Florida Senate - 2015                      CS for CS for SB 7066
       
       
        
       By the Committees on Rules; Health Policy; and Regulated
       Industries
       
       
       
       
       595-03805-15                                          20157066c2
    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; requiring the department to select two
   20         applicants in specified regions for licensure as a
   21         dispensing organization; requiring the department to
   22         issue 10 additional licenses to qualified applicants
   23         by lottery; authorizing applicants to operate in any
   24         region of the state; prohibiting a dispensing
   25         organization from having cultivation or processing
   26         facilities outside the region in which it is licensed;
   27         requiring the department to select by lottery another
   28         applicant in certain circumstances; requiring the
   29         department to conduct a new lottery after the
   30         revocation or the denial of renewal of a license;
   31         requiring the department to conduct a lottery at
   32         specified intervals if there are available dispensing
   33         organization licenses; providing an exemption for the
   34         application process; requiring the department to use
   35         an application form that requires specified
   36         information from the applicant; requiring the
   37         department to impose specified application fees;
   38         requiring the department to inspect each dispensing
   39         organization’s properties, cultivation facilities,
   40         processing facilities, and retail facilities before
   41         those facilities may operate; authorizing followup
   42         inspections at reasonable hours; providing that
   43         licensure constitutes permission for the department to
   44         enter and inspect the premises and facilities of any
   45         dispensing organization; authorizing the department to
   46         inspect any licensed dispensing organization;
   47         requiring dispensing organizations to make all
   48         facility premises, equipment, documents, low-THC
   49         cannabis, and low-THC cannabis products available to
   50         the department upon inspection; authorizing the
   51         department to test low-THC cannabis or low-THC
   52         cannabis products; authorizing the department to
   53         suspend or revoke a license, deny or refuse to renew a
   54         license, or impose a maximum administrative penalty
   55         for specified acts or omissions; requiring the
   56         department to create a permitting process for vehicles
   57         used for the transportation of low-THC cannabis or
   58         low-THC cannabis products; authorizing the department
   59         to adopt rules as necessary for implementation of
   60         specified provisions and procedures, and to provide
   61         specified guidance; providing procedures and
   62         requirements for an applicant seeking licensure as a
   63         dispensing organization or the renewal of its license;
   64         requiring the dispensing organization to verify
   65         specified information of specified persons in certain
   66         circumstances; authorizing a dispensing organization
   67         to have cultivation facilities, processing facilities,
   68         and retail facilities; authorizing a retail facility
   69         to be established in a municipality only after such an
   70         ordinance has been created; authorizing a retail
   71         facility to be established in the unincorporated areas
   72         of a county only after such an ordinance has been
   73         created; requiring retail facilities to have all
   74         utilities and resources necessary to store and
   75         dispense low-THC and low-THC cannabis products;
   76         requiring retail facilities to be secured with
   77         specified theft-prevention systems; requiring a
   78         dispensing organization to provide the department with
   79         specified updated information within a specified
   80         period; authorizing a dispensing organization to
   81         transport low-THC cannabis or low-THC cannabis
   82         products in vehicles in certain circumstances;
   83         requiring such vehicles to be operated by specified
   84         persons in certain circumstances; requiring a fee for
   85         a vehicle permit; requiring the signature of the
   86         designated driver with a vehicle permit application;
   87         providing for expiration of the permit in certain
   88         circumstances; requiring the department to cancel a
   89         vehicle permit upon the request of specified persons;
   90         providing that the licensee authorizes the inspection
   91         and search of his or her vehicle without a search
   92         warrant by specified persons; requiring all low-THC
   93         cannabis and low-THC cannabis products to be tested by
   94         an independent testing laboratory before the
   95         dispensing organization may dispense it; requiring the
   96         independent testing laboratory to provide the lab
   97         results to the dispensing organization for a specified
   98         determination; requiring all low-THC cannabis and low
   99         THC cannabis products to be labeled with specified
  100         information before dispensing; requiring the
  101         University of Florida College of Pharmacy to establish
  102         and maintain a specified safety and efficacy research
  103         program; providing program requirements; requiring the
  104         department to provide information from the
  105         prescription drug monitoring program to the University
  106         of Florida as needed; requiring the Agency for Health
  107         Care Administration to provide access to specified
  108         patient records under certain circumstances;
  109         prohibiting persons who have direct or indirect
  110         interest in a dispensing organization and the
  111         dispensing organization’s managers, employees, and
  112         contractors who directly interact with low-THC
  113         cannabis and low-THC cannabis products from making
  114         recommendations, offering prescriptions, or providing
  115         medical advice to qualified patients; providing that
  116         the act does not provide an exception to the
  117         prohibition against driving under the influence;
  118         authorizing specified individuals to manufacture,
  119         possess, sell, deliver, distribute, dispense, and
  120         lawfully dispose of reasonable quantities of low-THC
  121         cannabis; authorizing a licensed laboratory and its
  122         employees to receive and possess low-THC cannabis in
  123         certain circumstances; providing that specified rules
  124         adopted by the department are exempt from the
  125         requirement to be ratified by the Legislature;
  126         amending s. 381.987, F.S.; requiring the department to
  127         allow specified persons engaged in research to access
  128         the compassionate use registry; amending s. 893.055,
  129         F.S.; providing that persons engaged in research at
  130         the University of Florida shall have access to
  131         specified information; amending s. 893.0551, F.S.;
  132         providing a specified public records exemption for
  133         persons engaged in research at the University of
  134         Florida; providing an effective date.
  135          
  136  Be It Enacted by the Legislature of the State of Florida:
  137  
  138         Section 1. Section 381.986, Florida Statutes, is amended to
  139  read:
  140         381.986 Compassionate use of low-THC cannabis.—
  141         (1) DEFINITIONS.—As used in this section, the term:
  142         (a) “Applicant” means a person that has submitted an
  143  application to the department for licensure or renewal as a
  144  dispensing organization.
