Florida Senate - 2017                                    SB 1666
       
       
        
       By Senator Braynon
       
       
       
       
       
       35-01039-17                                           20171666__
    1                        A bill to be entitled                      
    2         An act relating to medical use of marijuana; amending
    3         s. 381.986, F.S.; providing legislative intent;
    4         defining, redefining, and deleting terms; authorizing
    5         physicians to issue physician certifications to
    6         specified patients for the provision of marijuana and
    7         marijuana delivery devices; requiring physicians to
    8         meet certain conditions to be authorized to issue and
    9         make determinations in physician certifications;
   10         requiring certain physicians to annually reexamine and
   11         reassess patients and update patient information in
   12         the compassionate use registry; providing requirements
   13         for physician certification for patients who are non
   14         Florida residents; providing that a prior order for
   15         low-THC cannabis or medical cannabis issued is
   16         considered a physician certification under certain
   17         circumstances; providing requirements for such
   18         certifications; revising criminal penalties; reducing
   19         the number of hours of coursework required of
   20         physicians who issue physician certifications;
   21         providing that physicians who meet specified
   22         requirements are grandfathered for the purpose of
   23         specified education requirements; authorizing
   24         qualifying patients over the age of 21 to designate or
   25         remove caregivers; requiring caregivers to meet
   26         specified requirements, including a 1-hour course on
   27         the administration of marijuana; authorizing a
   28         qualifying patient to designate only one caregiver at
   29         any given time; providing exceptions; authorizing a
   30         caregiver to assist only one qualifying patient at any
   31         given time; providing exceptions; requiring the
   32         Department of Health to register on the compassionate
   33         use registry a caregiver and to issue him or her a
   34         caregiver identification card if the caregiver meets
   35         certain requirements; providing requirements for
   36         assisting a qualifying patient who is under the age of
   37         18; revising the list of entities that have access to
   38         the compassionate use registry; requiring the
   39         department to adopt rules by a specified date;
   40         authorizing the department to charge a fee for
   41         identification cards; requiring the department to
   42         begin issuing identification cards to qualified
   43         registrants by a specific date; providing requirements
   44         for the identification cards; requiring the department
   45         to register certain dispensing organizations as
   46         medical marijuana treatment centers (MMTCs) by a
   47         certain date; deleting provisions to conform to
   48         changes made by the act; requiring the department to
   49         register additional MMTCs in accordance with a
   50         specified schedule; prohibiting an entity from being
   51         issued more than one MMTC registration; requiring the
   52         department to review the number of qualifying patients
   53         every 6 months; limiting the number of MMTCs;
   54         decreasing the required performance bond amount under
   55         certain circumstances; requiring the department to
   56         create a 30-minute educational program for qualifying
   57         patients; revising the operational requirements for
   58         MMTCs; authorizing the department to waive certain
   59         requirements in the MMTC registration application
   60         under specified circumstances; providing requirements
   61         for MMTCs to grow, process, and dispense marijuana,
   62         rather than requirements for dispensing organizations
   63         to grow, process, and dispense low-THC cannabis or
   64         medical cannabis; providing a contract option that
   65         requires an independent testing laboratory to directly
   66         test an MMTC’s marijuana final product; requiring that
   67         marijuana receptacles be opaque, childproof, and
   68         tamper-evident; reducing the time that samples are
   69         required to be retained; requiring verification of
   70         patient and caregiver identification cards, rather
   71         than registration cards, and amount and type of
   72         marijuana before dispensing; requiring compliance with
   73         certain standards in the production and dispensing of
   74         edibles or food products; requiring an MMTC to enter
   75         additional information into the compassionate use
   76         registry; providing requirements to ensure the safety
   77         and security of premises and facilities of MMTCs,
   78         rather than the safety and security of premises and
   79         facilities of dispensing organizations; requiring an
   80         MMTC to register all owners and employees with the
   81         department; requiring an MMTC to present a floor plan
   82         to the department; defining terms to provide criteria
   83         on visitor access to MMTC areas; providing
   84         requirements to ensure the safe and sanitary transport
   85         of marijuana, rather than the safe transport of low
   86         THC cannabis and medical cannabis; requiring a vehicle
   87         transporting marijuana to be legally parked under
   88         certain circumstances; revising the department’s
   89         authority and responsibilities; requiring the
   90         department to adopt rules relating to ownership
   91         changes or changes in an owner’s investment interest;
   92         conforming provisions to changes made by the act;
   93         providing circumstances under which the department may
   94         suspend, revoke, or refuse to renew an MMTC’s
   95         registration; providing rulemaking authority;
   96         authorizing an MMTC employee to administer marijuana
   97         under certain circumstances; providing construction;
   98         conforming provisions to changes made by the act;
   99         providing that a physician who issues a physician
  100         certification is immune to civil claims and claims for
  101         medical malpractice under certain circumstances;
  102         providing that a health insurance provider or a
  103         governmental agency or authority is not required to
  104         reimburse expenses related to the use of marijuana;
  105         authorizing certain institutes or state universities
  106         to possess, test, transport, or dispose of marijuana
  107         for research purposes; prohibiting a person from
  108         offering, advertising, or performing services, and
  109         from owning, operating, and maintaining certain
  110         facilities, without registration; providing penalties;
  111         prohibiting the importation of marijuana; authorizing
  112         the exportation of marijuana and products containing
  113         marijuana under certain circumstances; providing
  114         severability; amending ss. 381.987, 385.211, 499.0295,
  115         and 1004.441, F.S.; conforming provisions to changes
  116         made by the act; providing a directive to the Division
  117         of Law Revision and Information; providing an
  118         effective date.
  119          
  120  Be It Enacted by the Legislature of the State of Florida:
  121  
  122         Section 1. Section 381.986, Florida Statutes, is amended to
  123  read:
  124         381.986 Compassionate use of marijuana low-THC and medical
  125  cannabis.—
  126         (1) LEGISLATIVE INTENT.—
  127         (a) It is the intent of the Legislature to implement s. 29,
  128  Art. X of the State Constitution by creating a unified
  129  regulatory structure within the framework of this section for
  130  the acquisition, cultivation, possession, processing, transfer,
  131  transportation, sale, distribution, or dispensing of marijuana,
  132  products containing marijuana, related supplies, or educational
  133  materials to qualifying patients or their caregivers.
  134         (b) The Legislature intends that all rules adopted by the
  135  Department of Health to implement this section be adopted
  136  pursuant to s. 120.536(1) or s. 120.54. The Legislature intends
  137  that the department use emergency rulemaking procedures pursuant
  138  to s. 120.54(4) to adopt rules under this section if necessary
  139  to meet any deadline for rulemaking established in s. 29, Art. X
  140  of the State Constitution.
  141         (c) Further, the Legislature intends that all registrations
  142  for the purposes specified in paragraph (a) be issued solely in
  143  accordance with the requirements of this section and all rules
  144  adopted under this section.
  145         (2) DEFINITIONS.—As used in this section, the term:
  146         (a) “Caregiver” means a person who:
  147         1. Is at least 21 years old unless he or she is a close
  148  relative of the qualifying patient and the patient demonstrates
  149  a need for assistance with the medical use of marijuana;
  150         2. Has agreed in writing to assist the qualifying patient
  151  with the qualifying patient’s medical use of marijuana; and
  152         3. Does not receive compensation, other than actual
  153  expenses incurred, for assisting the qualifying patient with the
  154  medical use of marijuana unless the caregiver is acting pursuant
  155  to employment in a licensed facility “Cannabis delivery device”
  156  means an object used, intended for use, or designed for use in
  157  preparing, storing, ingesting, inhaling, or otherwise
  158  introducing low-THC cannabis or medical cannabis into the human
  159  body.
  160         (b)“Close relative” means a spouse, parent, sibling,
  161  grandparent, child, or grandchild, whether related by whole or
  162  half blood, by marriage, or by adoption.
  163         (c)(b)Debilitating medical condition” means cancer,
  164  epilepsy, glaucoma, a positive status for human immunodeficiency
  165  virus, acquired immune deficiency syndrome, posttraumatic stress
  166  disorder, amyotrophic lateral sclerosis, Crohn’s disease,
  167  Parkinson’s disease, multiple sclerosis, a physical medical
  168  condition that chronically produces symptoms of seizures or
  169  severe and persistent muscle spasms, a terminal condition, or
  170  any other debilitating medical condition of the same kind or
  171  class as, or comparable to, those conditions enumerated in this
  172  paragraph and for which a physician believes that the use of
  173  medical cannabis would likely outweigh the potential health
  174  risks to a patient “Dispensing organization” means an
  175  organization approved by the department to cultivate, process,
  176  transport, and dispense low-THC cannabis or medical cannabis
  177  pursuant to this section.
