Florida Senate - 2016                          SENATOR AMENDMENT
       Bill No. SB 460
       
       
       
       
       
       
                                Ì369986oÎ369986                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                   Comm: RS            .                                
                  02/29/2016           .                                
                                       .                                
                 Floor: PD/2R          .                                
             02/23/2016 12:41 PM       .                                
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       Senator Bradley moved the following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Section 381.986, Florida Statutes, is amended to
    6  read:
    7         381.986 Compassionate use of low-THC and medical cannabis.—
    8         (1) DEFINITIONS.—As used in this section, the term:
    9         (a)“Cannabis delivery device” means an object used,
   10  intended for use, or designed for use in preparing, storing,
   11  ingesting, inhaling, or otherwise introducing low-THC cannabis
   12  or medical cannabis into the human body.
   13         (b)(a) “Dispensing organization” means an organization
   14  approved by the department to cultivate, process, transport, and
   15  dispense low-THC cannabis or medical cannabis pursuant to this
   16  section.
   17         (c)“Independent testing laboratory” means a laboratory,
   18  including the managers, employees, or contractors of the
   19  laboratory, which has no direct or indirect interest in a
   20  dispensing organization.
   21         (d)“Legal representative” means the qualified patient’s
   22  parent, legal guardian acting pursuant to a court’s
   23  authorization as required under s. 744.3215(4), health care
   24  surrogate acting pursuant to the qualified patient’s written
   25  consent or a court’s authorization as required under s. 765.113,
   26  or an individual who is authorized under a power of attorney to
   27  make health care decisions on behalf of the qualified patient.
   28         (e)(b) “Low-THC cannabis” means a plant of the genus
   29  Cannabis, the dried flowers of which contain 0.8 percent or less
   30  of tetrahydrocannabinol and more than 10 percent of cannabidiol
   31  weight for weight; the seeds thereof; the resin extracted from
   32  any part of such plant; or any compound, manufacture, salt,
   33  derivative, mixture, or preparation of such plant or its seeds
   34  or resin that is dispensed only from a dispensing organization.
   35         (f)“Medical cannabis” means all parts of any plant of the
   36  genus Cannabis, whether growing or not; the seeds thereof; the
   37  resin extracted from any part of the plant; and every compound,
   38  manufacture, sale, derivative, mixture, or preparation of the
   39  plant or its seeds or resin that is dispensed only from a
   40  dispensing organization for medical use by an eligible patient
   41  as defined in s. 499.0295.
   42         (g)(c) “Medical use” means administration of the ordered
   43  amount of low-THC cannabis or medical cannabis. The term does
   44  not include the:
   45         1. Possession, use, or administration of low-THC cannabis
   46  or medical cannabis by smoking.
   47         2.The term also does not include the Transfer of low-THC
   48  cannabis or medical cannabis to a person other than the
   49  qualified patient for whom it was ordered or the qualified
   50  patient’s legal representative on behalf of the qualified
   51  patient.
   52         3.Use or administration of low-THC cannabis or medical
   53  cannabis:
   54         a.On any form of public transportation.
   55         b.In any public place.
   56         c.In a qualified patient’s place of employment, if
   57  restricted by his or her employer.
   58         d.In a state correctional institution as defined in s.
   59  944.02 or a correctional institution as defined in s. 944.241.
   60         e.On the grounds of a preschool, primary school, or
   61  secondary school.
   62         f.On a school bus or in a vehicle, aircraft, or motorboat.
   63         (h)(d) “Qualified patient” means a resident of this state
   64  who has been added to the compassionate use registry by a
   65  physician licensed under chapter 458 or chapter 459 to receive
   66  low-THC cannabis or medical cannabis from a dispensing
   67  organization.
   68         (i)(e) “Smoking” means burning or igniting a substance and
   69  inhaling the smoke. Smoking does not include the use of a
   70  vaporizer.
   71         (2) PHYSICIAN ORDERING.—Effective January 1, 2015, A
   72  physician is authorized to order licensed under chapter 458 or
   73  chapter 459 who has examined and is treating a patient suffering
   74  from cancer or a physical medical condition that chronically
   75  produces symptoms of seizures or severe and persistent muscle
   76  spasms may order for the patient’s medical use low-THC cannabis
   77  to treat a qualified patient suffering from cancer or a physical
   78  medical condition that chronically produces symptoms of seizures
   79  or severe and persistent muscle spasms; order low-THC cannabis
   80  such disease, disorder, or condition or to alleviate symptoms of
   81  such disease, disorder, or condition, if no other satisfactory
   82  alternative treatment options exist for the qualified that
   83  patient; order medical cannabis to treat an eligible patient as
   84  defined in s. 499.0295; or order a cannabis delivery device for
   85  the medical use of low-THC cannabis or medical cannabis, only if
   86  the physician and all of the following conditions apply:
   87         (a)Holds an active, unrestricted license as a physician
   88  under chapter 458 or an osteopathic physician under chapter 459;
   89         (b)Has treated the patient for at least 3 months
   90  immediately preceding the patient’s registration in the
   91  compassionate use registry;
   92         (c)Has successfully completed the course and examination
   93  required under paragraph (4)(a);
   94         (a) The patient is a permanent resident of this state.
