ENROLLED
       2019 Legislature      CS for CS for CS for SB 182, 1st Engrossed
       
       
       
       
       
       
                                                              2019182er
    1  
    2         An act relating to the medical use of marijuana;
    3         amending s. 381.986, F.S.; redefining the term
    4         “marijuana delivery device” to provide an exception to
    5         the requirement that such devices must be purchased
    6         from a medical marijuana treatment center for devices
    7         that are intended for the medical use of marijuana by
    8         smoking; redefining the term “medical use” to include
    9         the possession, use, or administration of marijuana in
   10         a form for smoking; conforming provisions to changes
   11         made by the act; restricting the smoking of marijuana
   12         in enclosed indoor workplaces; requiring a patient’s
   13         informed consent form to include the negative health
   14         risks associated with smoking marijuana; conforming a
   15         provision to changes made by the act; requiring a
   16         qualified physician to submit specified documentation
   17         to the Board of Medicine and the Board of Osteopathic
   18         Medicine upon determining that smoking is an
   19         appropriate route of administration for a qualified
   20         patient, other than a patient diagnosed with a
   21         terminal condition; prohibiting a physician from
   22         certifying a patient under 18 years of age to smoke
   23         marijuana for medical use unless the patient is
   24         diagnosed with a terminal condition and the physician
   25         makes a certain determination in concurrence with a
   26         second physician who is a pediatrician; requiring a
   27         qualified physician to obtain the written informed
   28         consent of such patient’s parent or legal guardian
   29         before certifying the patient to smoke marijuana for
   30         medical use; requiring the qualified physician to use
   31         a certain informed consent form adopted in rule by the
   32         boards; requiring the boards to review specified
   33         documentation and adopt certain practice standards by
   34         rule by a specified date; establishing a supply limit
   35         for a physician certification for marijuana in a form
   36         for smoking; authorizing a qualified physician to
   37         request an exception to the supply limit and
   38         possession limit for marijuana in a form for smoking;
   39         authorizing more than one caregiver to assist with a
   40         qualified patient’s medical use of marijuana if the
   41         patient is participating in a certain research program
   42         in a teaching nursing home; authorizing a caregiver to
   43         be listed in the medical marijuana use registry as a
   44         designated caregiver for qualified patients who are
   45         participating in a certain research program in a
   46         teaching nursing home; prohibiting a medical marijuana
   47         treatment center that produces prerolled marijuana
   48         cigarettes from using wrapping paper made with tobacco
   49         or hemp; requiring that marijuana in a form for
   50         smoking meet certain packaging and labeling
   51         requirements; requiring the Department of Health to
   52         adopt rules regulating the types, appearance, and
   53         labeling of marijuana delivery devices; prohibiting a
   54         medical marijuana treatment center from dispensing
   55         more than a specified supply limit of marijuana in a
   56         form for smoking; revising a provision prohibiting a
   57         medical marijuana treatment center from dispensing or
   58         selling specified products; establishing possession
   59         limits on marijuana in a form for smoking for a
   60         qualified patient; allowing marijuana delivery devices
   61         to be purchased from a vendor other than a medical
   62         marijuana treatment center; providing applicability;
   63         amending s. 1004.4351, F.S.; renaming the Coalition
   64         for Medical Marijuana Research and Education as the
   65         Consortium for Medical Marijuana Clinical Outcomes
   66         Research; establishing the consortium for a specified
   67         purpose; renaming the Medical Marijuana Research and
   68         Education Board as the Medical Marijuana Research
   69         Board; requiring the board to direct the operations of
   70         the consortium; providing membership of the board;
   71         providing for the appointment of a consortium
   72         director; providing duties of the consortium director;
   73         requiring the board to annually adopt a plan for
   74         medical marijuana research; requiring the plan to
   75         include specified information; providing research
   76         requirements for the plan; requiring the board to
   77         award funds to members of the consortium; requiring
   78         the board to collaborate with and authorizing the
   79         board to award funds to teaching nursing homes for
   80         certain research; requiring the board to issue an
   81         annual report to the Governor and Legislature by a
   82         specified date; requiring the department to submit
   83         certain data sets to the board; amending s. 381.987,
   84         F.S.; conforming provisions to changes made by the
   85         act; providing appropriations; providing an effective
   86         date.
   87          
   88  Be It Enacted by the Legislature of the State of Florida:
   89  
   90         Section 1. Paragraphs (g) and (j) of subsection (1),
   91  subsection (4), paragraphs (c) and (d) of subsection (6),
   92  paragraph (e) of subsection (8), subsection (14), and subsection
   93  (15) of section 381.986, Florida Statutes, are amended to read:
   94         381.986 Medical use of marijuana.—
   95         (1) DEFINITIONS.—As used in this section, the term:
   96         (g) “Marijuana delivery device” means an object used,
   97  intended for use, or designed for use in preparing, storing,
   98  ingesting, inhaling, or otherwise introducing marijuana into the
   99  human body, and which is dispensed from a medical marijuana
  100  treatment center for medical use by a qualified patient, except
  101  that delivery devices intended for the medical use of marijuana
  102  by smoking need not be dispensed from a medical marijuana
  103  treatment center in order to qualify as marijuana delivery
  104  devices.
  105         (j) “Medical use” means the acquisition, possession, use,
  106  delivery, transfer, or administration of marijuana authorized by
  107  a physician certification. The term does not include:
  108         1. Possession, use, or administration of marijuana that was
  109  not purchased or acquired from a medical marijuana treatment
  110  center.
  111         2. Possession, use, or administration of marijuana in a
  112  form for smoking, in the form of commercially produced food
  113  items other than edibles, or of marijuana seeds or flower,
  114  except for flower in a sealed, tamper-proof receptacle for
  115  vaping.
  116         3. Use or administration of any form or amount of marijuana
  117  in a manner that is inconsistent with the qualified physician’s
  118  directions or physician certification.
