Florida Senate - 2015                   (Proposed Bill) SPB 7066
       
       
        
       FOR CONSIDERATION By the Committee on Regulated Industries
       
       
       
       
       
       580-02582A-15                                         20157066pb
    1                        A bill to be entitled                      
    2         An act relating to low-THC cannabis; amending s.
    3         381.986, F.S.; defining terms; revising the illnesses
    4         and symptoms for which a physician may order a patient
    5         the medical use of low-THC cannabis in certain
    6         circumstances; providing that a physician who
    7         improperly orders low-THC cannabis is subject to
    8         specified disciplinary action; revising the duties of
    9         the Department of Health; requiring the department to
   10         create a secure, electronic, and online compassionate
   11         use registry; requiring the department to begin to
   12         accept applications for licensure as a dispensing
   13         organization according to a specified application
   14         process; requiring the department to review all
   15         applications, notify applicants of deficient
   16         applications, and request any additional information
   17         within a specified period; requiring an application
   18         for licensure to be filed and complete by specified
   19         dates; providing for a lottery for licensure as a
   20         dispensing organization in certain circumstances;
   21         authorizing the department to issue additional
   22         licenses to qualified applicants in certain
   23         circumstances; providing an exemption for the
   24         application process; requiring the department to use
   25         an application form that requires specified
   26         information from the applicant; requiring the
   27         department to impose specified application fees;
   28         requiring the department to inspect each dispensing
   29         organization’s properties, cultivation facilities,
   30         processing facilities, and retail facilities before
   31         those facilities may operate; authorizing followup
   32         inspections at reasonable hours; providing that
   33         licensure constitutes permission for the department to
   34         enter and inspect the premises and facilities of any
   35         dispensing organization; authorizing the department to
   36         inspect any licensed dispensing organization;
   37         requiring dispensing organizations to make all
   38         facility premises, equipment, documents, low-THC
   39         cannabis, and low-THC cannabis products available to
   40         the department upon inspection; authorizing the
   41         department to test low-THC cannabis or low-THC
   42         cannabis products; authorizing the department to
   43         suspend or revoke a license, deny or refuse to renew a
   44         license, or impose a maximum administrative penalty
   45         for specified acts or omissions; requiring the
   46         department to create a permitting process for vehicles
   47         used for the transportation of low-THC cannabis or
   48         low-THC cannabis products; authorizing the department
   49         to adopt rules as necessary for implementation of
   50         specified provisions and procedures, and to provide
   51         specified guidance; providing procedures and
   52         requirements for an applicant seeking licensure as a
   53         dispensing organization or the renewal of its license;
   54         requiring the dispensing organization to verify
   55         specified information of specified persons in certain
   56         circumstances; authorizing a dispensing organization
   57         to have cultivation facilities, processing facilities,
   58         and retail facilities; requiring a dispensing
   59         organization to provide the department with specified
   60         updated information within a specified period;
   61         authorizing a dispensing organization to transport
   62         low-THC cannabis or low-THC cannabis products in
   63         vehicles in certain circumstances; requiring such
   64         vehicles to be operated by specified persons in
   65         certain circumstances; requiring a fee for a vehicle
   66         permit; requiring the signature of the designated
   67         driver with a vehicle permit application; providing
   68         for expiration of the permit in certain circumstances;
   69         requiring the department to cancel a vehicle permit
   70         upon the request of specified persons; providing that
   71         the licensee authorizes the inspection and search of
   72         his or her vehicle without a search warrant by
   73         specified persons; requiring all low-THC cannabis and
   74         low-THC cannabis products to be tested by an
   75         independent testing laboratory before the dispensing
   76         organization may dispense it; requiring the
   77         independent testing laboratory to provide the lab
   78         results to the dispensing organization for a specified
   79         determination; requiring all low-THC cannabis and low
   80         THC cannabis products to be labeled with specified
   81         information before dispensing; requiring the
   82         University of Florida College of Pharmacy to establish
   83         and maintain a specified safety and efficacy research
   84         program; providing program requirements; requiring the
   85         department to provide information from the
   86         prescription drug monitoring program to the University
   87         of Florida as needed; requiring the Agency for Health
   88         Care Administration to provide access to specified
   89         patient records under certain circumstances;
   90         authorizing specified individuals to manufacture,
   91         possess, sell, deliver, distribute, dispense, and
   92         lawfully dispose of reasonable quantities of low-THC
   93         cannabis; authorizing a licensed laboratory and its
   94         employees to receive and possess low-THC cannabis in
   95         certain circumstances; providing that specified rules
   96         adopted by the department are exempt from the
   97         requirement to be ratified by the Legislature;
   98         amending s. 381.987, F.S.; requiring the department to
   99         allow specified persons engaged in research to access
  100         the compassionate use registry; amending s. 893.055,
  101         F.S.; providing that persons engaged in research at
  102         the University of Florida shall have access to
  103         specified information; amending s. 893.0551, F.S.;
  104         providing a specified public records exemption for
  105         persons engaged in research at the University of
  106         Florida; providing an effective date.
  107          
  108  Be It Enacted by the Legislature of the State of Florida:
  109  
  110         Section 1. Section 381.986, Florida Statutes, is amended to
  111  read:
  112         381.986 Compassionate use of low-THC cannabis.—
  113         (1) DEFINITIONS.—As used in this section, the term:
  114         (a) “Applicant” means a person that has submitted an
  115  application to the department for licensure or renewal as a
  116  dispensing organization.
