Florida Senate - 2017 COMMITTEE AMENDMENT
Bill No. SB 406
Ì393994\Î393994
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
04/04/2017 .
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The Committee on Health Policy (Bradley) recommended the
following:
1 Senate Amendment (with title amendment)
2
3 Delete lines 616 - 775
4 and insert:
5 2. Have the marijuana tested by an independent testing
6 laboratory to ensure it meets the standards established by the
7 department’s quality control program Test the processed low-THC
8 cannabis and medical cannabis before it is they are dispensed.
9 Results must be verified and signed by two dispensing
10 organization employees. Before dispensing low-THC cannabis, the
11 dispensing organization must determine that the test results
12 indicate that the low-THC cannabis meets the definition of low
13 THC cannabis and, for medical cannabis and low-THC cannabis,
14 that all medical cannabis and low-THC cannabis is safe for human
15 consumption and free from contaminants that are unsafe for human
16 consumption. The dispensing organization must retain records of
17 all testing and samples of each homogenous batch of cannabis and
18 low-THC cannabis for at least 9 months. The dispensing
19 organization must contract with an independent testing
20 laboratory to perform audits on the dispensing organization’s
21 standard operating procedures, testing records, and samples and
22 provide the results to the department to confirm that the low
23 THC cannabis or medical cannabis meets the requirements of this
24 section and that the medical cannabis and low-THC cannabis is
25 safe for human consumption.
26 3. Package the marijuana low-THC cannabis or medical
27 cannabis in compliance with the United States Poison Prevention
28 Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.
29 4. Package the marijuana low-THC cannabis or medical
30 cannabis in a child-proof receptacle that has a firmly affixed
31 and legible label stating the following information:
32 a. A statement that the marijuana low-THC cannabis or
33 medical cannabis meets the requirements of subparagraph 2.;
34 b. The name of the MMTC dispensing organization from which
35 the marijuana medical cannabis or low-THC cannabis originates;
36 and
37 c. The batch number and harvest number from which the
38 marijuana medical cannabis or low-THC cannabis originates; and
39 d. The concentration of tetrahydrocannabinol and
40 cannabidiol in the product.
41 e. Any other information required by department rule
42 5. Reserve two processed samples from each batch and retain
43 such samples for at least 9 months for the purpose of testing
44 pursuant to the audit required under subparagraph 2.
45 (c) When dispensing marijuana low-THC cannabis, medical
46 cannabis, or a marijuana cannabis delivery device, an MMTC a
47 dispensing organization:
48 1. May not dispense more than the a 45-day supply of
49 marijuana authorized by a qualifying patient’s physician
50 certification low-THC cannabis or medical cannabis to a
51 qualifying patient or caregiver the patient’s legal
52 representative.
53 2. Must ensure its have the dispensing organization’s
54 employee who dispenses the marijuana low-THC cannabis, medical
55 cannabis, or marijuana a cannabis delivery device enters enter
56 into the compassionate use registry his or her name or unique
57 employee identifier.
58 3. Must verify that the qualifying patient and the
59 caregiver, if applicable, both have an active and valid
60 compassionate use registry identification card and that the
61 amount and type of marijuana dispensed matches the physician’s
62 certification in the compassionate use registry for that
63 qualifying patient that a physician has ordered the low-THC
64 cannabis, medical cannabis, or a specific type of a cannabis
65 delivery device for the patient.
66 4. Must label the marijuana with the recommended dose for
67 the qualifying patient receiving the marijuana.
68 5.4. May not dispense or sell any other type of marijuana
69 cannabis, alcohol, or illicit drug-related product, including
70 pipes, bongs, or wrapping papers, other than a physician-ordered
71 cannabis delivery device required for the medical use of
72 marijuana that is specified in a physician certification low-THC
73 cannabis or medical cannabis, while dispensing low-THC cannabis
74 or medical cannabis. A registered MMTC may produce and dispense
75 marijuana as an edible or food product but may not produce such
76 items in a format designed to be attractive to children. In
77 addition to the requirements of this section and department
78 rule, food products produced by an MMTC must meet all food
79 safety standards established in state and federal law,
80 including, but not limited to, the identification of the serving
81 size and the amount of THC in each serving.
82 5. Must verify that the patient has an active registration
83 in the compassionate use registry, the patient or patient’s
84 legal representative holds a valid and active registration card,
85 the order presented matches the order contents as recorded in
86 the registry, and the order has not already been filled.
