Florida Senate - 2017 SB 406
By Senator Bradley
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 defining and redefining terms; authorizing physicians
5 to issue physician certifications to specified
6 patients who meet certain conditions; authorizing
7 physicians to make specific determinations in
8 certifications; requiring physicians to meet certain
9 conditions to be authorized to issue and make
10 determinations in physician certifications; requiring
11 written consent of a parent or legal guardian for the
12 treatment of minors; requiring that certain physicians
13 annually reexamine and reassess patients and update
14 patient information in the compassionate use registry;
15 revising criminal penalties; authorizing a distance
16 learning format for a specified course and reducing
17 the number of hours required for the course; providing
18 that physicians who meet specified requirements are
19 grandfathered for the purpose of specified education
20 requirements; authorizing qualifying patients to
21 designate caregivers; requiring caregivers to meet
22 specified requirements; prohibiting a qualifying
23 patient from designating more than one caregiver at
24 any given time; providing exceptions; requiring the
25 Department of Health to register caregivers meeting
26 certain requirements on the compassionate use
27 registry; revising the entities to which the
28 compassionate use registry must be accessible;
29 requiring the department to adopt certain rules by a
30 specified date; authorizing the department to charge a
31 fee for identification cards; requiring the department
32 to begin issuing identification cards to qualified
33 registrants by a specific date; providing requirements
34 for the identification cards; requiring the department
35 to register certain dispensing organizations as
36 medical marijuana treatment centers by a certain date;
37 requiring the department to register additional
38 medical marijuana treatment centers in accordance with
39 a specified schedule; deleting obsolete provisions;
40 revising the operational requirements for medical
41 marijuana treatment centers; authorizing the
42 department to waive certain requirements under
43 specified circumstances; requiring that certain
44 receptacles be child proof; requiring that additional
45 information be included on certain labels; requiring
46 that a medical marijuana treatment center comply with
47 certain standards in the production and dispensing of
48 edible or food products; requiring a medical marijuana
49 treatment center to enter additional information into
50 the compassionate use registry; requiring a medical
51 marijuana treatment center to keep a copy of a
52 transportation manifest in certain vehicles at certain
53 times; requiring the department to adopt rules related
54 to ownership changes or changes in an owner’s
55 investment interest; providing applicability;
56 conforming provisions to changes made by the act;
57 amending ss. 381.987, 385.211, 499.0295, and 1004.441,
58 F.S.; conforming provisions to changes made by the
59 act; providing an effective date.
61 Be It Enacted by the Legislature of the State of Florida:
63 Section 1. Section 381.986, Florida Statutes, is amended to
65 381.986 Compassionate use of low-THC
and medical cannabis
66 and marijuana.—
67 (1) DEFINITIONS.—As used in this section, the term:
68 (a) “Cannabis delivery device” means an object used,
69 intended for use, or designed for use in preparing, storing,
70 ingesting, inhaling, or otherwise introducing marijuana low-THC
71 cannabis or medical cannabis into the human body.
72 (b) “Caregiver” has the same meaning as provided in s. 29,
73 Art. X of the State Constitution.
74 (c) “Chronic nonmalignant pain” means pain that is caused
75 by a debilitating medical condition or that originates from a
76 debilitating medical condition and persists beyond the usual
77 course of that debilitating medical condition.
78 (d) “Close relative” means a spouse, parent, sibling,
79 grandparent, child, or grandchild, whether related by whole or
80 half-blood, by marriage, or by adoption.
81 (e) (b) “Debilitating medical condition” has the same
82 meaning as provided in s. 29, Art. X of the State Constitution
83 “ Dispensing organization ” means an organization approved by the
84 department to cultivate, process, transport, and dispense low
85 THC cannabis or medical cannabis pursuant to this section.
86 (f) (c) “Independent testing laboratory” means a laboratory,
87 including the managers, employees, or contractors of the
88 laboratory, which has no direct or indirect interest in a
89 medical marijuana treatment center a dispensing organization.
90 (g) (d) “Legal representative” means the qualifying
91 qualified patient’s parent, legal guardian acting pursuant to a
92 court’s authorization as required under s. 744.3215(4), health
93 care surrogate acting pursuant to the qualifying qualified
94 patient’s written consent or a court’s authorization as required
95 under s. 765.113, or an individual who is authorized under a
96 power of attorney to make health care decisions on behalf of the
97 qualifying qualified patient.
98 (h) (e) “Low-THC cannabis” means a plant of the genus
99 Cannabis, the dried flowers of which contain 0.8 percent or less
100 of tetrahydrocannabinol and more than 10 percent of cannabidiol
101 weight for weight; the seeds thereof; the resin extracted from
102 any part of such plant; or any compound, manufacture, salt,
103 derivative, mixture, or preparation of such plant or its seeds
104 or resin that is dispensed only by a medical marijuana treatment
105 center from a dispensing organization.
106 (i) (f) “Marijuana” has the same meaning as provided in s.
107 29, Art. X of the State Constitution “ Medical cannabis ” means
108 all parts of any plant of the genus Cannabis , whether growing or
109 not; the seeds thereof; the resin extracted from any part of the
110 plant; and every compound, manufacture, sale, derivative,
111 mixture, or preparation of the plant or its seeds or resin that
112 is dispensed only from a dispensing organization for medical use
113 by an eligible patient as defined in s. 499.0295.
114 (j) “Medical marijuana treatment center” or “MMTC” has the
115 same meaning as provided in s. 29, Art. X of the State
117 (k) (g) “Medical use” has the same meaning as provided in s.
118 29, Art. X of the State Constitution means administration of the
119 ordered amount of low-THC cannabis or medical cannabis. The term
120 does not include the:
121 1. Possession, use, or administration of marijuana low-THC
122 cannabis or medical cannabis by smoking.
123 2. Possession, use, or administration of marijuana that was
124 not purchased or acquired from an MMTC registered with the
125 Department of Health.
126 3. 2. Transfer of marijuana low-THC cannabis or medical
127 cannabis to a person other than the qualifying qualified patient
128 for whom it was ordered or the qualifying qualified patient’s
129 caregiver legal representative on behalf of the qualifying
130 qualified patient.
131 4. Use or administration of any type or amount of marijuana
132 not specified on the qualifying patient’s physician
134 5. 3. Use or administration of marijuana low-THC cannabis or
135 medical cannabis:
136 a. On any form of public transportation.
