Florida Senate - 2017 SB 1388
By Senator Artiles
1 A bill to be entitled
2 An act relating to medical cannabis; amending s.
3 381.986, F.S.; defining, redefining, and deleting
4 terms; authorizing physicians to issue physician
5 certifications for medical cannabis or cannabis
6 delivery devices, instead of ordering low-THC
7 cannabis, for patients suffering from a debilitating
8 medical condition; authorizing physicians to make
9 specific determinations in certifications; requiring
10 physicians to meet certain conditions to be authorized
11 to issue such physician certifications; providing
12 criminal penalties; deleting provisions requiring
13 successful completion of a specified course and
14 examination by a physician who orders low-THC cannabis
15 and by a medical director of a dispensing
16 organization; requiring the Department of Health to
17 register medical marijuana treatment centers, rather
18 than to authorize the establishment of dispensing
19 organizations; requiring the department to register
20 additional medical marijuana treatment centers under
21 certain circumstances; requiring the department to
22 authorize the establishment of medical marijuana
23 testing facilities; prohibiting a medical marijuana
24 testing facility from being owned by certain persons;
25 providing rulemaking authority; conforming provisions
26 to changes made by the act; deleting provisions
27 relating to the department’s issuance of registration
28 cards for patients and their legal representatives;
29 requiring the department to establish a quality
30 control program that requires medical cannabis to be
31 tested by a medical marijuana testing facility;
32 requiring medical marijuana treatment centers to
33 submit samples of medical cannabis to a medical
34 marijuana testing facility; providing testing
35 specifications; requiring retention of testing
36 records; providing rulemaking authority; conforming
37 provisions to changes made by the act; amending ss.
38 381.987, 385.211, 499.0295, 893.02, and 1004.441,
39 F.S.; conforming provisions to changes made by the
40 act; providing an effective date.
42 Be It Enacted by the Legislature of the State of Florida:
44 Section 1. Section 381.986, Florida Statutes, is amended to
46 381.986 Compassionate use of
low-THC and medical cannabis.—
47 (1) DEFINITIONS.—As used in this section, the term:
48 (a) “Cannabis delivery device” means an object used,
49 intended for use, or designed for use in preparing, storing,
50 ingesting, inhaling, or otherwise introducing low-THC cannabis
51 or medical cannabis into the human body.
52 (b) “Caregiver” means a person who is at least 21 years
53 old, who has agreed to assist with a qualifying patient’s
54 medical use of marijuana, and who has obtained a valid caregiver
55 identification card issued by the department.
56 (c) “Debilitating medical condition” means cancer,
57 epilepsy, glaucoma, positive status for human immunodeficiency
58 virus (HIV), acquired immune deficiency syndrome (AIDS),
59 posttraumatic stress disorder (PTSD), amyotrophic lateral
60 sclerosis (ALS), Crohn’s disease, Parkinson’s disease, multiple
61 sclerosis, or other debilitating medical conditions of the same
62 kind or class as or comparable to those enumerated and for which
63 a physician believes that the medical use of marijuana would
64 likely outweigh the potential health risks for a patient
65 “Dispensing organization” means an organization approved by the
66 department to cultivate, process, transport, and dispense low
67 THC cannabis or medical cannabis pursuant to this section.
68 (c) “Independent testing laboratory” means a laboratory,
69 including the managers, employees, or contractors of the
70 laboratory, which has no direct or indirect interest in a
71 dispensing organization.
72 (d) “Legal representative” means the qualified patient’s
73 parent, legal guardian acting pursuant to a court’s
74 authorization as required under s. 744.3215(4), health care
75 surrogate acting pursuant to the qualified patient’s written
76 consent or a court’s authorization as required under s. 765.113,
77 or an individual who is authorized under a power of attorney to
78 make health care decisions on behalf of the qualified patient.
79 (e) “Low-THC canna bis” means a plant of the genus Cannabis ,
80 the dried flowers of which contain 0.8 percent or less of
81 tetrahydrocannabinol and more than 10 percent of cannabidiol
82 weight for weight; the seeds thereof; the resin extracted from
83 any part of such plant; or any compound, manufacture, salt,
84 derivative, mixture, or preparation of such plant or its seeds
85 or resin that is dispensed only from a dispensing organization.
86 (d) (f) “Medical cannabis” means all parts of any plant of
87 the genus Cannabis, whether growing or not; the seeds thereof;
88 the resin extracted from any part of the plant; and every
89 compound, manufacture, sale, derivative, mixture, or preparation
90 of the plant or its seeds or resin that is dispensed only from a
91 medical marijuana treatment center dispensing organization for
92 medical use by a qualifying an eligible patient as defined in s.
94 (e) “Medical marijuana treatment center” or “MMTC” means an
95 entity that is registered with the department and that:
96 1. Acquires, cultivates, possesses, or processes marijuana
97 or products containing marijuana, including developing related
98 products such as food, tinctures, aerosols, oils, or ointments,
99 for sale to qualifying patients or their caregivers; or
100 2. Transfers, transports, sells, distributes, or dispenses
101 marijuana, products containing marijuana, related supplies, or
102 educational materials to qualifying patients or their
104 (f) “Medical marijuana testing facility” means an entity
105 that is licensed by the department and that is certified by the
106 department, or by an accredited, third-party laboratory
107 certification body that meets department standards, to obtain,
108 transport, store, analyze, and dispose of samples of medical
109 cannabis for the purpose of certifying the safety and potency of
110 medical cannabis.
111 (g) “Medical use” means the acquisition, transportation,
112 possession, use, or administration of an amount of medical
113 cannabis in accordance with department rules, or of related
114 supplies, by a qualifying patient or a caregiver for use for the
115 treatment of a debilitating medical condition of the qualifying
116 patient administration of the ordered amount of low-THC cannabis
117 or medical cannabis. The term does not include the:
118 1. Possession, use, or administration of low-THC cannabis
119 or medical cannabis by smoking.
