Florida Senate - 2015                             CS for SB 7066
       
       
        
       By the Committees on Health Policy; and Regulated Industries
       
       
       
       
       
       588-03206-15                                          20157066c1
    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; authorizing a retail facility
   59         to be established in a municipality only after such an
   60         ordinance has been created; authorizing a retail
   61         facility to be established in the unincorporated areas
   62         of a county only after such an ordinance has been
   63         created; requiring retail facilities to have all
   64         utilities and resources necessary to store and
   65         dispense low-THC and low-THC cannabis products;
   66         requiring retail facilities to be secured with
   67         specified theft-prevention systems; requiring a
   68         dispensing organization to provide the department with
   69         specified updated information within a specified
   70         period; authorizing a dispensing organization to
   71         transport low-THC cannabis or low-THC cannabis
   72         products in vehicles in certain circumstances;
   73         requiring such vehicles to be operated by specified
   74         persons in certain circumstances; requiring a fee for
   75         a vehicle permit; requiring the signature of the
   76         designated driver with a vehicle permit application;
   77         providing for expiration of the permit in certain
   78         circumstances; requiring the department to cancel a
   79         vehicle permit upon the request of specified persons;
   80         providing that the licensee authorizes the inspection
   81         and search of his or her vehicle without a search
   82         warrant by specified persons; requiring all low-THC
   83         cannabis and low-THC cannabis products to be tested by
   84         an independent testing laboratory before the
   85         dispensing organization may dispense it; requiring the
   86         independent testing laboratory to provide the lab
   87         results to the dispensing organization for a specified
   88         determination; requiring all low-THC cannabis and low
   89         THC cannabis products to be labeled with specified
   90         information before dispensing; requiring the
   91         University of Florida College of Pharmacy to establish
   92         and maintain a specified safety and efficacy research
   93         program; providing program requirements; requiring the
   94         department to provide information from the
   95         prescription drug monitoring program to the University
   96         of Florida as needed; requiring the Agency for Health
   97         Care Administration to provide access to specified
   98         patient records under certain circumstances; providing
   99         that the act does not provide an exception to the
  100         prohibition against driving under the influence;
  101         authorizing specified individuals to manufacture,
  102         possess, sell, deliver, distribute, dispense, and
  103         lawfully dispose of reasonable quantities of low-THC
  104         cannabis; authorizing a licensed laboratory and its
  105         employees to receive and possess low-THC cannabis in
  106         certain circumstances; providing that specified rules
  107         adopted by the department are exempt from the
  108         requirement to be ratified by the Legislature;
  109         amending s. 381.987, F.S.; requiring the department to
  110         allow specified persons engaged in research to access
  111         the compassionate use registry; amending s. 893.055,
  112         F.S.; providing that persons engaged in research at
  113         the University of Florida shall have access to
  114         specified information; amending s. 893.0551, F.S.;
  115         providing a specified public records exemption for
  116         persons engaged in research at the University of
  117         Florida; providing an effective date.
  118          
  119  Be It Enacted by the Legislature of the State of Florida:
  120  
  121         Section 1. Section 381.986, Florida Statutes, is amended to
  122  read:
  123         381.986 Compassionate use of low-THC cannabis.—
  124         (1) DEFINITIONS.—As used in this section, the term:
  125         (a) “Applicant” means a person that has submitted an
  126  application to the department for licensure or renewal as a
  127  dispensing organization.
  128         (b) “Batch” means a specific quantity of low-THC cannabis
  129  product that is intended to have uniform character and quality,
  130  within specified limits, and is produced at the same time from
  131  one or more harvests.
  132         (c) “Dispensing organization” means an applicant licensed
  133  organization approved by the department to cultivate, process,
  134  and dispense low-THC cannabis pursuant to this section.
  135         (d) “Harvest” means a specifically identified and numbered
  136  quantity of low-THC cannabis cultivated using the same
  137  herbicides, pesticides, and fungicides and harvested at the same
  138  time from a single facility.
  139         (e)(b) “Low-THC cannabis” means a plant of the genus
  140  Cannabis, the dried flowers of which contain 0.8 percent or less
  141  of tetrahydrocannabinol and more than 10 percent of cannabidiol
  142  weight for weight; the seeds thereof; the resin extracted from
  143  any part of such plant; or any compound, manufacture, salt,
  144  derivative, mixture, or preparation of such plant or its seeds
  145  or resin that is dispensed only from a dispensing organization.
  146         (f) “Low-THC cannabis product” means any product derived
  147  from low-THC cannabis, including the resin extracted from any
  148  part of such plant or any compound, manufacture, salt,
  149  derivative, mixture, or preparation of such plant or its seeds
  150  or resin which is dispensed from a dispensing organization. Low
  151  THC cannabis products include, but are not limited to, oils,
  152  tinctures, creams, encapsulations, and food products. All low
  153  THC cannabis products must maintain concentrations, weight for
  154  weight, of 0.8 percent or less of tetrahydrocannabinol and more
  155  than 10 percent of cannabidiol.
