Florida Senate - 2019 SENATOR AMENDMENT
Bill No. CS for CS for CS for SB 182
Senate . House
Floor: 1/AD/2R .
03/07/2019 02:43 PM .
Senator Brandes moved the following:
1 Senate Amendment (with title amendment)
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Paragraphs (g) and (j) of subsection (1),
6 subsection (4), paragraphs (c) and (d) of subsection (6),
7 paragraph (e) of subsection (8), subsection (14), and subsection
8 (15) of section 381.986, Florida Statutes, are amended to read:
9 381.986 Medical use of marijuana.—
10 (1) DEFINITIONS.—As used in this section, the term:
11 (g) “Marijuana delivery device” means an object used,
12 intended for use, or designed for use in preparing, storing,
13 ingesting, inhaling, or otherwise introducing marijuana into the
14 human body
, and which is dispensed from a medical marijuana
15 treatment center for medical use by a qualified patient.
16 (j) “Medical use” means the acquisition, possession, use,
17 delivery, transfer, or administration of marijuana authorized by
18 a physician certification. The term does not include:
19 1. Possession, use, or administration of marijuana that was
20 not purchased or acquired from a medical marijuana treatment
22 2. Possession, use, or administration of marijuana in a
23 form for smoking, in the form of commercially produced food
24 items other than edibles , or of marijuana seeds or flower
25 ,except for flower in a sealed, tamper-proof receptacle for
27 3. Use or administration of any form or amount of marijuana
28 in a manner that is inconsistent with the qualified physician’s
29 directions or physician certification.
30 4. Transfer of marijuana to a person other than the
31 qualified patient for whom it was authorized or the qualified
32 patient’s caregiver on behalf of the qualified patient.
33 5. Use or administration of marijuana in the following
35 a. On any form of public transportation, except for low-THC
36 cannabis not in a form for smoking.
37 b. In any public place, except for low-THC cannabis not in
38 a form for smoking.
39 c. In a qualified patient’s place of employment, except
40 when permitted by his or her employer.
41 d. In a state correctional institution, as defined in s.
42 944.02, or a correctional institution, as defined in s. 944.241.
43 e. On the grounds of a preschool, primary school, or
44 secondary school, except as provided in s. 1006.062.
45 f. In a school bus, a vehicle, an aircraft, or a motorboat,
46 except for low-THC cannabis not in a form for smoking.
47 6. The smoking of marijuana in an enclosed indoor workplace
48 as defined in s. 386.203(5).
49 (4) PHYSICIAN CERTIFICATION.—
50 (a) A qualified physician may issue a physician
51 certification only if the qualified physician:
52 1. Conducted a physical examination while physically
53 present in the same room as the patient and a full assessment of
54 the medical history of the patient.
55 2. Diagnosed the patient with at least one qualifying
56 medical condition.
57 3. Determined that the medical use of marijuana would
58 likely outweigh the potential health risks for the patient, and
59 such determination must be documented in the patient’s medical
60 record. If a patient is younger than 18 years of age, a second
61 physician must concur with this determination, and such
62 concurrence must be documented in the patient’s medical record.
63 4. Determined whether the patient is pregnant and
64 documented such determination in the patient’s medical record. A
65 physician may not issue a physician certification, except for
66 low-THC cannabis, to a patient who is pregnant.
67 5. Reviewed the patient’s controlled drug prescription
68 history in the prescription drug monitoring program database
69 established pursuant to s. 893.055.
70 6. Reviews the medical marijuana use registry and confirmed
71 that the patient does not have an active physician certification
72 from another qualified physician.
73 7. Registers as the issuer of the physician certification
74 for the named qualified patient on the medical marijuana use
75 registry in an electronic manner determined by the department,
77 a. Enters into the registry the contents of the physician
78 certification, including the patient’s qualifying condition and
79 the dosage not to exceed the daily dose amount determined by the
80 department, the amount and forms of marijuana authorized for the
81 patient, and any types of marijuana delivery devices needed by
82 the patient for the medical use of marijuana.
83 b. Updates the registry within 7 days after any change is
84 made to the original physician certification to reflect such
86 c. Deactivates the registration of the qualified patient
87 and the patient’s caregiver when the physician no longer
88 recommends the medical use of marijuana for the patient.
89 8. Obtains the voluntary and informed written consent of
90 the patient for medical use of marijuana each time the qualified
91 physician issues a physician certification for the patient,
92 which shall be maintained in the patient’s medical record. The
93 patient, or the patient’s parent or legal guardian if the
94 patient is a minor, must sign the informed consent acknowledging
95 that the qualified physician has sufficiently explained its
96 content. The qualified physician must use a standardized
97 informed consent form adopted in rule by the Board of Medicine
98 and the Board of Osteopathic Medicine, which must include, at a
99 minimum, information related to:
100 a. The Federal Government’s classification of marijuana as
101 a Schedule I controlled substance.
102 b. The approval and oversight status of marijuana by the
103 Food and Drug Administration.
104 c. The current state of research on the efficacy of
105 marijuana to treat the qualifying conditions set forth in this
107 d. The potential for addiction.
108 e. The potential effect that marijuana may have on a
109 patient’s coordination, motor skills, and cognition, including a
110 warning against operating heavy machinery, operating a motor
111 vehicle, or engaging in activities that require a person to be
112 alert or respond quickly.
113 f. The potential side effects of marijuana use, including
114 the negative health risks associated with smoking marijuana.
115 g. The risks, benefits, and drug interactions of marijuana.
116 h. That the patient’s de-identified health information
117 contained in the physician certification and medical marijuana
118 use registry may be used for research purposes.
