Florida Senate - 2017                                    SB 1758
       
       
        
       By Senator Grimsley
       
       
       
       
       
       26-00705C-17                                          20171758__
    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 that a prior
   13         order issued for low-THC cannabis or medical cannabis
   14         is considered a physician certification under certain
   15         circumstances; providing requirements for such orders;
   16         revising criminal penalties; reducing the number of
   17         hours of coursework required of physicians who issue
   18         physician certifications; providing that physicians
   19         who meet specified requirements are grandfathered for
   20         the purpose of specified education requirements;
   21         authorizing qualifying patients to designate
   22         caregivers; requiring caregivers to meet specified
   23         requirements; prohibiting a qualifying patient from
   24         designating more than one caregiver at any given time;
   25         providing exceptions; requiring the Department of
   26         Health to register on the compassionate use registry a
   27         caregiver and to issue him or her a caregiver
   28         identification card if the caregiver meets certain
   29         requirements; revising the list of entities that have
   30         access to the compassionate use registry; requiring
   31         the department to adopt rules by a specified date;
   32         authorizing the department to charge a fee for
   33         identification cards; requiring the department to
   34         begin issuing identification cards to qualified
   35         registrants by a specific date; providing requirements
   36         for the identification cards; requiring the department
   37         to register certain dispensing organizations as
   38         medical marijuana treatment centers (MMTCs) by a
   39         certain date; requiring the department to register
   40         additional MMTCs in accordance with a specified
   41         schedule; providing an exception to certain
   42         registration requirements for certain applicants;
   43         authorizing certain performance bonds to be used only
   44         for reimbursement to the department for damages
   45         incurred as a result of the MMTC’s failure to meet
   46         certain requirements or department rules; deleting
   47         obsolete provisions; revising the operational
   48         requirements for MMTCs; authorizing the department to
   49         waive certain requirements in the MMTC registration
   50         application under specified circumstances; providing
   51         requirements for MMTCs to grow, process, and dispense
   52         marijuana; providing a contract option that requires
   53         an independent testing laboratory to directly test an
   54         MMTC’s marijuana final product; requiring that
   55         marijuana receptacles be childproof; reducing the time
   56         that samples are required to be retained; requiring
   57         verification of patient and caregiver identification
   58         cards, rather than registration cards, and amount and
   59         type of marijuana before dispensing; requiring MMTC
   60         compliance with certain standards in the production
   61         and dispensing of edibles or food products; requiring
   62         an MMTC to enter additional information into the
   63         compassionate use registry; providing requirements to
   64         ensure the safety and security of premises and
   65         facilities of MMTCs, rather than dispensing
   66         organizations, and the safe transport of marijuana;
   67         requiring a vehicle transporting marijuana to be
   68         legally parked under certain circumstances; revising
   69         the department authority and responsibilities;
   70         requiring the department to adopt rules relating to
   71         ownership changes or changes in an owner’s investment
   72         interest; authorizing the department to suspend,
   73         revoke, or refuse to renew an MMTC’s registration if
   74         the MMTC commits repeated violations that remain
   75         uncured within a specified time limit; authorizing
   76         emergency rulemaking procedures under certain
   77         circumstances; prohibiting a municipality or county
   78         from banning dispensing facilities; conforming
   79         provisions to changes made by the act; providing
   80         construction; authorizing certain institutes or state
   81         universities to possess, test, transport, or dispose
   82         of marijuana for research purposes; prohibiting a
   83         person from offering or advertising services, and from
   84         owning, operating, and maintaining certain facilities,
   85         without registration; providing penalties including an
   86         administrative fine imposed under certain
   87         circumstances; prohibiting importation of marijuana;
   88         authorizing exportation of marijuana and products
   89         containing marijuana under certain circumstances;
   90         amending ss. 381.987, 385.211, 499.0295, and 1004.441,
   91         F.S.; conforming provisions to changes made by the
   92         act; providing a directive to the Division of Law
   93         Revision and Information; providing an effective date.
   94          
   95  Be It Enacted by the Legislature of the State of Florida:
   96  
   97         Section 1. Section 381.986, Florida Statutes, is amended to
   98  read:
   99         381.986 Compassionate use of marijuana low-THC and medical
  100  cannabis.—
  101         (1) LEGISLATIVE INTENT.—
  102         (a) It is the intent of the Legislature to implement s. 29,
  103  Art. X of the State Constitution by creating a unified
  104  regulatory structure within the framework of this section for
  105  the acquisition, cultivation, possession, processing, transfer,
  106  transportation, sale, distribution, and dispensing of marijuana,
  107  products containing marijuana, related supplies, or educational
  108  materials to qualifying patients or their caregivers.
  109         (b) The Legislature intends that all rules adopted by the
  110  Department of Health to implement this section be adopted
  111  pursuant to s. 120.536(1) or s. 120.54. The Legislature intends
  112  that the department use emergency rulemaking procedures pursuant
  113  to s. 120.54(4) to adopt rules under this section if necessary
  114  to meet any deadline for rulemaking established in s. 29, Art. X
  115  of the State Constitution.
  116         (c) Further, the Legislature intends that all registrations
  117  for the purposes specified in paragraph (a) be issued solely in
  118  accordance with the requirements of this section and all rules
  119  adopted under this section.
  120         (2) DEFINITIONS.—As used in this section, the term:
  121         (a) “Caregiver” means a person who:
  122         1. Is at least 21 years of age unless he or she is a close
  123  relative of the qualifying patient;
  124         2. Has agreed in writing to assist the qualifying patient
  125  with the qualifying patient’s medical use of marijuana; and
  126         3. Does not receive compensation, other than actual
  127  expenses incurred, for assisting the qualifying patient with the
  128  medical use of marijuana unless the caregiver is acting pursuant
  129  to employment in a licensed facility “Cannabis delivery device”
  130  means an object used, intended for use, or designed for use in
  131  preparing, storing, ingesting, inhaling, or otherwise
  132  introducing low-THC cannabis or medical cannabis into the human
  133  body.
  134         (b)“Close relative” means a spouse, parent, sibling,
  135  grandparent, child, or grandchild, whether related by whole or
  136  half blood, by marriage, or by adoption.
  137         (c)(b)Debilitating medical condition” means cancer,
  138  epilepsy, glaucoma, a positive status for human immunodeficiency
  139  virus, acquired immune deficiency syndrome, posttraumatic stress
  140  disorder, amyotrophic lateral sclerosis, Crohn’s disease,
  141  Parkinson’s disease, multiple sclerosis, a physical medical
  142  condition that chronically produces symptoms of seizures or
  143  severe and persistent muscle spasms, a terminal condition, or
  144  other debilitating medical conditions of the same kind or class
  145  as, or comparable to, those conditions enumerated in this
  146  paragraph and for which a physician believes that the use of
  147  marijuana would likely outweigh the potential health risks to a
  148  patient “Dispensing organization” means an organization approved
  149  by the department to cultivate, process, transport, and dispense
  150  low-THC cannabis or medical cannabis pursuant to this section.
  151         (d)(c) “Independent testing laboratory” means a laboratory,
  152  including the managers, employees, or contractors of the
  153  laboratory:,
  154         1. Which has no direct or indirect interest in a medical
  155  marijuana treatment center; and
  156         2. In which no medical marijuana treatment center has any
  157  direct or indirect interest dispensing organization.
  158         (e)(d) “Legal representative” means the qualifying
  159  qualified patient’s parent, legal guardian acting pursuant to a
  160  court’s authorization as required under s. 744.3215(4), health
  161  care surrogate acting pursuant to the qualifying qualified
  162  patient’s written consent or a court’s authorization as required
  163  under s. 765.113, or an individual who is authorized under a
  164  power of attorney to make health care decisions on behalf of the
  165  qualifying qualified patient.