  119         4. Transfer of marijuana to a person other than the
  120  qualified patient for whom it was authorized or the qualified
  121  patient’s caregiver on behalf of the qualified patient.
  122         5. Use or administration of marijuana in the following
  123  locations:
  124         a. On any form of public transportation, except for low-THC
  125  cannabis not in a form for smoking.
  126         b. In any public place, except for low-THC cannabis not in
  127  a form for smoking.
  128         c. In a qualified patient’s place of employment, except
  129  when permitted by his or her employer.
  130         d. In a state correctional institution, as defined in s.
  131  944.02, or a correctional institution, as defined in s. 944.241.
  132         e. On the grounds of a preschool, primary school, or
  133  secondary school, except as provided in s. 1006.062.
  134         f. In a school bus, a vehicle, an aircraft, or a motorboat,
  135  except for low-THC cannabis not in a form for smoking.
  136         6. The smoking of marijuana in an enclosed indoor workplace
  137  as defined in s. 386.203(5).
  138         (4) PHYSICIAN CERTIFICATION.—
  139         (a) A qualified physician may issue a physician
  140  certification only if the qualified physician:
  141         1. Conducted a physical examination while physically
  142  present in the same room as the patient and a full assessment of
  143  the medical history of the patient.
  144         2. Diagnosed the patient with at least one qualifying
  145  medical condition.
  146         3. Determined that the medical use of marijuana would
  147  likely outweigh the potential health risks for the patient, and
  148  such determination must be documented in the patient’s medical
  149  record. If a patient is younger than 18 years of age, a second
  150  physician must concur with this determination, and such
  151  concurrence must be documented in the patient’s medical record.
  152         4. Determined whether the patient is pregnant and
  153  documented such determination in the patient’s medical record. A
  154  physician may not issue a physician certification, except for
  155  low-THC cannabis, to a patient who is pregnant.
  156         5. Reviewed the patient’s controlled drug prescription
  157  history in the prescription drug monitoring program database
  158  established pursuant to s. 893.055.
  159         6. Reviews the medical marijuana use registry and confirmed
  160  that the patient does not have an active physician certification
  161  from another qualified physician.
  162         7. Registers as the issuer of the physician certification
  163  for the named qualified patient on the medical marijuana use
  164  registry in an electronic manner determined by the department,
  165  and:
  166         a. Enters into the registry the contents of the physician
  167  certification, including the patient’s qualifying condition and
  168  the dosage not to exceed the daily dose amount determined by the
  169  department, the amount and forms of marijuana authorized for the
  170  patient, and any types of marijuana delivery devices needed by
  171  the patient for the medical use of marijuana.
  172         b. Updates the registry within 7 days after any change is
  173  made to the original physician certification to reflect such
  174  change.
  175         c. Deactivates the registration of the qualified patient
  176  and the patient’s caregiver when the physician no longer
  177  recommends the medical use of marijuana for the patient.
  178         8. Obtains the voluntary and informed written consent of
  179  the patient for medical use of marijuana each time the qualified
  180  physician issues a physician certification for the patient,
  181  which shall be maintained in the patient’s medical record. The
  182  patient, or the patient’s parent or legal guardian if the
  183  patient is a minor, must sign the informed consent acknowledging
  184  that the qualified physician has sufficiently explained its
  185  content. The qualified physician must use a standardized
  186  informed consent form adopted in rule by the Board of Medicine
  187  and the Board of Osteopathic Medicine, which must include, at a
  188  minimum, information related to:
  189         a. The Federal Government’s classification of marijuana as
  190  a Schedule I controlled substance.
  191         b. The approval and oversight status of marijuana by the
  192  Food and Drug Administration.
  193         c. The current state of research on the efficacy of
  194  marijuana to treat the qualifying conditions set forth in this
  195  section.
  196         d. The potential for addiction.
  197         e. The potential effect that marijuana may have on a
  198  patient’s coordination, motor skills, and cognition, including a
  199  warning against operating heavy machinery, operating a motor
  200  vehicle, or engaging in activities that require a person to be
  201  alert or respond quickly.
  202         f. The potential side effects of marijuana use, including
  203  the negative health risks associated with smoking marijuana.
  204         g. The risks, benefits, and drug interactions of marijuana.
  205         h. That the patient’s de-identified health information
  206  contained in the physician certification and medical marijuana
  207  use registry may be used for research purposes.
  208         (b) If a qualified physician issues a physician
  209  certification for a qualified patient diagnosed with a
  210  qualifying medical condition pursuant to paragraph (2)(k), the
  211  physician must submit the following to the applicable board
  212  within 14 days after issuing the physician certification:
  213         1. Documentation supporting the qualified physician’s
  214  opinion that the medical condition is of the same kind or class
  215  as the conditions in paragraphs (2)(a)-(j).
  216         2. Documentation that establishes the efficacy of marijuana
  217  as treatment for the condition.
  218         3. Documentation supporting the qualified physician’s
  219  opinion that the benefits of medical use of marijuana would
  220  likely outweigh the potential health risks for the patient.
  221         4. Any other documentation as required by board rule.
  222  
  223  The department must submit such documentation to the Consortium
  224  Coalition for Medical Marijuana Clinical Outcomes Research and
  225  Education established pursuant to s. 1004.4351.
  226         (c) If a qualified physician determines that smoking is an
  227  appropriate route of administration for a qualified patient,
  228  other than a patient diagnosed with a terminal condition, the
  229  qualified physician must submit the following documentation to
  230  the applicable board:
  231         1. A list of other routes of administration, if any,
  232  certified by a qualified physician that the patient has tried,
  233  the length of time the patient used such routes of
  234  administration, and an assessment of the effectiveness of those
  235  routes of administration in treating the qualified patient’s
  236  qualifying condition.
  237         2.Research documenting the effectiveness of smoking as a
  238  route of administration to treat similarly situated patients
  239  with the same qualifying condition as the qualified patient.
