Florida Senate - 2019 CS for CS for CS for SB 182
By the Committees on Rules; Innovation, Industry, and
Technology; and Health Policy; and Senators Brandes and Stewart
595-02513-19 2019182c3
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 eliminate the
5 requirement that such devices must be purchased from a
6 medical marijuana treatment center; redefining the
7 term “medical use” to include the possession, use, or
8 administration of marijuana in a form for smoking;
9 restricting the smoking of marijuana in enclosed
10 indoor workplaces; conforming a provision to changes
11 made by the act; requiring a patient’s informed
12 consent form to include the risks specifically
13 associated with smoking marijuana; prohibiting a
14 physician from certifying a patient under 18 years of
15 age to smoke marijuana for medical use unless the
16 patient is diagnosed with a terminal condition and the
17 physician makes a certain determination in concurrence
18 with a second physician who is a pediatrician;
19 conforming a provision to changes made by the act;
20 requiring the Board of Medicine and the Board of
21 Osteopathic Medicine to adopt certain practice
22 standards by rule; requiring the Department of Health
23 to provide the boards with certain information from
24 the medical marijuana use registry, as necessary;
25 establishing supply limits for physician
26 certifications for marijuana in a form for smoking;
27 requiring each medical marijuana treatment center to
28 produce and make available for purchase at least one
29 type of pre-rolled marijuana cigarette; requiring that
30 marijuana in a form for smoking meet certain packaging
31 and labeling requirements; requiring a medical
32 marijuana treatment center to ensure that a marijuana
33 delivery device meets certain packaging and labeling
34 requirements; requiring the department to adopt rules
35 specifying certain packaging and labeling requirements
36 for marijuana delivery devices; prohibiting a medical
37 marijuana treatment center from dispensing more than a
38 specified supply limit of marijuana in a form for
39 smoking; deleting a provision prohibiting a medical
40 marijuana treatment center from dispensing or selling
41 specified products; allowing marijuana delivery
42 devices to be purchased from a vendor other than a
43 medical marijuana treatment center; providing
44 applicability; amending s. 1004.4351, F.S.; renaming
45 the Coalition for Medical Marijuana Research and
46 Education as the Consortium for Medical Marijuana
47 Clinical Outcomes Research; establishing the
48 consortium for a specified purpose; renaming the
49 Medical Marijuana Research and Education Board as the
50 Medical Marijuana Research Board; requiring the board
51 to direct the operations of the consortium; providing
52 membership of the board; providing for the appointment
53 of a consortium director; providing duties of the
54 consortium director; requiring the board to annually
55 adopt a plan for medical marijuana research; requiring
56 the plan to include specified information; providing
57 research requirements for the plan; requiring the
58 board to issue an annual report to the Governor and
59 Legislature by a specified date; requiring the
60 department to submit certain data sets to the board;
61 amending s. 381.987, F.S.; conforming provisions to
62 changes made by the act; repealing proviso language in
63 s. 3, ch. 2018-9, Laws of Florida, relating to
64 salaries and benefits positions and other personnel
65 services of the department; providing an effective
66 date.
67
68 Be It Enacted by the Legislature of the State of Florida:
69
70 Section 1. Paragraphs (g) and (j) of subsection (1),
71 subsection (4), paragraph (e) of subsection (8), and subsections
72 (14) and (15) of section 381.986, Florida Statutes, are amended
73 to read:
74 381.986 Medical use of marijuana.—
75 (1) DEFINITIONS.—As used in this section, the term:
76 (g) “Marijuana delivery device” means an object used,
77 intended for use, or designed for use in preparing, storing,
78 ingesting, inhaling, or otherwise introducing marijuana into the
79 human body, and which is dispensed from a medical marijuana
80 treatment center for medical use by a qualified patient, except
81 that delivery devices intended for the medical use of marijuana
82 by smoking need not be dispensed from a medical marijuana
83 treatment center in order to qualify as marijuana delivery
84 devices.
85 (j) “Medical use” means the acquisition, possession, use,
86 delivery, transfer, or administration of marijuana authorized by
87 a physician certification. The term does not include:
88 1. Possession, use, or administration of marijuana that was
89 not purchased or acquired from a medical marijuana treatment
90 center.
91 2. Possession, use, or administration of marijuana in a
92 form for smoking, in the form of commercially produced food
93 items other than edibles, or of marijuana seeds or flower,
94 except for flower in a sealed, tamper-proof receptacle for
95 vaping.
96 3. Use or administration of any form or amount of marijuana
97 in a manner that is inconsistent with the qualified physician’s
98 directions or physician certification.
99 4. Transfer of marijuana to a person other than the
100 qualified patient for whom it was authorized or the qualified
101 patient’s caregiver on behalf of the qualified patient.
102 5. The smoking of marijuana in an enclosed indoor workplace
103 as defined in s. 386.203(5).
104 6.5. Use or administration of marijuana in the following
105 locations:
106 a. On any form of public transportation, except for low-THC
107 cannabis.
108 b. In any public place, except for low-THC cannabis.
109 c. In a qualified patient’s place of employment, except
110 when permitted by his or her employer.
