 adopt rules under this section as necessary to ensure that rules
529 are adopted on or before July 3, 2017. The department may charge
530 a reasonable fee associated with the issuance and renewal of
531 patient and caregiver identification cards. By October 3, 2017,
532 the department shall begin issuing identification cards to adult
533 patients who are residents of this state and who have a
534 physician certification that meets the requirements of
535 subsection (3); minor patients who are residents of this state
536 and who have a physician certification that meets the
537 requirements of subsection (3) and the written consent of a
538 parent or legal guardian; and caregivers registered pursuant to
539 subsection (7). Patient and caregiver identification cards must
540 be resistant to counterfeiting and tampering and must include at
541 least the following:
542 1. The name, address, and date of birth of the patient or
543 caregiver, as appropriate;
544 2. Designation of the cardholder as a patient or caregiver;
545 3. A unique numeric identifier for the patient or caregiver
546 which is matched to the identifier used for such person in the
547 department’s compassionate use registry. A caregiver’s numeric
548 identifier and file in the compassionate use registry must be
549 linked to the file of the patient or patients the caregiver is
550 assisting so that the caregiver’s status may be verified for
551 each patient individually;
552 4. The expiration date, which must be 1 year after the date
553 of issuance of the identification card or the date treatment
554 ends as provided in the patient’s physician certification,
555 whichever occurs first; and
556 5. For a caregiver who is assisting three or fewer
557 qualifying patients, the name and unique numeric identifier, or
558 the names and unique numeric identifiers, of the qualifying
559 patient, or the qualifying patients, that the caregiver is
560 assisting.
561 (c) Deem a dispensing organization approved under s. 2,
562 chapter 2014-157, Laws of Florida, or s. 3, chapter 2016-123,
563 Laws of Florida, before June 1, 2017, to meet the requirements
564 for approval as an MMTC under this section. The department shall
565 presume such dispensing organization to be registered with the
566 department as an MMTC and shall authorize such dispensing
567 organization to acquire, cultivate, possess, or process
568 marijuana or products containing marijuana, including developing
569 related products such as food, tinctures, aerosols, oils, or
570 ointments, for sale to qualifying patients and their caregivers;
571 or to transfer, transport, sell, distribute, or dispense
572 marijuana, products containing marijuana, related supplies, and
573 educational materials to qualifying patients or their
574 caregivers. If holding a valid certificate of registration by
575 the Department of Agriculture and Consumer Services pursuant to
576 s. 581.131 is not required for the renewal of the registration
577 approval, the Department of Health shall renew the approval of
578 such dispensing organization as an MMTC biennially upon payment
579 by the dispensing organization of the biennial renewal fee
580 Authorize the establishment of five dispensing organizations to
581 ensure reasonable statewide accessibility and availability as
582 necessary for patients registered in the compassionate use
583 registry and who are ordered low-THC cannabis, medical cannabis,
584 or a cannabis delivery device under this section, one in each of
585 the following regions: northwest Florida, northeast Florida,
586 central Florida, southeast Florida, and southwest Florida.
587 (d) Register 10 additional MMTCs before October 3, 2017,
588 including, but not limited to, 1 applicant per occurrence which
589 is a recognized class member of Pigford v. Glickman, 185 F.R.D.
590 82 (D.D.C. 1999), or In re Black Farmers Litig., 856 F. Supp. 2d
591 1 (D.D.C. 2011), and which is a member of the Black Farmers and
592 Agriculturalists Association. All applicants must meet the
593 requirements in this subsection and in subsection (9) and be an
594 entity registered to do business in this state for at least 5
595 consecutive years as of the date of the application. Upon the
596 registration of every additional 25,000 active qualified
597 patients in the compassionate use registry after January 1,
598 2018, the department shall register 4 additional MMTCs.
599 1. An entity may not be issued more than 1 registration.
600 2. The department shall review the number of qualifying
601 patients every 6 months.
602 3. The department may not register more than 1 MMTC for
603 every 10 pharmacies licensed in this state.
604 (e) The department shall Develop an application form for
605 registration as an MMTC and impose an initial application and
606 biennial renewal fee that is sufficient to cover the costs of
607 administering this section. To be registered as an MMTC, the An
608 applicant for approval as a dispensing organization must be able
609 to demonstrate:
610 1. The technical and technological ability to cultivate and
611 produce marijuana low-THC cannabis. The applicant must possess a
612 valid certificate of registration issued by the Department of
613 Agriculture and Consumer Services pursuant to s. 581.131 that is
614 issued for the cultivation of more than 400,000 plants, be
615 operated by a nurseryman as defined in s. 581.011, and have been
616 operated as a registered nursery in this state for at least 30
617 continuous years.
618 2. The ability to secure the premises, resources, and
619 personnel necessary to operate as an MMTC a dispensing
620 organization.
621 3. The ability to maintain accountability of all raw
622 materials, finished products, and any byproducts to prevent
623 diversion or unlawful access to or possession of these
624 substances.