   95         (d)(b)Has determined The physician determines that the
   96  risks of treating the patient with ordering low-THC cannabis or
   97  medical cannabis are reasonable in light of the potential
   98  benefit to the for that patient. If a patient is younger than 18
   99  years of age, a second physician must concur with this
  100  determination, and such determination must be documented in the
  101  patient’s medical record;.
  102         (e)(c) The physician Registers as the orderer of low-THC
  103  cannabis or medical cannabis for the named patient on the
  104  compassionate use registry maintained by the department and
  105  updates the registry to reflect the contents of the order,
  106  including the amount of low-THC cannabis or medical cannabis
  107  that will provide the patient with not more than a 45-day supply
  108  and a cannabis delivery device needed by the patient for the
  109  medical use of low-THC cannabis or medical cannabis. The
  110  physician must also update the registry within 7 days after any
  111  change is made to the original order to reflect the change. The
  112  physician shall deactivate the registration of the patient and
  113  the patient’s legal representative patient’s registration when
  114  treatment is discontinued;.
  115         (f)(d)The physician Maintains a patient treatment plan
  116  that includes the dose, route of administration, planned
  117  duration, and monitoring of the patient’s symptoms and other
  118  indicators of tolerance or reaction to the low-THC cannabis or
  119  medical cannabis;.
  120         (g)(e)The physician Submits the patient treatment plan
  121  quarterly to the University of Florida College of Pharmacy for
  122  research on the safety and efficacy of low-THC cannabis and
  123  medical cannabis on patients;.
  124         (h)(f)The physician Obtains the voluntary written informed
  125  consent of the patient or the patient’s legal representative
  126  guardian to treatment with low-THC cannabis after sufficiently
  127  explaining the current state of knowledge in the medical
  128  community of the effectiveness of treatment of the patient’s
  129  condition with low-THC cannabis, the medically acceptable
  130  alternatives, and the potential risks and side effects;
  131         (i)Obtains written informed consent as defined in and
  132  required under s. 499.0295, if the physician is ordering medical
  133  cannabis for an eligible patient pursuant to that section; and
  134         (j)Is not a medical director employed by a dispensing
  135  organization.
  136         (3) PENALTIES.—
  137         (a) A physician commits a misdemeanor of the first degree,
  138  punishable as provided in s. 775.082 or s. 775.083, if the
  139  physician orders low-THC cannabis for a patient without a
  140  reasonable belief that the patient is suffering from:
  141         1. Cancer or a physical medical condition that chronically
  142  produces symptoms of seizures or severe and persistent muscle
  143  spasms that can be treated with low-THC cannabis; or
  144         2. Symptoms of cancer or a physical medical condition that
  145  chronically produces symptoms of seizures or severe and
  146  persistent muscle spasms that can be alleviated with low-THC
  147  cannabis.
  148         (b)A physician commits a misdemeanor of the first degree,
  149  punishable as provided in s. 775.082 or s. 775.083, if the
  150  physician orders medical cannabis for a patient without a
  151  reasonable belief that the patient has a terminal condition as
  152  defined in s. 499.0295.
  153         (c)(b)A Any person who fraudulently represents that he or
  154  she has cancer, or a physical medical condition that chronically
  155  produces symptoms of seizures or severe and persistent muscle
  156  spasms, or a terminal condition to a physician for the purpose
  157  of being ordered low-THC cannabis, medical cannabis, or a
  158  cannabis delivery device by such physician commits a misdemeanor
  159  of the first degree, punishable as provided in s. 775.082 or s.
  160  775.083.
  161         (d)An eligible patient as defined in s. 499.0295 who uses
  162  medical cannabis, and such patient’s legal representative who
  163  administers medical cannabis, in plain view of or in a place
  164  open to the general public, on the grounds of a school, or in a
  165  school bus, vehicle, aircraft, or motorboat commits a
  166  misdemeanor of the first degree, punishable as provided in s.
  167  775.082 or s. 775.083.
  168         (e)A physician who orders low-THC cannabis, medical
  169  cannabis, or a cannabis delivery device and receives
  170  compensation from a dispensing organization related to the
  171  ordering of low-THC cannabis, medical cannabis, or a cannabis
  172  delivery device is subject to disciplinary action under the
  173  applicable practice act and s. 456.072(1)(n).
