Florida Senate - 2024 SB 1096
By Senator Harrell
31-00855-24 20241096__
1 A bill to be entitled
2 An act relating to medical marijuana edibles; amending
3 s. 381.986, F.S.; revising the packaging and labeling
4 requirements for medical marijuana edibles; providing
5 an effective date.
6
7 Be It Enacted by the Legislature of the State of Florida:
8
9 Section 1. Paragraph (e) of subsection (8) of section
10 381.986, Florida Statutes, is amended to read:
11 381.986 Medical use of marijuana.—
12 (8) MEDICAL MARIJUANA TREATMENT CENTERS.—
13 (e) A licensed medical marijuana treatment center shall
14 cultivate, process, transport, and dispense marijuana for
15 medical use. A licensed medical marijuana treatment center may
16 not contract for services directly related to the cultivation,
17 processing, and dispensing of marijuana or marijuana delivery
18 devices, except that a medical marijuana treatment center
19 licensed pursuant to subparagraph (a)1. may contract with a
20 single entity for the cultivation, processing, transporting, and
21 dispensing of marijuana and marijuana delivery devices. A
22 licensed medical marijuana treatment center must, at all times,
23 maintain compliance with the criteria demonstrated and
24 representations made in the initial application and the criteria
25 established in this subsection. Upon request, the department may
26 grant a medical marijuana treatment center a variance from the
27 representations made in the initial application. Consideration
28 of such a request shall be based upon the individual facts and
29 circumstances surrounding the request. A variance may not be
30 granted unless the requesting medical marijuana treatment center
31 can demonstrate to the department that it has a proposed
32 alternative to the specific representation made in its
33 application which fulfills the same or a similar purpose as the
34 specific representation in a way that the department can
35 reasonably determine will not be a lower standard than the
36 specific representation in the application. A variance may not
37 be granted from the requirements in subparagraph 2. and
38 subparagraphs (b)1. and 2.
39 1. A licensed medical marijuana treatment center may
40 transfer ownership to an individual or entity who meets the
41 requirements of this section. A publicly traded corporation or
42 publicly traded company that meets the requirements of this
43 section is not precluded from ownership of a medical marijuana
44 treatment center. To accommodate a change in ownership:
45 a. The licensed medical marijuana treatment center shall
46 notify the department in writing at least 60 days before the
47 anticipated date of the change of ownership.
48 b. The individual or entity applying for initial licensure
49 due to a change of ownership must submit an application that
50 must be received by the department at least 60 days before the
51 date of change of ownership.
52 c. Upon receipt of an application for a license, the
53 department shall examine the application and, within 30 days
54 after receipt, notify the applicant in writing of any apparent
55 errors or omissions and request any additional information
56 required.
57 d. Requested information omitted from an application for
58 licensure must be filed with the department within 21 days after
59 the department’s request for omitted information or the
60 application shall be deemed incomplete and shall be withdrawn
61 from further consideration and the fees shall be forfeited.
62 e. Within 30 days after the receipt of a complete
63 application, the department shall approve or deny the
64 application.
65 2. A medical marijuana treatment center, and any individual
66 or entity who directly or indirectly owns, controls, or holds
67 with power to vote 5 percent or more of the voting shares of a
68 medical marijuana treatment center, may not acquire direct or
69 indirect ownership or control of any voting shares or other form
70 of ownership of any other medical marijuana treatment center.
71 3. A medical marijuana treatment center may not enter into
72 any form of profit-sharing arrangement with the property owner
73 or lessor of any of its facilities where cultivation,
74 processing, storing, or dispensing of marijuana and marijuana
75 delivery devices occurs.
76 4. All employees of a medical marijuana treatment center
77 must be 21 years of age or older and have passed a background
78 screening pursuant to subsection (9).
79 5. Each medical marijuana treatment center must adopt and
80 enforce policies and procedures to ensure employees and
81 volunteers receive training on the legal requirements to
82 dispense marijuana to qualified patients.