625 4. An infrastructure reasonably located to dispense
626 marijuana low-THC cannabis to registered qualifying patients
627 statewide or regionally as determined by the department.
628 5. The financial ability to maintain operations for the
629 duration of the 2-year approval cycle, including the provision
630 of certified financials to the department. Upon approval, the
631 applicant must post a $5 million performance bond. However, upon
632 an MMTC’s a dispensing organization’s serving at least 1,000
633 qualifying qualified patients, the dispensing organization is
634 only required to maintain only a $1 $2 million performance bond,
635 to apply retroactively to all registrations.
636 6. That all owners with a 5 percent or greater share and
637 all managers have been fingerprinted and have successfully
638 passed a level 2 background screening pursuant to s. 435.04.
639 7. The employment of a medical director to supervise the
640 activities of the MMTC dispensing organization.
641 (c) Upon the registration of 250,000 active qualified
642 patients in the compassionate use registry, approve three
643 dispensing organizations, including, but not limited to, an
644 applicant that is a recognized class member of Pigford v.
645 Glickman, 185 F.R.D. 82 (D.D.C. 1999), or In Re Black Farmers
646 Litig., 856 F. Supp. 2d 1 (D.D.C. 2011), and a member of the
647 Black Farmers and Agriculturalists Association, which must meet
648 the requirements of subparagraphs (b)2.-7. and demonstrate the
649 technical and technological ability to cultivate and produce
650 low-THC cannabis.
651 (f)(d) Allow an MMTC a dispensing organization to make a
652 wholesale purchase of marijuana low-THC cannabis or medical
653 cannabis from, or a distribution of marijuana low-THC cannabis
654 or medical cannabis to, another MMTC dispensing organization.
655 (g)(e) Monitor physician registration in the compassionate
656 use registry and the issuance of physician certifications
657 pursuant to subsection (3) and ordering of low-THC cannabis,
658 medical cannabis, or a cannabis delivery device for ordering
659 practices that could facilitate unlawful diversion or misuse of
660 marijuana low-THC cannabis, medical cannabis, or a marijuana
661 cannabis delivery device and take disciplinary action as
662 indicated.
663 (h) Create a 30-minute educational program for qualifying
664 patients on the responsible use of marijuana. The program must
665 address the safe consumption of edible marijuana products and
666 keeping the patient’s marijuana from children and unauthorized
667 users.
668 (9)(6) MEDICAL MARIJUANA TREATMENT CENTERS DISPENSING
669 ORGANIZATION.—In order to be an MMTC, an entity must register
670 with the department. An MMTC An approved dispensing organization
671 must, at all times, maintain compliance with the criteria
672 demonstrated for selection and approval as a dispensing
673 organization under subsection (5) and the criteria required in
674 this subsection and all representations made to the department
675 in the MMTC’s application for registration. Upon request, the
676 department may grant an MMTC one or more variances from the
677 representations made in the MMTC’s application. Consideration of
678 such a variance shall be based upon the facts and circumstances
679 surrounding the request. A variance may not be granted unless
680 the requesting MMTC can demonstrate to the department that it
681 has a proposed alternative to the specific representation made
682 in its application which fulfills the same or a similar purpose
683 as the specific representation in a way that the department can
684 reasonably determine will not be a lower standard than the
685 specific representation in the application. An MMTC is not
686 required to obtain a variance for deviations from the MMTC’s
687 application for registration which do not materially affect the
688 MMTC’s operations or the quality of the marijuana dispensed by
689 the MMTC or for deviations from the MMTC’s application which are
690 needed to conform to current statutes or rules.
691 (a) When growing marijuana low-THC cannabis or medical
692 cannabis, an MMTC a dispensing organization:
693 1. May use pesticides determined by the department, after
694 consultation with the Department of Agriculture and Consumer
695 Services, to be safely applied to plants intended for human
696 consumption, but may not use pesticides designated as
697 restricted-use pesticides pursuant to s. 487.042.
698 2. Must grow marijuana low-THC cannabis or medical cannabis
699 within an enclosed structure and in a room separate from any
700 other plant.
701 3. Must inspect seeds and growing plants for plant pests
702 that endanger or threaten the horticultural and agricultural
703 interests of the state, notify the Department of Agriculture and
704 Consumer Services within 10 calendar days after a determination
705 that a plant is infested or infected by such plant pest, and
706 implement and maintain phytosanitary policies and procedures.
707 4. Must perform fumigation or treatment of plants, or the
708 removal and destruction of infested or infected plants, in
709 accordance with chapter 581 and any rules adopted thereunder.
710 (b) When processing marijuana, an MMTC low-THC cannabis or
711 medical cannabis, a dispensing organization must:
712 1. Follow health and safety standards established by the
713 department. The department shall require the use of food grade
714 solvents, equipment, and procedures in the processing of
715 marijuana to ensure safe consumption.
716 2. Process the marijuana low-THC cannabis or medical
717 cannabis within an enclosed structure and in a room separate
718 from other plants or products.