87 6. Must, upon dispensing the marijuana low-THC cannabis,
88 medical cannabis, or marijuana cannabis delivery device, record
89 in the registry the date, time, quantity, and form of marijuana
90 low-THC cannabis or medical cannabis dispensed; and the type of
91 marijuana cannabis delivery device dispensed; and the name and
92 compassionate use registry identification number of the
93 qualifying patient or caregiver to whom the marijuana delivery
94 device was dispensed.
95 (d) To ensure the safety and security of its premises and
96 any off-site storage facilities, and to maintain adequate
97 controls against the diversion, theft, and loss of marijuana
98 low-THC cannabis, medical cannabis, or marijuana cannabis
99 delivery devices, an MMTC a dispensing organization shall:
100 1.a. Maintain a fully operational security alarm system
101 that secures all entry points and perimeter windows and is
102 equipped with motion detectors; pressure switches; and duress,
103 panic, and hold-up alarms; or
104 b. Maintain a video surveillance system that records
105 continuously 24 hours each day and meets at least one of the
106 following criteria:
107 (I) Cameras are fixed in a place that allows for the clear
108 identification of persons and activities in controlled areas of
109 the premises. Controlled areas include grow rooms, processing
110 rooms, storage rooms, disposal rooms or areas, and point-of-sale
111 rooms;
112 (II) Cameras are fixed in entrances and exits to the
113 premises, which shall record from both indoor and outdoor, or
114 ingress and egress, vantage points;
115 (III) Recorded images must clearly and accurately display
116 the time and date; or
117 (IV) Retain video surveillance recordings for a minimum of
118 45 days, or longer upon the request of a law enforcement agency.
119 2. Ensure that the MMTC’s organization’s outdoor premises
120 have sufficient lighting from dusk until dawn.
121 3. Implement Establish and maintain a tracking system using
122 a vendor approved by the department which that traces the
123 marijuana low-THC cannabis or medical cannabis from seed to
124 sale. The tracking system must shall include notification of key
125 events as determined by the department, including when cannabis
126 seeds are planted, when cannabis plants are harvested and
127 destroyed, and when marijuana low-THC cannabis or medical
128 cannabis is transported, sold, stolen, diverted, or lost.
129 4. Not dispense from its premises marijuana low-THC
130 cannabis, medical cannabis, or a cannabis delivery device
131 between the hours of 9 p.m. and 7 a.m., but may perform all
132 other operations and deliver marijuana low-THC cannabis and
133 medical cannabis to qualifying qualified patients 24 hours each
134 day.
135 5. Store marijuana low-THC cannabis or medical cannabis in
136 a secured, locked room or a vault.
137 6. Require at least two of its employees, or two employees
138 of a security agency with whom it contracts, to be on the
139 premises at all times.
140 7. Require each employee or contractor to wear a photo
141 identification badge at all times while on the premises.
142 8. Require each visitor to wear a visitor’s pass at all
143 times while on the premises.
144 9. Implement an alcohol and drug-free workplace policy.
145 10. Report to local law enforcement within 24 hours after
146 it is notified or becomes aware of the theft, diversion, or loss
147 of marijuana low-THC cannabis or medical cannabis.
148 (e) To ensure the safe transport of marijuana low-THC
149 cannabis or medical cannabis to MMTC dispensing organization
150 facilities, independent testing laboratories, or qualifying
151 patients, the MMTC dispensing organization must:
152 1. Maintain a transportation manifest, which must be
153 retained for at least 1 year. A copy of the manifest must be in
154 the vehicle at all times when transporting marijuana.
155 2. Ensure only vehicles in good working order are used to
156 transport marijuana low-THC cannabis or medical cannabis.
157 3. Lock marijuana low-THC cannabis or medical cannabis in a
158 separate compartment or container within the vehicle.
159 4. Require at least two persons to be in a vehicle
160 transporting marijuana low-THC cannabis or medical cannabis, and
161 require at least one person to remain in the vehicle while the
162 marijuana low-THC cannabis or medical cannabis is being
163 delivered.
164 5. Provide specific safety and security training to
165 employees transporting or delivering marijuana low-THC cannabis
166 or medical cannabis.
167 (8) MARIJUANA QUALITY CONTROL PROGRAM AND INDEPENDENT
168 TESTING LABORATORY LICENSURE.—
169 (a) The department shall establish a quality control
170 program requiring marijuana to be tested by an independent
171 testing laboratory for potency and contaminants before sale to
172 qualifying patients and caregivers.