  166         (f)(e) “Low-THC cannabis” means a plant of the genus
  167  Cannabis, the dried flowers of which contain 0.8 percent or less
  168  of tetrahydrocannabinol and more than 10 percent of cannabidiol
  169  weight for weight; the seeds thereof; the resin extracted from
  170  any part of such plant; or any compound, manufacture, salt,
  171  derivative, mixture, or preparation of such plant or its seeds
  172  or resin that is dispensed only by a medical marijuana treatment
  173  center from a dispensing organization.
  174         (g)(f)Marijuana” has the same meaning as provided in s.
  175  29, Art. X of the State Constitution “Medical cannabis” means
  176  all parts of any plant of the genus Cannabis, whether growing or
  177  not; the seeds thereof; the resin extracted from any part of the
  178  plant; and every compound, manufacture, sale, derivative,
  179  mixture, or preparation of the plant or its seeds or resin that
  180  is dispensed only from a dispensing organization for medical use
  181  by an eligible patient as defined in s. 499.0295.
  182         (h) “Marijuana delivery device” means an object used,
  183  intended for use, or designed for use in preparing, storing,
  184  ingesting, inhaling, or otherwise introducing marijuana or low
  185  THC cannabis into the human body.
  186         (i)“Medical marijuana treatment center” or “MMTC” has the
  187  same meaning as provided in s. 29, Art. X of the State
  188  Constitution.
  189         (j)(g) “Medical use” has the same meaning as provided in s.
  190  29, Art. X of the State Constitution means administration of the
  191  ordered amount of low-THC cannabis or medical cannabis. The term
  192  does not include the:
  193         1. The possession, use, or administration of marijuana low
  194  THC cannabis or medical cannabis by smoking. As used in this
  195  subparagraph, the term “smoking” means burning or igniting a
  196  substance and inhaling the smoke. Smoking does not include the
  197  use of a vaporizer.
  198         2. The possession, use, or administration of marijuana that
  199  is not purchased or acquired from a medical marijuana treatment
  200  center.
  201         3.The transfer of marijuana low-THC cannabis or medical
  202  cannabis to a person other than the qualifying qualified patient
  203  for whom it was ordered or the qualifying qualified patient’s
  204  caregiver legal representative on behalf of the qualifying
  205  qualified patient.
  206         4.3.The use or administration of marijuana low-THC
  207  cannabis or medical cannabis:
  208         a. On any form of public transportation.
  209         b. In any public place.
  210         c. In a qualifying qualified patient’s place of employment,
  211  if restricted by his or her employer.
  212         d. In a state correctional institution as defined in s.
  213  944.02 or a correctional institution as defined in s. 944.241.
  214         e. On the grounds of a preschool, primary school, or
  215  secondary school.
  216         f. On a school bus or in a vehicle, aircraft, or motorboat.
  217         (k)(h)Qualifying patient” has the same meaning as
  218  provided in s. 29, Art. X of the State Constitution. The term
  219  also includes eligible patients, as defined in s. 499.0295, and
  220  patients who are issued a physician certification under
  221  subsection (3). A patient is not a qualifying patient unless he
  222  or she is registered with the department and has been issued a
  223  “Qualified patient” means a resident of this state who has been
  224  added to the compassionate use registry identification card by a
  225  physician licensed under chapter 458 or chapter 459 to receive
  226  low-THC cannabis or medical cannabis from a dispensing
  227  organization.
  228         (i) “Smoking” means burning or igniting a substance and
  229  inhaling the smoke. Smoking does not include the use of a
  230  vaporizer.
  231         (3)(2) PHYSICIAN CERTIFICATION ORDERING.—A physician is
  232  authorized to issue a physician certification for the provision
  233  of marijuana and marijuana delivery devices order low-THC
  234  cannabis to treat a qualified patient suffering from cancer or a
  235  physical medical condition that chronically produces symptoms of
  236  seizures or severe and persistent muscle spasms; order low-THC
  237  cannabis to alleviate symptoms of such disease, disorder, or
  238  condition, if no other satisfactory alternative treatment
  239  options exist for the qualified patient; order medical cannabis
  240  to treat a qualifying an eligible patient as defined in s.
  241  499.0295; or order a cannabis delivery device for the medical
  242  use of low-THC cannabis or medical cannabis, only if the
  243  physician:
  244         (a) Holds an active, unrestricted license as a physician
  245  under chapter 458 or an osteopathic physician under chapter 459;
  246         (b) Has treated the patient for at least 3 months
  247  immediately preceding the patient’s registration in the
  248  compassionate use registry;
  249         (c) Has successfully completed the course and examination
  250  required under paragraph (6)(a) (4)(a);
  251         (c)Has conducted a physical examination and made a full
  252  assessment of the medical history of the patient;
  253         (d) Has determined that the medical use of marijuana would
  254  likely outweigh the potential health risks of treating the
  255  patient with low-THC cannabis or medical cannabis are reasonable
  256  in light of the potential benefit to the patient. If a patient
  257  is younger than 18 years of age, a second physician must concur
  258  with this determination, and such determination must be
  259  documented in the patient’s medical record;
  260         (e) Registers as the patient’s physician orderer of low-THC
  261  cannabis or medical cannabis for the named patient on the
  262  compassionate use registry maintained by the department and
  263  updates the registry to reflect the contents of the order,
  264  including the amount of marijuana which low-THC cannabis or
  265  medical cannabis that will provide the patient with not more
  266  than a 45-day supply and any marijuana a cannabis delivery
  267  device needed by the patient for the medical use of marijuana
  268  low-THC cannabis or medical cannabis. A physician may certify an
  269  amount greater than a 45-day supply of marijuana if the
  270  physician has a reasonable belief that the patient will use the
  271  additional marijuana in a medically appropriate way. The
  272  physician must also update the registry within 7 days after any
  273  change is made to the physician certification original order to
  274  reflect the change. The physician shall deactivate the
  275  registration of the patient and the patient’s legal
  276  representative when the physician no longer recommends the
  277  medical use of marijuana for the patient treatment is
  278  discontinued;
  279         (f) At least annually, recertifies the qualifying patient
  280  pursuant to this subsection Maintains a patient treatment plan
  281  that includes the dose, route of administration, planned
  282  duration, and monitoring of the patient’s symptoms and other
  283  indicators of tolerance or reaction to the low-THC cannabis or
  284  medical cannabis; and
  285         (g) Submits the patient treatment plan quarterly to the
  286  University of Florida College of Pharmacy for research on the
  287  safety and efficacy of low-THC cannabis and medical cannabis on
  288  patients;
  289         (h) Obtains the voluntary written informed consent of the
  290  patient or the patient’s legal representative to treatment with
  291  low-THC cannabis after sufficiently explaining the current state
  292  of knowledge in the medical community of the effectiveness of
  293  treatment of the patient’s condition with low-THC cannabis, the
  294  medically acceptable alternatives, and the potential risks and
  295  side effects;
  296         (i) Obtains written informed consent as defined in and
  297  required under s. 499.0295, if the physician is ordering medical
  298  cannabis for an eligible patient pursuant to that section; and
  299         (g)(j) Is not a medical director employed by an MMTC a
  300  dispensing organization.
  301         (4)(3)GRANDFATHERING.—An order for low-THC cannabis or
  302  medical cannabis issued pursuant to former s. 381.986, Florida
  303  Statutes 2016, and registered with the compassionate use
  304  registry on or before the effective date of this act shall be
  305  considered a physician certification issued pursuant to this
  306  section. The details and expiration date of such certification
  307  must be identical to the details and expiration date of the
  308  order as logged in the compassionate use registry. Until the
  309  department begins issuing compassionate use registry
  310  identification cards, all patients with such orders shall be
  311  considered qualifying patients, notwithstanding the requirement
  312  that a qualifying patient have a compassionate use registry
  313  identification card.
  314         (5) PENALTIES.—
  315         (a) A physician commits a misdemeanor of the first degree,
  316  punishable as provided in s. 775.082 or s. 775.083, if the
  317  physician issues a physician certification for marijuana to
  318  orders low-THC cannabis for a patient without a reasonable
  319  belief that the patient is suffering from a debilitating medical
  320  condition:
  321         1. Cancer or a physical medical condition that chronically
  322  produces symptoms of seizures or severe and persistent muscle
  323  spasms that can be treated with low-THC cannabis; or
  324         2. Symptoms of cancer or a physical medical condition that
  325  chronically produces symptoms of seizures or severe and
  326  persistent muscle spasms that can be alleviated with low-THC
  327  cannabis.
