Florida Cannabis Law 2014

 

2         An act relating to cannabis; providing a short title;

3         creating s. 381.986, F.S.; defining terms; authorizing

4         specified physicians to order low-THC cannabis for use

5         by specified patients; providing conditions;

6         prohibiting specified acts by physicians or persons

7         seeking low-THC cannabis; providing criminal

8         penalties; requiring physician education; providing

9         duties of the Department of Health; requiring the

10         department to create a compassionate use registry;

11         providing requirements for the registry; requiring the

12         department to authorize a specified number of

13         dispensing organizations; authorizing rulemaking;

14         providing requirements and duties for a dispensing

15         organization; providing exceptions to specified laws;

16         creating s. 385.211, F.S.; defining the term “low-THC

17         cannabis”; authorizing certain medical centers to

18         conduct research on cannabidiol and low-THC cannabis;

19         authorizing state or privately obtained research funds

20         to be used to support such research; creating s.

21         385.212, F.S.; requiring the department to establish

22         an Office of Compassionate Use; authorizing the office

23         to engage in specified activities; authorizing

24         rulemaking; amending s. 893.02, F.S.; revising the

25         term “cannabis” as used in the Florida Comprehensive

26         Drug Abuse Prevention and Control Act and as

27         applicable to certain criminal offenses proscribing

28         the sale, manufacture, delivery, possession,

29         dispensing, distribution, or purchase of cannabis, to

30         which penalties apply; creating s. 1004.441, F.S.;

31         defining the term “low-THC cannabis”; authorizing

32         state universities with both medical and agricultural

33         research programs to conduct specified research on

34         cannabidiol and low-THC cannabis; authorizing state or

35         privately obtained research funds to be used to

36         support such research; providing an appropriation to

37         the department for research of cannabidiol and its

38         effect on intractable childhood epilepsy; specifying

39         how biomedical research funding for research of

40         cannabidiol and its effect on intractable childhood

41         epilepsy shall be awarded; specifying who may apply

42         for such funding; providing an effective date.

43

44  Be It Enacted by the Legislature of the State of Florida:

45

46         Section 1. This act may be cited as the “Compassionate

47  Medical Cannabis Act of 2014.”

48         Section 2. Section 381.986, Florida Statutes, is created to

49  read:

50         381.986 Compassionate use of low-THC cannabis.—

51         (1) DEFINITIONS.—As used in this section, the term:

52         (a) “Dispensing organization” means an organization

53  approved by the department to cultivate, process, and dispense

54  low-THC cannabis pursuant to this section.

55         (b) “Low-THC cannabis” means a plant of the genus Cannabis,

56  the dried flowers of which contain 0.8 percent or less of

57  tetrahydrocannabinol and more than 10 percent of cannabidiol

58  weight for weight; the seeds thereof; the resin extracted from

59  any part of such plant; or any compound, manufacture, salt,

60  derivative, mixture, or preparation of such plant or its seeds

61  or resin that is dispensed only from a dispensing organization.

62         (c) “Medical use” means administration of the ordered

63  amount of low-THC cannabis. The term does not include the

64  possession, use, or administration by smoking. The term also

65  does not include the transfer of low-THC cannabis to a person

66  other than the qualified patient for whom it was ordered or the

67  qualified patient’s legal representative on behalf of the

68  qualified patient.

69         (d) “Qualified patient” means a resident of this state who

70  has been added to the compassionate use registry by a physician

71  licensed under chapter 458 or chapter 459 to receive low-THC

72  cannabis from a dispensing organization.

73         (e) “Smoking” means burning or igniting a substance and

74  inhaling the smoke. Smoking does not include the use of a

75  vaporizer.

76         (2) PHYSICIAN ORDERING.—Effective January 1, 2015, a

77  physician licensed under chapter 458 or chapter 459 who has

78  examined and is treating a patient suffering from cancer or a

79  physical medical condition that chronically produces symptoms of

80  seizures or severe and persistent muscle spasms may order for

81  the patient’s medical use low-THC cannabis to treat such

82  disease, disorder, or condition or to alleviate symptoms of such

83  disease, disorder, or condition, if no other satisfactory

84  alternative treatment options exist for that patient and all of

85  the following conditions apply:

86         (a) The patient is a permanent resident of this state.