173 1. The quality control program must require MMTCs to submit
174 samples from each batch or lot of marijuana harvested or
175 manufactured to an independent testing laboratory for testing to
176 ensure, at a minimum, that the labeling of the potency of
177 tetrahydrocannabinol and all other marketed cannabinoids or
178 terpenes is accurate and that the medical cannabis dispensed to
179 qualifying patients is safe for human consumption.
180 2. An MMTC must maintain records of all tests conducted,
181 including the results of each test and any additional
182 information, as required by the department.
183 3. The department shall adopt all rules necessary to create
184 and oversee the quality control program, which must include, at
185 a minimum:
186 a. Permissible levels of variation in potency labeling and
187 standards requiring tetrahydrocannabinol in edible marijuana
188 products to be distributed consistently throughout the product;
189 b. Permissible levels of contaminants and mandatory testing
190 for contaminants to confirm that the tested marijuana is safe
191 for human consumption. This testing must include, but is not
192 limited to, testing for microbiological impurity, residual
193 solvents, and pesticide residues;
194 c. The destruction of medical cannabis determined to be
195 inaccurately labeled or unsafe for human consumption after the
196 MMTC has an opportunity to take remedial action;
197 d. The collection, storage, handling, recording, and
198 destruction of samples of marijuana by independent testing
199 laboratories; and
200 e. Security, inventory tracking, and record retention.
201 (b) The department must license all independent testing
202 laboratories to ensure that all marijuana is tested for potency
203 and contaminants in accordance with the department’s quality
204 control program. An independent testing laboratory may collect
205 and accept samples of, and possess, store, transport, and test
206 marijuana. An independent testing laboratory may not be owned by
207 a person who also possesses an ownership interest in an MMTC. A
208 clinical laboratory licensed by the agency pursuant to Part I of
209 chapter 483 and that performs non-waived clinical tests is
210 exempt from the requirement to be licensed by the department
211 pursuant to this paragraph but must be certified to perform all
212 required tests pursuant to subparagraph 2.
213 1. The department shall develop rules establishing
214 independent testing laboratory license requirements and a
215 process for licensing independent testing laboratories; develop
216 an application form for an independent testing laboratory
217 license; and impose an initial application fee and a biennial
218 renewal fee sufficient to cover the costs of administering this
219 subsection.
220 2. In addition to licensure, an independent testing
221 laboratory must be certified to perform all required tests by
222 the department. The department must issue a certification to an
223 independent testing laboratory that has been certified by a
224 third-party laboratory certification body approved by the
225 department. The department shall establish reasonable rules for
226 the certification and operation of independent testing
227 laboratories. Rules for certification must, at a minimum,
228 address standards relating to:
229 a. Personnel qualifications;
230 b. Equipment and methodology;
231 c. Proficiency testing;
232 d. Tracking;
233 e. Sampling;
234 f. Chain of custody;
235 g. Record and sample retention;
236 h. Reporting;
237 i. Audit and inspection; and
238 j. Security.
239 3. The department shall suspend or reduce any mandatory
240 testing requirement specified in its quality control program if
241 the number of licensed and certified independent testing
242 laboratories is insufficient to process the tests necessary to
243 meet the patient demand for MMTCs.
244 4. An independent testing laboratory may accept only
245 samples composed of marijuana which are obtained from a sample
246 source approved by the department. At a minimum, these sources
247 must include an MMTC, a researcher affiliated with an accredited
248 university or research hospital, a qualifying patient, and a
249 caregiver.
250
251 ================= T I T L E A M E N D M E N T ================
252 And the title is amended as follows:
253 Delete line 53
254 and insert:
255 times; requiring the department to establish a quality
256 control program that requires medical marijuana
257 treatment centers to submit samples from each batch or
258 lot of marijuana to an independent testing laboratory;
259 requiring a medical marijuana treatment center to
260 maintain records of all tests conducted; requiring the
261 department to adopt rules to create and oversee the
262 quality control program; providing that the department
263 must license independent testing laboratories;
264 authorizing an independent testing laboratory to
265 collect and accept samples of, possess, store,
266 transport, and test marijuana; prohibiting a person
267 with an ownership interest in a medical marijuana
268 treatment center from owning an independent testing
269 laboratory; requiring the department to develop rules
270 and a process for licensing requirements; authorizing
271 the department to impose application and renewal fees;
272 specifying that an independent testing laboratory must
273 be certified to perform required tests; requiring the
274 department to suspend or reduce any mandatory testing
275 if the number of licensed and certified independent
276 testing laboratories is insufficient to process the
277 tests necessary to meet the patient demand for medical
278 marijuana treatment centers; providing that an
279 independent testing laboratory may only accept certain
280 samples; requiring the department to adopt rules
281 related