  328         (b) A physician commits a misdemeanor of the first degree,
  329  punishable as provided in s. 775.082 or s. 775.083, if the
  330  physician orders medical cannabis for a patient without a
  331  reasonable belief that the patient has a terminal condition as
  332  defined in s. 499.0295.
  333         (c) A person who fraudulently represents that he or she has
  334  a debilitating cancer, a physical medical condition that
  335  chronically produces symptoms of seizures or severe and
  336  persistent muscle spasms, or a terminal condition to a physician
  337  for the purpose of being issued a physician certification for
  338  marijuana ordered low-THC cannabis, medical cannabis, or a
  339  marijuana cannabis delivery device by such physician commits a
  340  misdemeanor of the first degree, punishable as provided in s.
  341  775.082 or s. 775.083.
  342         (c)(d)A qualifying An eligible patient as defined in s.
  343  499.0295 who uses marijuana medical cannabis, and such patient’s
  344  caregiver legal representative who administers marijuana medical
  345  cannabis, in plain view of or in a place open to the general
  346  public, on the grounds of a place of education school, or in an
  347  aircraft, a motorboat, a school bus, a train, or a vehicle,
  348  aircraft, or motorboat, commits a misdemeanor of the first
  349  degree, punishable as provided in s. 775.082 or s. 775.083.
  350         (d)Except as provided in paragraph (c), a caregiver who
  351  violates any provision of this section or applicable department
  352  rule commits, upon the first offense, a misdemeanor of the
  353  second degree, punishable as provided in s. 775.082 or s.
  354  775.083, and, upon the second and subsequent offenses, a
  355  misdemeanor of the first degree, punishable as provided in s.
  356  775.082 or s. 775.083.
  357         (e) A physician who issues a physician certification for
  358  marijuana orders low-THC cannabis, medical cannabis, or a
  359  marijuana cannabis delivery device and receives compensation
  360  from an MMTC a dispensing organization related to issuing the
  361  physician certification for marijuana the ordering of low-THC
  362  cannabis, medical cannabis, or a marijuana cannabis delivery
  363  device is subject to disciplinary action under the applicable
  364  practice act and s. 456.072(1)(n).
  365         (6)(4) PHYSICIAN EDUCATION.—
  366         (a) Before a physician may issue a physician certification
  367  pursuant to subsection (3) ordering low-THC cannabis, medical
  368  cannabis, or a cannabis delivery device for medical use by a
  369  patient in this state, the appropriate board shall require the
  370  ordering physician to successfully complete a 4-hour an 8-hour
  371  course and subsequent examination offered by the Florida Medical
  372  Association or the Florida Osteopathic Medical Association which
  373  that encompasses the clinical indications for the appropriate
  374  use of marijuana low-THC cannabis and medical cannabis, the
  375  appropriate marijuana cannabis delivery devices, the
  376  contraindications for such use, and the relevant state and
  377  federal laws governing the issuance of physician certifications,
  378  as well as the ordering, dispensing, and possessing of these
  379  substances and devices. The course and examination shall be
  380  administered at least quarterly annually. Successful completion
  381  of the course may be used by a physician to satisfy 4 hours 8
  382  hours of the continuing medical education requirements required
  383  by his or her respective board for licensure renewal. This
  384  course may be offered in a distance learning format. A physician
  385  who has completed an 8-hour course and subsequent examination
  386  offered by the Florida Medical Association or the Florida
  387  Osteopathic Medical Association which encompasses the clinical
  388  indications for the appropriate use of marijuana and who is
  389  registered in the compassionate use registry on the effective
  390  date of this act is deemed to meet the requirements of this
  391  paragraph.
  392         (b) The appropriate board shall require the medical
  393  director of each MMTC dispensing organization to hold an active,
  394  unrestricted license as a physician under chapter 458 or as an
  395  osteopathic physician under chapter 459 and successfully
  396  complete a 2-hour course and subsequent examination offered by
  397  the Florida Medical Association or the Florida Osteopathic
  398  Medical Association which that encompasses appropriate safety
  399  procedures and knowledge of marijuana low-THC cannabis, medical
  400  cannabis, and marijuana cannabis delivery devices.
  401         (c) Successful completion of the course and examination
  402  specified in paragraph (a) is required for every physician who
  403  orders low-THC cannabis, medical cannabis, or a cannabis
  404  delivery device each time such physician renews his or her
  405  license. In addition, successful completion of the course and
  406  examination specified in paragraph (b) is required for the
  407  medical director of each dispensing organization each time such
  408  physician renews his or her license.
  409         (d) A physician who fails to comply with this subsection
  410  and who issues a physician certification for marijuana orders
  411  low-THC cannabis, medical cannabis, or a marijuana cannabis
  412  delivery device may be subject to disciplinary action under the
  413  applicable practice act and under s. 456.072(1)(k).
  414         (7) CAREGIVERS.—
  415         (a)During the course of registration with the department
  416  for inclusion on the compassionate use registry, or at any time
  417  while registered, a qualifying patient may designate an
  418  individual as his or her caregiver to assist him or her with the
  419  medical use of marijuana. The designated caregiver must pass a
  420  level 2 screening pursuant to chapter 435 unless the patient is
  421  a close relative of the caregiver.
  422         (b)A qualifying patient may have only one designated
  423  caregiver at any given time unless all of the qualifying
  424  patient’s caregivers are his or her close relatives or legal
  425  representatives.
  426         (c)A caregiver may assist only one qualifying patient at
  427  any given time unless:
  428         1.All qualifying patients the caregiver is assisting are
  429  close relatives of each other and the caregiver is the legal
  430  representative of at least one of the patients; or
  431         2.All qualifying patients the caregiver is assisting are
  432  receiving hospice services, or are residents in the same
  433  assisted living facility, nursing home, or other licensed
  434  facility and have requested the assistance of that caregiver
  435  with the medical use of marijuana; the caregiver is an employee
  436  of the hospice or licensed facility; and the caregiver provides
  437  personal care or services directly to clients of the hospice or
  438  licensed facility as a part of his or her employment duties at
  439  the hospice or licensed facility.
  440         (d)The department must register a caregiver on the
  441  compassionate use registry and issue him or her a caregiver
  442  identification card if he or she:
  443         1. Is designated by a qualifying patient, provides hospice
  444  services to a qualifying patient, or is requested by a
  445  qualifying patient in a licensed facility for assistance with
  446  the medical use of marijuana; and
  447         2. Meets all of the requirements of this subsection and
  448  department rules.
  449         (8)(5) DUTIES OF THE DEPARTMENT.—The department shall:
  450         (a) Create and maintain a secure, electronic, and online
  451  compassionate use registry for the registration of physicians,
  452  qualifying patients, and caregivers the legal representatives of
  453  patients as provided under this section. The registry must be
  454  accessible to:
  455         1.Physicians licensed under chapter 458 or chapter 459, to
  456  ensure proper care for patients requesting physician
  457  certifications;
  458         2.Practitioners licensed to prescribe prescription drugs,
  459  to ensure proper care for patients before prescribing
  460  medications that may interact with the medical use of marijuana;
  461         3. Law enforcement agencies, to verify the authorization of
  462  a qualifying patient or a qualifying patient’s caregiver to
  463  possess marijuana or a marijuana delivery device; and
  464         4.MMTCs, to a dispensing organization to verify the
  465  authorization of a qualifying patient or a qualifying patient’s
  466  caregiver legal representative to possess marijuana low-THC
  467  cannabis, medical cannabis, or a marijuana cannabis delivery
  468  device and to record the marijuana low-THC cannabis, medical
  469  cannabis, or marijuana cannabis delivery device dispensed. The
  470  registry must prevent an active registration of a qualifying
  471  patient by multiple physicians.
