Bill Text: FL S1758 | 2017 | Regular Session | Introduced
Bill Title: Medical Use of Marijuana
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2017-04-26 - Withdrawn from further consideration [S1758 Detail]
Download: Florida-2017-S1758-Introduced.html
Florida Senate - 2017 SB 1758
By Senator Grimsley
26-00705C-17 20171758__
1 A bill to be entitled
2 An act relating to medical use of marijuana; amending
3 s. 381.986, F.S.; providing legislative intent;
4 defining, redefining, and deleting terms; authorizing
5 physicians to issue physician certifications to
6 specified patients for the provision of marijuana and
7 marijuana delivery devices; requiring physicians to
8 meet certain conditions to be authorized to issue and
9 make determinations in physician certifications;
10 requiring certain physicians to annually reexamine and
11 reassess patients and update patient information in
12 the compassionate use registry; providing that a prior
13 order issued for low-THC cannabis or medical cannabis
14 is considered a physician certification under certain
15 circumstances; providing requirements for such orders;
16 revising criminal penalties; reducing the number of
17 hours of coursework required of physicians who issue
18 physician certifications; providing that physicians
19 who meet specified requirements are grandfathered for
20 the purpose of specified education requirements;
21 authorizing qualifying patients to designate
22 caregivers; requiring caregivers to meet specified
23 requirements; prohibiting a qualifying patient from
24 designating more than one caregiver at any given time;
25 providing exceptions; requiring the Department of
26 Health to register on the compassionate use registry a
27 caregiver and to issue him or her a caregiver
28 identification card if the caregiver meets certain
29 requirements; revising the list of entities that have
30 access to the compassionate use registry; requiring
31 the department to adopt rules by a specified date;
32 authorizing the department to charge a fee for
33 identification cards; requiring the department to
34 begin issuing identification cards to qualified
35 registrants by a specific date; providing requirements
36 for the identification cards; requiring the department
37 to register certain dispensing organizations as
38 medical marijuana treatment centers (MMTCs) by a
39 certain date; requiring the department to register
40 additional MMTCs in accordance with a specified
41 schedule; providing an exception to certain
42 registration requirements for certain applicants;
43 authorizing certain performance bonds to be used only
44 for reimbursement to the department for damages
45 incurred as a result of the MMTC’s failure to meet
46 certain requirements or department rules; deleting
47 obsolete provisions; revising the operational
48 requirements for MMTCs; authorizing the department to
49 waive certain requirements in the MMTC registration
50 application under specified circumstances; providing
51 requirements for MMTCs to grow, process, and dispense
52 marijuana; providing a contract option that requires
53 an independent testing laboratory to directly test an
54 MMTC’s marijuana final product; requiring that
55 marijuana receptacles be childproof; reducing the time
56 that samples are required to be retained; requiring
57 verification of patient and caregiver identification
58 cards, rather than registration cards, and amount and
59 type of marijuana before dispensing; requiring MMTC
60 compliance with certain standards in the production
61 and dispensing of edibles or food products; requiring
62 an MMTC to enter additional information into the
63 compassionate use registry; providing requirements to
64 ensure the safety and security of premises and
65 facilities of MMTCs, rather than dispensing
66 organizations, and the safe transport of marijuana;
67 requiring a vehicle transporting marijuana to be
68 legally parked under certain circumstances; revising
69 the department authority and responsibilities;
70 requiring the department to adopt rules relating to
71 ownership changes or changes in an owner’s investment
72 interest; authorizing the department to suspend,
73 revoke, or refuse to renew an MMTC’s registration if
74 the MMTC commits repeated violations that remain
75 uncured within a specified time limit; authorizing
76 emergency rulemaking procedures under certain
77 circumstances; prohibiting a municipality or county
78 from banning dispensing facilities; conforming
79 provisions to changes made by the act; providing
80 construction; authorizing certain institutes or state
81 universities to possess, test, transport, or dispose
82 of marijuana for research purposes; prohibiting a
83 person from offering or advertising services, and from
84 owning, operating, and maintaining certain facilities,
85 without registration; providing penalties including an
86 administrative fine imposed under certain
87 circumstances; prohibiting importation of marijuana;
88 authorizing exportation of marijuana and products
89 containing marijuana under certain circumstances;
90 amending ss. 381.987, 385.211, 499.0295, and 1004.441,
91 F.S.; conforming provisions to changes made by the
92 act; providing a directive to the Division of Law
93 Revision and Information; providing an effective date.
94
95 Be It Enacted by the Legislature of the State of Florida:
96
97 Section 1. Section 381.986, Florida Statutes, is amended to
98 read:
99 381.986 Compassionate use of marijuana low-THC and medical
100 cannabis.—
101 (1) LEGISLATIVE INTENT.—
102 (a) It is the intent of the Legislature to implement s. 29,
103 Art. X of the State Constitution by creating a unified
104 regulatory structure within the framework of this section for
105 the acquisition, cultivation, possession, processing, transfer,
106 transportation, sale, distribution, and dispensing of marijuana,
107 products containing marijuana, related supplies, or educational
108 materials to qualifying patients or their caregivers.
109 (b) The Legislature intends that all rules adopted by the
110 Department of Health to implement this section be adopted
111 pursuant to s. 120.536(1) or s. 120.54. The Legislature intends
112 that the department use emergency rulemaking procedures pursuant
113 to s. 120.54(4) to adopt rules under this section if necessary
114 to meet any deadline for rulemaking established in s. 29, Art. X
115 of the State Constitution.
116 (c) Further, the Legislature intends that all registrations
117 for the purposes specified in paragraph (a) be issued solely in
118 accordance with the requirements of this section and all rules
119 adopted under this section.
120 (2) DEFINITIONS.—As used in this section, the term:
121 (a) “Caregiver” means a person who:
122 1. Is at least 21 years of age unless he or she is a close
123 relative of the qualifying patient;
124 2. Has agreed in writing to assist the qualifying patient
125 with the qualifying patient’s medical use of marijuana; and
126 3. Does not receive compensation, other than actual
127 expenses incurred, for assisting the qualifying patient with the
128 medical use of marijuana unless the caregiver is acting pursuant
129 to employment in a licensed facility “Cannabis delivery device”
130 means an object used, intended for use, or designed for use in
131 preparing, storing, ingesting, inhaling, or otherwise
132 introducing low-THC cannabis or medical cannabis into the human
133 body.
134 (b) “Close relative” means a spouse, parent, sibling,
135 grandparent, child, or grandchild, whether related by whole or
136 half blood, by marriage, or by adoption.
137 (c)(b) “Debilitating medical condition” means cancer,
138 epilepsy, glaucoma, a positive status for human immunodeficiency
139 virus, acquired immune deficiency syndrome, posttraumatic stress
140 disorder, amyotrophic lateral sclerosis, Crohn’s disease,
141 Parkinson’s disease, multiple sclerosis, a physical medical
142 condition that chronically produces symptoms of seizures or
143 severe and persistent muscle spasms, a terminal condition, or
144 other debilitating medical conditions of the same kind or class
145 as, or comparable to, those conditions enumerated in this
146 paragraph and for which a physician believes that the use of
147 marijuana would likely outweigh the potential health risks to a
148 patient “Dispensing organization” means an organization approved
149 by the department to cultivate, process, transport, and dispense
150 low-THC cannabis or medical cannabis pursuant to this section.
151 (d)(c) “Independent testing laboratory” means a laboratory,
152 including the managers, employees, or contractors of the
153 laboratory:,
154 1. Which has no direct or indirect interest in a medical
155 marijuana treatment center; and
156 2. In which no medical marijuana treatment center has any
157 direct or indirect interest dispensing organization.
