Florida Senate - 2017                                    SB 1388
       
       
        
       By Senator Artiles
       
       
       
       
       
       40-01186-17                                           20171388__
    1                        A bill to be entitled                      
    2         An act relating to medical cannabis; amending s.
    3         381.986, F.S.; defining, redefining, and deleting
    4         terms; authorizing physicians to issue physician
    5         certifications for medical cannabis or cannabis
    6         delivery devices, instead of ordering low-THC
    7         cannabis, for patients suffering from a debilitating
    8         medical condition; authorizing physicians to make
    9         specific determinations in certifications; requiring
   10         physicians to meet certain conditions to be authorized
   11         to issue such physician certifications; providing
   12         criminal penalties; deleting provisions requiring
   13         successful completion of a specified course and
   14         examination by a physician who orders low-THC cannabis
   15         and by a medical director of a dispensing
   16         organization; requiring the Department of Health to
   17         register medical marijuana treatment centers, rather
   18         than to authorize the establishment of dispensing
   19         organizations; requiring the department to register
   20         additional medical marijuana treatment centers under
   21         certain circumstances; requiring the department to
   22         authorize the establishment of medical marijuana
   23         testing facilities; prohibiting a medical marijuana
   24         testing facility from being owned by certain persons;
   25         providing rulemaking authority; conforming provisions
   26         to changes made by the act; deleting provisions
   27         relating to the department’s issuance of registration
   28         cards for patients and their legal representatives;
   29         requiring the department to establish a quality
   30         control program that requires medical cannabis to be
   31         tested by a medical marijuana testing facility;
   32         requiring medical marijuana treatment centers to
   33         submit samples of medical cannabis to a medical
   34         marijuana testing facility; providing testing
   35         specifications; requiring retention of testing
   36         records; providing rulemaking authority; conforming
   37         provisions to changes made by the act; amending ss.
   38         381.987, 385.211, 499.0295, 893.02, and 1004.441,
   39         F.S.; conforming provisions to changes made by the
   40         act; providing an effective date.
   41          
   42  Be It Enacted by the Legislature of the State of Florida:
   43  
   44         Section 1. Section 381.986, Florida Statutes, is amended to
   45  read:
   46         381.986 Compassionate use of low-THC and medical cannabis.—
   47         (1) DEFINITIONS.—As used in this section, the term:
   48         (a) “Cannabis delivery device” means an object used,
   49  intended for use, or designed for use in preparing, storing,
   50  ingesting, inhaling, or otherwise introducing low-THC cannabis
   51  or medical cannabis into the human body.
   52         (b) “Caregiver” means a person who is at least 21 years
   53  old, who has agreed to assist with a qualifying patient’s
   54  medical use of marijuana, and who has obtained a valid caregiver
   55  identification card issued by the department.
   56         (c)“Debilitating medical condition” means cancer,
   57  epilepsy, glaucoma, positive status for human immunodeficiency
   58  virus (HIV), acquired immune deficiency syndrome (AIDS),
   59  posttraumatic stress disorder (PTSD), amyotrophic lateral
   60  sclerosis (ALS), Crohn’s disease, Parkinson’s disease, multiple
   61  sclerosis, or other debilitating medical conditions of the same
   62  kind or class as or comparable to those enumerated and for which
   63  a physician believes that the medical use of marijuana would
   64  likely outweigh the potential health risks for a patient
   65  “Dispensing organization” means an organization approved by the
   66  department to cultivate, process, transport, and dispense low
   67  THC cannabis or medical cannabis pursuant to this section.
   68         (c) “Independent testing laboratory” means a laboratory,
   69  including the managers, employees, or contractors of the
   70  laboratory, which has no direct or indirect interest in a
   71  dispensing organization.
   72         (d) “Legal representative” means the qualified patient’s
   73  parent, legal guardian acting pursuant to a court’s
   74  authorization as required under s. 744.3215(4), health care
   75  surrogate acting pursuant to the qualified patient’s written
   76  consent or a court’s authorization as required under s. 765.113,
   77  or an individual who is authorized under a power of attorney to
   78  make health care decisions on behalf of the qualified patient.
   79         (e) “Low-THC cannabis” means a plant of the genus Cannabis,
   80  the dried flowers of which contain 0.8 percent or less of
   81  tetrahydrocannabinol and more than 10 percent of cannabidiol
   82  weight for weight; the seeds thereof; the resin extracted from
   83  any part of such plant; or any compound, manufacture, salt,
   84  derivative, mixture, or preparation of such plant or its seeds
   85  or resin that is dispensed only from a dispensing organization.
   86         (d)(f) “Medical cannabis” means all parts of any plant of
   87  the genus Cannabis, whether growing or not; the seeds thereof;
   88  the resin extracted from any part of the plant; and every
   89  compound, manufacture, sale, derivative, mixture, or preparation
   90  of the plant or its seeds or resin that is dispensed only from a
   91  medical marijuana treatment center dispensing organization for
   92  medical use by a qualifying an eligible patient as defined in s.
   93  499.0295.
   94         (e) “Medical marijuana treatment center” or “MMTC” means an
   95  entity that is registered with the department and that:
   96         1. Acquires, cultivates, possesses, or processes marijuana
   97  or products containing marijuana, including developing related
   98  products such as food, tinctures, aerosols, oils, or ointments,
   99  for sale to qualifying patients or their caregivers; or
  100         2. Transfers, transports, sells, distributes, or dispenses
  101  marijuana, products containing marijuana, related supplies, or
  102  educational materials to qualifying patients or their
  103  caregivers.
  104         (f) “Medical marijuana testing facility” means an entity
  105  that is licensed by the department and that is certified by the
  106  department, or by an accredited, third-party laboratory
  107  certification body that meets department standards, to obtain,
  108  transport, store, analyze, and dispose of samples of medical
  109  cannabis for the purpose of certifying the safety and potency of
  110  medical cannabis.