  178         (d)(c) “Independent testing laboratory” means a laboratory,
  179  including the managers, employees, or contractors of the
  180  laboratory:,
  181         1. Which has no direct or indirect interest in a medical
  182  marijuana treatment center; and
  183         2. In which no medical marijuana treatment center has any
  184  direct or indirect interest dispensing organization.
  185         (e)(d) “Legal representative” means the qualifying
  186  qualified patient’s parent, legal guardian acting pursuant to a
  187  court’s authorization as required under s. 744.3215(4), health
  188  care surrogate acting pursuant to the qualifying qualified
  189  patient’s written consent or a court’s authorization as required
  190  under s. 765.113, or an individual who is authorized under a
  191  power of attorney to make health care decisions on behalf of the
  192  qualifying qualified patient.
  193         (f)(e) “Low-THC cannabis” means a plant of the genus
  194  Cannabis, the dried flowers of which contain 0.8 percent or less
  195  of tetrahydrocannabinol and more than 10 percent of cannabidiol
  196  weight for weight; the seeds thereof; the resin extracted from
  197  any part of such plant; or any compound, manufacture, salt,
  198  derivative, mixture, or preparation of such plant or its seeds
  199  or resin that is dispensed only by a medical marijuana treatment
  200  center from a dispensing organization.
  201         (g)(f)Marijuana” has the same meaning as provided in s.
  202  29, Art. X of the State Constitution “Medical cannabis” means
  203  all parts of any plant of the genus Cannabis, whether growing or
  204  not; the seeds thereof; the resin extracted from any part of the
  205  plant; and every compound, manufacture, sale, derivative,
  206  mixture, or preparation of the plant or its seeds or resin that
  207  is dispensed only from a dispensing organization for medical use
  208  by an eligible patient as defined in s. 499.0295.
  209         (h) “Marijuana delivery device” means an object used,
  210  intended for use, or designed for use in preparing, storing,
  211  ingesting, inhaling, or otherwise introducing marijuana or low
  212  THC cannabis into the human body.
  213         (i)“Medical marijuana treatment center” or “MMTC” has the
  214  same meaning as provided in s. 29, Art. X of the State
  215  Constitution.
  216         (j)(g) “Medical use” has the same meaning as provided in s.
  217  29, Art. X of the State Constitution means administration of the
  218  ordered amount of low-THC cannabis or medical cannabis. The term
  219  does not include the:
  220         1. The possession, use, or administration of marijuana low
  221  THC cannabis or medical cannabis by smoking. As used in this
  222  subparagraph, the term “smoking” means burning or igniting a
  223  substance and inhaling the smoke. Smoking does not include the
  224  use of a vaporizer.
  225         2. The possession, use, or administration of marijuana that
  226  is not purchased or acquired from a medical marijuana treatment
  227  center.
  228         3.The transfer of marijuana low-THC cannabis or medical
  229  cannabis to a person other than the qualifying qualified patient
  230  for whom it was ordered or the qualifying qualified patient’s
  231  caregiver legal representative on behalf of the qualifying
  232  qualified patient.
  233         4.3.The use or administration of marijuana low-THC
  234  cannabis or medical cannabis:
  235         a. On any form of public transportation.
  236         b. In any public place.
  237         c. In a qualifying qualified patient’s place of employment,
  238  if restricted by his or her employer.
  239         d. In a state correctional institution as defined in s.
  240  944.02 or a correctional institution as defined in s. 944.241.
  241         e. On the grounds of a preschool, primary school, or
  242  secondary school.
  243         f. On a school bus or in a vehicle, aircraft, or motorboat.
  244         (k)(h)Qualifying patient” has the same meaning as
  245  provided in s. 29, Art. X of the State Constitution. The term
  246  also includes eligible patients, as defined in s. 499.0295. A
  247  patient is not a qualifying patient unless he or she is
  248  registered with the department and has been issued a “Qualified
  249  patient” means a resident of this state who has been added to
  250  the compassionate use registry identification card by a
  251  physician licensed under chapter 458 or chapter 459 to receive
  252  low-THC cannabis or medical cannabis from a dispensing
  253  organization.
  254         (i) “Smoking” means burning or igniting a substance and
  255  inhaling the smoke. Smoking does not include the use of a
  256  vaporizer.
  257         (3)(2) PHYSICIAN CERTIFICATION ORDERING.—A physician is
  258  authorized to issue a physician certification for the provision
  259  of marijuana and marijuana delivery devices order low-THC
  260  cannabis to treat a qualified patient suffering from cancer or a
  261  physical medical condition that chronically produces symptoms of
  262  seizures or severe and persistent muscle spasms; order low-THC
  263  cannabis to alleviate symptoms of such disease, disorder, or
  264  condition, if no other satisfactory alternative treatment
  265  options exist for the qualified patient; order medical cannabis
  266  to treat a qualifying an eligible patient as defined in s.
  267  499.0295; or order a cannabis delivery device for the medical
  268  use of low-THC cannabis or medical cannabis, only if the
  269  physician:
  270         (a) Holds an active, unrestricted license as a physician
  271  under chapter 458 or an osteopathic physician under chapter 459;
  272         (b) Has treated the patient for at least 3 months
  273  immediately preceding the patient’s registration in the
  274  compassionate use registry;
  275         (c) Has successfully completed the course and examination
  276  required under paragraph (6)(a) (4)(a);
  277         (c)Has conducted a physical examination and made a full
  278  assessment of the medical history of the patient;
  279         (d) Has determined that the medical use of marijuana would
  280  likely outweigh the potential health risks of treating the
  281  patient with low-THC cannabis or medical cannabis are reasonable
  282  in light of the potential benefit to the patient. If a patient
  283  is younger than 18 years of age, a second physician must concur
  284  with this determination, and such determination must be
  285  documented in the patient’s medical record;
  286         (e) Registers as the patient’s physician orderer of low-THC
  287  cannabis or medical cannabis for the named patient on the
  288  compassionate use registry maintained by the department and
  289  updates the registry to reflect the contents of the order,
  290  including the amount of marijuana which low-THC cannabis or
  291  medical cannabis that will provide the patient with not more
  292  than a 90-day 45-day supply and any marijuana a cannabis
  293  delivery device needed by the patient for the medical use of
  294  marijuana low-THC cannabis or medical cannabis. A physician may
  295  certify an amount greater than a 90-day supply of marijuana if
  296  the physician has a reasonable belief that the patient will use
  297  the additional marijuana in a medically appropriate way. The
  298  physician must also update the registry within 7 days after any
  299  change is made to the physician certification original order to
  300  reflect the change. The physician shall deactivate the
  301  registration of the patient and the patient’s legal
  302  representative when the physician no longer recommends the
  303  medical use of marijuana for the patient treatment is
  304  discontinued;
  305         (f) At least annually, recertifies the qualifying patient
  306  pursuant to this subsection. The physician must require that a
  307  non-Florida resident be physically present during the initial
  308  exam and all followup exams. Before being issued a physician
  309  certification, a qualifying patient who is a non-Florida
  310  resident must:
  311         1. Affirm that his or her stay in this state is for at
  312  least 30 days;
  313         2. Provide proof that he or she holds a state-issued
  314  identification card or certification in another state with a
  315  medical marijuana program; or
  316         3. Elect to wait 2 weeks after the date of receiving a
  317  physician certification to obtain marijuana. A non-Florida
  318  resident who elects to wait under this subparagraph may not be
  319  issued a physician certification for marijuana for more than 6
  320  months; and
  321         (g) Submits the patient treatment plan quarterly to the
  322  University of Florida College of Pharmacy for research on the
  323  safety and efficacy of low-THC cannabis and medical cannabis on
  324  patients;
  325         (h) Obtains the voluntary written informed consent of the
  326  patient or the patient’s legal representative to treatment with
  327  low-THC cannabis after sufficiently explaining the current state
  328  of knowledge in the medical community of the effectiveness of
  329  treatment of the patient’s condition with low-THC cannabis, the
  330  medically acceptable alternatives, and the potential risks and
  331  side effects;
  332         (i) Obtains written informed consent as defined in and
  333  required under s. 499.0295, if the physician is ordering medical
  334  cannabis for an eligible patient pursuant to that section; and
  335         (g)(j) Is not a medical director employed by an MMTC a
  336  dispensing organization.
