Florida Senate - 2016                          SENATOR AMENDMENT
       Bill No. CS for SB 460
       
       
       
       
       
       
                                Ì926164.Î926164                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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                 Floor: NC/2R          .                                
             03/04/2016 10:09 AM       .                                
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       Senator Clemens moved the following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete lines 311 - 698
    4  and insert:
    5         (5) DUTIES AND POWERS OF THE DEPARTMENT.—By January 1,
    6  2015, The department shall:
    7         (a) The department shall create a secure, electronic, and
    8  online compassionate use registry for the registration of
    9  physicians and patients as provided under this section. The
   10  registry must be accessible to law enforcement agencies and to a
   11  dispensing organization in order to verify patient authorization
   12  for low-THC cannabis and record the low-THC cannabis dispensed.
   13  The registry must prevent an active registration of a patient by
   14  multiple physicians.
   15         (b)1.Beginning July 8, 2016, the department shall accept
   16  applications for licensure as dispensing organizations. A
   17  dispensing organization may be licensed to cultivate or process
   18  low-THC cannabis or low-THC cannabis products or dispense low
   19  THC cannabis or low-THC cannabis products through a dispensing
   20  facility. A dispensing organization may be licensed to conduct
   21  one or more of these activities. The department shall review
   22  each application to determine whether the applicant meets the
   23  criteria in subsection (6) and qualifies for licensure.
   24         2. Within 10 days after receiving an application for
   25  licensure, the department shall examine the application, notify
   26  the applicant of any apparent errors or omissions, and request
   27  any additional information the department is allowed by law to
   28  require. An application for licensure must be filed with the
   29  department no later than 5 p.m. on August 1, 2016, and all
   30  applications must be complete no later than 5 p.m. on August 30,
   31  2016.
   32         3. Once licensed, applicants may operate in any region in
   33  the state, but a dispensing organization licensed to cultivate
   34  or process low-THC cannabis may not have cultivation or
   35  processing facilities outside the region in which it is
   36  licensed.
   37         4.The department shall license a selected applicant unless
   38  the applicant fails to pay the licensure fee within 10 days
   39  after selection.
   40         5.This section is exempt from s. 120.60(1) Authorize the
   41  establishment of five dispensing organizations to ensure
   42  reasonable statewide accessibility and availability as necessary
   43  for patients registered in the compassionate use registry and
   44  who are ordered low-THC cannabis under this section, one in each
   45  of the following regions: northwest Florida, northeast Florida,
   46  central Florida, southeast Florida, and southwest Florida.
   47         (c) The department shall use develop an application form
   48  that requires the applicant to state, as applicable:
   49         1. Whether the application is for initial licensure or
   50  renewal licensure;
   51         2. Whether the application is for licensure as a
   52  cultivator, processor, or dispenser of low-THC cannabis;
   53         3. The name, the physical address, and the mailing address
   54  of the applicant;
   55         4. For a cultivating or processing license, the address
   56  listed on the Department of Agriculture and Consumer Services
   57  certificate of registration required in paragraph (6)(b);
   58         5. The name, address, license number, and contact
   59  information for the applicant’s medical director; and
   60         6. All information required to be included by subsection
   61  (6).
   62         (d) The department shall and impose an initial application
   63  fee of $10,000, an initial licensure fee of $25,000, and a
   64  biennial renewal fee of $25,000 that is sufficient to cover the
   65  costs of administering this section. An applicant for approval
   66  as a dispensing organization must be able to demonstrate:
   67         1. The technical and technological ability to cultivate and
   68  produce low-THC cannabis. The applicant must possess a valid
   69  certificate of registration issued by the Department of
   70  Agriculture and Consumer Services pursuant to s. 581.131 that is
   71  issued for the cultivation of more than 400,000 plants, be
   72  operated by a nurseryman as defined in s. 581.011, and have been
   73  operated as a registered nursery in this state for at least 30
   74  continuous years.
   75         2. The ability to secure the premises, resources, and
   76  personnel necessary to operate as a dispensing organization.
   77         3. The ability to maintain accountability of all raw
   78  materials, finished products, and any byproducts to prevent
   79  diversion or unlawful access to or possession of these
   80  substances.
   81         4. An infrastructure reasonably located to dispense low-THC
   82  cannabis to registered patients statewide or regionally as
   83  determined by the department.
   84         5. The financial ability to maintain operations for the
   85  duration of the 2-year approval cycle, including the provision
   86  of certified financials to the department. Upon approval, the
   87  applicant must post a $5 million performance bond.