  111         (g) “Medical use” means the acquisition, transportation,
  112  possession, use, or administration of an amount of medical
  113  cannabis in accordance with department rules, or of related
  114  supplies, by a qualifying patient or a caregiver for use for the
  115  treatment of a debilitating medical condition of the qualifying
  116  patient administration of the ordered amount of low-THC cannabis
  117  or medical cannabis. The term does not include the:
  118         1. Possession, use, or administration of low-THC cannabis
  119  or medical cannabis by smoking.
  120         2. Transfer of low-THC cannabis or medical cannabis to a
  121  person other than the qualified patient for whom it was ordered
  122  or the qualified patient’s legal representative on behalf of the
  123  qualified patient.
  124         3. Use or administration of low-THC cannabis or medical
  125  cannabis:
  126         a. On any form of public transportation.
  127         b. In any public place.
  128         c. In a qualified patient’s place of employment, if
  129  restricted by his or her employer.
  130         d. In a state correctional institution as defined in s.
  131  944.02 or a correctional institution as defined in s. 944.241.
  132         e. On the grounds of a preschool, primary school, or
  133  secondary school.
  134         f. On a school bus or in a vehicle, aircraft, or motorboat.
  135         (h) “Person” means a natural person, partnership,
  136  association, company, corporation, limited liability company, or
  137  organization. The term does not include a governmental
  138  organization.
  139         (i)(h)“Qualifying patient” means a person who has been
  140  diagnosed to have a debilitating medical condition and who has a
  141  physician certification and a valid qualifying patient
  142  identification card “Qualified patient” means a resident of this
  143  state who has been added to the compassionate use registry by a
  144  physician licensed under chapter 458 or chapter 459 to receive
  145  low-THC cannabis or medical cannabis from a dispensing
  146  organization.
  147         (i) “Smoking” means burning or igniting a substance and
  148  inhaling the smoke. Smoking does not include the use of a
  149  vaporizer.
  150         (2) PHYSICIAN CERTIFICATION ORDERING.—A physician is
  151  authorized to issue a physician certification for medical order
  152  low-THC cannabis or a cannabis delivery device to treat a
  153  qualifying qualified patient suffering from a debilitating
  154  cancer or a physical medical condition that chronically produces
  155  symptoms of seizures or severe and persistent muscle spasms;
  156  order low-THC cannabis to alleviate symptoms of such disease,
  157  disorder, or condition, if no other satisfactory alternative
  158  treatment options exist for the qualified patient; order medical
  159  cannabis to treat an eligible patient as defined in s. 499.0295;
  160  or order a cannabis delivery device for the medical use of low
  161  THC cannabis or medical cannabis, only if the physician:
  162         (a) Holds an active, unrestricted license as a physician
  163  under chapter 458 or an osteopathic physician under chapter 459;
  164         (b) Has treated the patient for at least 3 months
  165  immediately preceding the patient’s registration in the
  166  compassionate use registry;
  167         (c) Has successfully completed the course and examination
  168  required under paragraph (4)(a);
  169         (d) Has determined that the risks of treating the patient
  170  with low-THC cannabis or medical cannabis are reasonable in
  171  light of the potential benefit to the patient. If a patient is
  172  younger than 18 years of age, a second physician must concur
  173  with this determination, and such determination must be
  174  documented in the patient’s medical record;
  175         (e) Registers as the patient’s physician orderer of low-THC
  176  cannabis or medical cannabis for the named patient on the
  177  compassionate use registry maintained by the department and
  178  updates the registry to reflect the contents of the order of
  179  medical cannabis, including the amount of low-THC cannabis or
  180  medical cannabis which that will provide the patient with not
  181  more than a 45-day supply and a cannabis delivery device needed
  182  by the patient for the medical use of low-THC cannabis or
  183  medical cannabis. The physician must also update the registry
  184  within 7 days after any change is made to the original order to
  185  reflect the change. The physician shall deactivate the
  186  registration of the patient and the patient’s caregiver legal
  187  representative when the physician no longer recommends the
  188  medical use of marijuana for the patient treatment is
  189  discontinued;
  190         (f) Maintains a patient treatment plan that includes the
  191  dose, route of administration, planned duration, and monitoring
  192  of the patient’s symptoms and other indicators of tolerance or
  193  reaction to the low-THC cannabis or medical cannabis;
  194         (g) Submits the patient treatment plan quarterly to the
  195  University of Florida College of Pharmacy for research on the
  196  safety and efficacy of low-THC cannabis and medical cannabis on
  197  patients;
  198         (h) Obtains the voluntary written informed consent of the
  199  patient or the patient’s caregiver legal representative to
  200  treatment with medical low-THC cannabis after sufficiently
  201  explaining the current state of knowledge in the medical
  202  community of the effectiveness of treatment of the patient’s
  203  condition with medical low-THC cannabis, the medically
  204  acceptable alternatives, and the potential risks and side
  205  effects;
  206         (i) Obtains written informed consent as defined in and
  207  required under s. 499.0295, if the physician is ordering medical
  208  cannabis for an eligible patient pursuant to that section; and
  209         (i)(j) Is not a medical director employed by an MMTC a
  210  dispensing organization.
  211         (3) PENALTIES.—
  212         (a) A physician commits a misdemeanor of the first degree,
  213  punishable as provided in s. 775.082 or s. 775.083, if the
  214  physician issues a physician certification for medical orders
  215  low-THC cannabis or a cannabis delivery device for a patient
  216  without a reasonable belief that the patient is suffering from a
  217  debilitating medical condition:
  218         1. Cancer or a physical medical condition that chronically
  219  produces symptoms of seizures or severe and persistent muscle
  220  spasms that can be treated with low-THC cannabis; or
  221         2. Symptoms of cancer or a physical medical condition that
  222  chronically produces symptoms of seizures or severe and
  223  persistent muscle spasms that can be alleviated with low-THC
  224  cannabis.
  225         (b) A physician commits a misdemeanor of the first degree,
  226  punishable as provided in s. 775.082 or s. 775.083, if the
  227  physician orders medical cannabis for a patient without a
  228  reasonable belief that the patient has a terminal condition as
  229  defined in s. 499.0295.
