Florida Senate - 2017 CS for SB 406
By the Committee on Health Policy; and Senators Bradley, Young,
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; revising the entities to which the
41 compassionate use registry must be accessible;
42 requiring the department to adopt certain rules by a
43 specified date; authorizing the department to charge a
44 fee for identification cards; requiring the department
45 to begin issuing identification cards to qualified
46 registrants by a specific date; providing requirements
47 for the identification cards; requiring the department
48 to register certain dispensing organizations as
49 medical marijuana treatment centers by a certain date;
50 requiring the department to register additional
51 medical marijuana treatment centers in accordance with
52 a specified schedule; deleting obsolete provisions;
53 revising the operational requirements for medical
54 marijuana treatment centers; authorizing the
55 department to waive certain requirements under
56 specified circumstances; requiring that certain
57 receptacles be childproof; requiring that additional
58 information be included on certain labels; requiring
59 that a medical marijuana treatment center comply with
60 certain standards in the production and dispensing of
61 edible or food products; requiring a medical marijuana
62 treatment center to enter additional information into
63 the compassionate use registry; requiring a medical
64 marijuana treatment center to keep a copy of a
65 transportation manifest in certain vehicles at certain
66 times; requiring the department to establish a quality
67 control program that requires medical marijuana
68 treatment centers to submit samples from each batch or
69 lot of marijuana to an independent testing laboratory;
70 requiring a medical marijuana treatment center to
71 maintain records of all tests conducted; requiring the
72 department to adopt rules to create and oversee the
73 quality control program; providing that the department
74 must license independent testing laboratories;
75 authorizing an independent testing laboratory to
76 collect and accept samples of, possess, store,
77 transport, and test marijuana; prohibiting a person
78 with an ownership interest in a medical marijuana
79 treatment center from owning an independent testing
80 laboratory; requiring the department to develop rules
81 and a process for licensing requirements; authorizing
82 the department to impose application and renewal fees;
83 specifying that an independent testing laboratory must
84 be certified to perform required tests; requiring the
85 department to suspend or reduce any mandatory testing
86 if the number of licensed and certified independent
87 testing laboratories is insufficient to process the
88 tests necessary to meet the patient demand for medical
89 marijuana treatment centers; providing that an
90 independent testing laboratory may only accept certain
91 samples; requiring the department to adopt rules
92 related to ownership changes or changes in an owner’s
93 investment interest; requiring the department to
94 establish, maintain, and control a seed-to-sale
95 tracking system for marijuana; providing
96 applicability; conforming provisions to changes made
97 by the act; providing that certain research
98 institutions may possess, test, transport, and dispose
99 of marijuana subject to certain conditions and as
100 provided by department rule; providing for the use of
101 emergency rulemaking procedures by the department;
102 creating s. 1004.4351, F.S.; providing a short title;
103 providing legislative findings; defining terms;
104 establishing the Coalition for Medical Marijuana
105 Research and Education within the H. Lee Moffitt
106 Cancer Center and Research Institute, Inc.; providing
107 a purpose for the coalition; establishing the Medical
108 Marijuana Research and Education Board to direct the
109 operations of the coalition; providing for the
110 appointment of board members; providing for terms of
111 office, reimbursement for certain expenses, and the
112 conduct of meetings of the board; authorizing the
113 board to appoint a coalition director; prescribing the
114 duties of the coalition director; requiring the board
115 to advise specified entities and officials regarding
116 medical marijuana research and education in this
117 state; requiring the board to annually adopt a Medical
118 Marijuana Research and Education Plan; providing
119 requirements for the plan; requiring the board to
120 issue an annual report to the Governor and the
121 Legislature by a specified date; specifying
122 responsibilities of the H. Lee Moffitt Cancer Center
123 and Research Institute, Inc.; amending ss. 381.987,
124 385.211, 499.0295, and 1004.441, F.S.; conforming
125 provisions to changes made by the act; providing a
126 directive to the Division of Law Revision and
127 Information; providing an effective date.
129 Be It Enacted by the Legislature of the State of Florida:
131 Section 1. Section 381.986, Florida Statutes, is amended to
133 381.986 Compassionate use of low-THC
and medical cannabis
134 and marijuana.—
135 (1) LEGISLATIVE INTENT.—
136 (a) It is the intent of the Legislature to implement s. 29,
137 Art. X of the State Constitution by creating a unified
138 regulatory structure within the framework of this section for
139 the acquisition, cultivation, possession, processing, transfer,
140 transportation, sale, distribution, and dispensing of marijuana,
141 products containing marijuana, related supplies, and educational
142 materials to qualifying patients or their caregivers.
143 (b) The Legislature intends that all rules adopted by the
144 Department of Health to implement this section be adopted
145 pursuant to s. 120.536(1) or s. 120.54. The Legislature intends
146 that the department use emergency rulemaking procedures pursuant
147 to s. 120.54(4) to adopt rules under this section if necessary
148 to meet any deadline for rulemaking established in s. 29, Art. X
149 of the State Constitution.
150 (c) Further, the Legislature intends that all registrations
151 for the purposes specified in paragraph (a) be issued solely in
152 accordance with the requirements of this section and all rules
153 adopted under this section.
154 (2) DEFINITIONS.—As used in this section, the term:
155 (a) “Cannabis delivery device” means an object used,
156 intended for use, or designed for use in preparing, storing,
157 ingesting, inhaling, or otherwise introducing marijuana low-THC
158 cannabis or medical cannabis into the human body.
159 (b) “Caregiver” has the same meaning as provided in s. 29,
160 Art. X of the State Constitution.
161 (c) “Chronic nonmalignant pain” means pain that is caused
162 by a debilitating medical condition or that originates from a
163 debilitating medical condition and persists beyond the usual
164 course of that debilitating medical condition.
165 (d) “Close relative” means a spouse, parent, sibling,
166 grandparent, child, or grandchild, whether related by whole or
167 half blood, by marriage, or by adoption.
168 (e) (b) “Debilitating medical condition” has the same
169 meaning as provided in s. 29, Art. X of the State Constitution
170 “ Dispensing organization ” means an organization approved by the
171 department to cultivate, process, transport, and dispense low
172 THC cannabis or medical cannabis pursuant to this section.
173 (f) (c) “Independent testing laboratory” means a laboratory,
174 including the managers, employees, or contractors of the
175 laboratory, which has no direct or indirect interest in a
176 medical marijuana treatment center a dispensing organization.
177 (g) (d) “Legal representative” means the qualifying
178 qualified patient’s parent, legal guardian acting pursuant to a
179 court’s authorization as required under s. 744.3215(4), health
180 care surrogate acting pursuant to the qualifying qualified
181 patient’s written consent or a court’s authorization as required
182 under s. 765.113, or an individual who is authorized under a
183 power of attorney to make health care decisions on behalf of the
184 qualifying qualified patient.
185 (h) (e) “Low-THC cannabis” means a plant of the genus
186 Cannabis, the dried flowers of which contain 0.8 percent or less
187 of tetrahydrocannabinol and more than 10 percent of cannabidiol
188 weight for weight; the seeds thereof; the resin extracted from
189 any part of such plant; or any compound, manufacture, salt,
190 derivative, mixture, or preparation of such plant or its seeds
191 or resin that is dispensed only by a medical marijuana treatment
192 center from a dispensing organization.
193 (i) (f) “Marijuana” has the same meaning as provided in s.
194 29, Art. X of the State Constitution “ Medical cannabis ” means
195 all parts of any plant of the genus Cannabis , whether growing or
196 not; the seeds thereof; the resin extracted from any part of the
197 plant; and every compound, manufacture, sale, derivative,
198 mixture, or preparation of the plant or its seeds or resin that
199 is dispensed only from a dispensing organization for medical use
200 by an eligible patient as defined in s. 499.0295.
201 (j) “Medical marijuana treatment center” or “MMTC” has the
202 same meaning as provided in s. 29, Art. X of the State
204 (k) (g) “Medical use” has the same meaning as provided in s.
205 29, Art. X of the State Constitution means administration of the
206 ordered amount of low-THC cannabis or medical cannabis. The term
207 does not include the:
208 1. Possession, use, or administration of marijuana low-THC
209 cannabis or medical cannabis by smoking.
210 2. Possession, use, or administration of marijuana that was
211 not purchased or acquired from an MMTC registered with the
212 Department of Health.
213 3. 2. Transfer of marijuana low-THC cannabis or medical
214 cannabis to a person other than the qualifying qualified patient
215 for whom it was ordered or the qualifying qualified patient’s
216 caregiver legal representative on behalf of the qualifying
217 qualified patient.