158 (e)(d) “Legal representative” means the qualifying
159 qualified patient’s parent, legal guardian acting pursuant to a
160 court’s authorization as required under s. 744.3215(4), health
161 care surrogate acting pursuant to the qualifying qualified
162 patient’s written consent or a court’s authorization as required
163 under s. 765.113, or an individual who is authorized under a
164 power of attorney to make health care decisions on behalf of the
165 qualifying qualified patient.
166 (f)(e) “Low-THC cannabis” means a plant of the genus
167 Cannabis, the dried flowers of which contain 0.8 percent or less
168 of tetrahydrocannabinol and more than 10 percent of cannabidiol
169 weight for weight; the seeds thereof; the resin extracted from
170 any part of such plant; or any compound, manufacture, salt,
171 derivative, mixture, or preparation of such plant or its seeds
172 or resin that is dispensed only by a medical marijuana treatment
173 center from a dispensing organization.
174 (g)(f) “Marijuana” has the same meaning as provided in s.
175 29, Art. X of the State Constitution “Medical cannabis” means
176 all parts of any plant of the genus Cannabis, whether growing or
177 not; the seeds thereof; the resin extracted from any part of the
178 plant; and every compound, manufacture, sale, derivative,
179 mixture, or preparation of the plant or its seeds or resin that
180 is dispensed only from a dispensing organization for medical use
181 by an eligible patient as defined in s. 499.0295.
182 (h) “Marijuana delivery device” means an object used,
183 intended for use, or designed for use in preparing, storing,
184 ingesting, inhaling, or otherwise introducing marijuana or low
185 THC cannabis into the human body.
186 (i) “Medical marijuana treatment center” or “MMTC” has the
187 same meaning as provided in s. 29, Art. X of the State
188 Constitution.
189 (j)(g) “Medical use” has the same meaning as provided in s.
190 29, Art. X of the State Constitution means administration of the
191 ordered amount of low-THC cannabis or medical cannabis. The term
192 does not include the:
193 1. The possession, use, or administration of marijuana low
194 THC cannabis or medical cannabis by smoking. As used in this
195 subparagraph, the term “smoking” means burning or igniting a
196 substance and inhaling the smoke. Smoking does not include the
197 use of a vaporizer.
198 2. The possession, use, or administration of marijuana that
199 is not purchased or acquired from a medical marijuana treatment
200 center.
201 3. The transfer of marijuana low-THC cannabis or medical
202 cannabis to a person other than the qualifying qualified patient
203 for whom it was ordered or the qualifying qualified patient’s
204 caregiver legal representative on behalf of the qualifying
205 qualified patient.
206 4.3. The use or administration of marijuana low-THC
207 cannabis or medical cannabis:
208 a. On any form of public transportation.
209 b. In any public place.
210 c. In a qualifying qualified patient’s place of employment,
211 if restricted by his or her employer.
212 d. In a state correctional institution as defined in s.
213 944.02 or a correctional institution as defined in s. 944.241.
214 e. On the grounds of a preschool, primary school, or
215 secondary school.
216 f. On a school bus or in a vehicle, aircraft, or motorboat.
217 (k)(h) “Qualifying patient” has the same meaning as
218 provided in s. 29, Art. X of the State Constitution. The term
219 also includes eligible patients, as defined in s. 499.0295, and
220 patients who are issued a physician certification under
221 subsection (3). A patient is not a qualifying patient unless he
222 or she is registered with the department and has been issued a
223 “Qualified patient” means a resident of this state who has been
224 added to the compassionate use registry identification card by a
225 physician licensed under chapter 458 or chapter 459 to receive
226 low-THC cannabis or medical cannabis from a dispensing
227 organization.
228 (i) “Smoking” means burning or igniting a substance and
229 inhaling the smoke. Smoking does not include the use of a
230 vaporizer.
231 (3)(2) PHYSICIAN CERTIFICATION ORDERING.—A physician is
232 authorized to issue a physician certification for the provision
233 of marijuana and marijuana delivery devices order low-THC
234 cannabis to treat a qualified patient suffering from cancer or a
235 physical medical condition that chronically produces symptoms of
236 seizures or severe and persistent muscle spasms; order low-THC
237 cannabis to alleviate symptoms of such disease, disorder, or
238 condition, if no other satisfactory alternative treatment
239 options exist for the qualified patient; order medical cannabis
240 to treat a qualifying an eligible patient as defined in s.
241 499.0295; or order a cannabis delivery device for the medical
242 use of low-THC cannabis or medical cannabis, only if the
243 physician:
244 (a) Holds an active, unrestricted license as a physician
245 under chapter 458 or an osteopathic physician under chapter 459;
246 (b) Has treated the patient for at least 3 months
247 immediately preceding the patient’s registration in the
248 compassionate use registry;
249 (c) Has successfully completed the course and examination
250 required under paragraph (6)(a) (4)(a);
251 (c) Has conducted a physical examination and made a full
252 assessment of the medical history of the patient;
253 (d) Has determined that the medical use of marijuana would
254 likely outweigh the potential health risks of treating the
255 patient with low-THC cannabis or medical cannabis are reasonable
256 in light of the potential benefit to the patient. If a patient
257 is younger than 18 years of age, a second physician must concur
258 with this determination, and such determination must be
259 documented in the patient’s medical record;
260 (e) Registers as the patient’s physician orderer of low-THC
261 cannabis or medical cannabis for the named patient on the
262 compassionate use registry maintained by the department and
263 updates the registry to reflect the contents of the order,
264 including the amount of marijuana which low-THC cannabis or
265 medical cannabis that will provide the patient with not more
266 than a 45-day supply and any marijuana a cannabis delivery
267 device needed by the patient for the medical use of marijuana
268 low-THC cannabis or medical cannabis. A physician may certify an
269 amount greater than a 45-day supply of marijuana if the
270 physician has a reasonable belief that the patient will use the
271 additional marijuana in a medically appropriate way. The
272 physician must also update the registry within 7 days after any
273 change is made to the physician certification original order to
274 reflect the change. The physician shall deactivate the
275 registration of the patient and the patient’s legal
276 representative when the physician no longer recommends the
277 medical use of marijuana for the patient treatment is
278 discontinued;
279 (f) At least annually, recertifies the qualifying patient
280 pursuant to this subsection Maintains a patient treatment plan
281 that includes the dose, route of administration, planned
282 duration, and monitoring of the patient’s symptoms and other
283 indicators of tolerance or reaction to the low-THC cannabis or
284 medical cannabis; and
285 (g) Submits the patient treatment plan quarterly to the
286 University of Florida College of Pharmacy for research on the
287 safety and efficacy of low-THC cannabis and medical cannabis on
288 patients;
289 (h) Obtains the voluntary written informed consent of the
290 patient or the patient’s legal representative to treatment with
291 low-THC cannabis after sufficiently explaining the current state
292 of knowledge in the medical community of the effectiveness of
293 treatment of the patient’s condition with low-THC cannabis, the
294 medically acceptable alternatives, and the potential risks and
295 side effects;
296 (i) Obtains written informed consent as defined in and
297 required under s. 499.0295, if the physician is ordering medical
298 cannabis for an eligible patient pursuant to that section; and
299 (g)(j) Is not a medical director employed by an MMTC a
300 dispensing organization.
301 (4)(3) GRANDFATHERING.—An order for low-THC cannabis or
302 medical cannabis issued pursuant to former s. 381.986, Florida
303 Statutes 2016, and registered with the compassionate use
304 registry on or before the effective date of this act shall be
305 considered a physician certification issued pursuant to this
306 section. The details and expiration date of such certification
307 must be identical to the details and expiration date of the
308 order as logged in the compassionate use registry. Until the
309 department begins issuing compassionate use registry
310 identification cards, all patients with such orders shall be
311 considered qualifying patients, notwithstanding the requirement
312 that a qualifying patient have a compassionate use registry
313 identification card.