  230         (b)(c) A person who fraudulently represents that he or she
  231  has a debilitating medical cancer, a physical medical condition
  232  that chronically produces symptoms of seizures or severe and
  233  persistent muscle spasms, or a terminal condition to a physician
  234  for the purpose of being issued a physician certification for
  235  ordered low-THC cannabis, medical cannabis, or a cannabis
  236  delivery device by such physician commits a misdemeanor of the
  237  first degree, punishable as provided in s. 775.082 or s.
  238  775.083.
  239         (c)(d)A qualifying An eligible patient as defined in s.
  240  499.0295 who uses medical cannabis, and such patient’s caregiver
  241  legal representative who administers medical cannabis, in plain
  242  view of or in a place open to the general public, on the grounds
  243  of a school, or in a school bus, vehicle, aircraft, or
  244  motorboat, commits a misdemeanor of the first degree, punishable
  245  as provided in s. 775.082 or s. 775.083.
  246         (d)(e) A physician who issues a physician certification for
  247  orders low-THC cannabis, medical cannabis, or a cannabis
  248  delivery device and receives compensation from an MMTC a
  249  dispensing organization related to the ordering of low-THC
  250  cannabis, medical cannabis, or a cannabis delivery device is
  251  subject to disciplinary action under the applicable practice act
  252  and s. 456.072(1)(n).
  253         (4) PHYSICIAN EDUCATION.—
  254         (a) Before a physician may issue a physician certification
  255  for ordering low-THC cannabis, medical cannabis, or a cannabis
  256  delivery device for medical use by a patient in this state, the
  257  appropriate board shall require the ordering physician to
  258  successfully complete an 8-hour course and subsequent
  259  examination offered by the Florida Medical Association or the
  260  Florida Osteopathic Medical Association which that encompasses
  261  the clinical indications for the appropriate use of low-THC
  262  cannabis and medical cannabis, the appropriate cannabis delivery
  263  devices, the contraindications for such use, and the relevant
  264  state and federal laws governing the issuance of physician
  265  certifications ordering, as well as the dispensing, and
  266  possessing of these substances and devices. The course and
  267  examination shall be administered at least annually. Successful
  268  completion of the course may be used by a physician to satisfy 8
  269  hours of the continuing medical education requirements required
  270  by his or her respective board for licensure renewal. This
  271  course may be offered in a distance learning format.
  272         (b) The appropriate board shall require the medical
  273  director of each MMTC dispensing organization to hold an active,
  274  unrestricted license as a physician under chapter 458 or as an
  275  osteopathic physician under chapter 459 and successfully
  276  complete a 2-hour course and subsequent examination offered by
  277  the Florida Medical Association or the Florida Osteopathic
  278  Medical Association which that encompasses appropriate safety
  279  procedures and knowledge of low-THC cannabis, medical cannabis,
  280  and cannabis delivery devices.
  281         (c) Successful completion of the course and examination
  282  specified in paragraph (a) is required for every physician who
  283  orders low-THC cannabis, medical cannabis, or a cannabis
  284  delivery device each time such physician renews his or her
  285  license. In addition, successful completion of the course and
  286  examination specified in paragraph (b) is required for the
  287  medical director of each dispensing organization each time such
  288  physician renews his or her license.
  289         (c)(d) A physician who fails to comply with this subsection
  290  and who issues a physician certification for orders low-THC
  291  cannabis, medical cannabis, or a cannabis delivery device may be
  292  subject to disciplinary action under the applicable practice act
  293  and under s. 456.072(1)(k).
  294         (5) DUTIES OF THE DEPARTMENT.—The department shall:
  295         (a) Create and maintain a secure, electronic, and online
  296  compassionate use registry for the registration of physicians,
  297  patients, and caregivers the legal representatives of patients
  298  as provided under this section. The registry must be accessible
  299  to law enforcement agencies and to MMTCs a dispensing
  300  organization to verify the authorization of a patient or a
  301  patient’s caregiver legal representative to possess low-THC
  302  cannabis, medical cannabis, or a cannabis delivery device and
  303  record the low-THC cannabis, medical cannabis, or cannabis
  304  delivery device dispensed. The registry must prevent an active
  305  registration of a patient by multiple physicians.
  306         (b) Within 6 months after the registration of 250,000
  307  active qualifying patients in the compassionate use registry,
  308  register five additional MMTCs, including, but not limited to,
  309  an applicant that is a recognized class member of Pigford v.
  310  Glickman, 185 F.R.D. 82 (D.D.C. 1999), or In re Black Farmers
  311  Litig., 856 F. Supp. 2d 1 (D.D.C. 2011), and that is a member of
  312  the Black Farmers and Agriculturalists Association.
  313  Additionally, the department must register an additional five
  314  MMTCs within 6 months after the registration of each of the
  315  following totals of the number of patients in the compassionate
  316  use registry: 350,000 qualifying patients; 400,000 qualifying
  317  patients; 500,000 qualifying patients; and then the registration
  318  of each additional 100,000 qualifying patients above 500,000, if
  319  a sufficient number of MMTC applicants meet the registration
  320  requirements established in this section and by department rule
  321  Authorize the establishment of five dispensing organizations to
  322  ensure reasonable statewide accessibility and availability as
  323  necessary for patients registered in the compassionate use
  324  registry and who are ordered low-THC cannabis, medical cannabis,
  325  or a cannabis delivery device under this section, one in each of
  326  the following regions: northwest Florida, northeast Florida,
  327  central Florida, southeast Florida, and southwest Florida. The
  328  department shall develop an application form and impose an
  329  initial application and biennial renewal fee that is sufficient
  330  to cover the costs of administering this section. An applicant
  331  for approval as an MMTC a dispensing organization must be able
  332  to demonstrate:
  333         1. The technical and technological ability to cultivate and
  334  produce medical low-THC cannabis. The applicant must possess a
  335  valid certificate of registration issued by the Department of
  336  Agriculture and Consumer Services pursuant to s. 581.131 that is
  337  issued for the cultivation of more than 400,000 plants, be
  338  operated by a nurseryman as defined in s. 581.011, and have been
  339  operated as a registered nursery in this state for at least 30
  340  continuous years.
  341         2. The ability to secure the premises, resources, and
  342  personnel necessary to operate as an MMTC a dispensing
  343  organization.