  174         (4) PHYSICIAN EDUCATION.—
  175         (a) Before ordering low-THC cannabis, medical cannabis, or
  176  a cannabis delivery device for medical use by a patient in this
  177  state, the appropriate board shall require the ordering
  178  physician licensed under chapter 458 or chapter 459 to
  179  successfully complete an 8-hour course and subsequent
  180  examination offered by the Florida Medical Association or the
  181  Florida Osteopathic Medical Association that encompasses the
  182  clinical indications for the appropriate use of low-THC cannabis
  183  and medical cannabis, the appropriate cannabis delivery devices
  184  mechanisms, the contraindications for such use, and as well as
  185  the relevant state and federal laws governing the ordering,
  186  dispensing, and possessing of these substances and devices this
  187  substance. The first course and examination shall be presented
  188  by October 1, 2014, and shall be administered at least annually
  189  thereafter. Successful completion of the course may be used by a
  190  physician to satisfy 8 hours of the continuing medical education
  191  requirements required by his or her respective board for
  192  licensure renewal. This course may be offered in a distance
  193  learning format.
  194         (b) The appropriate board shall require the medical
  195  director of each dispensing organization to hold an active,
  196  unrestricted license as a physician under chapter 458 or as an
  197  osteopathic physician under chapter 459 and approved under
  198  subsection (5) to successfully complete a 2-hour course and
  199  subsequent examination offered by the Florida Medical
  200  Association or the Florida Osteopathic Medical Association that
  201  encompasses appropriate safety procedures and knowledge of low
  202  THC cannabis, medical cannabis, and cannabis delivery devices.
  203         (c) Successful completion of the course and examination
  204  specified in paragraph (a) is required for every physician who
  205  orders low-THC cannabis, medical cannabis, or a cannabis
  206  delivery device each time such physician renews his or her
  207  license. In addition, successful completion of the course and
  208  examination specified in paragraph (b) is required for the
  209  medical director of each dispensing organization each time such
  210  physician renews his or her license.
  211         (d) A physician who fails to comply with this subsection
  212  and who orders low-THC cannabis, medical cannabis, or a cannabis
  213  delivery device may be subject to disciplinary action under the
  214  applicable practice act and under s. 456.072(1)(k).
  215         (5) DUTIES OF THE DEPARTMENT.—By January 1, 2015, The
  216  department shall:
  217         (a) Create and maintain a secure, electronic, and online
  218  compassionate use registry for the registration of physicians,
  219  and patients, and the legal representatives of patients as
  220  provided under this section. The registry must be accessible to
  221  law enforcement agencies and to a dispensing organization in
  222  order to verify the authorization of a patient or a patient’s
  223  legal representative to possess patient authorization for low
  224  THC cannabis, medical cannabis, or a cannabis delivery device
  225  and record the low-THC cannabis, medical cannabis, or cannabis
  226  delivery device dispensed. The registry must prevent an active
  227  registration of a patient by multiple physicians.
  228         (b) Authorize the establishment of five dispensing
  229  organizations to ensure reasonable statewide accessibility and
  230  availability as necessary for patients registered in the
  231  compassionate use registry and who are ordered low-THC cannabis,
  232  medical cannabis, or a cannabis delivery device under this
  233  section, one in each of the following regions: northwest
  234  Florida, northeast Florida, central Florida, southeast Florida,
  235  and southwest Florida. The department shall develop an
  236  application form and impose an initial application and biennial
  237  renewal fee that is sufficient to cover the costs of
  238  administering this section. An applicant for approval as a
  239  dispensing organization must be able to demonstrate:
  240         1. The technical and technological ability to cultivate and
  241  produce low-THC cannabis. The applicant must possess a valid
  242  certificate of registration issued by the Department of
  243  Agriculture and Consumer Services pursuant to s. 581.131 that is
  244  issued for the cultivation of more than 400,000 plants, be
  245  operated by a nurseryman as defined in s. 581.011, and have been
  246  operated as a registered nursery in this state for at least 30
  247  continuous years.
  248         2. The ability to secure the premises, resources, and
  249  personnel necessary to operate as a dispensing organization.
  250         3. The ability to maintain accountability of all raw
  251  materials, finished products, and any byproducts to prevent
  252  diversion or unlawful access to or possession of these
  253  substances.
  254         4. An infrastructure reasonably located to dispense low-THC
  255  cannabis to registered patients statewide or regionally as
  256  determined by the department.
  257         5. The financial ability to maintain operations for the
  258  duration of the 2-year approval cycle, including the provision
  259  of certified financials to the department. Upon approval, the
  260  applicant must post a $5 million performance bond. However, upon
  261  a dispensing organization’s serving at least 1,000 qualified
  262  patients, the dispensing organization is only required to
  263  maintain a $2 million performance bond.
  264         6. That all owners and managers have been fingerprinted and
  265  have successfully passed a level 2 background screening pursuant
  266  to s. 435.04.
  267         7. The employment of a medical director who is a physician
  268  licensed under chapter 458 or chapter 459 to supervise the
  269  activities of the dispensing organization.