  156         (g)(c) “Medical use” means administration of the ordered
  157  amount of low-THC cannabis. The term does not include:
  158         1. The possession, use, or administration by smoking;.
  159         2.The term also does not include The transfer of low-THC
  160  cannabis to a person other than the qualified patient for whom
  161  it was ordered or the qualified patient’s legal representative
  162  who is registered in the compassionate use registry on behalf of
  163  the qualified patient; or.
  164         3. The use or administration of low-THC cannabis or low-THC
  165  cannabis products:
  166         a. On any form of public transportation.
  167         b. In any public place.
  168         c. In a registered qualified patient’s place of work, if
  169  restricted by his or her employer.
  170         d. In a correctional facility.
  171         e. On the grounds of any preschool, primary school, or
  172  secondary school.
  173         f. On a school bus.
  174         (h)(d) “Qualified patient” means a resident of this state
  175  who has been added to the compassionate use registry by a
  176  physician licensed under chapter 458 or chapter 459 to receive
  177  low-THC cannabis from a dispensing organization.
  178         (i)(e) “Smoking” means burning or igniting a substance and
  179  inhaling the smoke. Smoking does not include the use of a
  180  vaporizer.
  181         (2) PHYSICIAN ORDERING.—
  182         (a)Effective January 1, 2015, A physician licensed under
  183  chapter 458 or chapter 459 who has examined and is treating a
  184  patient suffering from cancer, human immunodeficiency virus,
  185  acquired immune deficiency syndrome, epilepsy, amyotrophic
  186  lateral sclerosis, multiple sclerosis, Crohn’s disease,
  187  Parkinson’s disease, paraplegia, quadriplegia, or terminal
  188  illness a physical medical condition that chronically produces
  189  symptoms of seizures or severe and persistent muscle spasms may
  190  order for the patient’s medical use low-THC cannabis to treat
  191  such disease, disorder, or condition; or to alleviate symptoms
  192  of such disease, disorder, or condition;, or to alleviate
  193  symptoms caused by a treatment for such disease, disorder, or
  194  condition if no other satisfactory alternative treatment options
  195  exist for that patient and all of the following conditions
  196  apply:
  197         1.(a) The patient is a permanent resident of this state.
  198         2.(b) The physician determines that the risks of ordering
  199  low-THC cannabis are reasonable in light of the potential
  200  benefit for that patient. If a patient is younger than 18 years
  201  of age, a second physician must concur with this determination,
  202  and such determination must be documented in the patient’s
  203  medical record.
  204         3.(c) The physician registers the patient, the patient’s
  205  legal representative if requested by the patient, and himself or
  206  herself as the orderer of low-THC cannabis for the named patient
  207  on the compassionate use registry maintained by the department
  208  and updates the registry to reflect the contents of the order.
  209  If the patient is a minor, the physician must register a legal
  210  representative on the compassionate use registry. The physician
  211  shall deactivate the patient’s registration when treatment is
  212  discontinued.
  213         4.(d) The physician maintains a patient treatment plan that
  214  includes the dose, route of administration, planned duration,
  215  and monitoring of the patient’s symptoms and other indicators of
  216  tolerance or reaction to the low-THC cannabis.
  217         5.(e) The physician submits the patient treatment plan, as
  218  well as any other requested medical records, quarterly to the
  219  University of Florida College of Pharmacy for research on the
  220  safety and efficacy of low-THC cannabis on patients pursuant to
  221  subsection (8).
  222         6.(f) The physician obtains the voluntary informed consent
  223  of the patient or the patient’s legal guardian to treatment with
  224  low-THC cannabis after sufficiently explaining the current state
  225  of knowledge in the medical community of the effectiveness of
  226  treatment of the patient’s conditions or symptoms condition with
  227  low-THC cannabis, the medically acceptable alternatives, and the
  228  potential risks and side effects.
  229         (b)A physician who improperly orders low-THC cannabis is
  230  subject to disciplinary action under the applicable practice act
  231  and under s. 456.072(1)(k).
  232         (3) PENALTIES.—
  233         (a) A physician commits a misdemeanor of the first degree,
  234  punishable as provided in s. 775.082 or s. 775.083, if the
  235  physician orders low-THC cannabis for a patient without a
  236  reasonable belief that the patient is suffering from at least
  237  one of the conditions listed in subsection (2).:
  238         1. Cancer or a physical medical condition that chronically
  239  produces symptoms of seizures or severe and persistent muscle
  240  spasms that can be treated with low-THC cannabis; or
  241         2. Symptoms of cancer or a physical medical condition that
  242  chronically produces symptoms of seizures or severe and
  243  persistent muscle spasms that can be alleviated with low-THC
  244  cannabis.