120 2. Transfer of low-THC cannabis or medical cannabis to a
121 person other than the qualified patient for whom it was ordered
122 or the qualified patient’s legal representative on behalf of the
123 qualified patient.
124 3. Use or administration of low-THC cannabis or medical
126 a. On any form of public transportation.
127 b. In any public place.
128 c. In a qualified patient’s place of employment, if
129 restricted by his or her employer.
130 d. In a state correctional institution as defined in s.
131 944.02 or a correctional institution as defined in s. 944.241.
132 e. On the grounds of a preschool, primary school, or
133 secondary school.
134 f. On a school bus or in a vehicle, aircraft, or motorboat.
135 (h) “Person” means a natural person, partnership,
136 association, company, corporation, limited liability company, or
137 organization. The term does not include a governmental
139 (i) (h) “Qualifying patient” means a person who has been
140 diagnosed to have a debilitating medical condition and who has a
141 physician certification and a valid qualifying patient
142 identification card “Qualified patient” means a resident of this
143 state who has been added to the compassionate use registry by a
144 physician licensed under chapter 458 or chapter 459 to receive
145 low-THC cannabis or medical cannabis from a dispensing
147 (i) “Smoking” means burning or igniting a substance and
148 inhaling the smoke. Smoking does not include the use of a
150 (2) PHYSICIAN CERTIFICATION ORDERING.—A physician is
151 authorized to issue a physician certification for medical order
152 low-THC cannabis or a cannabis delivery device to treat a
153 qualifying qualified patient suffering from a debilitating
154 cancer or a physical medical condition that chronically produces
155 symptoms of seizures or severe and persistent muscle spasms;
156 order low-THC cannabis to alleviate symptoms of such disease,
157 disorder, or condition, if no other satisfactory alternative
158 treatment options exist for the qualified patient; order medical
159 cannabis to treat an eligible patient as defined in s. 499.0295;
160 or order a cannabis delivery device for the medical use of low
161 THC cannabis or medical cannabis, only if the physician:
162 (a) Holds an active, unrestricted license as a physician
163 under chapter 458 or an osteopathic physician under chapter 459;
164 (b) Has treated the patient for at least 3 months
165 immediately preceding the patient’s registration in the
166 compassionate use registry;
167 (c) Has successfully completed the course and examination
168 required under paragraph (4)(a);
169 (d) Has determined that the risks of treating the patient
170 with low-THC cannabis or medical cannabis are reasonable in
171 light of the potential benefit to the patient. If a patient is
172 younger than 18 years of age, a second physician must concur
173 with this determination, and such determination must be
174 documented in the patient’s medical record;
175 (e) Registers as the patient’s physician orderer of low-THC
176 cannabis or medical cannabis for the named patient on the
177 compassionate use registry maintained by the department and
178 updates the registry to reflect the contents of the order of
179 medical cannabis, including the amount of low-THC cannabis or
180 medical cannabis which that will provide the patient with not
181 more than a 45-day supply and a cannabis delivery device needed
182 by the patient for the medical use of low-THC cannabis or
183 medical cannabis. The physician must also update the registry
184 within 7 days after any change is made to the original order to
185 reflect the change. The physician shall deactivate the
186 registration of the patient and the patient’s caregiver legal
187 representative when the physician no longer recommends the
188 medical use of marijuana for the patient treatment is
190 (f) Maintains a patient treatment plan that includes the
191 dose, route of administration, planned duration, and monitoring
192 of the patient’s symptoms and other indicators of tolerance or
193 reaction to the low-THC cannabis or medical cannabis;
194 (g) Submits the patient treatment plan quarterly to the
195 University of Florida College of Pharmacy for research on the
196 safety and efficacy of low-THC cannabis and medical cannabis on
198 (h) Obtains the voluntary written informed consent of the
199 patient or the patient’s caregiver legal representative to
200 treatment with medical low-THC cannabis after sufficiently
201 explaining the current state of knowledge in the medical
202 community of the effectiveness of treatment of the patient’s
203 condition with medical low-THC cannabis, the medically
204 acceptable alternatives, and the potential risks and side
206 (i) Obtains written informed consent as defined in and
207 required under s. 499.0295, if the physician is ordering medical
208 cannabis for an eligible patient pursuant to that section; and
209 (i) (j) Is not a medical director employed by an MMTC a
210 dispensing organization.
211 (3) PENALTIES.—
212 (a) A physician commits a misdemeanor of the first degree,
213 punishable as provided in s. 775.082 or s. 775.083, if the
214 physician issues a physician certification for medical orders
215 low-THC cannabis or a cannabis delivery device for a patient
216 without a reasonable belief that the patient is suffering from a
217 debilitating medical condition :
218 1. Cancer or a physical medical condition that chronically
219 produces symptoms of seizures or severe and persistent muscle
220 spasms that can be treated with low-THC cannabis; or
221 2. Symptoms of cancer or a physical medical condition that
222 chronically produces symptoms of seizures or severe and
223 persistent muscle spasms that can be alleviated with low-THC
225 (b) A physician commits a misdemeanor of the first degree,
226 punishable as provided in s. 775.082 or s. 775.083, if the
227 physician orders medical cannabis for a patient without a
228 reasonable belief that the patient has a terminal condition as
229 defined in s. 499.0295.
230 (b) (c) A person who fraudulently represents that he or she
231 has a debilitating medical cancer, a physical medical condition
232 that chronically produces symptoms of seizures or severe and
233 persistent muscle spasms, or a terminal condition to a physician
234 for the purpose of being issued a physician certification for
235 ordered low-THC cannabis, medical cannabis , or a cannabis
236 delivery device by such physician commits a misdemeanor of the
237 first degree, punishable as provided in s. 775.082 or s.