  270         (c)Upon the registration of 250,000 qualified patients in
  271  the compassionate use registry, approve three additional
  272  dispensing organizations, which must meet the requirements of
  273  subparagraphs (b)2.-7. for such approval.
  274         (d)Allow a dispensing organization to make a wholesale
  275  purchase of low-THC cannabis or medical cannabis from, or a
  276  distribution of low-THC cannabis or medical cannabis to, another
  277  dispensing organization.
  278         (e)(c) Monitor physician registration and ordering of low
  279  THC cannabis, medical cannabis, or a cannabis delivery device
  280  for ordering practices that could facilitate unlawful diversion
  281  or misuse of low-THC cannabis, medical cannabis, or a cannabis
  282  delivery device and take disciplinary action as indicated.
  283         (d) Adopt rules necessary to implement this section.
  284         (6) DISPENSING ORGANIZATION.—An approved dispensing
  285  organization must, at all times, shall maintain compliance with
  286  the criteria demonstrated for selection and approval as a
  287  dispensing organization under subsection (5) and the criteria
  288  required in this subsection at all times.
  289         (a)When growing low-THC cannabis or medical cannabis, a
  290  dispensing organization:
  291         1.May use pesticides determined by the department, after
  292  consultation with the Department of Agriculture and Consumer
  293  Services, to be safely applied to plants intended for human
  294  consumption, but may not use pesticides designated as
  295  restricted-use pesticides pursuant to s. 487.042.
  296         2.Must grow and process low-THC cannabis or medical
  297  cannabis within an enclosed structure and in a room separate
  298  from any other plant.
  299         3.Must inspect seeds and growing plants for plant pests
  300  that endanger or threaten the horticultural and agricultural
  301  interests of the state, notify the Department of Agriculture and
  302  Consumer Services within 10 calendar days after a determination
  303  that a plant is infested or infected by such plant pest, and
  304  implement and maintain phytosanitary policies and procedures.
  305         4.Must perform fumigation or treatment of plants, or the
  306  removal and destruction of infested or infected plants, in
  307  accordance with chapter 581 and any rules adopted thereunder.
  308         (b)When processing low-THC cannabis or medical cannabis, a
  309  dispensing organization must:
  310         1.Process the low-THC cannabis or medical cannabis in an
  311  enclosure separate from other plants or products.
  312         2.Test the processed low-THC cannabis and medical cannabis
  313  before they are dispensed. Results must be verified and signed
  314  by two dispensing organization employees. Before dispensing low
  315  THC cannabis, the dispensing organization must determine that
  316  the test results indicate that the low-THC cannabis meets the
  317  definition of low-THC cannabis and, for medical cannabis and
  318  low-THC cannabis, that all medical cannabis and low-THC cannabis
  319  is safe for human consumption and free from contaminants that
  320  are unsafe for human consumption. The dispensing organization
  321  must retain records of all testing and samples of each
  322  homogenous batch of cannabis and low-THC cannabis for at least 9
  323  months. The dispensing organization must contract with an
  324  independent testing laboratory to perform audits on the
  325  dispensing organization’s standard operating procedures, testing
  326  records, and samples and provide the results to the department
  327  to confirm that the low-THC cannabis or medical cannabis meets
  328  the requirements of this section and that the medical cannabis
  329  and low-THC cannabis is safe for human consumption.
  330         3.Package the low-THC cannabis or medical cannabis in
  331  compliance with the United States Poison Prevention Packaging
  332  Act of 1970, 15 U.S.C. ss. 1471 et seq.
  333         4.Package the low-THC cannabis or medical cannabis in a
  334  receptacle that has a firmly affixed and legible label stating
  335  the following information:
  336         a.A statement that the low-THC cannabis or medical
  337  cannabis meets the requirements of subparagraph 2.;
  338         b.The name of the dispensing organization from which the
  339  medical cannabis or low-THC cannabis originates; and
  340         c.The batch number and harvest number from which the
  341  medical cannabis or low-THC cannabis originates.
  342         5.Reserve two processed samples from each batch and retain
  343  such samples for at least 9 months for the purpose of testing
  344  pursuant to the audit required under subparagraph 2.
  345         (c)When dispensing low-THC cannabis, medical cannabis, or
  346  a cannabis delivery device, a dispensing organization:
  347         1.May not dispense more than a 45-day supply of low-THC
  348  cannabis or medical cannabis to a patient or the patient’s legal
  349  representative.
  350         2.Must have the dispensing organization’s employee who
  351  dispenses the low-THC cannabis, medical cannabis, or a cannabis
  352  delivery device enter into the compassionate use registry his or
  353  her name or unique employee identifier.
  354         3.Must verify in the compassionate use registry that a
  355  physician has ordered the low-THC cannabis, medical cannabis, or
  356  a specific type of a cannabis delivery device for the patient.
