Florida Senate - 2014                        COMMITTEE AMENDMENT
       Bill No. CS for SB 1030
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  04/23/2014           .                                

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