  337         (4)(3)GRANDFATHERING.—An order for low-THC cannabis or
  338  medical cannabis issued pursuant to former s. 381.986, Florida
  339  Statutes 2016, and registered with the compassionate use
  340  registry on or before the effective date of this act shall be
  341  considered a physician certification issued pursuant to this
  342  section. The details and expiration date of such certification
  343  must be identical to the details and expiration date of the
  344  order as logged in the compassionate use registry. Until the
  345  department begins issuing compassionate use registry
  346  identification cards, all patients with such orders shall be
  347  considered qualifying patients, notwithstanding the requirement
  348  that a qualifying patient have a compassionate use registry
  349  identification card.
  350         (5) PENALTIES.—
  351         (a) A physician commits a misdemeanor of the first degree,
  352  punishable as provided in s. 775.082 or s. 775.083, if the
  353  physician issues a physician certification for marijuana to
  354  orders low-THC cannabis for a patient without a reasonable
  355  belief that the patient is suffering from a debilitating medical
  356  condition:
  357         1. Cancer or a physical medical condition that chronically
  358  produces symptoms of seizures or severe and persistent muscle
  359  spasms that can be treated with low-THC cannabis; or
  360         2. Symptoms of cancer or a physical medical condition that
  361  chronically produces symptoms of seizures or severe and
  362  persistent muscle spasms that can be alleviated with low-THC
  363  cannabis.
  364         (b) A physician commits a misdemeanor of the first degree,
  365  punishable as provided in s. 775.082 or s. 775.083, if the
  366  physician orders medical cannabis for a patient without a
  367  reasonable belief that the patient has a terminal condition as
  368  defined in s. 499.0295.
  369         (c) A person who fraudulently represents that he or she has
  370  a debilitating cancer, a physical medical condition that
  371  chronically produces symptoms of seizures or severe and
  372  persistent muscle spasms, or a terminal condition to a physician
  373  for the purpose of being issued a physician certification for
  374  marijuana ordered low-THC cannabis, medical cannabis, or a
  375  marijuana cannabis delivery device by such physician commits a
  376  misdemeanor of the first degree, punishable as provided in s.
  377  775.082 or s. 775.083.
  378         (c)(d)A qualifying An eligible patient as defined in s.
  379  499.0295 who uses marijuana medical cannabis, and such patient’s
  380  caregiver legal representative who administers marijuana medical
  381  cannabis, in plain view of or in a place open to the general
  382  public, on the grounds of a place of education school, or in an
  383  aircraft, a motorboat, a school bus, a train, or a vehicle,
  384  aircraft, or motorboat, commits a misdemeanor of the first
  385  degree, punishable as provided in s. 775.082 or s. 775.083.
  386         (d)Except as provided in paragraph (c), a caregiver who
  387  violates any provision of this section or applicable department
  388  rule commits, upon the first offense, a misdemeanor of the
  389  second degree, punishable as provided in s. 775.082 or s.
  390  775.083, and, upon the second and subsequent offenses, a
  391  misdemeanor of the first degree, punishable as provided in s.
  392  775.082 or s. 775.083.
  393         (e) A physician who issues a physician certification for
  394  marijuana orders low-THC cannabis, medical cannabis, or a
  395  marijuana cannabis delivery device and receives compensation
  396  from an MMTC a dispensing organization related to issuing the
  397  physician certification for marijuana the ordering of low-THC
  398  cannabis, medical cannabis, or a marijuana cannabis delivery
  399  device is subject to disciplinary action under the applicable
  400  practice act and s. 456.072(1)(n).
  401         (6)(4) PHYSICIAN EDUCATION.—
  402         (a) Before a physician may issue a physician certification
  403  pursuant to subsection (3) ordering low-THC cannabis, medical
  404  cannabis, or a cannabis delivery device for medical use by a
  405  patient in this state, the appropriate board shall require the
  406  ordering physician to successfully complete a 4-hour an 8-hour
  407  course and subsequent examination offered by the Florida Medical
  408  Association or the Florida Osteopathic Medical Association which
  409  that encompasses the clinical indications for the appropriate
  410  use of marijuana low-THC cannabis and medical cannabis, the
  411  appropriate marijuana cannabis delivery devices, the
  412  contraindications for such use, and the relevant state and
  413  federal laws governing the issuance of physician certifications,
  414  as well as the ordering, dispensing, and possessing of these
  415  substances and devices. The course and examination shall be
  416  administered at least quarterly annually. Successful completion
  417  of the course may be used by a physician to satisfy 4 hours 8
  418  hours of the continuing medical education requirements required
  419  by his or her respective board for licensure renewal. This
  420  course may be offered in a distance learning format. A physician
  421  who has completed a 4-hour course and subsequent examination
  422  offered by the Florida Medical Association or the Florida
  423  Osteopathic Medical Association which encompasses the clinical
  424  indications for the appropriate use of marijuana and who is
  425  registered in the compassionate use registry on the effective
  426  date of this act is deemed to meet the requirements of this
  427  paragraph.
  428         (b) The appropriate board shall require the medical
  429  director of each MMTC dispensing organization to hold an active,
  430  unrestricted license as a physician under chapter 458 or as an
  431  osteopathic physician under chapter 459 and successfully
  432  complete a 2-hour course and subsequent examination offered by
  433  the Florida Medical Association or the Florida Osteopathic
  434  Medical Association which that encompasses appropriate safety
  435  procedures and knowledge of marijuana low-THC cannabis, medical
  436  cannabis, and marijuana cannabis delivery devices.
  437         (c) Successful completion of the course and examination
  438  specified in paragraph (a) is required for every physician who
  439  orders low-THC cannabis, medical cannabis, or a cannabis
  440  delivery device each time such physician renews his or her
  441  license. In addition, successful completion of the course and
  442  examination specified in paragraph (b) is required for the
  443  medical director of each dispensing organization each time such
  444  physician renews his or her license.
  445         (d) A physician who fails to comply with this subsection
  446  and who issues a physician certification for marijuana orders
  447  low-THC cannabis, medical cannabis, or a marijuana cannabis
  448  delivery device may be subject to disciplinary action under the
  449  applicable practice act and under s. 456.072(1)(k).
  450         (7) CAREGIVERS.—
  451         (a)During the course of registration with the department
  452  for inclusion on the compassionate use registry, or at any time
  453  while registered, a qualifying patient over the age of 21 may
  454  designate or remove an individual as his or her caregiver to
  455  assist him or her with the medical use of marijuana. The
  456  designated caregiver must pass a level 2 screening pursuant to
  457  chapter 435 unless the patient is a close relative of the
  458  caregiver and the patient demonstrates a need for assistance
  459  with the medical use of marijuana. The department shall create a
  460  1-hour course for caregivers and a subsequent examination that
  461  encompass basic information on the procedure and administration
  462  of marijuana. The department shall require the designated
  463  caregiver to successfully complete the course and pass the
  464  subsequent examination before registering an individual as a
  465  caregiver.
  466         (b)A qualifying patient may have only one designated
  467  caregiver at any given time unless all of the qualifying
  468  patient’s caregivers are his or her close relatives or legal
  469  representatives.
  470         (c)A caregiver may assist only one qualifying patient at
  471  any given time unless:
  472         1.All qualifying patients the caregiver is assisting are
  473  close relatives of each other and the caregiver is the legal
  474  representative of at least one of the patients; or
  475         2.All qualifying patients the caregiver is assisting are
  476  receiving hospice services, or are residents in the same
  477  assisted living facility, nursing home, or other licensed
  478  facility and have requested the assistance of that caregiver
  479  with the medical use of marijuana; the caregiver is an employee
  480  of the hospice or licensed facility; and the caregiver provides
  481  personal care or services directly to clients of the hospice or
  482  licensed facility as a part of his or her employment duties at
  483  the hospice or licensed facility.
  484         (d)The department must register a caregiver on the
  485  compassionate use registry and issue him or her a caregiver
  486  identification card if he or she:
  487         1. Is designated by a qualifying patient, provides hospice
  488  services to a qualifying patient, or is requested by a
  489  qualifying patient in a licensed facility for assistance with
  490  the medical use of marijuana; and
  491         2. Meets all of the requirements of this subsection and
  492  department rules.
  493         (e) If a qualifying patient is under the age of 18, only a
  494  parent, legal guardian, caregiver, or health care provider may
  495  assist the patient in the purchasing and administering of
  496  marijuana for medical use. A qualifying patient under the age of
  497  18 may not purchase marijuana.