239 (c) (d) A qualifying An eligible patient as defined in s.
240 499.0295 who uses medical cannabis, and such patient’s caregiver
241 legal representative who administers medical cannabis, in plain
242 view of or in a place open to the general public, on the grounds
243 of a school, or in a school bus, vehicle, aircraft, or
244 motorboat, commits a misdemeanor of the first degree, punishable
245 as provided in s. 775.082 or s. 775.083.
246 (d) (e) A physician who issues a physician certification for
247 orders low-THC cannabis, medical cannabis , or a cannabis
248 delivery device and receives compensation from an MMTC a
249 dispensing organization related to the ordering of low-THC
250 cannabis, medical cannabis , or a cannabis delivery device is
251 subject to disciplinary action under the applicable practice act
252 and s. 456.072(1)(n).
253 (4) PHYSICIAN EDUCATION.—
254 (a) Before a physician may issue a physician certification
255 for ordering low-THC cannabis , medical cannabis , or a cannabis
256 delivery device for medical use by a patient in this state, the
257 appropriate board shall require the ordering physician to
258 successfully complete an 8-hour course and subsequent
259 examination offered by the Florida Medical Association or the
260 Florida Osteopathic Medical Association which that encompasses
261 the clinical indications for the appropriate use of low-THC
262 cannabis and medical cannabis, the appropriate cannabis delivery
263 devices, the contraindications for such use, and the relevant
264 state and federal laws governing the issuance of physician
265 certifications ordering, as well as the dispensing , and
266 possessing of these substances and devices. The course and
267 examination shall be administered at least annually. Successful
268 completion of the course may be used by a physician to satisfy 8
269 hours of the continuing medical education requirements required
270 by his or her respective board for licensure renewal. This
271 course may be offered in a distance learning format.
272 (b) The appropriate board shall require the medical
273 director of each MMTC dispensing organization to hold an active,
274 unrestricted license as a physician under chapter 458 or as an
275 osteopathic physician under chapter 459 and successfully
276 complete a 2-hour course and subsequent examination offered by
277 the Florida Medical Association or the Florida Osteopathic
278 Medical Association which that encompasses appropriate safety
279 procedures and knowledge of low-THC cannabis, medical cannabis ,
280 and cannabis delivery devices.
281 (c) Successful completion of the course and examination
282 specified in paragraph (a) is required for every physician who
283 orders low-THC cannabis, medical cannabis, or a cannabis
284 delivery device each time such physician renews his or her
285 license. In addition, successful completion of the course and
286 examination specified in paragraph (b) is required for the
287 medical director of each dispensing organization each time such
288 physician renews his or her license.
289 (c) (d) A physician who fails to comply with this subsection
290 and who issues a physician certification for orders low-THC
291 cannabis, medical cannabis , or a cannabis delivery device may be
292 subject to disciplinary action under the applicable practice act
293 and under s. 456.072(1)(k).
294 (5) DUTIES OF THE DEPARTMENT.—The department shall:
295 (a) Create and maintain a secure, electronic, and online
296 compassionate use registry for the registration of physicians,
297 patients, and caregivers the legal representatives of patients
298 as provided under this section. The registry must be accessible
299 to law enforcement agencies and to MMTCs a dispensing
300 organization to verify the authorization of a patient or a
301 patient’s caregiver legal representative to possess low-THC
302 cannabis, medical cannabis , or a cannabis delivery device and
303 record the low-THC cannabis, medical cannabis , or cannabis
304 delivery device dispensed. The registry must prevent an active
305 registration of a patient by multiple physicians.
306 (b) Within 6 months after the registration of 250,000
307 active qualifying patients in the compassionate use registry,
308 register five additional MMTCs, including, but not limited to,
309 an applicant that is a recognized class member of Pigford v.
310 Glickman, 185 F.R.D. 82 (D.D.C. 1999), or In re Black Farmers
311 Litig., 856 F. Supp. 2d 1 (D.D.C. 2011), and that is a member of
312 the Black Farmers and Agriculturalists Association.
313 Additionally, the department must register an additional five
314 MMTCs within 6 months after the registration of each of the
315 following totals of the number of patients in the compassionate
316 use registry: 350,000 qualifying patients; 400,000 qualifying
317 patients; 500,000 qualifying patients; and then the registration
318 of each additional 100,000 qualifying patients above 500,000, if
319 a sufficient number of MMTC applicants meet the registration
320 requirements established in this section and by department rule
321 Authorize the establishment of five dispensing organizations to
322 ensure reasonable statewide accessibility and availability as
323 necessary for patients registered in the compassionate use
324 registry and who are ordered low-THC cannabis, medical cannabis,
325 or a cannabis delivery device under this section, one in each of
326 the following regions: northwest Florida, northeast Florida,
327 central Florida, southeast Florida, and southwest Florida. The
328 department shall develop an application form and impose an
329 initial application and biennial renewal fee that is sufficient
330 to cover the costs of administering this section. An applicant
331 for approval as an MMTC a dispensing organization must be able
332 to demonstrate:
333 1. The technical and technological ability to cultivate and
334 produce medical low-THC cannabis. The applicant must possess a
335 valid certificate of registration issued by the Department of
336 Agriculture and Consumer Services pursuant to s. 581.131 that is
337 issued for the cultivation of more than 400,000 plants, be
338 operated by a nurseryman as defined in s. 581.011, and have been
339 operated as a registered nursery in this state for at least 30
340 continuous years.