137 b. In any public place.
138 c. In a qualifying qualified patient’s place of employment,
139 if restricted by his or her employer.
140 d. In a state correctional institution as defined in s.
141 944.02 or a correctional institution as defined in s. 944.241.
142 e. On the grounds of a preschool, primary school, or
143 secondary school.
144 f. On a school bus or in a vehicle, aircraft, or motorboat.
145 (l) (h) “Qualifying Qualified patient” has the same meaning
146 as provided in s. 29, Art. X of the State Constitution but also
147 includes eligible patients, as that term is defined in s.
148 499.0295, and patients who are issued a physician certification
149 under subparagraph (2)(a)2. or subparagraph (2)(a)3. A patient
150 is not a qualifying patient unless he or she is registered with
151 the department and has been issued a compassionate use registry
152 identification card means a resident of this state who has been
153 added to the compassionate use registry by a physician licensed
154 under chapter 458 or chapter 459 to receive low-THC cannabis or
155 medical cannabis from a dispensing organization.
156 (m) (i) “Smoking” means burning or igniting a substance and
157 inhaling the smoke. Smoking does not include the use of a
159 (2) PHYSICIAN CERTIFICATION ORDERING.—
160 (a) A physician is authorized to issue a physician
161 certification to:
162 1. A patient suffering from a debilitating medical
163 condition, which allows the patient to receive marijuana for the
164 patient’s medical use;
165 2. A order low-THC cannabis to treat a qualified patient
166 suffering from cancer or a physical medical condition that
167 chronically produces symptoms of seizures or severe and
168 persistent muscle spasms, which allows the patient to receive
169 low-THC cannabis for the patient’s medical use;
170 3. A patient suffering from chronic nonmalignant pain, if
171 the physician has diagnosed an underlying debilitating medical
172 condition as the cause of the pain, which allows the patient to
173 receive marijuana for the patient’s medical use order low-THC
174 cannabis to alleviate the patient’s pain symptoms of such
175 disease, disorder, or condition, if no other satisfactory
176 alternative treatment options exist for the qualified patient;
178 4. order medical cannabis to treat An eligible patient as
179 defined in s. 499.0295, which allows the patient to receive
180 marijuana for the patient’s medical use. ;
181 (b) In the physician certification, the physician may also
182 specify one or more or order a cannabis delivery devices to
183 assist with device for the patient’s medical use of marijuana.
184 low-THC cannabis or medical cannabis,
185 (c) A physician may certify a patient and specify a
186 delivery device under paragraphs (a) and (b) only if the
188 1. (a) Holds an active, unrestricted license as a physician
189 under chapter 458 or an osteopathic physician under chapter 459;
190 (b) Has treated the patient for at least 3 months
191 immediately preceding the patient’s registration in the
192 compassionate use registry;
193 2. (c) Has successfully completed the course and examination
194 required under paragraph (4)(a);
195 3. Has conducted a physical examination and made a full
196 assessment of the medical history of the patient;
197 4. Has determined that, in the physician’s professional
198 opinion, the patient meets one or more of the criteria specified
199 in paragraph (a);
200 5. (d) Has determined that the medical use of marijuana
201 would likely outweigh the potential health risks to of treating
202 the patient with low-THC cannabis or medical cannabis are
203 reasonable in light of the potential benefit to the patient . If
204 a patient is younger than 18 years of age, a second physician
205 must concur with this determination, and such determination must
206 be documented in the patient’s medical record;
207 6. (e) Registers as the patient’s physician orderer of low
208 THC cannabis or medical cannabis for the named patient on the
209 compassionate use registry maintained by the department and
210 updates the registry to reflect the contents of the order,
211 including the amount of marijuana low-THC cannabis or medical
212 cannabis that will provide the patient with not more than a 90
213 day 45-day supply and any a cannabis delivery device needed by
214 the patient for the medical use of marijuana low-THC cannabis or
215 medical cannabis. If the physician’s recommended amount of
216 marijuana for a 90-day supply changes, the physician must also
217 update the registry within 7 days after the any change is made
218 to the original order to reflect the change. The physician shall
219 deactivate the registration of the patient and the patient’s
220 legal representative when the physician no longer recommends the
221 medical use of marijuana for the patient treatment is
223 7. (f) Maintains a patient treatment plan that includes the
224 dose, route of administration, planned duration, and monitoring
225 of the patient’s symptoms and other indicators of tolerance or
226 reaction to the marijuana low-THC cannabis or medical cannabis;
227 8. (g) Submits the patient treatment plan quarterly to the
228 University of Florida College of Pharmacy for research on the
229 safety and efficacy of marijuana low-THC cannabis and medical
230 cannabis on patients; and
231 9. (h) Obtains the voluntary written informed consent of the
232 patient or the patient’s legal representative to treatment with
233 marijuana low-THC cannabis after sufficiently explaining the
234 current state of knowledge in the medical community of the
235 effectiveness of treatment of the patient’s condition with
236 marijuana low-THC cannabis , the medically acceptable
237 alternatives, and the potential risks and side effects. If the
238 patient is a minor, the patient’s parent or legal guardian must
239 consent to treatment in writing. If the patient is an eligible
240 patient as defined in s. 499.0295, the physician must obtain
241 written informed consent as defined in and required by s.
242 499.0295. ;
243 (d) At least annually, a physician must recertify the
244 qualifying patient pursuant to paragraph (c).
245 (i) Obtains written informed consent as defined in and
246 required under s. 499.0295, if the physician is ordering medical
247 cannabis for an eligible patient pursuant to that section; and
248 (e) (j) A physician may not issue a physician certification
249 if the physician is not a medical director employed by an MMTC a
250 dispensing organization.
251 (f) An order for low-THC cannabis or medical cannabis
252 issued pursuant to former s. 381.986, Florida Statutes 2016 and
253 registered with the compassionate use registry on the effective
254 date of this act, shall be considered a physician certification
255 issued pursuant to this subsection. The details and expiration
256 date of such certification must be identical to the details and
257 expiration date of the order as logged in the compassionate use
258 registry. Until the department begins issuing compassionate use
259 registry identification cards, all patients with such orders
260 shall be considered qualifying patients, notwithstanding the
261 requirement that a qualifying patient have a compassionate use
262 registry identification card.
