Florida Senate - 2017 CS for CS for SB 406
By the Committees on Appropriations; and Health Policy; and
Senators Bradley, Young, and Hutson
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 requiring a physician to conduct a physical
12 examination and make a full assessment of the medical
13 history of a patient and make certain determinations
14 before the physician may certify a patient and specify
15 a delivery device; requiring a physician to review the
16 compassionate use registry and confirm that a patient
17 does not have an active physician certification issued
18 by another physician before the physician may certify
19 a patient and specify a delivery device; specifying
20 certain persons who may assist a qualifying patient
21 under the age of 18 in the purchasing and
22 administering of marijuana; prohibiting qualifying
23 patients under the age of 18 from purchasing
24 marijuana; providing that a physician may in certain
25 circumstances certify an amount greater than a 90-day
26 supply; eliminating the requirement that physicians
27 maintain patient treatment plans and submit the
28 treatment plans to the University of Florida College
29 of Pharmacy; requiring written consent of a parent or
30 legal guardian for the treatment of minors; requiring
31 that certain physicians annually reexamine and
32 reassess patients and update patient information in
33 the compassionate use registry; revising criminal
34 penalties; prohibiting a medical marijuana treatment
35 center from advertising services it is not authorized
36 to provide; providing fines; prohibiting a person or
37 entity from advertising or providing medical marijuana
38 treatment center services without being registered
39 with the Department of Health as a medical marijuana
40 treatment center; providing penalties; authorizing a
41 distance learning format for a specified course and
42 reducing the number of hours required for the course;
43 providing that physicians who meet specified
44 requirements are grandfathered for the purpose of
45 specified education requirements; authorizing
46 qualifying patients to designate caregivers; requiring
47 caregivers to meet specified requirements; prohibiting
48 a qualifying patient from designating more than one
49 caregiver at any given time; providing exceptions;
50 requiring the department to register caregivers
51 meeting certain requirements on the compassionate use
52 registry; prohibiting a nursing home or assisted
53 living facility from preventing certain residents from
54 hiring a caregiver; authorizing a nursing home or
55 assisted living facility to prohibit its employees
56 from acting as caregivers to residents; providing that
57 a nursing home or assisted living facility is not
58 required to provide a caregiver to certain residents;
59 revising the entities to which the compassionate use
60 registry must be accessible; requiring the department
61 to adopt certain rules by a specified date;
62 authorizing the department to charge a fee for
63 identification cards; requiring the department to
64 begin issuing identification cards to qualified
65 registrants by a specific date; requiring the
66 department to make certain determinations before
67 issuing an identification card to a patient; providing
68 that a patient or the parent or legal guardian of a
69 patient must provide the department with certain
70 documentation to qualify for an identification card;
71 requiring the department to adopt a rule listing
72 documents that a patient may provide to qualify for an
73 identification card; providing requirements for the
74 identification cards; requiring the department to
75 register certain dispensing organizations as medical
76 marijuana treatment centers by a certain date;
77 requiring the department to register additional
78 medical marijuana treatment centers in accordance with
79 a specified schedule; deleting obsolete provisions;
80 revising the operational requirements for medical
81 marijuana treatment centers; authorizing the
82 department to waive certain requirements under
83 specified circumstances; requiring that certain
84 receptacles be childproof; requiring that additional
85 information be included on certain labels; requiring
86 that a medical marijuana treatment center comply with
87 certain standards in the production and dispensing of
88 edible or food products; requiring a medical marijuana
89 treatment center to enter additional information into
90 the compassionate use registry; restricting the number
91 of dispensing facilities that may dispense marijuana;
92 providing an exception; requiring a medical marijuana
93 treatment center to keep a copy of a transportation
94 manifest in certain vehicles at certain times;
95 requiring the department to establish a quality
96 control program that requires medical marijuana
97 treatment centers to submit samples from each batch or
98 lot of marijuana to an independent testing laboratory;
99 requiring a medical marijuana treatment center to
100 maintain records of all tests conducted; requiring the
101 department to adopt rules to create and oversee the
102 quality control program; providing that the department
103 must license independent testing laboratories;
104 authorizing an independent testing laboratory to
105 collect and accept samples of, possess, store,
106 transport, and test marijuana; prohibiting a person
107 with an ownership interest in a medical marijuana
108 treatment center from owning an independent testing
109 laboratory; requiring the department to develop rules
110 and a process for licensing requirements; authorizing
111 the department to impose application and renewal fees;
112 specifying that an independent testing laboratory must
113 be certified to perform required tests; requiring the
114 department to suspend or reduce any mandatory testing
115 if the number of licensed and certified independent
116 testing laboratories is insufficient to process the
117 tests necessary to meet the patient demand for medical
118 marijuana treatment centers; providing that an
119 independent testing laboratory may only accept certain
120 samples; requiring the department to approve a medical
121 marijuana treatment center’s request for a change in
122 ownership, equity structure, or transfer of
123 registration to a new entity if certain criteria are
124 met; providing an exception to a requirement regarding
125 the submission of fingerprints and passing of a
126 background check; providing that a request is deemed
127 approved if not denied by the department within a
128 specified timeframe; requiring the department to adopt
129 rules; requiring the department to establish,
130 maintain, and control a seed-to-sale tracking system
131 for marijuana; providing applicability; conforming
132 provisions to changes made by the act; providing that
133 certain research institutions may possess, test,
134 transport, and dispose of marijuana subject to certain
135 conditions and as provided by department rule;
136 providing for the use of emergency rulemaking
137 procedures by the department; creating s. 1004.4351,
138 F.S.; providing a short title; providing legislative
139 findings; defining terms; establishing the Coalition
140 for Medical Marijuana Research and Education within
141 the H. Lee Moffitt Cancer Center and Research
142 Institute, Inc.; providing a purpose for the
143 coalition; requiring the department to electronically
144 submit to the coalition a data set that includes
145 certain information for each patient registered with
146 the compassionate use registry; requiring the
147 coalition to review the data submitted by the
148 department and to make certain determinations and to
149 potentially issue recommendations for changes to state
150 law and rules; establishing the Medical Marijuana
151 Research and Education Board to direct the operations
152 of the coalition; providing for the appointment of
153 board members; providing for terms of office,
154 reimbursement for certain expenses, and the conduct of
155 meetings of the board; authorizing the board to
156 appoint a coalition director; prescribing the duties
157 of the coalition director; requiring the board to
158 advise specified entities and officials regarding
159 medical marijuana research and education in this
160 state; requiring the board to annually adopt a Medical
161 Marijuana Research and Education Plan; providing
162 requirements for the plan; requiring the board to
163 issue an annual report to the Governor and the
164 Legislature by a specified date; specifying
165 responsibilities of the H. Lee Moffitt Cancer Center
166 and Research Institute, Inc.; amending ss. 381.987,
167 385.211, 499.0295, and 1004.441, F.S.; conforming
168 provisions to changes made by the act; providing a
169 directive to the Division of Law Revision and
170 Information; providing an effective date.
172 Be It Enacted by the Legislature of the State of Florida:
174 Section 1. Section 381.986, Florida Statutes, is amended to
176 381.986 Compassionate use of low-THC
and medical cannabis
177 and marijuana.—
178 (1) LEGISLATIVE INTENT.—
179 (a) It is the intent of the Legislature to implement s. 29,
180 Art. X of the State Constitution by creating a unified
181 regulatory structure within the framework of this section for
182 the acquisition, cultivation, possession, processing, transfer,
183 transportation, sale, distribution, and dispensing of marijuana,
184 products containing marijuana, related supplies, and educational
185 materials to qualifying patients or their caregivers.
186 (b) The Legislature intends that all rules adopted by the
187 Department of Health to implement this section be adopted
188 pursuant to s. 120.536(1) or s. 120.54. The Legislature intends
189 that the department use emergency rulemaking procedures pursuant
190 to s. 120.54(4) to adopt rules under this section if necessary
191 to meet any deadline for rulemaking established in s. 29, Art. X
192 of the State Constitution.
193 (c) Further, the Legislature intends that all registrations
194 for the purposes specified in paragraph (a) be issued solely in
195 accordance with the requirements of this section and all rules
196 adopted under this section.
197 (2) DEFINITIONS.—As used in this section, the term:
198 (a) “Cannabis delivery device” means an object used,
199 intended for use, or designed for use in preparing, storing,
200 ingesting, inhaling, or otherwise introducing marijuana low-THC
201 cannabis or medical cannabis into the human body.
202 (b) “Caregiver” has the same meaning as provided in s. 29,
203 Art. X of the State Constitution.
204 (c) “Chronic nonmalignant pain” means pain that is caused
205 by a debilitating medical condition or that originates from a
206 debilitating medical condition and persists beyond the usual
207 course of that debilitating medical condition.
208 (d) “Close relative” means a spouse, parent, sibling,
209 grandparent, child, or grandchild, whether related by whole or
210 half blood, by marriage, or by adoption.
211 (e) (b) “Debilitating medical condition” has the same
212 meaning as provided in s. 29, Art. X of the State Constitution
213 “ Dispensing organization ” means an organization approved by the
214 department to cultivate, process, transport, and dispense low
215 THC cannabis or medical cannabis pursuant to this section.
216 (f) (c) “Independent testing laboratory” means a laboratory,
217 including the managers, employees, or contractors of the
218 laboratory, which has no direct or indirect interest in a
219 medical marijuana treatment center a dispensing organization.