  117         (b) “Batch” means a specific quantity of low-THC cannabis
  118  product that is intended to have uniform character and quality,
  119  within specified limits, and is produced at the same time from
  120  one or more harvests.
  121         (c) “Dispensing organization” means an applicant licensed
  122  organization approved by the department to cultivate, process,
  123  and dispense low-THC cannabis pursuant to this section.
  124         (d) “Harvest” means a specifically identified and numbered
  125  quantity of low-THC cannabis cultivated using the same
  126  herbicides, pesticides, and fungicides and harvested at the same
  127  time from a single facility.
  128         (e)(b) “Low-THC cannabis” means a plant of the genus
  129  Cannabis, the dried flowers of which contain 0.8 percent or less
  130  of tetrahydrocannabinol and more than 10 percent of cannabidiol
  131  weight for weight; the seeds thereof; the resin extracted from
  132  any part of such plant; or any compound, manufacture, salt,
  133  derivative, mixture, or preparation of such plant or its seeds
  134  or resin that is dispensed only from a dispensing organization.
  135         (f) “Low-THC cannabis product” means any product derived
  136  from low-THC cannabis, including the resin extracted from any
  137  part of such plant or any compound, manufacture, salt,
  138  derivative, mixture, or preparation of such plant or its seeds
  139  or resin which is dispensed from a dispensing organization. Low
  140  THC cannabis products include, but are not limited to, oils,
  141  tinctures, creams, encapsulations, and food products. All low
  142  THC cannabis products must maintain concentrations, weight for
  143  weight, of 0.8 percent or less of tetrahydrocannabinol and more
  144  than 10 percent of cannabidiol.
  145         (g)(c) “Medical use” means administration of the ordered
  146  amount of low-THC cannabis. The term does not include:
  147         1. The possession, use, or administration by smoking;.
  148         2.The term also does not include The transfer of low-THC
  149  cannabis to a person other than the qualified patient for whom
  150  it was ordered or the qualified patient’s legal representative
  151  who is registered in the compassionate use registry on behalf of
  152  the qualified patient; or.
  153         3. The use or administration of medical-grade marijuana:
  154         a. On any form of public transportation.
  155         b. In any public place.
  156         c. In a registered qualified patient’s place of work, if
  157  restricted by his or her employer.
  158         d. In a correctional facility.
  159         e. On the grounds of any preschool, primary school, or
  160  secondary school.
  161         f. On a school bus.
  162         (h)(d) “Qualified patient” means a resident of this state
  163  who has been added to the compassionate use registry by a
  164  physician licensed under chapter 458 or chapter 459 to receive
  165  low-THC cannabis from a dispensing organization.
  166         (i)(e) “Smoking” means burning or igniting a substance and
  167  inhaling the smoke. Smoking does not include the use of a
  168  vaporizer.
  169         (2) PHYSICIAN ORDERING.—
  170         (a)Effective January 1, 2015, A physician licensed under
  171  chapter 458 or chapter 459 who has examined and is treating a
  172  patient suffering from cancer, human immunodeficiency virus,
  173  acquired immune deficiency syndrome, epilepsy, amyotrophic
  174  lateral sclerosis, multiple sclerosis, Crohn’s disease,
  175  Parkinson’s disease, paraplegia, quadriplegia, or terminal
  176  illness a physical medical condition that chronically produces
  177  symptoms of seizures or severe and persistent muscle spasms may
  178  order for the patient’s medical use low-THC cannabis to treat
  179  such disease, disorder, or condition; or to alleviate symptoms
  180  of such disease, disorder, or condition;, or to alleviate
  181  symptoms caused by a treatment for such disease, disorder, or
  182  condition if no other satisfactory alternative treatment options
  183  exist for that patient and all of the following conditions
  184  apply:
  185         1.(a) The patient is a permanent resident of this state.
  186         2.(b) The physician determines that the risks of ordering
  187  low-THC cannabis are reasonable in light of the potential
  188  benefit for that patient. If a patient is younger than 18 years
  189  of age, a second physician must concur with this determination,
  190  and such determination must be documented in the patient’s
  191  medical record.
  192         3.(c) The physician registers the patient, the patient’s
  193  legal representative if requested by the patient, and himself or
  194  herself as the orderer of low-THC cannabis for the named patient
  195  on the compassionate use registry maintained by the department
  196  and updates the registry to reflect the contents of the order.
  197  If the patient is a minor, the physician must register a legal
  198  representative on the compassionate use registry. The physician
  199  shall deactivate the patient’s registration when treatment is
  200  discontinued.
  201         4.(d) The physician maintains a patient treatment plan that
  202  includes the dose, route of administration, planned duration,
  203  and monitoring of the patient’s symptoms and other indicators of
  204  tolerance or reaction to the low-THC cannabis.