119 (b) If a qualified physician issues a physician
120 certification for a qualified patient diagnosed with a
121 qualifying medical condition pursuant to paragraph (2)(k), the
122 physician must submit the following to the applicable board
123 within 14 days after issuing the physician certification:
124 1. Documentation supporting the qualified physician’s
125 opinion that the medical condition is of the same kind or class
126 as the conditions in paragraphs (2)(a)-(j).
127 2. Documentation that establishes the efficacy of marijuana
128 as treatment for the condition.
129 3. Documentation supporting the qualified physician’s
130 opinion that the benefits of medical use of marijuana would
131 likely outweigh the potential health risks for the patient.
132 4. Any other documentation as required by board rule.
134 The department must submit such documentation to the Consortium
135 Coalition for Medical Marijuana Clinical Outcomes Research and
136 Education established pursuant to s. 1004.4351.
137 (c) If a qualified physician determines that smoking is an
138 appropriate route of administration for a qualified patient,
139 other than a patient diagnosed with a terminal condition, the
140 qualified physician must submit the following documentation to
141 the applicable board:
142 1. A list of other routes of administration, if any,
143 certified by a qualified physician that the patient has tried,
144 the length of time the patient used such routes of
145 administration, and an assessment of the effectiveness of those
146 routes of administration in treating the qualified patient’s
147 qualifying condition.
148 2. Research documenting the effectiveness of smoking as a
149 route of administration to treat similarly situated patients
150 with the same qualifying condition as the qualified patient.
151 3. A statement signed by the qualified physician
152 documenting the qualified physician’s opinion that the benefits
153 of smoking marijuana for medical use outweigh the risks for the
154 qualified patient.
155 (d) A qualified physician may not issue a physician
156 certification for marijuana in a form for smoking to a patient
157 under 18 years of age unless the patient is diagnosed with a
158 terminal condition, the qualified physician determines that
159 smoking is the most effective route of administration for the
160 patient, and a second physician who is a board-certified
161 pediatrician concurs with such determination. Such determination
162 and concurrence must be documented in the patient’s medical
163 record and in the medical marijuana use registry. The certifying
164 physician must obtain the written informed consent of such
165 patient’s parent or legal guardian before issuing a physician
166 certification to the patient for marijuana in a form for
167 smoking. The qualified physician must use a standardized
168 informed consent form adopted in rule by the Board of Medicine
169 and the Board of Osteopathic Medicine which must include
170 information concerning the negative health effects of smoking
171 marijuana on persons under 18 years of age and an
172 acknowledgement that the qualified physician has sufficiently
173 explained the contents of the form.
174 (e) The Board of Medicine and the Board of Osteopathic
175 Medicine shall review the documentation submitted pursuant to
176 paragraph (c) and shall each, by July 1, 2021, adopt by rule
177 practice standards for the certification of smoking as a route
178 of administration.
179 (f) (c) A qualified physician may not issue a physician
180 certification for more than three 70-day supply limits of
181 marijuana or more than one 35-day supply limit of marijuana in a
182 form for smoking. The department shall quantify by rule a daily
183 dose amount with equivalent dose amounts for each allowable form
184 of marijuana dispensed by a medical marijuana treatment center.
185 The department shall use the daily dose amount to calculate a
186 70-day supply.
187 1. A qualified physician may request an exception to the
188 daily dose amount limit, the 35-day supply limit of marijuana in
189 a form for smoking, and the 4-ounce possession limit of
190 marijuana in a form for smoking established in paragraph
191 (14)(a). The request shall be made electronically on a form
192 adopted by the department in rule and must include, at a
194 a. The qualified patient’s qualifying medical condition.
195 b. The dosage and route of administration that was
196 insufficient to provide relief to the qualified patient.
197 c. A description of how the patient will benefit from an
198 increased amount.
199 d. The minimum daily dose amount of marijuana that would be
200 sufficient for the treatment of the qualified patient’s
201 qualifying medical condition.
202 2. A qualified physician must provide the qualified
203 patient’s records upon the request of the department.
204 3. The department shall approve or disapprove the request
205 within 14 days after receipt of the complete documentation
206 required by this paragraph. The request shall be deemed approved
207 if the department fails to act within this time period.
208 (g) (d) A qualified physician must evaluate an existing
209 qualified patient at least once every 30 weeks before issuing a
210 new physician certification. A physician must:
211 1. Determine if the patient still meets the requirements to
212 be issued a physician certification under paragraph (a).
213 2. Identify and document in the qualified patient’s medical
214 records whether the qualified patient experienced either of the
215 following related to the medical use of marijuana:
216 a. An adverse drug interaction with any prescription or
217 nonprescription medication; or
218 b. A reduction in the use of, or dependence on, other types
219 of controlled substances as defined in s. 893.02.
220 3. Submit a report with the findings required pursuant to
221 subparagraph 2. to the department. The department shall submit
222 such reports to the Consortium Coalition for Medical Marijuana
223 Clinical Outcomes Research and Education established pursuant to
224 s. 1004.4351.
225 (h) (e) An active order for low-THC cannabis or medical
226 cannabis issued pursuant to former s. 381.986, Florida Statutes
227 2016, and registered with the compassionate use registry before
228 June 23, 2017, is deemed a physician certification, and all
229 patients possessing such orders are deemed qualified patients
230 until the department begins issuing medical marijuana use
231 registry identification cards.