220 (g) (d) “Legal representative” means the qualifying
221 qualified patient’s parent, legal guardian acting pursuant to a
222 court’s authorization as required under s. 744.3215(4), health
223 care surrogate acting pursuant to the qualifying qualified
224 patient’s written consent or a court’s authorization as required
225 under s. 765.113, or an individual who is authorized under a
226 power of attorney to make health care decisions on behalf of the
227 qualifying qualified patient.
228 (h) (e) “Low-THC cannabis” means a plant of the genus
229 Cannabis, the dried flowers of which contain 0.8 percent or less
230 of tetrahydrocannabinol and more than 10 percent of cannabidiol
231 weight for weight; the seeds thereof; the resin extracted from
232 any part of such plant; or any compound, manufacture, salt,
233 derivative, mixture, or preparation of such plant or its seeds
234 or resin that is dispensed only by a medical marijuana treatment
235 center from a dispensing organization.
236 (i) (f) “Marijuana” has the same meaning as provided in s.
237 29, Art. X of the State Constitution “ Medical cannabis ” means
238 all parts of any plant of the genus Cannabis , whether growing or
239 not; the seeds thereof; the resin extracted from any part of the
240 plant; and every compound, manufacture, sale, derivative,
241 mixture, or preparation of the plant or its seeds or resin that
242 is dispensed only from a dispensing organization for medical use
243 by an eligible patient as defined in s. 499.0295.
244 (j) “Medical marijuana treatment center” or “MMTC” has the
245 same meaning as provided in s. 29, Art. X of the State
247 (k) (g) “Medical use” has the same meaning as provided in s.
248 29, Art. X of the State Constitution means administration of the
249 ordered amount of low-THC cannabis or medical cannabis. The term
250 does not include the:
251 1. Possession, use, or administration of marijuana low-THC
252 cannabis or medical cannabis by smoking.
253 2. Possession, use, or administration of marijuana that was
254 not purchased or acquired from an MMTC registered with the
256 3. 2. Transfer of marijuana low-THC cannabis or medical
257 cannabis to a person other than the qualifying qualified patient
258 for whom it was ordered or the qualifying qualified patient’s
259 caregiver legal representative on behalf of the qualifying
260 qualified patient.
261 4. Use or administration of any type or amount of marijuana
262 not specified on the qualifying patient’s physician
264 5. 3. Use or administration of marijuana low-THC cannabis or
265 medical cannabis:
266 a. On any form of public transportation.
267 b. In any public place.
268 c. In a qualifying qualified patient’s place of employment,
269 if restricted by his or her employer.
270 d. In a state correctional institution as defined in s.
271 944.02 or a correctional institution as defined in s. 944.241.
272 e. On the grounds of a preschool, primary school, or
273 secondary school.
274 f. On a school bus or in a vehicle, aircraft, or motorboat.
275 (l) (h) “Qualifying Qualified patient” has the same meaning
276 as provided in s. 29, Art. X of the State Constitution but also
277 includes eligible patients, as that term is defined in s.
278 499.0295, and patients who are issued a physician certification
279 under subparagraph (3)(a)2. or subparagraph (3)(a)3. A patient
280 is not a qualifying patient unless he or she is registered with
281 the department and has been issued a compassionate use registry
282 identification card means a resident of this state who has been
283 added to the compassionate use registry by a physician licensed
284 under chapter 458 or chapter 459 to receive low-THC cannabis or
285 medical cannabis from a dispensing organization.
286 (m) (i) “Smoking” means burning or igniting a substance and
287 inhaling the smoke. Smoking does not include the use of a
289 (3) (2) PHYSICIAN CERTIFICATION ORDERING.—
290 (a) A physician is authorized to issue a physician
291 certification to:
292 1. A patient suffering from a debilitating medical
293 condition, which allows the patient to receive marijuana for the
294 patient’s medical use;
295 2. A order low-THC cannabis to treat a qualified patient
296 suffering from cancer or a physical medical condition that
297 chronically produces symptoms of seizures or severe and
298 persistent muscle spasms, which allows the patient to receive
299 low-THC cannabis for the patient’s medical use;
300 3. A patient suffering from chronic nonmalignant pain, if
301 the physician has diagnosed an underlying debilitating medical
302 condition as the cause of the pain, which allows the patient to
303 receive marijuana for the patient’s medical use order low-THC
304 cannabis to alleviate the patient’s pain symptoms of such
305 disease, disorder, or condition, if no other satisfactory
306 alternative treatment options exist for the qualified patient;
307 4. order medical cannabis to treat An eligible patient as
308 defined in s. 499.0295, which allows the patient to receive
309 marijuana for the patient’s medical use; or
310 5. A patient who is not a resident of this state; who
311 qualifies under subparagraph 1., subparagraph 2., subparagraph
312 3., or subparagraph 4.; and who can lawfully obtain marijuana
313 through a medical marijuana program in the state that he or she
314 resides in.
315 (b) In the physician certification, the physician may also
316 specify one or more or order a cannabis delivery devices to
317 assist with device for the patient’s medical use of marijuana.
318 low-THC cannabis or medical cannabis,
319 (c) A physician may certify a patient and specify a
320 delivery device under paragraphs (a) and (b) only if the
322 1. (a) Holds an active, unrestricted license as a physician
323 under chapter 458 or an osteopathic physician under chapter 459;
324 (b) Has treated the patient for at least 3 months
325 immediately preceding the patient’s registration in the
326 compassionate use registry;
327 2. (c) Has successfully completed the course and examination
328 required under paragraph (5)(a) (4)(a);
329 3. Has conducted a physical examination and made a full
330 assessment of the medical history of the patient;
331 4. Has determined that, in the physician’s professional
332 opinion, the patient meets one or more of the criteria specified
333 in paragraph (a);
334 5. (d) Has determined that the medical use of marijuana
335 would likely outweigh the potential health risks to of treating
336 the patient with low-THC cannabis or medical cannabis are
337 reasonable in light of the potential benefit to the patient. If
338 a patient is younger than 18 years of age: ,
339 a. A second physician must concur with this determination,
340 and such determination must be documented in the patient’s
341 medical record;
342 b. Only a parent, legal guardian, caregiver, or health care
343 provider may assist the qualifying patient in the purchasing and
344 administering of marijuana for medical use; and
345 c. The qualifying patient may not purchase marijuana;
346 6. Has reviewed the compassionate use registry and
347 confirmed that the patient does not have an active physician
348 certification issued by another physician;
349 7. (e) Registers as the patient’s physician orderer of low
350 THC cannabis or medical cannabis for the named patient on the
351 compassionate use registry maintained by the department and
352 updates the registry to reflect the contents of the order,
353 including the amount of marijuana low-THC cannabis or medical
354 cannabis that will provide the patient with not more than a 90
355 day 45-day supply and a cannabis delivery device needed by the
356 patient for the medical use of marijuana low-THC cannabis or
357 medical cannabis. A physician may certify an amount greater than
358 a 90-day supply of marijuana if the physician has a reasonable
359 belief that the patient will use the additional marijuana in a
360 medically appropriate way. If the physician’s recommended amount
361 of marijuana for a 90-day supply changes, the physician must
362 also update the registry within 7 days after the any change is
363 made to the original order to reflect the change. The physician
364 shall deactivate the registration of the patient and the
365 patient’s legal representative when the physician no longer
366 recommends the medical use of marijuana for the patient
367 treatment is discontinued; and
368 (f) Maintains a patient treatment plan that includes the
369 dose, route of administration, planned duration, and monitoring
370 of the patient’s symptoms and other indicators of tolerance or
371 reaction to the low-THC cannabis or medical cannabis;
372 (g) Submits the patient treatment plan quarterly to the
373 University of Florida College of Pharmacy for research on the
374 safety and efficacy of low-THC cannabis and medical cannabis on
376 8. (h) Obtains the voluntary written informed consent of the
377 patient or the patient’s legal representative to treatment with
378 marijuana low-THC cannabis after sufficiently explaining the
379 current state of knowledge in the medical community of the
380 effectiveness of treatment of the patient’s condition with
381 marijuana low-THC cannabis , the medically acceptable
382 alternatives, and the potential risks and side effects. If the
383 patient is a minor, the patient’s parent or legal guardian must
384 consent to treatment in writing. If the patient is an eligible
385 patient as defined in s. 499.0295, the physician must obtain
386 written informed consent as defined in and required by s.
387 499.0295. ;
388 (d) At least annually, a physician must recertify the
389 qualifying patient pursuant to paragraph (c).
390 (i) Obtains written informed consent as defined in and
391 required under s. 499.0295, if the physician is ordering medical
392 cannabis for an eligible patient pursuant to that section; and
393 (e) (j) A physician may not issue a physician certification
394 if the physician is not a medical director employed by an MMTC a
395 dispensing organization.
396 (f) An order for low-THC cannabis or medical cannabis
397 issued pursuant to former s. 381.986, Florida Statutes 2016, and
398 registered with the compassionate use registry on the effective
399 date of this act, shall be considered a physician certification
400 issued pursuant to this subsection. The details and expiration
401 date of such certification must be identical to the details and
402 expiration date of the order as logged in the compassionate use
403 registry. Until the department begins issuing compassionate use
404 registry identification cards, all patients with such orders
405 shall be considered qualifying patients, notwithstanding the
406 requirement that a qualifying patient have a compassionate use
407 registry identification card.