  357         4.May not dispense or sell any other type of cannabis,
  358  alcohol, or illicit drug-related product, including pipes,
  359  bongs, or wrapping papers, other than a physician-ordered
  360  cannabis delivery device required for the medical use of low-THC
  361  cannabis or medical cannabis, while dispensing low-THC cannabis
  362  or medical cannabis.
  363         5.Must Before dispensing low-THC cannabis to a qualified
  364  patient, the dispensing organization shall verify that the
  365  patient has an active registration in the compassionate use
  366  registry, the patient or patient’s legal representative holds a
  367  valid and active registration card, the order presented matches
  368  the order contents as recorded in the registry, and the order
  369  has not already been filled.
  370         6.Must, upon dispensing the low-THC cannabis, medical
  371  cannabis, or cannabis delivery device, the dispensing
  372  organization shall record in the registry the date, time,
  373  quantity, and form of low-THC cannabis or medical cannabis
  374  dispensed and the type of cannabis delivery device dispensed.
  375         (d)To ensure the safety and security of its premises and
  376  any off-site storage facilities, and to maintain adequate
  377  controls against the diversion, theft, and loss of low-THC
  378  cannabis, medical cannabis, or cannabis delivery devices, a
  379  dispensing organization shall:
  380         1.a.Maintain a fully operational security alarm system
  381  that secures all entry points and perimeter windows and is
  382  equipped with motion detectors; pressure switches; and duress,
  383  panic, and hold-up alarms; or
  384         b.Maintain a video surveillance system that records
  385  continuously 24 hours each day and meets at least one of the
  386  following criteria:
  387         (I)Cameras are fixed in a place that allows for the clear
  388  identification of persons and activities in controlled areas of
  389  the premises. Controlled areas include grow rooms, processing
  390  rooms, storage rooms, disposal rooms or areas, and point-of-sale
  391  rooms;
  392         (II)Cameras are fixed in entrances and exits to the
  393  premises, which shall record from both indoor and outdoor, or
  394  ingress and egress, vantage points;
  395         (III)Recorded images must clearly and accurately display
  396  the time and date; or
  397         (IV)Retain video surveillance recordings for a minimum of
  398  45 days or longer upon the request of a law enforcement agency.
  399         2.Ensure that the organization’s outdoor premises have
  400  sufficient lighting from dusk until dawn.
  401         3.Establish and maintain a tracking system approved by the
  402  department that traces the low-THC cannabis or medical cannabis
  403  from seed to sale. The tracking system shall include
  404  notification of key events as determined by the department,
  405  including when cannabis seeds are planted, when cannabis plants
  406  are harvested and destroyed, and when low-THC cannabis or
  407  medical cannabis is transported, sold, stolen, diverted, or
  408  lost.
  409         4.Not dispense from its premises low-THC cannabis, medical
  410  cannabis, or a cannabis delivery device between the hours of 9
  411  p.m. and 7 a.m., but may perform all other operations and
  412  deliver low-THC cannabis and medical cannabis to qualified
  413  patients 24 hours each day.
  414         5.Store low-THC cannabis or medical cannabis in a secured,
  415  locked room or a vault.
  416         6.Require at least two of its employees, or two employees
  417  of a security agency with whom it contracts, to be on the
  418  premises at all times.
  419         7.Require each employee to wear a photo identification
  420  badge at all times while on the premises.
  421         8.Require each visitor to wear a visitor’s pass at all
  422  times while on the premises.
  423         9.Implement an alcohol and drug-free workplace policy.
  424         10.Report to local law enforcement within 24 hours after
  425  it is notified or becomes aware of the theft, diversion, or loss
  426  of low-THC cannabis or medical cannabis.
  427         (e)To ensure the safe transport of low-THC cannabis or
  428  medical cannabis to dispensing organization facilities,
  429  independent testing laboratories, or patients, the dispensing
  430  organization must:
  431         1.Maintain a transportation manifest, which must be
  432  retained for at least 1 year.
  433         2.Ensure only vehicles in good working order are used to
  434  transport low-THC cannabis or medical cannabis.
  435         3.Lock low-THC cannabis or medical cannabis in a separate
  436  compartment or container within the vehicle.
  437         4.Require at least two persons to be in a vehicle
  438  transporting low-THC cannabis or medical cannabis, and require
  439  at least one person to remain in the vehicle while the low-THC
  440  cannabis or medical cannabis is being delivered.
  441         5.Provide specific safety and security training to
  442  employees transporting or delivering low-THC cannabis or medical
  443  cannabis.
  444         (7)DEPARTMENT AUTHORITY AND RESPONSIBILITIES.—
  445         (a)The department may conduct announced or unannounced
  446  inspections of dispensing organizations to determine compliance
  447  with this section or rules adopted pursuant to this section.
  448         (b)The department shall inspect a dispensing organization
  449  upon complaint or notice provided to the department that the
  450  dispensing organization has dispensed low-THC cannabis or
  451  medical cannabis containing any mold, bacteria, or other
  452  contaminant that may cause or has caused an adverse effect to
  453  human health or the environment.