  145         (b) “Batch” means a specific quantity of low-THC cannabis
  146  product that is intended to have uniform character and quality,
  147  within specified limits, and is produced at the same time from
  148  one or more harvests.
  149         (c) “Dispensing organization” means an applicant licensed
  150  organization approved by the department to cultivate, process,
  151  and dispense low-THC cannabis pursuant to this section.
  152         (d) “Harvest” means a specifically identified and numbered
  153  quantity of low-THC cannabis cultivated using the same
  154  herbicides, pesticides, and fungicides and harvested at the same
  155  time from a single facility.
  156         (e) “Independent testing laboratory” means a laboratory,
  157  and the managers, employees, or contractors of the laboratory,
  158  which have no direct or indirect interest in a dispensing
  159  organization.
  160         (f)(b) “Low-THC cannabis” means a plant of the genus
  161  Cannabis, the dried flowers of which contain 0.8 percent or less
  162  of tetrahydrocannabinol and more than 10 percent of cannabidiol
  163  weight for weight; the seeds thereof; the resin extracted from
  164  any part of such plant; or any compound, manufacture, salt,
  165  derivative, mixture, or preparation of such plant or its seeds
  166  or resin that is dispensed only from a dispensing organization.
  167         (g) “Low-THC cannabis product” means any product derived
  168  from low-THC cannabis, including the resin extracted from any
  169  part of such plant or any compound, manufacture, salt,
  170  derivative, mixture, or preparation of such plant or its seeds
  171  or resin which is dispensed from a dispensing organization. Low
  172  THC cannabis products include, but are not limited to, oils,
  173  tinctures, creams, encapsulations, and food products. Low-THC
  174  cannabis food products may not include candy or similar
  175  confectionary products that appeal to children. All low-THC
  176  cannabis products must maintain concentrations, weight for
  177  weight, of 0.8 percent or less of tetrahydrocannabinol and more
  178  than 10 percent of cannabidiol.
  179         (h)(c) “Medical use” means administration of the ordered
  180  amount of low-THC cannabis. The term does not include:
  181         1. The possession, use, or administration by smoking.
  182         2.The term also does not include The transfer of low-THC
  183  cannabis to a person other than the qualified patient for whom
  184  it was ordered or the qualified patient’s legal representative
  185  who is registered in the compassionate use registry on behalf of
  186  the qualified patient.
  187         3. The use or administration of low-THC cannabis or low-THC
  188  cannabis products:
  189         a. On any form of public transportation.
  190         b. In any public place.
  191         c. In a registered qualified patient’s place of work, if
  192  restricted by his or her employer.
  193         d. In a correctional facility.
  194         e. On the grounds of any preschool, primary school, or
  195  secondary school.
  196         f. On a school bus.
  197         (i)(d) “Qualified patient” means a resident of this state
  198  who has been added to the compassionate use registry by a
  199  physician licensed under chapter 458 or chapter 459 to receive
  200  low-THC cannabis from a dispensing organization.
  201         (j)(e) “Smoking” means burning or igniting a substance and
  202  inhaling the smoke. Smoking does not include the use of a
  203  vaporizer.
  204         (2) PHYSICIAN ORDERING.—
  205         (a)Effective January 1, 2015, A physician licensed under
  206  chapter 458 or chapter 459 who has examined and is treating a
  207  patient suffering from cancer, human immunodeficiency virus,
  208  acquired immune deficiency syndrome, epilepsy, amyotrophic
  209  lateral sclerosis, autism, multiple sclerosis, Crohn’s disease,
  210  Parkinson’s disease, paraplegia, quadriplegia, or terminal
  211  illness a physical medical condition that chronically produces
  212  symptoms of seizures or severe and persistent muscle spasms may
  213  order for the patient’s medical use low-THC cannabis to treat
  214  such disease, disorder, or condition; or to alleviate symptoms
  215  of such disease, disorder, or condition; or to alleviate
  216  symptoms caused by a treatment for such disease, disorder, or
  217  condition, if no other satisfactory alternative treatment
  218  options exist for that patient and all of the following
  219  conditions apply:
  220         1.(a) The patient is a permanent resident of this state.
  221         2.(b) The physician determines that the risks of ordering
  222  low-THC cannabis are reasonable in light of the potential
  223  benefit for that patient. If a patient is younger than 18 years
  224  of age, a second physician must concur with this determination,
  225  and such determination must be documented in the patient’s
  226  medical record.
  227         3.(c) The physician registers the patient, the patient’s
  228  legal representative if requested by the patient, and himself or
  229  herself as the orderer of low-THC cannabis for the named patient
  230  on the compassionate use registry maintained by the department
  231  and updates the registry to reflect the contents of the order.
  232  If the patient is a minor, the physician must register a legal
  233  representative on the compassionate use registry. The physician
  234  shall deactivate the patient’s registration when treatment is
  235  discontinued.
  236         4.(d) The physician maintains a patient treatment plan that
  237  includes the dose, route of administration, planned duration,
  238  and monitoring of the patient’s symptoms and other indicators of
  239  tolerance or reaction to the low-THC cannabis.