408 (4) (3) PROHIBITED ACTS PENALTIES.—
409 (a) A physician commits a misdemeanor of the first degree,
410 punishable as provided in s. 775.082 or s. 775.083, if the
411 physician issues a physician certification for marijuana to
412 orders low-THC cannabis for a patient in a manner other than as
413 required in subsection (3) without a reasonable belief that the
414 patient is suffering from:
415 1. Cancer or A physical medical condition that chronically
416 produces symptoms of seizures or severe and persistent muscle
417 spasms that can be treated with low-THC cannabis; or
418 2. Symptoms of cancer or a physical medical condition that
419 chronically produces symptoms of seizures or severe and
420 persistent muscle spasms that can be alleviated with low-THC
422 (b) A physician commits a misdemeanor of the first degree,
423 punishable as provided in s. 775.082 or s. 775.083, if the
424 physician orders medical cannabis for a patient without a
425 reasonable belief that the patient has a terminal condition as
426 defined in s. 499.0295.
427 (b) (c) A person who fraudulently represents that he or she
428 has a debilitating medical condition cancer, a physical medical
429 condition that chronically produces symptoms of seizures or
430 severe and persistent muscle spasms, chronic nonmalignant pain,
431 or a terminal condition as defined in s. 499.0295 to a physician
432 for the purpose of being issued a physician certification for
433 marijuana ordered low-THC cannabis, medical cannabis, or a
434 cannabis delivery device by such physician commits a misdemeanor
435 of the first degree, punishable as provided in s. 775.082 or s.
437 (c) (d) A qualifying patient an eligible patient as defined
438 in s. 499.0295 who uses marijuana medical cannabis, and such
439 patient’s caregiver legal representative who administers
440 marijuana medical cannabis, in plain view of or in a place open
441 to the general public, on the grounds of a school, or in a
442 school bus, vehicle, aircraft, or motorboat, commits a
443 misdemeanor of the first degree, punishable as provided in s.
444 775.082 or s. 775.083.
445 (d) A qualifying patient or caregiver who cultivates
446 marijuana or who purchases or acquires marijuana from any person
447 or entity other than an MMTC commits a misdemeanor of the first
448 degree, punishable as provided in s. 775.082 or s. 775.083.
449 (e) A caregiver who violates any of the applicable
450 provisions of this section or applicable department rules
451 commits, upon the first offense, a misdemeanor of the second
452 degree, punishable as provided in s. 775.082 or s. 775.083, and,
453 upon the second and subsequent offenses, a misdemeanor of the
454 first degree, punishable as provided in s. 775.082 or s.
456 (f) (e) A physician who issues a physician certification for
457 marijuana orders low-THC cannabis, medical cannabis, or a
458 cannabis delivery device and receives compensation from an MMTC
459 a dispensing organization related to issuing the physician
460 certification for marijuana the ordering of low-THC cannabis,
461 medical cannabis, or a cannabis delivery device is subject to
462 disciplinary action under the applicable practice act and s.
464 (g) An MMTC that advertises or holds out to the public that
465 it may provide services other than services for which it is
466 registered to provide violates this section, and the department
467 may impose a fine on the MMTC pursuant to paragraph (10)(h).
468 (h) A person or entity that offers or advertises services
469 as an MMTC without registering as an MMTC with the department
470 violates this section. The operation or maintenance of a
471 facility as an MMTC, or the performance of a service that
472 requires registration, without proper registration is a
473 violation of this section.
474 1. If after receiving notification from the department,
475 such person or entity fails to cease operation, the department
476 may impose an administrative fine of up to $10,000 per
477 violation. Each day of continued operation is a separate
479 2. The department or any state attorney may, in addition to
480 other remedies provided in this section, bring an action for an
481 injunction to restrain any unauthorized activity or to enjoin
482 the future operation or maintenance of the unauthorized
483 dispensing organization or entity or the performance of any
484 service in violation of this section until compliance with this
485 section and department rules has been demonstrated to the
486 satisfaction of the department.
487 3. If found to be in violation of this paragraph, the
488 department may assess reasonable investigative and legal costs
489 for prosecution of the violation against the person or entity.
490 (5) (4) PHYSICIAN EDUCATION.—
491 (a) Before a physician may issue a physician certification
492 pursuant to subsection (3) ordering low-THC cannabis, medical
493 cannabis, or a cannabis delivery device for medical use by a
494 patient in this state, the appropriate board shall require the
495 ordering physician to successfully complete a 4-hour an 8-hour
496 course and subsequent examination offered by the Florida Medical
497 Association or the Florida Osteopathic Medical Association which
498 that encompasses the clinical indications for the appropriate
499 use of marijuana low-THC cannabis and medical cannabis, the
500 appropriate cannabis delivery devices, the contraindications for
501 such use, and the relevant state and federal laws governing the
502 issuance of physician certifications ordering, as well as
503 dispensing , and possessing of these substances and devices. The
504 course and examination shall be administered at least quarterly
505 annually. Successful completion of the course may be used by a
506 physician to satisfy 4 hours 8 hours of the continuing medical
507 education requirements required by his or her respective board
508 for licensure renewal. This course may be offered in a distance
509 learning format, including an electronic, online format that is
510 available on request. Physicians who have completed an 8-hour
511 course and subsequent examination offered by the Florida Medical
512 Association or the Florida Osteopathic Medical Association which
513 encompasses the clinical indications for the appropriate use of
514 marijuana and who are registered in the compassionate use
515 registry on the effective date of this act are deemed to meet
516 the requirements of this paragraph.
517 (b) The appropriate board shall require the medical
518 director of each MMTC dispensing organization to hold an active,
519 unrestricted license as a physician under chapter 458 or as an
520 osteopathic physician under chapter 459 and successfully
521 complete a 2-hour course and subsequent examination offered by
522 the Florida Medical Association or the Florida Osteopathic
523 Medical Association which that encompasses appropriate safety
524 procedures and knowledge of marijuana low-THC cannabis, medical
525 cannabis , and cannabis delivery devices.
526 (c) Successful completion of the course and examination
527 specified in paragraph (a) is required for every physician who
528 issues a physician certification for marijuana orders low-THC
529 cannabis, medical cannabis, or a cannabis delivery device each
530 time such physician renews his or her license. In addition,
531 successful completion of the course and examination specified in
532 paragraph (b) is required for the medical director of each
533 dispensing organization each time such physician renews his or
534 her license.
535 (d) A physician who fails to comply with this subsection
536 and issues a physician certification for marijuana who orders
537 low-THC cannabis, medical cannabis , or a cannabis delivery
538 device may be subject to disciplinary action under the
539 applicable practice act and under s. 456.072(1)(k).
540 (6) CAREGIVERS.—
541 (a) During the course of registration with the department
542 for inclusion on the compassionate use registry, or at any time
543 while registered, a qualifying patient may designate an
544 individual as his or her caregiver to assist him or her with the
545 medical use of marijuana. The designated caregiver must be 21
546 years of age or older, unless the patient is a close relative of
547 the caregiver; must agree in writing to be the qualifying
548 patient’s caregiver; may not receive compensation, other than
549 actual expenses incurred, for assisting the qualifying patient
550 with the medical use of marijuana, unless the caregiver is
551 acting pursuant to employment in a licensed facility in
552 accordance with subparagraph (c)2.; and must pass a level 2
553 screening pursuant to chapter 435, unless the patient is a close
554 relative of the caregiver.
555 (b) A qualifying patient may have only one designated
556 caregiver at any given time unless all of the patient’s
557 caregivers are his or her close relatives or legal
559 (c) A caregiver may assist only one qualifying patient at
560 any given time unless:
561 1. All qualifying patients the caregiver is assisting are
562 close relatives of each other and the caregiver is the legal
563 representative of at least one of the patients; or
564 2. All qualifying patients the caregiver is assisting are
565 receiving hospice services, or are residents, in the same
566 assisted living facility, nursing home, or other licensed
567 facility and have requested the assistance of that caregiver
568 with the medical use of marijuana; the caregiver is an employee
569 of the hospice or licensed facility; and the caregiver provides
570 personal care or services directly to clients of the hospice or
571 licensed facility as a part of his or her employment duties at
572 the hospice or licensed facility.
573 (d) The department must register a caregiver on the
574 compassionate use registry and issue him or her a caregiver
575 identification card if he or she is designated by a qualifying
576 patient pursuant to paragraph (a) and meets all of the
577 requirements of this subsection and department rule.
578 (e) A nursing home or assisted living facility may not
579 prevent a qualifying patient residing in the nursing home or
580 assisted living facility from hiring a caregiver. A nursing home
581 or assisted living facility may prohibit its employees from
582 acting as caregivers to residents of the nursing home or
583 assisted living facility. A nursing home or assisted living
584 facility is not required to provide a caregiver to a resident
585 who is a qualifying patient.
586 (7) (5) DUTIES OF THE DEPARTMENT.—The department shall:
587 (a) Create and maintain a secure, electronic, and online
588 compassionate use registry for the registration of physicians,
589 patients, and caregivers the legal representatives of patients
590 as provided under this section. The registry must be accessible
592 1. Practitioners licensed under chapter 458 or chapter 459,
593 to ensure proper care for patients requesting physician
595 2. Practitioners licensed to prescribe prescription drugs,
596 to ensure proper care for patients before prescribing
597 medications that may interact with the medical use of marijuana;
598 3. Law enforcement agencies, to verify the authorization of
599 a qualifying patient or a patient’s caregiver to possess
600 marijuana or a cannabis delivery device; and
601 4. MMTCs, to a dispensing organization to verify the
602 authorization of a qualifying patient or a patient’s caregiver
603 legal representative to possess marijuana low-THC cannabis,
604 medical cannabis , or a cannabis delivery device and to record
605 the marijuana low-THC cannabis, medical cannabis , or cannabis
606 delivery device dispensed.
