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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
A bill to be entitled 1
An act relating to medical marijuana packaging and 2
labeling; amending s. 381.986, F.S.; revising 3
requirements for the packaging and labeling of 4
edibles; providing 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 MARIJUA NA 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 cult ivation, 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
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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
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 requi rements 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
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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
the department's request for omitted information or the 59
application shall be deemed incomplete and shall be withdrawn 60
from further conside ration 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 65
individual or entity who directly or indirectl y owns, controls, 66
or holds with power to vote 5 percent or more of the voting 67
shares of a medical marijuana treatment center, may not acquire 68
direct or indirect ownership or control of any voting shares or 69
other form of ownership of any other medical marij uana treatment 70
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 mar ijuana 75
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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 cen ter must produce 100
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and 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 A ct, 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 manufact ured 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 standa rds 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
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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 law s 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 pr ocessing. The 150
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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 med ical 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 mee ts 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
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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 med ical 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, t ime 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
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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 an d 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 tw o 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
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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 240
in 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
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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 a way 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 260
types, appearance, and labeling of marijuana delivery devices 261
dispensed from a medical marijuana tr eatment center. The rules 262
must 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 and must include other than the medical 271
marijuana treatment center's department -approved logo, and the 272
marijuana universal symbol , the edible's statement of identity 273
as provided in 21 C.F.R. s. 101.3, and the net quantity of 274
contents as provided in 21 C.F.R. s. 101.10 5(a), (b), and (c). 275
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The receptacle must also include a list of all the edible's 276
nutrition facts, allergens, ingredients, storage instructions, 277
an expiration date, a legible and prominent warning to keep away 278
from children and pets, and a warning that the e dible has not 279
been produced or inspected 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 can nabis 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
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 o unces 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 marijuan a 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
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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 307
is 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 cannabi s, 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
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 c enter employees. 324
Section 2. This act shall take effect July 1, 2024. 325