  240         5.(e) The physician submits the patient treatment plan, as
  241  well as any other requested medical records, quarterly to the
  242  University of Florida College of Pharmacy for research on the
  243  safety and efficacy of low-THC cannabis on patients pursuant to
  244  subsection (8).
  245         6.(f) The physician obtains the voluntary informed consent
  246  of the patient or the patient’s legal guardian to treatment with
  247  low-THC cannabis after sufficiently explaining the current state
  248  of knowledge in the medical community of the effectiveness of
  249  treatment of the patient’s conditions or symptoms condition with
  250  low-THC cannabis, the medically acceptable alternatives, and the
  251  potential risks and side effects.
  252         (b)A physician who improperly orders low-THC cannabis is
  253  subject to disciplinary action under the applicable practice act
  254  and under s. 456.072(1)(k).
  255         (3) PENALTIES.—
  256         (a) A physician commits a misdemeanor of the first degree,
  257  punishable as provided in s. 775.082 or s. 775.083, if the
  258  physician orders low-THC cannabis for a patient without a
  259  reasonable belief that the patient is suffering from at least
  260  one of the conditions listed in subsection (2).:
  261         1. Cancer or a physical medical condition that chronically
  262  produces symptoms of seizures or severe and persistent muscle
  263  spasms that can be treated with low-THC cannabis; or
  264         2. Symptoms of cancer or a physical medical condition that
  265  chronically produces symptoms of seizures or severe and
  266  persistent muscle spasms that can be alleviated with low-THC
  267  cannabis.
  268         (b) Any person who fraudulently represents that he or she
  269  has at least one condition listed in subsection (2) cancer or a
  270  physical medical condition that chronically produces symptoms of
  271  seizures or severe and persistent muscle spasms to a physician
  272  for the purpose of being ordered low-THC cannabis by such
  273  physician commits a misdemeanor of the first degree, punishable
  274  as provided in s. 775.082 or s. 775.083.
  275         (4) PHYSICIAN EDUCATION.—
  276         (a) Before ordering low-THC cannabis for use by a patient
  277  in this state, the appropriate board shall require the ordering
  278  physician licensed under chapter 458 or chapter 459 to
  279  successfully complete an 8-hour course and subsequent
  280  examination offered by the Florida Medical Association or the
  281  Florida Osteopathic Medical Association that encompasses the
  282  clinical indications for the appropriate use of low-THC
  283  cannabis, the appropriate delivery mechanisms, the
  284  contraindications for such use, as well as the relevant state
  285  and federal laws governing the ordering, dispensing, and
  286  possessing of this substance. The first course and examination
  287  shall be presented by October 1, 2014, and shall be administered
  288  at least annually thereafter. Successful completion of the
  289  course may be used by a physician to satisfy 8 hours of the
  290  continuing medical education requirements required by his or her
  291  respective board for licensure renewal. This course may be
  292  offered in a distance learning format.
  293         (b) The appropriate board shall require the medical
  294  director of each dispensing organization approved under
  295  subsection (5) to successfully complete a 2-hour course and
  296  subsequent examination offered by the Florida Medical
  297  Association or the Florida Osteopathic Medical Association that
  298  encompasses appropriate safety procedures and knowledge of low
  299  THC cannabis.
  300         (c) Successful completion of the course and examination
  301  specified in paragraph (a) is required for every physician who
  302  orders low-THC cannabis each time such physician renews his or
  303  her license. In addition, successful completion of the course
  304  and examination specified in paragraph (b) is required for the
  305  medical director of each dispensing organization each time such
  306  physician renews his or her license.
  307         (d) A physician who fails to comply with this subsection
  308  and who orders low-THC cannabis may be subject to disciplinary
  309  action under the applicable practice act and under s.
  310  456.072(1)(k).
  311         (5) DUTIES AND POWERS OF THE DEPARTMENT.—By January 1,
  312  2015, The department shall:
  313         (a) The department shall create a secure, electronic, and
  314  online compassionate use registry for the registration of
  315  physicians and patients as provided under this section. The
  316  registry must be accessible to law enforcement agencies and to a
  317  dispensing organization in order to verify patient authorization
  318  for low-THC cannabis and record the low-THC cannabis dispensed.
  319  The registry must prevent an active registration of a patient by
  320  multiple physicians.
  321         (b)1.Beginning 7 days after the effective date of this
  322  act, the department shall accept applications for licensure as a
  323  dispensing organization. The department shall review each
  324  application to determine whether the applicant meets the
  325  criteria in subsection (6) and qualifies for licensure.
  326         2. Within 10 days after receiving an application for
  327  licensure, the department shall examine the application, notify
  328  the applicant of any apparent errors or omissions, and request
  329  any additional information the department is allowed by law to
  330  require. An application for licensure must be filed with the
  331  department no later than 5 p.m. on the 30th day after the
  332  effective date of this act, and all applications must be
  333  complete no later than 5 p.m. on the 60th day after the
  334  effective date of this act.
  335         3.Prior to the 75th day after the effective date of this
  336  act, the department shall select by lottery two applicants who
  337  meet the criteria in subsection (6) in each of the following
  338  regions:
  339         a.Northwest Florida, consisting of Bay, Calhoun, Escambia,
  340  Franklin, Gadsden, Gulf, Holmes, Jackson, Jefferson, Leon,
  341  Liberty, Madison, Santa Rosa, Okaloosa, Taylor, Wakulla, Walton,
  342  and Washington Counties.