608 The registry must prevent an active registration of a patient by
609 multiple physicians.
610 (b) By July 3, 2017, adopt rules establishing procedures
611 for the issuance, annual renewal, suspension, and revocation of
612 compassionate use registry identification cards for patients and
613 caregivers. The department may charge a reasonable fee
614 associated with the issuance and renewal of patient and
615 caregiver identification cards. By October 3, 2017, the
616 department shall begin issuing identification cards to adult
617 patients who have a physician certification that meets the
618 requirements of subsection (3); minor patients who have a
619 physician certification that meets the requirements of
620 subsection (3) and the written consent of a parent or legal
621 guardian; and caregivers registered pursuant to subsection (6).
622 1. Before issuing an identification card to a patient, the
623 department must determine that:
624 a. The patient is a permanent resident of the state or, for
625 a patient under the age of 18, the patient’s parent or legal
626 guardian is a permanent resident of the state. The patient, or
627 the parent or legal guardian of the patient, must prove
628 permanent residency by providing the department with a copy of a
629 valid Florida driver license or Florida identification card, a
630 copy of a utility bill in his or her name issued within the
631 prior 90 days which shows an address in this state, or a copy of
632 his or her Florida voter information card.
633 b. If the patient is not a permanent resident of the state:
634 (I) He or she is eligible to receive marijuana in his or
635 her state of permanent residence; and
636 (II) He or she will be remaining in this state for at least
637 3 consecutive months.
638 (A) An adult patient may provide the department with
639 documentation that may include, but is not limited to, a rental
640 agreement for a property in this state for period of at least 3
641 months, an employment contract based in this state which
642 indicates the employment is for a period of at least 3 months,
643 or a receipt for paid tuition at a school in this state for a
644 period of at least 3 months.
645 (B) A parent or legal guardian of a patient who is under
646 the age of 18 must provide documentation as described in sub
647 sub-sub-subparagraph (A) or in department rule and provide
648 additional documentation that the patient is his or her child or
651 The department shall adopt in rule a list of documents that a
652 patient may provide to qualify for an identification card under
653 this subparagraph.
654 2. Patient and caregiver identification cards must be
655 resistant to counterfeiting and tampering and must include at
656 least the following:
657 a. The name, address, and date of birth of the patient or
658 caregiver, as appropriate;
659 b. A full-face, passport-type, color photograph of the
660 patient or caregiver, as appropriate, taken within the 90 days
661 immediately preceding registration;
662 c. Designation of the cardholder as a patient or caregiver;
663 d. A unique identification number for the patient or
664 caregiver which is matched to the identification number used for
665 such person in the department’s compassionate use registry. A
666 caregiver’s identification number and file in the compassionate
667 use registry must be linked to the file of the patient or
668 patients the caregiver is assisting so that the caregiver’s
669 status may be verified for each patient individually;
670 e. The expiration date, which shall be 1 year after the
671 date of issuance of the identification card or the date
672 treatment ends, as provided in the patient’s physician
673 certification, whichever occurs first; and
674 f. For caregivers who are assisting three or fewer
675 qualifying patients, the names and identification number of the
676 qualifying patient or patients that the caregiver is assisting.
677 (c) As soon as practicable after the effective date of this
678 act, update its records by registering each dispensing
679 organization approved pursuant to chapter 2014-157, Laws of
680 Florida, or chapter 2016-123, Laws of Florida, as an MMTC with
681 an effective registration date that coincides with that
682 dispensing organization’s date of approval as a dispensing
683 organization. On the effective date of this act, all dispensing
684 organizations approved pursuant to chapter 2014-157, Laws of
685 Florida, or chapter 2016-123, Laws of Florida, are deemed to be
686 registered MMTCs. The department may not require a dispensing
687 organization approved pursuant to chapter 2014-157, Laws of
688 Florida, or chapter 2016-123, Laws of Florida, to submit an
689 application and may not charge the dispensing organization an
690 application or registration fee for the initial registration of
691 that dispensing organization as an MMTC pursuant to this
692 section. For purposes of the requirement that an MMTC comply
693 with the representations made in its application pursuant to
694 subsection (8), an MMTC registered pursuant to this paragraph
695 shall continue to comply with the representations made in its
696 application for approval as a dispensing organization, including
697 any revision authorized by the department before the effective
698 date of this act. After the effective date of this act, the
699 department may grant variances from the representations made in
700 a dispensing organization’s application for approval pursuant to
701 subsection (8). For purposes of the definition of the term
702 “marijuana” in s. 29, of Art. X of the State Constitution, an
703 MMTC is deemed to be a dispensing organization as that term is
704 defined in former s. 381.986(1)(a), Florida Statutes 2014
705 Authorize the establishment of five dispensing organizations to
706 ensure reasonable statewide accessibility and availability as
707 necessary for patients registered in the compassionate use
708 registry and who are ordered low-THC cannabis, medical cannabis,
709 or a cannabis delivery device under this section, one in each of
710 the following regions: northwest Florida, northeast Florida,
711 central Florida, southeast Florida, and southwest Florida.
712 (d) By October 3, 2017, register five additional MMTCs with
713 at least one of the MMTCs being an applicant that is a
714 recognized class member of Pigford v. Glickman, 185 F.R.D. 82
715 (D.D.C. 1999), or In re Black Farmers Litig., 856 F. Supp. 2d 1
716 (D.D.C. 2011), and a member of the Black Farmers and
717 Agriculturalists Association.
718 (e) Within 6 months after each instance of the registration
719 of 75,000 qualifying patients with the compassionate use
720 registry, register four additional MMTCs if a sufficient number
721 of MMTC applicants meet the registration requirements
722 established in this section and by department rule.
723 (f) Not issue more than one registration as an MMTC to a
724 person or an entity.
725 (g) Identify applicants with strong diversity plans
726 reflecting this state’s commitment to diversity.
727 (h) Implement training programs and other educational
728 programs to enable minority persons and minority business
729 enterprises, as defined in s. 288.703, and veteran business
730 enterprises, as defined in s. 295.187, to compete for MMTC
731 registration and contracts.
732 (i) The department shall Develop an application form for
733 registration as an MMTC and impose an initial application and
734 biennial renewal fee that is sufficient to cover the costs of
735 administering this section. To be registered as an MMTC, the an
736 applicant for approval as a dispensing organization must be able
737 to demonstrate:
738 1. That, for the 5 consecutive years before submitting the
739 application, the applicant has been registered to do business in
740 this state.
741 2. 1. The technical and technological ability to cultivate
742 and produce low-THC cannabis and marijuana. The applicant must
743 possess a valid certificate of registration issued by the
744 Department of Agriculture and Consumer Services pursuant to s.
745 581.131 that is issued for the cultivation of more than 400,000
746 plants, be operated by a nurseryman as defined in s. 581.011,
747 and have been operated as a registered nursery in this state for
748 at least 30 continuous years.
749 3. 2. The ability to secure the premises, resources, and
750 personnel necessary to operate as an MMTC a d ispensing
752 4. 3. The ability to maintain accountability of all raw
753 materials, finished products, and any byproducts to prevent
754 diversion or unlawful access to or possession of these
756 5. 4. An infrastructure reasonably located to dispense low
757 THC cannabis and marijuana to registered qualifying patients
758 statewide or regionally as determined by the department.
759 6. 5. The financial ability to maintain operations for the
760 duration of the 2-year approval cycle, including the provision
761 of certified financials to the department. Upon approval, the
762 applicant must post a $5 million performance bond. However, upon
763 an MMTC a dispensing organization’s serving at least 1,000
764 qualifying qualified patients, the MMTC dispensing organization
765 is only required to maintain a $2 million performance bond.
766 7. 6. That all owners and managers have been fingerprinted
767 and have successfully passed a level 2 background screening
768 pursuant to s. 435.04.
769 8. The ability to implement a diversity plan that promotes
770 and ensures the involvement of minority persons and minority
771 business enterprises, as defined in s. 288.703, or veteran
772 business enterprises, as defined in s. 295.187, in ownership,
773 management, employment, and contracting opportunities.
774 a. A diversity plan must be submitted with an MMTC
776 b. Upon registration renewal the MMTC must show the
777 effectiveness of the diversity plan by including the following:
778 (I) Representation of minority persons and veterans in the
779 MMTC’s workforce;
780 (II) Efforts to recruit minority persons and veterans for
781 employment; and
782 (III) A record of contracts for services with minority
783 business enterprises and veteran business enterprises.
784 9. 7. The employment of a medical director to supervise the
785 activities of the MMTC dispensing organization.
786 (c) Upon the registration of 250,000 active qualified
787 patients in the compassionate use registry, approve three
788 dispensing organizations, including, but not limited to, an
789 applicant that is a recognized class member of Pigford v.
790 Glickman , 185 F.R.D. 82 (D.D.C. 1999), or In Re Black Farmers
791 Litig. , 856 F. Supp. 2d 1 (D.D.C. 2011), and a member of the
792 Black Farmers and Agriculturalists Association, which must meet
793 the requirements of subparagraphs (b)2.-7. and demonstrate the
794 technical and technological ability to cultivate and produce
795 low-THC cannabis.