  240         3. A statement signed by the qualified physician
  241  documenting the qualified physician’s opinion that the benefits
  242  of smoking marijuana for medical use outweigh the risks for the
  243  qualified patient.
  244         (d) A qualified physician may not issue a physician
  245  certification for marijuana in a form for smoking to a patient
  246  under 18 years of age unless the patient is diagnosed with a
  247  terminal condition, the qualified physician determines that
  248  smoking is the most effective route of administration for the
  249  patient, and a second physician who is a board-certified
  250  pediatrician concurs with such determination. Such determination
  251  and concurrence must be documented in the patient’s medical
  252  record and in the medical marijuana use registry. The certifying
  253  physician must obtain the written informed consent of such
  254  patient’s parent or legal guardian before issuing a physician
  255  certification to the patient for marijuana in a form for
  256  smoking. The qualified physician must use a standardized
  257  informed consent form adopted in rule by the Board of Medicine
  258  and the Board of Osteopathic Medicine which must include
  259  information concerning the negative health effects of smoking
  260  marijuana on persons under 18 years of age and an
  261  acknowledgement that the qualified physician has sufficiently
  262  explained the contents of the form.
  263         (e) The Board of Medicine and the Board of Osteopathic
  264  Medicine shall review the documentation submitted pursuant to
  265  paragraph (c) and shall each, by July 1, 2021, adopt by rule
  266  practice standards for the certification of smoking as a route
  267  of administration.
  268         (f)(c) A qualified physician may not issue a physician
  269  certification for more than three 70-day supply limits of
  270  marijuana or more than six 35-day supply limits of marijuana in
  271  a form for smoking. The department shall quantify by rule a
  272  daily dose amount with equivalent dose amounts for each
  273  allowable form of marijuana dispensed by a medical marijuana
  274  treatment center. The department shall use the daily dose amount
  275  to calculate a 70-day supply.
  276         1. A qualified physician may request an exception to the
  277  daily dose amount limit, the 35-day supply limit of marijuana in
  278  a form for smoking, and the 4-ounce possession limit of
  279  marijuana in a form for smoking established in paragraph
  280  (14)(a). The request shall be made electronically on a form
  281  adopted by the department in rule and must include, at a
  282  minimum:
  283         a. The qualified patient’s qualifying medical condition.
  284         b. The dosage and route of administration that was
  285  insufficient to provide relief to the qualified patient.
  286         c. A description of how the patient will benefit from an
  287  increased amount.
  288         d. The minimum daily dose amount of marijuana that would be
  289  sufficient for the treatment of the qualified patient’s
  290  qualifying medical condition.
  291         2. A qualified physician must provide the qualified
  292  patient’s records upon the request of the department.
  293         3. The department shall approve or disapprove the request
  294  within 14 days after receipt of the complete documentation
  295  required by this paragraph. The request shall be deemed approved
  296  if the department fails to act within this time period.
  297         (g)(d) A qualified physician must evaluate an existing
  298  qualified patient at least once every 30 weeks before issuing a
  299  new physician certification. A physician must:
  300         1. Determine if the patient still meets the requirements to
  301  be issued a physician certification under paragraph (a).
  302         2. Identify and document in the qualified patient’s medical
  303  records whether the qualified patient experienced either of the
  304  following related to the medical use of marijuana:
  305         a. An adverse drug interaction with any prescription or
  306  nonprescription medication; or
  307         b. A reduction in the use of, or dependence on, other types
  308  of controlled substances as defined in s. 893.02.
  309         3. Submit a report with the findings required pursuant to
  310  subparagraph 2. to the department. The department shall submit
  311  such reports to the Consortium Coalition for Medical Marijuana
  312  Clinical Outcomes Research and Education established pursuant to
  313  s. 1004.4351.
  314         (h)(e) An active order for low-THC cannabis or medical
  315  cannabis issued pursuant to former s. 381.986, Florida Statutes
  316  2016, and registered with the compassionate use registry before
  317  June 23, 2017, is deemed a physician certification, and all
  318  patients possessing such orders are deemed qualified patients
  319  until the department begins issuing medical marijuana use
  320  registry identification cards.
  321         (i)(f) The department shall monitor physician registration
  322  in the medical marijuana use registry and the issuance of
  323  physician certifications for practices that could facilitate
  324  unlawful diversion or misuse of marijuana or a marijuana
  325  delivery device and shall take disciplinary action as
  326  appropriate.
  327         (j)(g) The Board of Medicine and the Board of Osteopathic
  328  Medicine shall jointly create a physician certification pattern
  329  review panel that shall review all physician certifications
  330  submitted to the medical marijuana use registry. The panel shall
  331  track and report the number of physician certifications and the
  332  qualifying medical conditions, dosage, supply amount, and form
  333  of marijuana certified. The panel shall report the data both by
  334  individual qualified physician and in the aggregate, by county,
  335  and statewide. The physician certification pattern review panel
  336  shall, beginning January 1, 2018, submit an annual report of its
  337  findings and recommendations to the Governor, the President of
  338  the Senate, and the Speaker of the House of Representatives.
  339         (k)(h) The department, the Board of Medicine, and the Board
  340  of Osteopathic Medicine may adopt rules pursuant to ss.
  341  120.536(1) and 120.54 to implement this subsection.
  342         (6) CAREGIVERS.—
  343         (c) A qualified patient may designate no more than one
  344  caregiver to assist with the qualified patient’s medical use of
  345  marijuana, unless:
  346         1. The qualified patient is a minor and the designated
  347  caregivers are parents or legal guardians of the qualified
  348  patient;
  349         2. The qualified patient is an adult who has an
  350  intellectual or developmental disability that prevents the
  351  patient from being able to protect or care for himself or
  352  herself without assistance or supervision and the designated
  353  caregivers are the parents or legal guardians of the qualified
  354  patient; or
  355         3. The qualified patient is admitted to a hospice program;
  356  or
  357         4. The qualified patient is participating in a research
  358  program in a teaching nursing home pursuant to s. 1004.4351.
