Florida Senate - 2019                          SENATOR AMENDMENT
       Bill No. CS for CS for CS for SB 182
       
       
       
       
       
       
                                Ì897266NÎ897266                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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                Floor: 1/AD/2R         .                                
             03/07/2019 02:43 PM       .                                
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       Senator Brandes moved the following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Paragraphs (g) and (j) of subsection (1),
    6  subsection (4), paragraphs (c) and (d) of subsection (6),
    7  paragraph (e) of subsection (8), subsection (14), and subsection
    8  (15) of section 381.986, Florida Statutes, are amended to read:
    9         381.986 Medical use of marijuana.—
   10         (1) DEFINITIONS.—As used in this section, the term:
   11         (g) “Marijuana delivery device” means an object used,
   12  intended for use, or designed for use in preparing, storing,
   13  ingesting, inhaling, or otherwise introducing marijuana into the
   14  human body, and which is dispensed from a medical marijuana
   15  treatment center for medical use by a qualified patient.
   16         (j) “Medical use” means the acquisition, possession, use,
   17  delivery, transfer, or administration of marijuana authorized by
   18  a physician certification. The term does not include:
   19         1. Possession, use, or administration of marijuana that was
   20  not purchased or acquired from a medical marijuana treatment
   21  center.
   22         2. Possession, use, or administration of marijuana in a
   23  form for smoking, in the form of commercially produced food
   24  items other than edibles, or of marijuana seeds or flower
   25  ,except for flower in a sealed, tamper-proof receptacle for
   26  vaping.
   27         3. Use or administration of any form or amount of marijuana
   28  in a manner that is inconsistent with the qualified physician’s
   29  directions or physician certification.
   30         4. Transfer of marijuana to a person other than the
   31  qualified patient for whom it was authorized or the qualified
   32  patient’s caregiver on behalf of the qualified patient.
   33         5. Use or administration of marijuana in the following
   34  locations:
   35         a. On any form of public transportation, except for low-THC
   36  cannabis not in a form for smoking.
   37         b. In any public place, except for low-THC cannabis not in
   38  a form for smoking.
   39         c. In a qualified patient’s place of employment, except
   40  when permitted by his or her employer.
   41         d. In a state correctional institution, as defined in s.
   42  944.02, or a correctional institution, as defined in s. 944.241.
   43         e. On the grounds of a preschool, primary school, or
   44  secondary school, except as provided in s. 1006.062.
   45         f. In a school bus, a vehicle, an aircraft, or a motorboat,
   46  except for low-THC cannabis not in a form for smoking.
   47         6. The smoking of marijuana in an enclosed indoor workplace
   48  as defined in s. 386.203(5).
   49         (4) PHYSICIAN CERTIFICATION.—
   50         (a) A qualified physician may issue a physician
   51  certification only if the qualified physician:
   52         1. Conducted a physical examination while physically
   53  present in the same room as the patient and a full assessment of
   54  the medical history of the patient.
   55         2. Diagnosed the patient with at least one qualifying
   56  medical condition.
   57         3. Determined that the medical use of marijuana would
   58  likely outweigh the potential health risks for the patient, and
   59  such determination must be documented in the patient’s medical
   60  record. If a patient is younger than 18 years of age, a second
   61  physician must concur with this determination, and such
   62  concurrence must be documented in the patient’s medical record.
   63         4. Determined whether the patient is pregnant and
   64  documented such determination in the patient’s medical record. A
   65  physician may not issue a physician certification, except for
   66  low-THC cannabis, to a patient who is pregnant.
   67         5. Reviewed the patient’s controlled drug prescription
   68  history in the prescription drug monitoring program database
   69  established pursuant to s. 893.055.
   70         6. Reviews the medical marijuana use registry and confirmed
   71  that the patient does not have an active physician certification
   72  from another qualified physician.