  343         b.Northeast Florida, consisting of Alachua, Baker,
  344  Bradford, Clay, Columbia, Dixie, Duval, Flagler, Gilchrist,
  345  Hamilton, Lafayette, Levy, Marion, Nassau, Putnam, St. Johns,
  346  Suwannee, and Union Counties.
  347         c.Central Florida, consisting of Brevard, Citrus, Hardee,
  348  Hernando, Hillsborough, Indian River, Lake, Orange, Osceola,
  349  Pasco, Pinellas, Polk, Seminole, St. Lucie, Sumter, and Volusia
  350  Counties.
  351         d.Southwest Florida, consisting of Charlotte, Collier,
  352  DeSoto, Glades, Hendry, Highlands, Lee, Manatee, Okeechobee, and
  353  Sarasota Counties.
  354         e.Southeast Florida, consisting of Broward, Miami-Dade,
  355  Martin, Monroe, and Palm Beach Counties.
  356         4.After the department has selected by lottery the 10
  357  dispensing organizations pursuant to subparagraph 3., the
  358  department shall select by lottery 10 more applicants who meet
  359  the criteria in subsection (6) for licensure. Once licensed,
  360  those applicants are authorized to operate in any region in the
  361  state, but a dispensing organization may not have cultivation or
  362  processing facilities outside the region in which it is
  363  licensed.
  364         5.The department shall license an applicant selected
  365  pursuant to subparagraph 3. or subparagraph 4. unless the
  366  applicant fails to pay the licensure fee within 10 days of
  367  selection. If a selected applicant fails to timely pay the
  368  licensure fee, the department shall select by lottery another
  369  applicant from the existing pool of eligible applicants.
  370         6.If the department revokes a license or denies the
  371  renewal of a license pursuant to paragraph (f), the department
  372  shall conduct a new lottery using the selection process outlined
  373  in this paragraph. The selection process must begin 24 hours
  374  after such revocation or denial.
  375         7.If the department does not have a sufficient pool of
  376  qualified applicants to issue 2 licenses in each region, or to
  377  license 10 dispensing organizations pursuant to subparagraph 4.,
  378  the department shall conduct a lottery using the process in this
  379  paragraph every 6 months until each region has 2 licensed
  380  dispensing organizations and 10 additional dispensing
  381  organizations are licensed, totaling 20 licensed dispensing
  382  organizations in this state.
  383         8.This section is exempt from s. 120.60(1) Authorize the
  384  establishment of five dispensing organizations to ensure
  385  reasonable statewide accessibility and availability as necessary
  386  for patients registered in the compassionate use registry and
  387  who are ordered low-THC cannabis under this section, one in each
  388  of the following regions: northwest Florida, northeast Florida,
  389  central Florida, southeast Florida, and southwest Florida.
  390         (c) The department shall use develop an application form
  391  that requires the applicant to state:
  392         1. Whether the application is for initial licensure or
  393  renewal licensure;
  394         2. The name, the physical address, the mailing address, the
  395  address listed on the Department of Agriculture and Consumer
  396  Services certificate required in paragraph (6)(b), and the
  397  contact information for the applicant and for the nursery that
  398  holds the Department of Agriculture and Consumer Services
  399  certificate, if different from the applicant;
  400         3. The name, address, and contact information for the
  401  operating nurseryman of the organization that holds the
  402  Department of Agriculture and Consumer Services certificate;
  403         4. The name, address, license number, and contact
  404  information for the applicant’s medical director; and
  405         5. All information required to be included by subsection
  406  (6).
  407         (d) The department shall and impose an initial application
  408  fee of $50,000, an initial licensure fee of $125,000, and a
  409  biennial renewal fee of $125,000 that is sufficient to cover the
  410  costs of administering this section. An applicant for approval
  411  as a dispensing organization must be able to demonstrate:
  412         1. The technical and technological ability to cultivate and
  413  produce low-THC cannabis. The applicant must possess a valid
  414  certificate of registration issued by the Department of
  415  Agriculture and Consumer Services pursuant to s. 581.131 that is
  416  issued for the cultivation of more than 400,000 plants, be
  417  operated by a nurseryman as defined in s. 581.011, and have been
  418  operated as a registered nursery in this state for at least 30
  419  continuous years.
  420         2. The ability to secure the premises, resources, and
  421  personnel necessary to operate as a dispensing organization.
  422         3. The ability to maintain accountability of all raw
  423  materials, finished products, and any byproducts to prevent
  424  diversion or unlawful access to or possession of these
  425  substances.
  426         4. An infrastructure reasonably located to dispense low-THC
  427  cannabis to registered patients statewide or regionally as
  428  determined by the department.
  429         5. The financial ability to maintain operations for the
  430  duration of the 2-year approval cycle, including the provision
  431  of certified financials to the department. Upon approval, the
  432  applicant must post a $5 million performance bond.
  433         6. That all owners and managers have been fingerprinted and
  434  have successfully passed a level 2 background screening pursuant
  435  to s. 435.04.
  436         7. The employment of a medical director who is a physician
  437  licensed under chapter 458 or chapter 459 to supervise the
  438  activities of the dispensing organization.
  439         (e) The department shall inspect each dispensing
  440  organization’s properties, cultivation facilities, processing
  441  facilities, and retail facilities before they begin operations
  442  and at least once every 2 years thereafter. The department may
  443  conduct additional announced or unannounced inspections,
  444  including followup inspections, at reasonable hours in order to
  445  ensure that such property and facilities maintain compliance
  446  with all applicable requirements in subsections (6) and (7) and
  447  to ensure that the dispensing organization has not committed any
  448  other act that would endanger the health, safety, or security of
  449  a qualified patient, dispensing organization staff, or the
  450  community in which the dispensing organization is located.
