Florida Senate - 2017 PROPOSED COMMITTEE SUBSTITUTE
Bill No. CS for SB 406
Proposed Committee Substitute by the Committee on Appropriations
(Appropriations Subcommittee on Health and Human Services)
1 A bill to be entitled
2 An act relating to compassionate use of low-THC
3 cannabis and marijuana; amending s. 381.986, F.S.;
4 providing legislative intent; defining and redefining
5 terms; authorizing physicians to issue physician
6 certifications to specified patients who meet certain
7 conditions; authorizing physicians to make specific
8 determinations in certifications; requiring physicians
9 to meet certain conditions to be authorized to issue
10 and make determinations in physician certifications;
11 specifying certain persons who may assist a qualifying
12 patient under the age of 18 in the purchasing and
13 administering of marijuana; prohibiting qualifying
14 patients under the age of 18 from purchasing
15 marijuana; providing that a physician may in certain
16 circumstances certify an amount greater than a 90-day
17 supply; requiring written consent of a parent or legal
18 guardian for the treatment of minors; requiring that
19 certain physicians annually reexamine and reassess
20 patients and update patient information in the
21 compassionate use registry; revising criminal
22 penalties; prohibiting a medical marijuana treatment
23 center from advertising services it is not authorized
24 to provide; providing fines; prohibiting a person or
25 entity from advertising or providing medical marijuana
26 treatment center services without being registered
27 with the department as a medical marijuana treatment
28 center; providing penalties; authorizing a distance
29 learning format for a specified course and reducing
30 the number of hours required for the course; providing
31 that physicians who meet specified requirements are
32 grandfathered for the purpose of specified education
33 requirements; authorizing qualifying patients to
34 designate caregivers; requiring caregivers to meet
35 specified requirements; prohibiting a qualifying
36 patient from designating more than one caregiver at
37 any given time; providing exceptions; requiring the
38 Department of Health to register caregivers meeting
39 certain requirements on the compassionate use
40 registry; prohibiting a nursing home or assisted
41 living facility from preventing certain residents from
42 hiring a caregiver; authorizing a nursing home or
43 assisted living facility to prohibit its employees
44 from acting as caregivers to residents; providing that
45 a nursing home or assisted living facility is not
46 required to provide a caregiver to certain residents;
47 revising the entities to which the compassionate use
48 registry must be accessible; requiring the department
49 to adopt certain rules by a specified date;
50 authorizing the department to charge a fee for
51 identification cards; requiring the department to
52 begin issuing identification cards to qualified
53 registrants by a specific date; providing requirements
54 for the identification cards; requiring the department
55 to register certain dispensing organizations as
56 medical marijuana treatment centers by a certain date;
57 requiring the department to register additional
58 medical marijuana treatment centers in accordance with
59 a specified schedule; deleting obsolete provisions;
60 revising the operational requirements for medical
61 marijuana treatment centers; authorizing the
62 department to waive certain requirements under
63 specified circumstances; requiring that certain
64 receptacles be childproof; requiring that additional
65 information be included on certain labels; requiring
66 that a medical marijuana treatment center comply with
67 certain standards in the production and dispensing of
68 edible or food products; requiring a medical marijuana
69 treatment center to enter additional information into
70 the compassionate use registry; restricting the number
71 of dispensing facilities that may dispense marijuana;
72 providing an exception; requiring a medical marijuana
73 treatment center to keep a copy of a transportation
74 manifest in certain vehicles at certain times;
75 requiring the department to establish a quality
76 control program that requires medical marijuana
77 treatment centers to submit samples from each batch or
78 lot of marijuana to an independent testing laboratory;
79 requiring a medical marijuana treatment center to
80 maintain records of all tests conducted; requiring the
81 department to adopt rules to create and oversee the
82 quality control program; providing that the department
83 must license independent testing laboratories;
84 authorizing an independent testing laboratory to
85 collect and accept samples of, possess, store,
86 transport, and test marijuana; prohibiting a person
87 with an ownership interest in a medical marijuana
88 treatment center from owning an independent testing
89 laboratory; requiring the department to develop rules
90 and a process for licensing requirements; authorizing
91 the department to impose application and renewal fees;
92 specifying that an independent testing laboratory must
93 be certified to perform required tests; requiring the
94 department to suspend or reduce any mandatory testing
95 if the number of licensed and certified independent
96 testing laboratories is insufficient to process the
97 tests necessary to meet the patient demand for medical
98 marijuana treatment centers; providing that an
99 independent testing laboratory may only accept certain
100 samples; requiring the department to adopt rules
101 related to ownership changes or changes in an owner’s
102 investment interest; requiring the department to
103 establish, maintain, and control a seed-to-sale
104 tracking system for marijuana; providing
105 applicability; conforming provisions to changes made
106 by the act; providing that certain research
107 institutions may possess, test, transport, and dispose
108 of marijuana subject to certain conditions and as
109 provided by department rule; providing for the use of
110 emergency rulemaking procedures by the department;
111 creating s. 1004.4351, F.S.; providing a short title;
112 providing legislative findings; defining terms;
113 establishing the Coalition for Medical Marijuana
114 Research and Education within the H. Lee Moffitt
115 Cancer Center and Research Institute, Inc.; providing
116 a purpose for the coalition; establishing the Medical
117 Marijuana Research and Education Board to direct the
118 operations of the coalition; providing for the
119 appointment of board members; providing for terms of
120 office, reimbursement for certain expenses, and the
121 conduct of meetings of the board; authorizing the
122 board to appoint a coalition director; prescribing the
123 duties of the coalition director; requiring the board
124 to advise specified entities and officials regarding
125 medical marijuana research and education in this
126 state; requiring the board to annually adopt a Medical
127 Marijuana Research and Education Plan; providing
128 requirements for the plan; requiring the board to
129 issue an annual report to the Governor and the
130 Legislature by a specified date; specifying
131 responsibilities of the H. Lee Moffitt Cancer Center
132 and Research Institute, Inc.; amending ss. 381.987,
133 385.211, 499.0295, and 1004.441, F.S.; conforming
134 provisions to changes made by the act; providing a
135 directive to the Division of Law Revision and
136 Information; providing an effective date.
138 Be It Enacted by the Legislature of the State of Florida:
140 Section 1. Section 381.986, Florida Statutes, is amended to
142 381.986 Compassionate use of low-THC
and medical cannabis
143 and marijuana.—
144 (1) LEGISLATIVE INTENT.—
145 (a) It is the intent of the Legislature to implement s. 29,
146 Art. X of the State Constitution by creating a unified
147 regulatory structure within the framework of this section for
148 the acquisition, cultivation, possession, processing, transfer,
149 transportation, sale, distribution, and dispensing of marijuana,
150 products containing marijuana, related supplies, and educational
151 materials to qualifying patients or their caregivers.
152 (b) The Legislature intends that all rules adopted by the
153 Department of Health to implement this section be adopted
154 pursuant to s. 120.536(1) or s. 120.54. The Legislature intends
155 that the department use emergency rulemaking procedures pursuant
156 to s. 120.54(4) to adopt rules under this section if necessary
157 to meet any deadline for rulemaking established in s. 29, Art. X
158 of the State Constitution.
159 (c) Further, the Legislature intends that all registrations
160 for the purposes specified in paragraph (a) be issued solely in
161 accordance with the requirements of this section and all rules
162 adopted under this section.
163 (2) DEFINITIONS.—As used in this section, the term:
164 (a) “Cannabis delivery device” means an object used,
165 intended for use, or designed for use in preparing, storing,
166 ingesting, inhaling, or otherwise introducing marijuana low-THC
167 cannabis or medical cannabis into the human body.
168 (b) “Caregiver” has the same meaning as provided in s. 29,
169 Art. X of the State Constitution.
170 (c) “Chronic nonmalignant pain” means pain that is caused
171 by a debilitating medical condition or that originates from a
172 debilitating medical condition and persists beyond the usual
173 course of that debilitating medical condition.
174 (d) “Close relative” means a spouse, parent, sibling,
175 grandparent, child, or grandchild, whether related by whole or
176 half blood, by marriage, or by adoption.
177 (e) (b) “Debilitating medical condition” has the same
178 meaning as provided in s. 29, Art. X of the State Constitution
179 “ Dispensing organization ” means an organization approved by the
180 department to cultivate, process, transport, and dispense low
181 THC cannabis or medical cannabis pursuant to this section.
182 (f) (c) “Independent testing laboratory” means a laboratory,
183 including the managers, employees, or contractors of the
184 laboratory, which has no direct or indirect interest in a
185 medical marijuana treatment center a dispensing organization.
186 (g) (d) “Legal representative” means the qualifying
187 qualified patient’s parent, legal guardian acting pursuant to a
188 court’s authorization as required under s. 744.3215(4), health
189 care surrogate acting pursuant to the qualifying qualified
190 patient’s written consent or a court’s authorization as required
191 under s. 765.113, or an individual who is authorized under a
192 power of attorney to make health care decisions on behalf of the
193 qualifying qualified patient.