   88         6. That all owners and managers have been fingerprinted and
   89  have successfully passed a level 2 background screening pursuant
   90  to s. 435.04.
   91         7. The employment of a medical director who is a physician
   92  licensed under chapter 458 or chapter 459 to supervise the
   93  activities of the dispensing organization.
   94         (e) The department shall inspect each dispensing
   95  organization’s properties, cultivation facilities, processing
   96  facilities, or dispensing facilities according to its licensure
   97  before they begin operations and at least once every 2 years
   98  thereafter. The department may conduct additional announced or
   99  unannounced inspections, including followup inspections, at
  100  reasonable hours in order to ensure that such properties or
  101  facilities maintain compliance with all applicable requirements
  102  in subsections (6) and (7) and to ensure that the dispensing
  103  organization has not committed any act that would endanger the
  104  health, safety, or security of a qualified patient, a dispensing
  105  organization staff member, or the community in which the
  106  dispensing organization is located. Licensure under this section
  107  constitutes permission for the department to enter and inspect
  108  the premises or facilities of any dispensing organization. A
  109  dispensing organization must make all facility premises,
  110  equipment, documents, low-THC cannabis, and low-THC cannabis
  111  products available, as applicable, to the department upon
  112  inspection. The department may test any low-THC cannabis or low
  113  THC cannabis product in order to ensure that it is safe for
  114  human consumption and that it meets the requirements in this
  115  section.
  116         (f)The department may suspend or revoke a license, deny or
  117  refuse to renew a license, or impose an administrative penalty
  118  not to exceed $10,000 for the following acts or omissions:
  119         1.Violating this section, s. 499.0295, or department rule.
  120         2.Failing to maintain qualifications for licensure.
  121         3.Endangering the health, safety, or security of a
  122  qualified patient.
  123         4.Improperly disclosing personal and confidential
  124  information of a qualified patient.
  125         5.Attempting to procure a license by bribery or fraudulent
  126  misrepresentation.
  127         6.Being convicted or found guilty of, or entering a plea
  128  of nolo contendere to, regardless of adjudication, a crime in
  129  any jurisdiction which directly relates to the business of a
  130  dispensing organization.
  131         7.Making or filing a report or record that the licensee
  132  knows to be false.
  133         8.Willfully failing to maintain a record required by this
  134  section or department rule.
  135         9.Willfully impeding or obstructing an employee or agent
  136  of the department in the furtherance of his or her official
  137  duties.
  138         10.Engaging in fraud or deceit, negligence, incompetence,
  139  or misconduct in the business practices of a licensee.
  140         11.Making misleading, deceptive, or fraudulent
  141  representations in or related to the business practices of a
  142  licensee.
  143         12.Having a license or the authority to engage in any
  144  regulated profession, occupation, or business that is related to
  145  the business practices of a dispensing organization revoked,
  146  suspended, or otherwise acted against, including the denial of
  147  licensure, by the licensing authority of any jurisdiction,
  148  including its agencies or subdivisions, for a violation that
  149  would constitute a violation under state law. A licensing
  150  authority’s acceptance of a relinquishment of licensure or a
  151  stipulation, consent order, or other settlement, offered in
  152  response to or in anticipation of the filing of charges against
  153  the license, shall be construed as an action against the
  154  license.
  155         13.Violating a lawful order of the department or an agency
  156  of the state, or failing to comply with a lawfully issued
  157  subpoena of the department or an agency of the state.
  158         (g) The department shall create a permitting process for
  159  all dispensing organization vehicles used for the transportation
  160  of low-THC cannabis or low-THC cannabis products.
  161         (h)(c)The department shall monitor physician registration
  162  and ordering of low-THC cannabis for ordering practices that
  163  could facilitate unlawful diversion or misuse of low-THC
  164  cannabis and take disciplinary action as indicated.
  165         (i)(d)The department shall adopt rules as necessary to
  166  implement this section.
  167         (6) DISPENSING ORGANIZATION.—
  168         (a)An applicant seeking licensure as a dispensing
  169  organization, or the renewal of its license, must submit an
  170  application to the department. An applicant may seek licensure
  171  as a dispensing organization to cultivate, process, or dispense
  172  low-THC cannabis. Each function of the dispensing organization
  173  requires separate licensure; however, an applicant may seek
  174  licensure for more than one function. The department must review
  175  all applications for completeness, including an appropriate
  176  inspection of the applicant’s property or facilities, as
  177  applicable, to verify the authenticity of the information
  178  provided in, or in connection with, the application. An
  179  applicant authorizes the department to inspect his or her
  180  property or facilities for licensure by applying under this
  181  subsection.
