Florida Senate - 2022 SB 1268



By Senator Gruters





23-01424-22 20221268__
1 A bill to be entitled
2 An act relating to cannabis regulation; amending s.
3 381.986, F.S.; revising the course and examination
4 requirements for qualified physicians and medical
5 directors; prohibiting qualified physicians from
6 engaging in certain advertising for their practices
7 relating to marijuana for medical use; providing
8 exceptions; authorizing qualified physicians to use
9 telehealth to perform patient examinations for
10 renewals of physician certifications for the medical
11 use of marijuana under certain circumstances;
12 requiring qualified physicians to conduct an initial
13 physical examination in person for certain existing
14 qualified patients before using telehealth to conduct
15 any examinations; revising the frequency with which
16 qualified physicians must evaluate existing qualified
17 patients for a physician certification for the medical
18 use of marijuana; revising the membership of the
19 physician certification pattern review panel; revising
20 the data that the panel is required to track and
21 report; revising the frequency with which medical
22 marijuana use registry identification cards must be
23 renewed; prohibiting the Department of Health from
24 renewing the license of a medical marijuana treatment
25 center under certain circumstances; prohibiting
26 medical marijuana treatment centers and certain
27 individuals and entities from employing qualified
28 physicians or having direct or indirect economic
29 interests in qualified physician practices and medical
30 marijuana testing laboratories; authorizing the
31 department to sample marijuana, rather than only
32 edibles, from dispensing facilities for specified
33 purposes; authorizing the department to sample
34 marijuana delivery devices from dispensing facilities
35 to determine that they are safe for patient use;
36 requiring that a medical marijuana treatment center
37 recall all marijuana, rather than only edibles, under
38 certain circumstances; revising advertising
39 requirements for medical marijuana treatment centers
40 to prohibit radio and television advertising; creating
41 the Medical Marijuana Testing Advisory Council adjunct
42 to the department for a specified purpose; requiring
43 the advisory council to operate in a specified manner;
44 requiring the department to provide staff and
45 administrative support for the advisory council;
46 providing for membership and meetings of the advisory
47 council; requiring the advisory council to submit an
48 annual report to the Governor and Legislature by a
49 specified date; providing requirements for the report;
50 requiring the department to post the report on its
51 website; authorizing the department and certain
52 employees to acquire, possess, test, transport, and
53 lawfully dispose of marijuana and marijuana delivery
54 devices; amending s. 381.988, F.S.; prohibiting
55 certified medical marijuana testing laboratories and
56 specified individuals from having economic interest in
57 or financial relationships with medical marijuana
58 treatment centers; providing construction; authorizing
59 the department and certain employees to acquire,
60 possess, test, transport, and lawfully dispose of
61 marijuana; amending s. 456.47, F.S.; authorizing
62 telehealth providers to use telehealth to treat and
63 evaluate existing qualified patients for the medical
64 use of marijuana; amending s. 581.217, F.S.; providing
65 and revising definitions; requiring hemp extract and
66 hemp extract products distributed in this state to be
67 registered with the Department of Agriculture and
68 Consumer Services; providing requirements for
69 registration certificates; providing that an applicant
70 who registers a hemp extract or hemp extract product
71 assumes full responsibility for the registration,
72 quality, and quantity of the extract or product
73 manufactured and distributed in this state; providing
74 for the expiration and renewal of such certificates;
75 providing application requirements; authorizing the
76 department to analyze samples of hemp extracts or hemp
77 extract products and inspect their labels to ensure
78 compliance with specified requirements; requiring the
79 department to deny registration certificate
80 applications under certain circumstances; prohibiting
81 the sale of hemp extract and hemp extract products
82 intended for ingestion to persons younger than 21
83 years of age; authorizing the department to make
84 certain determinations related to public health,
85 safety, and welfare; requiring the department to issue
86 immediate final orders regarding unregistered hemp
87 extracts and hemp extract products under certain
88 circumstances; authorizing the department to issue and
89 enforce stop-sale orders and revoke or suspend the
90 registration of any hemp extract or hemp extract
91 product under certain circumstances; authorizing the
92 department to impose a specified administrative fine
93 under certain circumstances; reenacting ss. 893.02(3),
94 916.1085(1)(a), 944.47(1)(a), 951.22(1)(h), and
95 985.711(1)(a), F.S., to incorporate the amendment made
96 to s. 581.217, F.S., in references thereto; providing
97 an effective date.