  344         3. The ability to maintain accountability of all raw
  345  materials, finished products, and any byproducts to prevent
  346  diversion or unlawful access to or possession of these
  347  substances.
  348         4. An infrastructure reasonably located to dispense medical
  349  low-THC cannabis to qualifying registered patients statewide or
  350  regionally as determined by the department.
  351         5. The financial ability to maintain operations for the
  352  duration of the 2-year approval cycle, including the provision
  353  of certified financials to the department. Upon approval, the
  354  applicant must post a $5 million performance bond. However, upon
  355  a dispensing organization’s serving at least 1,000 qualifying
  356  qualified patients, the MMTC dispensing organization is only
  357  required to maintain only a $2 million performance bond.
  358         6. That all owners and managers have been fingerprinted and
  359  have successfully passed a level 2 background screening pursuant
  360  to s. 435.04.
  361         7. The employment of a medical director to supervise the
  362  activities of the MMTC dispensing organization.
  363         (c) Upon the registration of 250,000 active qualified
  364  patients in the compassionate use registry, approve three
  365  dispensing organizations, including, but not limited to, an
  366  applicant that is a recognized class member of Pigford v.
  367  Glickman, 185 F.R.D. 82 (D.D.C. 1999), or In Re Black Farmers
  368  Litig., 856 F. Supp. 2d 1 (D.D.C. 2011), and a member of the
  369  Black Farmers and Agriculturalists Association, which must meet
  370  the requirements of subparagraphs (b)2.-7. and demonstrate the
  371  technical and technological ability to cultivate and produce
  372  low-THC cannabis.
  373         (c)(d) Allow an MMTC a dispensing organization to make a
  374  wholesale purchase of low-THC cannabis or medical cannabis from,
  375  or a distribution of low-THC cannabis or medical cannabis to,
  376  another MMTC dispensing organization.
  377         (d)(e) Monitor physician registration in the compassionate
  378  use registry and the issuance of physician certifications
  379  ordering of low-THC cannabis, medical cannabis, or a cannabis
  380  delivery device for ordering practices that could facilitate
  381  unlawful diversion or misuse of low-THC cannabis, medical
  382  cannabis, or a cannabis delivery device and take disciplinary
  383  action as indicated.
  384         (e) Authorize the establishment of medical marijuana
  385  testing facilities to ensure that all medical cannabis is tested
  386  for potency and contaminants in accordance with the department’s
  387  quality control program. A medical marijuana testing facility
  388  may collect and accept samples of, and possess, store,
  389  transport, and test medical cannabis. A medical marijuana
  390  testing facility may not be owned by a person who also possesses
  391  an ownership interest in an MMTC.
  392         1. The department shall develop regulations concerning
  393  medical marijuana testing facility license requirements,
  394  suitability, and processes; develop an application form for a
  395  medical marijuana testing facility license; and impose an
  396  initial application fee and a biennial renewal fee sufficient to
  397  cover the costs of administering this section.
  398         2. In addition to licensure, a medical marijuana testing
  399  facility must be certified to perform all required tests by the
  400  department or by an accredited, third-party laboratory
  401  certification body that meets department standards. The
  402  department shall establish reasonable rules for the
  403  certification and operation of medical marijuana testing
  404  facilities. Rules for certification must, at a minimum, address
  405  standards relating to:
  406         a.Personnel qualifications;
  407         b.Equipment and methodology;
  408         c.Proficiency testing;
  409         d.Tracking;
  410         e.Sampling;
  411         f.Chain of custody;
  412         g.Record and sample retention;
  413         h.Reporting;
  414         i.Audit and inspection; and
  415         j.Security.
  416         3. The department shall suspend or reduce any mandatory
  417  testing requirement specified in its quality control program if
  418  the number of licensed and certified medical marijuana testing
  419  facilities is insufficient to process the tests necessary to
  420  meet the current and anticipated market for MMTCs.
  421         4. A medical marijuana testing facility may accept only
  422  samples composed of medical cannabis which are obtained from a
  423  sample source approved by the department, including an MMTC, a
  424  researcher affiliated with an accredited university or research
  425  hospital, a qualifying patient, a caregiver, and any entity
  426  authorized by the department.
  427         (6) MEDICAL MARIJUANA TREATMENT CENTERS DISPENSING
  428  ORGANIZATION.—An approved MMTC dispensing organization must, at
  429  all times, maintain compliance with the criteria demonstrated
  430  for selection and approval as an MMTC a dispensing organization
  431  under subsection (5) and the criteria required in this
  432  subsection.
  433         (a) When growing low-THC cannabis or medical cannabis, an
  434  MMTC a dispensing organization:
  435         1. May use pesticides determined by the department, after
  436  consultation with the Department of Agriculture and Consumer
  437  Services, to be safely applied to plants intended for human
  438  consumption, but may not use pesticides designated as
  439  restricted-use pesticides pursuant to s. 487.042.
  440         2. Must grow low-THC cannabis or medical cannabis within an
  441  enclosed structure and in a room separate from any other plant.
  442         3. Must inspect seeds and growing plants for plant pests
  443  that endanger or threaten the horticultural and agricultural
  444  interests of the state, notify the Department of Agriculture and
  445  Consumer Services within 10 calendar days after a determination
  446  that a plant is infested or infected by such plant pest, and
  447  implement and maintain phytosanitary policies and procedures.
  448         4. Must perform fumigation or treatment of plants, or the
  449  removal and destruction of infested or infected plants, in
  450  accordance with chapter 581 and any rules adopted thereunder.
  451         (b) Before transferring medical cannabis to other licensed
  452  premises or selling or transferring medical cannabis to a
  453  qualifying patient or caregiver, an MMTC When processing low-THC
  454  cannabis or medical cannabis, a dispensing organization must:
  455         1. Have the Process the low-THC cannabis or medical
  456  cannabis within an enclosed structure and in a room separate
  457  from other plants or products.