87         (b) The physician determines that the risks of ordering

88  low-THC cannabis are reasonable in light of the potential

89  benefit for that patient. If a patient is younger than 18 years

90  of age, a second physician must concur with this determination,

91  and such determination must be documented in the patient’s

92  medical record.

93         (c) The physician registers as the orderer of low-THC

94  cannabis for the named patient on the compassionate use registry

95  maintained by the department and updates the registry to reflect

96  the contents of the order. The physician shall deactivate the

97  patient’s registration when treatment is discontinued.

98         (d) The physician maintains a patient treatment plan that

99  includes the dose, route of administration, planned duration,

100  and monitoring of the patient’s symptoms and other indicators of

101  tolerance or reaction to the low-THC cannabis.

102         (e) The physician submits the patient treatment plan

103  quarterly to the University of Florida College of Pharmacy for

104  research on the safety and efficacy of low-THC cannabis on

105  patients.

106         (f) The physician obtains the voluntary informed consent of

107  the patient or the patient’s legal guardian to treatment with

108  low-THC cannabis after sufficiently explaining the current state

109  of knowledge in the medical community of the effectiveness of

110  treatment of the patient’s condition with low-THC cannabis, the

111  medically acceptable alternatives, and the potential risks and

112  side effects.

113         (3) PENALTIES.—

114         (a) A physician commits a misdemeanor of the first degree,

115  punishable as provided in s. 775.082 or s. 775.083, if the

116  physician orders low-THC cannabis for a patient without a

117  reasonable belief that the patient is suffering from:

118         1. Cancer or a physical medical condition that chronically

119  produces symptoms of seizures or severe and persistent muscle

120  spasms that can be treated with low-THC cannabis; or

121         2. Symptoms of cancer or a physical medical condition that

122  chronically produces symptoms of seizures or severe and

123  persistent muscle spasms that can be alleviated with low-THC

124  cannabis.

125         (b) Any person who fraudulently represents that he or she

126  has cancer or a physical medical condition that chronically

127  produces symptoms of seizures or severe and persistent muscle

128  spasms to a physician for the purpose of being ordered low-THC

129  cannabis by such physician commits a misdemeanor of the first

130  degree, punishable as provided in s. 775.082 or s. 775.083.

131         (4) PHYSICIAN EDUCATION.—

132         (a) Before ordering low-THC cannabis for use by a patient

133  in this state, the appropriate board shall require the ordering

134  physician licensed under chapter 458 or chapter 459 to

135  successfully complete an 8-hour course and subsequent

136  examination offered by the Florida Medical Association or the

137  Florida Osteopathic Medical Association that encompasses the

138  clinical indications for the appropriate use of low-THC

139  cannabis, the appropriate delivery mechanisms, the

140  contraindications for such use, as well as the relevant state

141  and federal laws governing the ordering, dispensing, and

142  possessing of this substance. The first course and examination

143  shall be presented by October 1, 2014, and shall be administered

144  at least annually thereafter. Successful completion of the

145  course may be used by a physician to satisfy 8 hours of the

146  continuing medical education requirements required by his or her

147  respective board for licensure renewal. This course may be

148  offered in a distance learning format.

149         (b) The appropriate board shall require the medical

150  director of each dispensing organization approved under

151  subsection (5) to successfully complete a 2-hour course and

152  subsequent examination offered by the Florida Medical

153  Association or the Florida Osteopathic Medical Association that

154  encompasses appropriate safety procedures and knowledge of low

155  THC cannabis.

156         (c) Successful completion of the course and examination

157  specified in paragraph (a) is required for every physician who

158  orders low-THC cannabis each time such physician renews his or

159  her license. In addition, successful completion of the course

160  and examination specified in paragraph (b) is required for the

161  medical director of each dispensing organization each time such

162  physician renews his or her license.

163         (d) A physician who fails to comply with this subsection

164  and who orders low-THC cannabis may be subject to disciplinary

165  action under the applicable practice act and under s.

166  456.072(1)(k).

167         (5) DUTIES OF THE DEPARTMENT.—By January 1, 2015, the

168  department shall:

169         (a) Create a secure, electronic, and online compassionate

170  use registry for the registration of physicians and patients as

171  provided under this section. The registry must be accessible to

172  law enforcement agencies and to a dispensing organization in

173  order to verify patient authorization for low-THC cannabis and

174  record the low-THC cannabis dispensed. The registry must prevent

175  an active registration of a patient by multiple physicians.

