Florida Senate - 2014 CS for CS for SB 1030
By the Committees on Appropriations; and Health Policy; and
Senators Bradley, Bean, Brandes, Galvano, Sobel, Soto, Gardiner,
Stargel, and Simpson
576-04518A-14 20141030c2
1 A bill to be entitled
2 An act relating to low-THC cannabis; creating s.
3 456.60, F.S.; defining terms; authorizing specified
4 physicians to order low-THC cannabis for use by
5 specified patients; providing conditions; providing
6 education requirements for physicians; providing
7 duties of the Department of Health; requiring the
8 department to create a compassionate use registry;
9 providing requirements for the registry; requiring the
10 department to authorize a specified number of
11 dispensing organizations; authorizing the department
12 to adopt specified rules; requiring the department to
13 establish the Office of Compassionate Use; providing
14 for inspections of dispensing organizations by the
15 department and law enforcement agencies; providing
16 requirements and duties for a dispensing organization;
17 providing exceptions to specified laws; creating s.
18 385.30, F.S.; encouraging state universities with both
19 medical and agricultural programs to participate in
20 specified Federal Food and Drug Administration
21 approved research directed toward refractory or
22 intractable epilepsy relief in pediatric patients;
23 authorizing participating state universities to
24 annually request a grant from the department;
25 requiring a state university that requests a grant to
26 submit a specified report to the department; providing
27 applicability; creating s. 1004.441, F.S.; authorizing
28 state universities with both medical and agricultural
29 programs to conduct specified research on low-THC
30 cannabis; authorizing the use of current state or
31 privately obtained research funds to support such
32 research; authorizing the department to submit a
33 budget amendment request to use excess funds in the
34 Biomedical Research Trust Fund to implement this act;
35 providing an effective date.
36
37 Be It Enacted by the Legislature of the State of Florida:
38
39 Section 1. Section 456.60, Florida Statutes, is created to
40 read:
41 456.60 Compassionate use of low-THC cannabis.—
42 (1) DEFINITIONS.—As used in this section, the term:
43 (a) “Dispensing organization” means an organization
44 approved by the department to cultivate, process, and dispense
45 low-THC cannabis pursuant to this section.
46 (b) “Low-THC cannabis” means a substance that contains no
47 more than 0.8 percent of any tetrahydrocannabinol and at least
48 10 percent cannabidiol and that is dispensed only from a
49 dispensing organization.
50 (c) “Medical use” means administration of the ordered
51 amount of low-THC cannabis. The term does not include the
52 possession, use, or administration by smoking. The term also
53 does not include the transfer of low-THC cannabis to a person
54 other than the qualified patient for whom it was ordered or the
55 qualified patient’s legal representative on behalf of the
56 qualified patient.
57 (d) “Qualified patient” means a resident of this state who
58 has been added to the compassionate use registry by a physician
59 licensed under chapter 458 or chapter 459 to receive low-THC
60 cannabis from a dispensing organization.
61 (e) “Smoking” means burning or igniting a substance and
62 inhaling the smoke. Smoking does not include the use of a
63 vaporizer.
64 (2) PHYSICIAN ORDERING.—Effective January 1, 2015, a
65 physician licensed under chapter 458 or chapter 459 who has
66 examined and treated a patient suffering from a physical medical
67 condition, or from treatment for a medical condition, which
68 chronically produces symptoms of seizures or severe and
69 persistent muscle spasms may order for the patient’s medical use
70 low-THC cannabis to treat or alleviate such symptoms if all of
71 the following conditions apply:
72 (a) The patient is a permanent resident of this state.
73 (b) The physician has treated the patient for his or her
74 symptoms or a medical condition in which his or her symptoms
75 were present for at least 2 months.
76 (c) The physician determines the risks of ordering low-THC
77 cannabis are reasonable in light of the potential benefit for
78 that patient. If a patient is younger than 18 years of age, a
79 second physician must concur with this determination, and such
80 determination must be documented in the patient’s medical
81 record.