341 2. The ability to secure the premises, resources, and
342 personnel necessary to operate as an MMTC a dispensing
344 3. The ability to maintain accountability of all raw
345 materials, finished products, and any byproducts to prevent
346 diversion or unlawful access to or possession of these
348 4. An infrastructure reasonably located to dispense medical
349 low-THC cannabis to qualifying registered patients statewide or
350 regionally as determined by the department.
351 5. The financial ability to maintain operations for the
352 duration of the 2-year approval cycle, including the provision
353 of certified financials to the department. Upon approval, the
354 applicant must post a $5 million performance bond. However, upon
355 a dispensing organization’s serving at least 1,000 qualifying
356 qualified patients, the MMTC dispensing organization is only
357 required to maintain only a $2 million performance bond.
358 6. That all owners and managers have been fingerprinted and
359 have successfully passed a level 2 background screening pursuant
360 to s. 435.04.
361 7. The employment of a medical director to supervise the
362 activities of the MMTC dispensing organization.
363 (c) Upon the registration of 250,000 active qualified
364 patients in the compassionate use registry, approve three
365 dispensing organizations, including, but not limited to, an
366 applicant that is a recognized class member of Pigford v.
367 Glickman , 185 F.R.D. 82 (D.D.C. 1999), or In Re Black Farmers
368 Litig. , 856 F. Supp. 2d 1 (D.D.C. 2011), and a member of the
369 Black Farmers and Agriculturalists Association, which must meet
370 the requirements of subparagraphs (b)2.-7. and demonstrate the
371 technical and technological ability to cultivate and produce
372 low-THC cannabis.
373 (c) (d) Allow an MMTC a dispensing organization to make a
374 wholesale purchase of low-THC cannabis or medical cannabis from,
375 or a distribution of low-THC cannabis or medical cannabis to,
376 another MMTC dispensing organization.
377 (d) (e) Monitor physician registration in the compassionate
378 use registry and the issuance of physician certifications
379 ordering of low-THC cannabis, medical cannabis, or a cannabis
380 delivery device for ordering practices that could facilitate
381 unlawful diversion or misuse of low-THC cannabis, medical
382 cannabis , or a cannabis delivery device and take disciplinary
383 action as indicated.
384 (e) Authorize the establishment of medical marijuana
385 testing facilities to ensure that all medical cannabis is tested
386 for potency and contaminants in accordance with the department’s
387 quality control program. A medical marijuana testing facility
388 may collect and accept samples of, and possess, store,
389 transport, and test medical cannabis. A medical marijuana
390 testing facility may not be owned by a person who also possesses
391 an ownership interest in an MMTC.
392 1. The department shall develop regulations concerning
393 medical marijuana testing facility license requirements,
394 suitability, and processes; develop an application form for a
395 medical marijuana testing facility license; and impose an
396 initial application fee and a biennial renewal fee sufficient to
397 cover the costs of administering this section.
398 2. In addition to licensure, a medical marijuana testing
399 facility must be certified to perform all required tests by the
400 department or by an accredited, third-party laboratory
401 certification body that meets department standards. The
402 department shall establish reasonable rules for the
403 certification and operation of medical marijuana testing
404 facilities. Rules for certification must, at a minimum, address
405 standards relating to:
406 a. Personnel qualifications;
407 b. Equipment and methodology;
408 c. Proficiency testing;
409 d. Tracking;
410 e. Sampling;
411 f. Chain of custody;
412 g. Record and sample retention;
413 h. Reporting;
414 i. Audit and inspection; and
415 j. Security.
416 3. The department shall suspend or reduce any mandatory
417 testing requirement specified in its quality control program if
418 the number of licensed and certified medical marijuana testing
419 facilities is insufficient to process the tests necessary to
420 meet the current and anticipated market for MMTCs.
421 4. A medical marijuana testing facility may accept only
422 samples composed of medical cannabis which are obtained from a
423 sample source approved by the department, including an MMTC, a
424 researcher affiliated with an accredited university or research
425 hospital, a qualifying patient, a caregiver, and any entity
426 authorized by the department.
427 (6) MEDICAL MARIJUANA TREATMENT CENTERS DISPENSING
428 ORGANIZATION.—An approved MMTC dispensing organization must, at
429 all times, maintain compliance with the criteria demonstrated
430 for selection and approval as an MMTC a dispensing organization
431 under subsection (5) and the criteria required in this
433 (a) When growing low-THC cannabis or medical cannabis, an
434 MMTC a dispensing organization:
435 1. May use pesticides determined by the department, after
436 consultation with the Department of Agriculture and Consumer
437 Services, to be safely applied to plants intended for human
438 consumption, but may not use pesticides designated as
439 restricted-use pesticides pursuant to s. 487.042.
440 2. Must grow low-THC cannabis or medical cannabis within an
441 enclosed structure and in a room separate from any other plant.
442 3. Must inspect seeds and growing plants for plant pests
443 that endanger or threaten the horticultural and agricultural
444 interests of the state, notify the Department of Agriculture and
445 Consumer Services within 10 calendar days after a determination
446 that a plant is infested or infected by such plant pest, and
447 implement and maintain phytosanitary policies and procedures.
448 4. Must perform fumigation or treatment of plants, or the
449 removal and destruction of infested or infected plants, in
450 accordance with chapter 581 and any rules adopted thereunder.
451 (b) Before transferring medical cannabis to other licensed
452 premises or selling or transferring medical cannabis to a
453 qualifying patient or caregiver, an MMTC When processing low-THC
454 cannabis or medical cannabis, a dispensing organization must:
455 1. Have the Process the low-THC cannabis or medical
456 cannabis within an enclosed structure and in a room separate
457 from other plants or products.