232 (i) (f) The department shall monitor physician registration
233 in the medical marijuana use registry and the issuance of
234 physician certifications for practices that could facilitate
235 unlawful diversion or misuse of marijuana or a marijuana
236 delivery device and shall take disciplinary action as
238 (j) (g) The Board of Medicine and the Board of Osteopathic
239 Medicine shall jointly create a physician certification pattern
240 review panel that shall review all physician certifications
241 submitted to the medical marijuana use registry. The panel shall
242 track and report the number of physician certifications and the
243 qualifying medical conditions, dosage, supply amount, and form
244 of marijuana certified. The panel shall report the data both by
245 individual qualified physician and in the aggregate, by county,
246 and statewide. The physician certification pattern review panel
247 shall, beginning January 1, 2018, submit an annual report of its
248 findings and recommendations to the Governor, the President of
249 the Senate, and the Speaker of the House of Representatives.
250 (k) (h) The department, the Board of Medicine, and the Board
251 of Osteopathic Medicine may adopt rules pursuant to ss.
252 120.536(1) and 120.54 to implement this subsection.
253 (6) CAREGIVERS.—
254 (c) A qualified patient may designate no more than one
255 caregiver to assist with the qualified patient’s medical use of
256 marijuana, unless:
257 1. The qualified patient is a minor and the designated
258 caregivers are parents or legal guardians of the qualified
260 2. The qualified patient is an adult who has an
261 intellectual or developmental disability that prevents the
262 patient from being able to protect or care for himself or
263 herself without assistance or supervision and the designated
264 caregivers are the parents or legal guardians of the qualified
265 patient; or
266 3. The qualified patient is admitted to a hospice program;
268 4. The qualified patient is participating in a research
269 program in a teaching nursing home pursuant to s. 1004.4351.
270 (d) A caregiver may be registered in the medical marijuana
271 use registry as a designated caregiver for no more than one
272 qualified patient, unless:
273 1. The caregiver is a parent or legal guardian of more than
274 one minor who is a qualified patient;
275 2. The caregiver is a parent or legal guardian of more than
276 one adult who is a qualified patient and who has an intellectual
277 or developmental disability that prevents the patient from being
278 able to protect or care for himself or herself without
279 assistance or supervision; or
280 3. All qualified patients the caregiver has agreed to
281 assist are admitted to a hospice program and have requested the
282 assistance of that caregiver with the medical use of marijuana;
283 the caregiver is an employee of the hospice; and the caregiver
284 provides personal care or other services directly to clients of
285 the hospice in the scope of that employment; or
286 4. All qualified patients the caregiver has agreed to
287 assist are participating in a research program in a teaching
288 nursing home pursuant to s. 1004.4351.
289 (8) MEDICAL MARIJUANA TREATMENT CENTERS.—
290 (e) A licensed medical marijuana treatment center shall
291 cultivate, process, transport, and dispense marijuana for
292 medical use. A licensed medical marijuana treatment center may
293 not contract for services directly related to the cultivation,
294 processing, and dispensing of marijuana or marijuana delivery
295 devices, except that a medical marijuana treatment center
296 licensed pursuant to subparagraph (a)1. may contract with a
297 single entity for the cultivation, processing, transporting, and
298 dispensing of marijuana and marijuana delivery devices. A
299 licensed medical marijuana treatment center must, at all times,
300 maintain compliance with the criteria demonstrated and
301 representations made in the initial application and the criteria
302 established in this subsection. Upon request, the department may
303 grant a medical marijuana treatment center a variance from the
304 representations made in the initial application. Consideration
305 of such a request shall be based upon the individual facts and
306 circumstances surrounding the request. A variance may not be
307 granted unless the requesting medical marijuana treatment center
308 can demonstrate to the department that it has a proposed
309 alternative to the specific representation made in its
310 application which fulfills the same or a similar purpose as the
311 specific representation in a way that the department can
312 reasonably determine will not be a lower standard than the
313 specific representation in the application. A variance may not
314 be granted from the requirements in subparagraph 2. and
315 subparagraphs (b)1. and 2.
316 1. A licensed medical marijuana treatment center may
317 transfer ownership to an individual or entity who meets the
318 requirements of this section. A publicly traded corporation or
319 publicly traded company that meets the requirements of this
320 section is not precluded from ownership of a medical marijuana
321 treatment center. To accommodate a change in ownership:
322 a. The licensed medical marijuana treatment center shall
323 notify the department in writing at least 60 days before the
324 anticipated date of the change of ownership.
325 b. The individual or entity applying for initial licensure
326 due to a change of ownership must submit an application that
327 must be received by the department at least 60 days before the
328 date of change of ownership.
329 c. Upon receipt of an application for a license, the
330 department shall examine the application and, within 30 days
331 after receipt, notify the applicant in writing of any apparent
332 errors or omissions and request any additional information
334 d. Requested information omitted from an application for
335 licensure must be filed with the department within 21 days after
336 the department’s request for omitted information or the
337 application shall be deemed incomplete and shall be withdrawn
338 from further consideration and the fees shall be forfeited.
340 Within 30 days after the receipt of a complete application, the
341 department shall approve or deny the application.
342 2. A medical marijuana treatment center, and any individual
343 or entity who directly or indirectly owns, controls, or holds
344 with power to vote 5 percent or more of the voting shares of a
345 medical marijuana treatment center, may not acquire direct or
346 indirect ownership or control of any voting shares or other form
347 of ownership of any other medical marijuana treatment center.
348 3. A medical marijuana treatment center may not enter into
349 any form of profit-sharing arrangement with the property owner
350 or lessor of any of its facilities where cultivation,
351 processing, storing, or dispensing of marijuana and marijuana
352 delivery devices occurs.