  359         (d) A caregiver may be registered in the medical marijuana
  360  use registry as a designated caregiver for no more than one
  361  qualified patient, unless:
  362         1. The caregiver is a parent or legal guardian of more than
  363  one minor who is a qualified patient;
  364         2. The caregiver is a parent or legal guardian of more than
  365  one adult who is a qualified patient and who has an intellectual
  366  or developmental disability that prevents the patient from being
  367  able to protect or care for himself or herself without
  368  assistance or supervision; or
  369         3. All qualified patients the caregiver has agreed to
  370  assist are admitted to a hospice program and have requested the
  371  assistance of that caregiver with the medical use of marijuana;
  372  the caregiver is an employee of the hospice; and the caregiver
  373  provides personal care or other services directly to clients of
  374  the hospice in the scope of that employment; or
  375         4. All qualified patients the caregiver has agreed to
  376  assist are participating in a research program in a teaching
  377  nursing home pursuant to s. 1004.4351.
  378         (8) MEDICAL MARIJUANA TREATMENT CENTERS.—
  379         (e) A licensed medical marijuana treatment center shall
  380  cultivate, process, transport, and dispense marijuana for
  381  medical use. A licensed medical marijuana treatment center may
  382  not contract for services directly related to the cultivation,
  383  processing, and dispensing of marijuana or marijuana delivery
  384  devices, except that a medical marijuana treatment center
  385  licensed pursuant to subparagraph (a)1. may contract with a
  386  single entity for the cultivation, processing, transporting, and
  387  dispensing of marijuana and marijuana delivery devices. A
  388  licensed medical marijuana treatment center must, at all times,
  389  maintain compliance with the criteria demonstrated and
  390  representations made in the initial application and the criteria
  391  established in this subsection. Upon request, the department may
  392  grant a medical marijuana treatment center a variance from the
  393  representations made in the initial application. Consideration
  394  of such a request shall be based upon the individual facts and
  395  circumstances surrounding the request. A variance may not be
  396  granted unless the requesting medical marijuana treatment center
  397  can demonstrate to the department that it has a proposed
  398  alternative to the specific representation made in its
  399  application which fulfills the same or a similar purpose as the
  400  specific representation in a way that the department can
  401  reasonably determine will not be a lower standard than the
  402  specific representation in the application. A variance may not
  403  be granted from the requirements in subparagraph 2. and
  404  subparagraphs (b)1. and 2.
  405         1. A licensed medical marijuana treatment center may
  406  transfer ownership to an individual or entity who meets the
  407  requirements of this section. A publicly traded corporation or
  408  publicly traded company that meets the requirements of this
  409  section is not precluded from ownership of a medical marijuana
  410  treatment center. To accommodate a change in ownership:
  411         a. The licensed medical marijuana treatment center shall
  412  notify the department in writing at least 60 days before the
  413  anticipated date of the change of ownership.
  414         b. The individual or entity applying for initial licensure
  415  due to a change of ownership must submit an application that
  416  must be received by the department at least 60 days before the
  417  date of change of ownership.
  418         c. Upon receipt of an application for a license, the
  419  department shall examine the application and, within 30 days
  420  after receipt, notify the applicant in writing of any apparent
  421  errors or omissions and request any additional information
  422  required.
  423         d. Requested information omitted from an application for
  424  licensure must be filed with the department within 21 days after
  425  the department’s request for omitted information or the
  426  application shall be deemed incomplete and shall be withdrawn
  427  from further consideration and the fees shall be forfeited.
  428  
  429  Within 30 days after the receipt of a complete application, the
  430  department shall approve or deny the application.
  431         2. A medical marijuana treatment center, and any individual
  432  or entity who directly or indirectly owns, controls, or holds
  433  with power to vote 5 percent or more of the voting shares of a
  434  medical marijuana treatment center, may not acquire direct or
  435  indirect ownership or control of any voting shares or other form
  436  of ownership of any other medical marijuana treatment center.
  437         3. A medical marijuana treatment center may not enter into
  438  any form of profit-sharing arrangement with the property owner
  439  or lessor of any of its facilities where cultivation,
  440  processing, storing, or dispensing of marijuana and marijuana
  441  delivery devices occurs.
  442         4. All employees of a medical marijuana treatment center
  443  must be 21 years of age or older and have passed a background
  444  screening pursuant to subsection (9).
  445         5. Each medical marijuana treatment center must adopt and
  446  enforce policies and procedures to ensure employees and
  447  volunteers receive training on the legal requirements to
  448  dispense marijuana to qualified patients.
  449         6. When growing marijuana, a medical marijuana treatment
  450  center:
  451         a. May use pesticides determined by the department, after
  452  consultation with the Department of Agriculture and Consumer
  453  Services, to be safely applied to plants intended for human
  454  consumption, but may not use pesticides designated as
  455  restricted-use pesticides pursuant to s. 487.042.
  456         b. Must grow marijuana within an enclosed structure and in
  457  a room separate from any other plant.
  458         c. Must inspect seeds and growing plants for plant pests
  459  that endanger or threaten the horticultural and agricultural
  460  interests of the state in accordance with chapter 581 and any
  461  rules adopted thereunder.
  462         d. Must perform fumigation or treatment of plants, or
  463  remove and destroy infested or infected plants, in accordance
  464  with chapter 581 and any rules adopted thereunder.
  465         7. Each medical marijuana treatment center must produce and
  466  make available for purchase at least one low-THC cannabis
  467  product.
  468         8. A medical marijuana treatment center that produces
  469  edibles must hold a permit to operate as a food establishment
  470  pursuant to chapter 500, the Florida Food Safety Act, and must
  471  comply with all the requirements for food establishments
  472  pursuant to chapter 500 and any rules adopted thereunder.