458 2. Test the processed low-THC cannabis and medical cannabis
459 tested by a medical marijuana testing facility to ensure it
460 meets the standards established by the department’s quality
461 control program before it is they are dispensed in accordance
462 with department rule. Results must be verified and signed by two
463 dispensing organization employees. Before dispensing low-THC
464 cannabis, the dispensing organization must determine that the
465 test results indicate that the low-THC cannabis meets the
466 definition of low-THC cannabis and, for medical cannabis and
467 low-THC cannabis, that all medical cannabis and low-THC cannabis
468 is safe for human consumption and free from contaminants that
469 are unsafe for human consumption. The dispensing organization
470 must retain records of all testing and samples of each
471 homogenous batch of cannabis and low-THC cannabis for at least 9
472 months. The dispensing organization must contract with an
473 independent testing laboratory to perform audits on the
474 dispensing organization’s standard operating procedures, testing
475 records, and samples and provide the results to the department
476 to confirm that the low-THC cannabis or medical cannabis meets
477 the requirements of this section and that the medical cannabis
478 and low-THC cannabis is safe for human consumption.
479 2. 3. Package the low-THC cannabis or medical cannabis in
480 compliance with the United States Poison Prevention Packaging
481 Act of 1970, 15 U.S.C. ss. 1471 et seq.
482 3. 4. Package the low-THC cannabis or medical cannabis in a
483 receptacle that has a firmly affixed and legible label stating
484 the following information, and any other information required by
485 department rule:
486 a. A statement that the low-THC cannabis or medical
487 cannabis meets the requirements of subparagraph 1. 2.;
488 b. The name of the medical marijuana treatment center
489 dispensing organization from which the medical cannabis or low
490 THC cannabis originates; and
491 c. The batch number, lot number, or other unique
492 identification and harvest number from which the medical
493 cannabis or low-THC cannabis originates.
494 5. Reserve two processed samples from each batch and retain
495 such samples for at least 9 months for the purpose of testing
496 pursuant to the audit required under subparagraph 2.
497 (c) When dispensing low-THC cannabis, medical cannabis , or
498 a cannabis delivery device, an MMTC a dispensing organization:
499 1. May not dispense more than a 45-day supply of low-THC
500 cannabis or medical cannabis to a patient or the patient’s
501 caregiver legal representative.
502 2. Must have the MMTC’s dispensing organization’s employee
503 who dispenses the low-THC cannabis, medical cannabis , or a
504 cannabis delivery device enter into the compassionate use
505 registry his or her name or unique employee identifier.
506 3. Must verify in the compassionate use registry that a
507 physician has ordered the low-THC cannabis, medical cannabis , or
508 a specific type of a cannabis delivery device for the patient.
509 4. May not dispense or sell any other type of cannabis,
510 alcohol, or illicit drug-related product, including pipes,
511 bongs, or wrapping papers, other than a physician-ordered
512 cannabis delivery device required for the medical use of low-THC
513 cannabis or medical cannabis, while dispensing low-THC cannabis
514 or medical cannabis.
515 5. Must verify that the patient has an active registration
516 in the compassionate use registry, the patient or patient’s
517 caregiver legal representative holds a valid and active
518 identification registration card, the order presented matches
519 the order contents as recorded in the registry, and the order
520 has not already been filled.
521 6. Must, upon dispensing the low-THC cannabis, medical
522 cannabis , or cannabis delivery device, record in the registry
523 the date, time, quantity, and form of low-THC cannabis or
524 medical cannabis dispensed and the type of cannabis delivery
525 device dispensed.
526 (d) To ensure the safety and security of its premises and
527 any off-site storage facilities, and to maintain adequate
528 controls against the diversion, theft, and loss of low-THC
529 cannabis, medical cannabis , or cannabis delivery devices, an
530 MMTC a dispensing organization shall:
531 1.a. Maintain a fully operational security alarm system
532 that secures all entry points and perimeter windows and is
533 equipped with motion detectors; pressure switches; and duress,
534 panic, and hold-up alarms; or
535 b. Maintain a video surveillance system that records
536 continuously 24 hours each day and meets at least one of the
537 following criteria:
538 (I) Cameras are fixed in a place that allows for the clear
539 identification of persons and activities in controlled areas of
540 the premises. Controlled areas include grow rooms, processing
541 rooms, storage rooms, disposal rooms or areas, and point-of-sale
543 (II) Cameras are fixed in entrances and exits to the
544 premises, which shall record from both indoor and outdoor, or
545 ingress and egress, vantage points;
546 (III) Recorded images must clearly and accurately display
547 the time and date; or
548 (IV) Retain video surveillance recordings for a minimum of
549 45 days or longer upon the request of a law enforcement agency.
550 2. Ensure that the MMTC’s organization’s outdoor premises
551 have sufficient lighting from dusk until dawn.
552 3. Establish and maintain a tracking system approved by the
553 department which that traces the low-THC cannabis or medical
554 cannabis from seed to sale. The tracking system must shall
555 include notification of key events as determined by the
556 department, including when cannabis seeds are planted, when
557 cannabis plants are harvested and destroyed, and when low-THC
558 cannabis or medical cannabis is transported, sold, stolen,
559 diverted, or lost.
560 4. Not dispense from its premises low-THC cannabis, medical
561 cannabis , or a cannabis delivery device between the hours of 9
562 p.m. and 7 a.m., but may perform all other operations and
563 deliver low-THC cannabis and medical cannabis to qualifying
564 qualified patients 24 hours each day.
565 5. Store low-THC cannabis or medical cannabis in a secured,
566 locked room or a vault.
567 6. Require at least two of its employees, or two employees
568 of a security agency with whom it contracts, to be on the
569 premises at all times.
570 7. Require each employee to wear a photo identification
571 badge at all times while on the premises.
572 8. Require each visitor to wear a visitor’s pass at all
573 times while on the premises.
574 9. Implement an alcohol and drug-free workplace policy.