353 4. All employees of a medical marijuana treatment center
354 must be 21 years of age or older and have passed a background
355 screening pursuant to subsection (9).
356 5. Each medical marijuana treatment center must adopt and
357 enforce policies and procedures to ensure employees and
358 volunteers receive training on the legal requirements to
359 dispense marijuana to qualified patients.
360 6. When growing marijuana, a medical marijuana treatment
362 a. May use pesticides determined by the department, after
363 consultation with the Department of Agriculture and Consumer
364 Services, to be safely applied to plants intended for human
365 consumption, but may not use pesticides designated as
366 restricted-use pesticides pursuant to s. 487.042.
367 b. Must grow marijuana within an enclosed structure and in
368 a room separate from any other plant.
369 c. Must inspect seeds and growing plants for plant pests
370 that endanger or threaten the horticultural and agricultural
371 interests of the state in accordance with chapter 581 and any
372 rules adopted thereunder.
373 d. Must perform fumigation or treatment of plants, or
374 remove and destroy infested or infected plants, in accordance
375 with chapter 581 and any rules adopted thereunder.
376 7. Each medical marijuana treatment center must produce and
377 make available for purchase at least one low-THC cannabis
379 8. A medical marijuana treatment center that produces
380 edibles must hold a permit to operate as a food establishment
381 pursuant to chapter 500, the Florida Food Safety Act, and must
382 comply with all the requirements for food establishments
383 pursuant to chapter 500 and any rules adopted thereunder.
384 Edibles may not contain more than 200 milligrams of
385 tetrahydrocannabinol, and a single serving portion of an edible
386 may not exceed 10 milligrams of tetrahydrocannabinol. Edibles
387 may have a potency variance of no greater than 15 percent.
388 Edibles may not be attractive to children; be manufactured in
389 the shape of humans, cartoons, or animals; be manufactured in a
390 form that bears any reasonable resemblance to products available
391 for consumption as commercially available candy; or contain any
392 color additives. To discourage consumption of edibles by
393 children, the department shall determine by rule any shapes,
394 forms, and ingredients allowed and prohibited for edibles.
395 Medical marijuana treatment centers may not begin processing or
396 dispensing edibles until after the effective date of the rule.
397 The department shall also adopt sanitation rules providing the
398 standards and requirements for the storage, display, or
399 dispensing of edibles.
400 9. Within 12 months after licensure, a medical marijuana
401 treatment center must demonstrate to the department that all of
402 its processing facilities have passed a Food Safety Good
403 Manufacturing Practices, such as Global Food Safety Initiative
404 or equivalent, inspection by a nationally accredited certifying
405 body. A medical marijuana treatment center must immediately stop
406 processing at any facility which fails to pass this inspection
407 until it demonstrates to the department that such facility has
408 met this requirement.
409 10. A medical marijuana treatment center that produces
410 prerolled marijuana cigarettes may not use wrapping paper made
411 with tobacco or hemp.
412 11. 10. When processing marijuana, a medical marijuana
413 treatment center must:
414 a. Process the marijuana within an enclosed structure and
415 in a room separate from other plants or products.
416 b. Comply with department rules when processing marijuana
417 with hydrocarbon solvents or other solvents or gases exhibiting
418 potential toxicity to humans. The department shall determine by
419 rule the requirements for medical marijuana treatment centers to
420 use such solvents or gases exhibiting potential toxicity to
422 c. Comply with federal and state laws and regulations and
423 department rules for solid and liquid wastes. The department
424 shall determine by rule procedures for the storage, handling,
425 transportation, management, and disposal of solid and liquid
426 waste generated during marijuana production and processing. The
427 Department of Environmental Protection shall assist the
428 department in developing such rules.
429 d. Test the processed marijuana using a medical marijuana
430 testing laboratory before it is dispensed. Results must be
431 verified and signed by two medical marijuana treatment center
432 employees. Before dispensing, the medical marijuana treatment
433 center must determine that the test results indicate that low
434 THC cannabis meets the definition of low-THC cannabis, the
435 concentration of tetrahydrocannabinol meets the potency
436 requirements of this section, the labeling of the concentration
437 of tetrahydrocannabinol and cannabidiol is accurate, and all
438 marijuana is safe for human consumption and free from
439 contaminants that are unsafe for human consumption. The
440 department shall determine by rule which contaminants must be
441 tested for and the maximum levels of each contaminant which are
442 safe for human consumption. The Department of Agriculture and
443 Consumer Services shall assist the department in developing the
444 testing requirements for contaminants that are unsafe for human
445 consumption in edibles. The department shall also determine by
446 rule the procedures for the treatment of marijuana that fails to
447 meet the testing requirements of this section, s. 381.988, or
448 department rule. The department may select a random sample from
449 edibles available for purchase in a dispensing facility which
450 shall be tested by the department to determine that the edible
451 meets the potency requirements of this section, is safe for
452 human consumption, and the labeling of the tetrahydrocannabinol
453 and cannabidiol concentration is accurate. A medical marijuana
454 treatment center may not require payment from the department for
455 the sample. A medical marijuana treatment center must recall
456 edibles, including all edibles made from the same batch of
457 marijuana, which fail to meet the potency requirements of this
458 section, which are unsafe for human consumption, or for which
459 the labeling of the tetrahydrocannabinol and cannabidiol
460 concentration is inaccurate. The medical marijuana treatment
461 center must retain records of all testing and samples of each
462 homogenous batch of marijuana for at least 9 months. The medical
463 marijuana treatment center must contract with a marijuana
464 testing laboratory to perform audits on the medical marijuana
465 treatment center’s standard operating procedures, testing
466 records, and samples and provide the results to the department
467 to confirm that the marijuana or low-THC cannabis meets the
468 requirements of this section and that the marijuana or low-THC
469 cannabis is safe for human consumption. A medical marijuana
470 treatment center shall reserve two processed samples from each
471 batch and retain such samples for at least 9 months for the
472 purpose of such audits. A medical marijuana treatment center may
473 use a laboratory that has not been certified by the department
474 under s. 381.988 until such time as at least one laboratory
475 holds the required certification, but in no event later than
476 July 1, 2018.
477 e. Package the marijuana in compliance with the United
478 States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss.
479 1471 et seq.