314 (5) PENALTIES.—
315 (a) A physician commits a misdemeanor of the first degree,
316 punishable as provided in s. 775.082 or s. 775.083, if the
317 physician issues a physician certification for marijuana to
318 orders low-THC cannabis for a patient without a reasonable
319 belief that the patient is suffering from a debilitating medical
320 condition:
321 1. Cancer or a physical medical condition that chronically
322 produces symptoms of seizures or severe and persistent muscle
323 spasms that can be treated with low-THC cannabis; or
324 2. Symptoms of cancer or a physical medical condition that
325 chronically produces symptoms of seizures or severe and
326 persistent muscle spasms that can be alleviated with low-THC
327 cannabis.
328 (b) A physician commits a misdemeanor of the first degree,
329 punishable as provided in s. 775.082 or s. 775.083, if the
330 physician orders medical cannabis for a patient without a
331 reasonable belief that the patient has a terminal condition as
332 defined in s. 499.0295.
333 (c) A person who fraudulently represents that he or she has
334 a debilitating cancer, a physical medical condition that
335 chronically produces symptoms of seizures or severe and
336 persistent muscle spasms, or a terminal condition to a physician
337 for the purpose of being issued a physician certification for
338 marijuana ordered low-THC cannabis, medical cannabis, or a
339 marijuana cannabis delivery device by such physician commits a
340 misdemeanor of the first degree, punishable as provided in s.
341 775.082 or s. 775.083.
342 (c)(d) A qualifying An eligible patient as defined in s.
343 499.0295 who uses marijuana medical cannabis, and such patient’s
344 caregiver legal representative who administers marijuana medical
345 cannabis, in plain view of or in a place open to the general
346 public, on the grounds of a place of education school, or in an
347 aircraft, a motorboat, a school bus, a train, or a vehicle,
348 aircraft, or motorboat, commits a misdemeanor of the first
349 degree, punishable as provided in s. 775.082 or s. 775.083.
350 (d) Except as provided in paragraph (c), a caregiver who
351 violates any provision of this section or applicable department
352 rule commits, upon the first offense, a misdemeanor of the
353 second degree, punishable as provided in s. 775.082 or s.
354 775.083, and, upon the second and subsequent offenses, a
355 misdemeanor of the first degree, punishable as provided in s.
356 775.082 or s. 775.083.
357 (e) A physician who issues a physician certification for
358 marijuana orders low-THC cannabis, medical cannabis, or a
359 marijuana cannabis delivery device and receives compensation
360 from an MMTC a dispensing organization related to issuing the
361 physician certification for marijuana the ordering of low-THC
362 cannabis, medical cannabis, or a marijuana cannabis delivery
363 device is subject to disciplinary action under the applicable
364 practice act and s. 456.072(1)(n).
365 (6)(4) PHYSICIAN EDUCATION.—
366 (a) Before a physician may issue a physician certification
367 pursuant to subsection (3) ordering low-THC cannabis, medical
368 cannabis, or a cannabis delivery device for medical use by a
369 patient in this state, the appropriate board shall require the
370 ordering physician to successfully complete a 4-hour an 8-hour
371 course and subsequent examination offered by the Florida Medical
372 Association or the Florida Osteopathic Medical Association which
373 that encompasses the clinical indications for the appropriate
374 use of marijuana low-THC cannabis and medical cannabis, the
375 appropriate marijuana cannabis delivery devices, the
376 contraindications for such use, and the relevant state and
377 federal laws governing the issuance of physician certifications,
378 as well as the ordering, dispensing, and possessing of these
379 substances and devices. The course and examination shall be
380 administered at least quarterly annually. Successful completion
381 of the course may be used by a physician to satisfy 4 hours 8
382 hours of the continuing medical education requirements required
383 by his or her respective board for licensure renewal. This
384 course may be offered in a distance learning format. A physician
385 who has completed an 8-hour course and subsequent examination
386 offered by the Florida Medical Association or the Florida
387 Osteopathic Medical Association which encompasses the clinical
388 indications for the appropriate use of marijuana and who is
389 registered in the compassionate use registry on the effective
390 date of this act is deemed to meet the requirements of this
391 paragraph.
392 (b) The appropriate board shall require the medical
393 director of each MMTC dispensing organization to hold an active,
394 unrestricted license as a physician under chapter 458 or as an
395 osteopathic physician under chapter 459 and successfully
396 complete a 2-hour course and subsequent examination offered by
397 the Florida Medical Association or the Florida Osteopathic
398 Medical Association which that encompasses appropriate safety
399 procedures and knowledge of marijuana low-THC cannabis, medical
400 cannabis, and marijuana cannabis delivery devices.
401 (c) Successful completion of the course and examination
402 specified in paragraph (a) is required for every physician who
403 orders low-THC cannabis, medical cannabis, or a cannabis
404 delivery device each time such physician renews his or her
405 license. In addition, successful completion of the course and
406 examination specified in paragraph (b) is required for the
407 medical director of each dispensing organization each time such
408 physician renews his or her license.
409 (d) A physician who fails to comply with this subsection
410 and who issues a physician certification for marijuana orders
411 low-THC cannabis, medical cannabis, or a marijuana cannabis
412 delivery device may be subject to disciplinary action under the
413 applicable practice act and under s. 456.072(1)(k).
414 (7) CAREGIVERS.—
415 (a) During the course of registration with the department
416 for inclusion on the compassionate use registry, or at any time
417 while registered, a qualifying patient may designate an
418 individual as his or her caregiver to assist him or her with the
419 medical use of marijuana. The designated caregiver must pass a
420 level 2 screening pursuant to chapter 435 unless the patient is
421 a close relative of the caregiver.
422 (b) A qualifying patient may have only one designated
423 caregiver at any given time unless all of the qualifying
424 patient’s caregivers are his or her close relatives or legal
425 representatives.
426 (c) A caregiver may assist only one qualifying patient at
427 any given time unless:
428 1. All qualifying patients the caregiver is assisting are
429 close relatives of each other and the caregiver is the legal
430 representative of at least one of the patients; or
431 2. All qualifying patients the caregiver is assisting are
432 receiving hospice services, or are residents in the same
433 assisted living facility, nursing home, or other licensed
434 facility and have requested the assistance of that caregiver
435 with the medical use of marijuana; the caregiver is an employee
436 of the hospice or licensed facility; and the caregiver provides
437 personal care or services directly to clients of the hospice or
438 licensed facility as a part of his or her employment duties at
439 the hospice or licensed facility.
440 (d) The department must register a caregiver on the
441 compassionate use registry and issue him or her a caregiver
442 identification card if he or she:
443 1. Is designated by a qualifying patient, provides hospice
444 services to a qualifying patient, or is requested by a
445 qualifying patient in a licensed facility for assistance with
446 the medical use of marijuana; and
447 2. Meets all of the requirements of this subsection and
448 department rules.
449 (8)(5) DUTIES OF THE DEPARTMENT.—The department shall:
450 (a) Create and maintain a secure, electronic, and online
451 compassionate use registry for the registration of physicians,
452 qualifying patients, and caregivers the legal representatives of
453 patients as provided under this section. The registry must be
454 accessible to:
455 1. Physicians licensed under chapter 458 or chapter 459, to
456 ensure proper care for patients requesting physician
457 certifications;
458 2. Practitioners licensed to prescribe prescription drugs,
459 to ensure proper care for patients before prescribing
460 medications that may interact with the medical use of marijuana;
461 3. Law enforcement agencies, to verify the authorization of
462 a qualifying patient or a qualifying patient’s caregiver to
463 possess marijuana or a marijuana delivery device; and
464 4. MMTCs, to a dispensing organization to verify the
465 authorization of a qualifying patient or a qualifying patient’s
466 caregiver legal representative to possess marijuana low-THC
467 cannabis, medical cannabis, or a marijuana cannabis delivery
468 device and to record the marijuana low-THC cannabis, medical
469 cannabis, or marijuana cannabis delivery device dispensed. The
470 registry must prevent an active registration of a qualifying
471 patient by multiple physicians.