  458         2. Test the processed low-THC cannabis and medical cannabis
  459  tested by a medical marijuana testing facility to ensure it
  460  meets the standards established by the department’s quality
  461  control program before it is they are dispensed in accordance
  462  with department rule. Results must be verified and signed by two
  463  dispensing organization employees. Before dispensing low-THC
  464  cannabis, the dispensing organization must determine that the
  465  test results indicate that the low-THC cannabis meets the
  466  definition of low-THC cannabis and, for medical cannabis and
  467  low-THC cannabis, that all medical cannabis and low-THC cannabis
  468  is safe for human consumption and free from contaminants that
  469  are unsafe for human consumption. The dispensing organization
  470  must retain records of all testing and samples of each
  471  homogenous batch of cannabis and low-THC cannabis for at least 9
  472  months. The dispensing organization must contract with an
  473  independent testing laboratory to perform audits on the
  474  dispensing organization’s standard operating procedures, testing
  475  records, and samples and provide the results to the department
  476  to confirm that the low-THC cannabis or medical cannabis meets
  477  the requirements of this section and that the medical cannabis
  478  and low-THC cannabis is safe for human consumption.
  479         2.3. Package the low-THC cannabis or medical cannabis in
  480  compliance with the United States Poison Prevention Packaging
  481  Act of 1970, 15 U.S.C. ss. 1471 et seq.
  482         3.4. Package the low-THC cannabis or medical cannabis in a
  483  receptacle that has a firmly affixed and legible label stating
  484  the following information, and any other information required by
  485  department rule:
  486         a. A statement that the low-THC cannabis or medical
  487  cannabis meets the requirements of subparagraph 1. 2.;
  488         b. The name of the medical marijuana treatment center
  489  dispensing organization from which the medical cannabis or low
  490  THC cannabis originates; and
  491         c. The batch number, lot number, or other unique
  492  identification and harvest number from which the medical
  493  cannabis or low-THC cannabis originates.
  494         5. Reserve two processed samples from each batch and retain
  495  such samples for at least 9 months for the purpose of testing
  496  pursuant to the audit required under subparagraph 2.
  497         (c) When dispensing low-THC cannabis, medical cannabis, or
  498  a cannabis delivery device, an MMTC a dispensing organization:
  499         1. May not dispense more than a 45-day supply of low-THC
  500  cannabis or medical cannabis to a patient or the patient’s
  501  caregiver legal representative.
  502         2. Must have the MMTC’s dispensing organization’s employee
  503  who dispenses the low-THC cannabis, medical cannabis, or a
  504  cannabis delivery device enter into the compassionate use
  505  registry his or her name or unique employee identifier.
  506         3. Must verify in the compassionate use registry that a
  507  physician has ordered the low-THC cannabis, medical cannabis, or
  508  a specific type of a cannabis delivery device for the patient.
  509         4. May not dispense or sell any other type of cannabis,
  510  alcohol, or illicit drug-related product, including pipes,
  511  bongs, or wrapping papers, other than a physician-ordered
  512  cannabis delivery device required for the medical use of low-THC
  513  cannabis or medical cannabis, while dispensing low-THC cannabis
  514  or medical cannabis.
  515         5. Must verify that the patient has an active registration
  516  in the compassionate use registry, the patient or patient’s
  517  caregiver legal representative holds a valid and active
  518  identification registration card, the order presented matches
  519  the order contents as recorded in the registry, and the order
  520  has not already been filled.
  521         6. Must, upon dispensing the low-THC cannabis, medical
  522  cannabis, or cannabis delivery device, record in the registry
  523  the date, time, quantity, and form of low-THC cannabis or
  524  medical cannabis dispensed and the type of cannabis delivery
  525  device dispensed.
  526         (d) To ensure the safety and security of its premises and
  527  any off-site storage facilities, and to maintain adequate
  528  controls against the diversion, theft, and loss of low-THC
  529  cannabis, medical cannabis, or cannabis delivery devices, an
  530  MMTC a dispensing organization shall:
  531         1.a. Maintain a fully operational security alarm system
  532  that secures all entry points and perimeter windows and is
  533  equipped with motion detectors; pressure switches; and duress,
  534  panic, and hold-up alarms; or
  535         b. Maintain a video surveillance system that records
  536  continuously 24 hours each day and meets at least one of the
  537  following criteria:
  538         (I) Cameras are fixed in a place that allows for the clear
  539  identification of persons and activities in controlled areas of
  540  the premises. Controlled areas include grow rooms, processing
  541  rooms, storage rooms, disposal rooms or areas, and point-of-sale
  542  rooms;
  543         (II) Cameras are fixed in entrances and exits to the
  544  premises, which shall record from both indoor and outdoor, or
  545  ingress and egress, vantage points;
  546         (III) Recorded images must clearly and accurately display
  547  the time and date; or
  548         (IV) Retain video surveillance recordings for a minimum of
  549  45 days or longer upon the request of a law enforcement agency.
  550         2. Ensure that the MMTC’s organization’s outdoor premises
  551  have sufficient lighting from dusk until dawn.
  552         3. Establish and maintain a tracking system approved by the
  553  department which that traces the low-THC cannabis or medical
  554  cannabis from seed to sale. The tracking system must shall
  555  include notification of key events as determined by the
  556  department, including when cannabis seeds are planted, when
  557  cannabis plants are harvested and destroyed, and when low-THC
  558  cannabis or medical cannabis is transported, sold, stolen,
  559  diverted, or lost.
  560         4. Not dispense from its premises low-THC cannabis, medical
  561  cannabis, or a cannabis delivery device between the hours of 9
  562  p.m. and 7 a.m., but may perform all other operations and
  563  deliver low-THC cannabis and medical cannabis to qualifying
  564  qualified patients 24 hours each day.
  565         5. Store low-THC cannabis or medical cannabis in a secured,
  566  locked room or a vault.
  567         6. Require at least two of its employees, or two employees
  568  of a security agency with whom it contracts, to be on the
  569  premises at all times.
  570         7. Require each employee to wear a photo identification
  571  badge at all times while on the premises.
  572         8. Require each visitor to wear a visitor’s pass at all
  573  times while on the premises.
  574         9. Implement an alcohol and drug-free workplace policy.