  205         5.(e) The physician submits the patient treatment plan, as
  206  well as any other requested medical records, quarterly to the
  207  University of Florida College of Pharmacy for research on the
  208  safety and efficacy of low-THC cannabis on patients pursuant to
  209  subsection (8).
  210         6.(f) The physician obtains the voluntary informed consent
  211  of the patient or the patient’s legal guardian to treatment with
  212  low-THC cannabis after sufficiently explaining the current state
  213  of knowledge in the medical community of the effectiveness of
  214  treatment of the patient’s conditions or symptoms condition with
  215  low-THC cannabis, the medically acceptable alternatives, and the
  216  potential risks and side effects.
  217         (b)A physician who improperly orders low-THC cannabis is
  218  subject to disciplinary action under the applicable practice act
  219  and under s. 456.072(1)(k).
  220         (3) PENALTIES.—
  221         (a) A physician commits a misdemeanor of the first degree,
  222  punishable as provided in s. 775.082 or s. 775.083, if the
  223  physician orders low-THC cannabis for a patient without a
  224  reasonable belief that the patient is suffering from at least
  225  one of the conditions listed in subsection (2).:
  226         1. Cancer or a physical medical condition that chronically
  227  produces symptoms of seizures or severe and persistent muscle
  228  spasms that can be treated with low-THC cannabis; or
  229         2. Symptoms of cancer or a physical medical condition that
  230  chronically produces symptoms of seizures or severe and
  231  persistent muscle spasms that can be alleviated with low-THC
  232  cannabis.
  233         (b) Any person who fraudulently represents that he or she
  234  has at least one condition listed in subsection (2) cancer or a
  235  physical medical condition that chronically produces symptoms of
  236  seizures or severe and persistent muscle spasms to a physician
  237  for the purpose of being ordered low-THC cannabis by such
  238  physician commits a misdemeanor of the first degree, punishable
  239  as provided in s. 775.082 or s. 775.083.
  240         (4) PHYSICIAN EDUCATION.—
  241         (a) Before ordering low-THC cannabis for use by a patient
  242  in this state, the appropriate board shall require the ordering
  243  physician licensed under chapter 458 or chapter 459 to
  244  successfully complete an 8-hour course and subsequent
  245  examination offered by the Florida Medical Association or the
  246  Florida Osteopathic Medical Association that encompasses the
  247  clinical indications for the appropriate use of low-THC
  248  cannabis, the appropriate delivery mechanisms, the
  249  contraindications for such use, as well as the relevant state
  250  and federal laws governing the ordering, dispensing, and
  251  possessing of this substance. The first course and examination
  252  shall be presented by October 1, 2014, and shall be administered
  253  at least annually thereafter. Successful completion of the
  254  course may be used by a physician to satisfy 8 hours of the
  255  continuing medical education requirements required by his or her
  256  respective board for licensure renewal. This course may be
  257  offered in a distance learning format.
  258         (b) The appropriate board shall require the medical
  259  director of each dispensing organization approved under
  260  subsection (5) to successfully complete a 2-hour course and
  261  subsequent examination offered by the Florida Medical
  262  Association or the Florida Osteopathic Medical Association that
  263  encompasses appropriate safety procedures and knowledge of low
  264  THC cannabis.
  265         (c) Successful completion of the course and examination
  266  specified in paragraph (a) is required for every physician who
  267  orders low-THC cannabis each time such physician renews his or
  268  her license. In addition, successful completion of the course
  269  and examination specified in paragraph (b) is required for the
  270  medical director of each dispensing organization each time such
  271  physician renews his or her license.
  272         (d) A physician who fails to comply with this subsection
  273  and who orders low-THC cannabis may be subject to disciplinary
  274  action under the applicable practice act and under s.
  275  456.072(1)(k).
  276         (5) DUTIES AND POWERS OF THE DEPARTMENT.—By January 1,
  277  2015, The department shall:
  278         (a) The department shall create a secure, electronic, and
  279  online compassionate use registry for the registration of
  280  physicians and patients as provided under this section. The
  281  registry must be accessible to law enforcement agencies and to a
  282  dispensing organization in order to verify patient authorization
  283  for low-THC cannabis and record the low-THC cannabis dispensed.
  284  The registry must prevent an active registration of a patient by
  285  multiple physicians.
  286         (b)1.Beginning 7 days after the effective date of this
  287  act, the department shall accept applications for licensure as a
  288  dispensing organization. The department shall review each
  289  application to determine whether the applicant meets the
  290  criteria in subsection (6) and qualifies for licensure.
  291         2. Within 10 days after receiving an application for
  292  licensure, the department shall examine the application, notify
  293  the applicant of any apparent errors or omissions, and request
  294  any additional information the department is allowed by law to
  295  require. An application for licensure must be filed with the
  296  department no later than 5 p.m. on the 30th day after the
  297  effective date of this act, and all applications must be
  298  complete no later than 5 p.m. on the 60th day after the
  299  effective date of this act.