  472         (b) By July 3, 2017, adopt rules, pursuant to s. 120.536(1)
  473  or s. 120.54, establishing procedures for the issuance, annual
  474  renewal, suspension, and revocation of compassionate use
  475  registry identification cards for qualifying patients and
  476  caregivers who are residents of this state. The department may
  477  use emergency rulemaking procedures pursuant to s. 120.54(4) to
  478  adopt rules under this section as necessary to ensure that rules
  479  are adopted on or before July 3, 2017. The department may charge
  480  a reasonable fee associated with the issuance and renewal of
  481  patient and caregiver identification cards. By October 3, 2017,
  482  the department shall begin issuing identification cards to adult
  483  patients who are residents of this state and who have a
  484  physician certification that meets the requirements of
  485  subsection (3); minor patients who are residents of this state
  486  and who have a physician certification that meets the
  487  requirements of subsection (3) and the written consent of a
  488  parent or legal guardian; and caregivers registered pursuant to
  489  subsection (7). Patient and caregiver identification cards must
  490  be resistant to counterfeiting and tampering and must include at
  491  least the following:
  492         1. The name, address, and date of birth of the patient or
  493  caregiver, as appropriate;
  494         2. Designation of the cardholder as a patient or caregiver;
  495         3.A unique numeric identifier for the patient or caregiver
  496  which is matched to the identifier used for such person in the
  497  department’s compassionate use registry. A caregiver’s numeric
  498  identifier and file in the compassionate use registry must be
  499  linked to the file of the patient or patients the caregiver is
  500  assisting so that the caregiver’s status may be verified for
  501  each patient individually;
  502         4. The expiration date, which must be 1 year after the date
  503  of issuance of the identification card or the date treatment
  504  ends as provided in the patient’s physician certification,
  505  whichever occurs first; and
  506         5. For a caregiver who is assisting three or fewer
  507  qualifying patients, the names and unique numeric identifiers of
  508  the qualifying patient or patients that the caregiver is
  509  assisting.
  510         (c)Deem a dispensing organization approved under s. 2,
  511  chapter 2014-157, Laws of Florida, or s. 3, chapter 2016-123,
  512  Laws of Florida, before June 1, 2017, to meet the requirements
  513  for approval as an MMTC under this section. The department shall
  514  presume such dispensing organization to be registered with the
  515  department as an MMTC and shall authorize such dispensing
  516  organization to acquire, cultivate, possess, and process
  517  marijuana or products containing marijuana, including developing
  518  related products such as food, tinctures, aerosols, oils, or
  519  ointments, for sale to qualifying patients and their caregivers;
  520  and to transfer, transport, sell, distribute, or dispense
  521  marijuana, products containing marijuana, related supplies, and
  522  educational materials to qualifying patients or their
  523  caregivers. The department must renew the registration of such
  524  dispensing organization as an MMTC biennially upon the
  525  dispensing organization’s payment of the biennial renewal fee,
  526  unless the dispensing organization is required to hold a valid
  527  certificate of registration from the Department of Agriculture
  528  and Consumer Services pursuant to s. 581.131 and fails to
  529  maintain such registration Authorize the establishment of five
  530  dispensing organizations to ensure reasonable statewide
  531  accessibility and availability as necessary for patients
  532  registered in the compassionate use registry and who are ordered
  533  low-THC cannabis, medical cannabis, or a cannabis delivery
  534  device under this section, one in each of the following regions:
  535  northwest Florida, northeast Florida, central Florida, southeast
  536  Florida, and southwest Florida.
  537         (d)Within 6 months after the registration of each
  538  occurrence of 250,000 active qualifying patients in the
  539  compassionate use registry, begin the application process for
  540  registering three additional MMTCs, including, but not limited
  541  to, one applicant per occurrence which is a recognized class
  542  member of Pigford v. Glickman, 185 F.R.D. 82 (D.D.C. 1999), or
  543  In re Black Farmers Litig., 856 F. Supp. 2d 1 (D.D.C. 2011), and
  544  which is a member of the Black Farmers and Agriculturalists
  545  Association. Each applicant must meet the requirements in this
  546  subsection and in subsection (9) and be an entity registered to
  547  do business in this state for at least 5 consecutive years as of
  548  the date of the application. Notwithstanding any other
  549  provisions of this subsection, applicants who are recognized
  550  class members of Pigford v. Glickman, 185 F.R.D. 82 (D.D.C.
  551  1999), or In re Black Farmers Litig., 856 F. Supp. 2d 1 (D.D.C.
  552  2011), and which are members of the Black Farmers and
  553  Agriculturalists Association need not have been operated as a
  554  registered nursery in this state for at least 30 continuous
  555  years.
  556         (e)The department shall Develop an application form for
  557  registration as an MMTC and impose an initial application and
  558  biennial renewal fee that is sufficient to cover the costs of
  559  administering this section. To be registered as an MMTC, the An
  560  applicant for approval as a dispensing organization must be able
  561  to demonstrate:
  562         1. The technical and technological ability to cultivate and
  563  produce marijuana low-THC cannabis. The applicant must possess a
  564  valid certificate of registration issued by the Department of
  565  Agriculture and Consumer Services pursuant to s. 581.131 that is
  566  issued for the cultivation of more than 400,000 plants, be
  567  operated by a nurseryman as defined in s. 581.011, and have been
  568  operated as a registered nursery in this state for at least 30
  569  continuous years.
  570         2. The ability to secure the premises, resources, and
  571  personnel necessary to operate as an MMTC a dispensing
  572  organization.
  573         3. The ability to maintain accountability of all raw
  574  materials, finished products, and any byproducts to prevent
  575  diversion or unlawful access to or possession of these
  576  substances.
  577         4. An infrastructure reasonably located to dispense
  578  marijuana low-THC cannabis to registered qualifying patients
  579  statewide or regionally as determined by the department.
  580         5. The financial ability to maintain operations for the
  581  duration of the 2-year approval cycle, including the provision
  582  of certified financials to the department. Upon approval, the
  583  applicant must post a $5 million performance bond. However, upon
  584  an MMTC’s a dispensing organization’s serving at least 1,000
  585  qualifying qualified patients, the MMTC dispensing organization
  586  is only required to maintain only a $2 million performance bond.
  587  A performance bond posted under this subparagraph may be used
  588  only for reimbursement to the department for any damages
  589  incurred by the department as a result of an MMTC’s failure to
  590  perform its obligations under this section or department rules.
  591  Such damages include:
  592         a. All costs and expenses incurred by the department to
  593  nonrenew or revoke the applicant’s registration for cause and to
  594  register a replacement MMTC; and
  595         b. All costs and expenses incurred by qualifying patients
  596  for transportation and delivery of marijuana which would not
  597  have been incurred but for the revocation of the applicant’s
  598  registration, if claims for such costs and expenses are
  599  submitted to the department.
  600         6. That all owners with a 5 percent or greater share in the
  601  applicant and managers have been fingerprinted and have
  602  successfully passed a level 2 background screening pursuant to
  603  s. 435.04.
  604         7. The employment of a medical director to supervise the
  605  activities of the MMTC dispensing organization.
  606         (c) Upon the registration of 250,000 active qualified
  607  patients in the compassionate use registry, approve three
  608  dispensing organizations, including, but not limited to, an
  609  applicant that is a recognized class member of Pigford v.
  610  Glickman, 185 F.R.D. 82 (D.D.C. 1999), or In Re Black Farmers
  611  Litig., 856 F. Supp. 2d 1 (D.D.C. 2011), and a member of the
  612  Black Farmers and Agriculturalists Association, which must meet
  613  the requirements of subparagraphs (b)2.-7. and demonstrate the
  614  technical and technological ability to cultivate and produce
  615  low-THC cannabis.
  616         (f)(d) Allow an MMTC a dispensing organization to make a
  617  wholesale purchase of marijuana low-THC cannabis or medical
  618  cannabis from, or a distribution of marijuana low-THC cannabis
  619  or medical cannabis to, another MMTC dispensing organization.