83 6. When growing marijuana, a medical marijuana treatment
84 center:
85 a. May use pesticides determined by the department, after
86 consultation with the Department of Agriculture and Consumer
87 Services, to be safely applied to plants intended for human
88 consumption, but may not use pesticides designated as
89 restricted-use pesticides pursuant to s. 487.042.
90 b. Must grow marijuana within an enclosed structure and in
91 a room separate from any other plant.
92 c. Must inspect seeds and growing plants for plant pests
93 that endanger or threaten the horticultural and agricultural
94 interests of the state in accordance with chapter 581 and any
95 rules adopted thereunder.
96 d. Must perform fumigation or treatment of plants, or
97 remove and destroy infested or infected plants, in accordance
98 with chapter 581 and any rules adopted thereunder.
99 7. Each medical marijuana treatment center must produce and
100 make available for purchase at least one low-THC cannabis
101 product.
102 8. A medical marijuana treatment center that produces
103 edibles must hold a permit to operate as a food establishment
104 pursuant to chapter 500, the Florida Food Safety Act, and must
105 comply with all the requirements for food establishments
106 pursuant to chapter 500 and any rules adopted thereunder.
107 Edibles may not contain more than 200 milligrams of
108 tetrahydrocannabinol, and a single serving portion of an edible
109 may not exceed 10 milligrams of tetrahydrocannabinol. Edibles
110 may have a potency variance of no greater than 15 percent.
111 Marijuana products, including edibles, may not be attractive to
112 children; be manufactured in the shape of humans, cartoons, or
113 animals; be manufactured in a form that bears any reasonable
114 resemblance to products available for consumption as
115 commercially available candy; or contain any color additives. To
116 discourage consumption of edibles by children, the department
117 shall determine by rule any shapes, forms, and ingredients
118 allowed and prohibited for edibles. Medical marijuana treatment
119 centers may not begin processing or dispensing edibles until
120 after the effective date of the rule. The department shall also
121 adopt sanitation rules providing the standards and requirements
122 for the storage, display, or dispensing of edibles.
123 9. Within 12 months after licensure, a medical marijuana
124 treatment center must demonstrate to the department that all of
125 its processing facilities have passed a Food Safety Good
126 Manufacturing Practices, such as Global Food Safety Initiative
127 or equivalent, inspection by a nationally accredited certifying
128 body. A medical marijuana treatment center must immediately stop
129 processing at any facility which fails to pass this inspection
130 until it demonstrates to the department that such facility has
131 met this requirement.
132 10. A medical marijuana treatment center that produces
133 prerolled marijuana cigarettes may not use wrapping paper made
134 with tobacco or hemp.
135 11. When processing marijuana, a medical marijuana
136 treatment center must:
137 a. Process the marijuana within an enclosed structure and
138 in a room separate from other plants or products.
139 b. Comply with department rules when processing marijuana
140 with hydrocarbon solvents or other solvents or gases exhibiting
141 potential toxicity to humans. The department shall determine by
142 rule the requirements for medical marijuana treatment centers to
143 use such solvents or gases exhibiting potential toxicity to
144 humans.
145 c. Comply with federal and state laws and regulations and
146 department rules for solid and liquid wastes. The department
147 shall determine by rule procedures for the storage, handling,
148 transportation, management, and disposal of solid and liquid
149 waste generated during marijuana production and processing. The
150 Department of Environmental Protection shall assist the
151 department in developing such rules.