  245         (b) Any person who fraudulently represents that he or she
  246  has at least one condition listed in subsection (2) cancer or a
  247  physical medical condition that chronically produces symptoms of
  248  seizures or severe and persistent muscle spasms to a physician
  249  for the purpose of being ordered low-THC cannabis by such
  250  physician commits a misdemeanor of the first degree, punishable
  251  as provided in s. 775.082 or s. 775.083.
  252         (4) PHYSICIAN EDUCATION.—
  253         (a) Before ordering low-THC cannabis for use by a patient
  254  in this state, the appropriate board shall require the ordering
  255  physician licensed under chapter 458 or chapter 459 to
  256  successfully complete an 8-hour course and subsequent
  257  examination offered by the Florida Medical Association or the
  258  Florida Osteopathic Medical Association that encompasses the
  259  clinical indications for the appropriate use of low-THC
  260  cannabis, the appropriate delivery mechanisms, the
  261  contraindications for such use, as well as the relevant state
  262  and federal laws governing the ordering, dispensing, and
  263  possessing of this substance. The first course and examination
  264  shall be presented by October 1, 2014, and shall be administered
  265  at least annually thereafter. Successful completion of the
  266  course may be used by a physician to satisfy 8 hours of the
  267  continuing medical education requirements required by his or her
  268  respective board for licensure renewal. This course may be
  269  offered in a distance learning format.
  270         (b) The appropriate board shall require the medical
  271  director of each dispensing organization approved under
  272  subsection (5) to successfully complete a 2-hour course and
  273  subsequent examination offered by the Florida Medical
  274  Association or the Florida Osteopathic Medical Association that
  275  encompasses appropriate safety procedures and knowledge of low
  276  THC cannabis.
  277         (c) Successful completion of the course and examination
  278  specified in paragraph (a) is required for every physician who
  279  orders low-THC cannabis each time such physician renews his or
  280  her license. In addition, successful completion of the course
  281  and examination specified in paragraph (b) is required for the
  282  medical director of each dispensing organization each time such
  283  physician renews his or her license.
  284         (d) A physician who fails to comply with this subsection
  285  and who orders low-THC cannabis may be subject to disciplinary
  286  action under the applicable practice act and under s.
  287  456.072(1)(k).
  288         (5) DUTIES AND POWERS OF THE DEPARTMENT.—By January 1,
  289  2015, The department shall:
  290         (a) The department shall create a secure, electronic, and
  291  online compassionate use registry for the registration of
  292  physicians and patients as provided under this section. The
  293  registry must be accessible to law enforcement agencies and to a
  294  dispensing organization in order to verify patient authorization
  295  for low-THC cannabis and record the low-THC cannabis dispensed.
  296  The registry must prevent an active registration of a patient by
  297  multiple physicians.
  298         (b)1.Beginning 7 days after the effective date of this
  299  act, the department shall accept applications for licensure as a
  300  dispensing organization. The department shall review each
  301  application to determine whether the applicant meets the
  302  criteria in subsection (6) and qualifies for licensure.
  303         2. Within 10 days after receiving an application for
  304  licensure, the department shall examine the application, notify
  305  the applicant of any apparent errors or omissions, and request
  306  any additional information the department is allowed by law to
  307  require. An application for licensure must be filed with the
  308  department no later than 5 p.m. on the 30th day after the
  309  effective date of this act, and all applications must be
  310  complete no later than 5 p.m. on the 60th day after the
  311  effective date of this act.
  312         3. If fewer than 20 applicants meet the criteria specified
  313  in subsection (6), the department shall, by the 75th day after
  314  the effective date of this act, license each such applicant. If
  315  more than 20 applicants meet these criteria, licensure shall be
  316  determined by lottery.
  317         4. Beginning March 15, 2016, and every 6 months thereafter,
  318  if fewer than 20 dispensing organization licenses have been
  319  issued in this state, the department may issue additional
  320  licenses to qualified applicants up to the 20-organization
  321  maximum. The department shall use the same timeframes as set
  322  forth in subparagraphs 1.-3., beginning 75 days before the date
  323  specified for issuing additional licenses. If the number of
  324  qualified applicants under this subparagraph exceeds the number
  325  of dispensing organization licenses available for issuance,
  326  licensure shall be determined by lottery.
  327         5. This section is exempt from s. 120.60 Authorize the
  328  establishment of five dispensing organizations to ensure
  329  reasonable statewide accessibility and availability as necessary
  330  for patients registered in the compassionate use registry and
  331  who are ordered low-THC cannabis under this section, one in each
  332  of the following regions: northwest Florida, northeast Florida,
  333  central Florida, southeast Florida, and southwest Florida.