  620         (g)(e) Monitor physician registration in the compassionate
  621  use registry and the issuance of physician certifications
  622  pursuant to subsection (3) and ordering of low-THC cannabis,
  623  medical cannabis, or a cannabis delivery device for ordering
  624  practices that could facilitate unlawful diversion or misuse of
  625  marijuana low-THC cannabis, medical cannabis, or a marijuana
  626  cannabis delivery device and take disciplinary action as
  627  indicated.
  628         (9)(6)MEDICAL MARIJUANA TREATMENT CENTERS DISPENSING
  629  ORGANIZATION.—In order to be an MMTC, an entity must register
  630  with the department. An MMTC An approved dispensing organization
  631  must, at all times, maintain compliance with the criteria
  632  demonstrated for selection and approval as a dispensing
  633  organization under subsection (5) and the criteria required in
  634  this subsection and all representations made to the department
  635  in the MMTC’s application for registration. Upon request, the
  636  department may grant an MMTC one or more variances from the
  637  representations made in the MMTC’s application. Consideration of
  638  such a variance shall be based upon the facts and circumstances
  639  surrounding the request. A variance may not be granted unless
  640  the requesting MMTC can demonstrate to the department that it
  641  has a proposed alternative to the specific representation made
  642  in its application which fulfills the same or a similar purpose
  643  as the specific representation in a way that the department can
  644  reasonably determine will not be a lower standard than the
  645  specific representation in the application. An MMTC is not
  646  required to obtain a variance for deviations from the MMTC’s
  647  application for registration which do not materially affect the
  648  MMTC’s operations or the quality of the marijuana dispensed by
  649  the MMTC or for deviations from the MMTC’s application which are
  650  needed to conform to current statutes or rules.
  651         (a) When growing marijuana low-THC cannabis or medical
  652  cannabis, an MMTC a dispensing organization:
  653         1. May use pesticides determined by the department, after
  654  consultation with the Department of Agriculture and Consumer
  655  Services, to be safely applied to plants intended for human
  656  consumption, but may not use pesticides designated as
  657  restricted-use pesticides pursuant to s. 487.042.
  658         2. Must grow marijuana low-THC cannabis or medical cannabis
  659  within an enclosed structure and in a room separate from any
  660  other plant.
  661         3. Must inspect seeds and growing plants for plant pests
  662  that endanger or threaten the horticultural and agricultural
  663  interests of the state, notify the Department of Agriculture and
  664  Consumer Services within 10 calendar days after a determination
  665  that a plant is infested or infected by such plant pest, and
  666  implement and maintain phytosanitary policies and procedures.
  667         4. Must perform fumigation or treatment of plants, or the
  668  removal and destruction of infested or infected plants, in
  669  accordance with chapter 581 and any rules adopted thereunder.
  670         (b) When processing marijuana, an MMTC low-THC cannabis or
  671  medical cannabis, a dispensing organization must:
  672         1. Process the marijuana low-THC cannabis or medical
  673  cannabis within an enclosed structure and in a room separate
  674  from other plants or products.
  675         2. Test the processed marijuana low-THC cannabis and
  676  medical cannabis before it is they are dispensed. Results must
  677  be verified and signed by two MMTC dispensing organization
  678  employees. Before dispensing marijuana low-THC cannabis, the
  679  MMTC dispensing organization must determine that the marijuana
  680  test results indicate that the low-THC cannabis meets the
  681  definition of low-THC cannabis and, for medical cannabis and
  682  low-THC cannabis, that all medical cannabis and low-THC cannabis
  683  is safe for human consumption and free from contaminants that
  684  are unsafe for human consumption. The MMTC dispensing
  685  organization must retain records of all testing and samples of
  686  each homogenous batch of marijuana cannabis and low-THC cannabis
  687  for at least 6 9 months. The MMTC dispensing organization must
  688  contract with an independent testing laboratory to:
  689         a. Perform audits on the MMTC’s dispensing organization’s
  690  standard operating procedures, testing records, and samples and
  691  provide the results to the department to confirm that the
  692  marijuana low-THC cannabis or medical cannabis meets the
  693  requirements of this section and that the marijuana medical
  694  cannabis and low-THC cannabis is safe for human consumption; or
  695         b.Directly test the marijuana final product to ensure that
  696  it meets the requirements of this section and is safe for human
  697  consumption before it is dispensed or distributed.
  698         3. Package the marijuana low-THC cannabis or medical
  699  cannabis in compliance with the United States Poison Prevention
  700  Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.
  701         4. Package the marijuana low-THC cannabis or medical
  702  cannabis in a childproof receptacle that has a firmly affixed
  703  and legible label stating the following information:
  704         a. A statement that the marijuana low-THC cannabis or
  705  medical cannabis meets the requirements of subparagraph 2.;
  706         b. The name of the MMTC dispensing organization from which
  707  the marijuana medical cannabis or low-THC cannabis originates;
  708  and
  709         c. The batch number and harvest number from which the
  710  marijuana medical cannabis or low-THC cannabis originates.
  711         5. Reserve two processed samples from each batch and retain
  712  such samples for at least 6 9 months for the purpose of testing
  713  pursuant to the audit required under subparagraph 2.
  714         (c) When dispensing marijuana low-THC cannabis, medical
  715  cannabis, or a marijuana cannabis delivery device, an MMTC a
  716  dispensing organization:
  717         1. May not dispense more than the a 45-day supply of
  718  marijuana low-THC cannabis or medical cannabis to a qualifying
  719  patient or the qualifying patient’s caregiver which is indicated
  720  on the qualifying patient’s physician certification legal
  721  representative.
  722         2. Must ensure that have the dispensing organization’s
  723  employee who dispenses the marijuana low-THC cannabis, medical
  724  cannabis, or marijuana a cannabis delivery device enters enter
  725  into the compassionate use registry his or her name or unique
  726  employee identifier.
  727         3. Must verify that the qualifying patient and the
  728  caregiver, if applicable, both have an active and valid
  729  compassionate use registry identification card and that the
  730  amount and type of marijuana dispensed match the physician’s
  731  certification in the compassionate use registry for that
  732  qualifying patient that a physician has ordered the low-THC
  733  cannabis, medical cannabis, or a specific type of a cannabis
  734  delivery device for the patient.
  735         4. May not dispense or sell any other type of marijuana
  736  cannabis, alcohol, or illicit drug-related product, including
  737  pipes, bongs, or wrapping papers, other than a marijuana
  738  physician-ordered cannabis delivery device required for the
  739  medical use of marijuana which is specified in the physician
  740  certification. An MMTC may produce and dispense marijuana as an
  741  edible or food product but may not produce such items in a
  742  format designed to be attractive to children. In addition to the
  743  requirements of this section and department rule, food products
  744  produced by an MMTC must meet all food safety standards
  745  established in state and federal law, including, but not limited
  746  to, the identification of the serving size and the amount of
  747  tetrahydrocannabinol in each serving low-THC cannabis or medical
  748  cannabis, while dispensing low-THC cannabis or medical cannabis.
  749         5. Must verify that the patient has an active registration
  750  in the compassionate use registry, the patient or patient’s
  751  legal representative holds a valid and active registration card,
  752  the order presented matches the order contents as recorded in
  753  the registry, and the order has not already been filled.
  754         5.6. Must, upon dispensing the marijuana low-THC cannabis,
  755  medical cannabis, or marijuana cannabis delivery device, record
  756  in the registry the date, time, quantity, and form of marijuana
  757  low-THC cannabis or medical cannabis dispensed; and the type of
  758  marijuana cannabis delivery device dispensed; and the name and
  759  compassionate use registry numeric identifier of the qualifying
  760  patient or caregiver to whom the marijuana or marijuana delivery
  761  device was dispensed.