82 (d) The physician registers as the orderer of low-THC
83 cannabis for the named patient on the compassionate use registry
84 maintained by the department and updates the registry to reflect
85 the contents of the order. The physician shall inactivate the
86 patient’s registration when treatment is discontinued.
87 (e) The physician maintains a patient treatment plan that
88 includes the dose, route of administration, planned duration,
89 and monitoring of the patient’s symptoms and other indicators of
90 tolerance or reaction to the low-THC cannabis.
91 (f) The physician submits the patient treatment plan
92 quarterly to the University of Florida College of Pharmacy for
93 research on the safety and efficacy of low-THC cannabis on
94 patients with such symptoms.
95 (3) PHYSICIAN EDUCATION.—Before ordering low-THC cannabis
96 for use by a patient in this state, the appropriate board shall
97 require the ordering physician licensed under chapter 458 or
98 chapter 459 to successfully complete an 8-hour course and
99 subsequent examination offered by the Florida Medical
100 Association which must encompass the clinical indications for
101 the appropriate use of low-THC cannabis, the appropriate
102 delivery mechanisms, the contraindications for such use, as well
103 as the relevant state and federal laws governing the ordering,
104 dispensing, and possessing of such substance. The first course
105 and examination shall be presented by October 1, 2014, and shall
106 be administered at least annually thereafter. Successful
107 completion of the course may be used by a physician to satisfy 8
108 hours of the continuing medical education requirements required
109 by his or her respective board for licensure renewal. The course
110 may be offered in a distance learning format.
111 (4) DUTIES OF THE DEPARTMENT.—
112 (a) By January 1, 2015, the department shall:
113 1. Create a secure, electronic, and online compassionate
114 use registry for the registration of physicians and patients as
115 provided under this section. The registry must be accessible to
116 law enforcement agencies and to a dispensing organization in
117 order to verify patient authorization for low-THC cannabis and
118 record the low-THC cannabis dispensed. The registry must prevent
119 an active registration of a patient by multiple physicians.
120 2. Authorize at least one, but no more than four,
121 dispensing organizations, to ensure reasonable statewide
122 accessibility and availability as necessary for patients
123 registered in the compassionate use registry and who are ordered
124 low-THC cannabis under this section. The department shall
125 develop an application form and impose an initial application
126 and biennial renewal fee that is sufficient to cover the costs
127 of administering this section. An applicant for approval as a
128 dispensing organization must be able to demonstrate:
129 a. The technical and technological ability to cultivate and
130 produce low-THC cannabis.
131 b. The ability to secure the premises, resources, and
132 personnel necessary to operate as a dispensing organization.
133 c. The ability to maintain accountability of all raw
134 materials, finished product, and any byproducts to prevent
135 diversion or unlawful access to or possession of these
136 substances.
137 d. An infrastructure reasonably located to dispense low-THC
138 cannabis to registered patients statewide or regionally as
139 determined by the department.
140 e. The financial ability to maintain operations for the
141 duration of the 2-year approval cycle.
142 f. That all owners, managers, and employees have been
143 fingerprinted and successfully passed background screening
144 pursuant to s. 435.04.
145 3. Implement a process for timely issuing identification
146 cards to patients registered in the compassionate use registry.
147 The identification card expires 1 year after the date issued. A
148 new identification card may be issued to a patient for whom a
149 physician continues registration and treatment with low-THC
150 cannabis.
151 (b) The department shall monitor physician registration and
152 the ordering of low-THC cannabis for ordering practices that
153 could facilitate unlawful diversion or misuse of low-THC
154 cannabis, and take disciplinary action as indicated.
155 (c) The department shall monitor and inspect the activities
156 of each approved dispensing organization for compliance with
157 this section.
158 (d) The department may adopt rules pertaining to:
159 1. The submission of relevant information to the
160 compassionate use registry in order to issue patient
161 identification cards; and
162 2. Recordkeeping requirements to demonstrate compliance
163 with this section, including maintaining records for the
164 production and finished product testing of low-THC cannabis.
165 (e) The department shall establish the Office of
166 Compassionate Use under the direction of the Deputy State Health
167 Officer to administer this section, including access to the
168 compassionate use registry under s. 456.61, and s. 385.30.