   73         7. Registers as the issuer of the physician certification
   74  for the named qualified patient on the medical marijuana use
   75  registry in an electronic manner determined by the department,
   76  and:
   77         a. Enters into the registry the contents of the physician
   78  certification, including the patient’s qualifying condition and
   79  the dosage not to exceed the daily dose amount determined by the
   80  department, the amount and forms of marijuana authorized for the
   81  patient, and any types of marijuana delivery devices needed by
   82  the patient for the medical use of marijuana.
   83         b. Updates the registry within 7 days after any change is
   84  made to the original physician certification to reflect such
   85  change.
   86         c. Deactivates the registration of the qualified patient
   87  and the patient’s caregiver when the physician no longer
   88  recommends the medical use of marijuana for the patient.
   89         8. Obtains the voluntary and informed written consent of
   90  the patient for medical use of marijuana each time the qualified
   91  physician issues a physician certification for the patient,
   92  which shall be maintained in the patient’s medical record. The
   93  patient, or the patient’s parent or legal guardian if the
   94  patient is a minor, must sign the informed consent acknowledging
   95  that the qualified physician has sufficiently explained its
   96  content. The qualified physician must use a standardized
   97  informed consent form adopted in rule by the Board of Medicine
   98  and the Board of Osteopathic Medicine, which must include, at a
   99  minimum, information related to:
  100         a. The Federal Government’s classification of marijuana as
  101  a Schedule I controlled substance.
  102         b. The approval and oversight status of marijuana by the
  103  Food and Drug Administration.
  104         c. The current state of research on the efficacy of
  105  marijuana to treat the qualifying conditions set forth in this
  106  section.
  107         d. The potential for addiction.
  108         e. The potential effect that marijuana may have on a
  109  patient’s coordination, motor skills, and cognition, including a
  110  warning against operating heavy machinery, operating a motor
  111  vehicle, or engaging in activities that require a person to be
  112  alert or respond quickly.
  113         f. The potential side effects of marijuana use, including
  114  the negative health risks associated with smoking marijuana.
  115         g. The risks, benefits, and drug interactions of marijuana.
  116         h. That the patient’s de-identified health information
  117  contained in the physician certification and medical marijuana
  118  use registry may be used for research purposes.
  119         (b) If a qualified physician issues a physician
  120  certification for a qualified patient diagnosed with a
  121  qualifying medical condition pursuant to paragraph (2)(k), the
  122  physician must submit the following to the applicable board
  123  within 14 days after issuing the physician certification:
  124         1. Documentation supporting the qualified physician’s
  125  opinion that the medical condition is of the same kind or class
  126  as the conditions in paragraphs (2)(a)-(j).
  127         2. Documentation that establishes the efficacy of marijuana
  128  as treatment for the condition.
  129         3. Documentation supporting the qualified physician’s
  130  opinion that the benefits of medical use of marijuana would
  131  likely outweigh the potential health risks for the patient.
  132         4. Any other documentation as required by board rule.
  133  
  134  The department must submit such documentation to the Consortium
  135  Coalition for Medical Marijuana Clinical Outcomes Research and
  136  Education established pursuant to s. 1004.4351.
  137         (c) If a qualified physician determines that smoking is an
  138  appropriate route of administration for a qualified patient,
  139  other than a patient diagnosed with a terminal condition, the
  140  qualified physician must submit the following documentation to
  141  the applicable board:
  142         1. A list of other routes of administration, if any,
  143  certified by a qualified physician that the patient has tried,
  144  the length of time the patient used such routes of
  145  administration, and an assessment of the effectiveness of those
  146  routes of administration in treating the qualified patient’s
  147  qualifying condition.
  148         2.Research documenting the effectiveness of smoking as a
  149  route of administration to treat similarly situated patients
  150  with the same qualifying condition as the qualified patient.
  151         3. A statement signed by the qualified physician
  152  documenting the qualified physician’s opinion that the benefits
  153  of smoking marijuana for medical use outweigh the risks for the
  154  qualified patient.