  498         (8)(5) DUTIES OF THE DEPARTMENT.—The department shall:
  499         (a) Create and maintain a secure, electronic, and online
  500  compassionate use registry for the registration of physicians,
  501  qualifying patients, and caregivers the legal representatives of
  502  patients as provided under this section. The registry must be
  503  accessible to:
  504         1.Physicians licensed under chapter 458 or chapter 459, to
  505  ensure proper care for patients requesting physician
  506  certifications;
  507         2.Practitioners licensed to prescribe prescription drugs,
  508  to ensure proper care for patients before prescribing
  509  medications that may interact with the medical use of marijuana;
  510         3. Law enforcement agencies, only for the purpose of
  511  verifying the authorization of a qualifying patient or a
  512  qualifying patient’s caregiver to possess marijuana or a
  513  marijuana delivery device; and
  514         4.MMTCs, to a dispensing organization to verify the
  515  authorization of a qualifying patient or a qualifying patient’s
  516  caregiver legal representative to possess marijuana low-THC
  517  cannabis, medical cannabis, or a marijuana cannabis delivery
  518  device and to record the marijuana low-THC cannabis, medical
  519  cannabis, or marijuana cannabis delivery device dispensed. The
  520  registry must prevent an active registration of a qualifying
  521  patient by multiple physicians.
  522         (b) By July 3, 2017, adopt rules, pursuant to s. 120.536(1)
  523  or s. 120.54, establishing procedures for the issuance, annual
  524  renewal, suspension, and revocation of compassionate use
  525  registry identification cards for qualifying patients and
  526  caregivers who are residents of this state. The department may
  527  use emergency rulemaking procedures pursuant to s. 120.54(4) to
  528  adopt rules under this section as necessary to ensure that rules
  529  are adopted on or before July 3, 2017. The department may charge
  530  a reasonable fee associated with the issuance and renewal of
  531  patient and caregiver identification cards. By October 3, 2017,
  532  the department shall begin issuing identification cards to adult
  533  patients who are residents of this state and who have a
  534  physician certification that meets the requirements of
  535  subsection (3); minor patients who are residents of this state
  536  and who have a physician certification that meets the
  537  requirements of subsection (3) and the written consent of a
  538  parent or legal guardian; and caregivers registered pursuant to
  539  subsection (7). Patient and caregiver identification cards must
  540  be resistant to counterfeiting and tampering and must include at
  541  least the following:
  542         1. The name, address, and date of birth of the patient or
  543  caregiver, as appropriate;
  544         2. Designation of the cardholder as a patient or caregiver;
  545         3. A unique numeric identifier for the patient or caregiver
  546  which is matched to the identifier used for such person in the
  547  department’s compassionate use registry. A caregiver’s numeric
  548  identifier and file in the compassionate use registry must be
  549  linked to the file of the patient or patients the caregiver is
  550  assisting so that the caregiver’s status may be verified for
  551  each patient individually;
  552         4. The expiration date, which must be 1 year after the date
  553  of issuance of the identification card or the date treatment
  554  ends as provided in the patient’s physician certification,
  555  whichever occurs first; and
  556         5. For a caregiver who is assisting three or fewer
  557  qualifying patients, the name and unique numeric identifier, or
  558  the names and unique numeric identifiers, of the qualifying
  559  patient, or the qualifying patients, that the caregiver is
  560  assisting.
  561         (c)Deem a dispensing organization approved under s. 2,
  562  chapter 2014-157, Laws of Florida, or s. 3, chapter 2016-123,
  563  Laws of Florida, before June 1, 2017, to meet the requirements
  564  for approval as an MMTC under this section. The department shall
  565  presume such dispensing organization to be registered with the
  566  department as an MMTC and shall authorize such dispensing
  567  organization to acquire, cultivate, possess, or process
  568  marijuana or products containing marijuana, including developing
  569  related products such as food, tinctures, aerosols, oils, or
  570  ointments, for sale to qualifying patients and their caregivers;
  571  or to transfer, transport, sell, distribute, or dispense
  572  marijuana, products containing marijuana, related supplies, and
  573  educational materials to qualifying patients or their
  574  caregivers. If holding a valid certificate of registration by
  575  the Department of Agriculture and Consumer Services pursuant to
  576  s. 581.131 is not required for the renewal of the registration
  577  approval, the Department of Health shall renew the approval of
  578  such dispensing organization as an MMTC biennially upon payment
  579  by the dispensing organization of the biennial renewal fee
  580  Authorize the establishment of five dispensing organizations to
  581  ensure reasonable statewide accessibility and availability as
  582  necessary for patients registered in the compassionate use
  583  registry and who are ordered low-THC cannabis, medical cannabis,
  584  or a cannabis delivery device under this section, one in each of
  585  the following regions: northwest Florida, northeast Florida,
  586  central Florida, southeast Florida, and southwest Florida.
  587         (d)Register 10 additional MMTCs before October 3, 2017,
  588  including, but not limited to, 1 applicant per occurrence which
  589  is a recognized class member of Pigford v. Glickman, 185 F.R.D.
  590  82 (D.D.C. 1999), or In re Black Farmers Litig., 856 F. Supp. 2d
  591  1 (D.D.C. 2011), and which is a member of the Black Farmers and
  592  Agriculturalists Association. All applicants must meet the
  593  requirements in this subsection and in subsection (9) and be an
  594  entity registered to do business in this state for at least 5
  595  consecutive years as of the date of the application. Upon the
  596  registration of every additional 25,000 active qualified
  597  patients in the compassionate use registry after January 1,
  598  2018, the department shall register 4 additional MMTCs.
  599         1. An entity may not be issued more than 1 registration.
  600         2. The department shall review the number of qualifying
  601  patients every 6 months.
  602         3. The department may not register more than 1 MMTC for
  603  every 10 pharmacies licensed in this state.
  604         (e)The department shall Develop an application form for
  605  registration as an MMTC and impose an initial application and
  606  biennial renewal fee that is sufficient to cover the costs of
  607  administering this section. To be registered as an MMTC, the An
  608  applicant for approval as a dispensing organization must be able
  609  to demonstrate:
  610         1. The technical and technological ability to cultivate and
  611  produce marijuana low-THC cannabis. The applicant must possess a
  612  valid certificate of registration issued by the Department of
  613  Agriculture and Consumer Services pursuant to s. 581.131 that is
  614  issued for the cultivation of more than 400,000 plants, be
  615  operated by a nurseryman as defined in s. 581.011, and have been
  616  operated as a registered nursery in this state for at least 30
  617  continuous years.
  618         2. The ability to secure the premises, resources, and
  619  personnel necessary to operate as an MMTC a dispensing
  620  organization.
  621         3. The ability to maintain accountability of all raw
  622  materials, finished products, and any byproducts to prevent
  623  diversion or unlawful access to or possession of these
  624  substances.
  625         4. An infrastructure reasonably located to dispense
  626  marijuana low-THC cannabis to registered qualifying patients
  627  statewide or regionally as determined by the department.
  628         5. The financial ability to maintain operations for the
  629  duration of the 2-year approval cycle, including the provision
  630  of certified financials to the department. Upon approval, the
  631  applicant must post a $5 million performance bond. However, upon
  632  an MMTC’s a dispensing organization’s serving at least 1,000
  633  qualifying qualified patients, the dispensing organization is
  634  only required to maintain only a $1 $2 million performance bond,
  635  to apply retroactively to all registrations.
  636         6. That all owners with a 5 percent or greater share and
  637  all managers have been fingerprinted and have successfully
  638  passed a level 2 background screening pursuant to s. 435.04.
  639         7. The employment of a medical director to supervise the
  640  activities of the MMTC dispensing organization.
  641         (c) Upon the registration of 250,000 active qualified
  642  patients in the compassionate use registry, approve three
  643  dispensing organizations, including, but not limited to, an
  644  applicant that is a recognized class member of Pigford v.
  645  Glickman, 185 F.R.D. 82 (D.D.C. 1999), or In Re Black Farmers
  646  Litig., 856 F. Supp. 2d 1 (D.D.C. 2011), and a member of the
  647  Black Farmers and Agriculturalists Association, which must meet
  648  the requirements of subparagraphs (b)2.-7. and demonstrate the
  649  technical and technological ability to cultivate and produce
  650  low-THC cannabis.
  651         (f)(d) Allow an MMTC a dispensing organization to make a
  652  wholesale purchase of marijuana low-THC cannabis or medical
  653  cannabis from, or a distribution of marijuana low-THC cannabis
  654  or medical cannabis to, another MMTC dispensing organization.