472 (b) By July 3, 2017, adopt rules, pursuant to s. 120.536(1)
473 or s. 120.54, establishing procedures for the issuance, annual
474 renewal, suspension, and revocation of compassionate use
475 registry identification cards for qualifying patients and
476 caregivers who are residents of this state. The department may
477 use emergency rulemaking procedures pursuant to s. 120.54(4) to
478 adopt rules under this section as necessary to ensure that rules
479 are adopted on or before July 3, 2017. The department may charge
480 a reasonable fee associated with the issuance and renewal of
481 patient and caregiver identification cards. By October 3, 2017,
482 the department shall begin issuing identification cards to adult
483 patients who are residents of this state and who have a
484 physician certification that meets the requirements of
485 subsection (3); minor patients who are residents of this state
486 and who have a physician certification that meets the
487 requirements of subsection (3) and the written consent of a
488 parent or legal guardian; and caregivers registered pursuant to
489 subsection (7). Patient and caregiver identification cards must
490 be resistant to counterfeiting and tampering and must include at
491 least the following:
492 1. The name, address, and date of birth of the patient or
493 caregiver, as appropriate;
494 2. Designation of the cardholder as a patient or caregiver;
495 3. A unique numeric identifier for the patient or caregiver
496 which is matched to the identifier used for such person in the
497 department’s compassionate use registry. A caregiver’s numeric
498 identifier and file in the compassionate use registry must be
499 linked to the file of the patient or patients the caregiver is
500 assisting so that the caregiver’s status may be verified for
501 each patient individually;
502 4. The expiration date, which must be 1 year after the date
503 of issuance of the identification card or the date treatment
504 ends as provided in the patient’s physician certification,
505 whichever occurs first; and
506 5. For a caregiver who is assisting three or fewer
507 qualifying patients, the names and unique numeric identifiers of
508 the qualifying patient or patients that the caregiver is
509 assisting.
510 (c) Deem a dispensing organization approved under s. 2,
511 chapter 2014-157, Laws of Florida, or s. 3, chapter 2016-123,
512 Laws of Florida, before June 1, 2017, to meet the requirements
513 for approval as an MMTC under this section. The department shall
514 presume such dispensing organization to be registered with the
515 department as an MMTC and shall authorize such dispensing
516 organization to acquire, cultivate, possess, and process
517 marijuana or products containing marijuana, including developing
518 related products such as food, tinctures, aerosols, oils, or
519 ointments, for sale to qualifying patients and their caregivers;
520 and to transfer, transport, sell, distribute, or dispense
521 marijuana, products containing marijuana, related supplies, and
522 educational materials to qualifying patients or their
523 caregivers. The department must renew the registration of such
524 dispensing organization as an MMTC biennially upon the
525 dispensing organization’s payment of the biennial renewal fee,
526 unless the dispensing organization is required to hold a valid
527 certificate of registration from the Department of Agriculture
528 and Consumer Services pursuant to s. 581.131 and fails to
529 maintain such registration Authorize the establishment of five
530 dispensing organizations to ensure reasonable statewide
531 accessibility and availability as necessary for patients
532 registered in the compassionate use registry and who are ordered
533 low-THC cannabis, medical cannabis, or a cannabis delivery
534 device under this section, one in each of the following regions:
535 northwest Florida, northeast Florida, central Florida, southeast
536 Florida, and southwest Florida.
537 (d) Within 6 months after the registration of each
538 occurrence of 250,000 active qualifying patients in the
539 compassionate use registry, begin the application process for
540 registering three additional MMTCs, including, but not limited
541 to, one applicant per occurrence which is a recognized class
542 member of Pigford v. Glickman, 185 F.R.D. 82 (D.D.C. 1999), or
543 In re Black Farmers Litig., 856 F. Supp. 2d 1 (D.D.C. 2011), and
544 which is a member of the Black Farmers and Agriculturalists
545 Association. Each applicant must meet the requirements in this
546 subsection and in subsection (9) and be an entity registered to
547 do business in this state for at least 5 consecutive years as of
548 the date of the application. Notwithstanding any other
549 provisions of this subsection, applicants who are recognized
550 class members of Pigford v. Glickman, 185 F.R.D. 82 (D.D.C.
551 1999), or In re Black Farmers Litig., 856 F. Supp. 2d 1 (D.D.C.
552 2011), and which are members of the Black Farmers and
553 Agriculturalists Association need not have been operated as a
554 registered nursery in this state for at least 30 continuous
555 years.
556 (e) The department shall Develop an application form for
557 registration as an MMTC and impose an initial application and
558 biennial renewal fee that is sufficient to cover the costs of
559 administering this section. To be registered as an MMTC, the An
560 applicant for approval as a dispensing organization must be able
561 to demonstrate:
562 1. The technical and technological ability to cultivate and
563 produce marijuana low-THC cannabis. The applicant must possess a
564 valid certificate of registration issued by the Department of
565 Agriculture and Consumer Services pursuant to s. 581.131 that is
566 issued for the cultivation of more than 400,000 plants, be
567 operated by a nurseryman as defined in s. 581.011, and have been
568 operated as a registered nursery in this state for at least 30
569 continuous years.
570 2. The ability to secure the premises, resources, and
571 personnel necessary to operate as an MMTC a dispensing
572 organization.
573 3. The ability to maintain accountability of all raw
574 materials, finished products, and any byproducts to prevent
575 diversion or unlawful access to or possession of these
576 substances.
577 4. An infrastructure reasonably located to dispense
578 marijuana low-THC cannabis to registered qualifying patients
579 statewide or regionally as determined by the department.
580 5. The financial ability to maintain operations for the
581 duration of the 2-year approval cycle, including the provision
582 of certified financials to the department. Upon approval, the
583 applicant must post a $5 million performance bond. However, upon
584 an MMTC’s a dispensing organization’s serving at least 1,000
585 qualifying qualified patients, the MMTC dispensing organization
586 is only required to maintain only a $2 million performance bond.
587 A performance bond posted under this subparagraph may be used
588 only for reimbursement to the department for any damages
589 incurred by the department as a result of an MMTC’s failure to
590 perform its obligations under this section or department rules.
591 Such damages include:
592 a. All costs and expenses incurred by the department to
593 nonrenew or revoke the applicant’s registration for cause and to
594 register a replacement MMTC; and
595 b. All costs and expenses incurred by qualifying patients
596 for transportation and delivery of marijuana which would not
597 have been incurred but for the revocation of the applicant’s
598 registration, if claims for such costs and expenses are
599 submitted to the department.
600 6. That all owners with a 5 percent or greater share in the
601 applicant and managers have been fingerprinted and have
602 successfully passed a level 2 background screening pursuant to
603 s. 435.04.
604 7. The employment of a medical director to supervise the
605 activities of the MMTC dispensing organization.
606 (c) Upon the registration of 250,000 active qualified
607 patients in the compassionate use registry, approve three
608 dispensing organizations, including, but not limited to, an
609 applicant that is a recognized class member of Pigford v.