263 (3) PENALTIES.—
264 (a) A physician commits a misdemeanor of the first degree,
265 punishable as provided in s. 775.082 or s. 775.083, if the
266 physician issues a physician certification for marijuana to
267 orders low-THC cannabis for a patient in a manner other than as
268 required in subsection (2) without a reasonable belief that the
269 patient is suffering from:
270 1. Cancer or A physical medical condition that chronically
271 produces symptoms of seizures or severe and persistent muscle
272 spasms that can be treated with low-THC cannabis; or
273 2. Symptoms of cancer or a physical medical condition that
274 chronically produces symptoms of seizures or severe and
275 persistent muscle spasms that can be alleviated with low-THC
277 (b) A physician commits a misdemeanor of the first degree,
278 punishable as provided in s. 775.082 or s. 775.083, if the
279 physician orders medical cannabis for a patient without a
280 reasonable belief that the patient has a terminal condition as
281 defined in s. 499.0295.
282 (b) (c) A person who fraudulently represents that he or she
283 has a debilitating medical condition cancer, a physical medical
284 condition that chronically produces symptoms of seizures or
285 severe and persistent muscle spasms, chronic nonmalignant pain,
286 or a terminal condition as defined in s. 499.0295 to a physician
287 for the purpose of being issued a physician certification for
288 marijuana ordered low-THC cannabis, medical cannabis , or a
289 cannabis delivery device by such physician commits a misdemeanor
290 of the first degree, punishable as provided in s. 775.082 or s.
292 (c) (d) A qualifying patient an eligible patient as defined
293 in s. 499.0295 who uses marijuana medical cannabis, and such
294 patient’s caregiver legal representative who administers
295 marijuana medical cannabis, in plain view of or in a place open
296 to the general public, on the grounds of a school, or in a
297 school bus, vehicle, aircraft, or motorboat, commits a
298 misdemeanor of the first degree, punishable as provided in s.
299 775.082 or s. 775.083.
300 (d) A qualifying patient or caregiver who cultivates
301 marijuana or who purchases or acquires marijuana from any person
302 or entity other than an MMTC commits a misdemeanor of the first
303 degree, punishable as provided in s. 775.082 or s. 775.083.
304 (e) A caregiver who violates any of the applicable
305 provisions of this section or applicable department rules
306 commits, upon the first offense, a misdemeanor of the second
307 degree, punishable as provided in s. 775.082 or s. 775.083 and,
308 upon the second and subsequent offenses, a misdemeanor of the
309 first degree, punishable as provided in s. 775.082 or s.
311 (f) (e) A physician who issues a physician certification for
312 marijuana orders low-THC cannabis, medical cannabis , or a
313 cannabis delivery device and receives compensation from an MMTC
314 a dispensing organization related to issuing the physician
315 certification for marijuana the ordering of low-THC cannabis,
316 medical cannabis , or a cannabis delivery device is subject to
317 disciplinary action under the applicable practice act and s.
319 (4) PHYSICIAN EDUCATION.—
320 (a) Before a physician may issue a physician certification
321 pursuant to subsection (2) ordering low-THC cannabis, medical
322 cannabis, or a cannabis delivery device for medical use by a
323 patient in this state, the appropriate board shall require the
324 ordering physician to successfully complete a 4-hour an 8-hour
325 course and subsequent examination offered by the Florida Medical
326 Association or the Florida Osteopathic Medical Association which
327 that encompasses the clinical indications for the appropriate
328 use of marijuana low-THC cannabis and medical cannabis, the
329 appropriate cannabis delivery devices, the contraindications for
330 such use, and the relevant state and federal laws governing the
331 issuance of physician certifications ordering, as well as
332 dispensing , and possessing of these substances and devices. The
333 course and examination shall be administered at least quarterly
334 annually. Successful completion of the course may be used by a
335 physician to satisfy 4 hours 8 hours of the continuing medical
336 education requirements required by his or her respective board
337 for licensure renewal. This course may be offered in a distance
338 learning format, including an electronic, online format that is
339 available on request. Physicians who have completed an 8-hour
340 course and subsequent examination offered by the Florida Medical
341 Association or the Florida Osteopathic Medical Association which
342 encompasses the clinical indications for the appropriate use of
343 marijuana and who are registered in the compassionate use
344 registry on the effective date of this act, are deemed to meet
345 the requirements of this paragraph.
346 (b) The appropriate board shall require the medical
347 director of each MMTC dispensing organization to hold an active,
348 unrestricted license as a physician under chapter 458 or as an
349 osteopathic physician under chapter 459 and successfully
350 complete a 2-hour course and subsequent examination offered by
351 the Florida Medical Association or the Florida Osteopathic
352 Medical Association which that encompasses appropriate safety
353 procedures and knowledge of marijuana low-THC cannabis, medical
354 cannabis , and cannabis delivery devices.
355 (c) Successful completion of the course and examination
356 specified in paragraph (a) is required for every physician who
357 orders low-THC cannabis, medical cannabis, or a cannabis
358 delivery device each time such physician renews his or her
359 license. In addition, successful completion of the course and
360 examination specified in paragraph (b) is required for the
361 medical director of each dispensing organization each time such
362 physician renews his or her license.
363 (c) (d) A physician who fails to comply with this subsection
364 and issues a physician certification for marijuana who orders
365 low-THC cannabis, medical cannabis , or a cannabis delivery
366 device may be subject to disciplinary action under the
367 applicable practice act and under s. 456.072(1)(k).
368 (5) CAREGIVERS.—
369 (a) During the course of registration with the department
370 for inclusion on the compassionate use registry, or at any time
371 while registered, a qualifying patient may designate an
372 individual as his or her caregiver to assist him or her with the
373 medical use of marijuana. The designated caregiver must be 21
374 years of age or older, unless the patient is a close relative of
375 the caregiver; must agree in writing to be the qualifying
376 patient’s caregiver; may not receive compensation, other than
377 actual expenses incurred, for assisting the qualifying patient
378 with the medical use of marijuana unless the caregiver is acting
379 pursuant to employment in a licensed facility in accordance with
380 subparagraph (c)2.; and must pass a level 2 screening pursuant
381 to chapter 435, unless the patient is a close relative of the
383 (b) A qualifying patient may have only one designated
384 caregiver at any given time unless all of the patient’s
385 caregivers are his or her close relatives or legal
387 (c) A caregiver may assist only one qualifying patient at
388 any given time unless:
389 1. All qualifying patients the caregiver is assisting are
390 close relatives of each other and the caregiver is the legal
391 representative of at least one of the patients; or
392 2. All qualifying patients the caregiver is assisting are
393 receiving hospice services, or are residents, in the same
394 assisted living facility, nursing home, or other licensed
395 facility and have requested the assistance of that caregiver
396 with the medical use of marijuana; the caregiver is an employee
397 of the hospice or licensed facility; and the caregiver provides
398 personal care or services directly to clients of the hospice or
399 licensed facility as a part of his or her employment duties at
400 the hospice or licensed facility.