  334         (c) The department shall use develop an application form
  335  that requires the applicant to state:
  336         1. Whether the application is for initial licensure or
  337  renewal licensure;
  338         2. The name, the physical address, the mailing address, the
  339  address listed on the Department of Agriculture and Consumer
  340  Services certificate required in paragraph (6)(b), and the
  341  contact information for the applicant and for the nursery that
  342  holds the Department of Agriculture and Consumer Services
  343  certificate, if different from the applicant;
  344         3. The name, address, and contact information for the
  345  operating nurseryman of the organization that holds the
  346  Department of Agriculture and Consumer Services certificate;
  347         4. The name, address, license number, and contact
  348  information for the applicant’s medical director; and
  349         5. All information required to be included by subsection
  350  (6).
  351         (d) The department shall and impose an initial application
  352  fee of $50,000, an initial licensure fee of $125,000, and a
  353  biennial renewal fee of $125,000 that is sufficient to cover the
  354  costs of administering this section. An applicant for approval
  355  as a dispensing organization must be able to demonstrate:
  356         1. The technical and technological ability to cultivate and
  357  produce low-THC cannabis. The applicant must possess a valid
  358  certificate of registration issued by the Department of
  359  Agriculture and Consumer Services pursuant to s. 581.131 that is
  360  issued for the cultivation of more than 400,000 plants, be
  361  operated by a nurseryman as defined in s. 581.011, and have been
  362  operated as a registered nursery in this state for at least 30
  363  continuous years.
  364         2. The ability to secure the premises, resources, and
  365  personnel necessary to operate as a dispensing organization.
  366         3. The ability to maintain accountability of all raw
  367  materials, finished products, and any byproducts to prevent
  368  diversion or unlawful access to or possession of these
  369  substances.
  370         4. An infrastructure reasonably located to dispense low-THC
  371  cannabis to registered patients statewide or regionally as
  372  determined by the department.
  373         5. The financial ability to maintain operations for the
  374  duration of the 2-year approval cycle, including the provision
  375  of certified financials to the department. Upon approval, the
  376  applicant must post a $5 million performance bond.
  377         6. That all owners and managers have been fingerprinted and
  378  have successfully passed a level 2 background screening pursuant
  379  to s. 435.04.
  380         7. The employment of a medical director who is a physician
  381  licensed under chapter 458 or chapter 459 to supervise the
  382  activities of the dispensing organization.
  383         (e) The department shall inspect each dispensing
  384  organization’s properties, cultivation facilities, processing
  385  facilities, and retail facilities before they begin operations
  386  and at least once every 2 years thereafter. The department may
  387  conduct additional announced or unannounced inspections,
  388  including followup inspections, at reasonable hours in order to
  389  ensure that such property and facilities maintain compliance
  390  with all applicable requirements in subsections (6) and (7) and
  391  to ensure that the dispensing organization has not committed any
  392  other act that would endanger the health, safety, or security of
  393  a qualified patient, dispensing organization staff, or the
  394  community in which the dispensing organization is located.
  395  Licensure under this section constitutes permission for the
  396  department to enter and inspect the premises and facilities of
  397  any dispensing organization. The department may inspect any
  398  licensed dispensing organization, and a dispensing organization
  399  must make all facility premises, equipment, documents, low-THC
  400  cannabis, and low-THC cannabis products available to the
  401  department upon inspection. The department may test any low-THC
  402  cannabis or low-THC cannabis product in order to ensure that it
  403  is safe for human consumption and that it meets the requirements
  404  in this section.
  405         (f)The department may suspend or revoke a license, deny or
  406  refuse to renew a license, or impose an administrative penalty
  407  not to exceed $10,000 for the following acts or omissions:
  408         1.A violation of this section or department rule.
  409         2.Failing to maintain qualifications for licensure.
  410         3.Endangering the health, safety, or security of a
  411  qualified patient.
  412         4.Improperly disclosing personal and confidential
  413  information of the qualified patient.
  414         5.Attempting to procure a license by bribery or fraudulent
  415  misrepresentation.
  416         6.Being convicted or found guilty of, or entering a plea
  417  of nolo contendere to, regardless of adjudication, a crime in
  418  any jurisdiction which directly relates to the business of a
  419  dispensing organization.
  420         7.Making or filing a report or record that the licensee
  421  knows to be false.
  422         8.Willfully failing to maintain a record required by this
  423  section or rule of the department.
  424         9.Willfully impeding or obstructing an employee or agent
  425  of the department in the furtherance of his or her official
  426  duties.
  427         10.Engaging in fraud or deceit, negligence, incompetence,
  428  or misconduct in the business practices of a dispensing
  429  organization.
  430         11.Making misleading, deceptive, or fraudulent
  431  representations in or related to the business practices of a
  432  dispensing organization.
  433         12.Having a license or the authority to engage in any
  434  regulated profession, occupation, or business that is related to
  435  the business practices of a dispensing organization revoked,
  436  suspended, or otherwise acted against, including the denial of
  437  licensure, by the licensing authority of any jurisdiction,
  438  including its agencies or subdivisions, for a violation that
  439  would constitute a violation under state law. A licensing
  440  authority’s acceptance of a relinquishment of licensure or a
  441  stipulation, consent order, or other settlement, offered in
  442  response to or in anticipation of the filing of charges against
  443  the license, shall be construed as an action against the
  444  license.