111 d. In a state correctional institution, as defined in s.
112 944.02, or a correctional institution, as defined in s. 944.241.
113 e. On the grounds of a preschool, primary school, or
114 secondary school, except as provided in s. 1006.062.
115 f. In a school bus, a vehicle, an aircraft, or a motorboat,
116 except for low-THC cannabis.
117
118 For the purposes of this subparagraph, the exceptions for low
119 THC cannabis do not include the smoking of low-THC cannabis.
120 (4) PHYSICIAN CERTIFICATION.—
121 (a) A qualified physician may issue a physician
122 certification only if the qualified physician:
123 1. Conducted a physical examination while physically
124 present in the same room as the patient and a full assessment of
125 the medical history of the patient.
126 2. Diagnosed the patient with at least one qualifying
127 medical condition.
128 3. Determined that the medical use of marijuana would
129 likely outweigh the potential health risks for the patient, and
130 such determination must be documented in the patient’s medical
131 record. If a patient is younger than 18 years of age, a second
132 physician must concur with this determination, and such
133 concurrence must be documented in the patient’s medical record.
134 4. Determined whether the patient is pregnant and
135 documented such determination in the patient’s medical record. A
136 physician may not issue a physician certification, except for
137 low-THC cannabis, to a patient who is pregnant.
138 5. Reviewed the patient’s controlled drug prescription
139 history in the prescription drug monitoring program database
140 established pursuant to s. 893.055.
141 6. Reviews the medical marijuana use registry and confirmed
142 that the patient does not have an active physician certification
143 from another qualified physician.
144 7. Registers as the issuer of the physician certification
145 for the named qualified patient on the medical marijuana use
146 registry in an electronic manner determined by the department,
147 and:
148 a. Enters into the registry the contents of the physician
149 certification, including the patient’s qualifying condition and
150 the dosage not to exceed the daily dose amount determined by the
151 department, the amount and forms of marijuana authorized for the
152 patient, and any types of marijuana delivery devices needed by
153 the patient for the medical use of marijuana.
154 b. Updates the registry within 7 days after any change is
155 made to the original physician certification to reflect such
156 change.
157 c. Deactivates the registration of the qualified patient
158 and the patient’s caregiver when the physician no longer
159 recommends the medical use of marijuana for the patient.
160 8. Obtains the voluntary and informed written consent of
161 the patient for medical use of marijuana each time the qualified
162 physician issues a physician certification for the patient,
163 which shall be maintained in the patient’s medical record. The
164 patient, or the patient’s parent or legal guardian if the
165 patient is a minor, must sign the informed consent acknowledging
166 that the qualified physician has sufficiently explained its
167 content. 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, at a
170 minimum, information related to:
171 a. The Federal Government’s classification of marijuana as
172 a Schedule I controlled substance.
173 b. The approval and oversight status of marijuana by the
174 Food and Drug Administration.
175 c. The current state of research on the efficacy of
176 marijuana to treat the qualifying conditions set forth in this
177 section.
178 d. The potential for addiction.
179 e. The potential effect that marijuana may have on a
180 patient’s coordination, motor skills, and cognition, including a
181 warning against operating heavy machinery, operating a motor
182 vehicle, or engaging in activities that require a person to be
183 alert or respond quickly.
184 f. The potential side effects of marijuana use.
185 g. The risks, benefits, and drug interactions of marijuana.
186 h. The risks specifically associated with smoking
187 marijuana.
188 i.h. That the patient’s de-identified health information
189 contained in the physician certification and medical marijuana
190 use registry may be used for research purposes.
191
192 A physician may not certify the medical use of marijuana by
193 smoking for a patient under 18 years of age unless the patient
194 is diagnosed with a terminal condition, the certifying physician
195 determines that smoking is the most effective means of
196 administering medical marijuana for the patient, and a second
197 physician who is a pediatrician concurs with that determination.
198 Such determination and concurrence must be documented in the
199 patient’s medical record.
200 (b) If a qualified physician issues a physician
201 certification for a qualified patient diagnosed with a
202 qualifying medical condition pursuant to paragraph (2)(k), the
203 physician must submit the following to the applicable board
204 within 14 days after issuing the physician certification:
205 1. Documentation supporting the qualified physician’s
206 opinion that the medical condition is of the same kind or class
207 as the conditions in paragraphs (2)(a)-(j).
208 2. Documentation that establishes the efficacy of marijuana
209 as treatment for the condition.
210 3. Documentation supporting the qualified physician’s
211 opinion that the benefits of medical use of marijuana would
212 likely outweigh the potential health risks for the patient.
213 4. Any other documentation as required by board rule.
214
215 The department must submit such documentation to the Consortium
216 Coalition for Medical Marijuana Clinical Outcomes Research and
217 Education established pursuant to s. 1004.4351.
218 (c) The Board of Medicine and the Board of Osteopathic
219 Medicine shall each, by July 1, 2021, adopt by rule practice
220 standards for the certification of smoking as a route of
221 administration. The department shall provide the Board of
222 Medicine and the Board of Osteopathic Medicine information from
223 the medical marijuana use registry as necessary for the adoption
224 of practice standards under this paragraph. Such information may
225 not include a qualified physician’s, a qualified patient’s, or a
226 caregiver’s personal identifying information.
