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