152 d. Test the processed marijuana using a medical marijuana
153 testing laboratory before it is dispensed. Results must be
154 verified and signed by two medical marijuana treatment center
155 employees. Before dispensing, the medical marijuana treatment
156 center must determine that the test results indicate that low
157 THC cannabis meets the definition of low-THC cannabis, the
158 concentration of tetrahydrocannabinol meets the potency
159 requirements of this section, the labeling of the concentration
160 of tetrahydrocannabinol and cannabidiol is accurate, and all
161 marijuana is safe for human consumption and free from
162 contaminants that are unsafe for human consumption. The
163 department shall determine by rule which contaminants must be
164 tested for and the maximum levels of each contaminant which are
165 safe for human consumption. The Department of Agriculture and
166 Consumer Services shall assist the department in developing the
167 testing requirements for contaminants that are unsafe for human
168 consumption in edibles. The department shall also determine by
169 rule the procedures for the treatment of marijuana that fails to
170 meet the testing requirements of this section, s. 381.988, or
171 department rule. The department may select samples of marijuana
172 from a medical marijuana treatment center facility which shall
173 be tested by the department to determine whether the marijuana
174 meets the potency requirements of this section, is safe for
175 human consumption, and is accurately labeled with the
176 tetrahydrocannabinol and cannabidiol concentration or to verify
177 the result of marijuana testing conducted by a marijuana testing
178 laboratory. The department may also select samples of marijuana
179 delivery devices from a medical marijuana treatment center to
180 determine whether the marijuana delivery device is safe for use
181 by qualified patients. A medical marijuana treatment center may
182 not require payment from the department for the sample. A
183 medical marijuana treatment center must recall marijuana,
184 including all marijuana and marijuana products made from the
185 same batch of marijuana, that fails to meet the potency
186 requirements of this section, that is unsafe for human
187 consumption, or for which the labeling of the
188 tetrahydrocannabinol and cannabidiol concentration is
189 inaccurate. The department shall adopt rules to establish
190 marijuana potency variations of no greater than 15 percent using
191 negotiated rulemaking pursuant to s. 120.54(2)(d) which accounts
192 for, but is not limited to, time lapses between testing, testing
193 methods, testing instruments, and types of marijuana sampled for
194 testing. The department may not issue any recalls for product
195 potency as it relates to product labeling before issuing a rule
196 relating to potency variation standards. A medical marijuana
197 treatment center must also recall all marijuana delivery devices
198 determined to be unsafe for use by qualified patients. The
199 medical marijuana treatment center must retain records of all
200 testing and samples of each homogenous batch of marijuana for at
201 least 9 months. The medical marijuana treatment center must
202 contract with a marijuana testing laboratory to perform audits
203 on the medical marijuana treatment center’s standard operating
204 procedures, testing records, and samples and provide the results
205 to the department to confirm that the marijuana or low-THC
206 cannabis meets the requirements of this section and that the
207 marijuana or low-THC cannabis is safe for human consumption. A
208 medical marijuana treatment center shall reserve two processed
209 samples from each batch and retain such samples for at least 9
210 months for the purpose of such audits. A medical marijuana
211 treatment center may use a laboratory that has not been
212 certified by the department under s. 381.988 until such time as
213 at least one laboratory holds the required certification, but in
214 no event later than July 1, 2018.
215 e. Package the marijuana in compliance with the United
216 States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss.
217 1471 et seq.
218 f. Package the marijuana in a receptacle that has a firmly
219 affixed and legible label stating the following information:
220 (I) The marijuana or low-THC cannabis meets the
221 requirements of sub-subparagraph d.
222 (II) The name of the medical marijuana treatment center
223 from which the marijuana originates.
224 (III) The batch number and harvest number from which the
225 marijuana originates and the date dispensed.
226 (IV) The name of the physician who issued the physician
227 certification.
228 (V) The name of the patient.
229 (VI) The product name, if applicable, and dosage form,
230 including concentration of tetrahydrocannabinol and cannabidiol.
231 The product name may not contain wording commonly associated
232 with products that are attractive to children or which promote
233 the recreational use of marijuana.
234 (VII) The recommended dose.
235 (VIII) A warning that it is illegal to transfer medical
236 marijuana to another person.
237 (IX) A marijuana universal symbol developed by the
238 department.
239 12. The medical marijuana treatment center shall include in
240 each package a patient package insert with information on the
241 specific product dispensed related to:
242 a. Clinical pharmacology.
243 b. Indications and use.
244 c. Dosage and administration.
245 d. Dosage forms and strengths.
246 e. Contraindications.
247 f. Warnings and precautions.
248 g. Adverse reactions.