  473  Edibles may not contain more than 200 milligrams of
  474  tetrahydrocannabinol, and a single serving portion of an edible
  475  may not exceed 10 milligrams of tetrahydrocannabinol. Edibles
  476  may have a potency variance of no greater than 15 percent.
  477  Edibles may not be attractive to children; be manufactured in
  478  the shape of humans, cartoons, or animals; be manufactured in a
  479  form that bears any reasonable resemblance to products available
  480  for consumption as commercially available candy; or contain any
  481  color additives. To discourage consumption of edibles by
  482  children, the department shall determine by rule any shapes,
  483  forms, and ingredients allowed and prohibited for edibles.
  484  Medical marijuana treatment centers may not begin processing or
  485  dispensing edibles until after the effective date of the rule.
  486  The department shall also adopt sanitation rules providing the
  487  standards and requirements for the storage, display, or
  488  dispensing of edibles.
  489         9. Within 12 months after licensure, a medical marijuana
  490  treatment center must demonstrate to the department that all of
  491  its processing facilities have passed a Food Safety Good
  492  Manufacturing Practices, such as Global Food Safety Initiative
  493  or equivalent, inspection by a nationally accredited certifying
  494  body. A medical marijuana treatment center must immediately stop
  495  processing at any facility which fails to pass this inspection
  496  until it demonstrates to the department that such facility has
  497  met this requirement.
  498         10. A medical marijuana treatment center that produces
  499  prerolled marijuana cigarettes may not use wrapping paper made
  500  with tobacco or hemp.
  501         11.10. When processing marijuana, a medical marijuana
  502  treatment center must:
  503         a. Process the marijuana within an enclosed structure and
  504  in a room separate from other plants or products.
  505         b. Comply with department rules when processing marijuana
  506  with hydrocarbon solvents or other solvents or gases exhibiting
  507  potential toxicity to humans. The department shall determine by
  508  rule the requirements for medical marijuana treatment centers to
  509  use such solvents or gases exhibiting potential toxicity to
  510  humans.
  511         c. Comply with federal and state laws and regulations and
  512  department rules for solid and liquid wastes. The department
  513  shall determine by rule procedures for the storage, handling,
  514  transportation, management, and disposal of solid and liquid
  515  waste generated during marijuana production and processing. The
  516  Department of Environmental Protection shall assist the
  517  department in developing such rules.
  518         d. Test the processed marijuana using a medical marijuana
  519  testing laboratory before it is dispensed. Results must be
  520  verified and signed by two medical marijuana treatment center
  521  employees. Before dispensing, the medical marijuana treatment
  522  center must determine that the test results indicate that low
  523  THC cannabis meets the definition of low-THC cannabis, the
  524  concentration of tetrahydrocannabinol meets the potency
  525  requirements of this section, the labeling of the concentration
  526  of tetrahydrocannabinol and cannabidiol is accurate, and all
  527  marijuana is safe for human consumption and free from
  528  contaminants that are unsafe for human consumption. The
  529  department shall determine by rule which contaminants must be
  530  tested for and the maximum levels of each contaminant which are
  531  safe for human consumption. The Department of Agriculture and
  532  Consumer Services shall assist the department in developing the
  533  testing requirements for contaminants that are unsafe for human
  534  consumption in edibles. The department shall also determine by
  535  rule the procedures for the treatment of marijuana that fails to
  536  meet the testing requirements of this section, s. 381.988, or
  537  department rule. The department may select a random sample from
  538  edibles available for purchase in a dispensing facility which
  539  shall be tested by the department to determine that the edible
  540  meets the potency requirements of this section, is safe for
  541  human consumption, and the labeling of the tetrahydrocannabinol
  542  and cannabidiol concentration is accurate. A medical marijuana
  543  treatment center may not require payment from the department for
  544  the sample. A medical marijuana treatment center must recall
  545  edibles, including all edibles made from the same batch of
  546  marijuana, which fail to meet the potency requirements of this
  547  section, which are unsafe for human consumption, or for which
  548  the labeling of the tetrahydrocannabinol and cannabidiol
  549  concentration is inaccurate. The medical marijuana treatment
  550  center must retain records of all testing and samples of each
  551  homogenous batch of marijuana for at least 9 months. The medical
  552  marijuana treatment center must contract with a marijuana
  553  testing laboratory to perform audits on the medical marijuana
  554  treatment center’s standard operating procedures, testing
  555  records, and samples and provide the results to the department
  556  to confirm that the marijuana or low-THC cannabis meets the
  557  requirements of this section and that the marijuana or low-THC
  558  cannabis is safe for human consumption. A medical marijuana
  559  treatment center shall reserve two processed samples from each
  560  batch and retain such samples for at least 9 months for the
  561  purpose of such audits. A medical marijuana treatment center may
  562  use a laboratory that has not been certified by the department
  563  under s. 381.988 until such time as at least one laboratory
  564  holds the required certification, but in no event later than
  565  July 1, 2018.
  566         e. Package the marijuana in compliance with the United
  567  States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss.
  568  1471 et seq.
  569         f. Package the marijuana in a receptacle that has a firmly
  570  affixed and legible label stating the following information:
  571         (I) The marijuana or low-THC cannabis meets the
  572  requirements of sub-subparagraph d.
  573         (II) The name of the medical marijuana treatment center
  574  from which the marijuana originates.
  575         (III) The batch number and harvest number from which the
  576  marijuana originates and the date dispensed.
  577         (IV) The name of the physician who issued the physician
  578  certification.
  579         (V) The name of the patient.
  580         (VI) The product name, if applicable, and dosage form,
  581  including concentration of tetrahydrocannabinol and cannabidiol.
  582  The product name may not contain wording commonly associated
  583  with products marketed by or to children.
  584         (VII) The recommended dose.
  585         (VIII) A warning that it is illegal to transfer medical
  586  marijuana to another person.
  587         (IX) A marijuana universal symbol developed by the
  588  department.