480 f. Package the marijuana in a receptacle that has a firmly
481 affixed and legible label stating the following information:
482 (I) The marijuana or low-THC cannabis meets the
483 requirements of sub-subparagraph d.
484 (II) The name of the medical marijuana treatment center
485 from which the marijuana originates.
486 (III) The batch number and harvest number from which the
487 marijuana originates and the date dispensed.
488 (IV) The name of the physician who issued the physician
490 (V) The name of the patient.
491 (VI) The product name, if applicable, and dosage form,
492 including concentration of tetrahydrocannabinol and cannabidiol.
493 The product name may not contain wording commonly associated
494 with products marketed by or to children.
495 (VII) The recommended dose.
496 (VIII) A warning that it is illegal to transfer medical
497 marijuana to another person.
498 (IX) A marijuana universal symbol developed by the
500 12. 11. The medical marijuana treatment center shall include
501 in each package a patient package insert with information on the
502 specific product dispensed related to:
503 a. Clinical pharmacology.
504 b. Indications and use.
505 c. Dosage and administration.
506 d. Dosage forms and strengths.
507 e. Contraindications.
508 f. Warnings and precautions.
509 g. Adverse reactions.
510 13. In addition to the packaging and labeling requirements
511 specified in subparagraphs 11. and 12., marijuana in a form for
512 smoking must be packaged in a sealed receptacle with a legible
513 and prominent warning to keep away from children and a warning
514 that states marijuana smoke contains carcinogens and may
515 negatively affect health. Such receptacles for marijuana in a
516 form for smoking must be plain, opaque, and white without
517 depictions of the product or images other than the medical
518 marijuana treatment center’s department-approved logo and the
519 marijuana universal symbol.
520 14. The department shall adopt rules to regulate the types,
521 appearance, and labeling of marijuana delivery devices dispensed
522 from a medical marijuana treatment center. The rules must
523 require marijuana delivery devices to have an appearance
524 consistent with medical use.
525 15. 12. Each edible shall be individually sealed in plain,
526 opaque wrapping marked only with the marijuana universal symbol.
527 Where practical, each edible shall be marked with the marijuana
528 universal symbol. In addition to the packaging and labeling
529 requirements in subparagraphs 11. and 12. 10. and 11., edible
530 receptacles must be plain, opaque, and white without depictions
531 of the product or images other than the medical marijuana
532 treatment center’s department-approved logo and the marijuana
533 universal symbol. The receptacle must also include a list all of
534 the edible’s ingredients, storage instructions, an expiration
535 date, a legible and prominent warning to keep away from children
536 and pets, and a warning that the edible has not been produced or
537 inspected pursuant to federal food safety laws.
538 16. 13. When dispensing marijuana or a marijuana delivery
539 device, a medical marijuana treatment center:
540 a. May dispense any active, valid order for low-THC
541 cannabis, medical cannabis and cannabis delivery devices issued
542 pursuant to former s. 381.986, Florida Statutes 2016, which was
543 entered into the medical marijuana use registry before July 1,
545 b. May not dispense more than a 70-day supply of marijuana
546 within any 70-day period to a qualified patient or caregiver.
547 May not dispense more than one 35-day supply of marijuana in a
548 form for smoking within any 35-day period to a qualified patient
549 or caregiver. A 35-day supply of marijuana in a form for smoking
550 may not exceed 2.5 ounces unless an exception to this amount is
551 approved by the department pursuant to paragraph (4)(f).
552 c. Must have the medical marijuana treatment center’s
553 employee who dispenses the marijuana or a marijuana delivery
554 device enter into the medical marijuana use registry his or her
555 name or unique employee identifier.
556 d. Must verify that the qualified patient and the
557 caregiver, if applicable, each have an active registration in
558 the medical marijuana use registry and an active and valid
559 medical marijuana use registry identification card, the amount
560 and type of marijuana dispensed matches the physician
561 certification in the medical marijuana use registry for that
562 qualified patient, and the physician certification has not
563 already been filled.
564 e. May not dispense marijuana to a qualified patient who is
565 younger than 18 years of age. If the qualified patient is
566 younger than 18 years of age, marijuana may only be dispensed to
567 the qualified patient’s caregiver.
568 f. May not dispense or sell any other type of cannabis,
569 alcohol, or illicit drug-related product, including pipes ,
570 bongs, or wrapping papers made with tobacco or hemp, other than
571 a marijuana delivery device required for the medical use of
572 marijuana and which is specified in a physician certification.
573 g. Must, upon dispensing the marijuana or marijuana
574 delivery device, record in the registry the date, time,
575 quantity, and form of marijuana dispensed; the type of marijuana
576 delivery device dispensed; and the name and medical marijuana
577 use registry identification number of the qualified patient or
578 caregiver to whom the marijuana delivery device was dispensed.
579 h. Must ensure that patient records are not visible to
580 anyone other than the qualified patient, his or her caregiver,
581 and authorized medical marijuana treatment center employees.