796 (j) (d) Allow an MMTC a d ispensing organization to make a
797 wholesale purchase of marijuana low-THC cannabis or medical
798 cannabis from, or a distribution of marijuana low-THC cannabis
799 or medical cannabis to, another MMTC dispensing organization.
800 (k) (e) Monitor physician registration in the compassionate
801 use registry and the issuance of physician certifications
802 pursuant to subsection (3) ordering of low-THC cannabis, medical
803 cannabis, or a cannabis delivery device for ordering practices
804 that could facilitate unlawful diversion or misuse of marijuana
805 low-THC cannabis, medical cannabis , or a cannabis delivery
806 devices device and take disciplinary action as indicated.
807 (8) (6) MEDICAL MARIJUANA TREATMENT CENTERS DISPENSING
808 ORGANIZATION.—Each MMTC must register with the department. A
809 registered MMTC An approved dispensing organization must, at all
810 times, maintain compliance with paragraph (7)(i), the criteria
811 demonstrated for selection and approval as a dispensing
812 organization under subsection(5 ) and the criteria required in
813 this subsection, and all representations made to the department
814 in the MMTC’s application for registration. Upon request, the
815 department may grant an MMTC one or more variances from the
816 representations made in the MMTC’s application. Consideration of
817 such a variance shall be based upon the individual facts and
818 circumstances surrounding the request. A variance may not be
819 granted unless the requesting MMTC can demonstrate to the
820 department that it has a proposed alternative to the specific
821 representation made in its application which fulfills the same
822 or a similar purpose as the specific representation in a way
823 that the department can reasonably determine will not be a lower
824 standard than the specific representation in the application.
825 (a) When growing marijuana low-THC cannabis or medical
826 cannabis, an MMTC a dispensing organization:
827 1. May use pesticides determined by the department, after
828 consultation with the Department of Agriculture and Consumer
829 Services, to be safely applied to plants intended for human
830 consumption, but may not use pesticides designated as
831 restricted-use pesticides pursuant to s. 487.042.
832 2. Must grow marijuana low-THC cannabis or medical cannabis
833 within an enclosed structure and in a room separate from any
834 other plant.
835 3. Must inspect seeds and growing plants for plant pests
836 that endanger or threaten the horticultural and agricultural
837 interests of the state, notify the Department of Agriculture and
838 Consumer Services within 10 calendar days after a determination
839 that a plant is infested or infected by such plant pest, and
840 implement and maintain phytosanitary policies and procedures.
841 4. Must perform fumigation or treatment of plants, or the
842 removal and destruction of infested or infected plants, in
843 accordance with chapter 581 and any rules adopted thereunder.
844 (b) When processing marijuana low-THC cannabis or medical
845 cannabis, an MMTC a dispensing organization must:
846 1. Process the marijuana low-THC cannabis or medical
847 cannabis within an enclosed structure and in a room separate
848 from other plants or products.
849 2. Have the marijuana tested by an independent testing
850 laboratory to ensure it meets the standards established by the
851 department’s quality control program Test the processed low-THC
852 cannabis and medical cannabis before it is they are dispensed.
853 Results must be verified and signed by two dispensing
854 organization employees. Before dispensing low-THC cannabis, the
855 dispensing organization must determine that the test results
856 indicate that the low-THC cannabis meets the definition of low
857 THC cannabis and, for medical cannabis and low-THC cannabis,
858 that all medical cannabis and low-THC cannabis is safe for human
859 consumption and free from contaminants that are unsafe for human
860 consumption. The dispensing organization must retain records of
861 all testing and samples of each homogenous batch of cannabis and
862 low-THC cannabis for at least 9 months. The dispensing
863 organization must contract with an independent testing
864 laboratory to perform audits on the dispensing organization’s
865 standard operating procedures, testing records, and samples and
866 provide the results to the department to confirm that the low
867 THC cannabis or medical cannabis meets the requirements of this
868 section and that the medical cannabis and low-THC cannabis is
869 safe for human consumption.
870 3. Package the marijuana low-THC cannabis or medical
871 cannabis in compliance with the United States Poison Prevention
872 Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.
873 4. Package the marijuana low-THC cannabis or medical
874 cannabis in a childproof receptacle that has a firmly affixed
875 and legible label stating the following information:
876 a. A statement that the marijuana low-THC cannabis or
877 medical cannabis meets the requirements of subparagraph 2.;
878 b. The name of the MMTC dispensing organization from which
879 the marijuana medical cannabis or low-THC cannabis originates;
881 c. The batch number and harvest number from which the
882 marijuana medical cannabis or low-THC cannabis originates; and
883 d. The concentration of tetrahydrocannabinol and
884 cannabidiol in the product.
885 e. Any other information required by department rule
886 5. Reserve two processed samples from each batch and retain
887 such samples for at least 9 months for the purpose of testing
888 pursuant to the audit required under subparagraph 2.
889 (c) When dispensing marijuana low-THC cannabis, medical
890 cannabis , or a marijuana cannabis delivery device, an MMTC a
891 d ispensing organization:
892 1. May not dispense more than the a 45-day supply of
893 marijuana authorized by a qualifying patient’s physician
894 certification low-THC cannabis or medical cannabis to a
895 qualifying patient or caregiver the patient’s legal
897 2. Must ensure that the have the dispensing organization’s
898 employee who dispenses the marijuana low-THC cannabis, medical
899 cannabis , or marijuana a cannabis delivery device enters enter
900 into the compassionate use registry his or her name or unique
901 employee identifier.
902 3. Must verify that the qualifying patient and the
903 caregiver, if applicable, both have an active and valid
904 compassionate use registry identification card and that the
905 amount and type of marijuana dispensed match the physician
906 certification in the compassionate use registry for that
907 qualifying patient that a physician has ordered the low-THC
908 cannabis, medical cannabis, or a specific type of a cannabis
909 delivery device for the patient.
910 4. Must label the marijuana with the recommended dose for
911 the qualifying patient receiving the marijuana.
912 5. 4. May not dispense or sell any other type of marijuana
913 cannabis, alcohol, or illicit drug-related product, including
914 pipes, bongs, or wrapping papers, other than a physician-ordered
915 cannabis delivery device required for the medical use of
916 marijuana which is specified in a physician certification low
917 THC cannabis or medical cannabis , while dispensing low-THC
918 cannabis or medical cannabis. An MMTC may produce and dispense
919 marijuana as an edible or food product but may not produce such
920 items in a format designed to be attractive to children. In
921 addition to the requirements of this section and department
922 rule, food products produced by an MMTC must meet all food
923 safety standards established in state and federal law,
924 including, but not limited to, the identification of the serving
925 size and the amount of tetrahydrocannabinol in each serving.
926 5. Must verify that the patient has an active registration
927 in the compassionate use registry, the patient or patient’s
928 legal representative holds a valid and active registration card,
929 the order presented matches the order contents as recorded in
930 the registry, and the order has not already been filled.
931 6. Must, upon dispensing the marijuana l ow-THC cannabis,
932 medical cannabis , or marijuana cannabis delivery device, record
933 in the registry the date, time, quantity, and form of marijuana
934 low-THC cannabis or medical cannabis dispensed; and the type of
935 marijuana cannabis delivery device dispensed; and the name and
936 compassionate use registry identification number of the
937 qualifying patient or caregiver to whom the marijuana delivery
938 device was dispensed.
939 7. May not dispense marijuana from more than three
940 dispensing facilities. This subparagraph does not apply to MMTC
941 retail facilities that only dispense low-THC cannabis and sell
942 marijuana delivery devices to qualified patients.
943 (d) To ensure the safety and security of its premises and
944 any off-site storage facilities, and to maintain adequate
945 controls against the diversion, theft, and loss of marijuana
946 low-THC cannabis, medical cannabis , or marijuana cannabis
947 delivery devices, an MMTC a di spensing organization shall:
948 1.a. Maintain a fully operational security alarm system
949 that secures all entry points and perimeter windows and is
950 equipped with motion detectors; pressure switches; and duress,
951 panic, and hold-up alarms; or
952 b. Maintain a video surveillance system that records
953 continuously 24 hours each day and meets at least one of the
954 following criteria:
955 (I) Cameras are fixed in a place that allows for the clear
956 identification of persons and activities in controlled areas of
957 the premises. Controlled areas include grow rooms, processing
958 rooms, storage rooms, disposal rooms or areas, and point-of-sale
960 (II) Cameras are fixed in entrances and exits to the
961 premises, which shall record from both indoor and outdoor, or
962 ingress and egress, vantage points;
963 (III) Recorded images must clearly and accurately display
964 the time and date; or
965 (IV) Retain video surveillance recordings for a minimum of
966 45 days, or longer upon the request of a law enforcement agency.
967 2. Ensure that the MMTC’s organization’s outdoor premises
968 have sufficient lighting from dusk until dawn.
969 3. Implement Establish and maintain a tracking system using
970 a vendor approved by the department which that traces the
971 marijuana low-THC cannabis or medical cannabis from seed to
972 sale. The tracking system must shall include notification of key
973 events as determined by the department, including when cannabis
974 seeds are planted, when cannabis plants are harvested and
975 destroyed, and when marijuana low-THC cannabis or medical
976 cannabis is transported, sold, stolen, diverted, or lost.