249 13. In addition to the packaging and labeling requirements
250 specified in subparagraphs 11. and 12., marijuana in a form for
251 smoking must be packaged in a sealed receptacle with a legible
252 and prominent warning to keep away from children and a warning
253 that states marijuana smoke contains carcinogens and may
254 negatively affect health. Such receptacles for marijuana in a
255 form for smoking must be plain, opaque, and white without
256 depictions of the product or images other than the medical
257 marijuana treatment center’s department-approved logo and the
258 marijuana universal symbol.
259 14. The department shall adopt rules to regulate the types,
260 appearance, and labeling of marijuana delivery devices dispensed
261 from a medical marijuana treatment center. The rules must
262 require marijuana delivery devices to have an appearance
263 consistent with medical use.
264 15. Each edible must be individually sealed in plain,
265 opaque wrapping marked only with the marijuana universal symbol.
266 Where practical, each edible must be marked with the marijuana
267 universal symbol. In addition to the packaging and labeling
268 requirements in subparagraphs 11. and 12., edible receptacles
269 must be plain, opaque, and white without depictions of the
270 product or images, except that they must include other than the
271 medical marijuana treatment center’s department-approved logo
272 and the marijuana universal symbol. The receptacle must also
273 include the edible’s identity labeling statement as required by
274 21 C.F.R. s. 101.3; the declaration of net quantity of contents
275 as required by 21 C.F.R. s. 101.105(a), (b), and (c); a list of
276 all the edible’s nutrition facts, allergens, and ingredients;,
277 storage instructions;, an expiration date;, a legible and
278 prominent warning to keep away from children and pets;, and a
279 warning that the edible has not been produced or inspected
280 pursuant to federal food safety laws.
281 16. When dispensing marijuana or a marijuana delivery
282 device, a medical marijuana treatment center:
283 a. May dispense any active, valid order for low-THC
284 cannabis, medical cannabis and cannabis delivery devices issued
285 pursuant to former s. 381.986, Florida Statutes 2016, which was
286 entered into the medical marijuana use registry before July 1,
287 2017.
288 b. May not dispense more than a 70-day supply of marijuana
289 within any 70-day period to a qualified patient or caregiver.
290 May not dispense more than one 35-day supply of marijuana in a
291 form for smoking within any 35-day period to a qualified patient
292 or caregiver. A 35-day supply of marijuana in a form for smoking
293 may not exceed 2.5 ounces unless an exception to this amount is
294 approved by the department pursuant to paragraph (4)(f).
295 c. Must have the medical marijuana treatment center’s
296 employee who dispenses the marijuana or a marijuana delivery
297 device enter into the medical marijuana use registry his or her
298 name or unique employee identifier.
299 d. Must verify that the qualified patient and the
300 caregiver, if applicable, each have an active registration in
301 the medical marijuana use registry and an active and valid
302 medical marijuana use registry identification card, the amount
303 and type of marijuana dispensed matches the physician
304 certification in the medical marijuana use registry for that
305 qualified patient, and the physician certification has not
306 already been filled.
307 e. May not dispense marijuana to a qualified patient who is
308 younger than 18 years of age. If the qualified patient is
309 younger than 18 years of age, marijuana may only be dispensed to
310 the qualified patient’s caregiver.
311 f. May not dispense or sell any other type of cannabis,
312 alcohol, or illicit drug-related product, including pipes or
313 wrapping papers made with tobacco or hemp, other than a
314 marijuana delivery device required for the medical use of
315 marijuana and which is specified in a physician certification.
316 g. Must, upon dispensing the marijuana or marijuana
317 delivery device, record in the registry the date, time,
318 quantity, and form of marijuana dispensed; the type of marijuana
319 delivery device dispensed; and the name and medical marijuana
320 use registry identification number of the qualified patient or
321 caregiver to whom the marijuana delivery device was dispensed.
322 h. Must ensure that patient records are not visible to
323 anyone other than the qualified patient, his or her caregiver,
324 and authorized medical marijuana treatment center employees.
325 Section 2. This act shall take effect July 1, 2024.