227 (d)(c) A qualified physician may not issue a physician
228 certification for more than three 70-day supply limits of
229 marijuana or six 35-day supply limits of marijuana in a form for
230 smoking. The department shall quantify by rule a daily dose
231 amount with equivalent dose amounts for each allowable form of
232 marijuana dispensed by a medical marijuana treatment center. The
233 department shall use the daily dose amount to calculate a 70-day
234 supply or a 35-day supply, as appropriate.
235 1. A qualified physician may request an exception to the
236 daily dose amount limit. The request shall be made
237 electronically on a form adopted by the department in rule and
238 must include, at a minimum:
239 a. The qualified patient’s qualifying medical condition.
240 b. The dosage and route of administration that was
241 insufficient to provide relief to the qualified patient.
242 c. A description of how the patient will benefit from an
243 increased amount.
244 d. The minimum daily dose amount of marijuana that would be
245 sufficient for the treatment of the qualified patient’s
246 qualifying medical condition.
247 2. A qualified physician must provide the qualified
248 patient’s records upon the request of the department.
249 3. The department shall approve or disapprove the request
250 within 14 days after receipt of the complete documentation
251 required by this paragraph. The request shall be deemed approved
252 if the department fails to act within this time period.
253 (e)(d) A qualified physician must evaluate an existing
254 qualified patient at least once every 30 weeks before issuing a
255 new physician certification. A physician must:
256 1. Determine if the patient still meets the requirements to
257 be issued a physician certification under paragraph (a).
258 2. Identify and document in the qualified patient’s medical
259 records whether the qualified patient experienced either of the
260 following related to the medical use of marijuana:
261 a. An adverse drug interaction with any prescription or
262 nonprescription medication; or
263 b. A reduction in the use of, or dependence on, other types
264 of controlled substances as defined in s. 893.02.
265 3. Submit a report with the findings required pursuant to
266 subparagraph 2. to the department. The department shall submit
267 such reports to the Consortium Coalition for Medical Marijuana
268 Clinical Outcomes Research and Education established pursuant to
269 s. 1004.4351.
270 (f)(e) An active order for low-THC cannabis or medical
271 cannabis issued pursuant to former s. 381.986, Florida Statutes
272 2016, and registered with the compassionate use registry before
273 June 23, 2017, is deemed a physician certification, and all
274 patients possessing such orders are deemed qualified patients
275 until the department begins issuing medical marijuana use
276 registry identification cards.
277 (g)(f) The department shall monitor physician registration
278 in the medical marijuana use registry and the issuance of
279 physician certifications for practices that could facilitate
280 unlawful diversion or misuse of marijuana or a marijuana
281 delivery device and shall take disciplinary action as
282 appropriate.
283 (h)(g) The Board of Medicine and the Board of Osteopathic
284 Medicine shall jointly create a physician certification pattern
285 review panel that shall review all physician certifications
286 submitted to the medical marijuana use registry. The panel shall
287 track and report the number of physician certifications and the
288 qualifying medical conditions, dosage, supply amount, and form
289 of marijuana certified. The panel shall report the data both by
290 individual qualified physician and in the aggregate, by county,
291 and statewide. The physician certification pattern review panel
292 shall, beginning January 1, 2018, submit an annual report of its
293 findings and recommendations to the Governor, the President of
294 the Senate, and the Speaker of the House of Representatives.
295 (i)(h) The department, the Board of Medicine, and the Board
296 of Osteopathic Medicine may adopt rules pursuant to ss.
297 120.536(1) and 120.54 to implement this subsection.
298 (8) MEDICAL MARIJUANA TREATMENT CENTERS.—
299 (e) A licensed medical marijuana treatment center shall
300 cultivate, process, transport, and dispense marijuana for
301 medical use. A licensed medical marijuana treatment center may
302 not contract for services directly related to the cultivation,
303 processing, and dispensing of marijuana or marijuana delivery
304 devices, except that a medical marijuana treatment center
305 licensed pursuant to subparagraph (a)1. may contract with a
306 single entity for the cultivation, processing, transporting, and
307 dispensing of marijuana and marijuana delivery devices. A
308 licensed medical marijuana treatment center must, at all times,
309 maintain compliance with the criteria demonstrated and
310 representations made in the initial application and the criteria
311 established in this subsection. Upon request, the department may
312 grant a medical marijuana treatment center a variance from the
313 representations made in the initial application. Consideration
314 of such a request shall be based upon the individual facts and
315 circumstances surrounding the request. A variance may not be
316 granted unless the requesting medical marijuana treatment center
317 can demonstrate to the department that it has a proposed
318 alternative to the specific representation made in its
319 application which fulfills the same or a similar purpose as the
320 specific representation in a way that the department can
321 reasonably determine will not be a lower standard than the
322 specific representation in the application. A variance may not
323 be granted from the requirements in subparagraph 2. and
324 subparagraphs (b)1. and 2.