977 4. Not dispense from its premises marijuana low-THC
978 cannabis, medical cannabis , or a cannabis delivery device
979 between the hours of 9 p.m. and 7 a.m., but may perform all
980 other operations and deliver marijuana low-THC cannabis and
981 medical cannabis to qualifying qualified patients 24 hours each
983 5. Store marijuana low-THC cannabis or medical cannabis in
984 a secured, locked room or a vault.
985 6. Require at least two of its employees, or two employees
986 of a security agency with whom it contracts, to be on the
987 premises at all times.
988 7. Require each employee or contractor to wear a photo
989 identification badge at all times while on the premises.
990 8. Require each visitor to wear a visitor’s pass at all
991 times while on the premises.
992 9. Implement an alcohol and drug-free workplace policy.
993 10. Report to local law enforcement within 24 hours after
994 it is notified or becomes aware of the theft, diversion, or loss
995 of marijuana low-THC cannabis or medical cannabis.
996 (e) To ensure the safe transport of marijuana low-THC
997 cannabis or medical cannabis to MMTC dispensing organization
998 facilities, independent testing laboratories, or qualifying
999 patients, the MMTC dispensing organization must:
1000 1. Maintain a transportation manifest, which must be
1001 retained for at least 1 year. A copy of the manifest must be in
1002 the vehicle at all times when transporting marijuana.
1003 2. Ensure only vehicles in good working order are used to
1004 transport marijuana low-THC cannabis or medical cannabis.
1005 3. Lock marijuana low-THC cannabis or medical cannabis in a
1006 separate compartment or container within the vehicle.
1007 4. Require at least two persons to be in a vehicle
1008 transporting marijuana low-THC cannabis or medical cannabis, and
1009 require at least one person to remain in the vehicle while the
1010 marijuana low-THC cannabis or medical cannabis is being
1012 5. Provide specific safety and security training to
1013 employees transporting or delivering marijuana low-THC cannabis
1014 or medical cannabis.
1015 (9) MARIJUANA QUALITY CONTROL PROGRAM AND INDEPENDENT
1016 TESTING LABORATORY LICENSURE.—
1017 (a) The department shall establish a quality control
1018 program requiring marijuana to be tested by an independent
1019 testing laboratory for potency and contaminants before sale to
1020 qualifying patients and caregivers.
1021 1. The quality control program must require MMTCs to submit
1022 samples from each batch or lot of marijuana harvested or
1023 processed to an independent testing laboratory for testing to
1024 ensure, at a minimum, that the labeling of the potency of
1025 tetrahydrocannabinol and all other marketed cannabinoids or
1026 terpenes is accurate and that the marijuana dispensed to
1027 qualifying patients is safe for human consumption.
1028 2. An MMTC must maintain records of all tests conducted,
1029 including the results of each test and any additional
1030 information, as required by the department.
1031 3. The department shall adopt all rules necessary to create
1032 and oversee the quality control program, which must include, at
1033 a minimum:
1034 a. Permissible levels of variation in potency labeling and
1035 standards requiring tetrahydrocannabinol in edible marijuana
1036 products to be distributed consistently throughout the product;
1037 b. Permissible levels of contaminants and mandatory testing
1038 for contaminants to confirm that the tested marijuana is safe
1039 for human consumption. This testing must include, but is not
1040 limited to, testing for microbiological impurity, residual
1041 solvents, and pesticide residues;
1042 c. The destruction of marijuana determined to be
1043 inaccurately labeled or unsafe for human consumption after the
1044 MMTC has an opportunity to take remedial action;
1045 d. The collection, storage, handling, recording, and
1046 destruction of samples of marijuana by independent testing
1047 laboratories; and
1048 e. Security, inventory tracking, and record retention.
1049 (b) The department must license all independent testing
1050 laboratories to ensure that all marijuana is tested for potency
1051 and contaminants in accordance with the department’s quality
1052 control program. An independent testing laboratory may collect
1053 and accept samples of, and possess, store, transport, and test
1054 marijuana. An independent testing laboratory may not be owned by
1055 a person who also possesses an ownership interest in an MMTC. A
1056 clinical laboratory that is licensed by the Agency for Health
1057 Care Administration pursuant to part I of chapter 483 and that
1058 performs nonwaived clinical tests is exempt from the requirement
1059 to be licensed by the department pursuant to this paragraph but
1060 must be certified to perform all required tests pursuant to
1061 subparagraph 2.
1062 1. The department shall develop rules establishing
1063 independent testing laboratory license requirements and a
1064 process for licensing independent testing laboratories; develop
1065 an application form for an independent testing laboratory
1066 license; and impose an initial application fee and a biennial
1067 renewal fee sufficient to cover the costs of administering this
1069 2. In addition to licensure, an independent testing
1070 laboratory must be certified to perform all required tests by
1071 the department. The department must issue a certification to an
1072 independent testing laboratory that has been certified by a
1073 third-party laboratory certification body approved by the
1074 department. The department shall establish reasonable rules for
1075 the certification and operation of independent testing
1076 laboratories. Rules for certification must, at a minimum,
1077 address standards relating to:
1078 a. Personnel qualifications;
1079 b. Equipment and methodology;
1080 c. Proficiency testing;
1081 d. Tracking;
1082 e. Sampling;
1083 f. Chain of custody;
1084 g. Record and sample retention;
1085 h. Reporting;
1086 i. Audit and inspection; and
1087 j. Security.
1088 3. The department shall suspend or reduce any mandatory
1089 testing requirement specified in its quality control program if
1090 the number of licensed and certified independent testing
1091 laboratories is insufficient to process the tests necessary to
1092 meet the patients’ demand for marijuana.
1093 4. An independent testing laboratory may accept only
1094 samples composed of marijuana which are obtained from a sample
1095 source approved by the department. At a minimum, these sources
1096 must include an MMTC, a researcher affiliated with an accredited
1097 university or research hospital, a qualifying patient, and a
1099 (10) (7) DEPARTMENT AUTHORITY AND RESPONSIBILITIES.—
1100 (a) The department may conduct announced or unannounced
1101 inspections of MMTCs dispensing organizations to determine
1102 compliance with this section or rules adopted pursuant to this
1104 (b) The department shall inspect an MMTC a d ispensing
1105 organization upon complaint or notice provided to the department
1106 that the MMTC dispensing organization has dispensed marijuana
1107 low-THC cannabis or medical cannabis containing any mold,
1108 bacteria, or other contaminant that may cause or has caused an
1109 adverse effect to human health or the environment.
1110 (c) The department shall conduct at least a biennial
1111 inspection of each MMTC dispensing organization to evaluate the
1112 MMTC’s dispensing organization’s records, personnel, equipment,
1113 processes, security measures, sanitation practices, and quality
1114 assurance practices.
1115 (d) The department shall approve an MMTC’s request for a
1116 change in ownership, equity structure, or transfer of
1117 registration to a new entity that meets the requirements in
1118 paragraph (7)(i) if individuals seeking a 5 percent or greater
1119 direct or indirect equity interest in the MMTC are fingerprinted
1120 and have successfully passed a level 2 background screening
1121 pursuant to s. 435.04. Individuals who seek or hold less than a
1122 5 percent direct or indirect equity interest in the MMTC are not
1123 required to be fingerprinted or pass the background check. A
1124 request for a change in MMTC ownership, equity structure, or
1125 transfer of registration is deemed approved if not denied by the
1126 department within 15 days after receipt of the request. The
1127 department shall adopt by rule a process which includes specific
1128 criteria for the approval or denial of such requests.
1129 (e) The department shall establish, maintain, and control a
1130 computer software tracking system that traces marijuana from
1131 seed to sale and allows real-time, 24-hour access by the
1132 department to data from all MMTCs and independent testing
1133 laboratories. The tracking system must, at a minimum, include
1134 notification of when marijuana seeds are planted, when marijuana
1135 plants are harvested and destroyed, and when marijuana is
1136 transported, sold, stolen, diverted, or lost. Each MMTC shall
1137 use the seed-to-sale tracking system selected by the department.
1138 (f) (d) The department may enter into interagency agreements
1139 with the Department of Agriculture and Consumer Services, the
1140 Department of Business and Professional Regulation, the
1141 Department of Transportation, the Department of Highway Safety
1142 and Motor Vehicles, and the Agency for Health Care
1143 Administration, and such agencies are authorized to enter into
1144 an interagency agreement with the department, to conduct
1145 inspections or perform other responsibilities assigned to the
1146 department under this section.
1147 (g) (e) The department must make a list of all approved
1148 MMTCs, dispensing organizations and qualified ordering
1149 physicians who are qualified to issue physician certifications,
1150 and medical directors publicly available on its website.
1151 (f) The department may establish a system for issuing and
1152 renewing registration cards for patients and their legal
1153 representatives, establish the circumstances under which the
1154 cards may be revoked by or must be returned to the department,
1155 and establish fees to implement such system. The department must
1156 require, at a minimum, the registration cards to:
1157 1. Provide the name, address, and date of birth of the
1158 patient or legal representative.
1159 2. Have a full-face, passport-type, color photograph of the
1160 patient or legal representative taken within the 90 days
1161 immediately preceding registration.
1162 3. Identify whether the cardholder is a patient or legal
1164 4. List a unique numeric identifier for the patient or
1165 legal representative that is matched to the identifier used for
1166 such person in the department’s compassionate use registry.