194 (h) (e) “Low-THC cannabis” means a plant of the genus
195 Cannabis, the dried flowers of which contain 0.8 percent or less
196 of tetrahydrocannabinol and more than 10 percent of cannabidiol
197 weight for weight; the seeds thereof; the resin extracted from
198 any part of such plant; or any compound, manufacture, salt,
199 derivative, mixture, or preparation of such plant or its seeds
200 or resin that is dispensed only by a medical marijuana treatment
201 center from a dispensing organization.
202 (i) (f) “Marijuana” has the same meaning as provided in s.
203 29, Art. X of the State Constitution “ Medical cannabis ” means
204 all parts of any plant of the genus Cannabis , whether growing or
205 not; the seeds thereof; the resin extracted from any part of the
206 plant; and every compound, manufacture, sale, derivative,
207 mixture, or preparation of the plant or its seeds or resin that
208 is dispensed only from a dispensing organization for medical use
209 by an eligible patient as defined in s. 499.0295.
210 (j) “Medical marijuana treatment center” or “MMTC” has the
211 same meaning as provided in s. 29, Art. X of the State
213 (k) (g) “Medical use” has the same meaning as provided in s.
214 29, Art. X of the State Constitution means administration of the
215 ordered amount of low-THC cannabis or medical cannabis. The term
216 does not include the:
217 1. Possession, use, or administration of marijuana low-THC
218 cannabis or medical cannabis by smoking.
219 2. Possession, use, or administration of marijuana that was
220 not purchased or acquired from an MMTC registered with the
221 Department of Health.
222 3. 2. Transfer of marijuana low-THC cannabis or medical
223 cannabis to a person other than the qualifying qualified patient
224 for whom it was ordered or the qualifying qualified patient’s
225 caregiver legal representative on behalf of the qualifying
226 qualified patient.
227 4. Use or administration of any type or amount of marijuana
228 not specified on the qualifying patient’s physician
230 5. 3. Use or administration of marijuana low-THC cannabis or
231 medical cannabis:
232 a. On any form of public transportation.
233 b. In any public place.
234 c. In a qualifying qualified patient’s place of employment,
235 if restricted by his or her employer.
236 d. In a state correctional institution as defined in s.
237 944.02 or a correctional institution as defined in s. 944.241.
238 e. On the grounds of a preschool, primary school, or
239 secondary school.
240 f. On a school bus or in a vehicle, aircraft, or motorboat.
241 (l) (h) “Qualifying Qualified patient” has the same meaning
242 as provided in s. 29, Art. X of the State Constitution but also
243 includes eligible patients, as that term is defined in s.
244 499.0295, and patients who are issued a physician certification
245 under subparagraph (3)(a)2. or subparagraph (3)(a)3. A patient
246 is not a qualifying patient unless he or she is registered with
247 the department and has been issued a compassionate use registry
248 identification card means a resident of this state who has been
249 added to the compassionate use registry by a physician licensed
250 under chapter 458 or chapter 459 to receive low-THC cannabis or
251 medical cannabis from a dispensing organization.
252 (m) (i) “Smoking” means burning or igniting a substance and
253 inhaling the smoke. Smoking does not include the use of a
255 (3) (2) PHYSICIAN CERTIFICATION ORDERING.—
256 (a) A physician is authorized to issue a physician
257 certification to:
258 1. A patient suffering from a debilitating medical
259 condition, which allows the patient to receive marijuana for the
260 patient’s medical use;
261 2. A order low-THC cannabis to treat a qualified patient
262 suffering from cancer or a physical medical condition that
263 chronically produces symptoms of seizures or severe and
264 persistent muscle spasms, which allows the patient to receive
265 low-THC cannabis for the patient’s medical use;
266 3. A patient suffering from chronic nonmalignant pain, if
267 the physician has diagnosed an underlying debilitating medical
268 condition as the cause of the pain, which allows the patient to
269 receive marijuana for the patient’s medical use order low-THC
270 cannabis to alleviate the patient’s pain symptoms of such
271 disease, disorder, or condition, if no other satisfactory
272 alternative treatment options exist for the qualified patient;
273 4. order medical cannabis to treat An eligible patient as
274 defined in s. 499.0295, which allows the patient to receive
275 marijuana for the patient’s medical use; or
276 5. A patient who is not a resident of this state; who
277 qualifies under subparagraph 1., subparagraph 2., subparagraph
278 3., or subparagraph 4.; and who can lawfully obtain marijuana
279 through a medical marijuana program in the state that he or she
280 resides in.
281 (b) In the physician certification, the physician may also
282 specify one or more or order a cannabis delivery devices to
283 assist with device for the patient’s medical use of marijuana.
284 low-THC cannabis or medical cannabis,
285 (c) A physician may certify a patient and specify a
286 delivery device under paragraphs (a) and (b) only if the
288 1. (a) Holds an active, unrestricted license as a physician
289 under chapter 458 or an osteopathic physician under chapter 459;
290 (b) Has treated the patient for at least 3 months
291 immediately preceding the patient’s registration in the
292 compassionate use registry;
293 2. (c) Has successfully completed the course and examination
294 required under paragraph (5)(a) (4)(a);
295 3. Has conducted a physical examination and made a full
296 assessment of the medical history of the patient;
297 4. Has determined that, in the physician’s professional
298 opinion, the patient meets one or more of the criteria specified
299 in paragraph (a);
300 5. (d) Has determined that the medical use of marijuana
301 would likely outweigh the potential health risks to of treating
302 the patient with low-THC cannabis or medical cannabis are
303 reasonable in light of the potential benefit to the patient. If
304 a patient is younger than 18 years of age: ,
305 a. A second physician must concur with this determination,
306 and such determination must be documented in the patient’s
307 medical record;
308 b. Only a parent, legal guardian, caregiver, or health care
309 provider may assist the qualifying patient in the purchasing and
310 administering of marijuana for medical use; and
311 c. The qualifying patient may not purchase marijuana;
312 6. (e) Registers as the patient’s physician orderer of low
313 THC cannabis or medical cannabis for the named patient on the
314 compassionate use registry maintained by the department and
315 updates the registry to reflect the contents of the order,
316 including the amount of marijuana low-THC cannabis or medical
317 cannabis that will provide the patient with not more than a 90
318 day 45-day supply and a cannabis delivery device needed by the
319 patient for the medical use of marijuana low-THC cannabis or
320 medical cannabis. A physician may certify an amount greater than
321 a 90-day supply of marijuana if the physician has a reasonable
322 belief that the patient will use the additional marijuana in a
323 medically appropriate way. If the physician’s recommended amount
324 of marijuana for a 90-day supply changes, the physician must
325 also update the registry within 7 days after the any change is
326 made to the original order to reflect the change. The physician
327 shall deactivate the registration of the patient and the
328 patient’s legal representative when the physician no longer
329 recommends the medical use of marijuana for the patient
330 treatment is discontinued;
331 7. (f) Maintains a patient treatment plan that includes the
332 dose, route of administration, planned duration, and monitoring
333 of the patient’s symptoms and other indicators of tolerance or
334 reaction to the marijuana low-THC cannabis or medical cannabis;
335 8. (g) Submits the patient treatment plan quarterly to the
336 University of Florida College of Pharmacy for research on the
337 safety and efficacy of marijuana low-THC cannabis and medical
338 cannabis on patients; and
339 9. (h) Obtains the voluntary written informed consent of the
340 patient or the patient’s legal representative to treatment with
341 marijuana low-THC cannabis after sufficiently explaining the
342 current state of knowledge in the medical community of the
343 effectiveness of treatment of the patient’s condition with
344 marijuana low-THC cannabis , the medically acceptable
345 alternatives, and the potential risks and side effects. If the
346 patient is a minor, the patient’s parent or legal guardian must
347 consent to treatment in writing. If the patient is an eligible
348 patient as defined in s. 499.0295, the physician must obtain
349 written informed consent as defined in and required by s.
350 499.0295. ;
351 (d) At least annually, a physician must recertify the
352 qualifying patient pursuant to paragraph (c).
353 (i) Obtains written informed consent as defined in and
354 required under s. 499.0295, if the physician is ordering medical
355 cannabis for an eligible patient pursuant to that section; and
356 (e) (j) A physician may not issue a physician certification
357 if the physician is not a medical director employed by an MMTC a
358 dispensing organization.
359 (f) An order for low-THC cannabis or medical cannabis
360 issued pursuant to former s. 381.986, Florida Statutes 2016, and
361 registered with the compassionate use registry on the effective
362 date of this act, shall be considered a physician certification
363 issued pursuant to this subsection. The details and expiration
364 date of such certification must be identical to the details and
365 expiration date of the order as logged in the compassionate use
366 registry. Until the department begins issuing compassionate use
367 registry identification cards, all patients with such orders
368 shall be considered qualifying patients, notwithstanding the
369 requirement that a qualifying patient have a compassionate use
370 registry identification card.