719 3.2. Test the processed marijuana low-THC cannabis and
720 medical cannabis before it is they are dispensed. Results must
721 be verified and signed by two MMTC dispensing organization
722 employees. Before dispensing marijuana low-THC cannabis, the
723 MMTC dispensing organization must determine that the marijuana
724 test results indicate that the low-THC cannabis meets the
725 definition of low-THC cannabis and, for medical cannabis and
726 low-THC cannabis, that all medical cannabis and low-THC cannabis
727 is safe for human consumption and free from contaminants that
728 are unsafe for human consumption. The MMTC dispensing
729 organization must retain records of all testing and samples of
730 each homogenous batch of marijuana cannabis and low-THC cannabis
731 for at least 6 9 months. The MMTC dispensing organization must
732 contract with an independent testing laboratory to:
733 a. Perform audits on the MMTC’s dispensing organization’s
734 standard operating procedures, testing records, and samples and
735 provide the results to the department to confirm that the
736 marijuana low-THC cannabis or medical cannabis meets the
737 requirements of this section and that the marijuana medical
738 cannabis and low-THC cannabis is safe for human consumption; or
739 b. Directly test the marijuana final product to ensure that
740 it meets the requirements of this section and is safe for human
741 consumption before it is dispensed or distributed.
742 4.3. Directly package the marijuana low-THC cannabis or
743 medical cannabis in compliance with the United States Poison
744 Prevention Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.
745 5.4. Package the marijuana low-THC cannabis or medical
746 cannabis in an opaque, childproof, and tamper-evident a
747 receptacle that has a firmly affixed and legible label stating
748 the following information:
749 a. A statement that the marijuana low-THC cannabis or
750 medical cannabis meets the requirements of subparagraphs 1.,
751 subparagraph 2. and 3.;
752 b. The name of the MMTC dispensing organization from which
753 the marijuana medical cannabis or low-THC cannabis originates
754 and the MMTC’s registration number; and
755 c. The batch number and harvest number from which the
756 marijuana medical cannabis or low-THC cannabis originates;
757 d. A universal symbol indicating that marijuana is
758 contained in the package; and
759 e. Warning statements.
760 6.5. Reserve two processed samples from each batch and
761 retain such samples for at least 6 9 months for the purpose of
762 testing pursuant to the audit required under subparagraph 3. 2.
763 (c) When dispensing marijuana low-THC cannabis, medical
764 cannabis, or a marijuana cannabis delivery device, an MMTC a
765 dispensing organization:
766 1. May not dispense more than the a 45-day supply of
767 marijuana low-THC cannabis or medical cannabis to a qualifying
768 patient or the qualifying patient’s caregiver which is indicated
769 on the qualifying patient’s physician certification legal
770 representative.
771 2. Must ensure that have the dispensing organization’s
772 employee who dispenses the marijuana low-THC cannabis, medical
773 cannabis, or a marijuana cannabis delivery device enters enter
774 into the compassionate use registry his or her name or unique
775 employee identifier.
776 3. Must verify that the qualifying patient and the
777 caregiver, if applicable, both have an active and valid
778 compassionate use registry identification card and that the
779 amount and type of marijuana dispensed match the physician’s
780 certification in the compassionate use registry for that
781 qualifying patient that a physician has ordered the low-THC
782 cannabis, medical cannabis, or a specific type of a cannabis
783 delivery device for the patient.
784 4. May not dispense or sell any other type of cannabis,
785 alcohol, or illicit drug-related product, including pipes,
786 bongs, or wrapping papers, other than a physician-ordered
787 marijuana cannabis delivery device required for the medical use
788 of marijuana which is specified in the physician certification.
789 An MMTC may produce and dispense marijuana as an edible or food
790 product but may not produce such items in a format designed to
791 be attractive to children. In addition to the requirements of
792 this section and department rule, food products produced by an
793 MMTC must meet all food safety standards established in state
794 and federal law, including, but not limited to, the
795 identification of the serving size and the amount of
796 tetrahydrocannabinol in each serving low-THC cannabis or medical
797 cannabis, while dispensing low-THC cannabis or medical cannabis.
798 5. Must verify that the patient has an active registration
799 in the compassionate use registry, the patient or patient’s
800 legal representative holds a valid and active registration card,
801 the order presented matches the order contents as recorded in
802 the registry, and the order has not already been filled.
803 5.6. Must, upon dispensing the marijuana low-THC cannabis,
804 medical cannabis, or marijuana cannabis delivery device, record
805 in the registry the date, time, quantity, and form of marijuana
806 low-THC cannabis or medical cannabis dispensed; and the type of
807 marijuana cannabis delivery device dispensed; and the name and
808 compassionate use registry numeric identifier of the qualifying
809 patient or caregiver to whom the marijuana delivery device was
810 dispensed.