  300         3. If fewer than 20 applicants meet the criteria specified
  301  in subsection (6), the department shall, by the 75th day after
  302  the effective date of this act, license each such applicant. If
  303  more than 20 applicants meet these criteria, licensure shall be
  304  determined by lottery.
  305         4. Beginning March 15, 2016, and every 6 months thereafter,
  306  if fewer than 20 dispensing organization licenses have been
  307  issued in this state, the department may issue additional
  308  licenses to qualified applicants up to the 20-organization
  309  maximum. If the number of qualified applicants under this
  310  subparagraph exceeds the number of dispensing organization
  311  licenses available for issuance, licensure shall be determined
  312  by lottery.
  313         5. This section is exempt from s. 120.60 Authorize the
  314  establishment of five dispensing organizations to ensure
  315  reasonable statewide accessibility and availability as necessary
  316  for patients registered in the compassionate use registry and
  317  who are ordered low-THC cannabis under this section, one in each
  318  of the following regions: northwest Florida, northeast Florida,
  319  central Florida, southeast Florida, and southwest Florida.
  320         (c) The department shall use develop an application form
  321  that requires the applicant to state:
  322         1. Whether the application is for initial licensure or
  323  renewal licensure;
  324         2. The name, the physical address, the mailing address, the
  325  address listed on the Department of Agriculture and Consumer
  326  Services certificate required in paragraph (6)(b), and the
  327  contact information for the applicant and for the nursery that
  328  holds the Department of Agriculture and Consumer Services
  329  certificate, if different from the applicant;
  330         3. The name, address, and contact information for the
  331  operating nurseryman of the organization that holds the
  332  Department of Agriculture and Consumer Services certificate;
  333         4. The name, address, license number, and contact
  334  information for the applicant’s medical director; and
  335         5. All information required to be included by subsection
  336  (6).
  337         (d) The department shall and impose an initial application
  338  fee of $50,000, an initial licensure fee of $125,000, and a
  339  biennial renewal fee of $125,000 that is sufficient to cover the
  340  costs of administering this section. An applicant for approval
  341  as a dispensing organization must be able to demonstrate:
  342         1. The technical and technological ability to cultivate and
  343  produce low-THC cannabis. The applicant must possess a valid
  344  certificate of registration issued by the Department of
  345  Agriculture and Consumer Services pursuant to s. 581.131 that is
  346  issued for the cultivation of more than 400,000 plants, be
  347  operated by a nurseryman as defined in s. 581.011, and have been
  348  operated as a registered nursery in this state for at least 30
  349  continuous years.
  350         2. The ability to secure the premises, resources, and
  351  personnel necessary to operate as a dispensing organization.
  352         3. The ability to maintain accountability of all raw
  353  materials, finished products, and any byproducts to prevent
  354  diversion or unlawful access to or possession of these
  355  substances.
  356         4. An infrastructure reasonably located to dispense low-THC
  357  cannabis to registered patients statewide or regionally as
  358  determined by the department.
  359         5. The financial ability to maintain operations for the
  360  duration of the 2-year approval cycle, including the provision
  361  of certified financials to the department. Upon approval, the
  362  applicant must post a $5 million performance bond.
  363         6. That all owners and managers have been fingerprinted and
  364  have successfully passed a level 2 background screening pursuant
  365  to s. 435.04.
  366         7. The employment of a medical director who is a physician
  367  licensed under chapter 458 or chapter 459 to supervise the
  368  activities of the dispensing organization.
  369         (e) The department shall inspect each dispensing
  370  organization’s properties, cultivation facilities, processing
  371  facilities, and retail facilities before they begin operations
  372  and at least once every 2 years thereafter. The department may
  373  conduct additional announced or unannounced inspections,
  374  including followup inspections, at reasonable hours in order to
  375  ensure that such property and facilities maintain compliance
  376  with all applicable requirements in subsections (6) and (7) and
  377  to ensure that the dispensing organization has not committed any
  378  other act that would endanger the health, safety, or security of
  379  a qualified patient, dispensing organization staff, or the
  380  community in which the dispensing organization is located.
  381  Licensure under this section constitutes permission for the
  382  department to enter and inspect the premises and facilities of
  383  any dispensing organization. The department may inspect any
  384  licensed dispensing organization, and a dispensing organization
  385  must make all facility premises, equipment, documents, low-THC
  386  cannabis, and low-THC cannabis products available to the
  387  department upon inspection. The department may test any low-THC
  388  cannabis or low-THC cannabis product in order to ensure that it
  389  is safe for human consumption and that it meets the requirements
  390  in this section.
  391         (f)The department may suspend or revoke a license, deny or
  392  refuse to renew a license, or impose an administrative penalty
  393  not to exceed $10,000 for the following acts or omissions:
  394         1.A violation of this section or department rule.
  395         2.Failing to maintain qualifications for licensure.
  396         3.Endangering the health, safety, or security of a
  397  qualified patient.
  398         4.Improperly disclosing personal and confidential
  399  information of the qualified patient.
  400         5.Attempting to procure a license by bribery or fraudulent
  401  misrepresentation.