371 (4) (3) PROHIBITED ACTS PENALTIES.—
372 (a) A physician commits a misdemeanor of the first degree,
373 punishable as provided in s. 775.082 or s. 775.083, if the
374 physician issues a physician certification for marijuana to
375 orders low-THC cannabis for a patient in a manner other than as
376 required in subsection (3) without a reasonable belief that the
377 patient is suffering from:
378 1. Cancer or A physical medical condition that chronically
379 produces symptoms of seizures or severe and persistent muscle
380 spasms that can be treated with low-THC cannabis; or
381 2. Symptoms of cancer or a physical medical condition that
382 chronically produces symptoms of seizures or severe and
383 persistent muscle spasms that can be alleviated with low-THC
385 (b) A physician commits a misdemeanor of the first degree,
386 punishable as provided in s. 775.082 or s. 775.083, if the
387 physician orders medical cannabis for a patient without a
388 reasonable belief that the patient has a terminal condition as
389 defined in s. 499.0295.
390 (b) (c) A person who fraudulently represents that he or she
391 has a debilitating medical condition cancer, a physical medical
392 condition that chronically produces symptoms of seizures or
393 severe and persistent muscle spasms, chronic nonmalignant pain,
394 or a terminal condition as defined in s. 499.0295 to a physician
395 for the purpose of being issued a physician certification for
396 marijuana ordered low-THC cannabis, medical cannabis, or a
397 cannabis delivery device by such physician commits a misdemeanor
398 of the first degree, punishable as provided in s. 775.082 or s.
400 (c) (d) A qualifying patient an eligible patient as defined
401 in s. 499.0295 who uses marijuana medical cannabis, and such
402 patient’s caregiver legal representative who administers
403 marijuana medical cannabis, in plain view of or in a place open
404 to the general public, on the grounds of a school, or in a
405 school bus, vehicle, aircraft, or motorboat, commits a
406 misdemeanor of the first degree, punishable as provided in s.
407 775.082 or s. 775.083.
408 (d) A qualifying patient or caregiver who cultivates
409 marijuana or who purchases or acquires marijuana from any person
410 or entity other than an MMTC commits a misdemeanor of the first
411 degree, punishable as provided in s. 775.082 or s. 775.083.
412 (e) A caregiver who violates any of the applicable
413 provisions of this section or applicable department rules
414 commits, upon the first offense, a misdemeanor of the second
415 degree, punishable as provided in s. 775.082 or s. 775.083, and,
416 upon the second and subsequent offenses, a misdemeanor of the
417 first degree, punishable as provided in s. 775.082 or s.
419 (f) (e) A physician who issues a physician certification for
420 marijuana orders low-THC cannabis, medical cannabis, or a
421 cannabis delivery device and receives compensation from an MMTC
422 a dispensing organization related to issuing the physician
423 certification for marijuana the ordering of low-THC cannabis,
424 medical cannabis, or a cannabis delivery device is subject to
425 disciplinary action under the applicable practice act and s.
427 (g) An MMTC that advertises or holds out to the public that
428 it may provide services other than services for which it is
429 registered to provide violates this section, and the department
430 may impose a fine on the MMTC pursuant to paragraph (10)(h).
431 (h) A person or entity that offers or advertises services
432 as an MMTC without registering as an MMTC with the department
433 violates this section. The operation or maintenance of a
434 facility as an MMTC, or the performance of a service that
435 requires registration, without proper registration is a
436 violation of this section.
437 1. If after receiving notification from the department,
438 such person or entity fails to cease operation, the department
439 may impose an administrative fine of up to $10,000 per
440 violation. Each day of continued operation is a separate
442 2. The department or any state attorney may, in addition to
443 other remedies provided in this section, bring an action for an
444 injunction to restrain any unauthorized activity or to enjoin
445 the future operation or maintenance of the unauthorized
446 dispensing organization or entity or the performance of any
447 service in violation of this section until compliance with this
448 section and department rules has been demonstrated to the
449 satisfaction of the department.
450 3. If found to be in violation of this paragraph, the
451 department may assess reasonable investigative and legal costs
452 for prosecution of the violation against the person or entity.
453 (5) (4) PHYSICIAN EDUCATION.—
454 (a) Before a physician may issue a physician certification
455 pursuant to subsection (3) ordering low-THC cannabis, medical
456 cannabis, or a cannabis delivery device for medical use by a
457 patient in this state, the appropriate board shall require the
458 ordering physician to successfully complete a 4-hour an 8-hour
459 course and subsequent examination offered by the Florida Medical
460 Association or the Florida Osteopathic Medical Association which
461 that encompasses the clinical indications for the appropriate
462 use of marijuana low-THC cannabis and medical cannabis, the
463 appropriate cannabis delivery devices, the contraindications for
464 such use, and the relevant state and federal laws governing the
465 issuance of physician certifications ordering, as well as
466 dispensing , and possessing of these substances and devices. The
467 course and examination shall be administered at least quarterly
468 annually. Successful completion of the course may be used by a
469 physician to satisfy 4 hours 8 hours of the continuing medical
470 education requirements required by his or her respective board
471 for licensure renewal. This course may be offered in a distance
472 learning format, including an electronic, online format that is
473 available on request. Physicians who have completed an 8-hour
474 course and subsequent examination offered by the Florida Medical
475 Association or the Florida Osteopathic Medical Association which
476 encompasses the clinical indications for the appropriate use of
477 marijuana and who are registered in the compassionate use
478 registry on the effective date of this act are deemed to meet
479 the requirements of this paragraph.
480 (b) The appropriate board shall require the medical
481 director of each MMTC dispensing organization to hold an active,
482 unrestricted license as a physician under chapter 458 or as an
483 osteopathic physician under chapter 459 and successfully
484 complete a 2-hour course and subsequent examination offered by
485 the Florida Medical Association or the Florida Osteopathic
486 Medical Association which that encompasses appropriate safety
487 procedures and knowledge of marijuana low-THC cannabis, medical
488 cannabis , and cannabis delivery devices.
489 (c) Successful completion of the course and examination
490 specified in paragraph (a) is required for every physician who
491 issues a physician certification for marijuana orders low-THC
492 cannabis, medical cannabis, or a cannabis delivery device each
493 time such physician renews his or her license. In addition,
494 successful completion of the course and examination specified in
495 paragraph (b) is required for the medical director of each
496 dispensing organization each time such physician renews his or
497 her license.
498 (d) A physician who fails to comply with this subsection
499 and issues a physician certification for marijuana who orders
500 low-THC cannabis, medical cannabis , or a cannabis delivery
501 device may be subject to disciplinary action under the
502 applicable practice act and under s. 456.072(1)(k).
503 (6) CAREGIVERS.—
504 (a) During the course of registration with the department
505 for inclusion on the compassionate use registry, or at any time
506 while registered, a qualifying patient may designate an
507 individual as his or her caregiver to assist him or her with the
508 medical use of marijuana. The designated caregiver must be 21
509 years of age or older, unless the patient is a close relative of
510 the caregiver; must agree in writing to be the qualifying
511 patient’s caregiver; may not receive compensation, other than
512 actual expenses incurred, for assisting the qualifying patient
513 with the medical use of marijuana, unless the caregiver is
514 acting pursuant to employment in a licensed facility in
515 accordance with subparagraph (c)2.; and must pass a level 2
516 screening pursuant to chapter 435, unless the patient is a close
517 relative of the caregiver.
518 (b) A qualifying patient may have only one designated
519 caregiver at any given time unless all of the patient’s
520 caregivers are his or her close relatives or legal
522 (c) A caregiver may assist only one qualifying patient at
523 any given time unless:
524 1. All qualifying patients the caregiver is assisting are
525 close relatives of each other and the caregiver is the legal
526 representative of at least one of the patients; or
527 2. All qualifying patients the caregiver is assisting are
528 receiving hospice services, or are residents, in the same
529 assisted living facility, nursing home, or other licensed
530 facility and have requested the assistance of that caregiver
531 with the medical use of marijuana; the caregiver is an employee
532 of the hospice or licensed facility; and the caregiver provides
533 personal care or services directly to clients of the hospice or
534 licensed facility as a part of his or her employment duties at
535 the hospice or licensed facility.
536 (d) The department must register a caregiver on the
537 compassionate use registry and issue him or her a caregiver
538 identification card if he or she is designated by a qualifying
539 patient pursuant to paragraph (a) and meets all of the
540 requirements of this subsection and department rule.