610 Glickman, 185 F.R.D. 82 (D.D.C. 1999), or In Re Black Farmers
611 Litig., 856 F. Supp. 2d 1 (D.D.C. 2011), and a member of the
612 Black Farmers and Agriculturalists Association, which must meet
613 the requirements of subparagraphs (b)2.-7. and demonstrate the
614 technical and technological ability to cultivate and produce
615 low-THC cannabis.
616 (f)(d) Allow an MMTC a dispensing organization to make a
617 wholesale purchase of marijuana low-THC cannabis or medical
618 cannabis from, or a distribution of marijuana low-THC cannabis
619 or medical cannabis to, another MMTC dispensing organization.
620 (g)(e) Monitor physician registration in the compassionate
621 use registry and the issuance of physician certifications
622 pursuant to subsection (3) and ordering of low-THC cannabis,
623 medical cannabis, or a cannabis delivery device for ordering
624 practices that could facilitate unlawful diversion or misuse of
625 marijuana low-THC cannabis, medical cannabis, or a marijuana
626 cannabis delivery device and take disciplinary action as
627 indicated.
628 (9)(6) MEDICAL MARIJUANA TREATMENT CENTERS DISPENSING
629 ORGANIZATION.—In order to be an MMTC, an entity must register
630 with the department. An MMTC An approved dispensing organization
631 must, at all times, maintain compliance with the criteria
632 demonstrated for selection and approval as a dispensing
633 organization under subsection (5) and the criteria required in
634 this subsection and all representations made to the department
635 in the MMTC’s application for registration. Upon request, the
636 department may grant an MMTC one or more variances from the
637 representations made in the MMTC’s application. Consideration of
638 such a variance shall be based upon the facts and circumstances
639 surrounding the request. A variance may not be granted unless
640 the requesting MMTC can demonstrate to the department that it
641 has a proposed alternative to the specific representation made
642 in its application which fulfills the same or a similar purpose
643 as the specific representation in a way that the department can
644 reasonably determine will not be a lower standard than the
645 specific representation in the application. An MMTC is not
646 required to obtain a variance for deviations from the MMTC’s
647 application for registration which do not materially affect the
648 MMTC’s operations or the quality of the marijuana dispensed by
649 the MMTC or for deviations from the MMTC’s application which are
650 needed to conform to current statutes or rules.
651 (a) When growing marijuana low-THC cannabis or medical
652 cannabis, an MMTC a dispensing organization:
653 1. May use pesticides determined by the department, after
654 consultation with the Department of Agriculture and Consumer
655 Services, to be safely applied to plants intended for human
656 consumption, but may not use pesticides designated as
657 restricted-use pesticides pursuant to s. 487.042.
658 2. Must grow marijuana low-THC cannabis or medical cannabis
659 within an enclosed structure and in a room separate from any
660 other plant.
661 3. Must inspect seeds and growing plants for plant pests
662 that endanger or threaten the horticultural and agricultural
663 interests of the state, notify the Department of Agriculture and
664 Consumer Services within 10 calendar days after a determination
665 that a plant is infested or infected by such plant pest, and
666 implement and maintain phytosanitary policies and procedures.
667 4. Must perform fumigation or treatment of plants, or the
668 removal and destruction of infested or infected plants, in
669 accordance with chapter 581 and any rules adopted thereunder.
670 (b) When processing marijuana, an MMTC low-THC cannabis or
671 medical cannabis, a dispensing organization must:
672 1. Process the marijuana low-THC cannabis or medical
673 cannabis within an enclosed structure and in a room separate
674 from other plants or products.
675 2. Test the processed marijuana low-THC cannabis and
676 medical cannabis before it is they are dispensed. Results must
677 be verified and signed by two MMTC dispensing organization
678 employees. Before dispensing marijuana low-THC cannabis, the
679 MMTC dispensing organization must determine that the marijuana
680 test results indicate that the low-THC cannabis meets the
681 definition of low-THC cannabis and, for medical cannabis and
682 low-THC cannabis, that all medical cannabis and low-THC cannabis
683 is safe for human consumption and free from contaminants that
684 are unsafe for human consumption. The MMTC dispensing
685 organization must retain records of all testing and samples of
686 each homogenous batch of marijuana cannabis and low-THC cannabis
687 for at least 6 9 months. The MMTC dispensing organization must
688 contract with an independent testing laboratory to:
689 a. Perform audits on the MMTC’s dispensing organization’s
690 standard operating procedures, testing records, and samples and
691 provide the results to the department to confirm that the
692 marijuana low-THC cannabis or medical cannabis meets the
693 requirements of this section and that the marijuana medical
694 cannabis and low-THC cannabis is safe for human consumption; or
695 b. Directly test the marijuana final product to ensure that
696 it meets the requirements of this section and is safe for human
697 consumption before it is dispensed or distributed.
698 3. Package the marijuana low-THC cannabis or medical
699 cannabis in compliance with the United States Poison Prevention
700 Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.
701 4. Package the marijuana low-THC cannabis or medical
702 cannabis in a childproof receptacle that has a firmly affixed
703 and legible label stating the following information:
704 a. A statement that the marijuana low-THC cannabis or
705 medical cannabis meets the requirements of subparagraph 2.;
706 b. The name of the MMTC dispensing organization from which
707 the marijuana medical cannabis or low-THC cannabis originates;
708 and
709 c. The batch number and harvest number from which the
710 marijuana medical cannabis or low-THC cannabis originates.
711 5. Reserve two processed samples from each batch and retain
712 such samples for at least 6 9 months for the purpose of testing
713 pursuant to the audit required under subparagraph 2.
714 (c) When dispensing marijuana low-THC cannabis, medical
715 cannabis, or a marijuana cannabis delivery device, an MMTC a
716 dispensing organization:
717 1. May not dispense more than the a 45-day supply of
718 marijuana low-THC cannabis or medical cannabis to a qualifying
719 patient or the qualifying patient’s caregiver which is indicated
720 on the qualifying patient’s physician certification legal
721 representative.
722 2. Must ensure that have the dispensing organization’s
723 employee who dispenses the marijuana low-THC cannabis, medical
724 cannabis, or marijuana a cannabis delivery device enters enter
725 into the compassionate use registry his or her name or unique
726 employee identifier.
727 3. Must verify that the qualifying patient and the
728 caregiver, if applicable, both have an active and valid
729 compassionate use registry identification card and that the
730 amount and type of marijuana dispensed match the physician’s
731 certification in the compassionate use registry for that
732 qualifying patient that a physician has ordered the low-THC
733 cannabis, medical cannabis, or a specific type of a cannabis
734 delivery device for the patient.
735 4. May not dispense or sell any other type of marijuana
736 cannabis, alcohol, or illicit drug-related product, including
737 pipes, bongs, or wrapping papers, other than a marijuana
738 physician-ordered cannabis delivery device required for the
739 medical use of marijuana which is specified in the physician
740 certification. An MMTC may produce and dispense marijuana as an
741 edible or food product but may not produce such items in a
742 format designed to be attractive to children. In addition to the
743 requirements of this section and department rule, food products
744 produced by an MMTC must meet all food safety standards
745 established in state and federal law, including, but not limited
746 to, the identification of the serving size and the amount of
747 tetrahydrocannabinol in each serving low-THC cannabis or medical
748 cannabis, while dispensing low-THC cannabis or medical cannabis.
749 5. Must verify that the patient has an active registration
750 in the compassionate use registry, the patient or patient’s
751 legal representative holds a valid and active registration card,
752 the order presented matches the order contents as recorded in
753 the registry, and the order has not already been filled.
754 5.6. Must, upon dispensing the marijuana low-THC cannabis,
755 medical cannabis, or marijuana cannabis delivery device, record
756 in the registry the date, time, quantity, and form of marijuana
757 low-THC cannabis or medical cannabis dispensed; and the type of
758 marijuana cannabis delivery device dispensed; and the name and
759 compassionate use registry numeric identifier of the qualifying
760 patient or caregiver to whom the marijuana or marijuana delivery
761 device was dispensed.