169 (5) DISPENSING ORGANIZATION.—
170 (a) An approved dispensing organization shall:
171 1. Maintain compliance with the criteria demonstrated for
172 selection and approval under subparagraph (4)(a)2. as a
173 dispensing organization at all times;
174 2. Maintain and make records available for inspection and
175 desk review by the department and law enforcement agencies; and
176 3. Make all premises, resources, raw materials, finished
177 product, byproducts, and vehicles available for inspection by
178 the department and law enforcement agencies.
179 (b) Before dispensing low-THC cannabis to a qualified
180 patient, the dispensing organization shall verify that the
181 patient has an active registration in the compassionate use
182 registry, the order presented matches the order contents as
183 recorded in the registry, and the order has not already been
184 filled. Upon dispensing the low-THC cannabis, the dispensing
185 organization shall record in the registry the date, time,
186 quantity, and form of low-THC cannabis dispensed.
187 (6) EXCEPTIONS TO OTHER SECTIONS OF LAW.—
188 (a) Notwithstanding any other section of law, but subject
189 to the requirements of this section, a qualified patient and the
190 qualified patient’s legal representative may purchase, acquire,
191 and possess for the patient’s medical use up to the amount of
192 low-THC cannabis ordered to the patient.
193 (b) Notwithstanding any other section of law, but subject
194 to the requirements of this section, an approved dispensing
195 organization and its owners, managers, and employees may
196 acquire, possess, cultivate, and lawfully dispose of excess
197 product in reasonable quantities to produce low-THC cannabis and
198 possess, process, and dispense low-THC cannabis.
199 (c) An approved dispensing organization is not subject to
200 licensure and regulation under chapter 465, and the owners,
201 managers, and employees of a dispensing organization are not
202 subject to licensure and regulation for the practice of pharmacy
203 under chapter 465.
204 Section 2. Section 385.30, Florida Statutes, is created to
205 read:
206 385.30 State university participation in approved studies
207 and clinical treatment plans.—
208 (1) All state universities with both medical and
209 agricultural research programs, including those that have
210 satellite campuses or research agreements with other similar
211 institutions, are encouraged to develop or participate in
212 Federal Food and Drug Administration-approved studies and
213 clinical research treatment plans using low-THC cannabis as
214 defined in s. 456.60 which are directed toward refractory or
215 intractable epilepsy relief in pediatric patients as authorized
216 by s. 1004.441.
217 (2) Each state university that is selected to participate
218 in a Federal Food and Drug Administration-approved study or
219 clinical treatment plan described in subsection (1) may request
220 from the Department of Health a grant of up to $100,000
221 annually.
222 (3) To be eligible for the annual grant, the participating
223 medical college or medical school must submit a report to the
224 Department of Health by January 1 of each year which contains,
225 at a minimum:
226 (a) The gender and age of each patient participating in the
227 study or clinical treatment plan during the calendar year;
228 (b) The names of participating physicians; and
229 (c) The level of seizure reduction in each participating
230 patient during the calendar year.
231 (4) The grant award decisions of the Department of Health
232 pursuant to this section are not subject to chapter 120.
233 Section 3. Section 1004.441, Florida Statutes, is created
234 to read:
235 1004.441 Refractory and intractable epilepsy treatment and
236 research.—Notwithstanding chapter 893, state universities with
237 both medical and agricultural research programs, including those
238 that have satellite campuses or research agreements with other
239 similar institutions, may conduct research on low-THC cannabis
240 as defined in s. 456.60. This research may include, but is not
241 limited to, the agricultural development, production, clinical
242 research, and use of liquid medical derivatives of low-THC
243 cannabis for the treatment for refractory or intractable
244 epilepsy. Current state or privately obtained research funds may
245 be used to support the activities authorized by this section.
246 Section 4. The Department of Health may submit a budget
247 amendment request using excess funds from the Biomedical
248 Research Trust Fund to implement this act during the 2014-2015
249 state fiscal year.
250 Section 5. This act shall take effect July 1, 2014.