541 (e) A nursing home or assisted living facility may not
542 prevent a qualifying patient residing in the nursing home or
543 assisted living facility from hiring a caregiver. A nursing home
544 or assisted living facility may prohibit its employees from
545 acting as caregivers to residents of the nursing home or
546 assisted living facility. A nursing home or assisted living
547 facility is not required to provide a caregiver to a resident
548 who is a qualifying patient.
549 (7) (5) DUTIES OF THE DEPARTMENT.—The department shall:
550 (a) Create and maintain a secure, electronic, and online
551 compassionate use registry for the registration of physicians,
552 patients, and caregivers the legal representatives of patients
553 as provided under this section. The registry must be accessible
555 1. Practitioners licensed under chapter 458 or chapter 459,
556 to ensure proper care for patients requesting physician
558 2. Practitioners licensed to prescribe prescription drugs,
559 to ensure proper care for patients before prescribing
560 medications that may interact with the medical use of marijuana;
561 3. Law enforcement agencies, to verify the authorization of
562 a qualifying patient or a patient’s caregiver to possess
563 marijuana or a cannabis delivery device; and
564 4. MMTCs, to a dispensing organization to verify the
565 authorization of a qualifying patient or a patient’s caregiver
566 legal representative to possess marijuana low-THC cannabis,
567 medical cannabis , or a cannabis delivery device and to record
568 the marijuana low-THC cannabis, medical cannabis , or cannabis
569 delivery device dispensed.
571 The registry must prevent an active registration of a patient by
572 multiple physicians.
573 (b) By July 3, 2017, adopt rules establishing procedures
574 for the issuance, annual renewal, suspension, and revocation of
575 compassionate use registry identification cards for patients and
576 caregivers. The department may charge a reasonable fee
577 associated with the issuance and renewal of patient and
578 caregiver identification cards. By October 3, 2017, the
579 department shall begin issuing identification cards to adult
580 patients who have a physician certification that meets the
581 requirements of subsection (3); minor patients who have a
582 physician certification that meets the requirements of
583 subsection (3) and the written consent of a parent or legal
584 guardian; and caregivers registered pursuant to subsection (6).
585 In addition to the other requirements of this section, the
586 department may issue a compassionate use registry identification
587 card to a patient who is not a resident of this state only after
588 the department has verified that the patient can lawfully obtain
589 marijuana through a medical marijuana program in the state that
590 he or she resides in. Patient and caregiver identification cards
591 must be resistant to counterfeiting and tampering and must
592 include at least the following:
593 1. The name, address, and date of birth of the patient or
594 caregiver, as appropriate;
595 2. A full-face, passport-type, color photograph of the
596 patient or caregiver, as appropriate, taken within the 90 days
597 immediately preceding registration;
598 3. Designation of the cardholder as a patient or caregiver;
599 4. A unique identification number for the patient or
600 caregiver which is matched to the identification number used for
601 such person in the department’s compassionate use registry. A
602 caregiver’s identification number and file in the compassionate
603 use registry must be linked to the file of the patient or
604 patients the caregiver is assisting so that the caregiver’s
605 status may be verified for each patient individually;
606 5. The expiration date, which shall be 1 year after the
607 date of issuance of the identification card or the date
608 treatment ends as provided in the patient’s physician
609 certification, whichever occurs first; and
610 6. For caregivers who are assisting three or fewer
611 qualifying patients, the names and identification number of the
612 qualifying patient or patients that the caregiver is assisting.
613 (c) As soon as practicable after the effective date of this
614 act, update its records by registering each dispensing
615 organization approved pursuant to chapter 2014-157, Laws of
616 Florida, or chapter 2016-123, Laws of Florida, as an MMTC with
617 an effective registration date that coincides with that
618 dispensing organization’s date of approval as a dispensing
619 organization. On the effective date of this act, all dispensing
620 organizations approved pursuant to chapter 2014-157, Laws of
621 Florida, or chapter 2016-123, Laws of Florida, are deemed to be
622 registered MMTCs. The department may not require a dispensing
623 organization approved pursuant to chapter 2014-157, Laws of
624 Florida, or chapter 2016-123, Laws of Florida, to submit an
625 application and may not charge the dispensing organization an
626 application or registration fee for the initial registration of
627 that dispensing organization as an MMTC pursuant to this
628 section. For purposes of the requirement that an MMTC comply
629 with the representations made in its application pursuant to
630 subsection (8), an MMTC registered pursuant to this paragraph
631 shall continue to comply with the representations made in its
632 application for approval as a dispensing organization, including
633 any revision authorized by the department before the effective
634 date of this act. After the effective date of this act, the
635 department may grant variances from the representations made in
636 a dispensing organization’s application for approval pursuant to
637 subsection (8). For purposes of the definition of the term
638 “marijuana” in s. 29, of Art. X of the State Constitution, an
639 MMTC is deemed to be a dispensing organization as that term is
640 defined in former s. 381.986(1)(a), Florida Statutes 2014
641 Authorize the establishment of five dispensing organizations to
642 ensure reasonable statewide accessibility and availability as
643 necessary for patients registered in the compassionate use
644 registry and who are ordered low-THC cannabis, medical cannabis,
645 or a cannabis delivery device under this section, one in each of
646 the following regions: northwest Florida, northeast Florida,
647 central Florida, southeast Florida, and southwest Florida.
648 (d) By October 3, 2017, register five additional MMTCs with
649 at least one of the MMTCs being an applicant that is a
650 recognized class member of Pigford v. Glickman, 185 F.R.D. 82
651 (D.D.C. 1999), or In re Black Farmers Litig., 856 F. Supp. 2d 1
652 (D.D.C. 2011), and a member of the Black Farmers and
653 Agriculturalists Association.
654 (e) Within 6 months after each instance of the registration
655 of 75,000 qualifying patients with the compassionate use
656 registry, register four additional MMTCs if a sufficient number
657 of MMTC applicants meet the registration requirements
658 established in this section and by department rule.
659 (f) Not issue more than one registration as an MMTC to a
660 person or an entity.
661 (g) The department shall Develop an application form for
662 registration as an MMTC and impose an initial application and
663 biennial renewal fee that is sufficient to cover the costs of
664 administering this section. To be registered as an MMTC, the an
665 applicant for approval as a dispensing organization must be able
666 to demonstrate:
667 1. That the applicant has been registered to do business in
668 this state for the previous 5 consecutive years before
669 submitting the application.
670 2. 1. The technical and technological ability to cultivate
671 and produce low-THC cannabis and marijuana. The applicant must
672 possess a valid certificate of registration issued by the
673 Department of Agriculture and Consumer Services pursuant to s.
674 581.131 that is issued for the cultivation of more than 400,000
675 plants, be operated by a nurseryman as defined in s. 581.011,
676 and have been operated as a registered nursery in this state for
677 at least 30 continuous years.
678 3. 2. The ability to secure the premises, resources, and
679 personnel necessary to operate as an MMTC a d ispensing
681 4. 3. The ability to maintain accountability of all raw
682 materials, finished products, and any byproducts to prevent
683 diversion or unlawful access to or possession of these
685 5. 4. An infrastructure reasonably located to dispense low
686 THC cannabis and marijuana to registered qualifying patients
687 statewide or regionally as determined by the department.
688 6. 5. The financial ability to maintain operations for the
689 duration of the 2-year approval cycle, including the provision
690 of certified financials to the department. Upon approval, the
691 applicant must post a $5 million performance bond. However, upon
692 an MMTC a dispensing organization’s serving at least 1,000
693 qualifying qualified patients, the MMTC dispensing organization
694 is only required to maintain a $2 million performance bond.
695 7. 6. That all owners and managers have been fingerprinted
696 and have successfully passed a level 2 background screening
697 pursuant to s. 435.04.
698 8. 7. The employment of a medical director to supervise the
699 activities of the MMTC dispensing organization.
700 (c) Upon the registration of 250,000 active qualified
701 patients in the compassionate use registry, approve three
702 dispensing organizations, including, but not limited to, an
703 applicant that is a recognized class member of Pigford v.
704 Glickman , 185 F.R.D. 82 (D.D.C. 1999), or In Re Black Farmers
705 Litig. , 856 F. Supp. 2d 1 (D.D.C. 2011), and a member of the
706 Black Farmers and Agriculturalists Association, which must meet
707 the requirements of subparagraphs (b)2.-7. and demonstrate the
708 technical and technological ability to cultivate and produce
709 low-THC cannabis.
710 (h) (d) Allow an MMTC a d ispensing organization to make a
711 wholesale purchase of marijuana low-THC cannabis or medical
712 cannabis from, or a distribution of marijuana low-THC cannabis
713 or medical cannabis to, another MMTC dispensing organization.
714 (i) (e) Monitor physician registration in the compassionate
715 use registry and the issuance of physician certifications
716 pursuant to subsection (3) ordering of low-THC cannabis, medical
717 cannabis, or a cannabis delivery device for ordering practices
718 that could facilitate unlawful diversion or misuse of marijuana
719 low-THC cannabis, medical cannabis , or a cannabis delivery
720 devices device and take disciplinary action as indicated.