  402         6.Being convicted or found guilty of, or entering a plea
  403  of nolo contendere to, regardless of adjudication, a crime in
  404  any jurisdiction which directly relates to the business of a
  405  dispensing organization.
  406         7.Making or filing a report or record that the licensee
  407  knows to be false.
  408         8.Willfully failing to maintain a record required by this
  409  section or rule of the department.
  410         9.Willfully impeding or obstructing an employee or agent
  411  of the department in the furtherance of his or her official
  412  duties.
  413         10.Engaging in fraud or deceit, negligence, incompetence,
  414  or misconduct in the business practices of a dispensing
  415  organization.
  416         11.Making misleading, deceptive, or fraudulent
  417  representations in or related to the business practices of a
  418  dispensing organization.
  419         12.Having a license or the authority to engage in any
  420  regulated profession, occupation, or business that is related to
  421  the business practices of a dispensing organization revoked,
  422  suspended, or otherwise acted against, including the denial of
  423  licensure, by the licensing authority of any jurisdiction,
  424  including its agencies or subdivisions, for a violation that
  425  would constitute a violation under state law. A licensing
  426  authority’s acceptance of a relinquishment of licensure or a
  427  stipulation, consent order, or other settlement, offered in
  428  response to or in anticipation of the filing of charges against
  429  the license, shall be construed as an action against the
  430  license.
  431         13.Violating a lawful order of the department or an agency
  432  of the state, or failing to comply with a lawfully issued
  433  subpoena of the department or an agency of the state.
  434         (g) The department shall create a permitting process for
  435  all dispensing organization vehicles used for the transportation
  436  of low-THC cannabis or low-THC cannabis products.
  437         (h)(c)The department shall monitor physician registration
  438  and ordering of low-THC cannabis for ordering practices that
  439  could facilitate unlawful diversion or misuse of low-THC
  440  cannabis and take disciplinary action as indicated.
  441         (i)(d)The department shall adopt rules as necessary to
  442  implement this section.
  443         (6) DISPENSING ORGANIZATION.—
  444         (a) An applicant seeking licensure as a dispensing
  445  organization, or the renewal of its license, must submit an
  446  application to the department. The department must review all
  447  applications for completeness, including an appropriate
  448  inspection of the applicant’s property and facilities to verify
  449  the authenticity of the information provided in, or in
  450  connection with, the application. An applicant authorizes the
  451  department to inspect his or her property and facilities for
  452  licensure by applying under this subsection.
  453         (b) In order to receive or maintain licensure as a
  454  dispensing organization, an applicant must provide proof that:
  455         1.The applicant, or a separate entity that is owned solely
  456  by the same persons or entities in the same ratio as the
  457  applicant, possesses a valid certificate of registration issued
  458  by the Department of Agriculture and Consumer Services pursuant
  459  to s. 581.131 for the cultivation of more than 400,000 plants,
  460  the applicant’s land is operated by a nurseryman as defined in
  461  s. 581.011, and the land has been operated as a registered
  462  nursery in this state for at least 30 continuous years.
  463         2. The personnel on staff or under contract for the
  464  applicant have experience cultivating and introducing multiple
  465  varieties of plants in this state, including plants that are not
  466  native to Florida; experience with propagating plants; and
  467  experience with genetic modification or breeding of plants.
  468         3. The personnel on staff or under contract for the
  469  applicant include at least one person who:
  470         a. Has at least 5 years’ experience with United States
  471  Department of Agriculture Good Agricultural Practices and Good
  472  Handling Practices;
  473         b. Has at least 5 years’ experience with United States Food
  474  and Drug Administration Good Manufacturing Practices for food
  475  production;
  476         c. Has a doctorate degree in organic chemistry or
  477  microbiology;
  478         d. Has at least 5 years of experience with laboratory
  479  procedures which includes analytical laboratory quality control
  480  measures, chain of custody procedures, and analytical laboratory
  481  methods;
  482         e. Has experience with cannabis cultivation and processing,
  483  including cannabis extraction techniques and producing cannabis
  484  products;
  485         f. Has experience and qualifications in chain of custody or
  486  other tracking mechanisms;
  487         g. Works solely on inventory control; and
  488         h. Works solely for security purposes.
  489         4. The persons who have a direct or indirect interest in
  490  the dispensing organization and the applicant’s managers,
  491  employees, and contractors who directly interact with low-THC
  492  cannabis or low-THC cannabis products have been fingerprinted
  493  and have successfully passed a level 2 background screening
  494  pursuant to s. 435.04.
  495         5. The applicant owns, or has at least a 2-year lease of,
  496  all properties, facilities, and equipment necessary for the
  497  cultivation and processing of low-THC cannabis. The applicant
  498  must provide a detailed description of each facility and its
  499  equipment, a cultivation and processing plan, and a detailed
  500  floor plan. The description must include proof that:
  501         a. The applicant is capable of sufficient cultivation and
  502  processing to serve at least 15,000 patients with an assumed
  503  daily use of 1,000 mg per patient per day of low-THC cannabis or
  504  low-THC cannabis product;
  505         b. The applicant has arranged for access to all utilities
  506  and resources necessary to cultivate or process low-THC cannabis
  507  at each listed facility; and
  508         c. Each facility is secured and has theft-prevention
  509  systems including an alarm system, cameras, and 24-hour security
  510  personnel.