325 1. A licensed medical marijuana treatment center may
326 transfer ownership to an individual or entity who meets the
327 requirements of this section. A publicly traded corporation or
328 publicly traded company that meets the requirements of this
329 section is not precluded from ownership of a medical marijuana
330 treatment center. To accommodate a change in ownership:
331 a. The licensed medical marijuana treatment center shall
332 notify the department in writing at least 60 days before the
333 anticipated date of the change of ownership.
334 b. The individual or entity applying for initial licensure
335 due to a change of ownership must submit an application that
336 must be received by the department at least 60 days before the
337 date of change of ownership.
338 c. Upon receipt of an application for a license, the
339 department shall examine the application and, within 30 days
340 after receipt, notify the applicant in writing of any apparent
341 errors or omissions and request any additional information
342 required.
343 d. Requested information omitted from an application for
344 licensure must be filed with the department within 21 days after
345 the department’s request for omitted information or the
346 application shall be deemed incomplete and shall be withdrawn
347 from further consideration and the fees shall be forfeited.
348
349 Within 30 days after the receipt of a complete application, the
350 department shall approve or deny the application.
351 2. A medical marijuana treatment center, and any individual
352 or entity who directly or indirectly owns, controls, or holds
353 with power to vote 5 percent or more of the voting shares of a
354 medical marijuana treatment center, may not acquire direct or
355 indirect ownership or control of any voting shares or other form
356 of ownership of any other medical marijuana treatment center.
357 3. A medical marijuana treatment center may not enter into
358 any form of profit-sharing arrangement with the property owner
359 or lessor of any of its facilities where cultivation,
360 processing, storing, or dispensing of marijuana and marijuana
361 delivery devices occurs.
362 4. All employees of a medical marijuana treatment center
363 must be 21 years of age or older and have passed a background
364 screening pursuant to subsection (9).
365 5. Each medical marijuana treatment center must adopt and
366 enforce policies and procedures to ensure employees and
367 volunteers receive training on the legal requirements to
368 dispense marijuana to qualified patients.
369 6. When growing marijuana, a medical marijuana treatment
370 center:
371 a. May use pesticides determined by the department, after
372 consultation with the Department of Agriculture and Consumer
373 Services, to be safely applied to plants intended for human
374 consumption, but may not use pesticides designated as
375 restricted-use pesticides pursuant to s. 487.042.
376 b. Must grow marijuana within an enclosed structure and in
377 a room separate from any other plant.
378 c. Must inspect seeds and growing plants for plant pests
379 that endanger or threaten the horticultural and agricultural
380 interests of the state in accordance with chapter 581 and any
381 rules adopted thereunder.
382 d. Must perform fumigation or treatment of plants, or
383 remove and destroy infested or infected plants, in accordance
384 with chapter 581 and any rules adopted thereunder.
385 7. Each medical marijuana treatment center must produce and
386 make available for purchase at least one low-THC cannabis
387 product.
388 8. Each medical marijuana treatment center must produce and
389 make available for purchase at least one type of pre-rolled
390 marijuana cigarette.
391 9.8. A medical marijuana treatment center that produces
392 edibles must hold a permit to operate as a food establishment
393 pursuant to chapter 500, the Florida Food Safety Act, and must
394 comply with all the requirements for food establishments
395 pursuant to chapter 500 and any rules adopted thereunder.
396 Edibles may not contain more than 200 milligrams of
397 tetrahydrocannabinol, and a single serving portion of an edible
398 may not exceed 10 milligrams of tetrahydrocannabinol. Edibles
399 may have a potency variance of no greater than 15 percent.
400 Edibles may not be attractive to children; be manufactured in
401 the shape of humans, cartoons, or animals; be manufactured in a
402 form that bears any reasonable resemblance to products available
403 for consumption as commercially available candy; or contain any
404 color additives. To discourage consumption of edibles by
405 children, the department shall determine by rule any shapes,
406 forms, and ingredients allowed and prohibited for edibles.
407 Medical marijuana treatment centers may not begin processing or
408 dispensing edibles until after the effective date of the rule.
409 The department shall also adopt sanitation rules providing the
410 standards and requirements for the storage, display, or
411 dispensing of edibles.
412 10.9. Within 12 months after licensure, a medical marijuana
413 treatment center must demonstrate to the department that all of
414 its processing facilities have passed a Food Safety Good
415 Manufacturing Practices, such as Global Food Safety Initiative
416 or equivalent, inspection by a nationally accredited certifying
417 body. A medical marijuana treatment center must immediately stop
418 processing at any facility which fails to pass this inspection
419 until it demonstrates to the department that such facility has
420 met this requirement.
421 11.10. When processing marijuana, a medical marijuana
422 treatment center must:
423 a. Process the marijuana within an enclosed structure and
424 in a room separate from other plants or products.
425 b. Comply with department rules when processing marijuana
426 with hydrocarbon solvents or other solvents or gases exhibiting
427 potential toxicity to humans. The department shall determine by
428 rule the requirements for medical marijuana treatment centers to
429 use such solvents or gases exhibiting potential toxicity to
430 humans.