  445         13.Violating a lawful order of the department or an agency
  446  of the state, or failing to comply with a lawfully issued
  447  subpoena of the department or an agency of the state.
  448         (g) The department shall create a permitting process for
  449  all dispensing organization vehicles used for the transportation
  450  of low-THC cannabis or low-THC cannabis products.
  451         (h)(c)The department shall monitor physician registration
  452  and ordering of low-THC cannabis for ordering practices that
  453  could facilitate unlawful diversion or misuse of low-THC
  454  cannabis and take disciplinary action as indicated.
  455         (i)(d)The department shall adopt rules as necessary to
  456  implement this section.
  457         (6) DISPENSING ORGANIZATION.—
  458         (a) An applicant seeking licensure as a dispensing
  459  organization, or the renewal of its license, must submit an
  460  application to the department. The department must review all
  461  applications for completeness, including an appropriate
  462  inspection of the applicant’s property and facilities to verify
  463  the authenticity of the information provided in, or in
  464  connection with, the application. An applicant authorizes the
  465  department to inspect his or her property and facilities for
  466  licensure by applying under this subsection.
  467         (b) In order to receive or maintain licensure as a
  468  dispensing organization, an applicant must provide proof that:
  469         1.The applicant, or a separate entity that is owned solely
  470  by the same persons or entities in the same ratio as the
  471  applicant, possesses a valid certificate of registration issued
  472  by the Department of Agriculture and Consumer Services pursuant
  473  to s. 581.131 for the cultivation of more than 400,000 plants,
  474  is operated by a nurseryman as defined in s. 581.011, and has
  475  been operated as a registered nursery in this state for at least
  476  30 continuous years.
  477         2. The personnel on staff or under contract for the
  478  applicant have experience cultivating and introducing multiple
  479  varieties of plants in this state, including plants that are not
  480  native to Florida; experience with propagating plants; and
  481  experience with genetic modification or breeding of plants.
  482         3. The personnel on staff or under contract for the
  483  applicant include at least one person who:
  484         a. Has at least 5 years’ experience with United States
  485  Department of Agriculture Good Agricultural Practices and Good
  486  Handling Practices;
  487         b. Has at least 5 years’ experience with United States Food
  488  and Drug Administration Good Manufacturing Practices for food
  489  production;
  490         c. Has a doctorate degree in organic chemistry or
  491  microbiology;
  492         d. Has at least 5 years of experience with laboratory
  493  procedures which includes analytical laboratory quality control
  494  measures, chain of custody procedures, and analytical laboratory
  495  methods;
  496         e. Has experience with cannabis cultivation and processing,
  497  including cannabis extraction techniques and producing cannabis
  498  products;
  499         f. Has experience and qualifications in chain of custody or
  500  other tracking mechanisms;
  501         g. Works solely on inventory control; and
  502         h. Works solely for security purposes.
  503         4. The persons who have a direct or indirect interest in
  504  the dispensing organization and the applicant’s managers,
  505  employees, and contractors who directly interact with low-THC
  506  cannabis or low-THC cannabis products have been fingerprinted
  507  and have successfully passed a level 2 background screening
  508  pursuant to s. 435.04.
  509         5. The applicant owns, or has at least a 2-year lease of,
  510  all properties, facilities, and equipment necessary for the
  511  cultivation and processing of low-THC cannabis. The applicant
  512  must provide a detailed description of each facility and its
  513  equipment, a cultivation and processing plan, and a detailed
  514  floor plan. The description must include proof that:
  515         a. The applicant is capable of sufficient cultivation and
  516  processing to serve at least 15,000 patients with an assumed
  517  daily use of 1,000 mg per patient per day of low-THC cannabis or
  518  low-THC cannabis product;
  519         b. The applicant has arranged for access to all utilities
  520  and resources necessary to cultivate or process low-THC cannabis
  521  at each listed facility; and
  522         c. Each facility is secured and has theft-prevention
  523  systems including an alarm system, cameras, and 24-hour security
  524  personnel.
  525         6. The applicant has diversion and tracking prevention
  526  procedures, including:
  527         a. A system for tracking low-THC material through
  528  cultivation, processing, and dispensing, including the use of
  529  batch and harvest numbers;
  530         b. An inventory control system for low-THC cannabis and
  531  low-THC cannabis products;
  532         c. A vehicle tracking and security system; and
  533         d. A cannabis waste-disposal plan.
  534         7. The applicant has recordkeeping policies and procedures
  535  in place.
  536         8. The applicant has a facility emergency management plan.
  537         9. The applicant has a plan for dispensing low-THC cannabis
  538  throughout the state. This plan must include planned retail
  539  facilities and a delivery plan for providing low-THC cannabis
  540  and low-THC cannabis products to qualified patients who cannot
  541  travel to a retail facility.