  511         6. The applicant has diversion and tracking prevention
  512  procedures, including:
  513         a. A system for tracking low-THC material through
  514  cultivation, processing, and dispensing, including the use of
  515  batch and harvest numbers;
  516         b. An inventory control system for low-THC cannabis and
  517  low-THC cannabis products;
  518         c. A vehicle tracking and security system; and
  519         d. A cannabis waste-disposal plan.
  520         7. The applicant has recordkeeping policies and procedures
  521  in place.
  522         8. The applicant has a facility emergency management plan.
  523         9. The applicant has a plan for dispensing low-THC cannabis
  524  throughout the state. This plan must include planned retail
  525  facilities and a delivery plan for providing low-THC cannabis
  526  and low-THC cannabis products to qualified patients who cannot
  527  travel to a retail facility.
  528         10. The applicant has financial documentation, including:
  529         a. Documentation that demonstrates the applicant’s
  530  financial ability to operate. If the applicant’s assets, credit,
  531  and projected revenues meet or exceed projected liabilities and
  532  expenses and the applicant provides independent evidence that
  533  the funds necessary for startup costs, working capital, and
  534  contingency financing exist and are available as needed, the
  535  applicant has demonstrated the financial ability to operate.
  536  Financial ability to operate must be documented by:
  537         I. The applicant’s audited financial statements. If the
  538  applicant is a newly formed entity and does not have a financial
  539  history of business upon which audited financial statements may
  540  be submitted, the applicant must provide audited financial
  541  statements for the separate entity that is owned solely by the
  542  same persons or entities in the same ratio as the applicant that
  543  possesses the valid certificate of registration issued by the
  544  Department of Agriculture and Consumer Services;
  545         II.The applicant’s projected financial statements,
  546  including a balance sheet, an income and expense statement, and
  547  a statement of cash flow for the first 2 years of operation,
  548  which provides evidence that the applicant has sufficient
  549  assets, credit, and projected revenues to cover liabilities and
  550  expenses; and
  551         III.A statement of the applicant’s estimated startup costs
  552  and sources of funds, including a break-even projection and
  553  documentation demonstrating that the applicant has the ability
  554  to fund all startup costs, working capital costs, and
  555  contingency financing requirements.
  556  
  557  All documents required under this sub-subparagraph shall be
  558  prepared in accordance with generally accepted accounting
  559  principles and signed by a certified public accountant. The
  560  statements required by sub-sub-subparagraph II. and III. may be
  561  presented as a compilation.
  562         b.A list of all subsidiaries of the applicant;
  563         c.A list of all lawsuits pending and completed within the
  564  past 7 years of which the applicant was a party; and
  565         d.Proof of a $1 million performance and compliance bond,
  566  or other equivalent means of security deemed equivalent by the
  567  department, such as an irrevocable letter of credit or a deposit
  568  in a trust account or financial institution, payable to the
  569  department, which must be posted once the applicant is approved
  570  as a dispensing organization. The purpose of the bond is to
  571  secure payment of any administrative penalties imposed by the
  572  department and any fees and costs incurred by the department
  573  regarding the dispensing organization license, such as the
  574  dispensing organization failing to pay 30 days after the fine or
  575  costs become final. The department may make a claim against such
  576  bond or security until 1 year after the dispensing
  577  organization’s license ceases to be valid or until 60 days after
  578  any administrative or legal proceeding authorized in this
  579  section involving the dispensing organization concludes,
  580  including any appeal, whichever occurs later.
  581         11. The employment of a medical director who is a physician
  582  licensed under chapter 458 or chapter 459 to supervise the
  583  activities of the dispensing organization.
  584         (c) An approved dispensing organization shall maintain
  585  compliance with the criteria in paragraphs (b), (d), and (e) and
  586  subsection (7) demonstrated for selection and approval as a
  587  dispensing organization under subsection (5) at all times.
  588  Before dispensing low-THC cannabis or low-THC cannabis products
  589  to a qualified patient or to the qualified patient’s legal
  590  representative, the dispensing organization shall verify the
  591  identity of the qualified patient or the qualified patient’s
  592  legal representative by requiring the qualified patient or the
  593  qualified patient’s legal representative to produce a
  594  government-issued identification card and shall verify that the
  595  qualified patient and the qualified patient’s legal
  596  representative have has an active registration in the
  597  compassionate use registry, that the order presented matches the
  598  order contents as recorded in the registry, and that the order
  599  has not already been filled. Upon dispensing the low-THC
  600  cannabis, the dispensing organization shall record in the
  601  registry the date, time, quantity, and form of low-THC cannabis
  602  dispensed.
  603         (d) A dispensing organization may have cultivation
  604  facilities, processing facilities, and retail facilities.