  182         (b) In order to receive, maintain, or renew licensure as a
  183  dispensing organization, an applicant must provide proof that:
  184         1.For a cultivating or processing license, the applicant,
  185  or a separate entity that is owned solely by the same persons or
  186  entities in the same ratio as the applicant, possesses a valid
  187  certificate of registration issued by the Department of
  188  Agriculture and Consumer Services pursuant to s. 581.131 for the
  189  cultivation of more than 400,000 plants.
  190         2. For a cultivating or processing license, the personnel
  191  on staff or under contract for the applicant have experience
  192  cultivating and introducing multiple varieties of plants in this
  193  state, including plants that are not native to Florida;
  194  experience with propagating plants; and experience with genetic
  195  modification or breeding of plants.
  196         3. For a cultivating or processing license, the personnel
  197  on staff or under contract for the applicant include at least
  198  one person who:
  199         a. Has at least 5 years’ experience with the United States
  200  Department of Agriculture Good Agricultural Practices and Good
  201  Handling Practices;
  202         b. Has at least 5 years’ experience with the United States
  203  Food and Drug Administration Current Good Manufacturing
  204  Practices for food production;
  205         c. Has a doctorate degree in organic chemistry or
  206  microbiology;
  207         d. Has at least 5 years’ of experience with laboratory
  208  procedures which includes analytical laboratory quality control
  209  measures, chain of custody procedures, and analytical laboratory
  210  methods;
  211         e. Has experience with cannabis cultivation and processing,
  212  including cannabis extraction techniques and producing cannabis
  213  products;
  214         f. Has experience and qualifications in chain of custody or
  215  other tracking mechanisms;
  216         g. Works solely on inventory control; and
  217         h. Works solely for security purposes.
  218         4. The persons who have a direct or indirect interest in
  219  any dispensing organization and the applicant’s managers,
  220  employees, and contractors who directly interact with low-THC
  221  cannabis or low-THC cannabis products have been fingerprinted
  222  and have successfully passed a level 2 background screening
  223  pursuant to s. 435.04.
  224         5. For a cultivating or processing license, the applicant
  225  owns, or has at least a 2-year lease of, all properties,
  226  facilities, and equipment necessary for the cultivation and
  227  processing of low-THC cannabis. The applicant must provide a
  228  detailed description of each facility and its equipment, a
  229  cultivation and processing plan, and a detailed floor plan. The
  230  description must include proof that:
  231         a. The applicant is capable of cultivating and processing
  232  sufficient low-THC cannabis or low-THC cannabis product to serve
  233  at least 15,000 patients with an assumed daily use of 1,000 mg
  234  per patient per day of low-THC cannabis or low-THC cannabis
  235  product;
  236         b. The applicant has arranged for access to all utilities
  237  and resources necessary to cultivate or process low-THC cannabis
  238  at each listed facility; and
  239         c. Each facility is secured and has theft-prevention
  240  systems, including an alarm system, cameras, and 24-hour
  241  security personnel.
  242         6. The applicant has diversion and tracking prevention
  243  procedures, as applicable, including:
  244         a. A system for tracking low-THC material through
  245  cultivation, processing, or dispensing, including the use of
  246  batch and harvest numbers;
  247         b. An inventory control system for low-THC cannabis and
  248  low-THC cannabis products;
  249         c. A vehicle tracking and security system; and
  250         d. A cannabis waste disposal plan.
  251         7. The applicant has recordkeeping policies and procedures
  252  in place.
  253         8. The applicant has a facility emergency management plan.
  254         9. For a dispensing license, the applicant has a plan for
  255  dispensing low-THC cannabis throughout the state. This plan must
  256  include planned dispensing facilities and a delivery plan for
  257  providing low-THC cannabis and low-THC cannabis products to
  258  qualified patients who cannot travel to a dispensing facility.
  259         10. The applicant has financial documentation, as
  260  applicable, including:
  261         a. Documentation that demonstrates the applicant’s
  262  financial ability to operate. If the applicant’s assets, credit,
  263  and projected revenues meet or exceed projected liabilities and
  264  expenses and the applicant provides independent evidence that
  265  the funds necessary for startup costs, working capital, and
  266  contingency financing exist and are available as needed, the
  267  applicant has demonstrated the financial ability to operate.