721 (8) (6) MEDICAL MARIJUANA TREATMENT CENTERS DISPENSING
722 ORGANIZATION.—Each MMTC must register with the department. A
723 registered MMTC An approved dispensing organization must, at all
724 times, maintain compliance with paragraph (7)(g), the criteria
725 demonstrated for selection and approval as a dispensing
726 organization under subsection(5 ) and the criteria required in
727 this subsection, and all representations made to the department
728 in the MMTC’s application for registration. Upon request, the
729 department may grant an MMTC one or more variances from the
730 representations made in the MMTC’s application. Consideration of
731 such a variance shall be based upon the individual facts and
732 circumstances surrounding the request. A variance may not be
733 granted unless the requesting MMTC can demonstrate to the
734 department that it has a proposed alternative to the specific
735 representation made in its application which fulfills the same
736 or a similar purpose as the specific representation in a way
737 that the department can reasonably determine will not be a lower
738 standard than the specific representation in the application.
739 (a) When growing marijuana low-THC cannabis or medical
740 cannabis, an MMTC a dispensing organization:
741 1. May use pesticides determined by the department, after
742 consultation with the Department of Agriculture and Consumer
743 Services, to be safely applied to plants intended for human
744 consumption, but may not use pesticides designated as
745 restricted-use pesticides pursuant to s. 487.042.
746 2. Must grow marijuana low-THC cannabis or medical cannabis
747 within an enclosed structure and in a room separate from any
748 other plant.
749 3. Must inspect seeds and growing plants for plant pests
750 that endanger or threaten the horticultural and agricultural
751 interests of the state, notify the Department of Agriculture and
752 Consumer Services within 10 calendar days after a determination
753 that a plant is infested or infected by such plant pest, and
754 implement and maintain phytosanitary policies and procedures.
755 4. Must perform fumigation or treatment of plants, or the
756 removal and destruction of infested or infected plants, in
757 accordance with chapter 581 and any rules adopted thereunder.
758 (b) When processing marijuana low-THC cannabis or medical
759 cannabis, an MMTC a dispensing organization must:
760 1. Process the marijuana low-THC cannabis or medical
761 cannabis within an enclosed structure and in a room separate
762 from other plants or products.
763 2. Have the marijuana tested by an independent testing
764 laboratory to ensure it meets the standards established by the
765 department’s quality control program Test the processed low-THC
766 cannabis and medical cannabis before it is they are dispensed.
767 Results must be verified and signed by two dispensing
768 organization employees. Before dispensing low-THC cannabis, the
769 dispensing organization must determine that the test results
770 indicate that the low-THC cannabis meets the definition of low
771 THC cannabis and, for medical cannabis and low-THC cannabis,
772 that all medical cannabis and low-THC cannabis is safe for human
773 consumption and free from contaminants that are unsafe for human
774 consumption. The dispensing organization must retain records of
775 all testing and samples of each homogenous batch of cannabis and
776 low-THC cannabis for at least 9 months. The dispensing
777 organization must contract with an independent testing
778 laboratory to perform audits on the dispensing organization’s
779 standard operating procedures, testing records, and samples and
780 provide the results to the department to confirm that the low
781 THC cannabis or medical cannabis meets the requirements of this
782 section and that the medical cannabis and low-THC cannabis is
783 safe for human consumption.
784 3. Package the marijuana low-THC cannabis or medical
785 cannabis in compliance with the United States Poison Prevention
786 Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.
787 4. Package the marijuana low-THC cannabis or medical
788 cannabis in a childproof receptacle that has a firmly affixed
789 and legible label stating the following information:
790 a. A statement that the marijuana low-THC cannabis or
791 medical cannabis meets the requirements of subparagraph 2.;
792 b. The name of the MMTC dispensing organization from which
793 the marijuana medical cannabis or low-THC cannabis originates;
795 c. The batch number and harvest number from which the
796 marijuana medical cannabis or low-THC cannabis originates; and
797 d. The concentration of tetrahydrocannabinol and
798 cannabidiol in the product.
799 e. Any other information required by department rule
800 5. Reserve two processed samples from each batch and retain
801 such samples for at least 9 months for the purpose of testing
802 pursuant to the audit required under subparagraph 2.
803 (c) When dispensing marijuana low-THC cannabis, medical
804 cannabis , or a marijuana cannabis delivery device, an MMTC a
805 d ispensing organization:
806 1. May not dispense more than the a 45-day supply of
807 marijuana authorized by a qualifying patient’s physician
808 certification low-THC cannabis or medical cannabis to a
809 qualifying patient or caregiver the patient’s legal
811 2. Must ensure that the have the dispensing organization’s
812 employee who dispenses the marijuana low-THC cannabis, medical
813 cannabis , or marijuana a cannabis delivery device enters enter
814 into the compassionate use registry his or her name or unique
815 employee identifier.
816 3. Must verify that the qualifying patient and the
817 caregiver, if applicable, both have an active and valid
818 compassionate use registry identification card and that the
819 amount and type of marijuana dispensed match the physician
820 certification in the compassionate use registry for that
821 qualifying patient that a physician has ordered the low-THC
822 cannabis, medical cannabis, or a specific type of a cannabis
823 delivery device for the patient.
824 4. Must label the marijuana with the recommended dose for
825 the qualifying patient receiving the marijuana.
826 5. 4. May not dispense or sell any other type of marijuana
827 cannabis, alcohol, or illicit drug-related product, including
828 pipes, bongs, or wrapping papers, other than a physician-ordered
829 cannabis delivery device required for the medical use of
830 marijuana which is specified in a physician certification low
831 THC cannabis or medical cannabis , while dispensing low-THC
832 cannabis or medical cannabis. An MMTC may produce and dispense
833 marijuana as an edible or food product but may not produce such
834 items in a format designed to be attractive to children. In
835 addition to the requirements of this section and department
836 rule, food products produced by an MMTC must meet all food
837 safety standards established in state and federal law,
838 including, but not limited to, the identification of the serving
839 size and the amount of tetrahydrocannabinol in each serving.
840 5. Must verify that the patient has an active registration
841 in the compassionate use registry, the patient or patient’s
842 legal representative holds a valid and active registration card,
843 the order presented matches the order contents as recorded in
844 the registry, and the order has not already been filled.
845 6. Must, upon dispensing the marijuana l ow-THC cannabis,
846 medical cannabis , or marijuana cannabis delivery device, record
847 in the registry the date, time, quantity, and form of marijuana
848 low-THC cannabis or medical cannabis dispensed; and the type of
849 marijuana cannabis delivery device dispensed; and the name and
850 compassionate use registry identification number of the
851 qualifying patient or caregiver to whom the marijuana delivery
852 device was dispensed.
853 7. May not dispense marijuana from more than three
854 dispensing facilities. This subparagraph does not apply to MMTC
855 retail facilities that only dispense low-THC cannabis and sell
856 marijuana delivery devices to qualified patients.
857 (d) To ensure the safety and security of its premises and
858 any off-site storage facilities, and to maintain adequate
859 controls against the diversion, theft, and loss of marijuana
860 low-THC cannabis, medical cannabis , or marijuana cannabis
861 delivery devices, an MMTC a di spensing organization shall:
862 1.a. Maintain a fully operational security alarm system
863 that secures all entry points and perimeter windows and is
864 equipped with motion detectors; pressure switches; and duress,
865 panic, and hold-up alarms; or
866 b. Maintain a video surveillance system that records
867 continuously 24 hours each day and meets at least one of the
868 following criteria:
869 (I) Cameras are fixed in a place that allows for the clear
870 identification of persons and activities in controlled areas of
871 the premises. Controlled areas include grow rooms, processing
872 rooms, storage rooms, disposal rooms or areas, and point-of-sale
874 (II) Cameras are fixed in entrances and exits to the
875 premises, which shall record from both indoor and outdoor, or
876 ingress and egress, vantage points;
877 (III) Recorded images must clearly and accurately display
878 the time and date; or
879 (IV) Retain video surveillance recordings for a minimum of
880 45 days, or longer upon the request of a law enforcement agency.
881 2. Ensure that the MMTC’s organization’s outdoor premises
882 have sufficient lighting from dusk until dawn.
883 3. Implement Establish and maintain a tracking system using
884 a vendor approved by the department which that traces the
885 marijuana low-THC cannabis or medical cannabis from seed to
886 sale. The tracking system must shall include notification of key
887 events as determined by the department, including when cannabis
888 seeds are planted, when cannabis plants are harvested and
889 destroyed, and when marijuana low-THC cannabis or medical
890 cannabis is transported, sold, stolen, diverted, or lost.