582 (14) EXCEPTIONS TO OTHER LAWS.—
583 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
584 any other provision of law, but subject to the requirements of
585 this section, a qualified patient and the qualified patient’s
586 caregiver may purchase from a medical marijuana treatment center
587 for the patient’s medical use a marijuana delivery device and up
588 to the amount of marijuana authorized in the physician
589 certification, but may not possess more than a 70-day supply of
590 marijuana, or the greater of 4 ounces of marijuana in a form for
591 smoking or an amount of marijuana in a form for smoking approved
592 by the department pursuant to paragraph (4)(f), at any given
593 time and all marijuana purchased must remain in its original
595 (b) Notwithstanding paragraph (a), s. 893.13, s. 893.135,
596 s. 893.147, or any other provision of law, a qualified patient
597 and the qualified patient’s caregiver may purchase and possess a
598 marijuana delivery device intended for the medical use of
599 marijuana by smoking from a vendor other than a medical
600 marijuana treatment center.
601 (c) (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147,
602 or any other provision of law, but subject to the requirements
603 of this section, an approved medical marijuana treatment center
604 and its owners, managers, and employees may manufacture,
605 possess, sell, deliver, distribute, dispense, and lawfully
606 dispose of marijuana or a marijuana delivery device as provided
607 in this section, s. 381.988, and by department rule. For the
608 purposes of this subsection, the terms “manufacture,”
609 “possession,” “deliver,” “distribute,” and “dispense” have the
610 same meanings as provided in s. 893.02.
611 (d) (c) Notwithstanding s. 893.13, s. 893.135, s. 893.147,
612 or any other provision of law, but subject to the requirements
613 of this section, a certified marijuana testing laboratory,
614 including an employee of a certified marijuana testing
615 laboratory acting within the scope of his or her employment, may
616 acquire, possess, test, transport, and lawfully dispose of
617 marijuana as provided in this section, in s. 381.988, and by
618 department rule.
619 (e) (d) A licensed medical marijuana treatment center and
620 its owners, managers, and employees are not subject to licensure
621 or regulation under chapter 465 or chapter 499 for
622 manufacturing, possessing, selling, delivering, distributing,
623 dispensing, or lawfully disposing of marijuana or a marijuana
624 delivery device, as provided in this section, in s. 381.988, and
625 by department rule.
626 (f) (e) This subsection does not exempt a person from
627 prosecution for a criminal offense related to impairment or
628 intoxication resulting from the medical use of marijuana or
629 relieve a person from any requirement under law to submit to a
630 breath, blood, urine, or other test to detect the presence of a
631 controlled substance.
632 (g) (f) Notwithstanding s. 893.13, s. 893.135, s. 893.147,
633 or any other provision of law, but subject to the requirements
634 of this section and pursuant to policies and procedures
635 established pursuant to s. 1006.62(8), school personnel may
636 possess marijuana that is obtained for medical use pursuant to
637 this section by a student who is a qualified patient.
638 (h) (g) Notwithstanding s. 893.13, s. 893.135, s. 893.147,
639 or any other provision of law, but subject to the requirements
640 of this section, a research institute established by a public
641 postsecondary educational institution, such as the H. Lee
642 Moffitt Cancer Center and Research Institute, Inc., established
643 under s. 1004.43, or a state university that has achieved the
644 preeminent state research university designation under s.
645 1001.7065 may possess, test, transport, and lawfully dispose of
646 marijuana for research purposes as provided by this section.
647 (15) APPLICABILITY.—
648 (a) This section does not limit the ability of an employer
649 to establish, continue, or enforce a drug-free workplace program
650 or policy.
651 (b) This section does not require an employer to
652 accommodate the medical use of marijuana in any workplace or any
653 employee working while under the influence of marijuana.
654 (c) This section does not create a cause of action against
655 an employer for wrongful discharge or discrimination.
656 (d) This section does not impair the ability of any party
657 to restrict or limit smoking or vaping marijuana on his or her
658 private property.
659 (e) This section does not prohibit the medical use of
660 marijuana or a caregiver assisting with the medical use of
661 marijuana in a nursing home facility licensed under part II of
662 chapter 400, a hospice facility licensed under part IV of
663 chapter 400, or an assisted living facility licensed under part
664 I of chapter 429, if the medical use of marijuana is not
665 prohibited in the facility’s policies.
666 (f) Marijuana, as defined in this section, is not
667 reimbursable under chapter 440.
668 Section 2. Section 1004.4351, Florida Statutes, is amended
669 to read:
670 1004.4351 Medical marijuana research and education.—
671 (1) SHORT TITLE.—This section shall be known and may be
672 cited as the “Medical Marijuana Research and Education Act.”
673 (2) LEGISLATIVE FINDINGS.—The Legislature finds that:
674 (a) The present state of knowledge concerning the use of
675 marijuana to alleviate pain and treat illnesses is limited
676 because permission to perform clinical studies on marijuana is
677 difficult to obtain, with access to research-grade marijuana so
678 restricted that little or no unbiased studies have been
680 (b) Under the State Constitution, marijuana is available
681 for the treatment of certain debilitating medical conditions.
682 (c) Additional clinical studies are needed to ensure that
683 the residents of this state obtain the correct dosing,
684 formulation, route, modality, frequency, quantity, and quality
685 of marijuana for specific illnesses.
686 (d) An effective medical marijuana research and education
687 program would mobilize the scientific , educational, and medical
688 resources that presently exist in this state to determine the
689 appropriate and best use of marijuana to treat illness.