  655         (g)(e) Monitor physician registration in the compassionate
  656  use registry and the issuance of physician certifications
  657  pursuant to subsection (3) and ordering of low-THC cannabis,
  658  medical cannabis, or a cannabis delivery device for ordering
  659  practices that could facilitate unlawful diversion or misuse of
  660  marijuana low-THC cannabis, medical cannabis, or a marijuana
  661  cannabis delivery device and take disciplinary action as
  662  indicated.
  663         (h) Create a 30-minute educational program for qualifying
  664  patients on the responsible use of marijuana. The program must
  665  address the safe consumption of edible marijuana products and
  666  keeping the patient’s marijuana from children and unauthorized
  667  users.
  668         (9)(6)MEDICAL MARIJUANA TREATMENT CENTERS DISPENSING
  669  ORGANIZATION.—In order to be an MMTC, an entity must register
  670  with the department. An MMTC An approved dispensing organization
  671  must, at all times, maintain compliance with the criteria
  672  demonstrated for selection and approval as a dispensing
  673  organization under subsection (5) and the criteria required in
  674  this subsection and all representations made to the department
  675  in the MMTC’s application for registration. Upon request, the
  676  department may grant an MMTC one or more variances from the
  677  representations made in the MMTC’s application. Consideration of
  678  such a variance shall be based upon the facts and circumstances
  679  surrounding the request. A variance may not be granted unless
  680  the requesting MMTC can demonstrate to the department that it
  681  has a proposed alternative to the specific representation made
  682  in its application which fulfills the same or a similar purpose
  683  as the specific representation in a way that the department can
  684  reasonably determine will not be a lower standard than the
  685  specific representation in the application. An MMTC is not
  686  required to obtain a variance for deviations from the MMTC’s
  687  application for registration which do not materially affect the
  688  MMTC’s operations or the quality of the marijuana dispensed by
  689  the MMTC or for deviations from the MMTC’s application which are
  690  needed to conform to current statutes or rules.
  691         (a) When growing marijuana low-THC cannabis or medical
  692  cannabis, an MMTC a dispensing organization:
  693         1. May use pesticides determined by the department, after
  694  consultation with the Department of Agriculture and Consumer
  695  Services, to be safely applied to plants intended for human
  696  consumption, but may not use pesticides designated as
  697  restricted-use pesticides pursuant to s. 487.042.
  698         2. Must grow marijuana low-THC cannabis or medical cannabis
  699  within an enclosed structure and in a room separate from any
  700  other plant.
  701         3. Must inspect seeds and growing plants for plant pests
  702  that endanger or threaten the horticultural and agricultural
  703  interests of the state, notify the Department of Agriculture and
  704  Consumer Services within 10 calendar days after a determination
  705  that a plant is infested or infected by such plant pest, and
  706  implement and maintain phytosanitary policies and procedures.
  707         4. Must perform fumigation or treatment of plants, or the
  708  removal and destruction of infested or infected plants, in
  709  accordance with chapter 581 and any rules adopted thereunder.
  710         (b) When processing marijuana, an MMTC low-THC cannabis or
  711  medical cannabis, a dispensing organization must:
  712         1. Follow health and safety standards established by the
  713  department. The department shall require the use of food grade
  714  solvents, equipment, and procedures in the processing of
  715  marijuana to ensure safe consumption.
  716         2. Process the marijuana low-THC cannabis or medical
  717  cannabis within an enclosed structure and in a room separate
  718  from other plants or products.
  719         3.2. Test the processed marijuana low-THC cannabis and
  720  medical cannabis before it is they are dispensed. Results must
  721  be verified and signed by two MMTC dispensing organization
  722  employees. Before dispensing marijuana low-THC cannabis, the
  723  MMTC dispensing organization must determine that the marijuana
  724  test results indicate that the low-THC cannabis meets the
  725  definition of low-THC cannabis and, for medical cannabis and
  726  low-THC cannabis, that all medical cannabis and low-THC cannabis
  727  is safe for human consumption and free from contaminants that
  728  are unsafe for human consumption. The MMTC dispensing
  729  organization must retain records of all testing and samples of
  730  each homogenous batch of marijuana cannabis and low-THC cannabis
  731  for at least 6 9 months. The MMTC dispensing organization must
  732  contract with an independent testing laboratory to:
  733         a. Perform audits on the MMTC’s dispensing organization’s
  734  standard operating procedures, testing records, and samples and
  735  provide the results to the department to confirm that the
  736  marijuana low-THC cannabis or medical cannabis meets the
  737  requirements of this section and that the marijuana medical
  738  cannabis and low-THC cannabis is safe for human consumption; or
  739         b.Directly test the marijuana final product to ensure that
  740  it meets the requirements of this section and is safe for human
  741  consumption before it is dispensed or distributed.
  742         4.3.Directly package the marijuana low-THC cannabis or
  743  medical cannabis in compliance with the United States Poison
  744  Prevention Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.
  745         5.4. Package the marijuana low-THC cannabis or medical
  746  cannabis in an opaque, childproof, and tamper-evident a
  747  receptacle that has a firmly affixed and legible label stating
  748  the following information:
  749         a. A statement that the marijuana low-THC cannabis or
  750  medical cannabis meets the requirements of subparagraphs 1.,
  751  subparagraph 2. and 3.;
  752         b. The name of the MMTC dispensing organization from which
  753  the marijuana medical cannabis or low-THC cannabis originates
  754  and the MMTC’s registration number; and
  755         c. The batch number and harvest number from which the
  756  marijuana medical cannabis or low-THC cannabis originates;
  757         d. A universal symbol indicating that marijuana is
  758  contained in the package; and
  759         e. Warning statements.
  760         6.5. Reserve two processed samples from each batch and
  761  retain such samples for at least 6 9 months for the purpose of
  762  testing pursuant to the audit required under subparagraph 3. 2.
  763         (c) When dispensing marijuana low-THC cannabis, medical
  764  cannabis, or a marijuana cannabis delivery device, an MMTC a
  765  dispensing organization:
  766         1. May not dispense more than the a 45-day supply of
  767  marijuana low-THC cannabis or medical cannabis to a qualifying
  768  patient or the qualifying patient’s caregiver which is indicated
  769  on the qualifying patient’s physician certification legal
  770  representative.
  771         2. Must ensure that have the dispensing organization’s
  772  employee who dispenses the marijuana low-THC cannabis, medical
  773  cannabis, or a marijuana cannabis delivery device enters enter
  774  into the compassionate use registry his or her name or unique
  775  employee identifier.
  776         3. Must verify that the qualifying patient and the
  777  caregiver, if applicable, both have an active and valid
  778  compassionate use registry identification card and that the
  779  amount and type of marijuana dispensed match the physician’s
  780  certification in the compassionate use registry for that
  781  qualifying patient that a physician has ordered the low-THC
  782  cannabis, medical cannabis, or a specific type of a cannabis
  783  delivery device for the patient.
  784         4. May not dispense or sell any other type of cannabis,
  785  alcohol, or illicit drug-related product, including pipes,
  786  bongs, or wrapping papers, other than a physician-ordered
  787  marijuana cannabis delivery device required for the medical use
  788  of marijuana which is specified in the physician certification.
  789  An MMTC may produce and dispense marijuana as an edible or food
  790  product but may not produce such items in a format designed to
  791  be attractive to children. In addition to the requirements of
  792  this section and department rule, food products produced by an
  793  MMTC must meet all food safety standards established in state
  794  and federal law, including, but not limited to, the
  795  identification of the serving size and the amount of
  796  tetrahydrocannabinol in each serving low-THC cannabis or medical
  797  cannabis, while dispensing low-THC cannabis or medical cannabis.
  798         5. Must verify that the patient has an active registration
  799  in the compassionate use registry, the patient or patient’s
  800  legal representative holds a valid and active registration card,
  801  the order presented matches the order contents as recorded in
  802  the registry, and the order has not already been filled.
  803         5.6. Must, upon dispensing the marijuana low-THC cannabis,
  804  medical cannabis, or marijuana cannabis delivery device, record
  805  in the registry the date, time, quantity, and form of marijuana
  806  low-THC cannabis or medical cannabis dispensed; and the type of
  807  marijuana cannabis delivery device dispensed; and the name and
  808  compassionate use registry numeric identifier of the qualifying
  809  patient or caregiver to whom the marijuana delivery device was
  810  dispensed.