811 (d) To ensure the safety and security of its premises and
812 any off-site storage facilities, and to maintain adequate
813 controls against the diversion, theft, and loss of marijuana
814 low-THC cannabis, medical cannabis, or marijuana cannabis
815 delivery devices, an MMTC a dispensing organization shall:
816 1.a. Maintain a fully operational security alarm system
817 that secures all entry points and perimeter windows and is
818 equipped with motion detectors; pressure switches; and duress,
819 panic, and hold-up alarms; or
820 b. Maintain a video surveillance system that records
821 continuously 24 hours each day and meets at least one of the
822 following criteria:
823 (I) Cameras are fixed in a place that allows for the clear
824 identification of persons and activities in controlled areas of
825 the premises. Controlled areas include grow rooms, processing
826 rooms, storage rooms, disposal rooms or areas, and point-of-sale
827 rooms;
828 (II) Cameras are fixed in entrances and exits to the
829 premises, which shall record from both indoor and outdoor, or
830 ingress and egress, vantage points;
831 (III) Recorded images must clearly and accurately display
832 the time and date; or
833 (IV) Retain video surveillance recordings for a minimum of
834 45 days or longer upon the request of a law enforcement agency.
835 2. Ensure that the MMTC’s organization’s outdoor premises
836 have sufficient lighting from dusk until dawn.
837 3. Establish and maintain a tracking system approved by the
838 department which that traces the marijuana low-THC cannabis or
839 medical cannabis from seed to sale. The tracking system must
840 shall include notification of key events as determined by the
841 department, including when marijuana cannabis seeds are planted,
842 when marijuana cannabis plants are harvested and destroyed, and
843 when marijuana low-THC cannabis or medical cannabis is
844 transported, sold, stolen, diverted, or lost.
845 4. Not dispense from its premises marijuana low-THC
846 cannabis, medical cannabis, or a marijuana cannabis delivery
847 device between the hours of 9 p.m. and 7 a.m., but may perform
848 all other operations and deliver marijuana low-THC cannabis and
849 medical cannabis to qualifying qualified patients 24 hours each
850 day.
851 5. Store marijuana low-THC cannabis or medical cannabis in
852 a secured, locked room or a vault.
853 6. Require at least two of its employees, or two employees
854 of a security agency with whom it contracts, to be on the
855 premises of any cultivation or processing facilities at all
856 times.
857 7. Require each employee or contractor to wear a photo
858 identification badge at all times while on the premises.
859 8. Require each visitor to wear a visitor’s pass at all
860 times while on the premises.
861 9. Implement an alcohol and drug-free workplace policy.
862 10. Report to local law enforcement within 24 hours after
863 it is notified or becomes aware of the theft, diversion, or loss
864 of marijuana low-THC cannabis or medical cannabis.
865 11. Register all MMTC owners and employees with the
866 department.
867 12. Present a floor plan to the department which designates
868 each area of the facility as a “limited access area,”
869 “restricted access area,” or “general access area.” As used in
870 this subparagraph, the term:
871 a. “Limited access area” means the area within an MMTC
872 where marijuana is cultivated, processed, stored, packaged, and
873 sold to other MMTCs. This area is accessible only to employees
874 and visitors escorted by an employee.
875 b. “Restricted access area” means the area within an MMTC
876 where marijuana is sold to qualifying patients and caregivers.
877 This area is accessible only to employees, qualifying patients,
878 and caregivers and to visitors escorted by an employee.
879 Individuals admitted into a restricted access area must provide
880 a photo identification as required by the department.
881 c. “General access area” means the area within an MMTC
882 where marijuana is not grown, cultivated, processed, stored,
883 packaged, processed for sale, or sold. This area is accessible
884 to visitors.
885 (e) To ensure the safe and sanitary transport of marijuana
886 low-THC cannabis or medical cannabis to MMTC dispensing
887 organization facilities, independent testing laboratories, or
888 qualifying patients, the MMTC dispensing organization must:
889 1. Maintain a transportation manifest, which must be
890 retained for at least 1 year.
891 2. Ensure only vehicles in good working order are used to
892 transport marijuana low-THC cannabis or medical cannabis.
893 3. Lock marijuana low-THC cannabis or medical cannabis in a
894 separate compartment or container within the vehicle.
895 4. Require at least two persons to be in a vehicle
896 transporting marijuana low-THC cannabis or medical cannabis, and
897 require at least one person to remain in the vehicle while the
898 marijuana low-THC cannabis or medical cannabis is being
899 delivered.
900 5. Ensure that any vehicle transporting marijuana to a
901 qualifying patient or caregiver is legally parked while
902 marijuana is being delivered to the qualifying patient or
903 caregiver.
904 6.5. Provide specific safety and security training to
905 employees transporting or delivering marijuana low-THC cannabis
906 or medical cannabis.
907 (10)(7) DEPARTMENT AUTHORITY AND RESPONSIBILITIES.—
908 (a) The department may conduct announced or unannounced
909 inspections of MMTCs dispensing organizations to determine
910 compliance with this section or rules adopted pursuant to this
911 section.