  268  Financial ability to operate must be documented by:
  269         I. The applicant’s audited financial statements. If the
  270  applicant is a newly formed entity and does not have a financial
  271  history of business upon which audited financial statements may
  272  be submitted, the applicant must provide audited financial
  273  statements for the separate entity that is owned solely by the
  274  same persons or entities in the same ratio as the applicant;
  275         II.The applicant’s projected financial statements,
  276  including a balance sheet, an income and expense statement, and
  277  a statement of cash flow for the first 2 years of operation,
  278  which provide evidence that the applicant has sufficient assets,
  279  credit, and projected revenues to cover liabilities and
  280  expenses; and
  281         III.A statement of the applicant’s estimated startup costs
  282  and sources of funds, including a break-even projection and
  283  documentation demonstrating that the applicant has the ability
  284  to fund all startup costs, working capital costs, and
  285  contingency financing requirements.
  286  
  287  All documents required under this sub-subparagraph shall be
  288  prepared in accordance with generally accepted accounting
  289  principles and signed by a certified public accountant. The
  290  statements required by sub-sub-subparagraphs II. and III. may be
  291  presented as a compilation;
  292         b.A list of all subsidiaries of the applicant;
  293         c.A list of all lawsuits pending and completed within the
  294  past 7 years of which the applicant was a party; and
  295         d.Proof of a $1 million performance and compliance bond,
  296  or other equivalent means of security deemed equivalent by the
  297  department, such as an irrevocable letter of credit or a deposit
  298  in a trust account or financial institution, payable to the
  299  department, which must be posted once the applicant is approved
  300  as a dispensing organization. The purpose of the bond is to
  301  secure payment of any administrative penalties imposed by the
  302  department and any fees and costs incurred by the department
  303  regarding the dispensing organization license, such as the
  304  dispensing organization failing to pay 30 days after the fine or
  305  costs become final. The department may make a claim against such
  306  bond or security until 1 year after the dispensing
  307  organization’s license ceases to be valid or until 60 days after
  308  any administrative or legal proceeding authorized in this
  309  section involving the dispensing organization concludes,
  310  including any appeal, whichever occurs later.
  311         11. The employment of a medical director who is a physician
  312  licensed under chapter 458 or chapter 459 to supervise the
  313  activities of the dispensing organization.
  314         (c) An approved dispensing organization shall maintain
  315  compliance with the criteria in paragraphs (b), (d), and (e) and
  316  subsection (7) demonstrated for selection and approval as a
  317  dispensing organization under subsection (5) at all times.
  318  Before dispensing low-THC cannabis or low-THC cannabis products
  319  to a qualified patient or to the qualified patient’s legal
  320  representative, the dispensing organization shall verify the
  321  identity of the qualified patient or the qualified patient’s
  322  legal representative by requiring the qualified patient or the
  323  qualified patient’s legal representative to produce a
  324  government-issued identification card and shall verify that the
  325  qualified patient and the qualified patient’s legal
  326  representative have has an active registration in the
  327  compassionate use registry, that the order presented matches the
  328  order contents as recorded in the registry, and that the order
  329  has not already been filled. Upon dispensing the low-THC
  330  cannabis or low-THC cannabis products, the dispensing
  331  organization shall record in the registry the date, time,
  332  quantity, and form of low-THC cannabis dispensed.
  333         (d)1. A dispensing organization may have cultivation
  334  facilities, processing facilities, or dispensing facilities.
  335         2. A municipality must determine by ordinance the criteria
  336  for the number and location of, and other permitting
  337  requirements for, all dispensing facilities located within its
  338  municipal boundaries. A dispensing facility may be established
  339  in a municipality only after such an ordinance has been created.
  340  A county must determine by ordinance the criteria for the
  341  number, location, and other permitting requirements for all
  342  dispensing facilities located within the unincorporated areas of
  343  that county. A dispensing facility may be established in the
  344  unincorporated areas of a county only after such an ordinance
  345  has been created. Dispensing facilities must have all utilities
  346  and resources necessary to store and dispense low-THC cannabis
  347  and low-THC cannabis products. Dispensing facilities must be
  348  secured and have theft-prevention systems, including an alarm
  349  system, cameras, and 24-hour security personnel. Dispensing
  350  facilities may not sell, or contract for the sale of, anything
  351  other than low-THC cannabis or low-THC cannabis products on the
  352  property of the dispensing facilities. Before a dispensing
  353  facility may dispense low-THC cannabis or a low-THC cannabis
  354  product, the dispensing organization must have a computer
  355  network compliant with the federal Health Insurance Portability
  356  and Accountability Act of 1996 which can access and upload data
  357  to the compassionate use registry and which shall be used by all
  358  dispensing facilities.