  454         (c)The department shall conduct at least a biennial
  455  inspection of each dispensing organization to evaluate the
  456  dispensing organization’s records, personnel, equipment,
  457  processes, security measures, sanitation practices, and quality
  458  assurance practices.
  459         (d)The department may enter into interagency agreements
  460  with the Department of Agriculture and Consumer Services, the
  461  Department of Business and Professional Regulation, the
  462  Department of Transportation, the Department of Highway Safety
  463  and Motor Vehicles, and the Agency for Health Care
  464  Administration, and such agencies are authorized to enter into
  465  an interagency agreement with the department, to conduct
  466  inspections or perform other responsibilities assigned to the
  467  department under this section.
  468         (e)The department must make a list of all approved
  469  dispensing organizations and qualified ordering physicians and
  470  medical directors publicly available on its website.
  471         (f)The department may establish a system for issuing and
  472  renewing registration cards for patients and their legal
  473  representatives, establish the circumstances under which the
  474  cards may be revoked by or must be returned to the department,
  475  and establish fees to implement such system. The department must
  476  require, at a minimum, the registration cards to:
  477         1.Provide the name, address, and date of birth of the
  478  patient or legal representative.
  479         2.Have a full-face, passport-type, color photograph of the
  480  patient or legal representative taken within the 90 days
  481  immediately preceding registration.
  482         3.Identify whether the cardholder is a patient or legal
  483  representative.
  484         4.List a unique numeric identifier for the patient or
  485  legal representative that is matched to the identifier used for
  486  such person in the department’s compassionate use registry.
  487         5.Provide the expiration date, which shall be 1 year after
  488  the date of the physician’s initial order of low-THC cannabis or
  489  medical cannabis.
  490         6.For the legal representative, provide the name and
  491  unique numeric identifier of the patient that the legal
  492  representative is assisting.
  493         7.Be resistant to counterfeiting or tampering.
  494         (g)The department may impose reasonable fines not to
  495  exceed $10,000 on a dispensing organization for any of the
  496  following violations:
  497         1.Violating this section, s. 499.0295, or department rule.
  498         2.Failing to maintain qualifications for approval.
  499         3.Endangering the health, safety, or security of a
  500  qualified patient.
  501         4.Improperly disclosing personal and confidential
  502  information of the qualified patient.
  503         5.Attempting to procure dispensing organization approval
  504  by bribery, fraudulent misrepresentation, or extortion.
  505         6.Being convicted or found guilty of, or entering a plea
  506  of guilty or nolo contendere to, regardless of adjudication, a
  507  crime in any jurisdiction which directly relates to the business
  508  of a dispensing organization.
  509         7.Making or filing a report or record that the dispensing
  510  organization knows to be false.
  511         8.Willfully failing to maintain a record required by this
  512  section or department rule.
  513         9.Willfully impeding or obstructing an employee or agent
  514  of the department in the furtherance of his or her official
  515  duties.
  516         10.Engaging in fraud or deceit, negligence, incompetence,
  517  or misconduct in the business practices of a dispensing
  518  organization.
  519         11.Making misleading, deceptive, or fraudulent
  520  representations in or related to the business practices of a
  521  dispensing organization.
  522         12.Having a license or the authority to engage in any
  523  regulated profession, occupation, or business that is related to
  524  the business practices of a dispensing organization suspended,
  525  revoked, or otherwise acted against by the licensing authority
  526  of any jurisdiction, including its agencies or subdivisions, for
  527  a violation that would constitute a violation under Florida law.
  528         13.Violating a lawful order of the department or an agency
  529  of the state, or failing to comply with a lawfully issued
  530  subpoena of the department or an agency of the state.
  531         (h)The department may suspend, revoke, or refuse to renew
  532  a dispensing organization’s approval if a dispensing
  533  organization commits any of the violations in paragraph (g).
  534         (i)The department shall renew the approval of a dispensing
  535  organization biennially if the dispensing organization meets the
  536  requirements of this section and pays the biennial renewal fee.
  537         (j)The department may adopt rules necessary to implement
  538  this section.
  539         (8)PREEMPTION.—
  540         (a)All matters regarding the regulation of the cultivation
  541  and processing of medical cannabis or low-THC cannabis by
  542  dispensing organizations are preempted to the state.
  543         (b)A municipality may determine by ordinance the criteria
  544  for the number and location of, and other permitting
  545  requirements that do not conflict with state law or department
  546  rule for, dispensing facilities of dispensing organizations
  547  located within its municipal boundaries. A county may determine
  548  by ordinance the criteria for the number, location, and other
  549  permitting requirements that do not conflict with state law or
  550  department rule for all dispensing facilities of dispensing
  551  organizations located within the unincorporated areas of that
  552  county.