  451  Licensure under this section constitutes permission for the
  452  department to enter and inspect the premises and facilities of
  453  any dispensing organization. The department may inspect any
  454  licensed dispensing organization, and a dispensing organization
  455  must make all facility premises, equipment, documents, low-THC
  456  cannabis, and low-THC cannabis products available to the
  457  department upon inspection. The department may test any low-THC
  458  cannabis or low-THC cannabis product in order to ensure that it
  459  is safe for human consumption and that it meets the requirements
  460  in this section.
  461         (f)The department may suspend or revoke a license, deny or
  462  refuse to renew a license, or impose an administrative penalty
  463  not to exceed $10,000 for the following acts or omissions:
  464         1.A violation of this section or department rule.
  465         2.Failing to maintain qualifications for licensure.
  466         3.Endangering the health, safety, or security of a
  467  qualified patient.
  468         4.Improperly disclosing personal and confidential
  469  information of the qualified patient.
  470         5.Attempting to procure a license by bribery or fraudulent
  471  misrepresentation.
  472         6.Being convicted or found guilty of, or entering a plea
  473  of nolo contendere to, regardless of adjudication, a crime in
  474  any jurisdiction which directly relates to the business of a
  475  dispensing organization.
  476         7.Making or filing a report or record that the licensee
  477  knows to be false.
  478         8.Willfully failing to maintain a record required by this
  479  section or rule of the department.
  480         9.Willfully impeding or obstructing an employee or agent
  481  of the department in the furtherance of his or her official
  482  duties.
  483         10.Engaging in fraud or deceit, negligence, incompetence,
  484  or misconduct in the business practices of a dispensing
  485  organization.
  486         11.Making misleading, deceptive, or fraudulent
  487  representations in or related to the business practices of a
  488  dispensing organization.
  489         12.Having a license or the authority to engage in any
  490  regulated profession, occupation, or business that is related to
  491  the business practices of a dispensing organization revoked,
  492  suspended, or otherwise acted against, including the denial of
  493  licensure, by the licensing authority of any jurisdiction,
  494  including its agencies or subdivisions, for a violation that
  495  would constitute a violation under state law. A licensing
  496  authority’s acceptance of a relinquishment of licensure or a
  497  stipulation, consent order, or other settlement, offered in
  498  response to or in anticipation of the filing of charges against
  499  the license, shall be construed as an action against the
  500  license.
  501         13.Violating a lawful order of the department or an agency
  502  of the state, or failing to comply with a lawfully issued
  503  subpoena of the department or an agency of the state.
  504         (g) The department shall create a permitting process for
  505  all dispensing organization vehicles used for the transportation
  506  of low-THC cannabis or low-THC cannabis products.
  507         (h)(c)The department shall monitor physician registration
  508  and ordering of low-THC cannabis for ordering practices that
  509  could facilitate unlawful diversion or misuse of low-THC
  510  cannabis and take disciplinary action as indicated.
  511         (i)(d)The department shall adopt rules as necessary to
  512  implement this section.
  513         (6) DISPENSING ORGANIZATION.—
  514         (a) An applicant seeking licensure as a dispensing
  515  organization, or the renewal of its license, must submit an
  516  application to the department. The department must review all
  517  applications for completeness, including an appropriate
  518  inspection of the applicant’s property and facilities to verify
  519  the authenticity of the information provided in, or in
  520  connection with, the application. An applicant authorizes the
  521  department to inspect his or her property and facilities for
  522  licensure by applying under this subsection.
  523         (b) In order to receive or maintain licensure as a
  524  dispensing organization, an applicant must provide proof that:
  525         1.The applicant, or a separate entity that is owned solely
  526  by the same persons or entities in the same ratio as the
  527  applicant, possesses a valid certificate of registration issued
  528  by the Department of Agriculture and Consumer Services pursuant
  529  to s. 581.131 for the cultivation of more than 400,000 plants,
  530  is operated by a nurseryman as defined in s. 581.011, and has
  531  been operated as a registered nursery in this state for at least
  532  30 continuous years.
  533         2. The personnel on staff or under contract for the
  534  applicant have experience cultivating and introducing multiple
  535  varieties of plants in this state, including plants that are not
  536  native to Florida; experience with propagating plants; and
  537  experience with genetic modification or breeding of plants.
  538         3. The personnel on staff or under contract for the
  539  applicant include at least one person who:
  540         a. Has at least 5 years’ experience with United States
  541  Department of Agriculture Good Agricultural Practices and Good
  542  Handling Practices;
  543         b. Has at least 5 years’ experience with United States Food
  544  and Drug Administration Good Manufacturing Practices for food
  545  production;
  546         c. Has a doctorate degree in organic chemistry or
  547  microbiology;
  548         d. Has at least 5 years’ of experience with laboratory
  549  procedures which includes analytical laboratory quality control
  550  measures, chain of custody procedures, and analytical laboratory
  551  methods;
  552         e. Has experience with cannabis cultivation and processing,
  553  including cannabis extraction techniques and producing cannabis
  554  products;
  555         f. Has experience and qualifications in chain of custody or
  556  other tracking mechanisms;
  557         g. Works solely on inventory control; and
  558         h. Works solely for security purposes.
  559         4. The persons who have a direct or indirect interest in
  560  the dispensing organization and the applicant’s managers,
  561  employees, and contractors who directly interact with low-THC
  562  cannabis or low-THC cannabis products have been fingerprinted
  563  and have successfully passed a level 2 background screening
  564  pursuant to s. 435.04.