  359         (e) Within 15 days after such information becoming
  360  available, a dispensing organization must provide the department
  361  with updated information, as applicable, including:
  362         1. The location and a detailed description of any new or
  363  proposed facility.
  364         2. The updated contact information, including electronic
  365  and voice communication, for all dispensing organization
  366  facilities.
  367         3. The registration information for any vehicle used for
  368  the transportation of low-THC cannabis and low-THC cannabis
  369  products, including confirmation that all such vehicles have
  370  tracking and security systems.
  371         4. A plan for the recall of any or all low-THC cannabis or
  372  low-THC cannabis products.
  373         (f)1. A dispensing organization may transport low-THC
  374  cannabis or low-THC cannabis products in a vehicle departing
  375  from its place of business only in a vehicle that is owned or
  376  leased by the licensee or by a person designated by the
  377  dispensing organization, and for which a valid vehicle permit
  378  has been issued for such vehicle by the department.
  379         2.A vehicle owned or leased by the dispensing
  380  organization, or by a person designated by the dispensing
  381  organization and approved by the department, must be operated by
  382  a person designated by the dispensing organization and approved
  383  by the department when transporting low-THC cannabis or low-THC
  384  products from the licensee’s place of business.
  385         3.A vehicle permit may be obtained by a dispensing
  386  organization upon application and payment of a fee of $5 per
  387  vehicle to the department. The signature of the person
  388  designated by the dispensing organization to drive the vehicle
  389  must be included on the vehicle permit application. Such permit
  390  remains valid and does not expire unless the licensee or any
  391  person designated by the dispensing organization disposes of his
  392  or her vehicle, or the licensee’s license is transferred,
  393  canceled, not renewed, or is revoked by the department,
  394  whichever occurs first. The department shall cancel a vehicle
  395  permit upon request of the licensee or owner of the vehicle.
  396         4.By acceptance of a license issued under this section,
  397  the licensee agrees that the permitted vehicle is, at all times
  398  it is being used to transport low-THC cannabis or low-THC
  399  cannabis products, subject to inspection and search without a
  400  search warrant by authorized employees of the department,
  401  sheriffs, deputy sheriffs, police officers, or other law
  402  enforcement officers to determine that the licensee is
  403  transporting such products in compliance with this section.
  404         (7)TESTING AND LABELING OF LOW-THC CANNABIS.—
  405         (a)All low-THC cannabis and low-THC cannabis products must
  406  be tested by an independent testing laboratory before the
  407  dispensing organization may dispense them. The independent
  408  testing laboratory shall provide the dispensing organization
  409  with lab results. Before dispensing, the dispensing organization
  410  must determine that the lab results indicate that the low-THC
  411  cannabis or low-THC cannabis product meets the definition of
  412  low-THC cannabis or low-THC cannabis product, is safe for human
  413  consumption, and is free from harmful contaminants.
  414         (b)All low-THC cannabis and low-THC cannabis products must
  415  be labeled before dispensing. The label must include, at a
  416  minimum:
  417         1. A statement that the low-THC cannabis or low-THC
  418  cannabis product meets the requirements in paragraph (a);
  419         2.The name of the independent testing laboratory that
  420  tested the low-THC cannabis or low-THC cannabis product;
  421         3.The name of the cultivation and processing facility
  422  where the low-THC cannabis or low-THC cannabis product
  423  originates; and
  424         4.The batch number and harvest number from which the low
  425  THC cannabis or low-THC cannabis product originates.
  426         (8) SAFETY AND EFFICACY RESEARCH FOR LOW-THC CANNABIS.—The
  427  University of Florida College of Pharmacy shall establish and
  428  maintain a safety and efficacy research program for the use of
  429  low-THC cannabis or low-THC cannabis products to treat
  430  qualifying conditions and symptoms. The program must include a
  431  fully integrated electronic information system for the broad
  432  monitoring of health outcomes and safety signal detection. The
  433  electronic information system must include information from the
  434  compassionate use registry; provider reports, including
  435  treatment plans, adverse event reports, and treatment
  436  discontinuation reports; patient reports of adverse impacts;
  437  event-triggered interviews and medical chart reviews performed
  438  by the University of Florida clinical research staff;
  439  information from external databases, including Medicaid billing
  440  reports and information in the prescription drug monitoring
  441  database for registered patients; and all other medical reports
  442  required by the University of Florida to conduct the research
  443  required by this subsection. The department must provide access
  444  to information from the compassionate use registry and the
  445  prescription drug monitoring database, established in s.