  155         (d) A qualified physician may not issue a physician
  156  certification for marijuana in a form for smoking to a patient
  157  under 18 years of age unless the patient is diagnosed with a
  158  terminal condition, the qualified physician determines that
  159  smoking is the most effective route of administration for the
  160  patient, and a second physician who is a board-certified
  161  pediatrician concurs with such determination. Such determination
  162  and concurrence must be documented in the patient’s medical
  163  record and in the medical marijuana use registry. The certifying
  164  physician must obtain the written informed consent of such
  165  patient’s parent or legal guardian before issuing a physician
  166  certification to the patient for marijuana in a form for
  167  smoking. The qualified physician must use a standardized
  168  informed consent form adopted in rule by the Board of Medicine
  169  and the Board of Osteopathic Medicine which must include
  170  information concerning the negative health effects of smoking
  171  marijuana on persons under 18 years of age and an
  172  acknowledgement that the qualified physician has sufficiently
  173  explained the contents of the form.
  174         (e) The Board of Medicine and the Board of Osteopathic
  175  Medicine shall review the documentation submitted pursuant to
  176  paragraph (c) and shall each, by July 1, 2021, adopt by rule
  177  practice standards for the certification of smoking as a route
  178  of administration.
  179         (f)(c) A qualified physician may not issue a physician
  180  certification for more than three 70-day supply limits of
  181  marijuana or more than one 35-day supply limit of marijuana in a
  182  form for smoking. The department shall quantify by rule a daily
  183  dose amount with equivalent dose amounts for each allowable form
  184  of marijuana dispensed by a medical marijuana treatment center.
  185  The department shall use the daily dose amount to calculate a
  186  70-day supply.
  187         1. A qualified physician may request an exception to the
  188  daily dose amount limit, the 35-day supply limit of marijuana in
  189  a form for smoking, and the 4-ounce possession limit of
  190  marijuana in a form for smoking established in paragraph
  191  (14)(a). The request shall be made electronically on a form
  192  adopted by the department in rule and must include, at a
  193  minimum:
  194         a. The qualified patient’s qualifying medical condition.
  195         b. The dosage and route of administration that was
  196  insufficient to provide relief to the qualified patient.
  197         c. A description of how the patient will benefit from an
  198  increased amount.
  199         d. The minimum daily dose amount of marijuana that would be
  200  sufficient for the treatment of the qualified patient’s
  201  qualifying medical condition.
  202         2. A qualified physician must provide the qualified
  203  patient’s records upon the request of the department.
  204         3. The department shall approve or disapprove the request
  205  within 14 days after receipt of the complete documentation
  206  required by this paragraph. The request shall be deemed approved
  207  if the department fails to act within this time period.
  208         (g)(d) A qualified physician must evaluate an existing
  209  qualified patient at least once every 30 weeks before issuing a
  210  new physician certification. A physician must:
  211         1. Determine if the patient still meets the requirements to
  212  be issued a physician certification under paragraph (a).
  213         2. Identify and document in the qualified patient’s medical
  214  records whether the qualified patient experienced either of the
  215  following related to the medical use of marijuana:
  216         a. An adverse drug interaction with any prescription or
  217  nonprescription medication; or
  218         b. A reduction in the use of, or dependence on, other types
  219  of controlled substances as defined in s. 893.02.
  220         3. Submit a report with the findings required pursuant to
  221  subparagraph 2. to the department. The department shall submit
  222  such reports to the Consortium Coalition for Medical Marijuana
  223  Clinical Outcomes Research and Education established pursuant to
  224  s. 1004.4351.
  225         (h)(e) An active order for low-THC cannabis or medical
  226  cannabis issued pursuant to former s. 381.986, Florida Statutes
  227  2016, and registered with the compassionate use registry before
  228  June 23, 2017, is deemed a physician certification, and all
  229  patients possessing such orders are deemed qualified patients
  230  until the department begins issuing medical marijuana use
  231  registry identification cards.