401 (d) The department must register a caregiver on the
402 compassionate use registry and issue him or her a caregiver
403 identification card if he or she is designated by a qualifying
404 patient pursuant to paragraph (a) and meets all of the
405 requirements of this subsection and department rule.
406 (6) (5) DUTIES OF THE DEPARTMENT.—The department shall:
407 (a) Create and maintain a secure, electronic, and online
408 compassionate use registry for the registration of physicians,
409 patients, and caregivers the legal representatives of patients
410 as provided under this section. The registry must be accessible
412 1. Practitioners licensed under chapter 458 or chapter 459,
413 to ensure proper care for patients requesting physician
415 2. Practitioners licensed to prescribe prescription drugs,
416 to ensure proper care for patients before prescribing
417 medications that may interact with the medical use of marijuana;
418 3. Law enforcement agencies, to verify the authorization of
419 a qualifying patient or a patient’s caregiver to possess
420 marijuana or a cannabis delivery device; and
421 4. MMTCs, to a dispensing organization to verify the
422 authorization of a qualifying patient or a patient’s caregiver
423 legal representative to possess marijuana low-THC cannabis,
424 medical cannabis , or a cannabis delivery device and to record
425 the marijuana low-THC cannabis, medical cannabis , or cannabis
426 delivery device dispensed.
428 The registry must prevent an active registration of a patient by
429 multiple physicians.
430 (b) By July 3, 2017, adopt rules establishing procedures
431 for the issuance, annual renewal, suspension, and revocation of
432 compassionate use registry identification cards for patients and
433 caregivers who are residents of this state. The department may
434 charge a reasonable fee associated with the issuance and renewal
435 of patient and caregiver identification cards. By October 3,
436 2017, the department shall begin issuing identification cards to
437 adult patients who are residents of this state and who have a
438 physician certification that meets the requirements of
439 subsection (2); minor patients who are residents of this state
440 and who have a physician certification that meets the
441 requirements of subsection (2) and the written consent of a
442 parent or legal guardian; and caregivers registered pursuant to
443 subsection (5). Patient and caregiver identification cards must
444 be resistant to counterfeiting and tampering and must include at
445 least the following:
446 1. The name, address, and date of birth of the patient or
447 caregiver, as appropriate;
448 2. A full-face, passport-type, color photograph of the
449 patient or caregiver, as appropriate, taken within the 90 days
450 immediately preceding registration;
451 3. Designation of the cardholder as a patient or caregiver;
452 4. A unique numeric identifier for the patient or caregiver
453 which is matched to the identifier used for such person in the
454 department’s compassionate use registry. A caregiver’s
455 identification number and file in the compassionate use registry
456 must be linked to the file of the patient or patients the
457 caregiver is assisting so that the caregiver’s status may be
458 verified for each patient individually;
459 5. The expiration date, which shall be 1 year after the
460 date of issuance of the identification card or the date
461 treatment ends as provided in the patient’s physician
462 certification, whichever occurs first; and
463 6. For caregivers who are assisting three or fewer
464 qualifying patients, the names and unique numeric identifiers of
465 the qualifying patient or patients that the caregiver is
467 (c) As soon as practicable after the effective date of this
468 act, update its records by registering each dispensing
469 organization approved pursuant to chapter 2014-157, Laws of
470 Florida, or chapter 2016-123, Laws of Florida, as an MMTC with
471 an effective registration date that coincides with that
472 dispensing organization’s date of approval as a dispensing
473 organization. On the effective date of this act, all dispensing
474 organizations approved pursuant to chapter 2014-157, Laws of
475 Florida, or chapter 2016-123, Laws of Florida, are deemed to be
476 registered MMTCs. The department may not require a dispensing
477 organization approved pursuant to chapter 2014-157, Laws of
478 Florida, or chapter 2016-123, Laws of Florida, to submit an
479 application and may not charge the dispensing organization an
480 application or registration fee for the initial registration of
481 that dispensing organization as an MMTC pursuant to this
482 section. For purposes of the requirement that an MMTC comply
483 with the representations made in its application pursuant to
484 subsection (7), an MMTC registered pursuant to this paragraph
485 shall continue to comply with the representations made in its
486 application for approval as a dispensing organization, including
487 any revision authorized by the department before the effective
488 date of this act. After the effective date of this act, the
489 department may grant variances from the representations made in
490 a dispensing organization’s application for approval pursuant to
491 subsection (7). For purposes of the definition of the term
492 “marijuana” in s. 29, of Art. X of the State Constitution, an
493 MMTC is deemed to be a dispensing organization as that term is
494 defined in former s. 381.986(1)(a), Florida Statutes 2014
495 Authorize the establishment of five dispensing organizations to
496 ensure reasonable statewide accessibility and availability as
497 necessary for patients registered in the compassionate use
498 registry and who are ordered low-THC cannabis, medical cannabis,
499 or a cannabis delivery device under this section, one in each of
500 the following regions: northwest Florida, northeast Florida,
501 central Florida, southeast Florida, and southwest Florida.
502 (d) Within 6 months after the registration of 250,000
503 active qualifying patients in the compassionate use registry,
504 the department must register five additional MMTCs, including,
505 but not limited to, an applicant that is a recognized class
506 member of Pigford v. Glickman, 185 F.R.D. 82 (D.D.C. 1999) or In
507 re Black Farmers Litig., 856 F. Supp. 2d 1 (D.D.C. 2011) and a
508 member of the Black Farmers and Agriculturalists Association.
509 Additionally, the department must register an additional five
510 MMTCs within 6 months after the registration of each of the
511 following totals of the number of patients in the compassionate
512 use registry: 350,000 qualifying patients; 400,000 qualifying
513 patients; 500,000 qualifying patients; and then the registration
514 of each additional 100,000 qualifying patients above 500,000, if
515 a sufficient number of MMTC applicants meet the registration
516 requirements established in this section and by department rule.