912 (b) The department shall inspect an MMTC a dispensing
913 organization upon complaint or notice provided to the department
914 that the MMTC dispensing organization has dispensed marijuana
915 low-THC cannabis or medical cannabis containing any mold,
916 bacteria, or other contaminant at a level that may cause or has
917 caused an adverse effect to human health or the environment.
918 (c) The department shall conduct at least a biennial
919 inspection of each MMTC dispensing organization to evaluate the
920 MMTC’s dispensing organization’s records, personnel, equipment,
921 processes, security measures, sanitation practices, and quality
922 assurance practices.
923 (d) The department shall adopt by rule a process for
924 approving changes in MMTC ownership or a change in an MMTC
925 owner’s investment interest of 5 percent or more. This process
926 must include specific criteria for the approval or denial of an
927 application for change of ownership or a change in investment
928 interest and procedures for screening applicants’ criminal and
929 financial histories.
930 (e) The department may enter into interagency agreements
931 with the Department of Agriculture and Consumer Services, the
932 Department of Business and Professional Regulation, the
933 Department of Law Enforcement, the Department of Transportation,
934 the Department of Highway Safety and Motor Vehicles, and the
935 Agency for Health Care Administration, and such agencies are
936 authorized to enter into an interagency agreement with the
937 department, to conduct inspections or perform other
938 responsibilities assigned to the department under this section.
939 (f)(e) The department must make a list of all approved
940 MMTCs, dispensing organizations and qualified ordering
941 physicians who are qualified to issue physician certifications,
942 and medical directors of MMTCs publicly available on its
943 website.
944 (f) The department may establish a system for issuing and
945 renewing registration cards for patients and their legal
946 representatives, establish the circumstances under which the
947 cards may be revoked by or must be returned to the department,
948 and establish fees to implement such system. The department must
949 require, at a minimum, the registration cards to:
950 1. Provide the name, address, and date of birth of the
951 patient or legal representative.
952 2. Have a full-face, passport-type, color photograph of the
953 patient or legal representative taken within the 90 days
954 immediately preceding registration.
955 3. Identify whether the cardholder is a patient or legal
956 representative.
957 4. List a unique numeric identifier for the patient or
958 legal representative that is matched to the identifier used for
959 such person in the department’s compassionate use registry.
960 5. Provide the expiration date, which shall be 1 year after
961 the date of the physician’s initial order of low-THC cannabis or
962 medical cannabis.
963 6. For the legal representative, provide the name and
964 unique numeric identifier of the patient that the legal
965 representative is assisting.
966 7. Be resistant to counterfeiting or tampering.
967 (g) The department may impose reasonable fines not to
968 exceed $10,000 on an MMTC a dispensing organization for any of
969 the following violations:
970 1. Violating this section, s. 499.0295, or department rule.
971 2. Failing to maintain qualifications registration with the
972 department for approval.
973 3. Endangering the health, safety, or security of a
974 qualifying qualified patient.
975 4. Improperly disclosing personal and confidential
976 information of a qualifying the qualified patient.
977 5. Attempting to procure MMTC registration with the
978 department dispensing organization approval by bribery,
979 fraudulent misrepresentation, or extortion.
980 6. Any owner or manager of the MMTC being convicted or
981 found guilty of, or entering a plea of guilty or nolo contendere
982 to, regardless of adjudication, a crime in any jurisdiction
983 which directly relates to the business of an MMTC a dispensing
984 organization.
985 7. Making or filing a report or record that the MMTC
986 dispensing organization knows to be false.
987 8. Willfully failing to maintain a record required by this
988 section or department rule.
989 9. Willfully impeding or obstructing an employee or agent
990 of the department in the furtherance of his or her official
991 duties.
992 10. Engaging in fraud or deceit, negligence, incompetence,
993 or misconduct in the business practices of an MMTC a dispensing
994 organization.
995 11. Making misleading, deceptive, or fraudulent
996 representations in or related to the business practices of an
997 MMTC a dispensing organization.
998 12. Having a license or the authority to engage in any
999 regulated profession, occupation, or business that is related to
1000 the business practices of an MMTC a dispensing organization
1001 suspended, revoked, or otherwise acted against by the licensing
1002 authority of any jurisdiction, including its agencies or
1003 subdivisions, for a violation that would constitute a violation
1004 under Florida law.
1005 13. Violating a lawful order of the department or an agency
1006 of the state, or failing to comply with a lawfully issued
1007 subpoena of the department or an agency of the state.
1008 (h) The department may suspend, revoke, or refuse to renew
1009 an MMTC’s registration with the department a dispensing
1010 organization’s approval if the MMTC a dispensing organization
1011 commits repeated violations specified any of the violations in
1012 paragraph (g) which remain uncured after 30 days’ notice from
1013 the department. The department may not suspend, revoke, or
1014 refuse to renew an MMTC’s registration due to an uncured
1015 violation if the MMTC begins taking action to cure the violation
1016 within 30 days after receiving a notice of the violation from
1017 the department and such action is pursuant to a corrective
1018 action plan filed by the MMTC with the department or if the MMTC
1019 takes reasonable steps to ensure that a future violation of a
1020 similar nature does not occur.