  589         12.11. The medical marijuana treatment center shall include
  590  in each package a patient package insert with information on the
  591  specific product dispensed related to:
  592         a. Clinical pharmacology.
  593         b. Indications and use.
  594         c. Dosage and administration.
  595         d. Dosage forms and strengths.
  596         e. Contraindications.
  597         f. Warnings and precautions.
  598         g. Adverse reactions.
  599         13. In addition to the packaging and labeling requirements
  600  specified in subparagraphs 11. and 12., marijuana in a form for
  601  smoking must be packaged in a sealed receptacle with a legible
  602  and prominent warning to keep away from children and a warning
  603  that states marijuana smoke contains carcinogens and may
  604  negatively affect health. Such receptacles for marijuana in a
  605  form for smoking must be plain, opaque, and white without
  606  depictions of the product or images other than the medical
  607  marijuana treatment center’s department-approved logo and the
  608  marijuana universal symbol.
  609         14. The department shall adopt rules to regulate the types,
  610  appearance, and labeling of marijuana delivery devices dispensed
  611  from a medical marijuana treatment center. The rules must
  612  require marijuana delivery devices to have an appearance
  613  consistent with medical use.
  614         15.12. Each edible shall be individually sealed in plain,
  615  opaque wrapping marked only with the marijuana universal symbol.
  616  Where practical, each edible shall be marked with the marijuana
  617  universal symbol. In addition to the packaging and labeling
  618  requirements in subparagraphs 11. and 12. 10. and 11., edible
  619  receptacles must be plain, opaque, and white without depictions
  620  of the product or images other than the medical marijuana
  621  treatment center’s department-approved logo and the marijuana
  622  universal symbol. The receptacle must also include a list all of
  623  the edible’s ingredients, storage instructions, an expiration
  624  date, a legible and prominent warning to keep away from children
  625  and pets, and a warning that the edible has not been produced or
  626  inspected pursuant to federal food safety laws.
  627         16.13. When dispensing marijuana or a marijuana delivery
  628  device, a medical marijuana treatment center:
  629         a. May dispense any active, valid order for low-THC
  630  cannabis, medical cannabis and cannabis delivery devices issued
  631  pursuant to former s. 381.986, Florida Statutes 2016, which was
  632  entered into the medical marijuana use registry before July 1,
  633  2017.
  634         b. May not dispense more than a 70-day supply of marijuana
  635  within any 70-day period to a qualified patient or caregiver.
  636  May not dispense more than one 35-day supply of marijuana in a
  637  form for smoking within any 35-day period to a qualified patient
  638  or caregiver. A 35-day supply of marijuana in a form for smoking
  639  may not exceed 2.5 ounces unless an exception to this amount is
  640  approved by the department pursuant to paragraph (4)(f).
  641         c. Must have the medical marijuana treatment center’s
  642  employee who dispenses the marijuana or a marijuana delivery
  643  device enter into the medical marijuana use registry his or her
  644  name or unique employee identifier.
  645         d. Must verify that the qualified patient and the
  646  caregiver, if applicable, each have an active registration in
  647  the medical marijuana use registry and an active and valid
  648  medical marijuana use registry identification card, the amount
  649  and type of marijuana dispensed matches the physician
  650  certification in the medical marijuana use registry for that
  651  qualified patient, and the physician certification has not
  652  already been filled.
  653         e. May not dispense marijuana to a qualified patient who is
  654  younger than 18 years of age. If the qualified patient is
  655  younger than 18 years of age, marijuana may only be dispensed to
  656  the qualified patient’s caregiver.
  657         f. May not dispense or sell any other type of cannabis,
  658  alcohol, or illicit drug-related product, including pipes,
  659  bongs, or wrapping papers made with tobacco or hemp, other than
  660  a marijuana delivery device required for the medical use of
  661  marijuana and which is specified in a physician certification.
  662         g. Must, upon dispensing the marijuana or marijuana
  663  delivery device, record in the registry the date, time,
  664  quantity, and form of marijuana dispensed; the type of marijuana
  665  delivery device dispensed; and the name and medical marijuana
  666  use registry identification number of the qualified patient or
  667  caregiver to whom the marijuana delivery device was dispensed.
  668         h. Must ensure that patient records are not visible to
  669  anyone other than the qualified patient, his or her caregiver,
  670  and authorized medical marijuana treatment center employees.
  671         (14) EXCEPTIONS TO OTHER LAWS.—
  672         (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  673  any other provision of law, but subject to the requirements of
  674  this section, a qualified patient and the qualified patient’s
  675  caregiver may purchase from a medical marijuana treatment center
  676  for the patient’s medical use a marijuana delivery device and up
  677  to the amount of marijuana authorized in the physician
  678  certification, but may not possess more than a 70-day supply of
  679  marijuana, or the greater of 4 ounces of marijuana in a form for
  680  smoking or an amount of marijuana in a form for smoking approved
  681  by the department pursuant to paragraph (4)(f), at any given
  682  time and all marijuana purchased must remain in its original
  683  packaging.
  684         (b) Notwithstanding paragraph (a), s. 893.13, s. 893.135,
  685  s. 893.147, or any other provision of law, a qualified patient
  686  and the qualified patient’s caregiver may purchase and possess a
  687  marijuana delivery device intended for the medical use of
  688  marijuana by smoking from a vendor other than a medical
  689  marijuana treatment center.
  690         (c)(b) Notwithstanding s. 893.13, s. 893.135, s. 893.147,
  691  or any other provision of law, but subject to the requirements
  692  of this section, an approved medical marijuana treatment center
  693  and its owners, managers, and employees may manufacture,
  694  possess, sell, deliver, distribute, dispense, and lawfully
  695  dispose of marijuana or a marijuana delivery device as provided
  696  in this section, s. 381.988, and by department rule. For the
  697  purposes of this subsection, the terms “manufacture,”
  698  “possession,” “deliver,” “distribute,” and “dispense” have the
  699  same meanings as provided in s. 893.02.