575 10. Report to local law enforcement within 24 hours after
576 it is notified or becomes aware of the theft, diversion, or loss
577 of low-THC cannabis or medical cannabis.
578 (e) To ensure the safe transport of low-THC cannabis or
579 medical cannabis to medical marijuana testing facilities, MMTCs,
580 caregivers dispensing organization facilities, independent
581 testing laboratories, or qualifying patients, an MMTC or medical
582 marijuana testing facility that transports medical cannabis the
583 dispensing organization must:
584 1. Maintain a transportation manifest, which must be
585 retained for at least 1 year.
586 2. Ensure only vehicles in good working order are used to
587 transport low-THC cannabis or medical cannabis.
588 3. Lock low-THC cannabis or medical cannabis in a separate
589 compartment or container within the vehicle.
590 4. Require at least two persons to be in a vehicle
591 transporting low-THC cannabis or medical cannabis, and require
592 at least one person to remain in the vehicle while the low-THC
593 cannabis or medical cannabis is being delivered.
594 5. Provide specific safety and security training to
595 employees transporting or delivering low-THC cannabis or medical
597 (7) DEPARTMENT AUTHORITY AND RESPONSIBILITIES.—
598 (a) The department may conduct announced or unannounced
599 inspections of MMTCs dispensing organizations to determine
600 compliance with this section or rules adopted pursuant to this
602 (b) The department shall inspect an MMTC a dispensing
603 organization upon complaint or notice provided to the department
604 that the MMTC dispensing organization has dispensed low-THC
605 cannabis or medical cannabis containing any mold, bacteria, or
606 other contaminant that may cause or has caused an adverse effect
607 to human health or the environment.
608 (c) The department shall conduct at least a biennial
609 inspection of each MMTC dispensing organization to evaluate the
610 MMTC’s dispensing organization’s records, personnel, equipment,
611 processes, security measures, sanitation practices, and quality
612 assurance practices.
613 (d) The department may enter into interagency agreements
614 with the Department of Agriculture and Consumer Services, the
615 Department of Business and Professional Regulation, the
616 Department of Transportation, the Department of Highway Safety
617 and Motor Vehicles, and the Agency for Health Care
618 Administration, and such agencies are authorized to enter into
619 an interagency agreement with the department, to conduct
620 inspections or perform other responsibilities assigned to the
621 department under this section.
622 (e) The department must make a list of all approved MMTCs,
623 physicians who are dispensing organizations and qualified to
624 issue physician certifications, ordering physicians and medical
625 directors of MMTCs publicly available on its website.
626 (f) The department may establish a system for issuing and
627 renewing registration cards for patients and their legal
628 representatives, establish the circumstances under which the
629 cards may be revoked by or must be returned to the department,
630 and establish fees to implement such system. The department must
631 require, at a minimum, the registration cards to:
632 1. Provide the name, address, and date of birth of the
633 patient or legal representative.
634 2. Have a full-face, passport-type, color photograph of the
635 patient or legal representative taken within the 90 days
636 immediately preceding registration.
637 3. Identify whether the cardholder is a patient or legal
639 4. List a unique numeric identifier for the patient or
640 legal representative that is matched to the identifier used for
641 such person in the department’s compassionate use registry.
642 5. Provide the expiration date, which shall be 1 year after
643 the date of the physician’s initial order of low-THC cannabis or
644 medical cannabis.
645 6. For the legal representative, provide the name and
646 unique numeric identifier of the patient that the legal
647 representative is assisting.
648 7. Be resistant to counterfeiting or tampering.
649 (f) (g) The department may impose reasonable fines not to
650 exceed $10,000 on an MMTC a dispensing organization for any of
651 the following violations:
652 1. Violating this section, s. 499.0295, or department rule.
653 2. Failing to maintain qualifications for approval.
654 3. Endangering the health, safety, or security of a
655 qualifying qualified patient.
656 4. Improperly disclosing personal and confidential
657 information of the qualifying qualified patient.
658 5. Attempting to procure MMTC dispensing organization
659 approval by bribery, fraudulent misrepresentation, or extortion.
660 6. Being convicted or found guilty of, or entering a plea
661 of guilty or nolo contendere to, regardless of adjudication, a
662 crime in any jurisdiction which directly relates to the business
663 of an MMTC a dispensing organization.
664 7. Making or filing a report or record that the MMTC
665 dispensing organization knows to be false.
666 8. Willfully failing to maintain a record required by this
667 section or department rule.
668 9. Willfully impeding or obstructing an employee or agent
669 of the department in the furtherance of his or her official
671 10. Engaging in fraud or deceit, negligence, incompetence,
672 or misconduct in the business practices of an MMTC a dispensing
674 11. Making misleading, deceptive, or fraudulent
675 representations in or related to the business practices of an
676 MMTC a dispensing organization.
677 12. Having a license or the authority to engage in any
678 regulated profession, occupation, or business that is related to
679 the business practices of an MMTC a dispensing organization
680 suspended, revoked, or otherwise acted against by the licensing
681 authority of any jurisdiction, including its agencies or
682 subdivisions, for a violation that would constitute a violation
683 under Florida law.
684 13. Violating a lawful order of the department or an agency
685 of the state, or failing to comply with a lawfully issued
686 subpoena of the department or an agency of the state.
687 (g) (h) The department may suspend, revoke, or refuse to
688 renew the a dispensing organization’s approval of an MMTC if the
689 MMTC a dispensing organization commits any of the violations in
690 paragraph (f) (g).
691 (h) (i) The department shall renew the approval of an MMTC a
692 dispensing organization biennially if the MMTC dispensing
693 organization meets the requirements of this section and pays the
694 biennial renewal fee.
695 (i)1. The department shall establish a quality control
696 program requiring medical cannabis to be tested by a medical
697 marijuana testing facility for potency and contaminants before
698 sale to qualifying patients and caregivers.