1021 (i) The department shall renew an MMTC’s registration with
1022 the department the approval of a dispensing organization
1023 biennially if the MMTC dispensing organization meets the
1024 requirements of this section and pays the biennial renewal fee.
1025 (j) The department may adopt rules necessary to implement
1026 this section pursuant to s. 120.536(1) or s. 120.54. The
1027 department may use emergency rulemaking procedures pursuant to
1028 s. 120.54(4) to adopt rules under this section if necessary to
1029 meet any deadline for rulemaking established in s. 29, Art. X of
1030 the State Constitution.
1031 (k) The department may adopt rules authorizing an MMTC to
1032 have specified employees administer marijuana. Marijuana may be
1033 administered only at an MMTC that is registered with the
1034 department as an administration facility.
1035 (11)(8) PREEMPTION.—
1036 (a) All matters regarding the regulation of the cultivation
1037 and processing of marijuana medical cannabis or low-THC cannabis
1038 by MMTCs dispensing organizations are preempted to the state.
1039 (b) A municipality may determine by ordinance the criteria
1040 for the number and location of, and other permitting
1041 requirements that do not conflict with state law or department
1042 rule for, dispensing facilities of MMTCs dispensing
1043 organizations located within its municipal boundaries. A county
1044 may determine by ordinance the criteria for the number,
1045 location, and other permitting requirements that do not conflict
1046 with state law or department rule for all dispensing facilities
1047 of MMTCs dispensing organizations located within the
1048 unincorporated areas of that county. This section does not
1049 preempt any law or ordinance of any county or municipality which
1050 imposes restrictions on the location of an MMTC if the law or
1051 ordinance does not unreasonably interfere with the availability
1052 of marijuana to qualifying patients.
1053 (12)(9) EXCEPTIONS TO OTHER LAWS.—
1054 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
1055 any other provision of law, but subject to the requirements of
1056 this section, a qualifying qualified patient, or a caregiver who
1057 has obtained a valid compassionate use registry identification
1058 card from the department, and the qualified patient’s legal
1059 representative may purchase from an MMTC and possess for the
1060 qualifying patient’s medical use, up to the amount of marijuana
1061 in the physician certification low-THC cannabis or medical
1062 cannabis ordered for the patient, but not more than a 90-day 45
1063 day supply, except as provided in (3)(e), and a marijuana
1064 cannabis delivery device specified in the physician
1065 certification ordered for the qualifying patient.
1066 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
1067 any other provision of law, but subject to the requirements of
1068 this section, an MMTC an approved dispensing organization and
1069 its owners, managers, contractors, and employees may
1070 manufacture, possess, sell, deliver, distribute, dispense, and
1071 lawfully dispose of reasonable quantities, as established by
1072 department rule, of marijuana low-THC cannabis, medical
1073 cannabis, or a marijuana cannabis delivery device. As used in
1074 For purposes of this subsection, the terms “manufacture,”
1075 “possession,” “deliver,” “distribute,” and “dispense” have the
1076 same meanings as provided in s. 893.02.
1077 (c) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
1078 any other provision of law, but subject to the requirements of
1079 this section, an approved independent testing laboratory may
1080 possess, test, transport, and lawfully dispose of marijuana low
1081 THC cannabis or medical cannabis as provided by department rule.
1082 (d) An MMTC approved dispensing organization and its
1083 owners, managers, contractors, and employees are not subject to
1084 licensure or regulation under chapter 465 or chapter 499 for
1085 manufacturing, possessing, selling, delivering, distributing,
1086 dispensing, or lawfully disposing of reasonable quantities, as
1087 established by department rule, of marijuana low-THC cannabis,
1088 medical cannabis, or a marijuana cannabis delivery device.
1089 (e) Exercise by an MMTC of An approved dispensing
1090 organization that continues to meet the requirements for
1091 approval is presumed to be registered with the department and to
1092 meet the regulations adopted by the department or its successor
1093 agency for the purpose of dispensing medical cannabis or low-THC
1094 cannabis under Florida law. Additionally, the authority provided
1095 to a dispensing organization in s. 499.0295 does not impair its
1096 registration with the department the approval of a dispensing
1097 organization.
1098 (f) This subsection does not exempt a person from
1099 prosecution for a criminal offense related to impairment or
1100 intoxication resulting from the medical use of marijuana low-THC
1101 cannabis or medical cannabis or relieve a person from any
1102 requirement under law to submit to a breath, blood, urine, or
1103 other test to detect the presence of a controlled substance.
1104 (g) This section does not affect or repeal laws relating to
1105 negligence or professional malpractice on the part of a
1106 caregiver, a physician, or an MMTC or its agents and employees.
1107 However, a physician who issues a physician certification and
1108 who fully complies with the requirements of this section is
1109 immune from liability in civil actions and claims for medical
1110 malpractice.