  700         (d)(c) Notwithstanding s. 893.13, s. 893.135, s. 893.147,
  701  or any other provision of law, but subject to the requirements
  702  of this section, a certified marijuana testing laboratory,
  703  including an employee of a certified marijuana testing
  704  laboratory acting within the scope of his or her employment, may
  705  acquire, possess, test, transport, and lawfully dispose of
  706  marijuana as provided in this section, in s. 381.988, and by
  707  department rule.
  708         (e)(d) A licensed medical marijuana treatment center and
  709  its owners, managers, and employees are not subject to licensure
  710  or regulation under chapter 465 or chapter 499 for
  711  manufacturing, possessing, selling, delivering, distributing,
  712  dispensing, or lawfully disposing of marijuana or a marijuana
  713  delivery device, as provided in this section, in s. 381.988, and
  714  by department rule.
  715         (f)(e) This subsection does not exempt a person from
  716  prosecution for a criminal offense related to impairment or
  717  intoxication resulting from the medical use of marijuana or
  718  relieve a person from any requirement under law to submit to a
  719  breath, blood, urine, or other test to detect the presence of a
  720  controlled substance.
  721         (g)(f) Notwithstanding s. 893.13, s. 893.135, s. 893.147,
  722  or any other provision of law, but subject to the requirements
  723  of this section and pursuant to policies and procedures
  724  established pursuant to s. 1006.62(8), school personnel may
  725  possess marijuana that is obtained for medical use pursuant to
  726  this section by a student who is a qualified patient.
  727         (h)(g) Notwithstanding s. 893.13, s. 893.135, s. 893.147,
  728  or any other provision of law, but subject to the requirements
  729  of this section, a research institute established by a public
  730  postsecondary educational institution, such as the H. Lee
  731  Moffitt Cancer Center and Research Institute, Inc., established
  732  under s. 1004.43, or a state university that has achieved the
  733  preeminent state research university designation under s.
  734  1001.7065 may possess, test, transport, and lawfully dispose of
  735  marijuana for research purposes as provided by this section.
  736         (15) APPLICABILITY.—
  737         (a) This section does not limit the ability of an employer
  738  to establish, continue, or enforce a drug-free workplace program
  739  or policy.
  740         (b) This section does not require an employer to
  741  accommodate the medical use of marijuana in any workplace or any
  742  employee working while under the influence of marijuana.
  743         (c) This section does not create a cause of action against
  744  an employer for wrongful discharge or discrimination.
  745         (d) This section does not impair the ability of any party
  746  to restrict or limit smoking or vaping marijuana on his or her
  747  private property.
  748         (e) This section does not prohibit the medical use of
  749  marijuana or a caregiver assisting with the medical use of
  750  marijuana in a nursing home facility licensed under part II of
  751  chapter 400, a hospice facility licensed under part IV of
  752  chapter 400, or an assisted living facility licensed under part
  753  I of chapter 429, if the medical use of marijuana is not
  754  prohibited in the facility’s policies.
  755         (f) Marijuana, as defined in this section, is not
  756  reimbursable under chapter 440.
  757         Section 2. Section 1004.4351, Florida Statutes, is amended
  758  to read:
  759         1004.4351 Medical marijuana research and education.—
  760         (1) SHORT TITLE.—This section shall be known and may be
  761  cited as the “Medical Marijuana Research and Education Act.”
  762         (2) LEGISLATIVE FINDINGS.—The Legislature finds that:
  763         (a) The present state of knowledge concerning the use of
  764  marijuana to alleviate pain and treat illnesses is limited
  765  because permission to perform clinical studies on marijuana is
  766  difficult to obtain, with access to research-grade marijuana so
  767  restricted that little or no unbiased studies have been
  768  performed.
  769         (b) Under the State Constitution, marijuana is available
  770  for the treatment of certain debilitating medical conditions.
  771         (c) Additional clinical studies are needed to ensure that
  772  the residents of this state obtain the correct dosing,
  773  formulation, route, modality, frequency, quantity, and quality
  774  of marijuana for specific illnesses.
  775         (d) An effective medical marijuana research and education
  776  program would mobilize the scientific, educational, and medical
  777  resources that presently exist in this state to determine the
  778  appropriate and best use of marijuana to treat illness.
  779         (3) DEFINITIONS.—As used in this section, the term:
  780         (a) “Board” means the Medical Marijuana Research and
  781  Education Board.
  782         (b) “Consortium” “Coalition” means the Consortium Coalition
  783  for Medical Marijuana Clinical Outcomes Research and Education.
  784         (c) “Marijuana” has the same meaning as provided in s. 29,
  785  Art. X of the State Constitution.
  786         (4) CONSORTIUM COALITION FOR MEDICAL MARIJUANA CLINICAL
  787  OUTCOMES RESEARCH AND EDUCATION.—
  788         (a) There is established within a state university
  789  designated by the Board of Governors the H. Lee Moffitt Cancer
  790  Center and Research Institute, Inc., the Consortium Coalition
  791  for Medical Marijuana Clinical Outcomes Research which shall
  792  consist of public and private universities and Education. The
  793  purpose of the consortium coalition is to conduct rigorous
  794  scientific research and, provide education, disseminate such
  795  research, and guide policy for the adoption of a statewide
  796  policy on ordering and dosing practices for the medical use of
  797  marijuana. The coalition shall be physically located at the H.