  565         5. The applicant owns, or has at least a 2-year lease of,
  566  all properties, facilities, and equipment necessary for the
  567  cultivation and processing of low-THC cannabis. The applicant
  568  must provide a detailed description of each facility and its
  569  equipment, a cultivation and processing plan, and a detailed
  570  floor plan. The description must include proof that:
  571         a. The applicant is capable of sufficient cultivation and
  572  processing to serve at least 15,000 patients with an assumed
  573  daily use of 1,000 mg per patient per day of low-THC cannabis or
  574  low-THC cannabis product;
  575         b. The applicant has arranged for access to all utilities
  576  and resources necessary to cultivate or process low-THC cannabis
  577  at each listed facility; and
  578         c. Each facility is secured and has theft-prevention
  579  systems including an alarm system, cameras, and 24-hour security
  580  personnel.
  581         6. The applicant has diversion and tracking prevention
  582  procedures, including:
  583         a. A system for tracking low-THC material through
  584  cultivation, processing, and dispensing, including the use of
  585  batch and harvest numbers;
  586         b. An inventory control system for low-THC cannabis and
  587  low-THC cannabis products;
  588         c. A vehicle tracking and security system; and
  589         d. A cannabis waste-disposal plan.
  590         7. The applicant has recordkeeping policies and procedures
  591  in place.
  592         8. The applicant has a facility emergency management plan.
  593         9. The applicant has a plan for dispensing low-THC cannabis
  594  throughout the state. This plan must include planned retail
  595  facilities and a delivery plan for providing low-THC cannabis
  596  and low-THC cannabis products to qualified patients who cannot
  597  travel to a retail facility.
  598         10. The applicant has financial documentation, including:
  599         a. Documentation that demonstrates the applicant’s
  600  financial ability to operate. If the applicant’s assets, credit,
  601  and projected revenues meet or exceed projected liabilities and
  602  expenses and the applicant provides independent evidence that
  603  the funds necessary for startup costs, working capital, and
  604  contingency financing exist and are available as needed, the
  605  applicant has demonstrated the financial ability to operate.
  606  Financial ability to operate must be documented by:
  607         I. The applicant’s audited financial statements. If the
  608  applicant is a newly formed entity and does not have a financial
  609  history of business upon which audited financial statements may
  610  be submitted, the applicant must provide audited financial
  611  statements for the separate entity that is owned solely by the
  612  same persons or entities in the same ratio as the applicant that
  613  possesses the valid certificate of registration issued by the
  614  Department of Agriculture and Consumer Services;
  615         II.The applicant’s projected financial statements,
  616  including a balance sheet, an income and expense statement, and
  617  a statement of cash flow for the first 2 years of operation,
  618  which provides evidence that the applicant has sufficient
  619  assets, credit, and projected revenues to cover liabilities and
  620  expenses; and
  621         III.A statement of the applicant’s estimated startup costs
  622  and sources of funds, including a break-even projection and
  623  documentation demonstrating that the applicant has the ability
  624  to fund all startup costs, working capital costs, and
  625  contingency financing requirements.
  626  
  627  All documents required under this sub-subparagraph shall be
  628  prepared in accordance with generally accepted accounting
  629  principles and signed by a certified public accountant. The
  630  statements required by sub-sub-subparagraphs II. and III. may be
  631  presented as a compilation.
  632         b.A list of all subsidiaries of the applicant;
  633         c.A list of all lawsuits pending and completed within the
  634  past 7 years of which the applicant was a party; and
  635         d.Proof of a $1 million performance and compliance bond,
  636  or other equivalent means of security deemed equivalent by the
  637  department, such as an irrevocable letter of credit or a deposit
  638  in a trust account or financial institution, payable to the
  639  department, which must be posted once the applicant is approved
  640  as a dispensing organization. The purpose of the bond is to
  641  secure payment of any administrative penalties imposed by the
  642  department and any fees and costs incurred by the department
  643  regarding the dispensing organization license, such as the
  644  dispensing organization failing to pay 30 days after the fine or
  645  costs become final. The department may make a claim against such
  646  bond or security until 1 year after the dispensing
  647  organization’s license ceases to be valid or until 60 days after
  648  any administrative or legal proceeding authorized in this
  649  section involving the dispensing organization concludes,
  650  including any appeal, whichever occurs later.
  651         11. The employment of a medical director who is a physician
  652  licensed under chapter 458 or chapter 459 to supervise the
  653  activities of the dispensing organization.
  654         (c) An approved dispensing organization shall maintain
  655  compliance with the criteria in paragraphs (b), (d), and (e) and
  656  subsection (7) demonstrated for selection and approval as a
  657  dispensing organization under subsection (5) at all times.
  658  Before dispensing low-THC cannabis or low-THC cannabis products
  659  to a qualified patient or to the qualified patient’s legal
  660  representative, the dispensing organization shall verify the
  661  identity of the qualified patient or the qualified patient’s
  662  legal representative by requiring the qualified patient or the
  663  qualified patient’s legal representative to produce a
  664  government-issued identification card and shall verify that the
  665  qualified patient and the qualified patient’s legal
  666  representative have has an active registration in the
  667  compassionate use registry, that the order presented matches the
  668  order contents as recorded in the registry, and that the order
  669  has not already been filled. Upon dispensing the low-THC
  670  cannabis, the dispensing organization shall record in the
  671  registry the date, time, quantity, and form of low-THC cannabis
  672  dispensed.
  673         (d) A dispensing organization may have cultivation
  674  facilities, processing facilities, and retail facilities.
