Florida Senate - 2024 SB 1096 By Senator Harrell 31-00855-24 20241096__ Page 1 of 12 CODING: Words stricken are deletions; words underlined are additions. A bill to be entitled 1

An act relating to medical marijuana edibles; amending 2 s. 381.986, F.S.; revising the packaging and labeling 3 requirements for medical marijuana edibles; providing 4 an effective date. 5 6 Be It Enacted by the Legislature of the State of Florida: 7 8

Section 1. Paragraph (

e) of subsection (8) of

section 9 381.986, Florida Statutes, is amended to read: 10 381.986 Medical use of marijuana.— 11

(8) MEDICAL MARIJUANA TREATMENT CENTERS.— 12 (

e) A licensed medical marijuana treatment center shall 13 cultivate, process, transport, and dispense marijuana for 14 medical use. A licensed medical marijuana treatment center may 15 not contract for services directly related to the cultivation, 16 processing, and dispensing of marijuana or marijuana delivery 17 devices, except that a medical marijuana treatment center 18 licensed pursuant to subparagraph (a)1. may contract with a 19 single entity for the cultivation, processing, transporting, and 20 dispensing of marijuana and marijuana delivery devices.

A 21 licensed medical marijuana treatment center must, at all times, 22 maintain compliance with the criteria demonstrated and 23 representations made in the initial application and the criteria 24 established in this subsection. Upon request, the department may 25 grant a medical marijuana treatment center a variance from the 26 representations made in the initial application. Consideration 27 of such a request shall be based upon the individual facts and 28 circumstances surrounding the request. A variance may not be 29

Florida Senate - 2024 SB 1096 31-00855-24 20241096__ Page 2 of 12 CODING: Words stricken are deletions; words underlined are additions. granted unless the requesting medical marijuana treatment center 30 can demonstrate to the department that it has a proposed 31 alternative to the specific representation made in its 32 application which fulfills the same or a similar purpose as the 33 specific representation in a way that the department can 34 reasonably determine will not be a lower standard than the 35 specific representation in the application.

A variance may not 36 be granted from the requirements in subparagraph 2. and 37 subparagraphs (b)1. and 2. 38 1. A licensed medical marijuana treatment center may 39 transfer ownership to an individual or entity who meets the 40 requirements of this section. A publicly traded corporation or 41 publicly traded company that meets the requirements of this 42

section is not precluded from ownership of a medical marijuana 43 treatment center. To accommodate a change in ownership: 44 a. The licensed medical marijuana treatment center shall 45 notify the department in writing at least 60 days before the 46 anticipated date of the change of ownership. 47 b. The individual or entity applying for initial licensure 48 due to a change of ownership must submit an application that 49 must be received by the department at least 60 days before the 50 date of change of ownership. 51 c.

Upon receipt of an application for a license, the 52 department shall examine the application and, within 30 days 53 after receipt, notify the applicant in writing of any apparent 54 errors or omissions and request any additional information 55 required. 56 d. Requested information omitted from an application for 57 licensure must be filed with the department within 21 days after 58

Florida Senate - 2024 SB 1096 31-00855-24 20241096__ Page 3 of 12 CODING: Words stricken are deletions; words underlined are additions. the department’s request for omitted information or the 59 application shall be deemed incomplete and shall be withdrawn 60 from further consideration and the fees shall be forfeited. 61 e. Within 30 days after the receipt of a complete 62 application, the department shall approve or deny the 63 application. 64 2.

A medical marijuana treatment center, and any individual 65 or entity who directly or indirectly owns, controls, or holds 66 with power to vote 5 percent or more of the voting shares of a 67 medical marijuana treatment center, may not acquire direct or 68 indirect ownership or control of any voting shares or other form 69 of ownership of any other medical marijuana treatment center. 70 3.

A medical marijuana treatment center may not enter into 71 any form of profit-sharing arrangement with the property owner 72 or lessor of any of its facilities where cultivation, 73 processing, storing, or dispensing of marijuana and marijuana 74 delivery devices occurs. 75 4. All employees of a medical marijuana treatment center 76 must be 21 years of age or older and have passed a background 77 screening pursuant to subsection (9). 78 5.

