Bill Text: FL S1030 | 2014 | Regular Session | Engrossed

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Cannabis

Spectrum: Slight Partisan Bill (Republican 7-2-2)

Status: (Passed) 2014-06-17 - Chapter No. 2014-157, companion bill(s) passed, see SB 1700 (Ch. 2014-158) [S1030 Detail]

Download: Florida-2014-S1030-Engrossed.html

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       CS for CS for SB 1030                            First Engrossed
       
       
       
       
       
       
       
       
       20141030e1
       
    1                        A bill to be entitled                      
    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.