699 a. The quality control program must require MMTCs to submit
700 samples from each batch or lot of medical cannabis harvested or
701 manufactured to a medical marijuana testing facility for testing
702 to ensure, at a minimum, that the labeling of the potency of
703 tetrahydrocannabinol and all other marketed cannabinoids or
704 terpenes is accurate and that the medical cannabis dispensed to
705 qualifying patients is safe for human consumption.
706 b. All samples submitted for testing to satisfy a test
707 required under the quality control program must be collected by
708 the medical marijuana testing facility or its certified agent in
709 accordance with department rules.
710 c. An MMTC must maintain records of all tests conducted on
711 medical cannabis, including the results of each test and any
712 additional information as required by the department.
713 2. The department shall adopt all rules necessary to create
714 and oversee the quality control program, which must include, at
715 a minimum:
716 a. Permissible levels of variation in potency labeling and
717 standards requiring tetrahydrocannabinol in edible medical
718 cannabis products to be distributed homogenously throughout the
720 b. Permissible levels of contaminants and mandatory testing
721 for contaminants to confirm that the tested medical cannabis is
722 safe for human consumption, which must include, but is not
723 limited to, testing for microbiological impurity, residual
724 solvents, and pesticide residues;
725 c. The destruction of medical cannabis determined to be
726 inaccurately labeled or unsafe for human consumption after the
727 MMTC has an opportunity to take remedial action;
728 d. The collection, storage, handling, recording, and
729 destruction of samples of medical cannabis by medical marijuana
730 testing facilities; and
731 e. Security, inventory tracking, and record retention.
732 (j) The department may adopt rules necessary to implement
733 and administer this section.
734 (8) PREEMPTION.—
735 (a) All matters regarding the regulation of the cultivation
736 and processing of medical cannabis or low-THC cannabis by MMTCs
737 dispensing organizations are preempted to the state.
738 (b) A municipality may determine by ordinance the criteria
739 for the number and location of, and other permitting
740 requirements that do not conflict with state law or department
741 rule for, dispensing facilities of MMTCs dispensing
742 organizations located within its municipal boundaries. A county
743 may determine by ordinance the criteria for the number,
744 location, and other permitting requirements that do not conflict
745 with state law or department rule for all dispensing facilities
746 of MMTCs dispensing organizations located within the
747 unincorporated areas of that county.
748 (9) EXCEPTIONS TO OTHER LAWS.—
749 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
750 any other provision of law, but subject to the requirements of
751 this section, a qualifying qualified patient or a caregiver and
752 the qualified patient’s legal representative may purchase and
753 possess for the qualifying patient’s medical use up to the
754 amount of low-THC cannabis or medical cannabis ordered for the
755 patient, but not more than a 45-day supply, and a cannabis
756 delivery device ordered for the patient.
757 (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
758 any other provision of law, but subject to the requirements of
759 this section, an MMTC an approved dispensing organization and
760 its owners, managers, and employees may manufacture, possess,
761 sell, deliver, distribute, dispense, and lawfully dispose of
762 reasonable quantities, as established by department rule, of
763 low-THC cannabis, medical cannabis , or a cannabis delivery
764 device. As used in For purposes of this subsection, the terms
765 “manufacture,” “possession,” “deliver,” “distribute,” and
766 “dispense” have the same meanings as provided in s. 893.02.
767 (c) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
768 any other provision of law, but subject to the requirements of
769 this section, a medical marijuana testing facility an approved
770 independent testing laboratory may possess, test, transport, and
771 lawfully dispose of low-THC cannabis or medical cannabis as
772 provided by department rule.
773 (d) An approved MMTC dispensing organization and its
774 owners, managers, and employees are not subject to licensure or
775 regulation under chapter 465 or chapter 499 for manufacturing,
776 possessing, selling, delivering, distributing, dispensing, or
777 lawfully disposing of reasonable quantities, as established by
778 department rule, of low-THC cannabis, medical cannabis , or a
779 cannabis delivery device.
780 (e) An approved MMTC dispensing organization that continues
781 to meet the requirements for approval is presumed to be
782 registered with the department and to meet the regulations
783 adopted by the department or its successor agency for the
784 purpose of dispensing medical cannabis or low-THC cannabis under
785 Florida law. Additionally, the authority provided to an MMTC a
786 dispensing organization in s. 499.0295 does not impair its
787 registration with the department the approval of a dispensing
789 (f) This subsection does not exempt a person from
790 prosecution for a criminal offense related to impairment or
791 intoxication resulting from the medical use of low-THC cannabis
792 or medical cannabis or relieve a person from any requirement
793 under law to submit to a breath, blood, urine, or other test to
794 detect the presence of a controlled substance.
795 Section 2. Subsections (1) and (2) of section 381.987,
796 Florida Statutes, are amended, and paragraphs (b) and (c) of
797 subsection (3) of that section are amended, to read:
798 381.987 Public records exemption for personal identifying
799 information in the compassionate use registry.—
800 (1) A patient’s personal identifying information held by
801 the department in the compassionate use registry established
802 under s. 381.986, including, but not limited to, the patient’s
803 name, address, telephone number, and government-issued
804 identification number, and all information pertaining to the
805 physician certification physician’s order for medical low-THC
806 cannabis and the dispensing thereof are confidential and exempt
807 from s. 119.07(1) and s. 24(a), Art. I of the State
809 (2) A physician’s identifying information held by the
810 department in the compassionate use registry established under
811 s. 381.986, including, but not limited to, the physician’s name,
812 address, telephone number, government-issued identification
813 number, and Drug Enforcement Administration number, and all
814 information pertaining to the physician certification
815 physician’s order for medical low-THC cannabis and the
816 dispensing thereof are confidential and exempt from s. 119.07(1)
817 and s. 24(a), Art. I of the State Constitution.