Each medical marijuana treatment center must adopt and 79 enforce policies and procedures to ensure employees and 80 volunteers receive training on the legal requirements to 81 dispense marijuana to qualified patients. 82 6. When growing marijuana, a medical marijuana treatment 83 center: 84 a. May use pesticides determined by the department, after 85 consultation with the Department of Agriculture and Consumer 86 Services, to be safely applied to plants intended for human 87

Florida Senate - 2024 SB 1096 31-00855-24 20241096__ Page 4 of 12 CODING: Words stricken are deletions; words underlined are additions. consumption, but may not use pesticides designated as 88 restricted-use pesticides pursuant to s. 487.042. 89 b. Must grow marijuana within an enclosed structure and in 90 a room separate from any other plant. 91 c. Must inspect seeds and growing plants for plant pests 92 that endanger or threaten the horticultural and agricultural 93 interests of the state in accordance with

chapter 581 and any 94 rules adopted thereunder. 95 d. Must perform fumigation or treatment of plants, or 96 remove and destroy infested or infected plants, in accordance 97 with

chapter 581 and any rules adopted thereunder. 98 7. Each medical marijuana treatment center must produce and 99 make available for purchase at least one low-THC cannabis 100 product. 101 8. A medical marijuana treatment center that produces 102 edibles must hold a permit to operate as a food establishment 103 pursuant to

chapter 500, the Florida Food Safety Act, and must 104 comply with all the requirements for food establishments 105 pursuant to

chapter 500 and any rules adopted thereunder. 106 Edibles may not contain more than 200 milligrams of 107 tetrahydrocannabinol, and a single serving portion of an edible 108 may not exceed 10 milligrams of tetrahydrocannabinol. Edibles 109 may have a potency variance of no greater than 15 percent. 110 Marijuana products, including edibles, may not be attractive to 111 children; be manufactured in the shape of humans, cartoons, or 112 animals; be manufactured in a form that bears any reasonable 113 resemblance to products available for consumption as 114 commercially available candy; or contain any color additives. To 115 discourage consumption of edibles by children, the department 116

Florida Senate - 2024 SB 1096 31-00855-24 20241096__ Page 5 of 12 CODING: Words stricken are deletions; words underlined are additions. shall determine by rule any shapes, forms, and ingredients 117 allowed and prohibited for edibles. Medical marijuana treatment 118 centers may not begin processing or dispensing edibles until 119 after the effective date of the rule. The department shall also 120 adopt sanitation rules providing the standards and requirements 121 for the storage, display, or dispensing of edibles. 122 9.

Within 12 months after licensure, a medical marijuana 123 treatment center must demonstrate to the department that all of 124 its processing facilities have passed a Food Safety Good 125 Manufacturing Practices, such as Global Food Safety Initiative 126 or equivalent, inspection by a nationally accredited certifying 127 body. A medical marijuana treatment center must immediately stop 128 processing at any facility which fails to pass this inspection 129 until it demonstrates to the department that such facility has 130 met this requirement. 131 10.

A medical marijuana treatment center that produces 132 prerolled marijuana cigarettes may not use wrapping paper made 133 with tobacco or hemp. 134 11. When processing marijuana, a medical marijuana 135 treatment center must: 136 a. Process the marijuana within an enclosed structure and 137 in a room separate from other plants or products. 138 b. Comply with department rules when processing marijuana 139 with hydrocarbon solvents or other solvents or gases exhibiting 140 potential toxicity to humans.

The department shall determine by 141 rule the requirements for medical marijuana treatment centers to 142 use such solvents or gases exhibiting potential toxicity to 143 humans. 144 c. Comply with federal and state laws and regulations and 145

Florida Senate - 2024 SB 1096 31-00855-24 20241096__ Page 6 of 12 CODING: Words stricken are deletions; words underlined are additions. department rules for solid and liquid wastes. The department 146 shall determine by rule procedures for the storage, handling, 147 transportation, management, and disposal of solid and liquid 148 waste generated during marijuana production and processing. The 149 Department of Environmental Protection shall assist the 150 department in developing such rules. 151 d. Test the processed marijuana using a medical marijuana 152 testing laboratory before it is dispensed.

Results must be 153 verified and signed by two medical marijuana treatment center 154 employees. Before dispensing, the medical marijuana treatment 155 center must determine that the test results indicate that low-156 THC cannabis meets the definition of low-THC cannabis, the 157 concentration of tetrahydrocannabinol meets the potency 158 requirements of this section, the labeling of the concentration 159 of tetrahydrocannabinol and cannabidiol is accurate, and all 160 marijuana is safe for human consumption and free from 161 contaminants that are unsafe for human consumption.