218 4. Use or administration of any type or amount of marijuana
219 not specified on the qualifying patient’s physician
221 5. 3. Use or administration of marijuana low-THC cannabis or
222 medical cannabis:
223 a. On any form of public transportation.
224 b. In any public place.
225 c. In a qualifying qualified patient’s place of employment,
226 if restricted by his or her employer.
227 d. In a state correctional institution as defined in s.
228 944.02 or a correctional institution as defined in s. 944.241.
229 e. On the grounds of a preschool, primary school, or
230 secondary school.
231 f. On a school bus or in a vehicle, aircraft, or motorboat.
232 (l) (h) “Qualifying Qualified patient” has the same meaning
233 as provided in s. 29, Art. X of the State Constitution but also
234 includes eligible patients, as that term is defined in s.
235 499.0295, and patients who are issued a physician certification
236 under subparagraph (3)(a)2. or subparagraph (3)(a)3. A patient
237 is not a qualifying patient unless he or she is registered with
238 the department and has been issued a compassionate use registry
239 identification card means a resident of this state who has been
240 added to the compassionate use registry by a physician licensed
241 under chapter 458 or chapter 459 to receive low-THC cannabis or
242 medical cannabis from a dispensing organization.
243 (m) (i) “Smoking” means burning or igniting a substance and
244 inhaling the smoke. Smoking does not include the use of a
246 (3) (2) PHYSICIAN CERTIFICATION ORDERING.—
247 (a) A physician is authorized to issue a physician
248 certification to:
249 1. A patient suffering from a debilitating medical
250 condition, which allows the patient to receive marijuana for the
251 patient’s medical use;
252 2. A order low-THC cannabis to treat a qualified patient
253 suffering from cancer or a physical medical condition that
254 chronically produces symptoms of seizures or severe and
255 persistent muscle spasms, which allows the patient to receive
256 low-THC cannabis for the patient’s medical use;
257 3. A patient suffering from chronic nonmalignant pain, if
258 the physician has diagnosed an underlying debilitating medical
259 condition as the cause of the pain, which allows the patient to
260 receive marijuana for the patient’s medical use order low-THC
261 cannabis to alleviate the patient’s pain symptoms of such
262 disease, disorder, or condition, if no other satisfactory
263 alternative treatment options exist for the qualified patient;
264 4. order medical cannabis to treat An eligible patient as
265 defined in s. 499.0295, which allows the patient to receive
266 marijuana for the patient’s medical use; or
267 5. A patient who is not a resident of this state; who
268 qualifies under subparagraph 1., subparagraph 2., subparagraph
269 3., or subparagraph 4.; and who can lawfully obtain marijuana
270 through a medical marijuana program in the state that he or she
271 resides in.
272 (b) In the physician certification, the physician may also
273 specify one or more or order a cannabis delivery devices to
274 assist with device for the patient’s medical use of marijuana.
275 low-THC cannabis or medical cannabis,
276 (c) A physician may certify a patient and specify a
277 delivery device under paragraphs (a) and (b) only if the
279 1. (a) Holds an active, unrestricted license as a physician
280 under chapter 458 or an osteopathic physician under chapter 459;
281 (b) Has treated the patient for at least 3 months
282 immediately preceding the patient’s registration in the
283 compassionate use registry;
284 2. (c) Has successfully completed the course and examination
285 required under paragraph (5)(a) (4)(a);
286 3. Has conducted a physical examination and made a full
287 assessment of the medical history of the patient;
288 4. Has determined that, in the physician’s professional
289 opinion, the patient meets one or more of the criteria specified
290 in paragraph (a);
291 5. (d) Has determined that the medical use of marijuana
292 would likely outweigh the potential health risks to of treating
293 the patient with low-THC cannabis or medical cannabis are
294 reasonable in light of the potential benefit to the patient. If
295 a patient is younger than 18 years of age: ,
296 a. A second physician must concur with this determination,
297 and such determination must be documented in the patient’s
298 medical record;
299 b. Only a parent, legal guardian, caregiver, or health care
300 provider may assist the qualifying patient in the purchasing and
301 administering of marijuana for medical use; and
302 c. The qualifying patient may not purchase marijuana;
303 6. (e) Registers as the patient’s physician orderer of low
304 THC cannabis or medical cannabis for the named patient on the
305 compassionate use registry maintained by the department and
306 updates the registry to reflect the contents of the order,
307 including the amount of marijuana low-THC cannabis or medical
308 cannabis that will provide the patient with not more than a 90
309 day 45-day supply and a cannabis delivery device needed by the
310 patient for the medical use of marijuana low-THC cannabis or
311 medical cannabis. A physician may certify an amount greater than
312 a 90-day supply of marijuana if the physician has a reasonable
313 belief that the patient will use the additional marijuana in a
314 medically appropriate way. If the physician’s recommended amount
315 of marijuana for a 90-day supply changes, the physician must
316 also update the registry within 7 days after the any change is
317 made to the original order to reflect the change. The physician
318 shall deactivate the registration of the patient and the
319 patient’s legal representative when the physician no longer
320 recommends the medical use of marijuana for the patient
321 treatment is discontinued;
322 7. (f) Maintains a patient treatment plan that includes the
323 dose, route of administration, planned duration, and monitoring
324 of the patient’s symptoms and other indicators of tolerance or
325 reaction to the marijuana low-THC cannabis or medical cannabis;
326 8. (g) Submits the patient treatment plan quarterly to the
327 University of Florida College of Pharmacy for research on the
328 safety and efficacy of marijuana low-THC cannabis and medical
329 cannabis on patients; and
330 9. (h) Obtains the voluntary written informed consent of the
331 patient or the patient’s legal representative to treatment with
332 marijuana low-THC cannabis after sufficiently explaining the
333 current state of knowledge in the medical community of the
334 effectiveness of treatment of the patient’s condition with
335 marijuana low-THC cannabis , the medically acceptable
336 alternatives, and the potential risks and side effects. If the
337 patient is a minor, the patient’s parent or legal guardian must
338 consent to treatment in writing. If the patient is an eligible
339 patient as defined in s. 499.0295, the physician must obtain
340 written informed consent as defined in and required by s.
341 499.0295. ;
342 (d) At least annually, a physician must recertify the
343 qualifying patient pursuant to paragraph (c).
344 (i) Obtains written informed consent as defined in and
345 required under s. 499.0295, if the physician is ordering medical
346 cannabis for an eligible patient pursuant to that section; and
347 (e) (j) A physician may not issue a physician certification
348 if the physician is not a medical director employed by an MMTC a
349 dispensing organization.
350 (f) An order for low-THC cannabis or medical cannabis
351 issued pursuant to former s. 381.986, Florida Statutes 2016, and
352 registered with the compassionate use registry on the effective
353 date of this act, shall be considered a physician certification
354 issued pursuant to this subsection. The details and expiration
355 date of such certification must be identical to the details and
356 expiration date of the order as logged in the compassionate use
357 registry. Until the department begins issuing compassionate use
358 registry identification cards, all patients with such orders
359 shall be considered qualifying patients, notwithstanding the
360 requirement that a qualifying patient have a compassionate use
361 registry identification card.
362 (4) (3) PROHIBITED ACTS PENALTIES.—
363 (a) A physician commits a misdemeanor of the first degree,
364 punishable as provided in s. 775.082 or s. 775.083, if the
365 physician issues a physician certification for marijuana to
366 orders low-THC cannabis for a patient in a manner other than as
367 required in subsection (3) without a reasonable belief that the
368 patient is suffering from:
369 1. Cancer or A physical medical condition that chronically
370 produces symptoms of seizures or severe and persistent muscle
371 spasms that can be treated with low-THC cannabis; or
372 2. Symptoms of cancer or a physical medical condition that
373 chronically produces symptoms of seizures or severe and
374 persistent muscle spasms that can be alleviated with low-THC
376 (b) A physician commits a misdemeanor of the first degree,
377 punishable as provided in s. 775.082 or s. 775.083, if the
378 physician orders medical cannabis for a patient without a
379 reasonable belief that the patient has a terminal condition as
380 defined in s. 499.0295.