  675         1. All matters regarding the location of cultivation
  676  facilities and processing facilities are preempted to the state.
  677  Cultivation facilities and processing facilities must be closed
  678  to the public, and low-THC cannabis may not be dispensed on the
  679  premises of such facilities.
  680         2. A municipality must determine by ordinance the criteria
  681  for the number and location of, and other permitting
  682  requirements for, all retail facilities located within its
  683  municipal boundaries. A retail facility may be established in a
  684  municipality only after such an ordinance has been created. A
  685  county must determine by ordinance the criteria for the number,
  686  location, and other permitting requirements for all retail
  687  facilities located within the unincorporated areas of that
  688  county. A retail facility may be established in the
  689  unincorporated areas of a county only after such an ordinance
  690  has been created. Retail facilities must have all utilities and
  691  resources necessary to store and dispense low-THC cannabis and
  692  low-THC cannabis products. Retail facilities must be secured and
  693  have theft-prevention systems, including an alarm system,
  694  cameras, and 24-hour security personnel. Retail facilities may
  695  not sell, or contract for the sale of, anything other than low
  696  THC cannabis or low-THC cannabis products on the property of the
  697  retail facility. Before a retail facility may dispense low-THC
  698  cannabis or a low-THC cannabis product, the dispensing
  699  organization must have a computer network compliant with the
  700  federal Health Insurance Portability and Accountability Act of
  701  1996 which is able to access and upload data to the
  702  compassionate use registry and which shall be used by all retail
  703  facilities.
  704         (e) Within 15 days after such information becoming
  705  available, a dispensing organization must provide the department
  706  with updated information, as applicable, including:
  707         1. The location and a detailed description of any new or
  708  proposed facilities.
  709         2. The updated contact information, including electronic
  710  and voice communication, for all dispensing organization
  711  facilities.
  712         3. The registration information for any vehicles used for
  713  the transportation of low-THC cannabis and low-THC cannabis
  714  products, including confirmation that all such vehicles have
  715  tracking and security systems.
  716         4. A plan for the recall of any or all low-THC cannabis or
  717  low-THC cannabis products.
  718         (f)1. A dispensing organization may transport low-THC
  719  cannabis or low-THC cannabis products in vehicles departing from
  720  their places of business only in vehicles that are owned or
  721  leased by the licensee or by a person designated by the
  722  dispensing organization, and for which a valid vehicle permit
  723  has been issued for such vehicle by the department.
  724         2.A vehicle owned or leased by the dispensing organization
  725  or a person designated by the dispensing organization and
  726  approved by the department must be operated by such person when
  727  transporting low-THC cannabis or low-THC products from the
  728  licensee’s place of business.
  729         3.A vehicle permit may be obtained by a dispensing
  730  organization upon application and payment of a fee of $5 per
  731  vehicle to the department. The signature of the person
  732  designated by the dispensing organization to drive the vehicle
  733  must be included on the vehicle permit application. Such permit
  734  remains valid and does not expire unless the licensee or any
  735  person designated by the dispensing organization disposes of his
  736  or her vehicle, or the licensee’s license is transferred,
  737  canceled, not renewed, or is revoked by the department,
  738  whichever occurs first. The department shall cancel a vehicle
  739  permit upon request of the licensee or owner of the vehicle.
  740         4.By acceptance of a license issued under this section,
  741  the licensee agrees that the licensed vehicle is, at all times
  742  it is being used to transport low-THC cannabis or low-THC
  743  cannabis products, subject to inspection and search without a
  744  search warrant by authorized employees of the department,
  745  sheriffs, deputy sheriffs, police officers, or other law
  746  enforcement officers to determine that the licensee is
  747  transporting such products in compliance with this section.
  748         (7)TESTING AND LABELING OF LOW-THC CANNABIS.
  749         (a)All low-THC cannabis and low-THC cannabis products must
  750  be tested by an independent testing laboratory before the
  751  dispensing organization may dispense them. The independent
  752  testing laboratory shall provide the dispensing organization
  753  with lab results. Before dispensing, the dispensing organization
  754  must determine that the lab results indicate that the low-THC
  755  cannabis or low-THC cannabis product meets the definition of
  756  low-THC cannabis or low-THC cannabis product, is safe for human
  757  consumption, and is free from harmful contaminants.
  758         (b)All low-THC cannabis and low-THC cannabis products must
  759  be labeled before dispensing. The label must include, at a
  760  minimum:
  761         1. A statement that the low-THC cannabis or low-THC
  762  cannabis product meets the requirements in paragraph (a);
  763         2.The name of the independent testing laboratory that
  764  tested the low-THC cannabis or low-THC cannabis product;
  765         3.The name of the cultivation and processing facility
  766  where the low-THC cannabis or low-THC cannabis product
  767  originates; and
  768         4.The batch number and harvest number from which the low
  769  THC cannabis or low-THC cannabis product originates.
  770         (8) SAFETY AND EFFICACY RESEARCH FOR LOW-THC CANNABIS.—The
  771  University of Florida College of Pharmacy shall establish and
  772  maintain a safety and efficacy research program for the use of
  773  low-THC cannabis or low-THC cannabis products to treat
  774  qualifying conditions and symptoms. The program must include a
  775  fully integrated electronic information system for the broad
  776  monitoring of health outcomes and safety signal detection. The
  777  electronic information system must include information from the
  778  compassionate use registry; provider reports, including
  779  treatment plans, adverse event reports, and treatment
  780  discontinuation reports; patient reports of adverse impacts;
  781  event-triggered interviews and medical chart reviews performed
  782  by University of Florida clinical research staff; information
  783  from external databases, including Medicaid billing reports and
  784  information in the prescription drug monitoring database for
  785  registered patients; and all other medical reports required by
  786  the University of Florida to conduct the research required by
  787  this subsection. The department must provide access to
  788  information from the compassionate use registry and the
  789  prescription drug monitoring database, established in s.