762 (d) To ensure the safety and security of its premises and
763 any off-site storage facilities, and to maintain adequate
764 controls against the diversion, theft, and loss of marijuana
765 low-THC cannabis, medical cannabis, or marijuana cannabis
766 delivery devices, an MMTC a dispensing organization shall:
767 1.a. Maintain a fully operational security alarm system
768 that secures all entry points and perimeter windows and is
769 equipped with motion detectors; pressure switches; and duress,
770 panic, and hold-up alarms; or
771 b. Maintain a video surveillance system that records
772 continuously 24 hours each day and meets at least one of the
773 following criteria:
774 (I) Cameras are fixed in a place that allows for the clear
775 identification of persons and activities in controlled areas of
776 the premises. Controlled areas include grow rooms, processing
777 rooms, storage rooms, disposal rooms or areas, and point-of-sale
778 rooms;
779 (II) Cameras are fixed in entrances and exits to the
780 premises, which shall record from both indoor and outdoor, or
781 ingress and egress, vantage points;
782 (III) Recorded images must clearly and accurately display
783 the time and date; or
784 (IV) Retain video surveillance recordings for a minimum of
785 45 days or longer upon the request of a law enforcement agency.
786 2. Ensure that the MMTC’s organization’s outdoor premises
787 have sufficient lighting from dusk until dawn.
788 3. Establish and maintain a tracking system approved by the
789 department which that traces the marijuana low-THC cannabis or
790 medical cannabis from seed to sale. The tracking system must
791 shall include notification of key events as determined by the
792 department, including when marijuana cannabis seeds are planted,
793 when marijuana cannabis plants are harvested and destroyed, and
794 when marijuana low-THC cannabis or medical cannabis is
795 transported, sold, stolen, diverted, or lost.
796 4. Not dispense from its premises marijuana low-THC
797 cannabis, medical cannabis, or a marijuana cannabis delivery
798 device between the hours of 9 p.m. and 7 a.m., but may perform
799 all other operations and deliver marijuana low-THC cannabis and
800 medical cannabis to qualifying qualified patients 24 hours each
801 day.
802 5. Store marijuana low-THC cannabis or medical cannabis in
803 a secured, locked room or a vault.
804 6. Require at least two of its employees, or two employees
805 of a security agency with whom it contracts, to be on the
806 premises of any cultivation or processing facilities at all
807 times.
808 7. Require each employee or contractor to wear a photo
809 identification badge at all times while on the premises.
810 8. Require each visitor to wear a visitor’s pass at all
811 times while on the premises.
812 9. Implement an alcohol and drug-free workplace policy.
813 10. Report to local law enforcement within 24 hours after
814 it is notified or becomes aware of the theft, diversion, or loss
815 of marijuana low-THC cannabis or medical cannabis.
816 (e) To ensure the safe transport of marijuana low-THC
817 cannabis or medical cannabis to MMTC dispensing organization
818 facilities, independent testing laboratories, or qualifying
819 patients, the MMTC dispensing organization must:
820 1. Maintain a transportation manifest, which must be
821 retained for at least 1 year.
822 2. Ensure only vehicles in good working order are used to
823 transport marijuana low-THC cannabis or medical cannabis.
824 3. Lock marijuana low-THC cannabis or medical cannabis in a
825 separate compartment or container within the vehicle.
826 4. Require at least two persons to be in a vehicle
827 transporting marijuana low-THC cannabis or medical cannabis, and
828 require at least one person to remain in the vehicle while the
829 marijuana low-THC cannabis or medical cannabis is being
830 delivered.
831 5. Ensure that any vehicle transporting marijuana to a
832 qualifying patient or caregiver is legally parked while
833 marijuana is being delivered to the qualifying patient or
834 caregiver.
835 6.5. Provide specific safety and security training to
836 employees transporting or delivering marijuana low-THC cannabis
837 or medical cannabis.
838 (10)(7) DEPARTMENT AUTHORITY AND RESPONSIBILITIES.—
839 (a) The department may conduct announced or unannounced
840 inspections of MMTCs dispensing organizations to determine
841 compliance with this section or rules adopted pursuant to this
842 section.
843 (b) The department shall inspect an MMTC a dispensing
844 organization upon complaint or notice provided to the department
845 that the MMTC dispensing organization has dispensed marijuana
846 low-THC cannabis or medical cannabis containing any mold,
847 bacteria, or other contaminant at a level that may cause or has
848 caused an adverse effect to human health or the environment.
849 (c) The department shall conduct at least a biennial
850 inspection of each MMTC dispensing organization to evaluate the
851 MMTC’s dispensing organization’s records, personnel, equipment,
852 processes, security measures, sanitation practices, and quality
853 assurance practices.
854 (d) The department shall adopt by rule a process for
855 approving changes in MMTC ownership or a change in an MMTC
856 owner’s investment interest of 5 percent or more. This process
857 shall be limited to verifying compliance with subparagraph
858 (8)(e)6.
859 (e) The department may enter into interagency agreements
860 with the Department of Agriculture and Consumer Services, the
861 Department of Business and Professional Regulation, the
862 Department of Law Enforcement, the Department of Transportation,
863 the Department of Highway Safety and Motor Vehicles, and the
864 Agency for Health Care Administration, and such agencies are
865 authorized to enter into an interagency agreement with the
866 department, to conduct inspections or perform other
867 responsibilities assigned to the department under this section.
868 (f)(e) The department must make a list of all approved
869 MMTCs, dispensing organizations and qualified ordering
870 physicians who are qualified to issue physician certifications,
871 and medical directors of MMTCs publicly available on its
872 website.
873 (f) The department may establish a system for issuing and
874 renewing registration cards for patients and their legal
875 representatives, establish the circumstances under which the
876 cards may be revoked by or must be returned to the department,
877 and establish fees to implement such system. The department must
878 require, at a minimum, the registration cards to:
879 1. Provide the name, address, and date of birth of the
880 patient or legal representative.
881 2. Have a full-face, passport-type, color photograph of the
882 patient or legal representative taken within the 90 days
883 immediately preceding registration.
884 3. Identify whether the cardholder is a patient or legal
885 representative.
886 4. List a unique numeric identifier for the patient or
887 legal representative that is matched to the identifier used for
888 such person in the department’s compassionate use registry.
889 5. Provide the expiration date, which shall be 1 year after
890 the date of the physician’s initial order of low-THC cannabis or
891 medical cannabis.
892 6. For the legal representative, provide the name and
893 unique numeric identifier of the patient that the legal
894 representative is assisting.
895 7. Be resistant to counterfeiting or tampering.
896 (g) The department may impose reasonable fines not to
897 exceed $10,000 on an MMTC a dispensing organization for any of
898 the following violations:
899 1. Violating this section, s. 499.0295, or department rule.
900 2. Failing to maintain qualifications for registration with
901 the department approval.
902 3. Endangering the health, safety, or security of a
903 qualifying qualified patient.
904 4. Improperly disclosing personal and confidential
905 information of a qualifying the qualified patient.
906 5. Attempting to procure MMTC registration with the
907 department dispensing organization approval by bribery,
908 fraudulent misrepresentation, or extortion.
909 6. Any owner or manager of the MMTC being convicted or
910 found guilty of, or entering a plea of guilty or nolo contendere
911 to, regardless of adjudication, a crime in any jurisdiction
912 which directly relates to the business of an MMTC a dispensing
913 organization.
914 7. Making or filing a report or record that the MMTC
915 dispensing organization knows to be false.
916 8. Willfully failing to maintain a record required by this
917 section or department rule.