  605         1. All matters regarding the location of cultivation
  606  facilities and processing facilities are preempted to the state.
  607  Cultivation facilities and processing facilities must be closed
  608  to the public, and low-THC cannabis may not be dispensed on the
  609  premises of such facilities.
  610         2. A county must determine by ordinance the criteria for
  611  the number, location, and other permitting requirements for all
  612  retail facilities located within that county. A retail facility
  613  may be established in a county only after such an ordinance has
  614  been created. Retail facilities must meet the requirements in
  615  subparagraphs (b)5. and (b)7. Retail facilities may not sell, or
  616  contract for the sale of, anything other than low-THC cannabis
  617  or low-THC cannabis products on the property of the retail
  618  facility. Before a retail facility may dispense low-THC cannabis
  619  or a low-THC cannabis product, the dispensing organization must
  620  have a computer network compliant with the federal Health
  621  Insurance Portability and Accountability Act of 1996 which is
  622  able to access and upload data to the compassionate use registry
  623  and which shall be used by all retail facilities.
  624         (e) Within 15 days of such information becoming available,
  625  a dispensing organization must provide the department with
  626  updated information, as applicable, including:
  627         1. The location and a detailed description of any new or
  628  proposed facilities.
  629         2. The updated contact information, including electronic
  630  and voice communication, for all dispensing organization
  631  facilities.
  632         3. The registration information for any vehicles used for
  633  the transportation of low-THC cannabis and low-THC cannabis
  634  product, including confirmation that all such vehicles have
  635  tracking and security systems.
  636         4. A plan for the recall of any or all low-THC cannabis or
  637  low-THC cannabis product.
  638         (f)1. A dispensing organization may transport low-THC
  639  cannabis or low-THC cannabis products in vehicles departing from
  640  their places of business only in vehicles that are owned or
  641  leased by the licensee or by a person designated by the
  642  dispensing organization, and for which a valid vehicle permit
  643  has been issued for such vehicle by the department.
  644         2.A vehicle owned or leased by the dispensing organization
  645  or a person designated by the dispensing organization and
  646  approved by the department must be operated by such person when
  647  transporting low-THC cannabis or low-THC products from the
  648  licensee’s place of business.
  649         3.A vehicle permit may be obtained by a dispensing
  650  organization upon application and payment of a fee of $5 per
  651  vehicle to the department. The signature of the person
  652  designated by the dispensing organization to drive the vehicle
  653  must be included on the vehicle permit application. Such permit
  654  remains valid and does not expire unless the licensee or any
  655  person designated by the dispensing organization disposes of his
  656  or her vehicle, or the licensee’s license is transferred,
  657  canceled, not renewed, or is revoked by the department,
  658  whichever occurs first. The department shall cancel a vehicle
  659  permit upon request of the licensee or owner of the vehicle.
  660         4.By acceptance of a license issued under this section,
  661  the licensee agrees that the licensed vehicle is, at all times
  662  it is being used to transport low-THC cannabis or low-THC
  663  cannabis products, subject to inspection and search without a
  664  search warrant by authorized employees of the department,
  665  sheriffs, deputy sheriffs, or police officers to determine that
  666  the licensee is transporting such products in compliance with
  667  this section.
  668         (7)TESTING AND LABELING OF LOW-THC CANNABIS.
  669         (a)All low-THC cannabis and low-THC cannabis products must
  670  be tested by an independent testing laboratory before the
  671  dispensing organization may dispense them. The independent
  672  testing laboratory shall provide the dispensing organization
  673  with lab results. Before dispensing, the dispensing organization
  674  must determine that the lab results indicate that the low-THC
  675  cannabis or low-THC cannabis product meets the definition of
  676  low-THC cannabis or low-THC cannabis product, is safe for human
  677  consumption, and is free from harmful contaminants.
  678         (b)All low-THC cannabis and low-THC cannabis products must
  679  be labeled before dispensing. The label must include, at a
  680  minimum:
  681         1. A statement that the low-THC cannabis or low-THC
  682  cannabis product meets the requirements in paragraph (a);
  683         2.The name of the independent testing laboratory that
  684  tested the low-THC cannabis or low-THC cannabis product;
  685         3.The name of the cultivation and processing facility
  686  where the low-THC cannabis or low-THC cannabis product
  687  originates; and
  688         4.The batch number and harvest number from which the low
  689  THC cannabis or low-THC cannabis product originates.
  690         (8) SAFETY AND EFFICACY RESEARCH FOR LOW-THC CANNABIS.—The
  691  University of Florida College of Pharmacy must establish and
  692  maintain a safety and efficacy research program for the use of
  693  low-THC cannabis or low-THC cannabis products to treat
  694  qualifying conditions and symptoms. The program must include a
  695  fully integrated electronic information system for the broad
  696  monitoring of health outcomes and safety signal detection. The
  697  electronic information system must include information from the
  698  compassionate use registry; provider reports, including
  699  treatment plans, adverse event reports, and treatment
  700  discontinuation reports; patient reports of adverse impacts;
  701  event-triggered interviews and medical chart reviews performed
  702  by University of Florida clinical research staff; information
  703  from external databases, including Medicaid billing reports and
  704  information in the prescription drug monitoring database for
  705  registered patients; and all other medical reports required by
  706  the University of Florida to conduct the research required by
  707  this subsection. The department must provide access to
  708  information from the compassionate use registry and the
  709  prescription drug monitoring database, established in s.