98
99 Be It Enacted by the Legislature of the State of Florida:
100
101 Section 1. Present paragraph (c) of subsection (3) of
102 section 381.986, Florida Statutes, is redesignated as paragraph
103 (d), present subsections (14) through (17) are redesignated as
104 subsections (15) through (18), respectively, a new paragraph (c)
105 is added to subsection (3), a new subsection (14) is added to
106 that section, and paragraph (i) is added to present subsection
107 (14), and paragraph (a) and present paragraph (c) of subsection
108 (3), paragraphs (a), (g), and (j) of subsection (4), paragraph
109 (a) of subsection (7), and paragraphs (b), (e), and (h) of
110 subsection (8) of that section are amended, to read:
111 381.986 Medical use of marijuana.—
112 (3) QUALIFIED PHYSICIANS AND MEDICAL DIRECTORS.—
113 (a) Before being approved as a qualified physician, as
114 defined in paragraph (1)(m), and before each license renewal, a
115 physician must successfully complete a 6-hour 2-hour course and
116 subsequent examination offered by the Florida Medical
117 Association or the Florida Osteopathic Medical Association which
118 address the potential health and safety risks and benefits of,
119 and the appropriate dosages for, prescribing marijuana for
120 medical use and encompass the requirements of this section and
121 any rules adopted hereunder. The course and examination shall be
122 administered at least annually and may be offered in a distance
123 learning format, including an electronic, online format that is
124 available upon request. The price of the course may not exceed
125 $500. A physician who has met the physician education
126 requirements of former s. 381.986(4), Florida Statutes 2016,
127 before June 23, 2017, shall be deemed to be in compliance with
128 this paragraph from June 23, 2017, until 90 days after the
129 course and examination required by this paragraph become
130 available.
131 (c) With respect to his or her practice relating to
132 marijuana for medical use under this section, a qualified
133 physician may not engage in radio or television advertising or
134 advertising that is visible to members of the public from any
135 street, sidewalk, park, or other public place, except:
136 1. The qualified physician’s practice may have a sign that
137 is affixed to the outside or hanging in the window of the
138 premises which identifies the qualified physician, a department
139 approved practice name, or a department-approved logo. A
140 qualified physician’s practice name and logo may not contain
141 wording or images commonly associated with marketing targeted
142 toward children or which promote the recreational use of
143 marijuana.
144 2. A qualified physician may engage in Internet advertising
145 and marketing for his or her practice under the following
146 conditions:
147 a. All advertisements must be approved by the department.
148 b. An advertisement may not have any content that
149 specifically targets individuals under the age of 18, including
150 cartoon characters or similar images.
151 c. An advertisement may not be an unsolicited pop-up
152 advertisement.
153 d. Opt-in marketing must include an easy and permanent opt
154 out feature.
155 (d)(c) Before being employed as a medical director, as
156 defined in paragraph (1)(i), and before each license renewal, a
157 medical director must successfully complete a 6-hour 2-hour
158 course and subsequent examination offered by the Florida Medical
159 Association or the Florida Osteopathic Medical Association which
160 address the potential health and safety risks and benefits of,
161 and the appropriate dosages for, prescribing marijuana for
162 medical use and encompass the requirements of this section and
163 any rules adopted hereunder. The course and examination shall be
164 administered at least annually and may be offered in a distance
165 learning format, including an electronic, online format that is
166 available upon request. The price of the course may not exceed
167 $500.
168 (4) PHYSICIAN CERTIFICATION.—
169 (a) A qualified physician may issue a physician
170 certification only if the qualified physician:
171 1. Conducted an a physical examination of while physically
172 present in the same room as the patient and a full assessment of
173 the medical history of the patient. For an initial
174 certification, the examination must be a physical examination
175 conducted while physically present in the same room as the
176 patient. For a certification renewal, the examination may be
177 conducted through telehealth under s. 456.47 only if such
178 examination is conducted by the same qualified physician who
179 conducted the examination for initial certification. If a
180 patient changes his or her qualified physician, the new
181 qualified physician must conduct an initial physical examination
182 of the patient while physically present in the same room before
183 conducting any examination through telehealth.
184 2. Diagnosed the patient with at least one qualifying
185 medical condition.
186 3. Determined that the medical use of marijuana would
187 likely outweigh the potential health risks for the patient, and
188 such determination must be documented in the patient’s medical
189 record. If a patient is younger than 18 years of age, a second
190 physician must concur with this determination, and such
191 concurrence must be documented in the patient’s medical record.