381 (b) (c) A person who fraudulently represents that he or she
382 has a debilitating medical condition cancer, a physical medical
383 condition that chronically produces symptoms of seizures or
384 severe and persistent muscle spasms, chronic nonmalignant pain,
385 or a terminal condition as defined in s. 499.0295 to a physician
386 for the purpose of being issued a physician certification for
387 marijuana ordered low-THC cannabis, medical cannabis, or a
388 cannabis delivery device by such physician commits a misdemeanor
389 of the first degree, punishable as provided in s. 775.082 or s.
391 (c) (d) A qualifying patient an eligible patient as defined
392 in s. 499.0295 who uses marijuana medical cannabis, and such
393 patient’s caregiver legal representative who administers
394 marijuana medical cannabis, in plain view of or in a place open
395 to the general public, on the grounds of a school, or in a
396 school bus, vehicle, aircraft, or motorboat, commits a
397 misdemeanor of the first degree, punishable as provided in s.
398 775.082 or s. 775.083.
399 (d) A qualifying patient or caregiver who cultivates
400 marijuana or who purchases or acquires marijuana from any person
401 or entity other than an MMTC commits a misdemeanor of the first
402 degree, punishable as provided in s. 775.082 or s. 775.083.
403 (e) A caregiver who violates any of the applicable
404 provisions of this section or applicable department rules
405 commits, upon the first offense, a misdemeanor of the second
406 degree, punishable as provided in s. 775.082 or s. 775.083, and,
407 upon the second and subsequent offenses, a misdemeanor of the
408 first degree, punishable as provided in s. 775.082 or s.
410 (f) (e) A physician who issues a physician certification for
411 marijuana orders low-THC cannabis, medical cannabis, or a
412 cannabis delivery device and receives compensation from an MMTC
413 a dispensing organization related to issuing the physician
414 certification for marijuana the ordering of low-THC cannabis,
415 medical cannabis, or a cannabis delivery device is subject to
416 disciplinary action under the applicable practice act and s.
418 (g) An MMTC that advertises or holds out to the public that
419 it may provide services other than services for which it is
420 registered to provide violates this section, and the department
421 may impose a fine on the MMTC pursuant to paragraph (10)(h).
422 (h) A person or entity that offers or advertises services
423 as an MMTC without registering as an MMTC with the department
424 violates this section. The operation or maintenance of a
425 facility as an MMTC, or the performance of a service that
426 requires registration, without proper registration is a
427 violation of this section.
428 1. If after receiving notification from the department,
429 such person or entity fails to cease operation, the department
430 may impose an administrative fine of up to $10,000 per
431 violation. Each day of continued operation is a separate
433 2. The department or any state attorney may, in addition to
434 other remedies provided in this section, bring an action for an
435 injunction to restrain any unauthorized activity or to enjoin
436 the future operation or maintenance of the unauthorized
437 dispensing organization or entity or the performance of any
438 service in violation of this section until compliance with this
439 section and department rules has been demonstrated to the
440 satisfaction of the department.
441 3. If found to be in violation of this paragraph, the
442 department may assess reasonable investigative and legal costs
443 for prosecution of the violation against the person or entity.
444 (5) (4) PHYSICIAN EDUCATION.—
445 (a) Before a physician may issue a physician certification
446 pursuant to subsection (3) ordering low-THC cannabis, medical
447 cannabis, or a cannabis delivery device for medical use by a
448 patient in this state, the appropriate board shall require the
449 ordering physician to successfully complete a 4-hour an 8-hour
450 course and subsequent examination offered by the Florida Medical
451 Association or the Florida Osteopathic Medical Association which
452 that encompasses the clinical indications for the appropriate
453 use of marijuana low-THC cannabis and medical cannabis, the
454 appropriate cannabis delivery devices, the contraindications for
455 such use, and the relevant state and federal laws governing the
456 issuance of physician certifications ordering, as well as
457 dispensing , and possessing of these substances and devices. The
458 course and examination shall be administered at least quarterly
459 annually. Successful completion of the course may be used by a
460 physician to satisfy 4 hours 8 hours of the continuing medical
461 education requirements required by his or her respective board
462 for licensure renewal. This course may be offered in a distance
463 learning format, including an electronic, online format that is
464 available on request. Physicians who have completed an 8-hour
465 course and subsequent examination offered by the Florida Medical
466 Association or the Florida Osteopathic Medical Association which
467 encompasses the clinical indications for the appropriate use of
468 marijuana and who are registered in the compassionate use
469 registry on the effective date of this act are deemed to meet
470 the requirements of this paragraph.
471 (b) The appropriate board shall require the medical
472 director of each MMTC dispensing organization to hold an active,
473 unrestricted license as a physician under chapter 458 or as an
474 osteopathic physician under chapter 459 and successfully
475 complete a 2-hour course and subsequent examination offered by
476 the Florida Medical Association or the Florida Osteopathic
477 Medical Association which that encompasses appropriate safety
478 procedures and knowledge of marijuana low-THC cannabis, medical
479 cannabis , and cannabis delivery devices.
480 (c) Successful completion of the course and examination
481 specified in paragraph (a) is required for every physician who
482 orders low-THC cannabis, medical cannabis, or a cannabis
483 delivery device each time such physician renews his or her
484 license. In addition, successful completion of the course and
485 examination specified in paragraph (b) is required for the
486 medical director of each dispensing organization each time such
487 physician renews his or her license.
488 (c) (d) A physician who fails to comply with this subsection
489 and issues a physician certification for marijuana who orders
490 low-THC cannabis, medical cannabis , or a cannabis delivery
491 device may be subject to disciplinary action under the
492 applicable practice act and under s. 456.072(1)(k).
493 (6) CAREGIVERS.—
494 (a) During the course of registration with the department
495 for inclusion on the compassionate use registry, or at any time
496 while registered, a qualifying patient may designate an
497 individual as his or her caregiver to assist him or her with the
498 medical use of marijuana. The designated caregiver must be 21
499 years of age or older, unless the patient is a close relative of
500 the caregiver; must agree in writing to be the qualifying
501 patient’s caregiver; may not receive compensation, other than
502 actual expenses incurred, for assisting the qualifying patient
503 with the medical use of marijuana, unless the caregiver is
504 acting pursuant to employment in a licensed facility in
505 accordance with subparagraph (c)2.; and must pass a level 2
506 screening pursuant to chapter 435, unless the patient is a close
507 relative of the caregiver.
508 (b) A qualifying patient may have only one designated
509 caregiver at any given time unless all of the patient’s
510 caregivers are his or her close relatives or legal
512 (c) A caregiver may assist only one qualifying patient at
513 any given time unless:
514 1. All qualifying patients the caregiver is assisting are
515 close relatives of each other and the caregiver is the legal
516 representative of at least one of the patients; or
517 2. All qualifying patients the caregiver is assisting are
518 receiving hospice services, or are residents, in the same
519 assisted living facility, nursing home, or other licensed
520 facility and have requested the assistance of that caregiver
521 with the medical use of marijuana; the caregiver is an employee
522 of the hospice or licensed facility; and the caregiver provides
523 personal care or services directly to clients of the hospice or
524 licensed facility as a part of his or her employment duties at
525 the hospice or licensed facility.
526 (d) The department must register a caregiver on the
527 compassionate use registry and issue him or her a caregiver
528 identification card if he or she is designated by a qualifying
529 patient pursuant to paragraph (a) and meets all of the
530 requirements of this subsection and department rule.
531 (7) (5) DUTIES OF THE DEPARTMENT.—The department shall:
532 (a) Create and maintain a secure, electronic, and online
533 compassionate use registry for the registration of physicians,
534 patients, and caregivers the legal representatives of patients
535 as provided under this section. The registry must be accessible
537 1. Practitioners licensed under chapter 458 or chapter 459,
538 to ensure proper care for patients requesting physician
540 2. Practitioners licensed to prescribe prescription drugs,
541 to ensure proper care for patients before prescribing
542 medications that may interact with the medical use of marijuana;
543 3. Law enforcement agencies, to verify the authorization of
544 a qualifying patient or a patient’s caregiver to possess
545 marijuana or a cannabis delivery device; and
546 4. MMTCs, to a dispensing organization to verify the
547 authorization of a qualifying patient or a patient’s caregiver
548 legal representative to possess marijuana low-THC cannabis,
549 medical cannabis , or a cannabis delivery device and to record
550 the marijuana low-THC cannabis, medical cannabis , or cannabis
551 delivery device dispensed.
553 The registry must prevent an active registration of a patient by
554 multiple physicians.