431 c. Comply with federal and state laws and regulations and
432 department rules for solid and liquid wastes. The department
433 shall determine by rule procedures for the storage, handling,
434 transportation, management, and disposal of solid and liquid
435 waste generated during marijuana production and processing. The
436 Department of Environmental Protection shall assist the
437 department in developing such rules.
438 d. Test the processed marijuana using a medical marijuana
439 testing laboratory before it is dispensed. Results must be
440 verified and signed by two medical marijuana treatment center
441 employees. Before dispensing, the medical marijuana treatment
442 center must determine that the test results indicate that low
443 THC cannabis meets the definition of low-THC cannabis, the
444 concentration of tetrahydrocannabinol meets the potency
445 requirements of this section, the labeling of the concentration
446 of tetrahydrocannabinol and cannabidiol is accurate, and all
447 marijuana is safe for human consumption and free from
448 contaminants that are unsafe for human consumption. The
449 department shall determine by rule which contaminants must be
450 tested for and the maximum levels of each contaminant which are
451 safe for human consumption. The Department of Agriculture and
452 Consumer Services shall assist the department in developing the
453 testing requirements for contaminants that are unsafe for human
454 consumption in edibles. The department shall also determine by
455 rule the procedures for the treatment of marijuana that fails to
456 meet the testing requirements of this section, s. 381.988, or
457 department rule. The department may select a random sample from
458 edibles available for purchase in a dispensing facility which
459 shall be tested by the department to determine that the edible
460 meets the potency requirements of this section, is safe for
461 human consumption, and the labeling of the tetrahydrocannabinol
462 and cannabidiol concentration is accurate. A medical marijuana
463 treatment center may not require payment from the department for
464 the sample. A medical marijuana treatment center must recall
465 edibles, including all edibles made from the same batch of
466 marijuana, which fail to meet the potency requirements of this
467 section, which are unsafe for human consumption, or for which
468 the labeling of the tetrahydrocannabinol and cannabidiol
469 concentration is inaccurate. The medical marijuana treatment
470 center must retain records of all testing and samples of each
471 homogenous batch of marijuana for at least 9 months. The medical
472 marijuana treatment center must contract with a marijuana
473 testing laboratory to perform audits on the medical marijuana
474 treatment center’s standard operating procedures, testing
475 records, and samples and provide the results to the department
476 to confirm that the marijuana or low-THC cannabis meets the
477 requirements of this section and that the marijuana or low-THC
478 cannabis is safe for human consumption. A medical marijuana
479 treatment center shall reserve two processed samples from each
480 batch and retain such samples for at least 9 months for the
481 purpose of such audits. A medical marijuana treatment center may
482 use a laboratory that has not been certified by the department
483 under s. 381.988 until such time as at least one laboratory
484 holds the required certification, but in no event later than
485 July 1, 2018.
486 e. Package the marijuana in compliance with the United
487 States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss.
488 1471 et seq.
489 f. Package the marijuana in a receptacle that has a firmly
490 affixed and legible label stating the following information:
491 (I) The marijuana or low-THC cannabis meets the
492 requirements of sub-subparagraph d.
493 (II) The name of the medical marijuana treatment center
494 from which the marijuana originates.
495 (III) The batch number and harvest number from which the
496 marijuana originates and the date dispensed.
497 (IV) The name of the physician who issued the physician
498 certification.
499 (V) The name of the patient.
500 (VI) The product name, if applicable, and dosage form,
501 including concentration of tetrahydrocannabinol and cannabidiol.
502 The product name may not contain wording commonly associated
503 with products marketed by or to children.
504 (VII) The recommended dose.
505 (VIII) A warning that it is illegal to transfer medical
506 marijuana to another person.
507 (IX) A marijuana universal symbol developed by the
508 department.
509 12.11. The medical marijuana treatment center shall include
510 in each package a patient package insert with information on the
511 specific product dispensed related to:
512 a. Clinical pharmacology.
513 b. Indications and use.
514 c. Dosage and administration.
515 d. Dosage forms and strengths.
516 e. Contraindications.
517 f. Warnings and precautions.
518 g. Adverse reactions.
519 13. In addition to the packaging and labeling requirements
520 in subparagraphs 11. and 12., marijuana in a form for smoking
521 must be packaged in a sealed receptacle with a legible and
522 prominent warning to keep away from children and a warning that
523 states marijuana smoke contains carcinogens and may negatively
524 affect health. Such receptacles for marijuana in a form for
525 smoking must be plain, opaque, and white without depictions of
526 the product or images other than the medical marijuana treatment
527 center’s department-approved logo and the marijuana universal
528 symbol.
529 14. Before dispensing a marijuana delivery device, a
530 medical marijuana treatment center must ensure that the
531 marijuana delivery device:
532 a. Has a firmly affixed, legible, and permanent label
533 showing the medical marijuana treatment center’s department
534 approved logo, including each individual marijuana cigarette or
535 wrapping paper.
536 b. Does not incorporate colors, shapes, forms, or designs
537 that are intended to make the marijuana delivery device
538 attractive to children or are likely, by their nature, to be
539 attractive to children. The department shall adopt rules
540 specifying allowable colors, shapes, forms, and designs for
541 marijuana delivery devices.