176         (b) Authorize the establishment of five dispensing

177  organizations to ensure reasonable statewide accessibility and

178  availability as necessary for patients registered in the

179  compassionate use registry and who are ordered low-THC cannabis

180  under this section, one in each of the following regions:

181  northwest Florida, northeast Florida, central Florida, southeast

182  Florida, and southwest Florida. The department shall develop an

183  application form and impose an initial application and biennial

184  renewal fee that is sufficient to cover the costs of

185  administering this section. An applicant for approval as a

186  dispensing organization must be able to demonstrate:

187         1. The technical and technological ability to cultivate and

188  produce low-THC cannabis. The applicant must possess a valid

189  certificate of registration issued by the Department of

190  Agriculture and Consumer Services pursuant to s. 581.131 that is

191  issued for the cultivation of more than 400,000 plants, be

192  operated by a nurseryman as defined in s. 581.011, and have been

193  operated as a registered nursery in this state for at least 30

194  continuous years.

195         2. The ability to secure the premises, resources, and

196  personnel necessary to operate as a dispensing organization.

197         3. The ability to maintain accountability of all raw

198  materials, finished products, and any byproducts to prevent

199  diversion or unlawful access to or possession of these

200  substances.

201         4. An infrastructure reasonably located to dispense low-THC

202  cannabis to registered patients statewide or regionally as

203  determined by the department.

204         5. The financial ability to maintain operations for the

205  duration of the 2-year approval cycle, including the provision

206  of certified financials to the department. Upon approval, the

207  applicant must post a $5 million performance bond.

208         6. That all owners and managers have been fingerprinted and

209  have successfully passed a level 2 background screening pursuant

210  to s. 435.04.

211         7. The employment of a medical director who is a physician

212  licensed under chapter 458 or chapter 459 to supervise the

213  activities of the dispensing organization.

214         (c) Monitor physician registration and ordering of low-THC

215  cannabis for ordering practices that could facilitate unlawful

216  diversion or misuse of low-THC cannabis and take disciplinary

217  action as indicated.

218         (d) Adopt rules necessary to implement this section.

219         (6) DISPENSING ORGANIZATION.—An approved dispensing

220  organization shall maintain compliance with the criteria

221  demonstrated for selection and approval as a dispensing

222  organization under subsection (5) at all times. Before

223  dispensing low-THC cannabis to a qualified patient, the

224  dispensing organization shall verify that the patient has an

225  active registration in the compassionate use registry, the order

226  presented matches the order contents as recorded in the

227  registry, and the order has not already been filled. Upon

228  dispensing the low-THC cannabis, the dispensing organization

229  shall record in the registry the date, time, quantity, and form

230  of low-THC cannabis dispensed.

231         (7) EXCEPTIONS TO OTHER LAWS.—

232         (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or

233  any other provision of law, but subject to the requirements of

234  this section, a qualified patient and the qualified patient’s

235  legal representative may purchase and possess for the patient’s

236  medical use up to the amount of low-THC cannabis ordered for the

237  patient.

238         (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or

239  any other provision of law, but subject to the requirements of

240  this section, an approved dispensing organization and its

241  owners, managers, and employees may manufacture, possess, sell,

242  deliver, distribute, dispense, and lawfully dispose of

243  reasonable quantities, as established by department rule, of

244  low-THC cannabis. For purposes of this subsection, the terms

245  “manufacture,” “possession,” “deliver,” “distribute,” and

246  “dispense” have the same meanings as provided in s. 893.02.

247         (c) An approved dispensing organization and its owners,

248  managers, and employees are not subject to licensure or

249  regulation under chapter 465 for manufacturing, possessing,

250  selling, delivering, distributing, dispensing, or lawfully

251  disposing of reasonable quantities, as established by department

252  rule, of low-THC cannabis.

253         Section 3. Section 385.211, Florida Statutes, is created to

254  read:

255         385.211 Refractory and intractable epilepsy treatment and

256  research at recognized medical centers.—

257         (1) As used in this section, the term “low-THC cannabis”

258  means “low-THC cannabis” as defined in s. 381.986 that is

259  dispensed only from a dispensing organization as defined in s.

260  381.986.

261         (2) Notwithstanding chapter 893, medical centers recognized

262  pursuant to s. 381.925 may conduct research on cannabidiol and

263  low-THC cannabis. This research may include, but is not limited

264  to, the agricultural development, production, clinical research,

265  and use of liquid medical derivatives of cannabidiol and low-THC

266  cannabis for the treatment for refractory or intractable

267  epilepsy. The authority for recognized medical centers to

268  conduct this research is derived from 21 C.F.R. parts 312 and

269  316. Current state or privately obtained research funds may be

270  used to support the activities described in this section.