  811         (d) To ensure the safety and security of its premises and
  812  any off-site storage facilities, and to maintain adequate
  813  controls against the diversion, theft, and loss of marijuana
  814  low-THC cannabis, medical cannabis, or marijuana cannabis
  815  delivery devices, an MMTC a dispensing organization shall:
  816         1.a. Maintain a fully operational security alarm system
  817  that secures all entry points and perimeter windows and is
  818  equipped with motion detectors; pressure switches; and duress,
  819  panic, and hold-up alarms; or
  820         b. Maintain a video surveillance system that records
  821  continuously 24 hours each day and meets at least one of the
  822  following criteria:
  823         (I) Cameras are fixed in a place that allows for the clear
  824  identification of persons and activities in controlled areas of
  825  the premises. Controlled areas include grow rooms, processing
  826  rooms, storage rooms, disposal rooms or areas, and point-of-sale
  827  rooms;
  828         (II) Cameras are fixed in entrances and exits to the
  829  premises, which shall record from both indoor and outdoor, or
  830  ingress and egress, vantage points;
  831         (III) Recorded images must clearly and accurately display
  832  the time and date; or
  833         (IV) Retain video surveillance recordings for a minimum of
  834  45 days or longer upon the request of a law enforcement agency.
  835         2. Ensure that the MMTC’s organization’s outdoor premises
  836  have sufficient lighting from dusk until dawn.
  837         3. Establish and maintain a tracking system approved by the
  838  department which that traces the marijuana low-THC cannabis or
  839  medical cannabis from seed to sale. The tracking system must
  840  shall include notification of key events as determined by the
  841  department, including when marijuana cannabis seeds are planted,
  842  when marijuana cannabis plants are harvested and destroyed, and
  843  when marijuana low-THC cannabis or medical cannabis is
  844  transported, sold, stolen, diverted, or lost.
  845         4. Not dispense from its premises marijuana low-THC
  846  cannabis, medical cannabis, or a marijuana cannabis delivery
  847  device between the hours of 9 p.m. and 7 a.m., but may perform
  848  all other operations and deliver marijuana low-THC cannabis and
  849  medical cannabis to qualifying qualified patients 24 hours each
  850  day.
  851         5. Store marijuana low-THC cannabis or medical cannabis in
  852  a secured, locked room or a vault.
  853         6. Require at least two of its employees, or two employees
  854  of a security agency with whom it contracts, to be on the
  855  premises of any cultivation or processing facilities at all
  856  times.
  857         7. Require each employee or contractor to wear a photo
  858  identification badge at all times while on the premises.
  859         8. Require each visitor to wear a visitor’s pass at all
  860  times while on the premises.
  861         9. Implement an alcohol and drug-free workplace policy.
  862         10. Report to local law enforcement within 24 hours after
  863  it is notified or becomes aware of the theft, diversion, or loss
  864  of marijuana low-THC cannabis or medical cannabis.
  865         11. Register all MMTC owners and employees with the
  866  department.
  867         12. Present a floor plan to the department which designates
  868  each area of the facility as a “limited access area,
  869  “restricted access area,” or “general access area.” As used in
  870  this subparagraph, the term:
  871         a. “Limited access area” means the area within an MMTC
  872  where marijuana is cultivated, processed, stored, packaged, and
  873  sold to other MMTCs. This area is accessible only to employees
  874  and visitors escorted by an employee.
  875         b. “Restricted access area” means the area within an MMTC
  876  where marijuana is sold to qualifying patients and caregivers.
  877  This area is accessible only to employees, qualifying patients,
  878  and caregivers and to visitors escorted by an employee.
  879  Individuals admitted into a restricted access area must provide
  880  a photo identification as required by the department.
  881         c. “General access area” means the area within an MMTC
  882  where marijuana is not grown, cultivated, processed, stored,
  883  packaged, processed for sale, or sold. This area is accessible
  884  to visitors.
  885         (e) To ensure the safe and sanitary transport of marijuana
  886  low-THC cannabis or medical cannabis to MMTC dispensing
  887  organization facilities, independent testing laboratories, or
  888  qualifying patients, the MMTC dispensing organization must:
  889         1. Maintain a transportation manifest, which must be
  890  retained for at least 1 year.
  891         2. Ensure only vehicles in good working order are used to
  892  transport marijuana low-THC cannabis or medical cannabis.
  893         3. Lock marijuana low-THC cannabis or medical cannabis in a
  894  separate compartment or container within the vehicle.
  895         4. Require at least two persons to be in a vehicle
  896  transporting marijuana low-THC cannabis or medical cannabis, and
  897  require at least one person to remain in the vehicle while the
  898  marijuana low-THC cannabis or medical cannabis is being
  899  delivered.
  900         5.Ensure that any vehicle transporting marijuana to a
  901  qualifying patient or caregiver is legally parked while
  902  marijuana is being delivered to the qualifying patient or
  903  caregiver.
  904         6.5. Provide specific safety and security training to
  905  employees transporting or delivering marijuana low-THC cannabis
  906  or medical cannabis.
  907         (10)(7) DEPARTMENT AUTHORITY AND RESPONSIBILITIES.—
  908         (a) The department may conduct announced or unannounced
  909  inspections of MMTCs dispensing organizations to determine
  910  compliance with this section or rules adopted pursuant to this
  911  section.
  912         (b) The department shall inspect an MMTC a dispensing
  913  organization upon complaint or notice provided to the department
  914  that the MMTC dispensing organization has dispensed marijuana
  915  low-THC cannabis or medical cannabis containing any mold,
  916  bacteria, or other contaminant at a level that may cause or has
  917  caused an adverse effect to human health or the environment.
  918         (c) The department shall conduct at least a biennial
  919  inspection of each MMTC dispensing organization to evaluate the
  920  MMTC’s dispensing organization’s records, personnel, equipment,
  921  processes, security measures, sanitation practices, and quality
  922  assurance practices.
  923         (d) The department shall adopt by rule a process for
  924  approving changes in MMTC ownership or a change in an MMTC
  925  owner’s investment interest of 5 percent or more. This process
  926  must include specific criteria for the approval or denial of an
  927  application for change of ownership or a change in investment
  928  interest and procedures for screening applicants’ criminal and
  929  financial histories.
  930         (e) The department may enter into interagency agreements
  931  with the Department of Agriculture and Consumer Services, the
  932  Department of Business and Professional Regulation, the
  933  Department of Law Enforcement, the Department of Transportation,
  934  the Department of Highway Safety and Motor Vehicles, and the
  935  Agency for Health Care Administration, and such agencies are
  936  authorized to enter into an interagency agreement with the
  937  department, to conduct inspections or perform other
  938  responsibilities assigned to the department under this section.
  939         (f)(e) The department must make a list of all approved
  940  MMTCs, dispensing organizations and qualified ordering
  941  physicians who are qualified to issue physician certifications,
  942  and medical directors of MMTCs publicly available on its
  943  website.
  944         (f) The department may establish a system for issuing and
  945  renewing registration cards for patients and their legal
  946  representatives, establish the circumstances under which the
  947  cards may be revoked by or must be returned to the department,
  948  and establish fees to implement such system. The department must
  949  require, at a minimum, the registration cards to:
  950         1. Provide the name, address, and date of birth of the
  951  patient or legal representative.
  952         2. Have a full-face, passport-type, color photograph of the
  953  patient or legal representative taken within the 90 days
  954  immediately preceding registration.
  955         3. Identify whether the cardholder is a patient or legal
  956  representative.
  957         4. List a unique numeric identifier for the patient or
  958  legal representative that is matched to the identifier used for
  959  such person in the department’s compassionate use registry.
  960         5. Provide the expiration date, which shall be 1 year after
  961  the date of the physician’s initial order of low-THC cannabis or
  962  medical cannabis.
  963         6. For the legal representative, provide the name and
  964  unique numeric identifier of the patient that the legal
  965  representative is assisting.
  966         7. Be resistant to counterfeiting or tampering.
  967         (g) The department may impose reasonable fines not to
  968  exceed $10,000 on an MMTC a dispensing organization for any of
  969  the following violations:
  970         1. Violating this section, s. 499.0295, or department rule.
  971         2. Failing to maintain qualifications registration with the
  972  department for approval.
  973         3. Endangering the health, safety, or security of a
  974  qualifying qualified patient.
  975         4. Improperly disclosing personal and confidential
  976  information of a qualifying the qualified patient.
  977         5. Attempting to procure MMTC registration with the
  978  department dispensing organization approval by bribery,
  979  fraudulent misrepresentation, or extortion.
  980         6. Any owner or manager of the MMTC being convicted or
  981  found guilty of, or entering a plea of guilty or nolo contendere
  982  to, regardless of adjudication, a crime in any jurisdiction
  983  which directly relates to the business of an MMTC a dispensing
  984  organization.