818 (3) The department shall allow access to the registry,
819 including access to confidential and exempt information, to:
820 (b) A medical marijuana treatment center dispensing
821 organization approved by the department pursuant to s. 381.986
822 which is attempting to verify the authenticity of a physician
823 certification physician’s order for medical low-THC cannabis,
824 including whether the physician certification order had been
825 previously filled and whether the physician certification order
826 was written for the person attempting to have it filled.
827 (c) A physician who has issued a physician certification
828 written an order for medical low-THC cannabis for the purpose of
829 monitoring the patient’s use of such cannabis or for the purpose
830 of determining, before issuing an order for medical low-THC
831 cannabis, whether another physician has ordered the patient’s
832 use of medical low-THC cannabis. The physician may access the
833 confidential and exempt information only for the patient for
834 whom he or she has ordered or is determining whether to order
835 the use of medical low-THC cannabis pursuant to s. 381.986.
836 Section 3. Section 385.211, Florida Statutes, is amended to
838 385.211 Refractory and intractable epilepsy treatment and
839 research at recognized medical centers.—
840 (1) As used in this section, the term “medical cannabis”
841 has the same meaning “low-THC cannabis” means “low-THC cannabis”
842 as defined in s. 381.986 that is dispensed only from a
843 dispensing organization as defined in s. 381.986.
844 (2) Notwithstanding chapter 893, medical centers recognized
845 pursuant to s. 381.925, or an academic medical research
846 institution legally affiliated with a licensed children’s
847 specialty hospital as defined in s. 395.002(28) which that
848 contracts with the Department of Health, may conduct research on
849 cannabidiol and medical low-THC cannabis. This research may
850 include, but is not limited to, the agricultural development,
851 production, clinical research, and use of liquid medical
852 derivatives of cannabidiol and medical low-THC cannabis for the
853 treatment for refractory or intractable epilepsy. The authority
854 for recognized medical centers to conduct this research is
855 derived from 21 C.F.R. parts 312 and 316. Current state or
856 privately obtained research funds may be used to support the
857 activities described in this section.
858 Section 4. Present paragraphs (b) and (c) of subsection (2)
859 of section 499.0295, Florida Statutes, are redesignated as
860 paragraphs (a) and (b), respectively, present paragraphs (a) and
861 (c) of that subsection are amended, a new paragraph (c) is added
862 to that subsection, and subsection (3) of that section is
863 amended, to read:
864 499.0295 Experimental treatments for terminal conditions.—
865 (2) As used in this section, the term:
866 (a) “Dispensing organization” means an organization
867 approved by the Department of Health under s. 381.986(5) to
868 cultivate, process, transport, and dispense low-THC cannabis,
869 medical cannabis , and cannabis delivery devices.
870 (b) (c) “Investigational drug, biological product, or
871 device” means:
872 1. A drug, biological product, or device that has
873 successfully completed phase 1 of a clinical trial but has not
874 been approved for general use by the United States Food and Drug
875 Administration and remains under investigation in a clinical
876 trial approved by the United States Food and Drug
877 Administration; or
878 2. Medical cannabis that is manufactured and sold by an
879 MMTC a dispensing organization.
880 (c) “Medical marijuana treatment center” or “MMTC” means an
881 organization registered with the Department of Health under s.
883 (3) Upon the request of an eligible patient, a manufacturer
884 may, or, upon the issuance of a physician certification a
885 physician’s order pursuant to s. 381.986, an MMTC a dispensing
886 organization may:
887 (a) Make its investigational drug, biological product, or
888 device available under this section.
889 (b) Provide an investigational drug, biological product,
890 device, or cannabis delivery device as defined in s. 381.986 to
891 an eligible patient without receiving compensation.
892 (c) Require an eligible patient to pay the costs of, or the
893 costs associated with, the manufacture of the investigational
894 drug, biological product, device, or cannabis delivery device as
895 defined in s. 381.986.
896 Section 5. Subsection (3) of section 893.02, Florida
897 Statutes, is amended to read:
898 893.02 Definitions.—The following words and phrases as used
899 in this chapter shall have the following meanings, unless the
900 context otherwise requires:
901 (3) “Cannabis” means all parts of any plant of the genus
902 Cannabis, whether growing or not; the seeds thereof; the resin
903 extracted from any part of the plant; and every compound,
904 manufacture, salt, derivative, mixture, or preparation of the
905 plant or its seeds or resin. The term does not include “medical
906 cannabis,” “low-THC cannabis,” as defined in s. 381.986, if
907 manufactured, possessed, sold, purchased, delivered,
908 distributed, or dispensed, in conformance with s. 381.986.
909 Section 6. Section 1004.441, Florida Statutes, is amended
910 to read:
911 1004.441 Refractory and intractable epilepsy treatment and
913 (1) As used in this section, the term “medical cannabis”
914 has the same meaning “low-THC cannabis” means “low-THC cannabis”
915 as defined in s. 381.986 that is dispensed only from a
916 dispensing organization as defined in s. 381.986.
917 (2) Notwithstanding chapter 893, state universities with
918 both medical and agricultural research programs, including those
919 that have satellite campuses or research agreements with other
920 similar institutions, may conduct research on cannabidiol and
921 medical low-THC cannabis. This research may include, but is not
922 limited to, the agricultural development, production, clinical
923 research, and use of liquid medical derivatives of cannabidiol
924 and medical low-THC cannabis for the treatment for refractory or
925 intractable epilepsy. The authority for state universities to
926 conduct this research is derived from 21 C.F.R. parts 312 and
927 316. Current state or privately obtained research funds may be
928 used to support the activities authorized by this section.
929 Section 7. This act shall take effect July 1, 2017.