555 (b) By July 3, 2017, adopt rules establishing procedures
556 for the issuance, annual renewal, suspension, and revocation of
557 compassionate use registry identification cards for patients and
558 caregivers. The department may charge a reasonable fee
559 associated with the issuance and renewal of patient and
560 caregiver identification cards. By October 3, 2017, the
561 department shall begin issuing identification cards to adult
562 patients who have a physician certification that meets the
563 requirements of subsection (3); minor patients who have a
564 physician certification that meets the requirements of
565 subsection (3) and the written consent of a parent or legal
566 guardian; and caregivers registered pursuant to subsection (6).
567 In addition to the other requirements of this section, the
568 department may issue a compassionate use registry identification
569 card to a patient who is not a resident of this state only after
570 the department has verified that the patient can lawfully obtain
571 marijuana through a medical marijuana program in the state that
572 he or she resides in. Patient and caregiver identification cards
573 must be resistant to counterfeiting and tampering and must
574 include at least the following:
575 1. The name, address, and date of birth of the patient or
576 caregiver, as appropriate;
577 2. A full-face, passport-type, color photograph of the
578 patient or caregiver, as appropriate, taken within the 90 days
579 immediately preceding registration;
580 3. Designation of the cardholder as a patient or caregiver;
581 4. A unique identification number for the patient or
582 caregiver which is matched to the identification number used for
583 such person in the department’s compassionate use registry. A
584 caregiver’s identification number and file in the compassionate
585 use registry must be linked to the file of the patient or
586 patients the caregiver is assisting so that the caregiver’s
587 status may be verified for each patient individually;
588 5. The expiration date, which shall be 1 year after the
589 date of issuance of the identification card or the date
590 treatment ends as provided in the patient’s physician
591 certification, whichever occurs first; and
592 6. For caregivers who are assisting three or fewer
593 qualifying patients, the names and identification number of the
594 qualifying patient or patients that the caregiver is assisting.
595 (c) As soon as practicable after the effective date of this
596 act, update its records by registering each dispensing
597 organization approved pursuant to chapter 2014-157, Laws of
598 Florida, or chapter 2016-123, Laws of Florida, as an MMTC with
599 an effective registration date that coincides with that
600 dispensing organization’s date of approval as a dispensing
601 organization. On the effective date of this act, all dispensing
602 organizations approved pursuant to chapter 2014-157, Laws of
603 Florida, or chapter 2016-123, Laws of Florida, are deemed to be
604 registered MMTCs. The department may not require a dispensing
605 organization approved pursuant to chapter 2014-157, Laws of
606 Florida, or chapter 2016-123, Laws of Florida, to submit an
607 application and may not charge the dispensing organization an
608 application or registration fee for the initial registration of
609 that dispensing organization as an MMTC pursuant to this
610 section. For purposes of the requirement that an MMTC comply
611 with the representations made in its application pursuant to
612 subsection (8), an MMTC registered pursuant to this paragraph
613 shall continue to comply with the representations made in its
614 application for approval as a dispensing organization, including
615 any revision authorized by the department before the effective
616 date of this act. After the effective date of this act, the
617 department may grant variances from the representations made in
618 a dispensing organization’s application for approval pursuant to
619 subsection (8). For purposes of the definition of the term
620 “marijuana” in s. 29, of Art. X of the State Constitution, an
621 MMTC is deemed to be a dispensing organization as that term is
622 defined in former s. 381.986(1)(a), Florida Statutes 2014
623 Authorize the establishment of five dispensing organizations to
624 ensure reasonable statewide accessibility and availability as
625 necessary for patients registered in the compassionate use
626 registry and who are ordered low-THC cannabis, medical cannabis,
627 or a cannabis delivery device under this section, one in each of
628 the following regions: northwest Florida, northeast Florida,
629 central Florida, southeast Florida, and southwest Florida.
630 (d) By October 3, 2017, register five additional MMTCs with
631 at least one of the MMTCs being an applicant that is a
632 recognized class member of Pigford v. Glickman, 185 F.R.D. 82
633 (D.D.C. 1999), or In re Black Farmers Litig., 856 F. Supp. 2d 1
634 (D.D.C. 2011), and a member of the Black Farmers and
635 Agriculturalists Association.
636 (e) Within 6 months after each instance of the registration
637 of 75,000 qualifying patients with the compassionate use
638 registry, register four additional MMTCs if a sufficient number
639 of MMTC applicants meet the registration requirements
640 established in this section and by department rule.
641 (f) Not issue more than one registration as an MMTC to a
642 person or an entity.
643 (g) The department shall Develop an application form for
644 registration as an MMTC and impose an initial application and
645 biennial renewal fee that is sufficient to cover the costs of
646 administering this section. To be registered as an MMTC, the an
647 applicant for approval as a dispensing organization must be able
648 to demonstrate:
649 1. That the applicant has been registered to do business in
650 this state for the previous 5 consecutive years before
651 submitting the application.
652 2. 1. The technical and technological ability to cultivate
653 and produce low-THC cannabis and marijuana. The applicant must
654 possess a valid certificate of registration issued by the
655 Department of Agriculture and Consumer Services pursuant to s.
656 581.131 that is issued for the cultivation of more than 400,000
657 plants, be operated by a nurseryman as defined in s. 581.011,
658 and have been operated as a registered nursery in this state for
659 at least 30 continuous years.
660 3. 2. The ability to secure the premises, resources, and
661 personnel necessary to operate as an MMTC a d ispensing
663 4. 3. The ability to maintain accountability of all raw
664 materials, finished products, and any byproducts to prevent
665 diversion or unlawful access to or possession of these
667 5. 4. An infrastructure reasonably located to dispense low
668 THC cannabis and marijuana to registered qualifying patients
669 statewide or regionally as determined by the department.
670 6. 5. The financial ability to maintain operations for the
671 duration of the 2-year approval cycle, including the provision
672 of certified financials to the department. Upon approval, the
673 applicant must post a $5 million performance bond. However, upon
674 an MMTC a dispensing organization’s serving at least 1,000
675 qualifying qualified patients, the MMTC dispensing organization
676 is only required to maintain a $2 million performance bond.
677 7. 6. That all owners and managers have been fingerprinted
678 and have successfully passed a level 2 background screening
679 pursuant to s. 435.04.
680 8. 7. The employment of a medical director to supervise the
681 activities of the MMTC dispensing organization.
682 (c) Upon the registration of 250,000 active qualified
683 patients in the compassionate use registry, approve three
684 dispensing organizations, including, but not limited to, an
685 applicant that is a recognized class member of Pigford v.
686 Glickman , 185 F.R.D. 82 (D.D.C. 1999), or In Re Black Farmers
687 Litig. , 856 F. Supp. 2d 1 (D.D.C. 2011), and a member of the
688 Black Farmers and Agriculturalists Association, which must meet
689 the requirements of subparagraphs (b)2.-7. and demonstrate the
690 technical and technological ability to cultivate and produce
691 low-THC cannabis.
692 (h) (d) Allow an MMTC a d ispensing organization to make a
693 wholesale purchase of marijuana low-THC cannabis or medical
694 cannabis from, or a distribution of marijuana low-THC cannabis
695 or medical cannabis to, another MMTC dispensing organization.
696 (i) (e) Monitor physician registration in the compassionate
697 use registry and the issuance of physician certifications
698 pursuant to subsection (3) ordering of low-THC cannabis, medical
699 cannabis, or a cannabis delivery device for ordering practices
700 that could facilitate unlawful diversion or misuse of marijuana
701 low-THC cannabis, medical cannabis , or a cannabis delivery
702 devices device and take disciplinary action as indicated.
703 (8) (6) MEDICAL MARIJUANA TREATMENT CENTERS DISPENSING
704 ORGANIZATION.—Each MMTC must register with the department. A
705 registered MMTC An approved dispensing organization must, at all
706 times, maintain compliance with paragraph (7)(g), the criteria
707 demonstrated for selection and approval as a dispensing
708 organization under subsection(5 ) and the criteria required in
709 this subsection, and all representations made to the department
710 in the MMTC’s application for registration. Upon request, the
711 department may grant an MMTC one or more variances from the
712 representations made in the MMTC’s application. Consideration of
713 such a variance shall be based upon the individual facts and
714 circumstances surrounding the request. A variance may not be
715 granted unless the requesting MMTC can demonstrate to the
716 department that it has a proposed alternative to the specific
717 representation made in its application which fulfills the same
718 or a similar purpose as the specific representation in a way
719 that the department can reasonably determine will not be a lower
720 standard than the specific representation in the application.