  710  893.055, as needed by the University of Florida to conduct
  711  research under this subsection. The Agency for Health Care
  712  Administration must provide access to registered patient
  713  Medicaid records, to the extent allowed under federal law, as
  714  needed by the University of Florida to conduct research under
  715  this subsection.
  716         (9)(7) EXCEPTIONS TO OTHER LAWS.—
  717         (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  718  any other provision of law, but subject to the requirements of
  719  this section, a qualified patient and the qualified patient’s
  720  legal representative who is registered with the department on
  721  the compassionate use registry may purchase and possess for the
  722  patient’s medical use up to the amount of low-THC cannabis
  723  ordered for the patient.
  724         (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  725  any other provision of law, but subject to the requirements of
  726  this section, an approved dispensing organization and its
  727  owners, managers, and employees and the owners, managers, and
  728  employees of contractors who have direct contact with low-THC
  729  cannabis or low-THC cannabis product may manufacture, possess,
  730  sell, deliver, distribute, dispense, and lawfully dispose of
  731  reasonable quantities, as established by department rule, of
  732  low-THC cannabis. For purposes of this subsection, the terms
  733  “manufacture,” “possession,” “deliver,” “distribute,” and
  734  “dispense” have the same meanings as provided in s. 893.02.
  735         (c) An approved dispensing organization and its owners,
  736  managers, and employees are not subject to licensure or
  737  regulation under chapter 465 or chapter 499 for manufacturing,
  738  possessing, selling, delivering, distributing, dispensing, or
  739  lawfully disposing of reasonable quantities, as established by
  740  department rule, of low-THC cannabis.
  741         (d) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  742  any other law, but subject to the requirements of this section,
  743  a licensed laboratory and its employees may receive and possess
  744  low-THC cannabis for the sole purpose of testing the low-THC
  745  cannabis to ensure compliance with this section.
  746         (10) Rules adopted by the department under this section are
  747  exempt from the requirement that they be ratified by the
  748  Legislature pursuant to s. 120.541(3).
  749         Section 2. Paragraph (g) is added to subsection (3) of
  750  section 381.987, Florida Statutes, to read:
  751         381.987 Public records exemption for personal identifying
  752  information in the compassionate use registry.—
  753         (3) The department shall allow access to the registry,
  754  including access to confidential and exempt information, to:
  755         (g) Persons engaged in research at the University of
  756  Florida pursuant to s. 381.986(8).
  757         Section 3. Paragraph (b) of subsection (7) of section
  758  893.055, Florida Statutes, is amended to read:
  759         893.055 Prescription drug monitoring program.—
  760         (7)
  761         (b) A pharmacy, prescriber, or dispenser shall have access
  762  to information in the prescription drug monitoring program’s
  763  database which relates to a patient of that pharmacy,
  764  prescriber, or dispenser in a manner established by the
  765  department as needed for the purpose of reviewing the patient’s
  766  controlled substance prescription history. Persons engaged in
  767  research at the University of Florida pursuant to s. 381.986(8)
  768  shall have access to information in the prescription drug
  769  monitoring program’s database which relates to qualified
  770  patients as defined in s. 381.986(1) for the purpose of
  771  conducting such research. Other access to the program’s database
  772  shall be limited to the program’s manager and to the designated
  773  program and support staff, who may act only at the direction of
  774  the program manager or, in the absence of the program manager,
  775  as authorized. Access by the program manager or such designated
  776  staff is for prescription drug program management only or for
  777  management of the program’s database and its system in support
  778  of the requirements of this section and in furtherance of the
  779  prescription drug monitoring program. Confidential and exempt
  780  information in the database shall be released only as provided
  781  in paragraph (c) and s. 893.0551. The program manager,
  782  designated program and support staff who act at the direction of
  783  or in the absence of the program manager, and any individual who
  784  has similar access regarding the management of the database from
  785  the prescription drug monitoring program shall submit
  786  fingerprints to the department for background screening. The
  787  department shall follow the procedure established by the
  788  Department of Law Enforcement to request a statewide criminal
  789  history record check and to request that the Department of Law
  790  Enforcement forward the fingerprints to the Federal Bureau of
  791  Investigation for a national criminal history record check.
  792         Section 4. Paragraph (h) is added to subsection (3) of
  793  section 893.0551, Florida Statutes, to read:
  794         893.0551 Public records exemption for the prescription drug
  795  monitoring program.—
  796         (3) The department shall disclose such confidential and
  797  exempt information to the following persons or entities upon
  798  request and after using a verification process to ensure the
  799  legitimacy of the request as provided in s. 893.055:
  800         (h) Persons engaged in research at the University of
  801  Florida pursuant to s. 381.986(8).
  802         Section 5. This act shall take effect upon becoming a law.