891 4. Not dispense from its premises marijuana low-THC
892 cannabis, medical cannabis , or a cannabis delivery device
893 between the hours of 9 p.m. and 7 a.m., but may perform all
894 other operations and deliver marijuana low-THC cannabis and
895 medical cannabis to qualifying qualified patients 24 hours each
897 5. Store marijuana low-THC cannabis or medical cannabis in
898 a secured, locked room or a vault.
899 6. Require at least two of its employees, or two employees
900 of a security agency with whom it contracts, to be on the
901 premises at all times.
902 7. Require each employee or contractor to wear a photo
903 identification badge at all times while on the premises.
904 8. Require each visitor to wear a visitor’s pass at all
905 times while on the premises.
906 9. Implement an alcohol and drug-free workplace policy.
907 10. Report to local law enforcement within 24 hours after
908 it is notified or becomes aware of the theft, diversion, or loss
909 of marijuana low-THC cannabis or medical cannabis.
910 (e) To ensure the safe transport of marijuana low-THC
911 cannabis or medical cannabis to MMTC dispensing organization
912 facilities, independent testing laboratories, or qualifying
913 patients, the MMTC dispensing organization must:
914 1. Maintain a transportation manifest, which must be
915 retained for at least 1 year. A copy of the manifest must be in
916 the vehicle at all times when transporting marijuana.
917 2. Ensure only vehicles in good working order are used to
918 transport marijuana low-THC cannabis or medical cannabis.
919 3. Lock marijuana low-THC cannabis or medical cannabis in a
920 separate compartment or container within the vehicle.
921 4. Require at least two persons to be in a vehicle
922 transporting marijuana low-THC cannabis or medical cannabis, and
923 require at least one person to remain in the vehicle while the
924 marijuana low-THC cannabis or medical cannabis is being
926 5. Provide specific safety and security training to
927 employees transporting or delivering marijuana low-THC cannabis
928 or medical cannabis.
929 (9) MARIJUANA QUALITY CONTROL PROGRAM AND INDEPENDENT
930 TESTING LABORATORY LICENSURE.—
931 (a) The department shall establish a quality control
932 program requiring marijuana to be tested by an independent
933 testing laboratory for potency and contaminants before sale to
934 qualifying patients and caregivers.
935 1. The quality control program must require MMTCs to submit
936 samples from each batch or lot of marijuana harvested or
937 processed to an independent testing laboratory for testing to
938 ensure, at a minimum, that the labeling of the potency of
939 tetrahydrocannabinol and all other marketed cannabinoids or
940 terpenes is accurate and that the marijuana dispensed to
941 qualifying patients is safe for human consumption.
942 2. An MMTC must maintain records of all tests conducted,
943 including the results of each test and any additional
944 information, as required by the department.
945 3. The department shall adopt all rules necessary to create
946 and oversee the quality control program, which must include, at
947 a minimum:
948 a. Permissible levels of variation in potency labeling and
949 standards requiring tetrahydrocannabinol in edible marijuana
950 products to be distributed consistently throughout the product;
951 b. Permissible levels of contaminants and mandatory testing
952 for contaminants to confirm that the tested marijuana is safe
953 for human consumption. This testing must include, but is not
954 limited to, testing for microbiological impurity, residual
955 solvents, and pesticide residues;
956 c. The destruction of marijuana determined to be
957 inaccurately labeled or unsafe for human consumption after the
958 MMTC has an opportunity to take remedial action;
959 d. The collection, storage, handling, recording, and
960 destruction of samples of marijuana by independent testing
961 laboratories; and
962 e. Security, inventory tracking, and record retention.
963 (b) The department must license all independent testing
964 laboratories to ensure that all marijuana is tested for potency
965 and contaminants in accordance with the department’s quality
966 control program. An independent testing laboratory may collect
967 and accept samples of, and possess, store, transport, and test
968 marijuana. An independent testing laboratory may not be owned by
969 a person who also possesses an ownership interest in an MMTC. A
970 clinical laboratory that is licensed by the Agency for Health
971 Care Administration pursuant to part I of chapter 483 and that
972 performs nonwaived clinical tests is exempt from the requirement
973 to be licensed by the department pursuant to this paragraph but
974 must be certified to perform all required tests pursuant to
975 subparagraph 2.
976 1. The department shall develop rules establishing
977 independent testing laboratory license requirements and a
978 process for licensing independent testing laboratories; develop
979 an application form for an independent testing laboratory
980 license; and impose an initial application fee and a biennial
981 renewal fee sufficient to cover the costs of administering this
983 2. In addition to licensure, an independent testing
984 laboratory must be certified to perform all required tests by
985 the department. The department must issue a certification to an
986 independent testing laboratory that has been certified by a
987 third-party laboratory certification body approved by the
988 department. The department shall establish reasonable rules for
989 the certification and operation of independent testing
990 laboratories. Rules for certification must, at a minimum,
991 address standards relating to:
992 a. Personnel qualifications;
993 b. Equipment and methodology;
994 c. Proficiency testing;
995 d. Tracking;
996 e. Sampling;
997 f. Chain of custody;
998 g. Record and sample retention;
999 h. Reporting;
1000 i. Audit and inspection; and
1001 j. Security.
1002 3. The department shall suspend or reduce any mandatory
1003 testing requirement specified in its quality control program if
1004 the number of licensed and certified independent testing
1005 laboratories is insufficient to process the tests necessary to
1006 meet the patients’ demand for marijuana.
1007 4. An independent testing laboratory may accept only
1008 samples composed of marijuana which are obtained from a sample
1009 source approved by the department. At a minimum, these sources
1010 must include an MMTC, a researcher affiliated with an accredited
1011 university or research hospital, a qualifying patient, and a
1013 (10) (7) DEPARTMENT AUTHORITY AND RESPONSIBILITIES.—
1014 (a) The department may conduct announced or unannounced
1015 inspections of MMTCs dispensing organizations to determine
1016 compliance with this section or rules adopted pursuant to this
1018 (b) The department shall inspect an MMTC a d ispensing
1019 organization upon complaint or notice provided to the department
1020 that the MMTC dispensing organization has dispensed marijuana
1021 low-THC cannabis or medical cannabis containing any mold,
1022 bacteria, or other contaminant that may cause or has caused an
1023 adverse effect to human health or the environment.
1024 (c) The department shall conduct at least a biennial
1025 inspection of each MMTC dispensing organization to evaluate the
1026 MMTC’s dispensing organization’s records, personnel, equipment,
1027 processes, security measures, sanitation practices, and quality
1028 assurance practices.
1029 (d) The department shall adopt by rule a process for
1030 approving changes in MMTC ownership or a change in an MMTC
1031 owner’s investment interest. This process must include specific
1032 criteria for the approval or denial of an application for change
1033 of ownership or a change in investment interest and procedures
1034 for screening applicants’ criminal and financial histories.
1035 (e) The department shall establish, maintain, and control a
1036 computer software tracking system that traces marijuana from
1037 seed to sale and allows real-time, 24-hour access by the
1038 department to data from all MMTCs and independent testing
1039 laboratories. The tracking system must, at a minimum, include
1040 notification of when marijuana seeds are planted, when marijuana
1041 plants are harvested and destroyed, and when marijuana is
1042 transported, sold, stolen, diverted, or lost. Each MMTC shall
1043 use the seed-to-sale tracking system selected by the department.
1044 (f) (d) The department may enter into interagency agreements
1045 with the Department of Agriculture and Consumer Services, the
1046 Department of Business and Professional Regulation, the
1047 Department of Transportation, the Department of Highway Safety
1048 and Motor Vehicles, and the Agency for Health Care
1049 Administration, and such agencies are authorized to enter into
1050 an interagency agreement with the department, to conduct
1051 inspections or perform other responsibilities assigned to the
1052 department under this section.
1053 (g) (e) The department must make a list of all approved
1054 MMTCs, dispensing organizations and qualified ordering
1055 physicians who are qualified to issue physician certifications,
1056 and medical directors publicly available on its website.
1057 (f) The department may establish a system for issuing and
1058 renewing registration cards for patients and their legal
1059 representatives, establish the circumstances under which the
1060 cards may be revoked by or must be returned to the department,
1061 and establish fees to implement such system. The department must
1062 require, at a minimum, the registration cards to:
1063 1. Provide the name, address, and date of birth of the
1064 patient or legal representative.
1065 2. Have a full-face, passport-type, color photograph of the
1066 patient or legal representative taken within the 90 days
1067 immediately preceding registration.
1068 3. Identify whether the cardholder is a patient or legal
1070 4. List a unique numeric identifier for the patient or
1071 legal representative that is matched to the identifier used for
1072 such person in the department’s compassionate use registry.
1073 5. Provide the expiration date, which shall be 1 year after
1074 the date of the physician’s initial order of low-THC cannabis or
1075 medical cannabis.