  446  893.055, as needed by the University of Florida to conduct
  447  research under this subsection. The Agency for Health Care
  448  Administration must provide access to registered patient
  449  Medicaid records, to the extent allowed under federal law, as
  450  needed by the University of Florida to conduct research under
  451  this subsection.
  452         (9) PERSONS WITH INTEREST IN THE DISPENSING ORGANIZATION.
  453  The persons who have direct or indirect interest in the
  454  dispensing organization and the dispensing organization’s
  455  managers, employees, and contractors who directly interact with
  456  low-THC cannabis or low-THC cannabis products may not make
  457  recommendations, offer prescriptions, or provide medical advice
  458  to qualified patients.
  459         (10)DEPARTMENT AUTHORITY AND RESPONSIBILITIES.—
  460         (a)The department may conduct announced or unannounced
  461  inspections of dispensing organizations to determine compliance
  462  with this section or rules adopted pursuant to this section.
  463         (b)The department shall inspect a dispensing organization
  464  upon complaint or notice provided to the department that the
  465  dispensing organization has dispensed low-THC cannabis or low
  466  THC cannabis products containing any mold, bacteria, or other
  467  contaminant that may cause or has caused an adverse effect to
  468  human health or the environment.
  469         (c)The department shall conduct at least a biennial
  470  inspection of each dispensing organization to evaluate the
  471  dispensing organization’s records, personnel, equipment,
  472  processes, security measures, sanitation practices, and quality
  473  assurance practices.
  474         (d)The department may enter into interagency agreements
  475  with the Department of Agriculture and Consumer Services, the
  476  Department of Business and Professional Regulation, the
  477  Department of Transportation, the Department of Highway Safety
  478  and Motor Vehicles, and the Agency for Health Care
  479  Administration, and such agencies are authorized to enter into
  480  an interagency agreement with the department, to conduct
  481  inspections or perform other responsibilities assigned to the
  482  department under this section.
  483         (e)The department must make a list of all approved
  484  dispensing organizations and qualified ordering physicians and
  485  medical directors publicly available on its website.
  486         (f)The department may establish a system for issuing and
  487  renewing registration cards for qualified patients and their
  488  legal representatives, establish the circumstances under which
  489  the cards may be revoked by or must be returned to the
  490  department, and establish fees to implement such system. The
  491  department must require, at a minimum, the registration cards
  492  to:
  493         1.Provide the name, address, and date of birth of the
  494  qualified patient or legal representative.
  495         2.Have a full-face, passport-type, color photograph of the
  496  qualified patient or legal representative taken within the 90
  497  days immediately preceding registration.
  498         3.Identify whether the cardholder is a qualified patient
  499  or legal representative.
  500         4.List a unique numeric identifier for the qualified
  501  patient or legal representative which is matched to the
  502  identifier used for such person in the department’s
  503  compassionate use registry.
  504         5.Provide the expiration date, which shall be 1 year after
  505  the date of the physician’s initial order of low-THC cannabis.
  506         6.For the legal representative, provide the name and
  507  unique numeric identifier of the qualified patient that the
  508  legal representative is assisting.
  509         7.Be resistant to counterfeiting or tampering.
  510         (g)The department may suspend, revoke, or refuse to renew
  511  a dispensing organization’s approval if a dispensing
  512  organization commits any of the violations in paragraph (g).
  513         (h)The department shall renew the approval of a dispensing
  514  organization biennially if the dispensing organization meets the
  515  requirements of this section and pays the biennial renewal fee.
  516         (i)The department may adopt rules necessary to implement
  517  this section.
  518         (11)PREEMPTION.—
  519         (a)All matters regarding the regulation of the cultivation
  520  and processing of medical cannabis or low-THC cannabis by
  521  dispensing organizations are preempted to the state.