690 (3) DEFINITIONS.—As used in this section, the term:
691 (a) “Board” means the Medical Marijuana Research and
692 Education Board.
693 (b) “Consortium” “Coalition” means the Consortium Coalition
694 for Medical Marijuana Clinical Outcomes Research and Education.
695 (c) “Marijuana” has the same meaning as provided in s. 29,
696 Art. X of the State Constitution.
697 (4) CONSORTIUM COALITION FOR MEDICAL MARIJUANA CLINICAL
698 OUTCOMES RESEARCH AND EDUCATION.—
699 (a) There is established within a state university
700 designated by the Board of Governors the H. Lee Moffitt Cancer
701 Center and Research Institute, Inc., the Consortium Coalition
702 for Medical Marijuana Clinical Outcomes Research which shall
703 consist of public and private universities and Education. The
704 purpose of the consortium coalition is to conduct rigorous
705 scientific research and , provide education, disseminate such
706 research , and guide policy for the adoption of a statewide
707 policy on ordering and dosing practices for the medical use of
708 marijuana. The coalition shall be physically located at the H.
709 Lee Moffitt Cancer Center and Research Institute, Inc.
710 (b) The Medical Marijuana Research and Education Board is
711 established to direct the operations of the consortium
712 coalition. The board shall be composed of seven members
713 representing each participating university appointed by the
714 president of each participating university the chief executive
715 officer of the H. Lee Moffitt Cancer Center and Research
716 Institute, Inc. Board members must have experience in a variety
717 of scientific and medical fields, including, but not limited to,
718 oncology, neurology, psychology, pediatrics, nutrition, and
719 addiction. Members shall be appointed to 4-year terms and may be
720 reappointed to serve additional terms. The chair shall be
721 elected by the board from among its members to serve a 2-year
722 term. The board shall meet at least semiannually at the call of
723 the chair or, in his or her absence or incapacity, the vice
724 chair. Four members constitute a quorum. A majority vote of the
725 members present is required for all actions of the board. The
726 board may prescribe, amend, and repeal a charter governing the
727 manner in which it conducts its business. A board member shall
728 serve without compensation but is entitled to be reimbursed for
729 travel expenses by the consortium coalition or the organization
730 he or she represents in accordance with s. 112.061.
731 (c) The consortium coalition shall be administered by a
732 coalition director, who shall be appointed by and serve at the
733 pleasure of the board. The coalition director shall, subject to
734 the approval of the board:
735 1. Propose a budget for the consortium coalition.
736 2. Foster the collaboration of scientists, researchers, and
737 other appropriate personnel in accordance with the consortium’s
738 coalition’s charter.
739 3. Engage individuals in public and private university
740 programs relevant to the consortium’s work to participate in the
742 4. 3. Identify and prioritize the research to be conducted
743 by the consortium coalition.
744 5. 4. Prepare a plan for medical marijuana research the
745 Medical Marijuana Research and Education Plan for submission to
746 the board.
747 6. 5. Apply for grants to obtain funding for research
748 conducted by the consortium coalition.
749 7. 6. Perform other duties as determined by the board.
750 (d) The board shall advise the Board of Governors, the
751 State Surgeon General, the Governor, and the Legislature with
752 respect to medical marijuana research and education in this
753 state. The board shall explore methods of implementing and
754 enforcing medical marijuana laws in relation to cancer control,
755 research, treatment, and education.
756 (d) (e) The board shall annually adopt a plan for medical
757 marijuana research. The plan must organize a program of research
758 that contributes to the body of scientific knowledge on the
759 effects of the medical use of marijuana and informs both policy
760 and medical practice related to the treatment of debilitating
761 medical conditions with marijuana. Research much include
762 tracking clinical outcomes, certification standards, dosing
763 standards, routes of administration, efficacy, and side effects.
764 Research must also include the study of the effects of smoking
765 marijuana to treat debilitating medical conditions. The board
766 must award funds to members of the consortium and to perform
767 research consistent with the plan. The board may also award
768 funds to teaching nursing homes, as defined in s. 430.08, for
769 research on medical use of marijuana to alleviate conditions
770 related to chronic disease and aging , known as the “Medical
771 Marijuana Research and Education Plan,” which must be in
772 accordance with state law and coordinate with existing programs
773 in this state. The plan must include recommendations for the
774 coordination and integration of medical, pharmacological,
775 nursing, paramedical, community, and other resources connected
776 with the treatment of debilitating medical conditions; research
777 related to the treatment of such medical conditions; and
779 (e) (f) By February 15 of each year, the board shall issue a
780 report to the Governor, the President of the Senate, and the
781 Speaker of the House of Representatives on research projects,
782 research findings, community outreach initiatives, and future
783 plans for the consortium coalition.
784 (f) (g) Beginning August 1, 2019 January 15, 2018, and
785 quarterly thereafter, the Department of Health shall submit to
786 the board a data set that includes, for each patient registered
787 in the medical marijuana use registry, the patient’s qualifying
788 medical condition and the daily dose amount, routes of
789 administration, and forms of marijuana certified for the
790 patient. The department shall also provide the board with such
791 data for all patients registered in the medical marijuana use
792 registry before August 1, 2019.
793 (5) RESPONSIBILITIES OF THE H. LEE MOFFITT CANCER CENTER
794 AND RESEARCH INSTITUTE, INC.—The H. Lee Moffitt Cancer Center
795 and Research Institute, Inc., shall allocate staff and provide
796 information and assistance, as the coalition’s budget permits,
797 to assist the board in fulfilling its responsibilities.