271         Section 4. Section 385.212, Florida Statutes, is created to

272  read:

273         385.212 Powers and duties of the Department of Health;

274  Office of Compassionate Use.—

275         (1) The Department of Health shall establish an Office of

276  Compassionate Use under the direction of the Deputy State Health

277  Officer.

278         (2) The Office of Compassionate Use may enhance access to

279  investigational new drugs for Florida patients through approved

280  clinical treatment plans or studies. The Office of Compassionate

281  Use may:

282         (a) Create a network of state universities and medical

283  centers recognized pursuant to s. 381.925.

284         (b) Make any necessary application to the United States

285  Food and Drug Administration or a pharmaceutical manufacturer to

286  facilitate enhanced access to compassionate use for Florida

287  patients.

288         (c) Enter into any agreements necessary to facilitate

289  enhanced access to compassionate use for Florida patients.

290         (3) The department may adopt rules necessary to implement

291  this section.

292         Section 5. Subsection (3) of section 893.02, Florida

293  Statutes, is amended to read:

294         893.02 Definitions.—The following words and phrases as used

295  in this chapter shall have the following meanings, unless the

296  context otherwise requires:

297         (3) “Cannabis” means all parts of any plant of the genus

298  Cannabis, whether growing or not; the seeds thereof; the resin

299  extracted from any part of the plant; and every compound,

300  manufacture, salt, derivative, mixture, or preparation of the

301  plant or its seeds or resin. The term does not include “low-THC

302  cannabis,” as defined in s. 381.986, if manufactured, possessed,

303  sold, purchased, delivered, distributed, or dispensed, in

304  conformance with s. 381.986.

305         Section 6. Section 1004.441, Florida Statutes, is created

306  to read:

307         1004.441 Refractory and intractable epilepsy treatment and

308  research.—

309         (1) As used in this section, the term “low-THC cannabis”

310  means “low-THC cannabis” as defined in s. 381.986 that is

311  dispensed only from a dispensing organization as defined in s.

312  381.986.

313         (2) Notwithstanding chapter 893, state universities with

314  both medical and agricultural research programs, including those

315  that have satellite campuses or research agreements with other

316  similar institutions, may conduct research on cannabidiol and

317  low-THC cannabis. This research may include, but is not limited

318  to, the agricultural development, production, clinical research,

319  and use of liquid medical derivatives of cannabidiol and low-THC

320  cannabis for the treatment for refractory or intractable

321  epilepsy. The authority for state universities to conduct this

322  research is derived from 21 C.F.R. parts 312 and 316. Current

323  state or privately obtained research funds may be used to

324  support the activities authorized by this section.

325         Section 7. (1) As used in this section, the term

326  “cannabidiol” means an extract from the cannabis plant that has

327  less than 0.8 percent tetrahydrocannabinol and the chemical

328  signature 2-[(1R,6R)-6-isopropenyl-3-methylcyclohex-2-en-1-yl]

329  5-pentylbenzene-1,3-diol, or a derivative thereof, as determined

330  by the International Union of Pure and Applied Chemistry.

331         (2) For the 2014-2015 fiscal year, $1 million in

332  nonrecurring general revenue is appropriated to the Department

333  of Health for the James and Esther King Biomedical Research

334  Program and shall be deposited into the Biomedical Research

335  Trust Fund. These funds shall be reserved for research of

336  cannabidiol and its effect on intractable childhood epilepsy.

337         (3) Biomedical research funding for research of cannabidiol

338  and its effect on intractable childhood epilepsy shall be

339  awarded pursuant to s. 215.5602, Florida Statutes. An

340  application for such funding may be submitted by any research

341  university in the state that has obtained approval from the

342  United States Food and Drug Administration for an exploratory

343  investigational new drug study of cannabidiol and its effect on

344  intractable childhood epilepsy. For purposes of this section,

345  the Biomedical Research Advisory Council created under s.

346  215.5602, Florida Statutes, shall advise the State Surgeon

347  General as to the direction and scope of research of cannabidiol

348  and its effect on intractable childhood epilepsy and the award

349  of research funding.

350         Section 8. This act shall take effect upon becoming a law.

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