1111 (h) This section does not require a health insurance
1112 provider or a governmental agency or authority to reimburse a
1113 person for expenses related to the use of marijuana.
1114 (i) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
1115 any other provision of law, but subject to the requirements of
1116 this section, a research institute established by a public
1117 postsecondary educational institution, such as the H. Lee
1118 Moffitt Cancer Center and Research Institute established in s.
1119 1004.43, or a state university that has achieved the preeminent
1120 state research university designation pursuant to s. 1001.7065,
1121 may possess, test, transport, and lawfully dispose of marijuana
1122 for research purposes as provided by department rule.
1123 (13) PROHIBITED ACTIVITIES.—
1124 (a) A person or entity may not offer or advertise services
1125 as an MMTC without registering as an MMTC with the department.
1126 An MMTC may not advertise or hold out to the public that it
1127 holds a registration for other than that for which it actually
1128 holds the registration.
1129 (b) The ownership, operation, or maintenance of an
1130 unauthorized dispensing organization or entity or the
1131 performance of a service that requires registration without
1132 proper registration is a violation of this section. The
1133 department or any state attorney may, in addition to other
1134 remedies provided in this section, bring an action for an
1135 injunction to restrain any unauthorized activity or to enjoin
1136 the future operation or maintenance of the unauthorized
1137 dispensing organization or entity or the performance of any
1138 service in violation of this section, until compliance with this
1139 section and department rules has been demonstrated to the
1140 satisfaction of the department.
1141 (c) If after receiving notification from the department,
1142 such person, organization, or entity fails to cease operation,
1143 the person, organization, or entity is subject to penalties as
1144 prescribed by this section. Each day of continued operation is a
1145 separate offense.
1146 (14) IMPORTATION AND EXPORTATION OF MARIJUANA.—
1147 (a) Marijuana may not be imported from outside this state.
1148 (b) Marijuana and products containing marijuana which are
1149 cultivated and produced in accordance with this section may be
1150 exported as authorized by federal law and the laws of the states
1151 or countries to which they are exported.
1152 (15) SEVERABILITY CLAUSE.—If any provision of this section
1153 or its application to any person or circumstance is held
1154 invalid, the invalidity does not affect other provisions or
1155 applications of this section which can be given effect without
1156 the invalid provision or application, and to this end the
1157 provisions of this section are severable.
1158 Section 2. Subsections (1) and (2) of section 381.987,
1159 Florida Statutes, are amended, and paragraphs (b) and (c) of
1160 subsection (3) of that section are amended, to read:
1161 381.987 Public records exemption for personal identifying
1162 information in the compassionate use registry.—
1163 (1) A patient’s personal identifying information held by
1164 the department in the compassionate use registry established
1165 under s. 381.986, including, but not limited to, the patient’s
1166 name, address, telephone number, and government-issued
1167 identification number, and all information pertaining to the
1168 physician certification physician’s order for marijuana low-THC
1169 cannabis and the dispensing thereof are confidential and exempt
1170 from s. 119.07(1) and s. 24(a), Art. I of the State
1171 Constitution.
1172 (2) A physician’s identifying information held by the
1173 department in the compassionate use registry established under
1174 s. 381.986, including, but not limited to, the physician’s name,
1175 address, telephone number, government-issued identification
1176 number, and Drug Enforcement Administration number, and all
1177 information pertaining to the physician certification
1178 physician’s order for marijuana low-THC cannabis and the
1179 dispensing thereof are confidential and exempt from s. 119.07(1)
1180 and s. 24(a), Art. I of the State Constitution.
1181 (3) The department shall allow access to the registry,
1182 including access to confidential and exempt information, to:
1183 (b) A medical marijuana treatment center dispensing
1184 organization approved by the department pursuant to s. 381.986
1185 which is attempting to verify the authenticity of a physician
1186 certification physician’s order for marijuana low-THC cannabis,
1187 including whether the physician certification order had been
1188 previously filled and whether the physician certification order
1189 was written for the person attempting to have it filled.
1190 (c) A physician who has issued a physician certification
1191 written an order for marijuana low-THC cannabis for the purpose
1192 of monitoring the patient’s use of such cannabis or for the
1193 purpose of determining, before issuing an order for marijuana
1194 low-THC cannabis, whether another physician has ordered the
1195 patient’s use of marijuana low-THC cannabis. The physician may
1196 access the confidential and exempt information only for the
1197 patient for whom he or she has ordered or is determining whether
1198 to order the use of marijuana low-THC cannabis pursuant to s.
1199 381.986.
1200 Section 3. Subsection (1) of section 385.211, Florida
1201 Statutes, is amended to read:
1202 385.211 Refractory and intractable epilepsy treatment and
1203 research at recognized medical centers.—
1204 (1) As used in this section, the term “low-THC cannabis”
1205 means “low-THC cannabis” as defined in s. 381.986 which that is
1206 dispensed only from a medical marijuana treatment center
1207 dispensing organization as defined in s. 381.986.