  762         (d) To ensure the safety and security of its premises and
  763  any off-site storage facilities, and to maintain adequate
  764  controls against the diversion, theft, and loss of marijuana
  765  low-THC cannabis, medical cannabis, or marijuana cannabis
  766  delivery devices, an MMTC a dispensing organization shall:
  767         1.a. Maintain a fully operational security alarm system
  768  that secures all entry points and perimeter windows and is
  769  equipped with motion detectors; pressure switches; and duress,
  770  panic, and hold-up alarms; or
  771         b. Maintain a video surveillance system that records
  772  continuously 24 hours each day and meets at least one of the
  773  following criteria:
  774         (I) Cameras are fixed in a place that allows for the clear
  775  identification of persons and activities in controlled areas of
  776  the premises. Controlled areas include grow rooms, processing
  777  rooms, storage rooms, disposal rooms or areas, and point-of-sale
  778  rooms;
  779         (II) Cameras are fixed in entrances and exits to the
  780  premises, which shall record from both indoor and outdoor, or
  781  ingress and egress, vantage points;
  782         (III) Recorded images must clearly and accurately display
  783  the time and date; or
  784         (IV) Retain video surveillance recordings for a minimum of
  785  45 days or longer upon the request of a law enforcement agency.
  786         2. Ensure that the MMTC’s organization’s outdoor premises
  787  have sufficient lighting from dusk until dawn.
  788         3. Establish and maintain a tracking system approved by the
  789  department which that traces the marijuana low-THC cannabis or
  790  medical cannabis from seed to sale. The tracking system must
  791  shall include notification of key events as determined by the
  792  department, including when marijuana cannabis seeds are planted,
  793  when marijuana cannabis plants are harvested and destroyed, and
  794  when marijuana low-THC cannabis or medical cannabis is
  795  transported, sold, stolen, diverted, or lost.
  796         4. Not dispense from its premises marijuana low-THC
  797  cannabis, medical cannabis, or a marijuana cannabis delivery
  798  device between the hours of 9 p.m. and 7 a.m., but may perform
  799  all other operations and deliver marijuana low-THC cannabis and
  800  medical cannabis to qualifying qualified patients 24 hours each
  801  day.
  802         5. Store marijuana low-THC cannabis or medical cannabis in
  803  a secured, locked room or a vault.
  804         6. Require at least two of its employees, or two employees
  805  of a security agency with whom it contracts, to be on the
  806  premises of any cultivation or processing facilities at all
  807  times.
  808         7. Require each employee or contractor to wear a photo
  809  identification badge at all times while on the premises.
  810         8. Require each visitor to wear a visitor’s pass at all
  811  times while on the premises.
  812         9. Implement an alcohol and drug-free workplace policy.
  813         10. Report to local law enforcement within 24 hours after
  814  it is notified or becomes aware of the theft, diversion, or loss
  815  of marijuana low-THC cannabis or medical cannabis.
  816         (e) To ensure the safe transport of marijuana low-THC
  817  cannabis or medical cannabis to MMTC dispensing organization
  818  facilities, independent testing laboratories, or qualifying
  819  patients, the MMTC dispensing organization must:
  820         1. Maintain a transportation manifest, which must be
  821  retained for at least 1 year.
  822         2. Ensure only vehicles in good working order are used to
  823  transport marijuana low-THC cannabis or medical cannabis.
  824         3. Lock marijuana low-THC cannabis or medical cannabis in a
  825  separate compartment or container within the vehicle.
  826         4. Require at least two persons to be in a vehicle
  827  transporting marijuana low-THC cannabis or medical cannabis, and
  828  require at least one person to remain in the vehicle while the
  829  marijuana low-THC cannabis or medical cannabis is being
  830  delivered.
  831         5.Ensure that any vehicle transporting marijuana to a
  832  qualifying patient or caregiver is legally parked while
  833  marijuana is being delivered to the qualifying patient or
  834  caregiver.
  835         6.5. Provide specific safety and security training to
  836  employees transporting or delivering marijuana low-THC cannabis
  837  or medical cannabis.
  838         (10)(7) DEPARTMENT AUTHORITY AND RESPONSIBILITIES.—
  839         (a) The department may conduct announced or unannounced
  840  inspections of MMTCs dispensing organizations to determine
  841  compliance with this section or rules adopted pursuant to this
  842  section.
  843         (b) The department shall inspect an MMTC a dispensing
  844  organization upon complaint or notice provided to the department
  845  that the MMTC dispensing organization has dispensed marijuana
  846  low-THC cannabis or medical cannabis containing any mold,
  847  bacteria, or other contaminant at a level that may cause or has
  848  caused an adverse effect to human health or the environment.
  849         (c) The department shall conduct at least a biennial
  850  inspection of each MMTC dispensing organization to evaluate the
  851  MMTC’s dispensing organization’s records, personnel, equipment,
  852  processes, security measures, sanitation practices, and quality
  853  assurance practices.
  854         (d) The department shall adopt by rule a process for
  855  approving changes in MMTC ownership or a change in an MMTC
  856  owner’s investment interest of 5 percent or more. This process
  857  shall be limited to verifying compliance with subparagraph
  858  (8)(e)6.
  859         (e) The department may enter into interagency agreements
  860  with the Department of Agriculture and Consumer Services, the
  861  Department of Business and Professional Regulation, the
  862  Department of Law Enforcement, the Department of Transportation,
  863  the Department of Highway Safety and Motor Vehicles, and the
  864  Agency for Health Care Administration, and such agencies are
  865  authorized to enter into an interagency agreement with the
  866  department, to conduct inspections or perform other
  867  responsibilities assigned to the department under this section.
  868         (f)(e) The department must make a list of all approved
  869  MMTCs, dispensing organizations and qualified ordering
  870  physicians who are qualified to issue physician certifications,
  871  and medical directors of MMTCs publicly available on its
  872  website.
  873         (f) The department may establish a system for issuing and
  874  renewing registration cards for patients and their legal
  875  representatives, establish the circumstances under which the
  876  cards may be revoked by or must be returned to the department,
  877  and establish fees to implement such system. The department must
  878  require, at a minimum, the registration cards to:
  879         1. Provide the name, address, and date of birth of the
  880  patient or legal representative.
  881         2. Have a full-face, passport-type, color photograph of the
  882  patient or legal representative taken within the 90 days
  883  immediately preceding registration.
  884         3. Identify whether the cardholder is a patient or legal
  885  representative.
  886         4. List a unique numeric identifier for the patient or
  887  legal representative that is matched to the identifier used for
  888  such person in the department’s compassionate use registry.
  889         5. Provide the expiration date, which shall be 1 year after
  890  the date of the physician’s initial order of low-THC cannabis or
  891  medical cannabis.
  892         6. For the legal representative, provide the name and
  893  unique numeric identifier of the patient that the legal
  894  representative is assisting.
  895         7. Be resistant to counterfeiting or tampering.
  896         (g) The department may impose reasonable fines not to
  897  exceed $10,000 on an MMTC a dispensing organization for any of
  898  the following violations:
  899         1. Violating this section, s. 499.0295, or department rule.
  900         2. Failing to maintain qualifications for registration with
  901  the department approval.
  902         3. Endangering the health, safety, or security of a
  903  qualifying qualified patient.
  904         4. Improperly disclosing personal and confidential
  905  information of a qualifying the qualified patient.
  906         5. Attempting to procure MMTC registration with the
  907  department dispensing organization approval by bribery,
  908  fraudulent misrepresentation, or extortion.
  909         6. Any owner or manager of the MMTC being convicted or
  910  found guilty of, or entering a plea of guilty or nolo contendere
  911  to, regardless of adjudication, a crime in any jurisdiction
  912  which directly relates to the business of an MMTC a dispensing
  913  organization.
  914         7. Making or filing a report or record that the MMTC
  915  dispensing organization knows to be false.
  916         8. Willfully failing to maintain a record required by this
  917  section or department rule.
  918         9. Willfully impeding or obstructing an employee or agent
  919  of the department in the furtherance of his or her official
  920  duties.