721 (a) When growing marijuana low-THC cannabis or medical
722 cannabis, an MMTC a dispensing organization:
723 1. May use pesticides determined by the department, after
724 consultation with the Department of Agriculture and Consumer
725 Services, to be safely applied to plants intended for human
726 consumption, but may not use pesticides designated as
727 restricted-use pesticides pursuant to s. 487.042.
728 2. Must grow marijuana low-THC cannabis or medical cannabis
729 within an enclosed structure and in a room separate from any
730 other plant.
731 3. Must inspect seeds and growing plants for plant pests
732 that endanger or threaten the horticultural and agricultural
733 interests of the state, notify the Department of Agriculture and
734 Consumer Services within 10 calendar days after a determination
735 that a plant is infested or infected by such plant pest, and
736 implement and maintain phytosanitary policies and procedures.
737 4. Must perform fumigation or treatment of plants, or the
738 removal and destruction of infested or infected plants, in
739 accordance with chapter 581 and any rules adopted thereunder.
740 (b) When processing marijuana low-THC cannabis or medical
741 cannabis, an MMTC a dispensing organization must:
742 1. Process the marijuana low-THC cannabis or medical
743 cannabis within an enclosed structure and in a room separate
744 from other plants or products.
745 2. Have the marijuana tested by an independent testing
746 laboratory to ensure it meets the standards established by the
747 department’s quality control program Test the processed low-THC
748 cannabis and medical cannabis before it is they are dispensed.
749 Results must be verified and signed by two dispensing
750 organization employees. Before dispensing low-THC cannabis, the
751 dispensing organization must determine that the test results
752 indicate that the low-THC cannabis meets the definition of low
753 THC cannabis and, for medical cannabis and low-THC cannabis,
754 that all medical cannabis and low-THC cannabis is safe for human
755 consumption and free from contaminants that are unsafe for human
756 consumption. The dispensing organization must retain records of
757 all testing and samples of each homogenous batch of cannabis and
758 low-THC cannabis for at least 9 months. The dispensing
759 organization must contract with an independent testing
760 laboratory to perform audits on the dispensing organization’s
761 standard operating procedures, testing records, and samples and
762 provide the results to the department to confirm that the low
763 THC cannabis or medical cannabis meets the requirements of this
764 section and that the medical cannabis and low-THC cannabis is
765 safe for human consumption.
766 3. Package the marijuana low-THC cannabis or medical
767 cannabis in compliance with the United States Poison Prevention
768 Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.
769 4. Package the marijuana low-THC cannabis or medical
770 cannabis in a childproof receptacle that has a firmly affixed
771 and legible label stating the following information:
772 a. A statement that the marijuana low-THC cannabis or
773 medical cannabis meets the requirements of subparagraph 2.;
774 b. The name of the MMTC dispensing organization from which
775 the marijuana medical cannabis or low-THC cannabis originates;
777 c. The batch number and harvest number from which the
778 marijuana medical cannabis or low-THC cannabis originates; and
779 d. The concentration of tetrahydrocannabinol and
780 cannabidiol in the product.
781 e. Any other information required by department rule
782 5. Reserve two processed samples from each batch and retain
783 such samples for at least 9 months for the purpose of testing
784 pursuant to the audit required under subparagraph 2.
785 (c) When dispensing marijuana low-THC cannabis, medical
786 cannabis , or a marijuana cannabis delivery device, an MMTC a
787 d ispensing organization:
788 1. May not dispense more than the a 45-day supply of
789 marijuana authorized by a qualifying patient’s physician
790 certification low-THC cannabis or medical cannabis to a
791 qualifying patient or caregiver the patient’s legal
793 2. Must ensure that the have the dispensing organization’s
794 employee who dispenses the marijuana low-THC cannabis, medical
795 cannabis , or marijuana a cannabis delivery device enters enter
796 into the compassionate use registry his or her name or unique
797 employee identifier.
798 3. Must verify that the qualifying patient and the
799 caregiver, if applicable, both have an active and valid
800 compassionate use registry identification card and that the
801 amount and type of marijuana dispensed match the physician
802 certification in the compassionate use registry for that
803 qualifying patient that a physician has ordered the low-THC
804 cannabis, medical cannabis, or a specific type of a cannabis
805 delivery device for the patient.
806 4. Must label the marijuana with the recommended dose for
807 the qualifying patient receiving the marijuana.
808 5. 4. May not dispense or sell any other type of marijuana
809 cannabis, alcohol, or illicit drug-related product, including
810 pipes, bongs, or wrapping papers, other than a physician-ordered
811 cannabis delivery device required for the medical use of
812 marijuana which is specified in a physician certification low
813 THC cannabis or medical cannabis , while dispensing low-THC
814 cannabis or medical cannabis. An MMTC may produce and dispense
815 marijuana as an edible or food product but may not produce such
816 items in a format designed to be attractive to children. In
817 addition to the requirements of this section and department
818 rule, food products produced by an MMTC must meet all food
819 safety standards established in state and federal law,
820 including, but not limited to, the identification of the serving
821 size and the amount of tetrahydrocannabinol in each serving.
822 5. Must verify that the patient has an active registration
823 in the compassionate use registry, the patient or patient’s
824 legal representative holds a valid and active registration card,
825 the order presented matches the order contents as recorded in
826 the registry, and the order has not already been filled.
827 6. Must, upon dispensing the marijuana l ow-THC cannabis,
828 medical cannabis , or marijuana cannabis delivery device, record
829 in the registry the date, time, quantity, and form of marijuana
830 low-THC cannabis or medical cannabis dispensed; and the type of
831 marijuana cannabis delivery device dispensed; and the name and
832 compassionate use registry identification number of the
833 qualifying patient or caregiver to whom the marijuana delivery
834 device was dispensed.
835 (d) To ensure the safety and security of its premises and
836 any off-site storage facilities, and to maintain adequate
837 controls against the diversion, theft, and loss of marijuana
838 low-THC cannabis, medical cannabis , or marijuana cannabis
839 delivery devices, an MMTC a di spensing organization shall:
840 1.a. Maintain a fully operational security alarm system
841 that secures all entry points and perimeter windows and is
842 equipped with motion detectors; pressure switches; and duress,
843 panic, and hold-up alarms; or
844 b. Maintain a video surveillance system that records
845 continuously 24 hours each day and meets at least one of the
846 following criteria:
847 (I) Cameras are fixed in a place that allows for the clear
848 identification of persons and activities in controlled areas of
849 the premises. Controlled areas include grow rooms, processing
850 rooms, storage rooms, disposal rooms or areas, and point-of-sale
852 (II) Cameras are fixed in entrances and exits to the
853 premises, which shall record from both indoor and outdoor, or
854 ingress and egress, vantage points;
855 (III) Recorded images must clearly and accurately display
856 the time and date; or
857 (IV) Retain video surveillance recordings for a minimum of
858 45 days, or longer upon the request of a law enforcement agency.
859 2. Ensure that the MMTC’s organization’s outdoor premises
860 have sufficient lighting from dusk until dawn.
861 3. Implement Establish and maintain a tracking system using
862 a vendor approved by the department which that traces the
863 marijuana low-THC cannabis or medical cannabis from seed to
864 sale. The tracking system must shall include notification of key
865 events as determined by the department, including when cannabis
866 seeds are planted, when cannabis plants are harvested and
867 destroyed, and when marijuana low-THC cannabis or medical
868 cannabis is transported, sold, stolen, diverted, or lost.
869 4. Not dispense from its premises marijuana low-THC
870 cannabis, medical cannabis , or a cannabis delivery device
871 between the hours of 9 p.m. and 7 a.m., but may perform all
872 other operations and deliver marijuana low-THC cannabis and
873 medical cannabis to qualifying qualified patients 24 hours each
875 5. Store marijuana low-THC cannabis or medical cannabis in
876 a secured, locked room or a vault.
877 6. Require at least two of its employees, or two employees
878 of a security agency with whom it contracts, to be on the
879 premises at all times.
880 7. Require each employee or contractor to wear a photo
881 identification badge at all times while on the premises.
882 8. Require each visitor to wear a visitor’s pass at all
883 times while on the premises.
884 9. Implement an alcohol and drug-free workplace policy.
885 10. Report to local law enforcement within 24 hours after
886 it is notified or becomes aware of the theft, diversion, or loss
887 of marijuana low-THC cannabis or medical cannabis.