  575         10. Report to local law enforcement within 24 hours after
  576  it is notified or becomes aware of the theft, diversion, or loss
  577  of low-THC cannabis or medical cannabis.
  578         (e) To ensure the safe transport of low-THC cannabis or
  579  medical cannabis to medical marijuana testing facilities, MMTCs,
  580  caregivers dispensing organization facilities, independent
  581  testing laboratories, or qualifying patients, an MMTC or medical
  582  marijuana testing facility that transports medical cannabis the
  583  dispensing organization must:
  584         1. Maintain a transportation manifest, which must be
  585  retained for at least 1 year.
  586         2. Ensure only vehicles in good working order are used to
  587  transport low-THC cannabis or medical cannabis.
  588         3. Lock low-THC cannabis or medical cannabis in a separate
  589  compartment or container within the vehicle.
  590         4. Require at least two persons to be in a vehicle
  591  transporting low-THC cannabis or medical cannabis, and require
  592  at least one person to remain in the vehicle while the low-THC
  593  cannabis or medical cannabis is being delivered.
  594         5. Provide specific safety and security training to
  595  employees transporting or delivering low-THC cannabis or medical
  596  cannabis.
  597         (7) DEPARTMENT AUTHORITY AND RESPONSIBILITIES.—
  598         (a) The department may conduct announced or unannounced
  599  inspections of MMTCs dispensing organizations to determine
  600  compliance with this section or rules adopted pursuant to this
  601  section.
  602         (b) The department shall inspect an MMTC a dispensing
  603  organization upon complaint or notice provided to the department
  604  that the MMTC dispensing organization has dispensed low-THC
  605  cannabis or medical cannabis containing any mold, bacteria, or
  606  other contaminant that may cause or has caused an adverse effect
  607  to human health or the environment.
  608         (c) The department shall conduct at least a biennial
  609  inspection of each MMTC dispensing organization to evaluate the
  610  MMTC’s dispensing organization’s records, personnel, equipment,
  611  processes, security measures, sanitation practices, and quality
  612  assurance practices.
  613         (d) The department may enter into interagency agreements
  614  with the Department of Agriculture and Consumer Services, the
  615  Department of Business and Professional Regulation, the
  616  Department of Transportation, the Department of Highway Safety
  617  and Motor Vehicles, and the Agency for Health Care
  618  Administration, and such agencies are authorized to enter into
  619  an interagency agreement with the department, to conduct
  620  inspections or perform other responsibilities assigned to the
  621  department under this section.
  622         (e) The department must make a list of all approved MMTCs,
  623  physicians who are dispensing organizations and qualified to
  624  issue physician certifications, ordering physicians and medical
  625  directors of MMTCs publicly available on its website.
  626         (f) The department may establish a system for issuing and
  627  renewing registration cards for patients and their legal
  628  representatives, establish the circumstances under which the
  629  cards may be revoked by or must be returned to the department,
  630  and establish fees to implement such system. The department must
  631  require, at a minimum, the registration cards to:
  632         1. Provide the name, address, and date of birth of the
  633  patient or legal representative.
  634         2. Have a full-face, passport-type, color photograph of the
  635  patient or legal representative taken within the 90 days
  636  immediately preceding registration.
  637         3. Identify whether the cardholder is a patient or legal
  638  representative.
  639         4. List a unique numeric identifier for the patient or
  640  legal representative that is matched to the identifier used for
  641  such person in the department’s compassionate use registry.
  642         5. Provide the expiration date, which shall be 1 year after
  643  the date of the physician’s initial order of low-THC cannabis or
  644  medical cannabis.
  645         6. For the legal representative, provide the name and
  646  unique numeric identifier of the patient that the legal
  647  representative is assisting.
  648         7. Be resistant to counterfeiting or tampering.
  649         (f)(g) The department may impose reasonable fines not to
  650  exceed $10,000 on an MMTC a dispensing organization for any of
  651  the following violations:
  652         1. Violating this section, s. 499.0295, or department rule.
  653         2. Failing to maintain qualifications for approval.
  654         3. Endangering the health, safety, or security of a
  655  qualifying qualified patient.
  656         4. Improperly disclosing personal and confidential
  657  information of the qualifying qualified patient.
  658         5. Attempting to procure MMTC dispensing organization
  659  approval by bribery, fraudulent misrepresentation, or extortion.
  660         6. Being convicted or found guilty of, or entering a plea
  661  of guilty or nolo contendere to, regardless of adjudication, a
  662  crime in any jurisdiction which directly relates to the business
  663  of an MMTC a dispensing organization.
  664         7. Making or filing a report or record that the MMTC
  665  dispensing organization knows to be false.
  666         8. Willfully failing to maintain a record required by this
  667  section or department rule.
  668         9. Willfully impeding or obstructing an employee or agent
  669  of the department in the furtherance of his or her official
  670  duties.
  671         10. Engaging in fraud or deceit, negligence, incompetence,
  672  or misconduct in the business practices of an MMTC a dispensing
  673  organization.
  674         11. Making misleading, deceptive, or fraudulent
  675  representations in or related to the business practices of an
  676  MMTC a dispensing organization.
  677         12. Having a license or the authority to engage in any
  678  regulated profession, occupation, or business that is related to
  679  the business practices of an MMTC a dispensing organization
  680  suspended, revoked, or otherwise acted against by the licensing
  681  authority of any jurisdiction, including its agencies or
  682  subdivisions, for a violation that would constitute a violation
  683  under Florida law.
  684         13. Violating a lawful order of the department or an agency
  685  of the state, or failing to comply with a lawfully issued
  686  subpoena of the department or an agency of the state.
  687         (g)(h) The department may suspend, revoke, or refuse to
  688  renew the a dispensing organization’s approval of an MMTC if the
  689  MMTC a dispensing organization commits any of the violations in
  690  paragraph (f) (g).
  691         (h)(i) The department shall renew the approval of an MMTC a
  692  dispensing organization biennially if the MMTC dispensing
  693  organization meets the requirements of this section and pays the
  694  biennial renewal fee.
  695         (i)1. The department shall establish a quality control
  696  program requiring medical cannabis to be tested by a medical
  697  marijuana testing facility for potency and contaminants before
  698  sale to qualifying patients and caregivers.