  798  Lee Moffitt Cancer Center and Research Institute, Inc.
  799         (b) The Medical Marijuana Research and Education Board is
  800  established to direct the operations of the consortium
  801  coalition. The board shall be composed of seven members
  802  representing each participating university appointed by the
  803  president of each participating university the chief executive
  804  officer of the H. Lee Moffitt Cancer Center and Research
  805  Institute, Inc. Board members must have experience in a variety
  806  of scientific and medical fields, including, but not limited to,
  807  oncology, neurology, psychology, pediatrics, nutrition, and
  808  addiction. Members shall be appointed to 4-year terms and may be
  809  reappointed to serve additional terms. The chair shall be
  810  elected by the board from among its members to serve a 2-year
  811  term. The board shall meet at least semiannually at the call of
  812  the chair or, in his or her absence or incapacity, the vice
  813  chair. Four members constitute a quorum. A majority vote of the
  814  members present is required for all actions of the board. The
  815  board may prescribe, amend, and repeal a charter governing the
  816  manner in which it conducts its business. A board member shall
  817  serve without compensation but is entitled to be reimbursed for
  818  travel expenses by the consortium coalition or the organization
  819  he or she represents in accordance with s. 112.061.
  820         (c) The consortium coalition shall be administered by a
  821  coalition director, who shall be appointed by and serve at the
  822  pleasure of the board. The coalition director shall, subject to
  823  the approval of the board:
  824         1. Propose a budget for the consortium coalition.
  825         2. Foster the collaboration of scientists, researchers, and
  826  other appropriate personnel in accordance with the consortium’s
  827  coalition’s charter.
  828         3. Engage individuals in public and private university
  829  programs relevant to the consortium’s work to participate in the
  830  consortium.
  831         4.3. Identify and prioritize the research to be conducted
  832  by the consortium coalition.
  833         5.4. Prepare a plan for medical marijuana research the
  834  Medical Marijuana Research and Education Plan for submission to
  835  the board.
  836         6.5. Apply for grants to obtain funding for research
  837  conducted by the consortium coalition.
  838         7.6. Perform other duties as determined by the board.
  839         (d) The board shall advise the Board of Governors, the
  840  State Surgeon General, the Governor, and the Legislature with
  841  respect to medical marijuana research and education in this
  842  state. The board shall explore methods of implementing and
  843  enforcing medical marijuana laws in relation to cancer control,
  844  research, treatment, and education.
  845         (d)(e) The board shall annually adopt a plan for medical
  846  marijuana research. The plan must organize a program of research
  847  that contributes to the body of scientific knowledge on the
  848  effects of the medical use of marijuana and informs both policy
  849  and medical practice related to the treatment of debilitating
  850  medical conditions with marijuana. Research must include
  851  tracking clinical outcomes, certification standards, dosing
  852  standards, routes of administration, efficacy, and side effects.
  853  Research must also include the study of the effects of smoking
  854  marijuana to treat debilitating medical conditions. The board
  855  must award funds to members of the consortium and to perform
  856  research consistent with the plan. The board shall collaborate
  857  with and may award funds to teaching nursing homes, as defined
  858  in s. 430.08, for research on medical use of marijuana to
  859  alleviate conditions related to chronic disease and aging, known
  860  as the “Medical Marijuana Research and Education Plan,” which
  861  must be in accordance with state law and coordinate with
  862  existing programs in this state. The plan must include
  863  recommendations for the coordination and integration of medical,
  864  pharmacological, nursing, paramedical, community, and other
  865  resources connected with the treatment of debilitating medical
  866  conditions; research related to the treatment of such medical
  867  conditions; and education.
  868         (e)(f) By February 15 of each year, the board shall issue a
  869  report to the Governor, the President of the Senate, and the
  870  Speaker of the House of Representatives on research projects,
  871  research findings, community outreach initiatives, and future
  872  plans for the consortium coalition.
  873         (f)(g) Beginning August 1, 2019 January 15, 2018, and
  874  quarterly thereafter, the Department of Health shall submit to
  875  the board a data set that includes, for each patient registered
  876  in the medical marijuana use registry, the patient’s qualifying
  877  medical condition and the daily dose amount, routes of
  878  administration, and forms of marijuana certified for the
  879  patient. The department shall also provide the board with such
  880  data for all patients registered in the medical marijuana use
  881  registry before August 1, 2019.
  882         (5) RESPONSIBILITIES OF THE H. LEE MOFFITT CANCER CENTER
  883  AND RESEARCH INSTITUTE, INC.—The H. Lee Moffitt Cancer Center
  884  and Research Institute, Inc., shall allocate staff and provide
  885  information and assistance, as the coalition’s budget permits,
  886  to assist the board in fulfilling its responsibilities.
  887         Section 3. Paragraph (h) of subsection (2) and paragraph
  888  (b) of subsection (3) of section 381.987, Florida Statutes, are
  889  amended to read:
  890         381.987 Public records exemption for personal identifying
  891  information relating to medical marijuana held by the
  892  department.—
  893         (2) The department shall allow access to the confidential
  894  and exempt information in the medical marijuana use registry to:
  895         (h) The Consortium Coalition for Medical Marijuana Clinical
  896  Outcomes Research and Education established in s. 1004.4351(4).
  897         (3) The department shall allow access to the confidential
  898  and exempt information pertaining to the physician certification
  899  for marijuana and the dispensing thereof, whether in the
  900  registry or otherwise held by the department, to:
  901         (b) The Consortium Coalition for Medical Marijuana Clinical
  902  Outcomes Research and Education pursuant to s. 381.986 for the
  903  purpose of conducting research regarding the medical use of
  904  marijuana.
  905         Section 4. (1) For the 2019-2020 fiscal year, the sum of
  906  $1.5 million in recurring funds is appropriated from the General
  907  Revenue Fund to the Board of Governors for the Consortium for
  908  Medical Marijuana Clinical Outcomes Research established under
  909  s. 1004.4351, Florida Statutes.
  910         (2) For the 2018-2019 fiscal year, the sum of $391,333 in
  911  nonrecurring funds is appropriated from the Grants and Donations
  912  Trust Fund to the Department of Health for the purpose of
  913  implementing the requirements of this act.
  914         (3) For the 2019-2020 fiscal year, the sum of $705,331 in
  915  recurring funds is appropriated from the Grants and Donations
  916  Trust Fund to the Department of Health for the purpose of
  917  implementing the requirements of this act.
  918         Section 5. This act shall take effect upon becoming a law.