918 9. Willfully impeding or obstructing an employee or agent
919 of the department in the furtherance of his or her official
920 duties.
921 10. Engaging in fraud or deceit, negligence, incompetence,
922 or misconduct in the business practices of an MMTC a dispensing
923 organization.
924 11. Making misleading, deceptive, or fraudulent
925 representations in or related to the business practices of an
926 MMTC a dispensing organization.
927 12. Having a license or the authority to engage in any
928 regulated profession, occupation, or business that is related to
929 the business practices of an MMTC a dispensing organization
930 suspended, revoked, or otherwise acted against by the licensing
931 authority of any jurisdiction, including its agencies or
932 subdivisions, for a violation that would constitute a violation
933 under Florida law.
934 13. Violating a lawful order of the department or an agency
935 of the state, or failing to comply with a lawfully issued
936 subpoena of the department or an agency of the state.
937 (h) The department may suspend, revoke, or refuse to renew
938 an MMTC’s registration with the department a dispensing
939 organization’s approval if the MMTC a dispensing organization
940 commits repeated violations specified any of the violations in
941 paragraph (g) which remain uncured after 30 days’ notice from
942 the department. The department may not suspend, revoke, or
943 refuse to renew an MMTC’s registration due to an uncured
944 violation if the MMTC begins taking action to cure the violation
945 within 30 days after receiving a notice of the violation from
946 the department and such action is pursuant to a corrective
947 action plan filed by the MMTC with the department or if the MMTC
948 takes reasonable steps to ensure that a future violation of a
949 similar nature does not occur.
950 (i) The department shall renew an MMTC’s registration with
951 the department the approval of a dispensing organization
952 biennially if the MMTC dispensing organization meets the
953 requirements of this section and pays the biennial renewal fee.
954 (j) The department may adopt rules necessary to implement
955 this section pursuant to s. 120.536(1) or s. 120.54. The
956 department may use emergency rulemaking procedures pursuant to
957 s. 120.54(4) to adopt rules under this section if necessary to
958 meet any deadline for rulemaking established in s. 29, Art. X of
959 the State Constitution.
960 (11)(8) PREEMPTION.—
961 (a) All matters regarding the regulation of the cultivation
962 and processing of marijuana medical cannabis or low-THC cannabis
963 by MMTCs dispensing organizations are preempted to the state.
964 (b) A municipality may determine by ordinance the criteria
965 for the number and location of, and other permitting
966 requirements that do not conflict with state law or department
967 rule for, dispensing facilities of MMTCs dispensing
968 organizations located within its municipal boundaries. A county
969 may determine by ordinance the criteria for the number,
970 location, and other permitting requirements that do not conflict
971 with state law or department rule for all dispensing facilities
972 of MMTCs dispensing organizations located within the
973 unincorporated areas of that county. A municipality or a county
974 may not ban dispensing facilities within its boundaries or enact
975 zoning or other such ordinances that would have the effect of
976 banning dispensing facilities within its boundaries.
977 (12)(9) EXCEPTIONS TO OTHER LAWS.—
978 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
979 any other provision of law, but subject to the requirements of
980 this section, a qualifying qualified patient, or a caregiver who
981 has obtained a valid compassionate use registry identification
982 card from the department, and the qualified patient’s legal
983 representative may purchase from an MMTC and possess for the
984 qualifying patient’s medical use up to the amount of marijuana
985 in the physician’s certification low-THC cannabis or medical
986 cannabis ordered for the patient, but not more than a 45-day
987 supply, except as provided in (3)(e), and a marijuana cannabis
988 delivery device specified in the physician’s certification
989 ordered for the qualifying patient.
990 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
991 any other provision of law, but subject to the requirements of
992 this section, an MMTC an approved dispensing organization and
993 its owners, managers, and employees may manufacture, possess,
994 sell, deliver, distribute, dispense, and lawfully dispose of
995 reasonable quantities, as established by department rule, of
996 marijuana low-THC cannabis, medical cannabis, or a marijuana
997 cannabis delivery device. As used in For purposes of this
998 subsection, the terms “manufacture,” “possession,” “deliver,”
999 “distribute,” and “dispense” have the same meanings as provided
1000 in s. 893.02.
1001 (c) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
1002 any other provision of law, but subject to the requirements of
1003 this section, an approved independent testing laboratory may
1004 possess, test, transport, and lawfully dispose of marijuana low
1005 THC cannabis or medical cannabis as provided by department rule.
1006 (d) An MMTC approved dispensing organization and its
1007 owners, managers, and employees are not subject to licensure or
1008 regulation under chapter 465 or chapter 499 for manufacturing,
1009 possessing, selling, delivering, distributing, dispensing, or
1010 lawfully disposing of reasonable quantities, as established by
1011 department rule, of marijuana low-THC cannabis, medical
1012 cannabis, or a marijuana cannabis delivery device.
1013 (e) Exercise by an MMTC of An approved dispensing
1014 organization that continues to meet the requirements for
1015 approval is presumed to be registered with the department and to
1016 meet the regulations adopted by the department or its successor
1017 agency for the purpose of dispensing medical cannabis or low-THC
1018 cannabis under Florida law. Additionally, the authority provided
1019 to a dispensing organization in s. 499.0295 does not impair its
1020 registration with the department the approval of a dispensing
1021 organization.
1022 (f) This subsection does not exempt a person from
1023 prosecution for a criminal offense related to impairment or
1024 intoxication resulting from the medical use of marijuana low-THC
1025 cannabis or medical cannabis or relieve a person from any
1026 requirement under law to submit to a breath, blood, urine, or
1027 other test to detect the presence of a controlled substance.
1028 (g) This section does not affect or repeal laws relating to
1029 negligence or professional malpractice on the part of a
1030 caregiver, a physician, or an MMTC or its agents and employees.
1031 (h) This section does not require a health insurance
1032 provider or a governmental agency or authority to reimburse a
1033 person for expenses related to the use of marijuana.
1034 (i) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
1035 any other provision of law, but subject to the requirements of
1036 this section, a research institute established by a public
1037 postsecondary educational institution, such as the H. Lee
1038 Moffitt Cancer Center and Research Institute established in s.
1039 1004.43, or a state university that has achieved the preeminent
1040 state research university designation pursuant to s. 1001.7065,
1041 may possess, test, transport, and lawfully dispose of marijuana
1042 for research purposes as provided by department rule.
1043 (13) PROHIBITED ACTIVITIES.—
1044 (a) A person or entity may not offer or advertise services
1045 as an MMTC without registering as an MMTC with the department.
1046 An MMTC may not advertise or hold out to the public that it
1047 holds a registration for other than that for which it actually
1048 holds the license.
1049 (b) The operation or maintenance of an unauthorized
1050 dispensing organization or entity or the performance of a
1051 service that requires registration without proper registration
1052 is a violation of this section. The department or any state
1053 attorney may, in addition to other remedies provided in this
1054 section, bring an action for an injunction to restrain any
1055 unauthorized activity or to enjoin the future operation or
1056 maintenance of the unauthorized dispensing organization or
1057 entity or the performance of any service in violation of this
1058 section until compliance with this section and department rules
1059 has been demonstrated to the satisfaction of the department.
1060 (c) If after receiving notification from the department,
1061 such person or entity fails to cease operation, the department
1062 may impose an administrative fine of up to $10,000 per
1063 violation, in addition to other penalties as prescribed by this
1064 section or applicable criminal law. In addition, the department
1065 may assess reasonable investigative and legal costs for
1066 prosecution of the violation against the person or entity. Each
1067 day of continued operation is a separate offense.
1068 (14) IMPORTATION AND EXPORTATION OF MARIJUANA.—
1069 (a) Marijuana may not be imported from outside this state.