  542         10. The applicant has financial documentation, including:
  543         a. Documentation that demonstrates the applicant’s
  544  financial ability to operate. If the applicant’s assets, credit,
  545  and projected revenues meet or exceed projected liabilities and
  546  expenses and the applicant provides independent evidence that
  547  the funds necessary for startup costs, working capital, and
  548  contingency financing exist and are available as needed, the
  549  applicant has demonstrated the financial ability to operate.
  550  Financial ability to operate must be documented by:
  551         I. The applicant’s audited financial statements. If the
  552  applicant is a newly formed entity and does not have a financial
  553  history of business upon which audited financial statements may
  554  be submitted, the applicant must provide audited financial
  555  statements for the separate entity that is owned solely by the
  556  same persons or entities in the same ratio as the applicant that
  557  possesses the valid certificate of registration issued by the
  558  Department of Agriculture and Consumer Services;
  559         II.The applicant’s projected financial statements,
  560  including a balance sheet, an income and expense statement, and
  561  a statement of cash flow for the first 2 years of operation,
  562  which provides evidence that the applicant has sufficient
  563  assets, credit, and projected revenues to cover liabilities and
  564  expenses; and
  565         III.A statement of the applicant’s estimated startup costs
  566  and sources of funds, including a break-even projection and
  567  documentation demonstrating that the applicant has the ability
  568  to fund all startup costs, working capital costs, and
  569  contingency financing requirements.
  570  
  571  All documents required under this sub-subparagraph shall be
  572  prepared in accordance with generally accepted accounting
  573  principles and signed by a certified public accountant. The
  574  statements required by sub-sub-subparagraph II. and III. may be
  575  presented as a compilation.
  576         b.A list of all subsidiaries of the applicant;
  577         c.A list of all lawsuits pending and completed within the
  578  past 7 years of which the applicant was a party; and
  579         d.Proof of a $1 million performance and compliance bond,
  580  or other equivalent means of security deemed equivalent by the
  581  department, such as an irrevocable letter of credit or a deposit
  582  in a trust account or financial institution, payable to the
  583  department, which must be posted once the applicant is approved
  584  as a dispensing organization. The purpose of the bond is to
  585  secure payment of any administrative penalties imposed by the
  586  department and any fees and costs incurred by the department
  587  regarding the dispensing organization license, such as the
  588  dispensing organization failing to pay 30 days after the fine or
  589  costs become final. The department may make a claim against such
  590  bond or security until 1 year after the dispensing
  591  organization’s license ceases to be valid or until 60 days after
  592  any administrative or legal proceeding authorized in this
  593  section involving the dispensing organization concludes,
  594  including any appeal, whichever occurs later.
  595         11. The employment of a medical director who is a physician
  596  licensed under chapter 458 or chapter 459 to supervise the
  597  activities of the dispensing organization.
  598         (c) An approved dispensing organization shall maintain
  599  compliance with the criteria in paragraphs (b), (d), and (e) and
  600  subsection (7) demonstrated for selection and approval as a
  601  dispensing organization under subsection (5) at all times.
  602  Before dispensing low-THC cannabis or low-THC cannabis products
  603  to a qualified patient or to the qualified patient’s legal
  604  representative, the dispensing organization shall verify the
  605  identity of the qualified patient or the qualified patient’s
  606  legal representative by requiring the qualified patient or the
  607  qualified patient’s legal representative to produce a
  608  government-issued identification card and shall verify that the
  609  qualified patient and the qualified patient’s legal
  610  representative have has an active registration in the
  611  compassionate use registry, that the order presented matches the
  612  order contents as recorded in the registry, and that the order
  613  has not already been filled. Upon dispensing the low-THC
  614  cannabis, the dispensing organization shall record in the
  615  registry the date, time, quantity, and form of low-THC cannabis
  616  dispensed.
  617         (d) A dispensing organization may have cultivation
  618  facilities, processing facilities, and retail facilities.
  619         1. All matters regarding the location of cultivation
  620  facilities and processing facilities are preempted to the state.
  621  Cultivation facilities and processing facilities must be closed
  622  to the public, and low-THC cannabis may not be dispensed on the
  623  premises of such facilities.
  624         2. A municipality must determine by ordinance the criteria
  625  for the number, location, and other permitting requirements for
  626  all retail facilities located within its municipal boundaries. A
  627  retail facility may be established in a municipality only after
  628  such an ordinance has been created. A county must determine by
  629  ordinance the criteria for the number, location, and other
  630  permitting requirements for all retail facilities located within
  631  the unincorporated areas of that county. A retail facility may
  632  be established in the unincorporated areas of a county only
  633  after such an ordinance has been created. Retail facilities must
  634  have all utilities and resources necessary to store and dispense
  635  low-THC cannabis and low-THC cannabis products. Retail
  636  facilities must be secured and have theft-prevention systems,
  637  including an alarm system, cameras, and 24-hour security
  638  personnel. Retail facilities may not sell, or contract for the
  639  sale of, anything other than low-THC cannabis or low-THC
  640  cannabis products on the property of the retail facility. Before
  641  a retail facility may dispense low-THC cannabis or a low-THC
  642  cannabis product, the dispensing organization must have a
  643  computer network compliant with the federal Health Insurance
  644  Portability and Accountability Act of 1996 which is able to
  645  access and upload data to the compassionate use registry and
  646  which shall be used by all retail facilities.