  921         10. Engaging in fraud or deceit, negligence, incompetence,
  922  or misconduct in the business practices of an MMTC a dispensing
  923  organization.
  924         11. Making misleading, deceptive, or fraudulent
  925  representations in or related to the business practices of an
  926  MMTC a dispensing organization.
  927         12. Having a license or the authority to engage in any
  928  regulated profession, occupation, or business that is related to
  929  the business practices of an MMTC a dispensing organization
  930  suspended, revoked, or otherwise acted against by the licensing
  931  authority of any jurisdiction, including its agencies or
  932  subdivisions, for a violation that would constitute a violation
  933  under Florida law.
  934         13. Violating a lawful order of the department or an agency
  935  of the state, or failing to comply with a lawfully issued
  936  subpoena of the department or an agency of the state.
  937         (h) The department may suspend, revoke, or refuse to renew
  938  an MMTC’s registration with the department a dispensing
  939  organization’s approval if the MMTC a dispensing organization
  940  commits repeated violations specified any of the violations in
  941  paragraph (g) which remain uncured after 30 days’ notice from
  942  the department. The department may not suspend, revoke, or
  943  refuse to renew an MMTC’s registration due to an uncured
  944  violation if the MMTC begins taking action to cure the violation
  945  within 30 days after receiving a notice of the violation from
  946  the department and such action is pursuant to a corrective
  947  action plan filed by the MMTC with the department or if the MMTC
  948  takes reasonable steps to ensure that a future violation of a
  949  similar nature does not occur.
  950         (i) The department shall renew an MMTC’s registration with
  951  the department the approval of a dispensing organization
  952  biennially if the MMTC dispensing organization meets the
  953  requirements of this section and pays the biennial renewal fee.
  954         (j) The department may adopt rules necessary to implement
  955  this section pursuant to s. 120.536(1) or s. 120.54. The
  956  department may use emergency rulemaking procedures pursuant to
  957  s. 120.54(4) to adopt rules under this section if necessary to
  958  meet any deadline for rulemaking established in s. 29, Art. X of
  959  the State Constitution.
  960         (11)(8) PREEMPTION.—
  961         (a) All matters regarding the regulation of the cultivation
  962  and processing of marijuana medical cannabis or low-THC cannabis
  963  by MMTCs dispensing organizations are preempted to the state.
  964         (b) A municipality may determine by ordinance the criteria
  965  for the number and location of, and other permitting
  966  requirements that do not conflict with state law or department
  967  rule for, dispensing facilities of MMTCs dispensing
  968  organizations located within its municipal boundaries. A county
  969  may determine by ordinance the criteria for the number,
  970  location, and other permitting requirements that do not conflict
  971  with state law or department rule for all dispensing facilities
  972  of MMTCs dispensing organizations located within the
  973  unincorporated areas of that county. A municipality or a county
  974  may not ban dispensing facilities within its boundaries or enact
  975  zoning or other such ordinances that would have the effect of
  976  banning dispensing facilities within its boundaries.
  977         (12)(9) EXCEPTIONS TO OTHER LAWS.—
  978         (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  979  any other provision of law, but subject to the requirements of
  980  this section, a qualifying qualified patient, or a caregiver who
  981  has obtained a valid compassionate use registry identification
  982  card from the department, and the qualified patient’s legal
  983  representative may purchase from an MMTC and possess for the
  984  qualifying patient’s medical use up to the amount of marijuana
  985  in the physician’s certification low-THC cannabis or medical
  986  cannabis ordered for the patient, but not more than a 45-day
  987  supply, except as provided in (3)(e), and a marijuana cannabis
  988  delivery device specified in the physician’s certification
  989  ordered for the qualifying patient.
  990         (b) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  991  any other provision of law, but subject to the requirements of
  992  this section, an MMTC an approved dispensing organization and
  993  its owners, managers, and employees may manufacture, possess,
  994  sell, deliver, distribute, dispense, and lawfully dispose of
  995  reasonable quantities, as established by department rule, of
  996  marijuana low-THC cannabis, medical cannabis, or a marijuana
  997  cannabis delivery device. As used in For purposes of this
  998  subsection, the terms “manufacture,” “possession,” “deliver,”
  999  “distribute,” and “dispense” have the same meanings as provided
 1000  in s. 893.02.
 1001         (c) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
 1002  any other provision of law, but subject to the requirements of
 1003  this section, an approved independent testing laboratory may
 1004  possess, test, transport, and lawfully dispose of marijuana low
 1005  THC cannabis or medical cannabis as provided by department rule.
 1006         (d) An MMTC approved dispensing organization and its
 1007  owners, managers, and employees are not subject to licensure or
 1008  regulation under chapter 465 or chapter 499 for manufacturing,
 1009  possessing, selling, delivering, distributing, dispensing, or
 1010  lawfully disposing of reasonable quantities, as established by
 1011  department rule, of marijuana low-THC cannabis, medical
 1012  cannabis, or a marijuana cannabis delivery device.
 1013         (e) Exercise by an MMTC of An approved dispensing
 1014  organization that continues to meet the requirements for
 1015  approval is presumed to be registered with the department and to
 1016  meet the regulations adopted by the department or its successor
 1017  agency for the purpose of dispensing medical cannabis or low-THC
 1018  cannabis under Florida law. Additionally, the authority provided
 1019  to a dispensing organization in s. 499.0295 does not impair its
 1020  registration with the department the approval of a dispensing
 1021  organization.
 1022         (f) This subsection does not exempt a person from
 1023  prosecution for a criminal offense related to impairment or
 1024  intoxication resulting from the medical use of marijuana low-THC
 1025  cannabis or medical cannabis or relieve a person from any
 1026  requirement under law to submit to a breath, blood, urine, or
 1027  other test to detect the presence of a controlled substance.
 1028         (g)This section does not affect or repeal laws relating to
 1029  negligence or professional malpractice on the part of a
 1030  caregiver, a physician, or an MMTC or its agents and employees.
 1031         (h)This section does not require a health insurance
 1032  provider or a governmental agency or authority to reimburse a
 1033  person for expenses related to the use of marijuana.
 1034         (i) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
 1035  any other provision of law, but subject to the requirements of
 1036  this section, a research institute established by a public
 1037  postsecondary educational institution, such as the H. Lee
 1038  Moffitt Cancer Center and Research Institute established in s.
 1039  1004.43, or a state university that has achieved the preeminent
 1040  state research university designation pursuant to s. 1001.7065,
 1041  may possess, test, transport, and lawfully dispose of marijuana
 1042  for research purposes as provided by department rule.
 1043         (13) PROHIBITED ACTIVITIES.—
 1044         (a)A person or entity may not offer or advertise services
 1045  as an MMTC without registering as an MMTC with the department.
 1046  An MMTC may not advertise or hold out to the public that it
 1047  holds a registration for other than that for which it actually
 1048  holds the license.
 1049         (b) The operation or maintenance of an unauthorized
 1050  dispensing organization or entity or the performance of a
 1051  service that requires registration without proper registration
 1052  is a violation of this section. The department or any state
 1053  attorney may, in addition to other remedies provided in this
 1054  section, bring an action for an injunction to restrain any
 1055  unauthorized activity or to enjoin the future operation or
 1056  maintenance of the unauthorized dispensing organization or
 1057  entity or the performance of any service in violation of this
 1058  section until compliance with this section and department rules
 1059  has been demonstrated to the satisfaction of the department.
 1060         (c) If after receiving notification from the department,
 1061  such person or entity fails to cease operation, the department
 1062  may impose an administrative fine of up to $10,000 per
 1063  violation, in addition to other penalties as prescribed by this
 1064  section or applicable criminal law. In addition, the department
 1065  may assess reasonable investigative and legal costs for
 1066  prosecution of the violation against the person or entity. Each
 1067  day of continued operation is a separate offense.
 1068         (14)IMPORTATION AND EXPORTATION OF MARIJUANA.—
 1069         (a)Marijuana may not be imported from outside this state.
