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.
   37  Be It Enacted by the Legislature of the State of Florida:
   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.
  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.
  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.