542 15.12. Each edible shall be individually sealed in plain,
543 opaque wrapping marked only with the marijuana universal symbol.
544 Where practical, each edible shall be marked with the marijuana
545 universal symbol. In addition to the packaging and labeling
546 requirements in subparagraphs 11. and 12. subparagraphs 10. and
547 11., edible receptacles must be plain, opaque, and white without
548 depictions of the product or images other than the medical
549 marijuana treatment center’s department-approved logo and the
550 marijuana universal symbol. The receptacle must also include a
551 list all of the edible’s ingredients, storage instructions, an
552 expiration date, a legible and prominent warning to keep away
553 from children and pets, and a warning that the edible has not
554 been produced or inspected pursuant to federal food safety laws.
555 16.13. When dispensing marijuana or a marijuana delivery
556 device, a medical marijuana treatment center:
557 a. May dispense any active, valid order for low-THC
558 cannabis, medical cannabis and cannabis delivery devices issued
559 pursuant to former s. 381.986, Florida Statutes 2016, which was
560 entered into the medical marijuana use registry before July 1,
561 2017.
562 b. May not dispense more than a 70-day supply of marijuana
563 or more than a 35-day supply of marijuana in a form for smoking
564 to a qualified patient or caregiver. A 35-day supply of
565 marijuana in a form for smoking may not exceed four ounces.
566 c. Must have the medical marijuana treatment center’s
567 employee who dispenses the marijuana or a marijuana delivery
568 device enter into the medical marijuana use registry his or her
569 name or unique employee identifier.
570 d. Must verify that the qualified patient and the
571 caregiver, if applicable, each have an active registration in
572 the medical marijuana use registry and an active and valid
573 medical marijuana use registry identification card, the amount
574 and type of marijuana dispensed matches the physician
575 certification in the medical marijuana use registry for that
576 qualified patient, and the physician certification has not
577 already been filled.
578 e. May not dispense marijuana to a qualified patient who is
579 younger than 18 years of age. If the qualified patient is
580 younger than 18 years of age, marijuana may only be dispensed
581 only to the qualified patient’s caregiver.
582 f. May not dispense or sell any other type of cannabis,
583 alcohol, or illicit drug-related product, including pipes,
584 bongs, or wrapping papers, other than a marijuana delivery
585 device required for the medical use of marijuana and which is
586 specified in a physician certification.
587 g. Must, upon dispensing the marijuana or marijuana
588 delivery device, record in the registry the date, time,
589 quantity, and form of marijuana dispensed; the type of marijuana
590 delivery device dispensed; and the name and medical marijuana
591 use registry identification number of the qualified patient or
592 caregiver to whom the marijuana delivery device was dispensed.
593 h. Must ensure that patient records are not visible to
594 anyone other than the qualified patient, his or her caregiver,
595 and authorized medical marijuana treatment center employees.
596 (14) EXCEPTIONS TO OTHER LAWS.—
597 (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
598 any other provision of law, but subject to the requirements of
599 this section, a qualified patient and the qualified patient’s
600 caregiver may purchase from a medical marijuana treatment center
601 for the patient’s medical use a marijuana delivery device and up
602 to the amount of marijuana authorized in the physician
603 certification, but may not possess more than a 70-day supply of
604 marijuana at any given time and all marijuana purchased must
605 remain in its original packaging.
606 (b) Notwithstanding paragraph (a), s. 893.13, s. 893.135,
607 s. 893.147, or any other provision of law, a qualified patient
608 and the qualified patient’s caregiver may purchase and possess a
609 marijuana delivery device intended for the medical use of
610 marijuana by smoking from a vendor other than a medical
611 marijuana treatment center.
612 (c)(b) Notwithstanding s. 893.13, s. 893.135, s. 893.147,
613 or any other provision of law, but subject to the requirements
614 of this section, an approved medical marijuana treatment center
615 and its owners, managers, and employees may manufacture,
616 possess, sell, deliver, distribute, dispense, and lawfully
617 dispose of marijuana or a marijuana delivery device as provided
618 in this section, s. 381.988, and by department rule. For the
619 purposes of this subsection, the terms “manufacture,”
620 “possession,” “deliver,” “distribute,” and “dispense” have the
621 same meanings as provided in s. 893.02.
622 (d)(c) Notwithstanding s. 893.13, s. 893.135, s. 893.147,
623 or any other provision of law, but subject to the requirements
624 of this section, a certified marijuana testing laboratory,
625 including an employee of a certified marijuana testing
626 laboratory acting within the scope of his or her employment, may
627 acquire, possess, test, transport, and lawfully dispose of
628 marijuana as provided in this section, in s. 381.988, and by
629 department rule.
630 (e)(d) A licensed medical marijuana treatment center and
631 its owners, managers, and employees are not subject to licensure
632 or regulation under chapter 465 or chapter 499 for
633 manufacturing, possessing, selling, delivering, distributing,
634 dispensing, or lawfully disposing of marijuana or a marijuana
635 delivery device, as provided in this section, in s. 381.988, and
636 by department rule.