 1070         (b)Marijuana and products containing marijuana which are
 1071  cultivated and produced in accordance with this section may be
 1072  exported as authorized by federal law and the laws of the states
 1073  or countries to which they are exported.
 1074         Section 2. Subsections (1) and (2) of section 381.987,
 1075  Florida Statutes, are amended, and paragraphs (b) and (c) of
 1076  subsection (3) of that section are amended, to read:
 1077         381.987 Public records exemption for personal identifying
 1078  information in the compassionate use registry.—
 1079         (1) A patient’s personal identifying information held by
 1080  the department in the compassionate use registry established
 1081  under s. 381.986, including, but not limited to, the patient’s
 1082  name, address, telephone number, and government-issued
 1083  identification number, and all information pertaining to the
 1084  physician certification physician’s order for marijuana low-THC
 1085  cannabis and the dispensing thereof are confidential and exempt
 1086  from s. 119.07(1) and s. 24(a), Art. I of the State
 1087  Constitution.
 1088         (2) A physician’s identifying information held by the
 1089  department in the compassionate use registry established under
 1090  s. 381.986, including, but not limited to, the physician’s name,
 1091  address, telephone number, government-issued identification
 1092  number, and Drug Enforcement Administration number, and all
 1093  information pertaining to the physician certification
 1094  physician’s order for marijuana low-THC cannabis and the
 1095  dispensing thereof are confidential and exempt from s. 119.07(1)
 1096  and s. 24(a), Art. I of the State Constitution.
 1097         (3) The department shall allow access to the registry,
 1098  including access to confidential and exempt information, to:
 1099         (b) A medical marijuana treatment center dispensing
 1100  organization approved by the department pursuant to s. 381.986
 1101  which is attempting to verify the authenticity of a physician
 1102  certification physician’s order for marijuana low-THC cannabis,
 1103  including whether the physician certification order had been
 1104  previously filled and whether the physician certification order
 1105  was written for the person attempting to have it filled.
 1106         (c) A physician who has issued a physician certification
 1107  written an order for marijuana low-THC cannabis for the purpose
 1108  of monitoring the patient’s use of such cannabis or for the
 1109  purpose of determining, before issuing an order for marijuana
 1110  low-THC cannabis, whether another physician has ordered the
 1111  patient’s use of marijuana low-THC cannabis. The physician may
 1112  access the confidential and exempt information only for the
 1113  patient for whom he or she has ordered or is determining whether
 1114  to order the use of marijuana low-THC cannabis pursuant to s.
 1115  381.986.
 1116         Section 3. Subsection (1) of section 385.211, Florida
 1117  Statutes, is amended to read:
 1118         385.211 Refractory and intractable epilepsy treatment and
 1119  research at recognized medical centers.—
 1120         (1) As used in this section, the term “low-THC cannabis”
 1121  means “low-THC cannabis” as defined in s. 381.986 which that is
 1122  dispensed only from a medical marijuana treatment center
 1123  dispensing organization as defined in s. 381.986.
 1124         Section 4. Subsections (2) and (3) of section 499.0295,
 1125  Florida Statutes, are amended to read:
 1126         499.0295 Experimental treatments for terminal conditions.—
 1127         (2) As used in this section, the term:
 1128         (a) “Dispensing organization” means an organization
 1129  approved by the Department of Health under s. 381.986(5) to
 1130  cultivate, process, transport, and dispense low-THC cannabis,
 1131  medical cannabis, and cannabis delivery devices.
 1132         (a)(b) “Eligible patient” means a person who:
 1133         1. Has a terminal condition that is attested to by the
 1134  patient’s physician and confirmed by a second independent
 1135  evaluation by a board-certified physician in an appropriate
 1136  specialty for that condition;
 1137         2. Has considered all other treatment options for the
 1138  terminal condition currently approved by the United States Food
 1139  and Drug Administration;
 1140         3. Has given written informed consent for the use of an
 1141  investigational drug, biological product, or device; and
 1142         4. Has documentation from his or her treating physician
 1143  that the patient meets the requirements of this paragraph.
 1144         (b)(c) “Investigational drug, biological product, or
 1145  device” means:
 1146         1. a drug, biological product, or device that has
 1147  successfully completed phase 1 of a clinical trial but has not
 1148  been approved for general use by the United States Food and Drug
 1149  Administration and remains under investigation in a clinical
 1150  trial approved by the United States Food and Drug
 1151  Administration; or
 1152         2. Medical cannabis that is manufactured and sold by a
 1153  dispensing organization.
 1154         (c)(d) “Terminal condition” means a progressive disease or
 1155  medical or surgical condition that causes significant functional
 1156  impairment, is not considered by a treating physician to be
 1157  reversible even with the administration of available treatment
 1158  options currently approved by the United States Food and Drug
 1159  Administration, and, without the administration of life
 1160  sustaining procedures, will result in death within 1 year after
 1161  diagnosis if the condition runs its normal course.
 1162         (d)(e) “Written informed consent” means a document that is
 1163  signed by a patient, a parent of a minor patient, a court
 1164  appointed guardian for a patient, or a health care surrogate
 1165  designated by a patient and includes:
 1166         1. An explanation of the currently approved products and
 1167  treatments for the patient’s terminal condition.
 1168         2. An attestation that the patient concurs with his or her
 1169  physician in believing that all currently approved products and
 1170  treatments are unlikely to prolong the patient’s life.
 1171         3. Identification of the specific investigational drug,
 1172  biological product, or device that the patient is seeking to
 1173  use.
 1174         4. A realistic description of the most likely outcomes of
 1175  using the investigational drug, biological product, or device.
 1176  The description shall include the possibility that new,
 1177  unanticipated, different, or worse symptoms might result and
 1178  death could be hastened by the proposed treatment. The
 1179  description shall be based on the physician’s knowledge of the
 1180  proposed treatment for the patient’s terminal condition.
 1181         5. A statement that the patient’s health plan or third
 1182  party administrator and physician are not obligated to pay for
 1183  care or treatment consequent to the use of the investigational
 1184  drug, biological product, or device unless required to do so by
 1185  law or contract.
 1186         6. A statement that the patient’s eligibility for hospice
 1187  care may be withdrawn if the patient begins treatment with the
 1188  investigational drug, biological product, or device and that
 1189  hospice care may be reinstated if the treatment ends and the
 1190  patient meets hospice eligibility requirements.
 1191         7. A statement that the patient understands he or she is
 1192  liable for all expenses consequent to the use of the
 1193  investigational drug, biological product, or device and that
 1194  liability extends to the patient’s estate, unless a contract
 1195  between the patient and the manufacturer of the investigational
 1196  drug, biological product, or device states otherwise.
 1197         (3) Upon the request of an eligible patient, a manufacturer
 1198  may, or, upon the issuance of a physician certification a
 1199  physician’s order pursuant to s. 381.986, an MMTC a dispensing
 1200  organization may:
 1201         (a) Make its investigational drug, biological product, or
 1202  device available under this section.
 1203         (b) Provide an investigational drug, biological product,
 1204  device, or marijuana cannabis delivery device as defined in s.
 1205  381.986 to an eligible patient without receiving compensation.
 1206         (c) Require an eligible patient to pay the costs of, or the
 1207  costs associated with, the manufacture of the investigational
 1208  drug, biological product, device, or marijuana cannabis delivery
 1209  device as defined in s. 381.986.
 1210         Section 5. Subsection (1) of section 1004.441, Florida
 1211  Statutes, is amended to read:
 1212         1004.441 Refractory and intractable epilepsy treatment and
 1213  research.—
 1214         (1) As used in this section, the term “low-THC cannabis”
 1215  means “low-THC cannabis” as defined in s. 381.986 which that is
 1216  dispensed only from a medical marijuana treatment center
 1217  dispensing organization as defined in s. 381.986.
 1218         Section 6. The Division of Law Revision and Information is
 1219  directed to replace the phrase “the effective date of this act”
 1220  wherever it occurs in this act with the date the act becomes a
 1221  law.
 1222         Section 7. This act shall take effect upon becoming a law.