  232         (i)(f) The department shall monitor physician registration
  233  in the medical marijuana use registry and the issuance of
  234  physician certifications for practices that could facilitate
  235  unlawful diversion or misuse of marijuana or a marijuana
  236  delivery device and shall take disciplinary action as
  237  appropriate.
  238         (j)(g) The Board of Medicine and the Board of Osteopathic
  239  Medicine shall jointly create a physician certification pattern
  240  review panel that shall review all physician certifications
  241  submitted to the medical marijuana use registry. The panel shall
  242  track and report the number of physician certifications and the
  243  qualifying medical conditions, dosage, supply amount, and form
  244  of marijuana certified. The panel shall report the data both by
  245  individual qualified physician and in the aggregate, by county,
  246  and statewide. The physician certification pattern review panel
  247  shall, beginning January 1, 2018, submit an annual report of its
  248  findings and recommendations to the Governor, the President of
  249  the Senate, and the Speaker of the House of Representatives.
  250         (k)(h) The department, the Board of Medicine, and the Board
  251  of Osteopathic Medicine may adopt rules pursuant to ss.
  252  120.536(1) and 120.54 to implement this subsection.
  253         (6) CAREGIVERS.—
  254         (c) A qualified patient may designate no more than one
  255  caregiver to assist with the qualified patient’s medical use of
  256  marijuana, unless:
  257         1. The qualified patient is a minor and the designated
  258  caregivers are parents or legal guardians of the qualified
  259  patient;
  260         2. The qualified patient is an adult who has an
  261  intellectual or developmental disability that prevents the
  262  patient from being able to protect or care for himself or
  263  herself without assistance or supervision and the designated
  264  caregivers are the parents or legal guardians of the qualified
  265  patient; or
  266         3. The qualified patient is admitted to a hospice program;
  267  or
  268         4. The qualified patient is participating in a research
  269  program in a teaching nursing home pursuant to s. 1004.4351.
  270         (d) A caregiver may be registered in the medical marijuana
  271  use registry as a designated caregiver for no more than one
  272  qualified patient, unless:
  273         1. The caregiver is a parent or legal guardian of more than
  274  one minor who is a qualified patient;
  275         2. The caregiver is a parent or legal guardian of more than
  276  one adult who is a qualified patient and who has an intellectual
  277  or developmental disability that prevents the patient from being
  278  able to protect or care for himself or herself without
  279  assistance or supervision; or
  280         3. All qualified patients the caregiver has agreed to
  281  assist are admitted to a hospice program and have requested the
  282  assistance of that caregiver with the medical use of marijuana;
  283  the caregiver is an employee of the hospice; and the caregiver
  284  provides personal care or other services directly to clients of
  285  the hospice in the scope of that employment; or
  286         4. All qualified patients the caregiver has agreed to
  287  assist are participating in a research program in a teaching
  288  nursing home pursuant to s. 1004.4351.
  289         (8) MEDICAL MARIJUANA TREATMENT CENTERS.—
  290         (e) A licensed medical marijuana treatment center shall
  291  cultivate, process, transport, and dispense marijuana for
  292  medical use. A licensed medical marijuana treatment center may
  293  not contract for services directly related to the cultivation,
  294  processing, and dispensing of marijuana or marijuana delivery
  295  devices, except that a medical marijuana treatment center
  296  licensed pursuant to subparagraph (a)1. may contract with a
  297  single entity for the cultivation, processing, transporting, and
  298  dispensing of marijuana and marijuana delivery devices. A
  299  licensed medical marijuana treatment center must, at all times,
  300  maintain compliance with the criteria demonstrated and
  301  representations made in the initial application and the criteria
  302  established in this subsection. Upon request, the department may
  303  grant a medical marijuana treatment center a variance from the
  304  representations made in the initial application. Consideration
  305  of such a request shall be based upon the individual facts and
  306  circumstances surrounding the request. A variance may not be
  307  granted unless the requesting medical marijuana treatment center
  308  can demonstrate to the department that it has a proposed
  309  alternative to the specific representation made in its
  310  application which fulfills the same or a similar purpose as the
  311  specific representation in a way that the department can
  312  reasonably determine will not be a lower standard than the
  313  specific representation in the application. A variance may not
  314  be granted from the requirements in subparagraph 2. and
  315  subparagraphs (b)1. and 2.