637 (f)(e) This subsection does not exempt a person from
638 prosecution for a criminal offense related to impairment or
639 intoxication resulting from the medical use of marijuana or
640 relieve a person from any requirement under law to submit to a
641 breath, blood, urine, or other test to detect the presence of a
642 controlled substance.
643 (g)(f) Notwithstanding s. 893.13, s. 893.135, s. 893.147,
644 or any other provision of law, but subject to the requirements
645 of this section and pursuant to policies and procedures
646 established pursuant to s. 1006.62(8), school personnel may
647 possess marijuana that is obtained for medical use pursuant to
648 this section by a student who is a qualified patient.
649 (h)(g) Notwithstanding s. 893.13, s. 893.135, s. 893.147,
650 or any other provision of law, but subject to the requirements
651 of this section, a research institute established by a public
652 postsecondary educational institution, such as the H. Lee
653 Moffitt Cancer Center and Research Institute, Inc., established
654 under s. 1004.43, or a state university that has achieved the
655 preeminent state research university designation under s.
656 1001.7065 may possess, test, transport, and lawfully dispose of
657 marijuana for research purposes as provided by this section.
658 (15) APPLICABILITY.—
659 (a) This section does not limit the ability of an employer
660 to establish, continue, or enforce a drug-free workplace program
661 or policy.
662 (b) This section does not require an employer to
663 accommodate the medical use of marijuana in any workplace or any
664 employee working while under the influence of marijuana.
665 (c) This section does not create a cause of action against
666 an employer for wrongful discharge or discrimination.
667 (d) This section does not impair the ability of any party
668 to restrict or limit smoking on his or her private property.
669 (e) This section does not prohibit the medical use of
670 marijuana, or a caregiver assisting with the medical use of
671 marijuana, in a nursing home licensed under part II of chapter
672 400; in a hospice facility licensed under part IV of chapter
673 400; or in an assisted living facility licensed under part I of
674 chapter 429, if the medical use of marijuana is not prohibited
675 in the facility’s policies.
676 (f) Marijuana, as defined in this section, is not
677 reimbursable under chapter 440.
678 Section 2. Section 1004.4351, Florida Statutes, is amended
679 to read:
680 1004.4351 Medical marijuana research and education.—
681 (1) SHORT TITLE.—This section shall be known and may be
682 cited as the “Medical Marijuana Research and Education Act.”
683 (2) LEGISLATIVE FINDINGS.—The Legislature finds that:
684 (a) The present state of knowledge concerning the use of
685 marijuana to alleviate pain and treat illnesses is limited
686 because permission to perform clinical studies on marijuana is
687 difficult to obtain, with access to research-grade marijuana so
688 restricted that little or no unbiased studies have been
689 performed.
690 (b) Under the State Constitution, marijuana is available
691 for the treatment of certain debilitating medical conditions.
692 (c) Additional clinical studies are needed to ensure that
693 the residents of this state obtain the correct dosing,
694 formulation, route, modality, frequency, quantity, and quality
695 of marijuana for specific illnesses.
696 (d) An effective medical marijuana research and education
697 program would mobilize the scientific, educational, and medical
698 resources that presently exist in this state to determine the
699 appropriate and best use of marijuana to treat illness.
700 (3) DEFINITIONS.—As used in this section, the term:
701 (a) “Board” means the Medical Marijuana Research and
702 Education Board.
703 (b) “Consortium” “Coalition” means the Consortium Coalition
704 for Medical Marijuana Clinical Outcomes Research and Education.
705 (c) “Marijuana” has the same meaning as provided in s. 29,
706 Art. X of the State Constitution.
707 (4) CONSORTIUM COALITION FOR MEDICAL MARIJUANA CLINICAL
708 OUTCOMES RESEARCH AND EDUCATION.—
709 (a) There is established within the H. Lee Moffitt Cancer
710 Center and Research Institute, Inc., the Consortium Coalition
711 for Medical Marijuana Clinical Outcomes Research consisting of
712 public and private universities and Education. The purpose of
713 the consortium coalition is to conduct rigorous scientific
714 research and, provide education, disseminate such research, and
715 guide policy for the adoption of a statewide policy on ordering
716 and dosing practices for the medical use of marijuana. The
717 consortium coalition shall be physically located at the H. Lee
718 Moffitt Cancer Center and Research Institute, Inc.
719 (b) The Medical Marijuana Research and Education Board is
720 established to direct the operations of the consortium
721 coalition. The board shall be composed of a chairperson
722 appointed by the H. Lee Moffitt Cancer Center and Research
723 Institute, Inc., a member appointed by the University of
724 Florida, and a member representing each other participating
725 university seven members appointed by the president of the
726 university the chief executive officer of the H. Lee Moffitt
727 Cancer Center and Research Institute, Inc. Board members must
728 have experience in a variety of scientific and medical fields,
729 including, but not limited to, oncology, neurology, psychology,
730 pediatrics, nutrition, and addiction. Members shall be appointed
731 to 4-year terms and may be reappointed to serve additional
732 terms. The chair shall be elected by the board from among its
733 members to serve a 2-year term. The board shall meet at least
734 semiannually at the call of the chair or, in his or her absence
735 or incapacity, the vice chair. Four members constitute a quorum.