  985         7. Making or filing a report or record that the MMTC
  986  dispensing organization knows to be false.
  987         8. Willfully failing to maintain a record required by this
  988  section or department rule.
  989         9. Willfully impeding or obstructing an employee or agent
  990  of the department in the furtherance of his or her official
  991  duties.
  992         10. Engaging in fraud or deceit, negligence, incompetence,
  993  or misconduct in the business practices of an MMTC a dispensing
  994  organization.
  995         11. Making misleading, deceptive, or fraudulent
  996  representations in or related to the business practices of an
  997  MMTC a dispensing organization.
  998         12. Having a license or the authority to engage in any
  999  regulated profession, occupation, or business that is related to
 1000  the business practices of an MMTC a dispensing organization
 1001  suspended, revoked, or otherwise acted against by the licensing
 1002  authority of any jurisdiction, including its agencies or
 1003  subdivisions, for a violation that would constitute a violation
 1004  under Florida law.
 1005         13. Violating a lawful order of the department or an agency
 1006  of the state, or failing to comply with a lawfully issued
 1007  subpoena of the department or an agency of the state.
 1008         (h) The department may suspend, revoke, or refuse to renew
 1009  an MMTC’s registration with the department a dispensing
 1010  organization’s approval if the MMTC a dispensing organization
 1011  commits repeated violations specified any of the violations in
 1012  paragraph (g) which remain uncured after 30 days’ notice from
 1013  the department. The department may not suspend, revoke, or
 1014  refuse to renew an MMTC’s registration due to an uncured
 1015  violation if the MMTC begins taking action to cure the violation
 1016  within 30 days after receiving a notice of the violation from
 1017  the department and such action is pursuant to a corrective
 1018  action plan filed by the MMTC with the department or if the MMTC
 1019  takes reasonable steps to ensure that a future violation of a
 1020  similar nature does not occur.
 1021         (i) The department shall renew an MMTC’s registration with
 1022  the department the approval of a dispensing organization
 1023  biennially if the MMTC dispensing organization meets the
 1024  requirements of this section and pays the biennial renewal fee.
 1025         (j) The department may adopt rules necessary to implement
 1026  this section pursuant to s. 120.536(1) or s. 120.54. The
 1027  department may use emergency rulemaking procedures pursuant to
 1028  s. 120.54(4) to adopt rules under this section if necessary to
 1029  meet any deadline for rulemaking established in s. 29, Art. X of
 1030  the State Constitution.
 1031         (k) The department may adopt rules authorizing an MMTC to
 1032  have specified employees administer marijuana. Marijuana may be
 1033  administered only at an MMTC that is registered with the
 1034  department as an administration facility.
 1035         (11)(8) PREEMPTION.—
 1036         (a) All matters regarding the regulation of the cultivation
 1037  and processing of marijuana medical cannabis or low-THC cannabis
 1038  by MMTCs dispensing organizations are preempted to the state.
 1039         (b) A municipality may determine by ordinance the criteria
 1040  for the number and location of, and other permitting
 1041  requirements that do not conflict with state law or department
 1042  rule for, dispensing facilities of MMTCs dispensing
 1043  organizations located within its municipal boundaries. A county
 1044  may determine by ordinance the criteria for the number,
 1045  location, and other permitting requirements that do not conflict
 1046  with state law or department rule for all dispensing facilities
 1047  of MMTCs dispensing organizations located within the
 1048  unincorporated areas of that county. This section does not
 1049  preempt any law or ordinance of any county or municipality which
 1050  imposes restrictions on the location of an MMTC if the law or
 1051  ordinance does not unreasonably interfere with the availability
 1052  of marijuana to qualifying patients.
 1053         (12)(9) EXCEPTIONS TO OTHER LAWS.—
 1054         (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
 1055  any other provision of law, but subject to the requirements of
 1056  this section, a qualifying qualified patient, or a caregiver who
 1057  has obtained a valid compassionate use registry identification
 1058  card from the department, and the qualified patient’s legal
 1059  representative may purchase from an MMTC and possess for the
 1060  qualifying patient’s medical use, up to the amount of marijuana
 1061  in the physician certification low-THC cannabis or medical
 1062  cannabis ordered for the patient, but not more than a 90-day 45
 1063  day supply, except as provided in (3)(e), and a marijuana
 1064  cannabis delivery device specified in the physician
 1065  certification ordered for the qualifying patient.
 1066         (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
 1067  any other provision of law, but subject to the requirements of
 1068  this section, an MMTC an approved dispensing organization and
 1069  its owners, managers, contractors, and employees may
 1070  manufacture, possess, sell, deliver, distribute, dispense, and
 1071  lawfully dispose of reasonable quantities, as established by
 1072  department rule, of marijuana low-THC cannabis, medical
 1073  cannabis, or a marijuana cannabis delivery device. As used in
 1074  For purposes of this subsection, the terms “manufacture,”
 1075  “possession,” “deliver,” “distribute,” and “dispense” have the
 1076  same meanings as provided in s. 893.02.
 1077         (c) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
 1078  any other provision of law, but subject to the requirements of
 1079  this section, an approved independent testing laboratory may
 1080  possess, test, transport, and lawfully dispose of marijuana low
 1081  THC cannabis or medical cannabis as provided by department rule.
 1082         (d) An MMTC approved dispensing organization and its
 1083  owners, managers, contractors, and employees are not subject to
 1084  licensure or regulation under chapter 465 or chapter 499 for
 1085  manufacturing, possessing, selling, delivering, distributing,
 1086  dispensing, or lawfully disposing of reasonable quantities, as
 1087  established by department rule, of marijuana low-THC cannabis,
 1088  medical cannabis, or a marijuana cannabis delivery device.
 1089         (e) Exercise by an MMTC of An approved dispensing
 1090  organization that continues to meet the requirements for
 1091  approval is presumed to be registered with the department and to
 1092  meet the regulations adopted by the department or its successor
 1093  agency for the purpose of dispensing medical cannabis or low-THC
 1094  cannabis under Florida law. Additionally, the authority provided
 1095  to a dispensing organization in s. 499.0295 does not impair its
 1096  registration with the department the approval of a dispensing
 1097  organization.
 1098         (f) This subsection does not exempt a person from
 1099  prosecution for a criminal offense related to impairment or
 1100  intoxication resulting from the medical use of marijuana low-THC
 1101  cannabis or medical cannabis or relieve a person from any
 1102  requirement under law to submit to a breath, blood, urine, or
 1103  other test to detect the presence of a controlled substance.
 1104         (g) This section does not affect or repeal laws relating to
 1105  negligence or professional malpractice on the part of a
 1106  caregiver, a physician, or an MMTC or its agents and employees.
 1107  However, a physician who issues a physician certification and
 1108  who fully complies with the requirements of this section is
 1109  immune from liability in civil actions and claims for medical
 1110  malpractice.
 1111         (h)This section does not require a health insurance
 1112  provider or a governmental agency or authority to reimburse a
 1113  person for expenses related to the use of marijuana.
 1114         (i) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
 1115  any other provision of law, but subject to the requirements of
 1116  this section, a research institute established by a public
 1117  postsecondary educational institution, such as the H. Lee
 1118  Moffitt Cancer Center and Research Institute established in s.
 1119  1004.43, or a state university that has achieved the preeminent
 1120  state research university designation pursuant to s. 1001.7065,
 1121  may possess, test, transport, and lawfully dispose of marijuana
 1122  for research purposes as provided by department rule.
 1123         (13) PROHIBITED ACTIVITIES.—
 1124         (a)A person or entity may not offer or advertise services
 1125  as an MMTC without registering as an MMTC with the department.
 1126  An MMTC may not advertise or hold out to the public that it
 1127  holds a registration for other than that for which it actually
 1128  holds the registration.
 1129         (b) The ownership, operation, or maintenance of an
 1130  unauthorized dispensing organization or entity or the
 1131  performance of a service that requires registration without
 1132  proper registration is a violation of this section. The
 1133  department or any state attorney may, in addition to other
 1134  remedies provided in this section, bring an action for an
 1135  injunction to restrain any unauthorized activity or to enjoin
 1136  the future operation or maintenance of the unauthorized
 1137  dispensing organization or entity or the performance of any
 1138  service in violation of this section, until compliance with this
 1139  section and department rules has been demonstrated to the
 1140  satisfaction of the department.
 1141         (c) If after receiving notification from the department,
 1142  such person, organization, or entity fails to cease operation,
 1143  the person, organization, or entity is subject to penalties as
 1144  prescribed by this section. Each day of continued operation is a
 1145  separate offense.