The 162 department shall determine by rule which contaminants must be 163 tested for and the maximum levels of each contaminant which are 164 safe for human consumption. The Department of Agriculture and 165 Consumer Services shall assist the department in developing the 166 testing requirements for contaminants that are unsafe for human 167 consumption in edibles. The department shall also determine by 168 rule the procedures for the treatment of marijuana that fails to 169 meet the testing requirements of this section, s. 381.988, or 170 department rule.

The department may select samples of marijuana 171 from a medical marijuana treatment center facility which shall 172 be tested by the department to determine whether the marijuana 173 meets the potency requirements of this section, is safe for 174

Florida Senate - 2024 SB 1096 31-00855-24 20241096__ Page 7 of 12 CODING: Words stricken are deletions; words underlined are additions. human consumption, and is accurately labeled with the 175 tetrahydrocannabinol and cannabidiol concentration or to verify 176 the result of marijuana testing conducted by a marijuana testing 177 laboratory. The department may also select samples of marijuana 178 delivery devices from a medical marijuana treatment center to 179 determine whether the marijuana delivery device is safe for use 180 by qualified patients.

A medical marijuana treatment center may 181 not require payment from the department for the sample. A 182 medical marijuana treatment center must recall marijuana, 183 including all marijuana and marijuana products made from the 184 same batch of marijuana, that fails to meet the potency 185 requirements of this section, that is unsafe for human 186 consumption, or for which the labeling of the 187 tetrahydrocannabinol and cannabidiol concentration is 188 inaccurate.

The department shall adopt rules to establish 189 marijuana potency variations of no greater than 15 percent using 190 negotiated rulemaking pursuant to s. 120.54(2)(

d) which accounts 191 for, but is not limited to, time lapses between testing, testing 192 methods, testing instruments, and types of marijuana sampled for 193 testing. The department may not issue any recalls for product 194 potency as it relates to product labeling before issuing a rule 195 relating to potency variation standards. A medical marijuana 196 treatment center must also recall all marijuana delivery devices 197 determined to be unsafe for use by qualified patients.

The 198 medical marijuana treatment center must retain records of all 199 testing and samples of each homogenous batch of marijuana for at 200 least 9 months. The medical marijuana treatment center must 201 contract with a marijuana testing laboratory to perform audits 202 on the medical marijuana treatment center’s standard operating 203

Florida Senate - 2024 SB 1096 31-00855-24 20241096__ Page 8 of 12 CODING: Words stricken are deletions; words underlined are additions. procedures, testing records, and samples and provide the results 204 to the department to confirm that the marijuana or low-THC 205 cannabis meets the requirements of this

section and that the 206 marijuana or low-THC cannabis is safe for human consumption. A 207 medical marijuana treatment center shall reserve two processed 208 samples from each batch and retain such samples for at least 9 209 months for the purpose of such audits. A medical marijuana 210 treatment center may use a laboratory that has not been 211 certified by the department under s. 381.988 until such time as 212 at least one laboratory holds the required certification, but in 213 no event later than July 1, 2018. 214 e.

Package the marijuana in compliance with the United 215 States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss. 216 1471 et seq. 217 f. Package the marijuana in a receptacle that has a firmly 218 affixed and legible label stating the following information: 219 (

I) The marijuana or low-THC cannabis meets the 220 requirements of sub-subparagraph d. 221 (II) The name of the medical marijuana treatment center 222 from which the marijuana originates. 223 (III) The batch number and harvest number from which the 224 marijuana originates and the date dispensed. 225 (IV) The name of the physician who issued the physician 226 certification. 227 (

V) The name of the patient. 228 (VI) The product name, if applicable, and dosage form, 229 including concentration of tetrahydrocannabinol and cannabidiol. 230 The product name may not contain wording commonly associated 231 with products that are attractive to children or which promote 232

Florida Senate - 2024 SB 1096 31-00855-24 20241096__ Page 9 of 12 CODING: Words stricken are deletions; words underlined are additions. the recreational use of marijuana. 233 (VII) The recommended dose. 234 (VIII) A warning that it is illegal to transfer medical 235 marijuana to another person. 236 (IX) A marijuana universal symbol developed by the 237 department. 238 12. The medical marijuana treatment center shall include in 239 each package a patient package insert with information on the 240 specific product dispensed related to: 241 a. Clinical pharmacology. 242 b. Indications and use. 243 c.