736 A majority vote of the members present is required for all
737 actions of the board. The board may prescribe, amend, and repeal
738 a charter governing the manner in which it conducts its
739 business. A board member shall serve without compensation but is
740 entitled to be reimbursed for travel expenses by the consortium
741 coalition or the organization he or she represents in accordance
742 with s. 112.061.
743 (c) The consortium coalition shall be administered by a
744 coalition director, who shall be appointed by the H. Lee Moffitt
745 Cancer Center and Research Institute, Inc and serve at the
746 pleasure of the board. The coalition director shall, subject to
747 the approval of the board:
748 1. Propose a budget for the consortium coalition.
749 2. Foster the collaboration of scientists, researchers, and
750 other appropriate personnel in accordance with the consortium’s
751 coalition’s charter.
752 3. Engage individuals in public and private university
753 programs relevant to the consortium’s work to participate in the
754 consortium.
755 4.3. Identify and prioritize the research to be conducted
756 by the consortium coalition.
757 5.4. Prepare a plan for medical marijuana research the
758 Medical Marijuana Research and Education Plan for submission to
759 the board.
760 6.5. Apply for grants to obtain funding for research
761 conducted by the consortium coalition.
762 7.6. Perform other duties as determined by the board.
763 (d) The board shall advise the Board of Governors, the
764 State Surgeon General, the Governor, and the Legislature with
765 respect to medical marijuana research and education in this
766 state. The board shall explore methods of implementing and
767 enforcing medical marijuana laws in relation to cancer control,
768 research, treatment, and education.
769 (d)(e) The board shall annually adopt a plan for medical
770 marijuana research. The plan shall organize a program of
771 research that contributes to the body of scientific knowledge on
772 the effects of the medical use of marijuana and informs both
773 policy and medical practice related to the treatment of
774 debilitating medical conditions with marijuana. Research shall
775 include tracking clinical outcomes, certification standards,
776 dosing standards, routes of administration, efficacy, and side
777 effects. Research must also include the study of the effects of
778 smoking marijuana to treat debilitating medical conditions. The
779 board must award funds to members of the consortium to perform
780 research consistent with the plan, known as the “Medical
781 Marijuana Research and Education Plan,” which must be in
782 accordance with state law and coordinate with existing programs
783 in this state. The plan must include recommendations for the
784 coordination and integration of medical, pharmacological,
785 nursing, paramedical, community, and other resources connected
786 with the treatment of debilitating medical conditions; research
787 related to the treatment of such medical conditions; and
788 education.
789 (e)(f) By February 15 of each year, the board shall issue a
790 report to the Governor, the President of the Senate, and the
791 Speaker of the House of Representatives on research projects,
792 research findings, community outreach initiatives, and future
793 plans for the consortium coalition.
794 (f)(g) Beginning August 1, 2019 January 15, 2018, and
795 quarterly thereafter, the Department of Health shall submit to
796 the board a data set that includes, for each patient registered
797 in the medical marijuana use registry, the patient’s qualifying
798 medical condition and the daily dose amount, routes of
799 administration, and forms of marijuana certified for the
800 patient. The department shall also submit to the board a data
801 set for all patients registered in the medical marijuana use
802 registry before August 1, 2019.
803 (5) RESPONSIBILITIES OF THE H. LEE MOFFITT CANCER CENTER
804 AND RESEARCH INSTITUTE, INC.—The H. Lee Moffitt Cancer Center
805 and Research Institute, Inc., shall allocate staff and provide
806 information and assistance, as the consortium’s coalition’s
807 budget permits, to assist the board in fulfilling its
808 responsibilities.
809 Section 3. Paragraph (h) of subsection (2) and paragraph
810 (b) of subsection (3) of section 381.987, Florida Statutes, are
811 amended to read:
812 381.987 Public records exemption for personal identifying
813 information relating to medical marijuana held by the
814 department.—
815 (2) The department shall allow access to the confidential
816 and exempt information in the medical marijuana use registry to:
817 (h) The Consortium Coalition for Medical Marijuana Clinical
818 Outcomes Research and Education established in s. 1004.4351(4).
819 (3) The department shall allow access to the confidential
820 and exempt information pertaining to the physician certification
821 for marijuana and the dispensing thereof, whether in the
822 registry or otherwise held by the department, to:
823 (b) The Consortium Coalition for Medical Marijuana Clinical
824 Outcomes Research and Education pursuant to s. 381.986 for the
825 purpose of conducting research regarding the medical use of
826 marijuana.
827 Section 4. The proviso following Specific Appropriation 422
828 in section 3 of chapter 2018-9, Laws of Florida, and the proviso
829 following Specific Appropriation 424 in section 3 of chapter
830 2018-9, Laws of Florida, are repealed and the funds appropriated
831 by those specific appropriations which were affected by those
832 provisos are released from reserve.
833 Section 5. This act shall take effect upon becoming a law.