  522         (b)A municipality may determine by ordinance the criteria
  523  for the number and location of, and other permitting
  524  requirements that do not conflict with state law or department
  525  rule for, dispensing facilities of dispensing organizations
  526  located within its municipal boundaries. A county may determine
  527  by ordinance the criteria for the number, location, and other
  528  permitting requirements that do not conflict with state law or
  529  department rule for all dispensing facilities of dispensing
  530  organizations located within the unincorporated areas of that
  531  county.
  532         (12)(7) EXCEPTIONS TO OTHER LAWS.—
  533         (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  534  any other provision of law, but subject to the requirements of
  535  this section, a qualified patient and the qualified patient’s
  536  legal representative who is registered with the department on
  537  the compassionate use registry may purchase and possess for the
  538  patient’s medical use up to the amount of low-THC cannabis or
  539  medical cannabis ordered for the patient, but not more than a
  540  45-day supply, and a cannabis delivery device ordered for the
  541  patient. This section does not exempt any person from the
  542  prohibition against driving under the influence provided in s.
  543  316.193.
  544         (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  545  any other provision of law, but subject to the requirements of
  546  this section, an approved dispensing organization and its
  547  owners, managers, and employees, and the owners, managers, and
  548  employees of contractors who have direct contact with low-THC
  549  cannabis or low-THC cannabis products may manufacture, possess,
  550  sell, deliver, distribute, dispense, and lawfully dispose of
  551  reasonable quantities, as established by department rule, of
  552  low-THC cannabis or low-THC cannabis products in accordance with
  553  their licensure. For purposes of this subsection, the terms
  554  “manufacture,” “possession,” “deliver,” “distribute,” and
  555  “dispense” have the same meanings as provided in s. 893.02.
  556         (c)Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  557  any other law, but subject to the requirements of this section,
  558  an approved independent testing laboratory may possess, test,
  559  transport, and lawfully dispose of low-THC cannabis or medical
  560  cannabis as provided by department rule.
  561         (d)(c) An approved dispensing organization and its owners,
  562  managers, and employees are not subject to licensure or
  563  regulation under chapter 465 or chapter 499 for manufacturing,
  564  possessing, selling, delivering, distributing, dispensing, or
  565  lawfully disposing of reasonable quantities, as established by
  566  department rule, of low-THC cannabis.
  567         (e) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  568  any other law, but subject to the requirements of this section,
  569  a licensed laboratory and its employees may receive and possess
  570  low-THC cannabis or low-THC cannabis products for the sole
  571  purpose of testing the low-THC cannabis or low-THC cannabis
  572  products to ensure compliance with this section.
  573         (f)A dispensing organization that continues to meet the
  574  requirements for approval is presumed to be registered with the
  575  department and to meet the regulations adopted by the department
  576  or its successor agency for the purpose of dispensing medical
  577  cannabis or low-THC cannabis under state law. Additionally, the
  578  authority provided to a dispensing organization in s. 499.0295
  579  does not impair the approval of a dispensing organization.
  580         (g)This subsection does not preclude a person from being
  581  prosecuted for a criminal offense related to impairment or
  582  intoxication resulting from the medical use of low-THC cannabis
  583  or medical cannabis or relieve a person from any requirement
  584  under law to submit to a breath, blood, urine, or other test to
  585  detect the presence of a controlled substance.
  586         (13) RULES.—Rules adopted by the department under this
  587  section are exempt from the requirement that they be ratified by
  588  the Legislature pursuant to s. 120.541(3).