1070 (b) Marijuana and products containing marijuana which are
1071 cultivated and produced in accordance with this section may be
1072 exported as authorized by federal law and the laws of the states
1073 or countries to which they are exported.
1074 Section 2. Subsections (1) and (2) of section 381.987,
1075 Florida Statutes, are amended, and paragraphs (b) and (c) of
1076 subsection (3) of that section are amended, to read:
1077 381.987 Public records exemption for personal identifying
1078 information in the compassionate use registry.—
1079 (1) A patient’s personal identifying information held by
1080 the department in the compassionate use registry established
1081 under s. 381.986, including, but not limited to, the patient’s
1082 name, address, telephone number, and government-issued
1083 identification number, and all information pertaining to the
1084 physician certification physician’s order for marijuana low-THC
1085 cannabis and the dispensing thereof are confidential and exempt
1086 from s. 119.07(1) and s. 24(a), Art. I of the State
1087 Constitution.
1088 (2) A physician’s identifying information held by the
1089 department in the compassionate use registry established under
1090 s. 381.986, including, but not limited to, the physician’s name,
1091 address, telephone number, government-issued identification
1092 number, and Drug Enforcement Administration number, and all
1093 information pertaining to the physician certification
1094 physician’s order for marijuana low-THC cannabis and the
1095 dispensing thereof are confidential and exempt from s. 119.07(1)
1096 and s. 24(a), Art. I of the State Constitution.
1097 (3) The department shall allow access to the registry,
1098 including access to confidential and exempt information, to:
1099 (b) A medical marijuana treatment center dispensing
1100 organization approved by the department pursuant to s. 381.986
1101 which is attempting to verify the authenticity of a physician
1102 certification physician’s order for marijuana low-THC cannabis,
1103 including whether the physician certification order had been
1104 previously filled and whether the physician certification order
1105 was written for the person attempting to have it filled.
1106 (c) A physician who has issued a physician certification
1107 written an order for marijuana low-THC cannabis for the purpose
1108 of monitoring the patient’s use of such cannabis or for the
1109 purpose of determining, before issuing an order for marijuana
1110 low-THC cannabis, whether another physician has ordered the
1111 patient’s use of marijuana low-THC cannabis. The physician may
1112 access the confidential and exempt information only for the
1113 patient for whom he or she has ordered or is determining whether
1114 to order the use of marijuana low-THC cannabis pursuant to s.
1115 381.986.
1116 Section 3. Subsection (1) of section 385.211, Florida
1117 Statutes, is amended to read:
1118 385.211 Refractory and intractable epilepsy treatment and
1119 research at recognized medical centers.—
1120 (1) As used in this section, the term “low-THC cannabis”
1121 means “low-THC cannabis” as defined in s. 381.986 which that is
1122 dispensed only from a medical marijuana treatment center
1123 dispensing organization as defined in s. 381.986.
1124 Section 4. Subsections (2) and (3) of section 499.0295,
1125 Florida Statutes, are amended to read:
1126 499.0295 Experimental treatments for terminal conditions.—
1127 (2) As used in this section, the term:
1128 (a) “Dispensing organization” means an organization
1129 approved by the Department of Health under s. 381.986(5) to
1130 cultivate, process, transport, and dispense low-THC cannabis,
1131 medical cannabis, and cannabis delivery devices.
1132 (a)(b) “Eligible patient” means a person who:
1133 1. Has a terminal condition that is attested to by the
1134 patient’s physician and confirmed by a second independent
1135 evaluation by a board-certified physician in an appropriate
1136 specialty for that condition;
1137 2. Has considered all other treatment options for the
1138 terminal condition currently approved by the United States Food
1139 and Drug Administration;
1140 3. Has given written informed consent for the use of an
1141 investigational drug, biological product, or device; and
1142 4. Has documentation from his or her treating physician
1143 that the patient meets the requirements of this paragraph.
1144 (b)(c) “Investigational drug, biological product, or
1145 device” means:
1146 1. a drug, biological product, or device that has
1147 successfully completed phase 1 of a clinical trial but has not
1148 been approved for general use by the United States Food and Drug
1149 Administration and remains under investigation in a clinical
1150 trial approved by the United States Food and Drug
1151 Administration; or
1152 2. Medical cannabis that is manufactured and sold by a
1153 dispensing organization.
1154 (c)(d) “Terminal condition” means a progressive disease or
1155 medical or surgical condition that causes significant functional
1156 impairment, is not considered by a treating physician to be
1157 reversible even with the administration of available treatment
1158 options currently approved by the United States Food and Drug
1159 Administration, and, without the administration of life
1160 sustaining procedures, will result in death within 1 year after
1161 diagnosis if the condition runs its normal course.
1162 (d)(e) “Written informed consent” means a document that is
1163 signed by a patient, a parent of a minor patient, a court
1164 appointed guardian for a patient, or a health care surrogate
1165 designated by a patient and includes:
1166 1. An explanation of the currently approved products and
1167 treatments for the patient’s terminal condition.
1168 2. An attestation that the patient concurs with his or her
1169 physician in believing that all currently approved products and
1170 treatments are unlikely to prolong the patient’s life.
1171 3. Identification of the specific investigational drug,
1172 biological product, or device that the patient is seeking to
1173 use.
1174 4. A realistic description of the most likely outcomes of
1175 using the investigational drug, biological product, or device.
1176 The description shall include the possibility that new,
1177 unanticipated, different, or worse symptoms might result and
1178 death could be hastened by the proposed treatment. The
1179 description shall be based on the physician’s knowledge of the
1180 proposed treatment for the patient’s terminal condition.
1181 5. A statement that the patient’s health plan or third
1182 party administrator and physician are not obligated to pay for
1183 care or treatment consequent to the use of the investigational
1184 drug, biological product, or device unless required to do so by
1185 law or contract.
1186 6. A statement that the patient’s eligibility for hospice
1187 care may be withdrawn if the patient begins treatment with the
1188 investigational drug, biological product, or device and that
1189 hospice care may be reinstated if the treatment ends and the
1190 patient meets hospice eligibility requirements.
1191 7. A statement that the patient understands he or she is
1192 liable for all expenses consequent to the use of the
1193 investigational drug, biological product, or device and that
1194 liability extends to the patient’s estate, unless a contract
1195 between the patient and the manufacturer of the investigational
1196 drug, biological product, or device states otherwise.
1197 (3) Upon the request of an eligible patient, a manufacturer
1198 may, or, upon the issuance of a physician certification a
1199 physician’s order pursuant to s. 381.986, an MMTC a dispensing
1200 organization may:
1201 (a) Make its investigational drug, biological product, or
1202 device available under this section.
1203 (b) Provide an investigational drug, biological product,
1204 device, or marijuana cannabis delivery device as defined in s.
1205 381.986 to an eligible patient without receiving compensation.
1206 (c) Require an eligible patient to pay the costs of, or the
1207 costs associated with, the manufacture of the investigational
1208 drug, biological product, device, or marijuana cannabis delivery
1209 device as defined in s. 381.986.
1210 Section 5. Subsection (1) of section 1004.441, Florida
1211 Statutes, is amended to read:
1212 1004.441 Refractory and intractable epilepsy treatment and
1213 research.—
1214 (1) As used in this section, the term “low-THC cannabis”
1215 means “low-THC cannabis” as defined in s. 381.986 which that is
1216 dispensed only from a medical marijuana treatment center
1217 dispensing organization as defined in s. 381.986.
1218 Section 6. The Division of Law Revision and Information is
1219 directed to replace the phrase “the effective date of this act”
1220 wherever it occurs in this act with the date the act becomes a
1221 law.
1222 Section 7. This act shall take effect upon becoming a law.