  553         (9)(7) EXCEPTIONS TO OTHER LAWS.—
  554         (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  555  any other provision of law, but subject to the requirements of
  556  this section, a qualified patient and the qualified patient’s
  557  legal representative may purchase and possess for the patient’s
  558  medical use up to the amount of low-THC cannabis or medical
  559  cannabis ordered for the patient, but not more than a 45-day
  560  supply, and a cannabis delivery device ordered for the patient.
  561         (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  562  any other provision of law, but subject to the requirements of
  563  this section, an approved dispensing organization and its
  564  owners, managers, and employees may manufacture, possess, sell,
  565  deliver, distribute, dispense, and lawfully dispose of
  566  reasonable quantities, as established by department rule, of
  567  low-THC cannabis, medical cannabis, or a cannabis delivery
  568  device. For purposes of this subsection, the terms
  569  “manufacture,” “possession,” “deliver,” “distribute,” and
  570  “dispense” have the same meanings as provided in s. 893.02.
  571         (c)Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  572  any other provision of law, but subject to the requirements of
  573  this section, an approved independent testing laboratory may
  574  possess, test, transport, and lawfully dispose of low-THC
  575  cannabis or medical cannabis as provided by department rule.
  576         (d)(c) An approved dispensing organization and its owners,
  577  managers, and employees are not subject to licensure or
  578  regulation under chapter 465 or chapter 499 for manufacturing,
  579  possessing, selling, delivering, distributing, dispensing, or
  580  lawfully disposing of reasonable quantities, as established by
  581  department rule, of low-THC cannabis, medical cannabis, or a
  582  cannabis delivery device.
  583         (e)An approved dispensing organization that continues to
  584  meet the requirements for approval is presumed to be registered
  585  with the department and to meet the regulations adopted by the
  586  department or its successor agency for the purpose of dispensing
  587  medical cannabis or low-THC cannabis under state law.
  588  Additionally, the authority provided to a dispensing
  589  organization in s. 499.0295 does not impair the approval of a
  590  dispensing organization.
  591         (f)This subsection does not preclude a person from being
  592  prosecuted for a criminal offense related to impairment or
  593  intoxication resulting from the medical use of low-THC cannabis
  594  or medical cannabis or relieve a person from any requirement
  595  under law to submit to a breath, blood, urine, or other test to
  596  detect the presence of a controlled substance.
  597         Section 2. Subsections (2) and (3) of section 499.0295,
  598  Florida Statutes, are amended to read:
  599         499.0295 Experimental treatments for terminal conditions.—
  600         (2) As used in this section, the term:
  601         (a)“Dispensing organization” means an organization
  602  approved by the Department of Health under s. 381.986(5) to
  603  cultivate, process, transport, and dispense low-THC cannabis,
  604  medical cannabis, and cannabis delivery devices.
  605         (b)(a) “Eligible patient” means a person who:
  606         1. Has a terminal condition that is attested to by the
  607  patient’s physician and confirmed by a second independent
  608  evaluation by a board-certified physician in an appropriate
  609  specialty for that condition;
  610         2. Has considered all other treatment options for the
  611  terminal condition currently approved by the United States Food
  612  and Drug Administration;
  613         3. Has given written informed consent for the use of an
  614  investigational drug, biological product, or device; and
  615         4. Has documentation from his or her treating physician
  616  that the patient meets the requirements of this paragraph.
  617         (c)(b) “Investigational drug, biological product, or
  618  device” means:
  619         1. A drug, biological product, or device that has
  620  successfully completed phase 1 of a clinical trial but has not
  621  been approved for general use by the United States Food and Drug
  622  Administration and remains under investigation in a clinical
  623  trial approved by the United States Food and Drug
  624  Administration; or
  625         2.Medical cannabis that is manufactured and sold by a
  626  dispensing organization.
  627         (d)(c) “Terminal condition” means a progressive disease or
  628  medical or surgical condition that causes significant functional
  629  impairment, is not considered by a treating physician to be
  630  reversible even with the administration of available treatment
  631  options currently approved by the United States Food and Drug
  632  Administration, and, without the administration of life
  633  sustaining procedures, will result in death within 1 year after
  634  diagnosis if the condition runs its normal course.
  635         (e)(d) “Written informed consent” means a document that is
  636  signed by a patient, a parent of a minor patient, a court
  637  appointed guardian for a patient, or a health care surrogate
  638  designated by a patient and includes:
  639         1. An explanation of the currently approved products and
  640  treatments for the patient’s terminal condition.
  641         2. An attestation that the patient concurs with his or her
  642  physician in believing that all currently approved products and
  643  treatments are unlikely to prolong the patient’s life.
  644         3. Identification of the specific investigational drug,
  645  biological product, or device that the patient is seeking to
  646  use.
  647         4. A realistic description of the most likely outcomes of
  648  using the investigational drug, biological product, or device.