  589  
  590  ================= T I T L E  A M E N D M E N T ================
  591  And the title is amended as follows:
  592         Delete lines 21 - 81
  593  and insert:
  594         requiring the department to accept applications for
  595         licensure as dispensing organizations according to a
  596         specified application process; authorizing a
  597         dispensing organization to be licensed to cultivate,
  598         to process, or to dispense low-THC cannabis; requiring
  599         the department to review all applications, notify
  600         applicants of deficient applications, and request any
  601         additional information within a specified period;
  602         requiring an application for licensure to be filed and
  603         complete by specified dates; authorizing licensed
  604         applicants to operate in any region of the state;
  605         prohibiting a dispensing organization licensed to
  606         cultivate or process low-THC cannabis from having
  607         cultivation or processing facilities outside the
  608         region in which it is licensed; requiring licensure
  609         fees to be paid within a specified timeframe;
  610         providing an exemption for the application process;
  611         requiring the department to use an application form
  612         that requires specified information from the
  613         applicant; specifying application fees, licensure
  614         fees, and renewal fees; requiring the department to
  615         inspect each dispensing organization’s properties,
  616         cultivation facilities, processing facilities, or
  617         dispensing facilities before those facilities may
  618         operate; authorizing followup inspections at
  619         reasonable hours; providing that licensure constitutes
  620         permission for the department to enter and inspect the
  621         premises or facilities of any dispensing organization;
  622         requiring dispensing organizations to make all
  623         facility premises, equipment, documents, low-THC
  624         cannabis, and low-THC cannabis products, as
  625         applicable, available to the department upon
  626         inspection; authorizing the department to test low-THC
  627         cannabis or low-THC cannabis products; authorizing the
  628         department to suspend or revoke a license, deny or
  629         refuse to renew a license, or impose an administrative
  630         penalty for specified acts or omissions; requiring the
  631         department to create a permitting process for vehicles
  632         used for the transportation of low-THC cannabis or
  633         low-THC cannabis products; providing procedures and
  634         requirements for an applicant seeking licensure as a
  635         dispensing organization or the renewal of its license;
  636         requiring the dispensing organization to verify
  637         specified information of specified persons in certain
  638         circumstances; authorizing a dispensing organization
  639         to have cultivation facilities, processing facilities,
  640         or dispensing facilities; providing that all matters
  641         regarding the location of cultivation facilities and
  642         processing facilities are preempted to the state;
  643         providing requirements for cultivation facilities and
  644         processing facilities; requiring a municipality to
  645         determine by ordinance specified criteria related to
  646         dispensing facilities; authorizing a dispensing
  647         facility to be established in a municipality only
  648         after such an ordinance has been created; authorizing
  649         a dispensing facility to be established in the
  650         unincorporated areas of a county only after such an
  651         ordinance has been created; requiring dispensing
  652         facilities to have all utilities and resources
  653         necessary to store and dispense low-THC and low-THC
  654         cannabis products; requiring dispensing facilities to
  655         be secured with specified theft-prevention systems;
  656         requiring a dispensing organization to provide the
  657         department with specified updated information within a
  658         specified period; authorizing a dispensing
  659         organization to transport low-THC cannabis or low-THC
  660         cannabis products in vehicles in certain
  661         circumstances; requiring such vehicles to be operated
  662         by specified persons in certain circumstances;
  663         requiring a fee for a vehicle permit; requiring the
  664         signature of the designated driver with a vehicle
  665         permit application; providing for expiration of the
  666         permit in certain circumstances; requiring the
  667         department to cancel a vehicle permit upon the request
  668         of specified persons; providing that the licensee
  669         authorizes the inspection and search of his or her
  670         vehicle without a search warrant by specified persons;
  671         requiring all low-THC cannabis and low-THC cannabis
  672         products to be tested by an independent testing
  673         laboratory before the dispensing organization may
  674         dispense them; requiring the independent testing
  675         laboratory to provide the lab results to the
  676         dispensing organization for a specified determination;
  677         requiring all low-THC cannabis and low-THC cannabis
  678         products to be labeled with specified information
  679         before dispensing; requiring the University of Florida
  680         College of Pharmacy to establish and maintain a
  681         specified safety and efficacy research program;
  682         providing program requirements; requiring the
  683         department to provide access to information from the
  684         compassionate use registry and the prescription drug
  685         monitoring program database to the University of
  686         Florida as needed; requiring the Agency for Health
  687         Care Administration to provide access to specified
  688         patient records under certain circumstances;
  689         prohibiting persons who have direct or indirect
  690         interest in a dispensing organization and the
  691         dispensing organization’s managers, employees, and
  692         contractors who directly interact with low-THC
  693         cannabis and low-THC cannabis products from making
  694         recommendations, offering prescriptions, or providing
  695         medical advice to qualified patients; revising duties
  696         and responsibilities of the department; providing that
  697         certain matters are preempted to the state;
  698         authorizing a municipality to determine by ordinance
  699         certain criteria relating to dispensing organizations;
  700         providing that the act does not provide an exception
  701         to the prohibition against driving under the
  702         influence; authorizing specified individuals to
  703         manufacture, possess, sell, deliver, distribute,
  704         dispense, and lawfully dispose of reasonable
  705         quantities of low-THC cannabis according to their
  706         licensure; authorizing a licensed laboratory and its
  707         employees to receive and possess low-THC cannabis in
  708         certain circumstances; providing applicability;
  709         providing that specified rules adopted by the
  710         department are exempt from the requirement to be
  711         ratified by the Legislature; amending s. 499.0295,
  712         F.S.;