  647         (e) Within 15 days of such information becoming available,
  648  a dispensing organization must provide the department with
  649  updated information, as applicable, including:
  650         1. The location and a detailed description of any new or
  651  proposed facilities.
  652         2. The updated contact information, including electronic
  653  and voice communication, for all dispensing organization
  654  facilities.
  655         3. The registration information for any vehicles used for
  656  the transportation of low-THC cannabis and low-THC cannabis
  657  product, including confirmation that all such vehicles have
  658  tracking and security systems.
  659         4. A plan for the recall of any or all low-THC cannabis or
  660  low-THC cannabis product.
  661         (f)1. A dispensing organization may transport low-THC
  662  cannabis or low-THC cannabis products in vehicles departing from
  663  their places of business only in vehicles that are owned or
  664  leased by the licensee or by a person designated by the
  665  dispensing organization, and for which a valid vehicle permit
  666  has been issued for such vehicle by the department.
  667         2.A vehicle owned or leased by the dispensing organization
  668  or a person designated by the dispensing organization and
  669  approved by the department must be operated by such person when
  670  transporting low-THC cannabis or low-THC products from the
  671  licensee’s place of business.
  672         3.A vehicle permit may be obtained by a dispensing
  673  organization upon application and payment of a fee of $5 per
  674  vehicle to the department. The signature of the person
  675  designated by the dispensing organization to drive the vehicle
  676  must be included on the vehicle permit application. Such permit
  677  remains valid and does not expire unless the licensee or any
  678  person designated by the dispensing organization disposes of his
  679  or her vehicle, or the licensee’s license is transferred,
  680  canceled, not renewed, or is revoked by the department,
  681  whichever occurs first. The department shall cancel a vehicle
  682  permit upon request of the licensee or owner of the vehicle.
  683         4.By acceptance of a license issued under this section,
  684  the licensee agrees that the licensed vehicle is, at all times
  685  it is being used to transport low-THC cannabis or low-THC
  686  cannabis products, subject to inspection and search without a
  687  search warrant by authorized employees of the department,
  688  sheriffs, deputy sheriffs, police officers, or other law
  689  enforcement officers to determine that the licensee is
  690  transporting such products in compliance with this section.
  691         (7)TESTING AND LABELING OF LOW-THC CANNABIS.
  692         (a)All low-THC cannabis and low-THC cannabis products must
  693  be tested by an independent testing laboratory before the
  694  dispensing organization may dispense them. The independent
  695  testing laboratory shall provide the dispensing organization
  696  with lab results. Before dispensing, the dispensing organization
  697  must determine that the lab results indicate that the low-THC
  698  cannabis or low-THC cannabis product meets the definition of
  699  low-THC cannabis or low-THC cannabis product, is safe for human
  700  consumption, and is free from harmful contaminants.
  701         (b)All low-THC cannabis and low-THC cannabis products must
  702  be labeled before dispensing. The label must include, at a
  703  minimum:
  704         1. A statement that the low-THC cannabis or low-THC
  705  cannabis product meets the requirements in paragraph (a);
  706         2.The name of the independent testing laboratory that
  707  tested the low-THC cannabis or low-THC cannabis product;
  708         3.The name of the cultivation and processing facility
  709  where the low-THC cannabis or low-THC cannabis product
  710  originates; and
  711         4.The batch number and harvest number from which the low
  712  THC cannabis or low-THC cannabis product originates.
  713         (8) SAFETY AND EFFICACY RESEARCH FOR LOW-THC CANNABIS.—The
  714  University of Florida College of Pharmacy must establish and
  715  maintain a safety and efficacy research program for the use of
  716  low-THC cannabis or low-THC cannabis products to treat
  717  qualifying conditions and symptoms. The program must include a
  718  fully integrated electronic information system for the broad
  719  monitoring of health outcomes and safety signal detection. The
  720  electronic information system must include information from the
  721  compassionate use registry; provider reports, including
  722  treatment plans, adverse event reports, and treatment
  723  discontinuation reports; patient reports of adverse impacts;
  724  event-triggered interviews and medical chart reviews performed
  725  by University of Florida clinical research staff; information
  726  from external databases, including Medicaid billing reports and
  727  information in the prescription drug monitoring database for
  728  registered patients; and all other medical reports required by
  729  the University of Florida to conduct the research required by
  730  this subsection. The department must provide access to
  731  information from the compassionate use registry and the
  732  prescription drug monitoring database, established in s.