  649  The description shall include the possibility that new,
  650  unanticipated, different, or worse symptoms might result and
  651  death could be hastened by the proposed treatment. The
  652  description shall be based on the physician’s knowledge of the
  653  proposed treatment for the patient’s terminal condition.
  654         5. A statement that the patient’s health plan or third
  655  party administrator and physician are not obligated to pay for
  656  care or treatment consequent to the use of the investigational
  657  drug, biological product, or device unless required to do so by
  658  law or contract.
  659         6. A statement that the patient’s eligibility for hospice
  660  care may be withdrawn if the patient begins treatment with the
  661  investigational drug, biological product, or device and that
  662  hospice care may be reinstated if the treatment ends and the
  663  patient meets hospice eligibility requirements.
  664         7. A statement that the patient understands he or she is
  665  liable for all expenses consequent to the use of the
  666  investigational drug, biological product, or device and that
  667  liability extends to the patient’s estate, unless a contract
  668  between the patient and the manufacturer of the investigational
  669  drug, biological product, or device states otherwise.
  670         (3) Upon the request of an eligible patient, a manufacturer
  671  may, or upon a physician’s order pursuant to s. 381.986, a
  672  dispensing organization may:
  673         (a) Make its investigational drug, biological product, or
  674  device available under this section.
  675         (b) Provide an investigational drug, biological product, or
  676  device, or cannabis delivery device as defined in s. 381.986 to
  677  an eligible patient without receiving compensation.
  678         (c) Require an eligible patient to pay the costs of, or the
  679  costs associated with, the manufacture of the investigational
  680  drug, biological product, or device, or cannabis delivery device
  681  as defined in s. 381.986.
  682         Section 3. (1)Notwithstanding s. 381.986(5)(b), Florida
  683  Statutes, a dispensing organization that receives notice from
  684  the Department of Health that it is approved as a region’s
  685  dispensing organization; posts a $5 million performance bond in
  686  compliance with rule 64-4.002(5)(e), Florida Administrative
  687  Code; meets the requirements of and requests cultivation
  688  authorization pursuant to rule 64-4.005(2), Florida
  689  Administrative Code; and expends at least $100,000 to fulfill
  690  its legal obligations as a dispensing organization shall be
  691  granted cultivation authorization by the Department of Health
  692  and is authorized to operate as a dispensing organization for
  693  the full term of its original approval and all subsequent
  694  renewals pursuant to s. 381.986, Florida Statutes.
  695         (2)An action taken before or after the effective date of
  696  this section by the Division of Administrative Hearings, the
  697  Department of Health, or a court of competent jurisdiction which
  698  has the effect of approving, pursuant to s. 381.986(5)(b),
  699  Florida Statutes, a dispensing organization that does not meet
  700  the criteria of subsection (1) does not impair an authorization
  701  granted pursuant to subsection (1) to a dispensing organization
  702  meeting the criteria of subsection (1). During the operations of
  703  any dispensing organization that meets the criteria of
  704  subsection (1), the Department of Health may enforce rule 64
  705  4.005, Florida Administrative Code, as filed on June 17, 2015.
  706         Section 4. This act shall take effect upon becoming a law.
  707  
  708  ================= T I T L E  A M E N D M E N T ================
  709  And the title is amended as follows:
  710         Delete everything before the enacting clause
  711  and insert:
  712                        A bill to be entitled                      
  713         An act relating to the medical use of cannabis;
  714         amending s. 381.986, F.S.; providing and revising
  715         definitions; revising requirements for physicians
  716         ordering low-THC cannabis; providing requirements for
  717         physicians ordering medical cannabis; providing
  718         penalties; providing that a physician who orders low
  719         THC cannabis or medical cannabis and receives related
  720         compensation from a dispensing organization is subject
  721         to disciplinary action; revising requirements relating
  722         to physician education; requiring the Department of
  723         Health to include legal representative information in
  724         its online compassionate use registry; revising
  725         requirements for dispensing organizations; revising
  726         duties and responsibilities of the department;
  727         revising standards to be met and maintained by
  728         dispensing organizations; authorizing an independent
  729         testing laboratory and its employees to possess, test,
  730         transport, and lawfully dispose of low-THC cannabis or
  731         medical cannabis under certain circumstances;
  732         exempting an approved dispensing organization and
  733         related persons from the Florida Drug and Cosmetic
  734         Act; providing applicability; amending s. 499.0295,
  735         F.S.; defining the term “dispensing organization”;
  736         revising the definition of the term “investigational
  737         drug, biological product, or device”; authorizing
  738         certain manufacturers to dispense cannabis delivery
  739         devices; authorizing certain dispensing organizations
  740         to provide low-THC cannabis, medical cannabis, and
  741         cannabis delivery devices to eligible patients;
  742         providing for dispensing organizations meeting
  743         specified criteria to be granted authorization to
  744         cultivate certain cannabis and operate as dispensing
  745         organizations; providing applicability; providing an
  746         effective date.