  316         1. A licensed medical marijuana treatment center may
  317  transfer ownership to an individual or entity who meets the
  318  requirements of this section. A publicly traded corporation or
  319  publicly traded company that meets the requirements of this
  320  section is not precluded from ownership of a medical marijuana
  321  treatment center. To accommodate a change in ownership:
  322         a. The licensed medical marijuana treatment center shall
  323  notify the department in writing at least 60 days before the
  324  anticipated date of the change of ownership.
  325         b. The individual or entity applying for initial licensure
  326  due to a change of ownership must submit an application that
  327  must be received by the department at least 60 days before the
  328  date of change of ownership.
  329         c. Upon receipt of an application for a license, the
  330  department shall examine the application and, within 30 days
  331  after receipt, notify the applicant in writing of any apparent
  332  errors or omissions and request any additional information
  333  required.
  334         d. Requested information omitted from an application for
  335  licensure must be filed with the department within 21 days after
  336  the department’s request for omitted information or the
  337  application shall be deemed incomplete and shall be withdrawn
  338  from further consideration and the fees shall be forfeited.
  339  
  340  Within 30 days after the receipt of a complete application, the
  341  department shall approve or deny the application.
  342         2. A medical marijuana treatment center, and any individual
  343  or entity who directly or indirectly owns, controls, or holds
  344  with power to vote 5 percent or more of the voting shares of a
  345  medical marijuana treatment center, may not acquire direct or
  346  indirect ownership or control of any voting shares or other form
  347  of ownership of any other medical marijuana treatment center.
  348         3. A medical marijuana treatment center may not enter into
  349  any form of profit-sharing arrangement with the property owner
  350  or lessor of any of its facilities where cultivation,
  351  processing, storing, or dispensing of marijuana and marijuana
  352  delivery devices occurs.
  353         4. All employees of a medical marijuana treatment center
  354  must be 21 years of age or older and have passed a background
  355  screening pursuant to subsection (9).
  356         5. Each medical marijuana treatment center must adopt and
  357  enforce policies and procedures to ensure employees and
  358  volunteers receive training on the legal requirements to
  359  dispense marijuana to qualified patients.
  360         6. When growing marijuana, a medical marijuana treatment
  361  center:
  362         a. May use pesticides determined by the department, after
  363  consultation with the Department of Agriculture and Consumer
  364  Services, to be safely applied to plants intended for human
  365  consumption, but may not use pesticides designated as
  366  restricted-use pesticides pursuant to s. 487.042.
  367         b. Must grow marijuana within an enclosed structure and in
  368  a room separate from any other plant.
  369         c. Must inspect seeds and growing plants for plant pests
  370  that endanger or threaten the horticultural and agricultural
  371  interests of the state in accordance with chapter 581 and any
  372  rules adopted thereunder.
  373         d. Must perform fumigation or treatment of plants, or
  374  remove and destroy infested or infected plants, in accordance
  375  with chapter 581 and any rules adopted thereunder.
  376         7. Each medical marijuana treatment center must produce and
  377  make available for purchase at least one low-THC cannabis
  378  product.
  379         8. A medical marijuana treatment center that produces
  380  edibles must hold a permit to operate as a food establishment
  381  pursuant to chapter 500, the Florida Food Safety Act, and must
  382  comply with all the requirements for food establishments
  383  pursuant to chapter 500 and any rules adopted thereunder.