  733  893.055, as needed by the University of Florida to conduct
  734  research under this subsection. The Agency for Health Care
  735  Administration must provide access to registered patient
  736  Medicaid records, to the extent allowed under federal law, as
  737  needed by the University of Florida to conduct research under
  738  this subsection.
  739         (9)(7) EXCEPTIONS TO OTHER LAWS.—
  740         (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  741  any other provision of law, but subject to the requirements of
  742  this section, a qualified patient and the qualified patient’s
  743  legal representative who is registered with the department on
  744  the compassionate use registry may purchase and possess for the
  745  patient’s medical use up to the amount of low-THC cannabis
  746  ordered for the patient. Nothing in this section exempts any
  747  person from the prohibition against driving under the influence
  748  provided in s. 316.193.
  749         (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  750  any other provision of law, but subject to the requirements of
  751  this section, an approved dispensing organization and its
  752  owners, managers, and employees and the owners, managers, and
  753  employees of contractors who have direct contact with low-THC
  754  cannabis or low-THC cannabis product may manufacture, possess,
  755  sell, deliver, distribute, dispense, and lawfully dispose of
  756  reasonable quantities, as established by department rule, of
  757  low-THC cannabis. For purposes of this subsection, the terms
  758  “manufacture,” “possession,” “deliver,” “distribute,” and
  759  “dispense” have the same meanings as provided in s. 893.02.
  760         (c) An approved dispensing organization and its owners,
  761  managers, and employees are not subject to licensure or
  762  regulation under chapter 465 or chapter 499 for manufacturing,
  763  possessing, selling, delivering, distributing, dispensing, or
  764  lawfully disposing of reasonable quantities, as established by
  765  department rule, of low-THC cannabis.
  766         (d) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  767  any other law, but subject to the requirements of this section,
  768  a licensed laboratory and its employees may receive and possess
  769  low-THC cannabis for the sole purpose of testing the low-THC
  770  cannabis to ensure compliance with this section.
  771         (10) Rules adopted by the department under this section are
  772  exempt from the requirement that they be ratified by the
  773  Legislature pursuant to s. 120.541(3).
  774         Section 2. Paragraph (g) is added to subsection (3) of
  775  section 381.987, Florida Statutes, to read:
  776         381.987 Public records exemption for personal identifying
  777  information in the compassionate use registry.—
  778         (3) The department shall allow access to the registry,
  779  including access to confidential and exempt information, to:
  780         (g) Persons engaged in research at the University of
  781  Florida pursuant to s. 381.986(8).
  782         Section 3. Paragraph (b) of subsection (7) of section
  783  893.055, Florida Statutes, is amended to read:
  784         893.055 Prescription drug monitoring program.—
  785         (7)
  786         (b) A pharmacy, prescriber, or dispenser shall have access
  787  to information in the prescription drug monitoring program’s
  788  database which relates to a patient of that pharmacy,
  789  prescriber, or dispenser in a manner established by the
  790  department as needed for the purpose of reviewing the patient’s
  791  controlled substance prescription history. Persons engaged in
  792  research at the University of Florida pursuant to s. 381.986(8)
  793  shall have access to information in the prescription drug
  794  monitoring program’s database which relates to qualified
  795  patients as defined in s. 381.986(1) for the purpose of
  796  conducting such research. Other access to the program’s database
  797  shall be limited to the program’s manager and to the designated
  798  program and support staff, who may act only at the direction of
  799  the program manager or, in the absence of the program manager,
  800  as authorized. Access by the program manager or such designated
  801  staff is for prescription drug program management only or for
  802  management of the program’s database and its system in support
  803  of the requirements of this section and in furtherance of the
  804  prescription drug monitoring program. Confidential and exempt
  805  information in the database shall be released only as provided
  806  in paragraph (c) and s. 893.0551. The program manager,
  807  designated program and support staff who act at the direction of
  808  or in the absence of the program manager, and any individual who
  809  has similar access regarding the management of the database from
  810  the prescription drug monitoring program shall submit
  811  fingerprints to the department for background screening. The
  812  department shall follow the procedure established by the
  813  Department of Law Enforcement to request a statewide criminal
  814  history record check and to request that the Department of Law
  815  Enforcement forward the fingerprints to the Federal Bureau of
  816  Investigation for a national criminal history record check.
  817         Section 4. Paragraph (h) is added to subsection (3) of
  818  section 893.0551, Florida Statutes, to read:
  819         893.0551 Public records exemption for the prescription drug
  820  monitoring program.—
  821         (3) The department shall disclose such confidential and
  822  exempt information to the following persons or entities upon
  823  request and after using a verification process to ensure the
  824  legitimacy of the request as provided in s. 893.055:
  825         (h) Persons engaged in research at the University of
  826  Florida pursuant to s. 381.986(8).
  827         Section 5. This act shall take effect upon becoming a law.