192 4. Determined whether the patient is pregnant and
193 documented such determination in the patient’s medical record. A
194 physician may not issue a physician certification, except for
195 low-THC cannabis, to a patient who is pregnant.
196 5. Reviewed the patient’s controlled drug prescription
197 history in the prescription drug monitoring program database
198 established pursuant to s. 893.055.
199 6. Reviews the medical marijuana use registry and confirmed
200 that the patient does not have an active physician certification
201 from another qualified physician.
202 7. Registers as the issuer of the physician certification
203 for the named qualified patient on the medical marijuana use
204 registry in an electronic manner determined by the department,
205 and:
206 a. Enters into the registry the contents of the physician
207 certification, including the patient’s qualifying condition and
208 the dosage not to exceed the daily dose amount determined by the
209 department, the amount and forms of marijuana authorized for the
210 patient, and any types of marijuana delivery devices needed by
211 the patient for the medical use of marijuana.
212 b. Updates the registry within 7 days after any change is
213 made to the original physician certification to reflect such
214 change.
215 c. Deactivates the registration of the qualified patient
216 and the patient’s caregiver when the physician no longer
217 recommends the medical use of marijuana for the patient.
218 8. Obtains the voluntary and informed written consent of
219 the patient for medical use of marijuana each time the qualified
220 physician issues a physician certification for the patient,
221 which shall be maintained in the patient’s medical record. The
222 patient, or the patient’s parent or legal guardian if the
223 patient is a minor, must sign the informed consent acknowledging
224 that the qualified physician has sufficiently explained its
225 content. The qualified physician must use a standardized
226 informed consent form adopted in rule by the Board of Medicine
227 and the Board of Osteopathic Medicine, which must include, at a
228 minimum, information related to:
229 a. The Federal Government’s classification of marijuana as
230 a Schedule I controlled substance.
231 b. The approval and oversight status of marijuana by the
232 Food and Drug Administration.
233 c. The current state of research on the efficacy of
234 marijuana to treat the qualifying conditions set forth in this
235 section.
236 d. The potential for addiction.
237 e. The potential effect that marijuana may have on a
238 patient’s coordination, motor skills, and cognition, including a
239 warning against operating heavy machinery, operating a motor
240 vehicle, or engaging in activities that require a person to be
241 alert or respond quickly.
242 f. The potential side effects of marijuana use, including
243 the negative health risks associated with smoking marijuana.
244 g. The risks, benefits, and drug interactions of marijuana.
245 h. That the patient’s de-identified health information
246 contained in the physician certification and medical marijuana
247 use registry may be used for research purposes.
248 (g) A qualified physician must evaluate an existing
249 qualified patient at least once every 34 30 weeks before issuing
250 a new physician certification. The evaluation may be conducted
251 through telehealth as defined in s. 456.47. A physician must:
252 1. Determine if the patient still meets the requirements to
253 be issued a physician certification under paragraph (a).
254 2. Identify and document in the qualified patient’s medical
255 records whether the qualified patient experienced either of the
256 following related to the medical use of marijuana:
257 a. An adverse drug interaction with any prescription or
258 nonprescription medication; or
259 b. A reduction in the use of, or dependence on, other types
260 of controlled substances as defined in s. 893.02.
261 3. Submit a report with the findings required pursuant to
262 subparagraph 2. to the department. The department shall submit
263 such reports to the Consortium for Medical Marijuana Clinical
264 Outcomes Research established pursuant to s. 1004.4351.
265 (j) The Board of Medicine and the Board of Osteopathic
266 Medicine shall jointly create a physician certification pattern
267 review panel that shall review all physician certifications
268 submitted to the medical marijuana use registry and consists of
269 at least one member who is a qualified physician. The panel
270 shall track and report the number of physician certifications
271 and the qualifying medical conditions, dosage, supply amount,
272 total milligrams dispensed for each qualified patient under each
273 qualified physician’s care, and form of marijuana certified. The
274 panel shall report the data both by individual qualified
275 physician, including his or her specialty and type of practice,
276 and in the aggregate, by county, and statewide. The physician
277 certification pattern review panel shall, beginning January 1,
278 2018, submit an annual report of its findings and
279 recommendations to the Governor, the President of the Senate,
280 and the Speaker of the House of Representatives.
281