888 (e) To ensure the safe transport of marijuana low-THC
889 cannabis or medical cannabis to MMTC dispensing organization
890 facilities, independent testing laboratories, or qualifying
891 patients, the MMTC dispensing organization must:
892 1. Maintain a transportation manifest, which must be
893 retained for at least 1 year. A copy of the manifest must be in
894 the vehicle at all times when transporting marijuana.
895 2. Ensure only vehicles in good working order are used to
896 transport marijuana low-THC cannabis or medical cannabis.
897 3. Lock marijuana low-THC cannabis or medical cannabis in a
898 separate compartment or container within the vehicle.
899 4. Require at least two persons to be in a vehicle
900 transporting marijuana low-THC cannabis or medical cannabis, and
901 require at least one person to remain in the vehicle while the
902 marijuana low-THC cannabis or medical cannabis is being
904 5. Provide specific safety and security training to
905 employees transporting or delivering marijuana low-THC cannabis
906 or medical cannabis.
907 (9) MARIJUANA QUALITY CONTROL PROGRAM AND INDEPENDENT
908 TESTING LABORATORY LICENSURE.—
909 (a) The department shall establish a quality control
910 program requiring marijuana to be tested by an independent
911 testing laboratory for potency and contaminants before sale to
912 qualifying patients and caregivers.
913 1. The quality control program must require MMTCs to submit
914 samples from each batch or lot of marijuana harvested or
915 processed to an independent testing laboratory for testing to
916 ensure, at a minimum, that the labeling of the potency of
917 tetrahydrocannabinol and all other marketed cannabinoids or
918 terpenes is accurate and that the marijuana dispensed to
919 qualifying patients is safe for human consumption.
920 2. An MMTC must maintain records of all tests conducted,
921 including the results of each test and any additional
922 information, as required by the department.
923 3. The department shall adopt all rules necessary to create
924 and oversee the quality control program, which must include, at
925 a minimum:
926 a. Permissible levels of variation in potency labeling and
927 standards requiring tetrahydrocannabinol in edible marijuana
928 products to be distributed consistently throughout the product;
929 b. Permissible levels of contaminants and mandatory testing
930 for contaminants to confirm that the tested marijuana is safe
931 for human consumption. This testing must include, but is not
932 limited to, testing for microbiological impurity, residual
933 solvents, and pesticide residues;
934 c. The destruction of marijuana determined to be
935 inaccurately labeled or unsafe for human consumption after the
936 MMTC has an opportunity to take remedial action;
937 d. The collection, storage, handling, recording, and
938 destruction of samples of marijuana by independent testing
939 laboratories; and
940 e. Security, inventory tracking, and record retention.
941 (b) The department must license all independent testing
942 laboratories to ensure that all marijuana is tested for potency
943 and contaminants in accordance with the department’s quality
944 control program. An independent testing laboratory may collect
945 and accept samples of, and possess, store, transport, and test
946 marijuana. An independent testing laboratory may not be owned by
947 a person who also possesses an ownership interest in an MMTC. A
948 clinical laboratory that is licensed by the Agency for Health
949 Care Administration pursuant to part I of chapter 483 and that
950 performs nonwaived clinical tests is exempt from the requirement
951 to be licensed by the department pursuant to this paragraph but
952 must be certified to perform all required tests pursuant to
953 subparagraph 2.
954 1. The department shall develop rules establishing
955 independent testing laboratory license requirements and a
956 process for licensing independent testing laboratories; develop
957 an application form for an independent testing laboratory
958 license; and impose an initial application fee and a biennial
959 renewal fee sufficient to cover the costs of administering this
961 2. In addition to licensure, an independent testing
962 laboratory must be certified to perform all required tests by
963 the department. The department must issue a certification to an
964 independent testing laboratory that has been certified by a
965 third-party laboratory certification body approved by the
966 department. The department shall establish reasonable rules for
967 the certification and operation of independent testing
968 laboratories. Rules for certification must, at a minimum,
969 address standards relating to:
970 a. Personnel qualifications;
971 b. Equipment and methodology;
972 c. Proficiency testing;
973 d. Tracking;
974 e. Sampling;
975 f. Chain of custody;
976 g. Record and sample retention;
977 h. Reporting;
978 i. Audit and inspection; and
979 j. Security.
980 3. The department shall suspend or reduce any mandatory
981 testing requirement specified in its quality control program if
982 the number of licensed and certified independent testing
983 laboratories is insufficient to process the tests necessary to
984 meet the patients’ demand for marijuana.
985 4. An independent testing laboratory may accept only
986 samples composed of marijuana which are obtained from a sample
987 source approved by the department. At a minimum, these sources
988 must include an MMTC, a researcher affiliated with an accredited
989 university or research hospital, a qualifying patient, and a
991 (10) (7) DEPARTMENT AUTHORITY AND RESPONSIBILITIES.—
992 (a) The department may conduct announced or unannounced
993 inspections of MMTCs dispensing organizations to determine
994 compliance with this section or rules adopted pursuant to this
996 (b) The department shall inspect an MMTC a d ispensing
997 organization upon complaint or notice provided to the department
998 that the MMTC dispensing organization has dispensed marijuana
999 low-THC cannabis or medical cannabis containing any mold,
1000 bacteria, or other contaminant that may cause or has caused an
1001 adverse effect to human health or the environment.
1002 (c) The department shall conduct at least a biennial
1003 inspection of each MMTC dispensing organization to evaluate the
1004 MMTC’s dispensing organization’s records, personnel, equipment,
1005 processes, security measures, sanitation practices, and quality
1006 assurance practices.
1007 (d) The department shall adopt by rule a process for
1008 approving changes in MMTC ownership or a change in an MMTC
1009 owner’s investment interest. This process must include specific
1010 criteria for the approval or denial of an application for change
1011 of ownership or a change in investment interest and procedures
1012 for screening applicants’ criminal and financial histories.
1013 (e) The department shall establish, maintain, and control a
1014 computer software tracking system that traces marijuana from
1015 seed to sale and allows real-time, 24-hour access by the
1016 department to data from all MMTCs and independent testing
1017 laboratories. The tracking system must, at a minimum, include
1018 notification of when marijuana seeds are planted, when marijuana
1019 plants are harvested and destroyed, and when marijuana is
1020 transported, sold, stolen, diverted, or lost. Each MMTC shall
1021 use the seed-to-sale tracking system selected by the department.
1022 (f) (d) The department may enter into interagency agreements
1023 with the Department of Agriculture and Consumer Services, the
1024 Department of Business and Professional Regulation, the
1025 Department of Transportation, the Department of Highway Safety
1026 and Motor Vehicles, and the Agency for Health Care
1027 Administration, and such agencies are authorized to enter into
1028 an interagency agreement with the department, to conduct
1029 inspections or perform other responsibilities assigned to the
1030 department under this section.
1031 (g) (e) The department must make a list of all approved
1032 MMTCs, dispensing organizations and qualified ordering
1033 physicians who are qualified to issue physician certifications,
1034 and medical directors publicly available on its website.
1035 (f) The department may establish a system for issuing and
1036 renewing registration cards for patients and their legal
1037 representatives, establish the circumstances under which the
1038 cards may be revoked by or must be returned to the department,
1039 and establish fees to implement such system. The department must
1040 require, at a minimum, the registration cards to:
1041 1. Provide the name, address, and date of birth of the
1042 patient or legal representative.
1043 2. Have a full-face, passport-type, color photograph of the
1044 patient or legal representative taken within the 90 days
1045 immediately preceding registration.
1046 3. Identify whether the cardholder is a patient or legal
1048 4. List a unique numeric identifier for the patient or
1049 legal representative that is matched to the identifier used for
1050 such person in the department’s compassionate use registry.
1051 5. Provide the expiration date, which shall be 1 year after
1052 the date of the physician’s initial order of low-THC cannabis or
1053 medical cannabis.
1054 6. For the legal representative, provide the name and
1055 unique numeric identifier of the patient that the legal
1056 representative is assisting.
1057 7. Be resistant to counterfeiting or tampering.
1058 (h) (g) The department may impose reasonable fines not to
1059 exceed $10,000 on an MMTC a dispensing organization for any of
1060 the following violations:
1061 1. Violating this section, s. 499.0295, or department rule.
1062 2. Failing to maintain qualifications for registration with
1063 the department approval.
1064 3. Endangering the health, safety, or security of a
1065 qualifying qualified patient.
1066 4. Improperly disclosing personal and confidential
1067 information of a qualifying the qualified patient.
1068 5. Attempting to procure MMTC registration with the
1069 department dispensing organization approval by bribery,
1070 fraudulent misrepresentation, or extortion.