1076 6. For the legal representative, provide the name and
1077 unique numeric identifier of the patient that the legal
1078 representative is assisting.
1079 7. Be resistant to counterfeiting or tampering.
1080 (h) (g) The department may impose reasonable fines not to
1081 exceed $10,000 on an MMTC a dispensing organization for any of
1082 the following violations:
1083 1. Violating this section, s. 499.0295, or department rule.
1084 2. Failing to maintain qualifications for registration with
1085 the department approval.
1086 3. Endangering the health, safety, or security of a
1087 qualifying qualified patient.
1088 4. Improperly disclosing personal and confidential
1089 information of a qualifying the qualified patient.
1090 5. Attempting to procure MMTC registration with the
1091 department dispensing organization approval by bribery,
1092 fraudulent misrepresentation, or extortion.
1093 6. Any owner or manager of the MMTC being convicted or
1094 found guilty of, or entering a plea of guilty or nolo contendere
1095 to, regardless of adjudication, a crime in any jurisdiction
1096 which directly relates to the business of an MMTC a d ispensing
1098 7. Making or filing a report or record that the MMTC
1099 dispensing organization knows to be false.
1100 8. Willfully failing to maintain a record required by this
1101 section or department rule.
1102 9. Willfully impeding or obstructing an employee or agent
1103 of the department in the furtherance of his or her official
1105 10. Engaging in fraud or deceit, negligence, incompetence,
1106 or misconduct in the business practices of an MMTC a dispensing
1108 11. Making misleading, deceptive, or fraudulent
1109 representations in or related to the business practices of an
1110 MMTC a dispensing organization.
1111 12. Having a license or the authority to engage in any
1112 regulated profession, occupation, or business that is related to
1113 the business practices of an MMTC a dispensing organization
1114 suspended, revoked, or otherwise acted against by the licensing
1115 authority of any jurisdiction, including its agencies or
1116 subdivisions, for a violation that would constitute a violation
1117 under Florida law.
1118 13. Violating a lawful order of the department or an agency
1119 of the state, or failing to comply with a lawfully issued
1120 subpoena of the department or an agency of the state.
1121 (i) (h) The department may suspend, revoke, or refuse to
1122 renew an MMTC’s registration with the department a dispensing
1123 organization’s approval if the MMTC a dispensing organization
1124 commits a violation specified any of the violations in paragraph
1125 (h) (g).
1126 (j) (i) The department shall renew an MMTC’s registration
1127 with the department the approval of a dispensing organization
1128 biennially if the MMTC dispensing organization meets the
1129 requirements of this section and pays the biennial renewal fee.
1130 (k) (j) The department may adopt rules necessary to
1131 implement this section.
1132 (11) (8) PREEMPTION.—
1133 (a) All matters regarding the regulation of the cultivation
1134 and processing of marijuana medical cannabis or low-THC cannabis
1135 by MMTCs dispensing organizations are preempted to the state.
1136 (b) A municipality may determine by ordinance the criteria
1137 for the number and location of, and other permitting
1138 requirements that do not conflict with state law or department
1139 rule for, dispensing facilities of MMTCs dispensing
1140 organizations located within its municipal boundaries. A county
1141 may determine by ordinance the criteria for the number,
1142 location, and other permitting requirements that do not conflict
1143 with state law or department rule for all dispensing facilities
1144 of MMTCs dispensing organizations located within the
1145 unincorporated areas of that county.
1146 (12) (9) EXCEPTIONS TO OTHER LAWS.—
1147 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
1148 any other provision of law, but subject to the requirements of
1149 this section, a qualifying qualified patient, or a caregiver who
1150 has obtained a valid compassionate use registry identification
1151 card from the department, and the qualified patient’s legal
1152 representative may purchase from an MMTC, and possess for the
1153 qualifying patient’s medical use, up to the amount of marijuana
1154 in the physician certification low-THC cannabis or medical
1155 cannabis ordere d for the patient, but not more than a 90-day 45
1156 day supply, and a cannabis delivery device specified in the
1157 physician certification ordered for the qualifying patient.
1158 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
1159 any other provision of law, but subject to the requirements of
1160 this section, an MMTC an approved dispensing organization and
1161 its owners, managers, contractors, and employees may
1162 manufacture, possess, sell, deliver, distribute, dispense,
1163 administer, and lawfully dispose of reasonable quantities, as
1164 established by department rule, of marijuana low-THC cannabis ,
1165 medical cannabis , or a cannabis delivery device. For purposes of
1166 this subsection, the terms “manufacture,” “possession,”
1167 “deliver,” “distribute,” and “dispense” have the same meanings
1168 as provided in s. 893.02.
1169 (c) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
1170 any other provision of law, but subject to the requirements of
1171 this section, an approved independent testing laboratory may
1172 possess, test, transport, and lawfully dispose of marijuana low
1173 THC cannabis or medical cannabis as provided by department rule.
1174 (d) An MMTC approved dispensing organization and its
1175 owners, managers, contractors, and employees are not subject to
1176 licensure or regulation under chapter 465 or chapter 499 for
1177 manufacturing, possessing, selling, delivering, distributing,
1178 dispensing, or lawfully disposing of reasonable quantities, as
1179 established by department rule, of marijuana low-THC cannabis ,
1180 medical cannabis , or a cannabis delivery device.
1181 (e) Exercise by an MMTC of An approved dispensing
1182 organization that continues to meet the requirements for
1183 approval is presumed to be registered with the department and to
1184 meet the regulations adopted by the department or its successor
1185 agency for the purpose of dispensing medical cannabis or low-THC
1186 cannabis under Florida law. Additionally, the authority provided
1187 to MMTCs a d ispensing organization in s. 499.0295 does not
1188 impair its registration with the department the approval of a
1189 d ispensing organization.
1190 (f) This subsection does not exempt a person from
1191 prosecution for a criminal offense related to impairment or
1192 intoxication resulting from the medical use of marijuana low-THC
1193 cannabis or medical cannabis or relieve a person from any
1194 requirement under law to submit to a breath, blood, urine, or
1195 other test to detect the presence of a controlled substance.
1196 (g) This section does not limit the ability of an employer
1197 to establish, continue, or enforce a drug-free workplace program
1198 or substance abuse policy. Notwithstanding any other provision
1199 of law, this section does not require an employer to accommodate
1200 the ingestion of marijuana in any workplace or any employee
1201 working while under the influence of marijuana. Notwithstanding
1202 any other provision of law, this section does not create a cause
1203 of action against an employer for wrongful discharge or
1205 (h) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
1206 any other provision of law, but subject to the requirements of
1207 this section, a research institute established by a public
1208 postsecondary educational institution, such as the H. Lee
1209 Moffitt Cancer Center and Research Institute established under
1210 s. 1004.43, or a state university that has achieved the
1211 preeminent state research university designation pursuant to s.
1212 1001.7065 may possess, test, transport, and lawfully dispose of
1213 marijuana for research purposes as provided by department rule.
1214 (13) RULEMAKING.—
1215 (a) The department and the applicable boards shall adopt
1216 emergency rules pursuant to s. 120.54(4) and this subsection
1217 necessary to implement this section. If an emergency rule
1218 adopted under this subsection is held to be unconstitutional or
1219 an invalid exercise of delegated legislative authority and
1220 becomes void, the department and the applicable boards may adopt
1221 an emergency rule to replace the rule that has become void. If
1222 the emergency rule adopted to replace the void emergency rule is
1223 also held to be unconstitutional or an invalid exercise of
1224 delegated legislative authority and becomes void, the department
1225 and the applicable boards must follow the nonemergency
1226 rulemaking procedures of the Administrative Procedures Act to
1227 replace the rule that has become void.
1228 (b) For emergency rules adopted under this subsection, the
1229 department and the applicable boards need not make the findings
1230 required by s. 120.54(4)(a). Emergency rules adopted under this
1231 subsection are exempt from ss. 120.54(3)(b) and 120.541. The
1232 department and the applicable boards shall meet the procedural
1233 requirements in s. 120.54(2)(a) if the department or the
1234 applicable boards have, before the effective date of this act,
1235 held any public workshops or hearings on the subject matter of
1236 emergency rules adopted under this subsection. Challenges to
1237 emergency rules adopted under this subsection are subject to the
1238 time schedules provided in s. 120.56(5).
1239 (c) Emergency rules adopted under this section are exempt
1240 from s. 120.54(4)(c) and shall remain in effect until replaced
1241 by rules adopted under the nonemergency rulemaking procedures of
1242 the Administrative Procedures Act. By January 1, 2018, the
1243 department and the applicable boards shall initiate nonemergency
1244 rulemaking pursuant to the Administrative Procedures Act by
1245 publishing a notice of rule development in the Florida
1246 Administrative Register. Except as provided in paragraph (a),
1247 after January 1, 2018, the department and applicable boards may
1248 not adopt rules pursuant to the emergency rulemaking procedures
1249 provided in this subsection.