Dosage and administration. 244 d. Dosage forms and strengths. 245 e. Contraindications. 246 f. Warnings and precautions. 247 g. Adverse reactions. 248 13. In addition to the packaging and labeling requirements 249 specified in subparagraphs 11. and 12., marijuana in a form for 250 smoking must be packaged in a sealed receptacle with a legible 251 and prominent warning to keep away from children and a warning 252 that states marijuana smoke contains carcinogens and may 253 negatively affect health.

Such receptacles for marijuana in a 254 form for smoking must be plain, opaque, and white without 255 depictions of the product or images other than the medical 256 marijuana treatment center’s department-approved logo and the 257 marijuana universal symbol. 258 14. The department shall adopt rules to regulate the types, 259 appearance, and labeling of marijuana delivery devices dispensed 260 from a medical marijuana treatment center. The rules must 261

Florida Senate - 2024 SB 1096 31-00855-24 20241096__ Page 10 of 12 CODING: Words stricken are deletions; words underlined are additions. require marijuana delivery devices to have an appearance 262 consistent with medical use. 263 15. Each edible must be individually sealed in plain, 264 opaque wrapping marked only with the marijuana universal symbol. 265 Where practical, each edible must be marked with the marijuana 266 universal symbol.

In addition to the packaging and labeling 267 requirements in subparagraphs 11. and 12., edible receptacles 268 must be plain, opaque, and white without depictions of the 269 product or images, except that they must include other than the 270 medical marijuana treatment center’s department-approved logo 271 and the marijuana universal symbol.

The receptacle must also 272 include the edible’s identity labeling statement as required by 273 21 C.F.R. s. 101.3; the declaration of net quantity of contents 274 as required by 21 C.F.R. s. 101.105(a), (b), and (c); a list of 275 all the edible’s nutrition facts, allergens, and ingredients;, 276 storage instructions;, an expiration date;, a legible and 277 prominent warning to keep away from children and pets;, and a 278 warning that the edible has not been produced or inspected 279 pursuant to federal food safety laws. 280 16.

When dispensing marijuana or a marijuana delivery 281 device, a medical marijuana treatment center: 282 a. May dispense any active, valid order for low-THC 283 cannabis, medical cannabis and cannabis delivery devices issued 284 pursuant to former s. 381.986, Florida Statutes 2016, which was 285 entered into the medical marijuana use registry before July 1, 286 2017. 287 b. May not dispense more than a 70-day supply of marijuana 288 within any 70-day period to a qualified patient or caregiver. 289 May not dispense more than one 35-day supply of marijuana in a 290

Florida Senate - 2024 SB 1096 31-00855-24 20241096__ Page 11 of 12 CODING: Words stricken are deletions; words underlined are additions. form for smoking within any 35-day period to a qualified patient 291 or caregiver. A 35-day supply of marijuana in a form for smoking 292 may not exceed 2.5 ounces unless an exception to this amount is 293 approved by the department pursuant to paragraph (4)(f). 294 c.

Must have the medical marijuana treatment center’s 295 employee who dispenses the marijuana or a marijuana delivery 296 device enter into the medical marijuana use registry his or her 297 name or unique employee identifier. 298 d.

Must verify that the qualified patient and the 299 caregiver, if applicable, each have an active registration in 300 the medical marijuana use registry and an active and valid 301 medical marijuana use registry identification card, the amount 302 and type of marijuana dispensed matches the physician 303 certification in the medical marijuana use registry for that 304 qualified patient, and the physician certification has not 305 already been filled. 306 e. May not dispense marijuana to a qualified patient who is 307 younger than 18 years of age.

If the qualified patient is 308 younger than 18 years of age, marijuana may only be dispensed to 309 the qualified patient’s caregiver. 310 f. May not dispense or sell any other type of cannabis, 311 alcohol, or illicit drug-related product, including pipes or 312 wrapping papers made with tobacco or hemp, other than a 313 marijuana delivery device required for the medical use of 314 marijuana and which is specified in a physician certification. 315 g.

Must, upon dispensing the marijuana or marijuana 316 delivery device, record in the registry the date, time, 317 quantity, and form of marijuana dispensed; the type of marijuana 318 delivery device dispensed; and the name and medical marijuana 319

Florida Senate - 2024 SB 1096 31-00855-24 20241096__ Page 12 of 12 CODING: Words stricken are deletions; words underlined are additions. use registry identification number of the qualified patient or 320 caregiver to whom the marijuana delivery device was dispensed. 321 h. Must ensure that patient records are not visible to 322 anyone other than the qualified patient, his or her caregiver, 323 and authorized medical marijuana treatment center employees. 324

Section 2. This act shall take effect July 1, 2024. 325