  699         a. The quality control program must require MMTCs to submit
  700  samples from each batch or lot of medical cannabis harvested or
  701  manufactured to a medical marijuana testing facility for testing
  702  to ensure, at a minimum, that the labeling of the potency of
  703  tetrahydrocannabinol and all other marketed cannabinoids or
  704  terpenes is accurate and that the medical cannabis dispensed to
  705  qualifying patients is safe for human consumption.
  706         b. All samples submitted for testing to satisfy a test
  707  required under the quality control program must be collected by
  708  the medical marijuana testing facility or its certified agent in
  709  accordance with department rules.
  710         c. An MMTC must maintain records of all tests conducted on
  711  medical cannabis, including the results of each test and any
  712  additional information as required by the department.
  713         2. The department shall adopt all rules necessary to create
  714  and oversee the quality control program, which must include, at
  715  a minimum:
  716         a.Permissible levels of variation in potency labeling and
  717  standards requiring tetrahydrocannabinol in edible medical
  718  cannabis products to be distributed homogenously throughout the
  719  product;
  720         b. Permissible levels of contaminants and mandatory testing
  721  for contaminants to confirm that the tested medical cannabis is
  722  safe for human consumption, which must include, but is not
  723  limited to, testing for microbiological impurity, residual
  724  solvents, and pesticide residues;
  725         c.The destruction of medical cannabis determined to be
  726  inaccurately labeled or unsafe for human consumption after the
  727  MMTC has an opportunity to take remedial action;
  728         d.The collection, storage, handling, recording, and
  729  destruction of samples of medical cannabis by medical marijuana
  730  testing facilities; and
  731         e.Security, inventory tracking, and record retention.
  732         (j) The department may adopt rules necessary to implement
  733  and administer this section.
  734         (8) PREEMPTION.—
  735         (a) All matters regarding the regulation of the cultivation
  736  and processing of medical cannabis or low-THC cannabis by MMTCs
  737  dispensing organizations are preempted to the state.
  738         (b) A municipality may determine by ordinance the criteria
  739  for the number and location of, and other permitting
  740  requirements that do not conflict with state law or department
  741  rule for, dispensing facilities of MMTCs dispensing
  742  organizations located within its municipal boundaries. A county
  743  may determine by ordinance the criteria for the number,
  744  location, and other permitting requirements that do not conflict
  745  with state law or department rule for all dispensing facilities
  746  of MMTCs dispensing organizations located within the
  747  unincorporated areas of that county.
  748         (9) EXCEPTIONS TO OTHER LAWS.—
  749         (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  750  any other provision of law, but subject to the requirements of
  751  this section, a qualifying qualified patient or a caregiver and
  752  the qualified patient’s legal representative may purchase and
  753  possess for the qualifying patient’s medical use up to the
  754  amount of low-THC cannabis or medical cannabis ordered for the
  755  patient, but not more than a 45-day supply, and a cannabis
  756  delivery device ordered for the patient.
  757         (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  758  any other provision of law, but subject to the requirements of
  759  this section, an MMTC an approved dispensing organization and
  760  its owners, managers, and employees may manufacture, possess,
  761  sell, deliver, distribute, dispense, and lawfully dispose of
  762  reasonable quantities, as established by department rule, of
  763  low-THC cannabis, medical cannabis, or a cannabis delivery
  764  device. As used in For purposes of this subsection, the terms
  765  “manufacture,” “possession,” “deliver,” “distribute,” and
  766  “dispense” have the same meanings as provided in s. 893.02.
  767         (c) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  768  any other provision of law, but subject to the requirements of
  769  this section, a medical marijuana testing facility an approved
  770  independent testing laboratory may possess, test, transport, and
  771  lawfully dispose of low-THC cannabis or medical cannabis as
  772  provided by department rule.
  773         (d) An approved MMTC dispensing organization and its
  774  owners, managers, and employees are not subject to licensure or
  775  regulation under chapter 465 or chapter 499 for manufacturing,
  776  possessing, selling, delivering, distributing, dispensing, or
  777  lawfully disposing of reasonable quantities, as established by
  778  department rule, of low-THC cannabis, medical cannabis, or a
  779  cannabis delivery device.
  780         (e) An approved MMTC dispensing organization that continues
  781  to meet the requirements for approval is presumed to be
  782  registered with the department and to meet the regulations
  783  adopted by the department or its successor agency for the
  784  purpose of dispensing medical cannabis or low-THC cannabis under
  785  Florida law. Additionally, the authority provided to an MMTC a
  786  dispensing organization in s. 499.0295 does not impair its
  787  registration with the department the approval of a dispensing
  788  organization.
  789         (f) This subsection does not exempt a person from
  790  prosecution for a criminal offense related to impairment or
  791  intoxication resulting from the medical use of low-THC cannabis
  792  or medical cannabis or relieve a person from any requirement
  793  under law to submit to a breath, blood, urine, or other test to
  794  detect the presence of a controlled substance.
  795         Section 2. Subsections (1) and (2) of section 381.987,
  796  Florida Statutes, are amended, and paragraphs (b) and (c) of
  797  subsection (3) of that section are amended, to read:
  798         381.987 Public records exemption for personal identifying
  799  information in the compassionate use registry.—
  800         (1) A patient’s personal identifying information held by
  801  the department in the compassionate use registry established
  802  under s. 381.986, including, but not limited to, the patient’s
  803  name, address, telephone number, and government-issued
  804  identification number, and all information pertaining to the
  805  physician certification physician’s order for medical low-THC
  806  cannabis and the dispensing thereof are confidential and exempt
  807  from s. 119.07(1) and s. 24(a), Art. I of the State
  808  Constitution.
  809         (2) A physician’s identifying information held by the
  810  department in the compassionate use registry established under
  811  s. 381.986, including, but not limited to, the physician’s name,
  812  address, telephone number, government-issued identification
  813  number, and Drug Enforcement Administration number, and all
  814  information pertaining to the physician certification
  815  physician’s order for medical low-THC cannabis and the
  816  dispensing thereof are confidential and exempt from s. 119.07(1)
  817  and s. 24(a), Art. I of the State Constitution.