1167 5. Provide the expiration date, which shall be 1 year after
1168 the date of the physician’s initial order of low-THC cannabis or
1169 medical cannabis.
1170 6. For the legal representative, provide the name and
1171 unique numeric identifier of the patient that the legal
1172 representative is assisting.
1173 7. Be resistant to counterfeiting or tampering.
1174 (h) (g) The department may impose reasonable fines not to
1175 exceed $10,000 on an MMTC a dispensing organization for any of
1176 the following violations:
1177 1. Violating this section, s. 499.0295, or department rule.
1178 2. Failing to maintain qualifications for registration with
1179 the department approval.
1180 3. Endangering the health, safety, or security of a
1181 qualifying qualified patient.
1182 4. Improperly disclosing personal and confidential
1183 information of a qualifying the qualified patient.
1184 5. Attempting to procure MMTC registration with the
1185 department dispensing organization approval by bribery,
1186 fraudulent misrepresentation, or extortion.
1187 6. Any owner or manager of the MMTC being convicted or
1188 found guilty of, or entering a plea of guilty or nolo contendere
1189 to, regardless of adjudication, a crime in any jurisdiction
1190 which directly relates to the business of an MMTC a d ispensing
1192 7. Making or filing a report or record that the MMTC
1193 dispensing organization knows to be false.
1194 8. Willfully failing to maintain a record required by this
1195 section or department rule.
1196 9. Willfully impeding or obstructing an employee or agent
1197 of the department in the furtherance of his or her official
1199 10. Engaging in fraud or deceit, negligence, incompetence,
1200 or misconduct in the business practices of an MMTC a dispensing
1202 11. Making misleading, deceptive, or fraudulent
1203 representations in or related to the business practices of an
1204 MMTC a dispensing organization.
1205 12. Having a license or the authority to engage in any
1206 regulated profession, occupation, or business that is related to
1207 the business practices of an MMTC a dispensing organization
1208 suspended, revoked, or otherwise acted against by the licensing
1209 authority of any jurisdiction, including its agencies or
1210 subdivisions, for a violation that would constitute a violation
1211 under Florida law.
1212 13. Violating a lawful order of the department or an agency
1213 of the state, or failing to comply with a lawfully issued
1214 subpoena of the department or an agency of the state.
1215 (i) (h) The department may suspend, revoke, or refuse to
1216 renew an MMTC’s registration with the department a dispensing
1217 organization’s approval if the MMTC a dispensing organization
1218 commits a violation specified any of the violations in paragraph
1219 (h) (g).
1220 (j) (i) The department shall renew an MMTC’s registration
1221 with the department the approval of a dispensing organization
1222 biennially if the MMTC dispensing organization meets the
1223 requirements of this section and pays the biennial renewal fee.
1224 (k) (j) The department may adopt rules necessary to
1225 implement this section.
1226 (11) (8) PREEMPTION.—
1227 (a) All matters regarding the regulation of the cultivation
1228 and processing of marijuana medical cannabis or low-THC cannabis
1229 by MMTCs dispensing organizations are preempted to the state.
1230 (b) A municipality may determine by ordinance the criteria
1231 for the number and location of, and other permitting
1232 requirements that do not conflict with state law or department
1233 rule for, dispensing facilities of MMTCs dispensing
1234 organizations located within its municipal boundaries. A county
1235 may determine by ordinance the criteria for the number,
1236 location, and other permitting requirements that do not conflict
1237 with state law or department rule for all dispensing facilities
1238 of MMTCs dispensing organizations located within the
1239 unincorporated areas of that county.
1240 (12) (9) EXCEPTIONS TO OTHER LAWS.—
1241 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
1242 any other provision of law, but subject to the requirements of
1243 this section, a qualifying qualified patient, or a caregiver who
1244 has obtained a valid compassionate use registry identification
1245 card from the department, and the qualified patient’s legal
1246 representative may purchase from an MMTC, and possess for the
1247 qualifying patient’s medical use, up to the amount of marijuana
1248 in the physician certification low-THC cannabis or medical
1249 cannabis ordere d for the patient, but not more than a 90-day 45
1250 day supply, and a cannabis delivery device specified in the
1251 physician certification ordered for the qualifying patient.
1252 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
1253 any other provision of law, but subject to the requirements of
1254 this section, an MMTC an approved dispensing organization and
1255 its owners, managers, contractors, and employees may
1256 manufacture, possess, sell, deliver, distribute, dispense,
1257 administer, and lawfully dispose of reasonable quantities, as
1258 established by department rule, of marijuana low-THC cannabis ,
1259 medical cannabis , or a cannabis delivery device. For purposes of
1260 this subsection, the terms “manufacture,” “possession,”
1261 “deliver,” “distribute,” and “dispense” have the same meanings
1262 as provided in s. 893.02.
1263 (c) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
1264 any other provision of law, but subject to the requirements of
1265 this section, an approved independent testing laboratory may
1266 possess, test, transport, and lawfully dispose of marijuana low
1267 THC cannabis or medical cannabis as provided by department rule.
1268 (d) An MMTC approved dispensing organization and its
1269 owners, managers, contractors, and employees are not subject to
1270 licensure or regulation under chapter 465 or chapter 499 for
1271 manufacturing, possessing, selling, delivering, distributing,
1272 dispensing, or lawfully disposing of reasonable quantities, as
1273 established by department rule, of marijuana low-THC cannabis ,
1274 medical cannabis , or a cannabis delivery device.
1275 (e) Exercise by an MMTC of An approved dispensing
1276 organization that continues to meet the requirements for
1277 approval is presumed to be registered with the department and to
1278 meet the regulations adopted by the department or its successor
1279 agency for the purpose of dispensing medical cannabis or low-THC
1280 cannabis under Florida law. Additionally, the authority provided
1281 to MMTCs a d ispensing organization in s. 499.0295 does not
1282 impair its registration with the department the approval of a
1283 d ispensing organization.
1284 (f) This subsection does not exempt a person from
1285 prosecution for a criminal offense related to impairment or
1286 intoxication resulting from the medical use of marijuana low-THC
1287 cannabis or medical cannabis or relieve a person from any
1288 requirement under law to submit to a breath, blood, urine, or
1289 other test to detect the presence of a controlled substance.
1290 (g) This section does not limit the ability of an employer
1291 to establish, continue, or enforce a drug-free workplace program
1292 or substance abuse policy. Notwithstanding any other provision
1293 of law, this section does not require an employer to accommodate
1294 the ingestion of marijuana in any workplace or any employee
1295 working while under the influence of marijuana. Notwithstanding
1296 any other provision of law, this section does not create a cause
1297 of action against an employer for wrongful discharge or
1299 (h) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
1300 any other provision of law, but subject to the requirements of
1301 this section, a research institute established by a public
1302 postsecondary educational institution, such as the H. Lee
1303 Moffitt Cancer Center and Research Institute established under
1304 s. 1004.43, or a state university that has achieved the
1305 preeminent state research university designation pursuant to s.
1306 1001.7065 may possess, test, transport, and lawfully dispose of
1307 marijuana for research purposes as provided by department rule.
1308 (13) RULEMAKING.—
1309 (a) The department and the applicable boards shall adopt
1310 emergency rules pursuant to s. 120.54(4) and this subsection
1311 necessary to implement this section. If an emergency rule
1312 adopted under this subsection is held to be unconstitutional or
1313 an invalid exercise of delegated legislative authority and
1314 becomes void, the department and the applicable boards may adopt
1315 an emergency rule to replace the rule that has become void. If
1316 the emergency rule adopted to replace the void emergency rule is
1317 also held to be unconstitutional or an invalid exercise of
1318 delegated legislative authority and becomes void, the department
1319 and the applicable boards must follow the nonemergency
1320 rulemaking procedures of the Administrative Procedures Act to
1321 replace the rule that has become void.
1322 (b) For emergency rules adopted under this subsection, the
1323 department and the applicable boards need not make the findings
1324 required by s. 120.54(4)(a). Emergency rules adopted under this
1325 subsection are exempt from ss. 120.54(3)(b) and 120.541. The
1326 department and the applicable boards shall meet the procedural
1327 requirements in s. 120.54(2)(a) if the department or the
1328 applicable boards have, before the effective date of this act,
1329 held any public workshops or hearings on the subject matter of
1330 emergency rules adopted under this subsection. Challenges to
1331 emergency rules adopted under this subsection are subject to the
1332 time schedules provided in s. 120.56(5).
1333 (c) Emergency rules adopted under this section are exempt
1334 from s. 120.54(4)(c) and shall remain in effect until replaced
1335 by rules adopted under the nonemergency rulemaking procedures of
1336 the Administrative Procedures Act. By January 1, 2018, the
1337 department and the applicable boards shall initiate nonemergency
1338 rulemaking pursuant to the Administrative Procedures Act by
1339 publishing a notice of rule development in the Florida
1340 Administrative Register. Except as provided in paragraph (a),
1341 after January 1, 2018, the department and applicable boards may
1342 not adopt rules pursuant to the emergency rulemaking procedures
1343 provided in this subsection.
1344 Section 2. Section 1004.4351, Florida Statutes, is created
1345 to read:
1346 1004.4351 Medical marijuana research and education.—
1347 (1) SHORT TITLE.—This section shall be known and may be
1348 cited as the “Medical Marijuana Research and Education Act.”