517 (e) The department shall develop an application form for
518 registration as an MMTC and impose an initial application and
519 biennial renewal fee that is sufficient to cover the costs of
520 administering this section. To be registered as an MMTC, the an
521 applicant for approval as a dispensing organization must be able
522 to demonstrate:
523 1. The technical and technological ability to cultivate and
524 produce low-THC cannabis and marijuana. The applicant must
525 possess a valid certificate of registration issued by the
526 Department of Agriculture and Consumer Services pursuant to s.
527 581.131 that is issued for the cultivation of more than 400,000
528 plants, be operated by a nurseryman as defined in s. 581.011,
529 and have been operated as a registered nursery in this state for
530 at least 30 continuous years.
531 2. The ability to secure the premises, resources, and
532 personnel necessary to operate as an MMTC a d ispensing
534 3. The ability to maintain accountability of all raw
535 materials, finished products, and any byproducts to prevent
536 diversion or unlawful access to or possession of these
538 4. An infrastructure reasonably located to dispense low-THC
539 cannabis and marijuana to registered qualifying patients
540 statewide or regionally as determined by the department.
541 5. The financial ability to maintain operations for the
542 duration of the 2-year approval cycle, including the provision
543 of certified financials to the department. Upon approval, the
544 applicant must post a $5 million performance bond. However, upon
545 an MMTC a dispensing organization’s serving at least 1,000
546 qualifying qualified patients, the MMTC dispensing organization
547 is only required to maintain a $2 million performance bond.
548 6. That all owners and managers have been fingerprinted and
549 have successfully passed a level 2 background screening pursuant
550 to s. 435.04.
551 7. The employment of a medical director to supervise the
552 activities of the MMTC dispensing organization.
553 (c) Upon the registration of 250,000 active qualified
554 patients in the compassionate use registry, approve three
555 dispensing organizations, including, but not limited to, an
556 applicant that is a recognized class member of Pigford v.
557 Glickman , 185 F.R.D. 82 (D.D.C. 1999), or In Re Black Farmers
558 Litig. , 856 F. Supp. 2d 1 (D.D.C. 2011), and a member of the
559 Black Farmers and Agriculturalists Association, which must meet
560 the requirements of subparagraphs (b)2.-7. and demonstrate the
561 technical and technological ability to cultivate and produce
562 low-THC cannabis.
563 (f) (d) Allow an MMTC a d ispensing organization to make a
564 wholesale purchase of marijuana low-THC cannabis or medical
565 cannabis from, or a distribution of marijuana low-THC cannabis
566 or medical cannabis to, another MMTC dispensing organization.
567 (g) (e) Monitor physician registration in the compassionate
568 use registry and the issuance of physician certifications
569 pursuant to subsection (2) ordering of low-THC cannabis, medical
570 cannabis, or a cannabis delivery device for ordering practices
571 that could facilitate unlawful diversion or misuse of marijuana
572 low-THC cannabis, medical cannabis , or a cannabis delivery
573 devices device and take disciplinary action as indicated.
574 (7) (6) MEDICAL MARIJUANA TREATMENT CENTERS DISPENSING
575 ORGANIZATION.—Each MMTC must register with the department. A
576 registered MMTC An approved dispensing organization must, at all
577 times, maintain compliance with paragraph (6)(e), the criteria
578 demonstrated for selection and approval as a dispensing
579 organization under subsection(5 ) and the criteria required in
580 this subsection, and all representations made to the department
581 in the MMTC’s application for registration. Upon request, the
582 department may grant an MMTC one or more variances from the
583 representations made in the MMTC’s application. Consideration of
584 such a variance shall be based upon the individual facts and
585 circumstances surrounding the request. A variance may not be
586 granted unless the requesting MMTC can demonstrate to the
587 department that it has a proposed alternative to the specific
588 representation made in its application which fulfills the same
589 or a similar purpose as the specific representation in a way
590 that the department can reasonably determine will not be a lower
591 standard than the specific representation in the application.
592 (a) When growing marijuana low-THC cannabis or medical
593 cannabis, an MMTC a dispensing organization:
594 1. May use pesticides determined by the department, after
595 consultation with the Department of Agriculture and Consumer
596 Services, to be safely applied to plants intended for human
597 consumption, but may not use pesticides designated as
598 restricted-use pesticides pursuant to s. 487.042.
599 2. Must grow marijuana low-THC cannabis or medical cannabis
600 within an enclosed structure and in a room separate from any
601 other plant.
602 3. Must inspect seeds and growing plants for plant pests
603 that endanger or threaten the horticultural and agricultural
604 interests of the state, notify the Department of Agriculture and
605 Consumer Services within 10 calendar days after a determination
606 that a plant is infested or infected by such plant pest, and
607 implement and maintain phytosanitary policies and procedures.
608 4. Must perform fumigation or treatment of plants, or the
609 removal and destruction of infested or infected plants, in
610 accordance with chapter 581 and any rules adopted thereunder.
611 (b) When processing marijuana low-THC cannabis or medical
612 cannabis, an MMTC a dispensing organization must:
613 1. Process the marijuana low-THC cannabis or medical
614 cannabis within an enclosed structure and in a room separate
615 from other plants or products.
616 2. Test the processed marijuana low-THC cannabis and
617 medical cannabis before it is they are dispensed. Results must
618 be verified and signed by two MMTC dispensing organization
619 employees. Before dispensing low-THC cannabis, the MMTC
620 dispensing organization must determine that the test results
621 indicate that the low-THC cannabis meets the definition of low
622 THC cannabis. Before dispensing marijuana, the MMTC must
623 determine and , for medical cannabis and low-THC cannabis , that
624 the marijuana all medical cannabis and low-THC cannabis is safe
625 for human consumption and free from contaminants that are unsafe
626 for human consumption. The MMTC dispensing organization must
627 retain records of all testing and samples of each homogenous
628 batch of marijuana cannabis and low-THC cannabis for at least 9
629 months. The MMTC dispensing organization must contract with an
630 independent testing laboratory to perform audits on the MMTC’s
631 dispensing organization’s standard operating procedures, testing
632 records, and samples and provide the results to the department
633 to confirm that the marijuana low-THC cannabis or medical
634 cannabis meets the requirements of this section and that the
635 marijuana medical cannabis and low-THC cannabis is safe for
636 human consumption.