  818         (3) The department shall allow access to the registry,
  819  including access to confidential and exempt information, to:
  820         (b) A medical marijuana treatment center dispensing
  821  organization approved by the department pursuant to s. 381.986
  822  which is attempting to verify the authenticity of a physician
  823  certification physician’s order for medical low-THC cannabis,
  824  including whether the physician certification order had been
  825  previously filled and whether the physician certification order
  826  was written for the person attempting to have it filled.
  827         (c) A physician who has issued a physician certification
  828  written an order for medical low-THC cannabis for the purpose of
  829  monitoring the patient’s use of such cannabis or for the purpose
  830  of determining, before issuing an order for medical low-THC
  831  cannabis, whether another physician has ordered the patient’s
  832  use of medical low-THC cannabis. The physician may access the
  833  confidential and exempt information only for the patient for
  834  whom he or she has ordered or is determining whether to order
  835  the use of medical low-THC cannabis pursuant to s. 381.986.
  836         Section 3. Section 385.211, Florida Statutes, is amended to
  837  read:
  838         385.211 Refractory and intractable epilepsy treatment and
  839  research at recognized medical centers.—
  840         (1) As used in this section, the term medical cannabis
  841  has the same meaning “low-THC cannabis” means “low-THC cannabis”
  842  as defined in s. 381.986 that is dispensed only from a
  843  dispensing organization as defined in s. 381.986.
  844         (2) Notwithstanding chapter 893, medical centers recognized
  845  pursuant to s. 381.925, or an academic medical research
  846  institution legally affiliated with a licensed children’s
  847  specialty hospital as defined in s. 395.002(28) which that
  848  contracts with the Department of Health, may conduct research on
  849  cannabidiol and medical low-THC cannabis. This research may
  850  include, but is not limited to, the agricultural development,
  851  production, clinical research, and use of liquid medical
  852  derivatives of cannabidiol and medical low-THC cannabis for the
  853  treatment for refractory or intractable epilepsy. The authority
  854  for recognized medical centers to conduct this research is
  855  derived from 21 C.F.R. parts 312 and 316. Current state or
  856  privately obtained research funds may be used to support the
  857  activities described in this section.
  858         Section 4. Present paragraphs (b) and (c) of subsection (2)
  859  of section 499.0295, Florida Statutes, are redesignated as
  860  paragraphs (a) and (b), respectively, present paragraphs (a) and
  861  (c) of that subsection are amended, a new paragraph (c) is added
  862  to that subsection, and subsection (3) of that section is
  863  amended, to read:
  864         499.0295 Experimental treatments for terminal conditions.—
  865         (2) As used in this section, the term:
  866         (a) “Dispensing organization” means an organization
  867  approved by the Department of Health under s. 381.986(5) to
  868  cultivate, process, transport, and dispense low-THC cannabis,
  869  medical cannabis, and cannabis delivery devices.
  870         (b)(c) “Investigational drug, biological product, or
  871  device” means:
  872         1. A drug, biological product, or device that has
  873  successfully completed phase 1 of a clinical trial but has not
  874  been approved for general use by the United States Food and Drug
  875  Administration and remains under investigation in a clinical
  876  trial approved by the United States Food and Drug
  877  Administration; or
  878         2. Medical cannabis that is manufactured and sold by an
  879  MMTC a dispensing organization.
  880         (c) Medical marijuana treatment center” or “MMTC” means an
  881  organization registered with the Department of Health under s.
  882  381.986.
  883         (3) Upon the request of an eligible patient, a manufacturer
  884  may, or, upon the issuance of a physician certification a
  885  physician’s order pursuant to s. 381.986, an MMTC a dispensing
  886  organization may:
  887         (a) Make its investigational drug, biological product, or
  888  device available under this section.
  889         (b) Provide an investigational drug, biological product,
  890  device, or cannabis delivery device as defined in s. 381.986 to
  891  an eligible patient without receiving compensation.
  892         (c) Require an eligible patient to pay the costs of, or the
  893  costs associated with, the manufacture of the investigational
  894  drug, biological product, device, or cannabis delivery device as
  895  defined in s. 381.986.
  896         Section 5. Subsection (3) of section 893.02, Florida
  897  Statutes, is amended to read:
  898         893.02 Definitions.—The following words and phrases as used
  899  in this chapter shall have the following meanings, unless the
  900  context otherwise requires:
  901         (3) “Cannabis” means all parts of any plant of the genus
  902  Cannabis, whether growing or not; the seeds thereof; the resin
  903  extracted from any part of the plant; and every compound,
  904  manufacture, salt, derivative, mixture, or preparation of the
  905  plant or its seeds or resin. The term does not include “medical
  906  cannabis,” “low-THC cannabis,” as defined in s. 381.986, if
  907  manufactured, possessed, sold, purchased, delivered,
  908  distributed, or dispensed, in conformance with s. 381.986.
  909         Section 6. Section 1004.441, Florida Statutes, is amended
  910  to read:
  911         1004.441 Refractory and intractable epilepsy treatment and
  912  research.—
  913         (1) As used in this section, the term “medical cannabis”
  914  has the same meaning “low-THC cannabis” means “low-THC cannabis”
  915  as defined in s. 381.986 that is dispensed only from a
  916  dispensing organization as defined in s. 381.986.
  917         (2) Notwithstanding chapter 893, state universities with
  918  both medical and agricultural research programs, including those
  919  that have satellite campuses or research agreements with other
  920  similar institutions, may conduct research on cannabidiol and
  921  medical low-THC cannabis. This research may include, but is not
  922  limited to, the agricultural development, production, clinical
  923  research, and use of liquid medical derivatives of cannabidiol
  924  and medical low-THC cannabis for the treatment for refractory or
  925  intractable epilepsy. The authority for state universities to
  926  conduct this research is derived from 21 C.F.R. parts 312 and
  927  316. Current state or privately obtained research funds may be
  928  used to support the activities authorized by this section.
  929         Section 7. This act shall take effect July 1, 2017.