  384  Edibles may not contain more than 200 milligrams of
  385  tetrahydrocannabinol, and a single serving portion of an edible
  386  may not exceed 10 milligrams of tetrahydrocannabinol. Edibles
  387  may have a potency variance of no greater than 15 percent.
  388  Edibles may not be attractive to children; be manufactured in
  389  the shape of humans, cartoons, or animals; be manufactured in a
  390  form that bears any reasonable resemblance to products available
  391  for consumption as commercially available candy; or contain any
  392  color additives. To discourage consumption of edibles by
  393  children, the department shall determine by rule any shapes,
  394  forms, and ingredients allowed and prohibited for edibles.
  395  Medical marijuana treatment centers may not begin processing or
  396  dispensing edibles until after the effective date of the rule.
  397  The department shall also adopt sanitation rules providing the
  398  standards and requirements for the storage, display, or
  399  dispensing of edibles.
  400         9. Within 12 months after licensure, a medical marijuana
  401  treatment center must demonstrate to the department that all of
  402  its processing facilities have passed a Food Safety Good
  403  Manufacturing Practices, such as Global Food Safety Initiative
  404  or equivalent, inspection by a nationally accredited certifying
  405  body. A medical marijuana treatment center must immediately stop
  406  processing at any facility which fails to pass this inspection
  407  until it demonstrates to the department that such facility has
  408  met this requirement.
  409         10. A medical marijuana treatment center that produces
  410  prerolled marijuana cigarettes may not use wrapping paper made
  411  with tobacco or hemp.
  412         11.10. When processing marijuana, a medical marijuana
  413  treatment center must:
  414         a. Process the marijuana within an enclosed structure and
  415  in a room separate from other plants or products.
  416         b. Comply with department rules when processing marijuana
  417  with hydrocarbon solvents or other solvents or gases exhibiting
  418  potential toxicity to humans. The department shall determine by
  419  rule the requirements for medical marijuana treatment centers to
  420  use such solvents or gases exhibiting potential toxicity to
  421  humans.
  422         c. Comply with federal and state laws and regulations and
  423  department rules for solid and liquid wastes. The department
  424  shall determine by rule procedures for the storage, handling,
  425  transportation, management, and disposal of solid and liquid
  426  waste generated during marijuana production and processing. The
  427  Department of Environmental Protection shall assist the
  428  department in developing such rules.