637 3. Package the marijuana low-THC cannabis or medical
638 cannabis in compliance with the United States Poison Prevention
639 Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.
640 4. Package the marijuana low-THC cannabis or medical
641 cannabis in a child-proof receptacle that has a firmly affixed
642 and legible label stating the following information:
643 a. A statement that the marijuana low-THC cannabis or
644 medical cannabis meets the requirements of subparagraph 2.;
645 b. The name of the MMTC dispensing organization from which
646 the marijuana medical cannabis or low-THC cannabis originates;
648 c. The batch number and harvest number from which the
649 marijuana medical cannabis or low-THC cannabis originates; and
650 d. The concentration of tetrahydrocannabinol and
651 cannabidiol in the product.
652 5. Reserve two processed samples from each batch and retain
653 such samples for at least 9 months for the purpose of testing
654 pursuant to the audit required under subparagraph 2.
655 (c) When dispensing marijuana low-THC cannabis, medical
656 cannabis , or a cannabis delivery device, an MMTC a d ispensing
658 1. May not dispense more than a 90-day 45-day supply of
659 marijuana low-THC cannabis or medical cannabis to a qualifying
660 patient or caregiver the patient’s legal representative.
661 2. Must ensure its have the dispensing organization’s
662 employee who dispenses the marijuana low-THC cannabis, medical
663 cannabis , or a cannabis delivery device enters enter into the
664 compassionate use registry his or her name or unique employee
666 3. Must verify that the qualifying patient and the
667 caregiver, if applicable, both have an active and valid
668 compassionate use registry identification card and that the
669 amount and type of marijuana dispensed matches the physician’s
670 certification in the compassionate use registry for that
671 qualifying patient that a physician has ordered the low-THC
672 cannabis, medical cannabis, or a specific type of a cannabis
673 delivery device for the patient.
674 4. Must label the low-THC cannabis or marijuana with the
675 recommended dose for the qualifying patient receiving the low
676 THC cannabis or marijuana.
677 5. 4. May not dispense or sell any other type of cannabis,
678 alcohol, or illicit drug-related product, including pipes,
679 bongs, or wrapping papers, other than a physician-ordered
680 cannabis delivery device required for the medical use of
681 marijuana that is specified in a physician certification low-THC
682 cannabis or medical cannabis , while dispensing low-THC cannabis
683 or medical cannabis. A registered MMTC may produce and dispense
684 marijuana as an edible or food product but may not produce such
685 items in a format designed to be attractive to children. In
686 addition to the requirements of this section and department
687 rule, food products produced by an MMTC must meet all food
688 safety standards established in state and federal law,
689 including, but not limited to, the identification of the serving
690 size and the amount of THC in each serving.
691 5. Must verify that the patient has an active registration
692 in the compassionate use registry, the patient or patient’s
693 legal representative holds a valid and active registration card,
694 the order presented matches the order contents as recorded in
695 the registry, and the order has not already been filled.
696 6. Must, upon dispensing the marijuana l ow-THC cannabis,
697 medical cannabis , or cannabis delivery device, record in the
698 registry the date, time, quantity, and form of marijuana low-THC
699 cannabis or medical cannabis dispensed; and the type of cannabis
700 delivery device dispensed; and the name and compassionate use
701 registry identification number of the qualifying patient or
702 caregiver to whom the marijuana or cannabis delivery device was
704 (d) To ensure the safety and security of its premises and
705 any off-site storage facilities, and to maintain adequate
706 controls against the diversion, theft, and loss of marijuana
707 low-THC cannabis, medical cannabis , or cannabis delivery
708 devices, an MMTC a di spensing organization shall:
709 1.a. Maintain a fully operational security alarm system
710 that secures all entry points and perimeter windows and is
711 equipped with motion detectors; pressure switches; and duress,
712 panic, and hold-up alarms; or
713 b. Maintain a video surveillance system that records
714 continuously 24 hours each day and meets at least one of the
715 following criteria:
716 (I) Cameras are fixed in a place that allows for the clear
717 identification of persons and activities in controlled areas of
718 the premises. Controlled areas include grow rooms, processing
719 rooms, storage rooms, disposal rooms or areas, and point-of-sale
721 (II) Cameras are fixed in entrances and exits to the
722 premises, which shall record from both indoor and outdoor, or
723 ingress and egress, vantage points;
724 (III) Recorded images must clearly and accurately display
725 the time and date; or
726 (IV) Retain video surveillance recordings for a minimum of
727 45 days, or longer upon the request of a law enforcement agency.
728 2. Ensure that the MMTC’s organization’s outdoor premises
729 have sufficient lighting from dusk until dawn.
730 3. Establish and maintain a tracking system approved by the
731 department which that traces the marijuana low-THC cannabis or
732 medical cannabis from seed to sale. The tracking system must
733 shall include notification of key events as determined by the
734 department, including when cannabis seeds are planted, when
735 cannabis plants are harvested and destroyed, and when marijuana
736 low-THC cannabis or medical cannabis is transported, sold,
737 stolen, diverted, or lost.
738 4. Not dispense from its premises marijuana low-THC
739 cannabis, medical cannabis , or a cannabis delivery device
740 between the hours of 9 p.m. and 7 a.m., but may perform all
741 other operations and deliver marijuana low-THC cannabis and
742 medical cannabis to qualifying qualified patients 24 hours each
744 5. Store marijuana low-THC cannabis or medical cannabis in
745 a secured, locked room or a vault.
746 6. Require at least two of its employees, or two employees
747 of a security agency with whom it contracts, to be on the
748 premises at all times.
749 7. Require each employee or contractor to wear a photo
750 identification badge at all times while on the premises.
751 8. Require each visitor to wear a visitor’s pass at all
752 times while on the premises.
753 9. Implement an alcohol and drug-free workplace policy.
754 10. Report to local law enforcement within 24 hours after
755 it is notified or becomes aware of the theft, diversion, or loss
756 of marijuana low-THC cannabis or medical cannabis.
757 (e) To ensure the safe transport of marijuana low-THC
758 cannabis or medical cannabis to MMTC dispensing organization
759 facilities, independent testing laboratories, or qualifying
760 patients, the MMTC dispensing organization must:
761 1. Maintain a transportation manifest, which must be
762 retained for at least 1 year. A copy of the manifest must be in
763 the vehicle at all times when transporting marijuana.