798 Section 3. Paragraph (h) of subsection (2) and paragraph
799 (b) of subsection (3) of section 381.987, Florida Statutes, are
800 amended to read:
801 381.987 Public records exemption for personal identifying
802 information relating to medical marijuana held by the
804 (2) The department shall allow access to the confidential
805 and exempt information in the medical marijuana use registry to:
806 (h) The Consortium Coalition for Medical Marijuana Clinical
807 Outcomes Research and Education established in s. 1004.4351(4).
808 (3) The department shall allow access to the confidential
809 and exempt information pertaining to the physician certification
810 for marijuana and the dispensing thereof, whether in the
811 registry or otherwise held by the department, to:
812 (b) The Consortium Coalition for Medical Marijuana Clinical
813 Outcomes Research and Education pursuant to s. 381.986 for the
814 purpose of conducting research regarding the medical use of
816 Section 4. (1) For the 2019-2020 fiscal year, the sum of
817 $1.5 million in recurring funds is appropriated from the General
818 Revenue Fund to the Board of Governors for the Consortium for
819 Medical Marijuana Clinical Outcomes Research established under
820 s. 1004.4351, Florida Statutes.
821 (2) For the 2018-2019 fiscal year, the sum of $391,333 in
822 nonrecurring funds is appropriated from the Grants and Donations
823 Trust Fund to the Department of Health for the purpose of
824 implementing the requirements of this act.
825 (3) For the 2019-2020 fiscal year, the sum of $705,331 in
826 recurring funds is appropriated from the Grants and Donations
827 Trust Fund to the Department of Health for the purpose of
828 implementing the requirements of this act.
829 Section 5. This act shall take effect upon becoming a law.
831 ================= T I T L E A M E N D M E N T ================
832 And the title is amended as follows:
833 Delete everything before the enacting clause
834 and insert:
835 A bill to be entitled
836 An act relating to the medical use of marijuana;
837 amending s. 381.986, F.S.; redefining the term
838 “marijuana delivery device” to eliminate the
839 requirement that such devices must be purchased from a
840 medical marijuana treatment center; redefining the
841 term “medical use” to include the possession, use, or
842 administration of marijuana in a form for smoking;
843 conforming provisions to changes made by the act;
844 restricting the smoking of marijuana in enclosed
845 indoor workplaces; requiring a patient’s informed
846 consent form to include the negative health risks
847 associated with smoking marijuana; conforming a
848 provision to changes made by the act; requiring a
849 qualified physician to submit specified documentation
850 to the Board of Medicine and the Board of Osteopathic
851 Medicine upon determining that smoking is an
852 appropriate route of administration for a qualified
853 patient, other than a patient diagnosed with a
854 terminal condition; prohibiting a physician from
855 certifying a patient under 18 years of age to smoke
856 marijuana for medical use unless the patient is
857 diagnosed with a terminal condition and the physician
858 makes a certain determination in concurrence with a
859 second physician who is a pediatrician; requiring a
860 qualified physician to obtain the written informed
861 consent of the such patient’s parent or legal guardian
862 before certifying the patient to smoke marijuana for
863 medical use; requiring the qualified physician to use
864 a certain informed consent form adopted in rule by the
865 boards; requiring the boards to review specified
866 documentation and adopt certain practice standards by
867 rule by a specified date; establishing a supply limit
868 for a physician certification for marijuana in a form
869 for smoking; authorizing a qualified physician to
870 request an exception to the supply limit and
871 possession limit for marijuana in a form for smoking;
872 authorizing more than one caregiver to assist with a
873 qualified patient’s medical use of marijuana if the
874 patient is participating in a certain research program
875 in a teaching nursing home; authorizing a caregiver to
876 be listed in the medical marijuana use registry as a
877 designated caregiver for qualified patients who are
878 participating in a certain research program in a
879 teaching nursing home; prohibiting a medical marijuana
880 treatment center that produces prerolled marijuana
881 cigarettes from using wrapping paper made with tobacco
882 or hemp; requiring that marijuana in a form for
883 smoking meet certain packaging and labeling
884 requirements; requiring the Department of Health to
885 adopt rules regulating the types, appearance, and
886 labeling of marijuana delivery devices; prohibiting a
887 medical marijuana treatment center from dispensing
888 more than a specified supply limit of marijuana in a
889 form for smoking; revising a provision prohibiting a
890 medical marijuana treatment center from dispensing or
891 selling specified products; establishing possession
892 limits on marijuana in a form for smoking for a
893 qualified patient; allowing marijuana delivery devices
894 to be purchased from a vendor other than a medical
895 marijuana treatment center; providing applicability;
896 amending s. 1004.4351, F.S.; renaming the Coalition
897 for Medical Marijuana Research and Education as the
898 Consortium for Medical Marijuana Clinical Outcomes
899 Research; establishing the consortium for a specified
900 purpose; renaming the Medical Marijuana Research and
901 Education Board as the Medical Marijuana Research
902 Board; requiring the board to direct the operations of
903 the consortium; providing membership of the board;
904 providing for the appointment of a consortium
905 director; providing duties of the consortium director;
906 requiring the board to annually adopt a plan for
907 medical marijuana research; requiring the plan to
908 include specified information; providing research
909 requirements for the plan; requiring the board to
910 award funds to members of the consortium; authorizing
911 the board to award funds to teaching nursing homes for
912 certain research; requiring the board to issue an
913 annual report to the Governor and Legislature by a
914 specified date; requiring the department to submit
915 certain data sets to the board; amending s. 381.987,
916 F.S.; conforming provisions to changes made by the
917 act; providing appropriations; providing an effective