  429         d. Test the processed marijuana using a medical marijuana
  430  testing laboratory before it is dispensed. Results must be
  431  verified and signed by two medical marijuana treatment center
  432  employees. Before dispensing, the medical marijuana treatment
  433  center must determine that the test results indicate that low
  434  THC cannabis meets the definition of low-THC cannabis, the
  435  concentration of tetrahydrocannabinol meets the potency
  436  requirements of this section, the labeling of the concentration
  437  of tetrahydrocannabinol and cannabidiol is accurate, and all
  438  marijuana is safe for human consumption and free from
  439  contaminants that are unsafe for human consumption. The
  440  department shall determine by rule which contaminants must be
  441  tested for and the maximum levels of each contaminant which are
  442  safe for human consumption. The Department of Agriculture and
  443  Consumer Services shall assist the department in developing the
  444  testing requirements for contaminants that are unsafe for human
  445  consumption in edibles. The department shall also determine by
  446  rule the procedures for the treatment of marijuana that fails to
  447  meet the testing requirements of this section, s. 381.988, or
  448  department rule. The department may select a random sample from
  449  edibles available for purchase in a dispensing facility which
  450  shall be tested by the department to determine that the edible
  451  meets the potency requirements of this section, is safe for
  452  human consumption, and the labeling of the tetrahydrocannabinol
  453  and cannabidiol concentration is accurate. A medical marijuana
  454  treatment center may not require payment from the department for
  455  the sample. A medical marijuana treatment center must recall
  456  edibles, including all edibles made from the same batch of
  457  marijuana, which fail to meet the potency requirements of this
  458  section, which are unsafe for human consumption, or for which
  459  the labeling of the tetrahydrocannabinol and cannabidiol
  460  concentration is inaccurate. The medical marijuana treatment
  461  center must retain records of all testing and samples of each
  462  homogenous batch of marijuana for at least 9 months. The medical
  463  marijuana treatment center must contract with a marijuana
  464  testing laboratory to perform audits on the medical marijuana
  465  treatment center’s standard operating procedures, testing
  466  records, and samples and provide the results to the department
  467  to confirm that the marijuana or low-THC cannabis meets the
  468  requirements of this section and that the marijuana or low-THC
  469  cannabis is safe for human consumption. A medical marijuana
  470  treatment center shall reserve two processed samples from each
  471  batch and retain such samples for at least 9 months for the
  472  purpose of such audits. A medical marijuana treatment center may
  473  use a laboratory that has not been certified by the department
  474  under s. 381.988 until such time as at least one laboratory
  475  holds the required certification, but in no event later than
  476  July 1, 2018.
  477         e. Package the marijuana in compliance with the United
  478  States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss.
  479  1471 et seq.
  480         f. Package the marijuana in a receptacle that has a firmly
  481  affixed and legible label stating the following information:
  482         (I) The marijuana or low-THC cannabis meets the
  483  requirements of sub-subparagraph d.
  484         (II) The name of the medical marijuana treatment center
  485  from which the marijuana originates.
  486         (III) The batch number and harvest number from which the
  487  marijuana originates and the date dispensed.
  488         (IV) The name of the physician who issued the physician
  489  certification.
  490         (V) The name of the patient.
  491         (VI) The product name, if applicable, and dosage form,
  492  including concentration of tetrahydrocannabinol and cannabidiol.
  493  The product name may not contain wording commonly associated
  494  with products marketed by or to children.
  495         (VII) The recommended dose.
  496         (VIII) A warning that it is illegal to transfer medical
  497  marijuana to another person.
  498         (IX) A marijuana universal symbol developed by the
  499  department.
  500         12.11. The medical marijuana treatment center shall include
  501  in each package a patient package insert with information on the
  502  specific product dispensed related to:
  503         a. Clinical pharmacology.
  504         b. Indications and use.
  505         c. Dosage and administration.
  506         d. Dosage forms and strengths.
  507         e. Contraindications.
  508         f. Warnings and precautions.
  509         g. Adverse reactions.
  510         13. In addition to the packaging and labeling requirements
  511  specified in subparagraphs 11. and 12., marijuana in a form for
  512  smoking must be packaged in a sealed receptacle with a legible
  513  and prominent warning to keep away from children and a warning
  514  that states marijuana smoke contains carcinogens and may
  515  negatively affect health. Such receptacles for marijuana in a
  516  form for smoking must be plain, opaque, and white without
  517  depictions of the product or images other than the medical
  518  marijuana treatment center’s department-approved logo and the
  519  marijuana universal symbol.
  520         14. The department shall adopt rules to regulate the types,
  521  appearance, and labeling of marijuana delivery devices dispensed
  522  from a medical marijuana treatment center. The rules must
  523  require marijuana delivery devices to have an appearance
  524  consistent with medical use.
  525         15.12. Each edible shall be individually sealed in plain,
  526  opaque wrapping marked only with the marijuana universal symbol.
  527  Where practical, each edible shall be marked with the marijuana
  528  universal symbol. In addition to the packaging and labeling
  529  requirements in subparagraphs 11. and 12. 10. and 11., edible
  530  receptacles must be plain, opaque, and white without depictions
  531  of the product or images other than the medical marijuana
  532  treatment center’s department-approved logo and the marijuana
  533  universal symbol. The receptacle must also include a list all of
  534  the edible’s ingredients, storage instructions, an expiration
  535  date, a legible and prominent warning to keep away from children
  536  and pets, and a warning that the edible has not been produced or
  537  inspected pursuant to federal food safety laws.