764 2. Ensure only vehicles in good working order are used to
765 transport marijuana low-THC cannabis or medical cannabis.
766 3. Lock marijuana low-THC cannabis or medical cannabis in a
767 separate compartment or container within the vehicle.
768 4. Require at least two persons to be in a vehicle
769 transporting marijuana low-THC cannabis or medical cannabis, and
770 require at least one person to remain in the vehicle while the
771 marijuana low-THC cannabis or medical cannabis is being
773 5. Provide specific safety and security training to
774 employees transporting or delivering marijuana low-THC cannabis
775 or medical cannabis.
776 (8) (7) DEPARTMENT AUTHORITY AND RESPONSIBILITIES.—
777 (a) The department may conduct announced or unannounced
778 inspections of MMTCs dispensing organizations to determine
779 compliance with this section or rules adopted pursuant to this
781 (b) The department shall inspect an MMTC a d ispensing
782 organization upon complaint or notice provided to the department
783 that the MMTC dispensing organization has dispensed marijuana
784 low-THC cannabis or medical cannabis containing any mold,
785 bacteria, or other contaminant that may cause or has caused an
786 adverse effect to human health or the environment.
787 (c) The department shall conduct at least a biennial
788 inspection of each MMTC dispensing organization to evaluate the
789 MMTC’s dispensing organization’s records, personnel, equipment,
790 processes, security measures, sanitation practices, and quality
791 assurance practices.
792 (d) The department shall adopt by rule a process for
793 approving changes in MMTC ownership or a change in an MMTC
794 owner’s investment interest. This process must include specific
795 criteria for the approval or denial of an application for change
796 of ownership or a change in investment interest and procedures
797 for screening applicants’ criminal and financial histories.
798 (e) (d) The department may enter into interagency agreements
799 with the Department of Agriculture and Consumer Services, the
800 Department of Business and Professional Regulation, the
801 Department of Transportation, the Department of Highway Safety
802 and Motor Vehicles, and the Agency for Health Care
803 Administration, and such agencies are authorized to enter into
804 an interagency agreement with the department, to conduct
805 inspections or perform other responsibilities assigned to the
806 department under this section.
807 (f) (e) The department must make a list of all approved
808 MMTCs, dispensing organizations and qualified ordering
809 physicians who are qualified to issue physician certifications,
810 and medical directors publicly available on its website.
811 (f) The department may establish a system for issuing and
812 renewing registration cards for patients and their legal
813 representatives, establish the circumstances under which the
814 cards may be revoked by or must be returned to the department,
815 and establish fees to implement such system. The department must
816 require, at a minimum, the registration cards to:
817 1. Provide the name, address, and date of birth of the
818 patient or legal representative.
819 2. Have a full-face, passport-type, color photograph of the
820 patient or legal representative taken within the 90 days
821 immediately preceding registration.
822 3. Identify whether the cardholder is a patient or legal
824 4. List a unique numeric identifier for the patient or
825 legal representative that is matched to the identifier used for
826 such person in the department’s compassionate use registry.
827 5. Provide the expiration date, which shall be 1 year after
828 the date of the physician’s initial order of low-THC cannabis or
829 medical cannabis.
830 6. For the legal representative, provide the name and
831 unique numeric identifier of the patient that the legal
832 representative is assisting.
833 7. Be resistant to counterfeiting or tampering.
834 (g) The department may impose reasonable fines not to
835 exceed $10,000 on an MMTC a dispensing organization for any of
836 the following violations:
837 1. Violating this section, s. 499.0295, or department rule.
838 2. Failing to maintain qualifications for registration with
839 the department approval.
840 3. Endangering the health, safety, or security of a
841 qualifying qualified patient.
842 4. Improperly disclosing personal and confidential
843 information of a qualifying the qualified patient.
844 5. Attempting to procure MMTC registration with the
845 department dispensing organization approval by bribery,
846 fraudulent misrepresentation, or extortion.
847 6. Any owner or manager of the MMTC being convicted or
848 found guilty of, or entering a plea of guilty or nolo contendere
849 to, regardless of adjudication, a crime in any jurisdiction
850 which directly relates to the business of an MMTC a d ispensing
852 7. Making or filing a report or record that the MMTC
853 dispensing organization knows to be false.
854 8. Willfully failing to maintain a record required by this
855 section or department rule.
856 9. Willfully impeding or obstructing an employee or agent
857 of the department in the furtherance of his or her official
859 10. Engaging in fraud or deceit, negligence, incompetence,
860 or misconduct in the business practices of an MMTC a dispensing
862 11. Making misleading, deceptive, or fraudulent
863 representations in or related to the business practices of an
864 MMTC a dispensing organization.
865 12. Having a license or the authority to engage in any
866 regulated profession, occupation, or business that is related to
867 the business practices of an MMTC a dispensing organization
868 suspended, revoked, or otherwise acted against by the licensing
869 authority of any jurisdiction, including its agencies or
870 subdivisions, for a violation that would constitute a violation
871 under Florida law.
872 13. Violating a lawful order of the department or an agency
873 of the state, or failing to comply with a lawfully issued
874 subpoena of the department or an agency of the state.
875 (h) The department may suspend, revoke, or refuse to renew
876 an MMTC’s registration with the department a dispensing
877 organization’s approval if the MMTC a dispensing organization
878 commits a violation specified any of the violations in paragraph
880 (i) The department shall renew an MMTC’s registration with
881 the department the approval of a dispensing organization
882 biennially if the MMTC dispensing organization meets the
883 requirements of this section and pays the biennial renewal fee.
884 (j) The department may adopt rules necessary to implement
885 this section.
886 (9) (8) PREEMPTION.—
887 (a) All matters regarding the regulation of the cultivation
888 and processing of marijuana medical cannabis or low-THC cannabis
889 by MMTCs dispensing organizations are preempted to the state.
890 (b) A municipality may determine by ordinance the criteria
891 for the number and location of, and other permitting
892 requirements that do not conflict with state law or department
893 rule for, dispensing facilities of MMTCs dispensing
894 organizations located within its municipal boundaries. A county
895 may determine by ordinance the criteria for the number,
896 location, and other permitting requirements that do not conflict
897 with state law or department rule for all dispensing facilities
898 of MMTCs dispensing organizations located within the
899 unincorporated areas of that county.