1208 Section 4. Subsections (2) and (3) of section 499.0295,
1209 Florida Statutes, are amended to read:
1210 499.0295 Experimental treatments for terminal conditions.—
1211 (2) As used in this section, the term:
1212 (a) “Dispensing organization” means an organization
1213 approved by the Department of Health under s. 381.986(5) to
1214 cultivate, process, transport, and dispense low-THC cannabis,
1215 medical cannabis, and cannabis delivery devices.
1216 (a)(b) “Eligible patient” means a person who:
1217 1. Has a terminal condition that is attested to by the
1218 patient’s physician and confirmed by a second independent
1219 evaluation by a board-certified physician in an appropriate
1220 specialty for that condition;
1221 2. Has considered all other treatment options for the
1222 terminal condition currently approved by the United States Food
1223 and Drug Administration;
1224 3. Has given written informed consent for the use of an
1225 investigational drug, biological product, or device; and
1226 4. Has documentation from his or her treating physician
1227 that the patient meets the requirements of this paragraph.
1228 (b)(c) “Investigational drug, biological product, or
1229 device” means:
1230 1. a drug, biological product, or device that has
1231 successfully completed phase 1 of a clinical trial but has not
1232 been approved for general use by the United States Food and Drug
1233 Administration and remains under investigation in a clinical
1234 trial approved by the United States Food and Drug
1235 Administration; or
1236 2. Medical cannabis that is manufactured and sold by a
1237 dispensing organization.
1238 (c)(d) “Terminal condition” means a progressive disease or
1239 medical or surgical condition that causes significant functional
1240 impairment, is not considered by a treating physician to be
1241 reversible even with the administration of available treatment
1242 options currently approved by the United States Food and Drug
1243 Administration, and, without the administration of life
1244 sustaining procedures, will result in death within 1 year after
1245 diagnosis if the condition runs its normal course.
1246 (d)(e) “Written informed consent” means a document that is
1247 signed by a patient, a parent of a minor patient, a court
1248 appointed guardian for a patient, or a health care surrogate
1249 designated by a patient and includes:
1250 1. An explanation of the currently approved products and
1251 treatments for the patient’s terminal condition.
1252 2. An attestation that the patient concurs with his or her
1253 physician in believing that all currently approved products and
1254 treatments are unlikely to prolong the patient’s life.
1255 3. Identification of the specific investigational drug,
1256 biological product, or device that the patient is seeking to
1257 use.
1258 4. A realistic description of the most likely outcomes of
1259 using the investigational drug, biological product, or device.
1260 The description shall include the possibility that new,
1261 unanticipated, different, or worse symptoms might result and
1262 death could be hastened by the proposed treatment. The
1263 description shall be based on the physician’s knowledge of the
1264 proposed treatment for the patient’s terminal condition.
1265 5. A statement that the patient’s health plan or third
1266 party administrator and physician are not obligated to pay for
1267 care or treatment consequent to the use of the investigational
1268 drug, biological product, or device unless required to do so by
1269 law or contract.
1270 6. A statement that the patient’s eligibility for hospice
1271 care may be withdrawn if the patient begins treatment with the
1272 investigational drug, biological product, or device and that
1273 hospice care may be reinstated if the treatment ends and the
1274 patient meets hospice eligibility requirements.
1275 7. A statement that the patient understands he or she is
1276 liable for all expenses consequent to the use of the
1277 investigational drug, biological product, or device and that
1278 liability extends to the patient’s estate, unless a contract
1279 between the patient and the manufacturer of the investigational
1280 drug, biological product, or device states otherwise.
1281 (3) Upon the request of an eligible patient, a manufacturer
1282 may, or, upon the issuance of a physician certification a
1283 physician’s order pursuant to s. 381.986, an MMTC a dispensing
1284 organization may:
1285 (a) Make its investigational drug, biological product, or
1286 device available under this section.
1287 (b) Provide an investigational drug, biological product,
1288 device, or cannabis delivery device as defined in s. 381.986 to
1289 an eligible patient without receiving compensation.
1290 (c) Require an eligible patient to pay the costs of, or the
1291 costs associated with, the manufacture of the investigational
1292 drug, biological product, device, or cannabis delivery device as
1293 defined in s. 381.986.
1294 Section 5. Subsection (1) of section 1004.441, Florida
1295 Statutes, is amended to read:
1296 1004.441 Refractory and intractable epilepsy treatment and
1297 research.—
1298 (1) As used in this section, the term “low-THC cannabis”
1299 means “low-THC cannabis” as defined in s. 381.986 which that is
1300 dispensed only from a medical marijuana treatment center
1301 dispensing organization as defined in s. 381.986.
1302 Section 6. The Division of Law Revision and Information is
1303 directed to replace the phrase “the effective date of this act”
1304 wherever it occurs in this act with the date the act becomes a
1305 law.
1306 Section 7. This act shall take effect upon becoming a law.