1349 (2) LEGISLATIVE FINDINGS.—The Legislature finds that:
1350 (a) The present state of knowledge concerning the use of
1351 marijuana to alleviate pain and treat illnesses is limited
1352 because permission to perform clinical studies on marijuana is
1353 difficult to obtain, with access to research-grade marijuana so
1354 restricted that little or no unbiased studies have been
1356 (b) Under the State Constitution, marijuana is available
1357 for the treatment of certain debilitating medical conditions.
1358 (c) Additional clinical studies are needed to ensure that
1359 the residents of this state obtain the correct dosing,
1360 formulation, route, modality, frequency, quantity, and quality
1361 of marijuana for specific illnesses.
1362 (d) An effective medical marijuana research and education
1363 program would mobilize the scientific, educational, and medical
1364 resources that presently exist in this state to determine the
1365 appropriate and best use of marijuana to treat illness.
1366 (3) DEFINITIONS.—As used in this section, the term:
1367 (a) “Board” means the Medical Marijuana Research and
1368 Education Board.
1369 (b) “Coalition” means the Coalition for Medical Marijuana
1370 Research and Education.
1371 (c) “Marijuana” has the same meaning as provided in s. 29,
1372 Art. X of the State Constitution.
1373 (4) COALITION FOR MEDICAL MARIJUANA RESEARCH AND
1375 (a) There is established within the H. Lee Moffitt Cancer
1376 Center and Research Institute, Inc., the Coalition for Medical
1377 Marijuana Research and Education. The purpose of the coalition
1378 is to conduct rigorous scientific research, provide education,
1379 disseminate research, and guide policy for the adoption of a
1380 statewide policy on ordering and dosing practices for the
1381 medicinal use of marijuana. The coalition shall be physically
1382 located at the H. Lee Moffitt Cancer Center and Research
1383 Institute, Inc.
1384 (b) Beginning January 15, 2018, and quarterly thereafter,
1385 the Department of Health shall electronically submit to the
1386 coalition a data set that includes, for each patient registered
1387 with the compassionate use registry, as described in s. 381.986:
1388 1. The debilitating medical condition, as defined in s.
1389 381.986, of the patient;
1390 2. The amount of marijuana certified, and the recommended
1391 length of time that the amount of marijuana is certified, for
1392 the patient;
1393 3. The route of administration of marijuana to the patient
1394 and any delivery device for the administration of marijuana to
1395 the patient; and
1396 4. The patient’s certifying physician.
1398 The coalition shall review the data submitted by the department.
1399 If, after review of the data, the coalition determines that
1400 state law and rules should be modified to address abuse or fraud
1401 of the system established in s. 29, Art. X of the State
1402 Constitution, s. 381.986, and associated rules, the coalition
1403 must include recommendations for changes to state law and rules
1404 to address such abuse or fraud in the report submitted by the
1405 board pursuant to paragraph (g).
1406 (c) The Medical Marijuana Research and Education Board is
1407 established to direct the operations of the coalition. The board
1408 shall be composed of seven members appointed by the chief
1409 executive officer of the H. Lee Moffitt Cancer Center and
1410 Research Institute, Inc. Board members must have experience in a
1411 variety of scientific and medical fields, including, but not
1412 limited to, oncology, neurology, psychology, pediatrics,
1413 nutrition, and addiction. Members shall be appointed to 4-year
1414 terms and may be reappointed to serve additional terms. The
1415 chair shall be elected by the board from among its members to
1416 serve a 2-year term. The board shall meet no less than
1417 semiannually, at the call of the chair or, in his or her absence
1418 or incapacity, the vice chair. Four members constitute a quorum.
1419 A majority vote of the members present is required for all
1420 actions of the board. The board may prescribe, amend, and repeal
1421 a charter governing the manner in which it conducts its
1422 business. A board member shall serve without compensation but is
1423 entitled to be reimbursed for travel expenses by the coalition
1424 or the organization he or she represents in accordance with s.
1426 (d) The coalition shall be administered by a coalition
1427 director, who shall be appointed by and serve at the pleasure of
1428 the board. The coalition director shall, subject to the approval
1429 of the board:
1430 1. Propose a budget for the coalition.
1431 2. Foster the collaboration of scientists, researchers, and
1432 other appropriate personnel in accordance with the coalition’s
1434 3. Identify and prioritize the research to be conducted by
1435 the coalition.
1436 4. Prepare the Medical Marijuana Research and Education
1437 Plan for submission to the board.
1438 5. Apply for grants to obtain funding for research
1439 conducted by the coalition.
1440 6. Perform other duties as determined by the board.
1441 (e) The board shall advise the Board of Governors, the
1442 State Surgeon General, the Governor, and the Legislature with
1443 respect to medical marijuana research and education in this
1444 state. The board shall explore methods of implementing and
1445 enforcing medical marijuana laws in relation to cancer control,
1446 research, treatment, and education.
1447 (f) The board shall annually adopt a plan for medical
1448 marijuana research, known as the “Medical Marijuana Research and
1449 Education Plan,” which must be in accordance with state law and
1450 coordinate with existing programs in this state. The plan must
1451 include recommendations for the coordination and integration of
1452 medical, nursing, paramedical, community, and other resources
1453 connected with the treatment of debilitating medical conditions,
1454 research related to the treatment of such medical conditions,
1455 and education.
1456 (g) By February 15 of each year, the board shall issue a
1457 report to the Governor, the President of the Senate, and the
1458 Speaker of the House of Representatives on research projects,
1459 community outreach initiatives, and future plans for the
1461 (5) RESPONSIBILITIES OF THE H. LEE MOFFITT CANCER CENTER
1462 AND RESEARCH INSTITUTE, INC.—The H. Lee Moffitt Cancer Center
1463 and Research Institute, Inc., shall allocate staff and provide
1464 information and assistance, as the coalition’s budget permits,
1465 to assist the board in fulfilling its responsibilities.
1466 Section 3. Paragraph (b) of subsection (3) of section
1467 381.987, Florida Statutes, is amended to read:
1468 381.987 Public records exemption for personal identifying
1469 information in the compassionate use registry.—
1470 (3) The department shall allow access to the registry,
1471 including access to confidential and exempt information, to:
1472 (b) A medical marijuana treatment center registered with
1473 dispensing organization approved by the department pursuant to
1474 s. 381.986 which is attempting to verify the authenticity of a
1475 physician certification physician’s order for marijuana low-THC
1476 cannabis, including whether the physician certification order
1477 had been previously filled and whether the physician
1478 certification order was written for the person attempting to
1479 have it filled.
1480 Section 4. Subsection (1) of section 385.211, Florida
1481 Statutes, is amended to read:
1482 385.211 Refractory and intractable epilepsy treatment and
1483 research at recognized medical centers.—
1484 (1) As used in this section, the term “low-THC cannabis”
1485 means “low-THC cannabis” as defined in s. 381.986 which that is
1486 dispensed only from a medical marijuana treatment center
1487 dispensing organization as defined in s. 381.986.
1488 Section 5. Present paragraphs (b) and (c) of subsection (2)
1489 of section 499.0295, Florida Statutes, are redesignated as
1490 paragraphs (a) and (b), respectively, present paragraphs (a) and
1491 (c) of that subsection are amended, a new paragraph (c) is added
1492 to that subsection, and subsection (3) of that section is
1493 amended, to read:
1494 499.0295 Experimental treatments for terminal conditions.—
1495 (2) As used in this section, the term:
1496 (a) “Dispensing organization” means an organization
1497 approved by the Department of Health under s. 381.986(5) to
1498 cultivate, process, transport, and dispense low-THC cannabis,
1499 medical cannabis , and cannabis delivery devices.
1500 (b) (c) “Investigational drug, biological product, or
1501 device” means:
1502 1. A drug, biological product, or device that has
1503 successfully completed phase 1 of a clinical trial but has not
1504 been approved for general use by the United States Food and Drug
1505 Administration and remains under investigation in a clinical
1506 trial approved by the United States Food and Drug
1507 Administration; or
1508 2. Marijuana Medical cannabis that is manufactured and sold
1509 by an MMTC a dispensing organization.
1510 (c) “Medical marijuana treatment center” or “MMTC” means an
1511 organization registered with the Department of Health under s.
1513 (3) Upon the request of an eligible patient, a manufacturer
1514 may, or upon the issuance of a physician certification a
1515 physician’s order pursuant to s. 381.986, an MMTC a dispensing
1516 organization may:
1517 (a) Make its investigational drug, biological product, or
1518 device available under this section.
1519 (b) Provide an investigational drug, biological product,
1520 device, or cannabis delivery device as defined in s. 381.986 to
1521 an eligible patient without receiving compensation.
1522 (c) Require an eligible patient to pay the costs of, or the
1523 costs associated with, the manufacture of the investigational
1524 drug, biological product, device, or cannabis delivery device as
1525 defined in s. 381.986.
1526 Section 6. Subsection (1) of section 1004.441, Florida
1527 Statutes, is amended to read:
1528 1004.441 Refractory and intractable epilepsy treatment and
1530 (1) As used in this section, the term “low-THC cannabis”
1531 means “low-THC cannabis” as defined in s. 381.986 which that is
1532 dispensed only from a medical marijuana treatment center
1533 dispensing organization as defined in s. 381.986.
1534 Section 7. The Division of Law Revision and Information is
1535 directed to replace the phrase “the effective date of this act”
1536 wherever it occurs in this act with the date the act becomes a
1538 Section 8. This act shall take effect upon becoming a law.