900 (10) (9) EXCEPTIONS TO OTHER LAWS.—
901 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
902 any other provision of law, but subject to the requirements of
903 this section, a qualifying qualified patient, or a caregiver who
904 has obtained a valid compassionate use registry identification
905 card from the department, and the qualified patient’s legal
906 representative may purchase from an MMTC, and possess for the
907 qualifying patient’s medical use, up to the amount of marijuana
908 in the physician’s certification low-THC cannabis or medical
909 cannabis ordere d for the patient, but not more than a 90-day 45
910 day supply, and a cannabis delivery device specified in the
911 physician’s certification ordered for the qualifying patient.
912 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
913 any other provision of law, but subject to the requirements of
914 this section, a registered MMTC an approved dispensing
915 organization and its owners, managers, contractors, and
916 employees may manufacture, possess, sell, deliver, distribute,
917 dispense, administer, and lawfully dispose of reasonable
918 quantities, as established by department rule, of marijuana low
919 THC cannabis , medical cannabis , or a cannabis delivery device.
920 For purposes of this subsection, the terms “manufacture,”
921 “possession,” “deliver,” “distribute,” and “dispense” have the
922 same meanings as provided in s. 893.02.
923 (c) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
924 any other provision of law, but subject to the requirements of
925 this section, an approved independent testing laboratory may
926 possess, test, transport, and lawfully dispose of marijuana low
927 THC cannabis or medical cannabis as provided by department rule.
928 (d) An approved MMTC dispensing organization and its
929 owners, managers, contractors, and employees are not subject to
930 licensure or regulation under chapter 465 or chapter 499 for
931 manufacturing, possessing, selling, delivering, distributing,
932 dispensing, or lawfully disposing of reasonable quantities, as
933 established by department rule, of marijuana low-THC cannabis ,
934 medical cannabis , or a cannabis delivery device.
935 (e) An approved dispensing organization that continues to
936 meet the requirements for approval is presumed to be registered
937 with the department and to meet the regulations adopted by the
938 department or its successor agency for the purpose of dispensing
939 medical cannabis or low-THC cannabis under Florida law.
940 Additionally, Exercise by an MMTC of the authority provided to
941 MMTCs a d ispensing organization in s. 499.0295 does not impair
942 its registration with the department the approval of a
943 d ispensing organization.
944 (f) This subsection does not exempt a person from
945 prosecution for a criminal offense related to impairment or
946 intoxication resulting from the medical use of marijuana low-THC
947 cannabis or medical cannabis or relieve a person from any
948 requirement under law to submit to a breath, blood, urine, or
949 other test to detect the presence of a controlled substance.
950 (g) This section does not limit the ability of an employer
951 to establish, continue, or enforce a drug-free workplace program
952 or policy.
953 Section 2. Paragraph (b) of subsection (3) of section
954 381.987, Florida Statutes, is amended to read:
955 381.987 Public records exemption for personal identifying
956 information in the compassionate use registry.—
957 (3) The department shall allow access to the registry,
958 including access to confidential and exempt information, to:
959 (b) A medical marijuana treatment center dispensing
960 organization approved by the department pursuant to s. 381.986
961 which is attempting to verify the authenticity of a physician’s
962 certification order for marijuana low-THC cannabis, including
963 whether the physician certification order had been previously
964 filled and whether the physician certification order was written
965 for the person attempting to have it filled.
966 Section 3. Subsection (1) of section 385.211, Florida
967 Statutes, is amended to read:
968 385.211 Refractory and intractable epilepsy treatment and
969 research at recognized medical centers.—
970 (1) As used in this section, the term “low-THC cannabis”
971 means “low-THC cannabis” as defined in s. 381.986 which that is
972 dispensed only from a medical marijuana treatment center
973 dispensing organization as defined in s. 381.986.
974 Section 4. Present paragraphs (b) and (c) of subsection (2)
975 of section 499.0295, Florida Statutes, are redesignated as
976 paragraphs (a) and (b), respectively, present paragraphs (a) and
977 (c) of that subsection are amended, a new paragraph (c) is added
978 to that subsection, and subsection (3) of that section is
979 amended, to read:
980 499.0295 Experimental treatments for terminal conditions.—
981 (2) As used in this section, the term:
982 (a) “Dispensing organization” means an organization
983 approved by the Department of Health under s. 381.986(5) to
984 cultivate, process, transport, and dispense low-THC cannabis,
985 medical cannabis , and cannabis delivery devices.
986 (b) (c) “Investigational drug, biological product, or
987 device” means:
988 1. A drug, biological product, or device that has
989 successfully completed phase 1 of a clinical trial but has not
990 been approved for general use by the United States Food and Drug
991 Administration and remains under investigation in a clinical
992 trial approved by the United States Food and Drug
993 Administration; or
994 2. Marijuana Medical cannabis that is manufactured and sold
995 by an MMTC a dispensing organization.
996 (c) “Medical marijuana treatment center” or “MMTC” means an
997 organization registered with the Department of Health under s.
999 (3) Upon the request of an eligible patient, a manufacturer
1000 may, or upon the issuance of a physician certification a
1001 physician’s order pursuant to s. 381.986, an MMTC a dispensing
1002 organization may:
1003 (a) Make its investigational drug, biological product, or
1004 device available under this section.
1005 (b) Provide an investigational drug, biological product,
1006 device, or cannabis delivery device as defined in s. 381.986 to
1007 an eligible patient without receiving compensation.
1008 (c) Require an eligible patient to pay the costs of, or the
1009 costs associated with, the manufacture of the investigational
1010 drug, biological product, device, or cannabis delivery device as
1011 defined in s. 381.986.
1012 Section 5. Subsection (1) of section 1004.441, Florida
1013 Statutes, is amended to read:
1014 1004.441 Refractory and intractable epilepsy treatment and
1016 (1) As used in this section, the term “low-THC cannabis”
1017 means “low-THC cannabis” as defined in s. 381.986 which that is
1018 dispensed only from a medical marijuana treatment center
1019 dispensing organization as defined in s. 381.986.
1020 Section 6. The Division of Law Revision and Information is
1021 directed to replace the phrase “the effective date of this act”
1022 wherever it occurs in this act with the date the act becomes a
1024 Section 7. This act shall take effect upon becoming a law.