1071 6. Any owner or manager of the MMTC being convicted or
1072 found guilty of, or entering a plea of guilty or nolo contendere
1073 to, regardless of adjudication, a crime in any jurisdiction
1074 which directly relates to the business of an MMTC a d ispensing
1076 7. Making or filing a report or record that the MMTC
1077 dispensing organization knows to be false.
1078 8. Willfully failing to maintain a record required by this
1079 section or department rule.
1080 9. Willfully impeding or obstructing an employee or agent
1081 of the department in the furtherance of his or her official
1083 10. Engaging in fraud or deceit, negligence, incompetence,
1084 or misconduct in the business practices of an MMTC a dispensing
1086 11. Making misleading, deceptive, or fraudulent
1087 representations in or related to the business practices of an
1088 MMTC a dispensing organization.
1089 12. Having a license or the authority to engage in any
1090 regulated profession, occupation, or business that is related to
1091 the business practices of an MMTC a dispensing organization
1092 suspended, revoked, or otherwise acted against by the licensing
1093 authority of any jurisdiction, including its agencies or
1094 subdivisions, for a violation that would constitute a violation
1095 under Florida law.
1096 13. Violating a lawful order of the department or an agency
1097 of the state, or failing to comply with a lawfully issued
1098 subpoena of the department or an agency of the state.
1099 (i) (h) The department may suspend, revoke, or refuse to
1100 renew an MMTC’s registration with the department a dispensing
1101 organization’s approval if the MMTC a dispensing organization
1102 commits a violation specified any of the violations in paragraph
1103 (h) (g).
1104 (j) (i) The department shall renew an MMTC’s registration
1105 with the department the approval of a dispensing organization
1106 biennially if the MMTC dispensing organization meets the
1107 requirements of this section and pays the biennial renewal fee.
1108 (k) (j) The department may adopt rules necessary to
1109 implement this section.
1110 (11) (8) PREEMPTION.—
1111 (a) All matters regarding the regulation of the cultivation
1112 and processing of marijuana medical cannabis or low-THC cannabis
1113 by MMTCs dispensing organizations are preempted to the state.
1114 (b) A municipality may determine by ordinance the criteria
1115 for the number and location of, and other permitting
1116 requirements that do not conflict with state law or department
1117 rule for, dispensing facilities of MMTCs dispensing
1118 organizations located within its municipal boundaries. A county
1119 may determine by ordinance the criteria for the number,
1120 location, and other permitting requirements that do not conflict
1121 with state law or department rule for all dispensing facilities
1122 of MMTCs dispensing organizations located within the
1123 unincorporated areas of that county.
1124 (12) (9) EXCEPTIONS TO OTHER LAWS.—
1125 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
1126 any other provision of law, but subject to the requirements of
1127 this section, a qualifying qualified patient, or a caregiver who
1128 has obtained a valid compassionate use registry identification
1129 card from the department, and the qualified patient’s legal
1130 representative may purchase from an MMTC, and possess for the
1131 qualifying patient’s medical use, up to the amount of marijuana
1132 in the physician certification low-THC cannabis or medical
1133 cannabis ordere d for the patient, but not more than a 90-day 45
1134 day supply, and a cannabis delivery device specified in the
1135 physician certification ordered for the qualifying patient.
1136 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
1137 any other provision of law, but subject to the requirements of
1138 this section, an MMTC an approved dispensing organization and
1139 its owners, managers, contractors, and employees may
1140 manufacture, possess, sell, deliver, distribute, dispense,
1141 administer, and lawfully dispose of reasonable quantities, as
1142 established by department rule, of marijuana low-THC cannabis ,
1143 medical cannabis , or a cannabis delivery device. For purposes of
1144 this subsection, the terms “manufacture,” “possession,”
1145 “deliver,” “distribute,” and “dispense” have the same meanings
1146 as provided in s. 893.02.
1147 (c) 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, an approved independent testing laboratory may
1150 possess, test, transport, and lawfully dispose of marijuana low
1151 THC cannabis or medical cannabis as provided by department rule.
1152 (d) An MMTC approved dispensing organization and its
1153 owners, managers, contractors, and employees are not subject to
1154 licensure or regulation under chapter 465 or chapter 499 for
1155 manufacturing, possessing, selling, delivering, distributing,
1156 dispensing, or lawfully disposing of reasonable quantities, as
1157 established by department rule, of marijuana low-THC cannabis ,
1158 medical cannabis , or a cannabis delivery device.
1159 (e) Exercise by an MMTC of An approved dispensing
1160 organization that continues to meet the requirements for
1161 approval is presumed to be registered with the department and to
1162 meet the regulations adopted by the department or its successor
1163 agency for the purpose of dispensing medical cannabis or low-THC
1164 cannabis under Florida law. Additionally, the authority provided
1165 to MMTCs a d ispensing organization in s. 499.0295 does not
1166 impair its registration with the department the approval of a
1167 d ispensing organization.
1168 (f) This subsection does not exempt a person from
1169 prosecution for a criminal offense related to impairment or
1170 intoxication resulting from the medical use of marijuana low-THC
1171 cannabis or medical cannabis or relieve a person from any
1172 requirement under law to submit to a breath, blood, urine, or
1173 other test to detect the presence of a controlled substance.
1174 (g) This section does not limit the ability of an employer
1175 to establish, continue, or enforce a drug-free workplace program
1176 or substance abuse policy. Notwithstanding any other provision
1177 of law, this section does not require an employer to accommodate
1178 the ingestion of marijuana in any workplace or any employee
1179 working while under the influence of marijuana. Notwithstanding
1180 any other provision of law, this section does not create a cause
1181 of action against an employer for wrongful discharge or
1183 (h) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
1184 any other provision of law, but subject to the requirements of
1185 this section, a research institute established by a public
1186 postsecondary educational institution, such as the H. Lee
1187 Moffitt Cancer Center and Research Institute established under
1188 s. 1004.43, or a state university that has achieved the
1189 preeminent state research university designation pursuant to s.
1190 1001.7065 may possess, test, transport, and lawfully dispose of
1191 marijuana for research purposes as provided by department rule.
1192 (13) RULEMAKING.—
1193 (a) The department and the applicable boards shall adopt
1194 emergency rules pursuant to s. 120.54(4) and this subsection
1195 necessary to implement this section. If an emergency rule
1196 adopted under this subsection is held to be unconstitutional or
1197 an invalid exercise of delegated legislative authority and
1198 becomes void, the department and the applicable boards may adopt
1199 an emergency rule to replace the rule that has become void. If
1200 the emergency rule adopted to replace the void emergency rule is
1201 also held to be unconstitutional or an invalid exercise of
1202 delegated legislative authority and becomes void, the department
1203 and the applicable boards must follow the nonemergency
1204 rulemaking procedures of the Administrative Procedures Act to
1205 replace the rule that has become void.
1206 (b) For emergency rules adopted under this subsection, the
1207 department and the applicable boards need not make the findings
1208 required by s. 120.54(4)(a). Emergency rules adopted under this
1209 subsection are exempt from ss. 120.54(3)(b) and 120.541. The
1210 department and the applicable boards shall meet the procedural
1211 requirements in s. 120.54(2)(a) if the department or the
1212 applicable boards have, before the effective date of this act,
1213 held any public workshops or hearings on the subject matter of
1214 emergency rules adopted under this subsection. Challenges to
1215 emergency rules adopted under this subsection are subject to the
1216 time schedules provided in s. 120.56(5).
1217 (c) Emergency rules adopted under this section are exempt
1218 from s. 120.54(4)(c) and shall remain in effect until replaced
1219 by rules adopted under the nonemergency rulemaking procedures of
1220 the Administrative Procedures Act. By January 1, 2018, the
1221 department and the applicable boards shall initiate nonemergency
1222 rulemaking pursuant to the Administrative Procedures Act by
1223 publishing a notice of rule development in the Florida
1224 Administrative Register. Except as provided in paragraph (a),
1225 after January 1, 2018, the department and applicable boards may
1226 not adopt rules pursuant to the emergency rulemaking procedures
1227 provided in this subsection.
1228 Section 2. Section 1004.4351, Florida Statutes, is created
1229 to read:
1230 1004.4351 Medical marijuana research and education.—
1231 (1) SHORT TITLE.—This section shall be known and may be
1232 cited as the “Medical Marijuana Research and Education Act.”