1250 Section 2. Section 1004.4351, Florida Statutes, is created
1251 to read:
1252 1004.4351 Medical marijuana research and education.—
1253 (1) SHORT TITLE.—This section shall be known and may be
1254 cited as the “Medical Marijuana Research and Education Act.”
1255 (2) LEGISLATIVE FINDINGS.—The Legislature finds that:
1256 (a) The present state of knowledge concerning the use of
1257 marijuana to alleviate pain and treat illnesses is limited
1258 because permission to perform clinical studies on marijuana is
1259 difficult to obtain, with access to research-grade marijuana so
1260 restricted that little or no unbiased studies have been
1262 (b) Under the State Constitution, marijuana is available
1263 for the treatment of certain debilitating medical conditions.
1264 (c) Additional clinical studies are needed to ensure that
1265 the residents of this state obtain the correct dosing,
1266 formulation, route, modality, frequency, quantity, and quality
1267 of marijuana for specific illnesses.
1268 (d) An effective medical marijuana research and education
1269 program would mobilize the scientific, educational, and medical
1270 resources that presently exist in this state to determine the
1271 appropriate and best use of marijuana to treat illness.
1272 (3) DEFINITIONS.—As used in this section, the term:
1273 (a) “Board” means the Medical Marijuana Research and
1274 Education Board.
1275 (b) “Coalition” means the Coalition for Medical Marijuana
1276 Research and Education.
1277 (c) “Marijuana”” has the same meaning as provided in s. 29,
1278 Art. X of the State Constitution.
1279 (4) COALITION FOR MEDICAL MARIJUANA RESEARCH AND
1281 (a) There is established within the H. Lee Moffitt Cancer
1282 Center and Research Institute, Inc., the Coalition for Medical
1283 Marijuana Research and Education. The purpose of the coalition
1284 is to conduct rigorous scientific research, provide education,
1285 disseminate research, and guide policy for the adoption of a
1286 statewide policy on ordering and dosing practices for the
1287 medicinal use of marijuana. The coalition shall be physically
1288 located at the H. Lee Moffitt Cancer Center and Research
1289 Institute, Inc.
1290 (b) The Medical Marijuana Research and Education Board is
1291 established to direct the operations of the coalition. The board
1292 shall be composed of seven members appointed by the chief
1293 executive officer of the H. Lee Moffitt Cancer Center and
1294 Research Institute, Inc. Board members must have experience in a
1295 variety of scientific and medical fields, including, but not
1296 limited to, oncology, neurology, psychology, pediatrics,
1297 nutrition, and addiction. Members shall be appointed to 4-year
1298 terms and may be reappointed to serve additional terms. The
1299 chair shall be elected by the board from among its members to
1300 serve a 2-year term. The board shall meet no less than
1301 semiannually, at the call of the chair or, in his or her absence
1302 or incapacity, the vice chair. Four members constitute a quorum.
1303 A majority vote of the members present is required for all
1304 actions of the board. The board may prescribe, amend, and repeal
1305 a charter governing the manner in which it conducts its
1306 business. A board member shall serve without compensation but is
1307 entitled to be reimbursed for travel expenses by the coalition
1308 or the organization he or she represents in accordance with s.
1310 (c) The coalition shall be administered by a coalition
1311 director, who shall be appointed by and serve at the pleasure of
1312 the board. The coalition director shall, subject to the approval
1313 of the board:
1314 1. Propose a budget for the coalition.
1315 2. Foster the collaboration of scientists, researchers, and
1316 other appropriate personnel in accordance with the coalition’s
1318 3. Identify and prioritize the research to be conducted by
1319 the coalition.
1320 4. Prepare the Medical Marijuana Research and Education
1321 Plan for submission to the board.
1322 5. Apply for grants to obtain funding for research
1323 conducted by the coalition.
1324 6. Perform other duties as determined by the board.
1325 (d) The board shall advise the Board of Governors, the
1326 State Surgeon General, the Governor, and the Legislature with
1327 respect to medical marijuana research and education in this
1328 state. The board shall explore methods of implementing and
1329 enforcing medical marijuana laws in relation to cancer control,
1330 research, treatment, and education.
1331 (e) The board shall annually adopt a plan for medical
1332 marijuana research, known as the “Medical Marijuana Research and
1333 Education Plan,” which must be in accordance with state law and
1334 coordinate with existing programs in this state. The plan must
1335 include recommendations for the coordination and integration of
1336 medical, nursing, paramedical, community, and other resources
1337 connected with the treatment of debilitating medical conditions,
1338 research related to the treatment of such medical conditions,
1339 and education.
1340 (f) By February 15 of each year, the board shall issue a
1341 report to the Governor, the President of the Senate, and the
1342 Speaker of the House of Representatives on research projects,
1343 community outreach initiatives, and future plans for the
1345 (5) RESPONSIBILITIES OF THE H. LEE MOFFITT CANCER CENTER
1346 AND RESEARCH INSTITUTE, INC.—The H. Lee Moffitt Cancer Center
1347 and Research Institute, Inc., shall allocate staff and provide
1348 information and assistance, as the coalition’s budget permits,
1349 to assist the board in fulfilling its responsibilities.
1350 Section 3. Paragraph (b) of subsection (3) of section
1351 381.987, Florida Statutes, is amended to read:
1352 381.987 Public records exemption for personal identifying
1353 information in the compassionate use registry.—
1354 (3) The department shall allow access to the registry,
1355 including access to confidential and exempt information, to:
1356 (b) A medical marijuana treatment center registered with
1357 dispensing organization approved by the department pursuant to
1358 s. 381.986 which is attempting to verify the authenticity of a
1359 physician certification physician’s order for marijuana low-THC
1360 cannabis, including whether the physician certification order
1361 had been previously filled and whether the physician
1362 certification order was written for the person attempting to
1363 have it filled.
1364 Section 4. Subsection (1) of section 385.211, Florida
1365 Statutes, is amended to read:
1366 385.211 Refractory and intractable epilepsy treatment and
1367 research at recognized medical centers.—
1368 (1) As used in this section, the term “low-THC cannabis”
1369 means “low-THC cannabis” as defined in s. 381.986 which that is
1370 dispensed only from a medical marijuana treatment center
1371 dispensing organization as defined in s. 381.986.
1372 Section 5. Present paragraphs (b) and (c) of subsection (2)
1373 of section 499.0295, Florida Statutes, are redesignated as
1374 paragraphs (a) and (b), respectively, present paragraphs (a) and
1375 (c) of that subsection are amended, a new paragraph (c) is added
1376 to that subsection, and subsection (3) of that section is
1377 amended, to read:
1378 499.0295 Experimental treatments for terminal conditions.—
1379 (2) As used in this section, the term:
1380 (a) “Dispensing organization” means an organization
1381 approved by the Department of Health under s. 381.986(5) to
1382 cultivate, process, transport, and dispense low-THC cannabis,
1383 medical cannabis , and cannabis delivery devices.
1384 (b) (c) “Investigational drug, biological product, or
1385 device” means:
1386 1. A drug, biological product, or device that has
1387 successfully completed phase 1 of a clinical trial but has not
1388 been approved for general use by the United States Food and Drug
1389 Administration and remains under investigation in a clinical
1390 trial approved by the United States Food and Drug
1391 Administration; or
1392 2. Marijuana Medical cannabis that is manufactured and sold
1393 by an MMTC a dispensing organization.
1394 (c) “Medical marijuana treatment center” or “MMTC” means an
1395 organization registered with the Department of Health under s.
1397 (3) Upon the request of an eligible patient, a manufacturer
1398 may, or upon the issuance of a physician certification a
1399 physician’s order pursuant to s. 381.986, an MMTC a dispensing
1400 organization may:
1401 (a) Make its investigational drug, biological product, or
1402 device available under this section.
1403 (b) Provide an investigational drug, biological product,
1404 device, or cannabis delivery device as defined in s. 381.986 to
1405 an eligible patient without receiving compensation.
1406 (c) Require an eligible patient to pay the costs of, or the
1407 costs associated with, the manufacture of the investigational
1408 drug, biological product, device, or cannabis delivery device as
1409 defined in s. 381.986.
1410 Section 6. Subsection (1) of section 1004.441, Florida
1411 Statutes, is amended to read:
1412 1004.441 Refractory and intractable epilepsy treatment and
1414 (1) As used in this section, the term “low-THC cannabis”
1415 means “low-THC cannabis” as defined in s. 381.986 which that is
1416 dispensed only from a medical marijuana treatment center
1417 dispensing organization as defined in s. 381.986.
1418 Section 7. The Division of Law Revision and Information is
1419 directed to replace the phrase “the effective date of this act”
1420 wherever it occurs in this act with the date the act becomes a
1422 Section 8. This act shall take effect upon becoming a law.