 1146         (14)IMPORTATION AND EXPORTATION OF MARIJUANA.—
 1147         (a)Marijuana may not be imported from outside this state.
 1148         (b)Marijuana and products containing marijuana which are
 1149  cultivated and produced in accordance with this section may be
 1150  exported as authorized by federal law and the laws of the states
 1151  or countries to which they are exported.
 1152         (15) SEVERABILITY CLAUSE.—If any provision of this section
 1153  or its application to any person or circumstance is held
 1154  invalid, the invalidity does not affect other provisions or
 1155  applications of this section which can be given effect without
 1156  the invalid provision or application, and to this end the
 1157  provisions of this section are severable.
 1158         Section 2. Subsections (1) and (2) of section 381.987,
 1159  Florida Statutes, are amended, and paragraphs (b) and (c) of
 1160  subsection (3) of that section are amended, to read:
 1161         381.987 Public records exemption for personal identifying
 1162  information in the compassionate use registry.—
 1163         (1) A patient’s personal identifying information held by
 1164  the department in the compassionate use registry established
 1165  under s. 381.986, including, but not limited to, the patient’s
 1166  name, address, telephone number, and government-issued
 1167  identification number, and all information pertaining to the
 1168  physician certification physician’s order for marijuana low-THC
 1169  cannabis and the dispensing thereof are confidential and exempt
 1170  from s. 119.07(1) and s. 24(a), Art. I of the State
 1171  Constitution.
 1172         (2) A physician’s identifying information held by the
 1173  department in the compassionate use registry established under
 1174  s. 381.986, including, but not limited to, the physician’s name,
 1175  address, telephone number, government-issued identification
 1176  number, and Drug Enforcement Administration number, and all
 1177  information pertaining to the physician certification
 1178  physician’s order for marijuana low-THC cannabis and the
 1179  dispensing thereof are confidential and exempt from s. 119.07(1)
 1180  and s. 24(a), Art. I of the State Constitution.
 1181         (3) The department shall allow access to the registry,
 1182  including access to confidential and exempt information, to:
 1183         (b) A medical marijuana treatment center dispensing
 1184  organization approved by the department pursuant to s. 381.986
 1185  which is attempting to verify the authenticity of a physician
 1186  certification physician’s order for marijuana low-THC cannabis,
 1187  including whether the physician certification order had been
 1188  previously filled and whether the physician certification order
 1189  was written for the person attempting to have it filled.
 1190         (c) A physician who has issued a physician certification
 1191  written an order for marijuana low-THC cannabis for the purpose
 1192  of monitoring the patient’s use of such cannabis or for the
 1193  purpose of determining, before issuing an order for marijuana
 1194  low-THC cannabis, whether another physician has ordered the
 1195  patient’s use of marijuana low-THC cannabis. The physician may
 1196  access the confidential and exempt information only for the
 1197  patient for whom he or she has ordered or is determining whether
 1198  to order the use of marijuana low-THC cannabis pursuant to s.
 1199  381.986.
 1200         Section 3. Subsection (1) of section 385.211, Florida
 1201  Statutes, is amended to read:
 1202         385.211 Refractory and intractable epilepsy treatment and
 1203  research at recognized medical centers.—
 1204         (1) As used in this section, the term “low-THC cannabis”
 1205  means “low-THC cannabis” as defined in s. 381.986 which that is
 1206  dispensed only from a medical marijuana treatment center
 1207  dispensing organization as defined in s. 381.986.
 1208         Section 4. Subsections (2) and (3) of section 499.0295,
 1209  Florida Statutes, are amended to read:
 1210         499.0295 Experimental treatments for terminal conditions.—
 1211         (2) As used in this section, the term:
 1212         (a) “Dispensing organization” means an organization
 1213  approved by the Department of Health under s. 381.986(5) to
 1214  cultivate, process, transport, and dispense low-THC cannabis,
 1215  medical cannabis, and cannabis delivery devices.
 1216         (a)(b) “Eligible patient” means a person who:
 1217         1. Has a terminal condition that is attested to by the
 1218  patient’s physician and confirmed by a second independent
 1219  evaluation by a board-certified physician in an appropriate
 1220  specialty for that condition;
 1221         2. Has considered all other treatment options for the
 1222  terminal condition currently approved by the United States Food
 1223  and Drug Administration;
 1224         3. Has given written informed consent for the use of an
 1225  investigational drug, biological product, or device; and
 1226         4. Has documentation from his or her treating physician
 1227  that the patient meets the requirements of this paragraph.
 1228         (b)(c) “Investigational drug, biological product, or
 1229  device” means:
 1230         1. a drug, biological product, or device that has
 1231  successfully completed phase 1 of a clinical trial but has not
 1232  been approved for general use by the United States Food and Drug
 1233  Administration and remains under investigation in a clinical
 1234  trial approved by the United States Food and Drug
 1235  Administration; or
 1236         2. Medical cannabis that is manufactured and sold by a
 1237  dispensing organization.
 1238         (c)(d) “Terminal condition” means a progressive disease or
 1239  medical or surgical condition that causes significant functional
 1240  impairment, is not considered by a treating physician to be
 1241  reversible even with the administration of available treatment
 1242  options currently approved by the United States Food and Drug
 1243  Administration, and, without the administration of life
 1244  sustaining procedures, will result in death within 1 year after
 1245  diagnosis if the condition runs its normal course.
 1246         (d)(e) “Written informed consent” means a document that is
 1247  signed by a patient, a parent of a minor patient, a court
 1248  appointed guardian for a patient, or a health care surrogate
 1249  designated by a patient and includes:
 1250         1. An explanation of the currently approved products and
 1251  treatments for the patient’s terminal condition.
 1252         2. An attestation that the patient concurs with his or her
 1253  physician in believing that all currently approved products and
 1254  treatments are unlikely to prolong the patient’s life.
 1255         3. Identification of the specific investigational drug,
 1256  biological product, or device that the patient is seeking to
 1257  use.
 1258         4. A realistic description of the most likely outcomes of
 1259  using the investigational drug, biological product, or device.
 1260  The description shall include the possibility that new,
 1261  unanticipated, different, or worse symptoms might result and
 1262  death could be hastened by the proposed treatment. The
 1263  description shall be based on the physician’s knowledge of the
 1264  proposed treatment for the patient’s terminal condition.
 1265         5. A statement that the patient’s health plan or third
 1266  party administrator and physician are not obligated to pay for
 1267  care or treatment consequent to the use of the investigational
 1268  drug, biological product, or device unless required to do so by
 1269  law or contract.
 1270         6. A statement that the patient’s eligibility for hospice
 1271  care may be withdrawn if the patient begins treatment with the
 1272  investigational drug, biological product, or device and that
 1273  hospice care may be reinstated if the treatment ends and the
 1274  patient meets hospice eligibility requirements.
 1275         7. A statement that the patient understands he or she is
 1276  liable for all expenses consequent to the use of the
 1277  investigational drug, biological product, or device and that
 1278  liability extends to the patient’s estate, unless a contract
 1279  between the patient and the manufacturer of the investigational
 1280  drug, biological product, or device states otherwise.
 1281         (3) Upon the request of an eligible patient, a manufacturer
 1282  may, or, upon the issuance of a physician certification a
 1283  physician’s order pursuant to s. 381.986, an MMTC a dispensing
 1284  organization may:
 1285         (a) Make its investigational drug, biological product, or
 1286  device available under this section.
 1287         (b) Provide an investigational drug, biological product,
 1288  device, or cannabis delivery device as defined in s. 381.986 to
 1289  an eligible patient without receiving compensation.
 1290         (c) Require an eligible patient to pay the costs of, or the
 1291  costs associated with, the manufacture of the investigational
 1292  drug, biological product, device, or cannabis delivery device as
 1293  defined in s. 381.986.
 1294         Section 5. Subsection (1) of section 1004.441, Florida
 1295  Statutes, is amended to read:
 1296         1004.441 Refractory and intractable epilepsy treatment and
 1297  research.—
 1298         (1) As used in this section, the term “low-THC cannabis”
 1299  means “low-THC cannabis” as defined in s. 381.986 which that is
 1300  dispensed only from a medical marijuana treatment center
 1301  dispensing organization as defined in s. 381.986.
 1302         Section 6. The Division of Law Revision and Information is
 1303  directed to replace the phrase “the effective date of this act”
 1304  wherever it occurs in this act with the date the act becomes a
 1305  law.
 1306         Section 7. This act shall take effect upon becoming a law.