  790  893.055, as needed by the University of Florida to conduct
  791  research under this subsection. The Agency for Health Care
  792  Administration must provide access to registered patient
  793  Medicaid records, to the extent allowed under federal law, as
  794  needed by the University of Florida to conduct research under
  795  this subsection.
  796         (9) The persons who have direct or indirect interest in the
  797  dispensing organization and the dispensing organization’s
  798  managers, employees, and contractors who directly interact with
  799  low-THC cannabis or low-THC cannabis products are prohibited
  800  from making recommendations, offering prescriptions, or
  801  providing medical advice to qualified patients.
  802         (10)(7) EXCEPTIONS TO OTHER LAWS.—
  803         (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  804  any other provision of law, but subject to the requirements of
  805  this section, a qualified patient and the qualified patient’s
  806  legal representative who is registered with the department on
  807  the compassionate use registry may purchase and possess for the
  808  patient’s medical use up to the amount of low-THC cannabis
  809  ordered for the patient. Nothing in this section exempts any
  810  person from the prohibition against driving under the influence
  811  provided in s. 316.193.
  812         (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  813  any other provision of law, but subject to the requirements of
  814  this section, an approved dispensing organization and its
  815  owners, managers, and employees and the owners, managers, and
  816  employees of contractors who have direct contact with low-THC
  817  cannabis or low-THC cannabis product may manufacture, possess,
  818  sell, deliver, distribute, dispense, and lawfully dispose of
  819  reasonable quantities, as established by department rule, of
  820  low-THC cannabis. For purposes of this subsection, the terms
  821  “manufacture,” “possession,” “deliver,” “distribute,” and
  822  “dispense” have the same meanings as provided in s. 893.02.
  823         (c) An approved dispensing organization and its owners,
  824  managers, and employees are not subject to licensure or
  825  regulation under chapter 465 or chapter 499 for manufacturing,
  826  possessing, selling, delivering, distributing, dispensing, or
  827  lawfully disposing of reasonable quantities, as established by
  828  department rule, of low-THC cannabis.
  829         (d) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  830  any other law, but subject to the requirements of this section,
  831  a licensed laboratory and its employees may receive and possess
  832  low-THC cannabis for the sole purpose of testing the low-THC
  833  cannabis to ensure compliance with this section.
  834         (11) Rules adopted by the department under this section are
  835  exempt from the requirement that they be ratified by the
  836  Legislature pursuant to s. 120.541(3).
  837         Section 2. Paragraph (g) is added to subsection (3) of
  838  section 381.987, Florida Statutes, to read:
  839         381.987 Public records exemption for personal identifying
  840  information in the compassionate use registry.—
  841         (3) The department shall allow access to the registry,
  842  including access to confidential and exempt information, to:
  843         (g) Persons engaged in research at the University of
  844  Florida pursuant to s. 381.986(8).
  845         Section 3. Paragraph (b) of subsection (7) of section
  846  893.055, Florida Statutes, is amended to read:
  847         893.055 Prescription drug monitoring program.—
  848         (7)
  849         (b) A pharmacy, prescriber, or dispenser shall have access
  850  to information in the prescription drug monitoring program’s
  851  database which relates to a patient of that pharmacy,
  852  prescriber, or dispenser in a manner established by the
  853  department as needed for the purpose of reviewing the patient’s
  854  controlled substance prescription history. Persons engaged in
  855  research at the University of Florida pursuant to s. 381.986(8)
  856  shall have access to information in the prescription drug
  857  monitoring program’s database which relates to qualified
  858  patients as defined in s. 381.986(1) for the purpose of
  859  conducting such research. Other access to the program’s database
  860  shall be limited to the program’s manager and to the designated
  861  program and support staff, who may act only at the direction of
  862  the program manager or, in the absence of the program manager,
  863  as authorized. Access by the program manager or such designated
  864  staff is for prescription drug program management only or for
  865  management of the program’s database and its system in support
  866  of the requirements of this section and in furtherance of the
  867  prescription drug monitoring program. Confidential and exempt
  868  information in the database shall be released only as provided
  869  in paragraph (c) and s. 893.0551. The program manager,
  870  designated program and support staff who act at the direction of
  871  or in the absence of the program manager, and any individual who
  872  has similar access regarding the management of the database from
  873  the prescription drug monitoring program shall submit
  874  fingerprints to the department for background screening. The
  875  department shall follow the procedure established by the
  876  Department of Law Enforcement to request a statewide criminal
  877  history record check and to request that the Department of Law
  878  Enforcement forward the fingerprints to the Federal Bureau of
  879  Investigation for a national criminal history record check.
  880         Section 4. Paragraph (h) is added to subsection (3) of
  881  section 893.0551, Florida Statutes, to read:
  882         893.0551 Public records exemption for the prescription drug
  883  monitoring program.—
  884         (3) The department shall disclose such confidential and
  885  exempt information to the following persons or entities upon
  886  request and after using a verification process to ensure the
  887  legitimacy of the request as provided in s. 893.055:
  888         (h) Persons engaged in research at the University of
  889  Florida pursuant to s. 381.986(8).
  890         Section 5. This act shall take effect upon becoming a law.