1233 (2) LEGISLATIVE FINDINGS.—The Legislature finds that:
1234 (a) The present state of knowledge concerning the use of
1235 marijuana to alleviate pain and treat illnesses is limited
1236 because permission to perform clinical studies on marijuana is
1237 difficult to obtain, with access to research-grade marijuana so
1238 restricted that little or no unbiased studies have been
1240 (b) Under the State Constitution, marijuana is available
1241 for the treatment of certain debilitating medical conditions.
1242 (c) Additional clinical studies are needed to ensure that
1243 the residents of this state obtain the correct dosing,
1244 formulation, route, modality, frequency, quantity, and quality
1245 of marijuana for specific illnesses.
1246 (d) An effective medical marijuana research and education
1247 program would mobilize the scientific, educational, and medical
1248 resources that presently exist in this state to determine the
1249 appropriate and best use of marijuana to treat illness.
1250 (3) DEFINITIONS.—As used in this section, the term:
1251 (a) “Board” means the Medical Marijuana Research and
1252 Education Board.
1253 (b) “Coalition” means the Coalition for Medical Marijuana
1254 Research and Education.
1255 (c) “Marijuana”” has the same meaning as provided in s. 29,
1256 Art. X of the State Constitution.
1257 (4) COALITION FOR MEDICAL MARIJUANA RESEARCH AND
1259 (a) There is established within the H. Lee Moffitt Cancer
1260 Center and Research Institute, Inc., the Coalition for Medical
1261 Marijuana Research and Education. The purpose of the coalition
1262 is to conduct rigorous scientific research, provide education,
1263 disseminate research, and guide policy for the adoption of a
1264 statewide policy on ordering and dosing practices for the
1265 medicinal use of marijuana. The coalition shall be physically
1266 located at the H. Lee Moffitt Cancer Center and Research
1267 Institute, Inc.
1268 (b) The Medical Marijuana Research and Education Board is
1269 established to direct the operations of the coalition. The board
1270 shall be composed of seven members appointed by the chief
1271 executive officer of the H. Lee Moffitt Cancer Center and
1272 Research Institute, Inc. Board members must have experience in a
1273 variety of scientific and medical fields, including, but not
1274 limited to, oncology, neurology, psychology, pediatrics,
1275 nutrition, and addiction. Members shall be appointed to 4-year
1276 terms and may be reappointed to serve additional terms. The
1277 chair shall be elected by the board from among its members to
1278 serve a 2-year term. The board shall meet no less than
1279 semiannually, at the call of the chair or, in his or her absence
1280 or incapacity, the vice chair. Four members constitute a quorum.
1281 A majority vote of the members present is required for all
1282 actions of the board. The board may prescribe, amend, and repeal
1283 a charter governing the manner in which it conducts its
1284 business. A board member shall serve without compensation but is
1285 entitled to be reimbursed for travel expenses by the coalition
1286 or the organization he or she represents in accordance with s.
1288 (c) The coalition shall be administered by a coalition
1289 director, who shall be appointed by and serve at the pleasure of
1290 the board. The coalition director shall, subject to the approval
1291 of the board:
1292 1. Propose a budget for the coalition.
1293 2. Foster the collaboration of scientists, researchers, and
1294 other appropriate personnel in accordance with the coalition’s
1296 3. Identify and prioritize the research to be conducted by
1297 the coalition.
1298 4. Prepare the Medical Marijuana Research and Education
1299 Plan for submission to the board.
1300 5. Apply for grants to obtain funding for research
1301 conducted by the coalition.
1302 6. Perform other duties as determined by the board.
1303 (d) The board shall advise the Board of Governors, the
1304 State Surgeon General, the Governor, and the Legislature with
1305 respect to medical marijuana research and education in this
1306 state. The board shall explore methods of implementing and
1307 enforcing medical marijuana laws in relation to cancer control,
1308 research, treatment, and education.
1309 (e) The board shall annually adopt a plan for medical
1310 marijuana research, known as the “Medical Marijuana Research and
1311 Education Plan,” which must be in accordance with state law and
1312 coordinate with existing programs in this state. The plan must
1313 include recommendations for the coordination and integration of
1314 medical, nursing, paramedical, community, and other resources
1315 connected with the treatment of debilitating medical conditions,
1316 research related to the treatment of such medical conditions,
1317 and education.
1318 (f) By February 15 of each year, the board shall issue a
1319 report to the Governor, the President of the Senate, and the
1320 Speaker of the House of Representatives on research projects,
1321 community outreach initiatives, and future plans for the
1323 (5) RESPONSIBILITIES OF THE H. LEE MOFFITT CANCER CENTER
1324 AND RESEARCH INSTITUTE, INC.—The H. Lee Moffitt Cancer Center
1325 and Research Institute, Inc., shall allocate staff and provide
1326 information and assistance, as the coalition’s budget permits,
1327 to assist the board in fulfilling its responsibilities.
1328 Section 3. Paragraph (b) of subsection (3) of section
1329 381.987, Florida Statutes, is amended to read:
1330 381.987 Public records exemption for personal identifying
1331 information in the compassionate use registry.—
1332 (3) The department shall allow access to the registry,
1333 including access to confidential and exempt information, to:
1334 (b) A medical marijuana treatment center registered with
1335 dispensing organization approved by the department pursuant to
1336 s. 381.986 which is attempting to verify the authenticity of a
1337 physician certification physician’s order for marijuana low-THC
1338 cannabis, including whether the physician certification order
1339 had been previously filled and whether the physician
1340 certification order was written for the person attempting to
1341 have it filled.
1342 Section 4. Subsection (1) of section 385.211, Florida
1343 Statutes, is amended to read:
1344 385.211 Refractory and intractable epilepsy treatment and
1345 research at recognized medical centers.—
1346 (1) As used in this section, the term “low-THC cannabis”
1347 means “low-THC cannabis” as defined in s. 381.986 which that is
1348 dispensed only from a medical marijuana treatment center
1349 dispensing organization as defined in s. 381.986.
1350 Section 5. Present paragraphs (b) and (c) of subsection (2)
1351 of section 499.0295, Florida Statutes, are redesignated as
1352 paragraphs (a) and (b), respectively, present paragraphs (a) and
1353 (c) of that subsection are amended, a new paragraph (c) is added
1354 to that subsection, and subsection (3) of that section is
1355 amended, to read:
1356 499.0295 Experimental treatments for terminal conditions.—
1357 (2) As used in this section, the term:
1358 (a) “Dispensing organization” means an organization
1359 approved by the Department of Health under s. 381.986(5) to
1360 cultivate, process, transport, and dispense low-THC cannabis,
1361 medical cannabis , and cannabis delivery devices.
1362 (b) (c) “Investigational drug, biological product, or
1363 device” means:
1364 1. A drug, biological product, or device that has
1365 successfully completed phase 1 of a clinical trial but has not
1366 been approved for general use by the United States Food and Drug
1367 Administration and remains under investigation in a clinical
1368 trial approved by the United States Food and Drug
1369 Administration; or
1370 2. Marijuana Medical cannabis that is manufactured and sold
1371 by an MMTC a dispensing organization.
1372 (c) “Medical marijuana treatment center” or “MMTC” means an
1373 organization registered with the Department of Health under s.
1375 (3) Upon the request of an eligible patient, a manufacturer
1376 may, or upon the issuance of a physician certification a
1377 physician’s order pursuant to s. 381.986, an MMTC a dispensing
1378 organization may:
1379 (a) Make its investigational drug, biological product, or
1380 device available under this section.
1381 (b) Provide an investigational drug, biological product,
1382 device, or cannabis delivery device as defined in s. 381.986 to
1383 an eligible patient without receiving compensation.
1384 (c) Require an eligible patient to pay the costs of, or the
1385 costs associated with, the manufacture of the investigational
1386 drug, biological product, device, or cannabis delivery device as
1387 defined in s. 381.986.
1388 Section 6. Subsection (1) of section 1004.441, Florida
1389 Statutes, is amended to read:
1390 1004.441 Refractory and intractable epilepsy treatment and
1392 (1) As used in this section, the term “low-THC cannabis”
1393 means “low-THC cannabis” as defined in s. 381.986 which that is
1394 dispensed only from a medical marijuana treatment center
1395 dispensing organization as defined in s. 381.986.
1396 Section 7. The Division of Law Revision and Information is
1397 directed to replace the phrase “the effective date of this act”
1398 wherever it occurs in this act with the date the act becomes a
1400 Section 8. This act shall take effect upon becoming a law.