  538         16.13. When dispensing marijuana or a marijuana delivery
  539  device, a medical marijuana treatment center:
  540         a. May dispense any active, valid order for low-THC
  541  cannabis, medical cannabis and cannabis delivery devices issued
  542  pursuant to former s. 381.986, Florida Statutes 2016, which was
  543  entered into the medical marijuana use registry before July 1,
  544  2017.
  545         b. May not dispense more than a 70-day supply of marijuana
  546  within any 70-day period to a qualified patient or caregiver.
  547  May not dispense more than one 35-day supply of marijuana in a
  548  form for smoking within any 35-day period to a qualified patient
  549  or caregiver. A 35-day supply of marijuana in a form for smoking
  550  may not exceed 2.5 ounces unless an exception to this amount is
  551  approved by the department pursuant to paragraph (4)(f).
  552         c. Must have the medical marijuana treatment center’s
  553  employee who dispenses the marijuana or a marijuana delivery
  554  device enter into the medical marijuana use registry his or her
  555  name or unique employee identifier.
  556         d. Must verify that the qualified patient and the
  557  caregiver, if applicable, each have an active registration in
  558  the medical marijuana use registry and an active and valid
  559  medical marijuana use registry identification card, the amount
  560  and type of marijuana dispensed matches the physician
  561  certification in the medical marijuana use registry for that
  562  qualified patient, and the physician certification has not
  563  already been filled.
  564         e. May not dispense marijuana to a qualified patient who is
  565  younger than 18 years of age. If the qualified patient is
  566  younger than 18 years of age, marijuana may only be dispensed to
  567  the qualified patient’s caregiver.
  568         f. May not dispense or sell any other type of cannabis,
  569  alcohol, or illicit drug-related product, including pipes,
  570  bongs, or wrapping papers made with tobacco or hemp, other than
  571  a marijuana delivery device required for the medical use of
  572  marijuana and which is specified in a physician certification.
  573         g. Must, upon dispensing the marijuana or marijuana
  574  delivery device, record in the registry the date, time,
  575  quantity, and form of marijuana dispensed; the type of marijuana
  576  delivery device dispensed; and the name and medical marijuana
  577  use registry identification number of the qualified patient or
  578  caregiver to whom the marijuana delivery device was dispensed.
  579         h. Must ensure that patient records are not visible to
  580  anyone other than the qualified patient, his or her caregiver,
  581  and authorized medical marijuana treatment center employees.
  582         (14) EXCEPTIONS TO OTHER LAWS.—
  583         (a) Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  584  any other provision of law, but subject to the requirements of
  585  this section, a qualified patient and the qualified patient’s
  586  caregiver may purchase from a medical marijuana treatment center
  587  for the patient’s medical use a marijuana delivery device and up
  588  to the amount of marijuana authorized in the physician
  589  certification, but may not possess more than a 70-day supply of
  590  marijuana, or the greater of 4 ounces of marijuana in a form for
  591  smoking or an amount of marijuana in a form for smoking approved
  592  by the department pursuant to paragraph (4)(f), at any given
  593  time and all marijuana purchased must remain in its original
  594  packaging.
  595         (b) Notwithstanding paragraph (a), s. 893.13, s. 893.135,
  596  s. 893.147, or any other provision of law, a qualified patient
  597  and the qualified patient’s caregiver may purchase and possess a
  598  marijuana delivery device intended for the medical use of
  599  marijuana by smoking from a vendor other than a medical
  600  marijuana treatment center.
  601         (c)(b) Notwithstanding s. 893.13, s. 893.135, s. 893.147,
  602  or any other provision of law, but subject to the requirements
  603  of this section, an approved medical marijuana treatment center
  604  and its owners, managers, and employees may manufacture,
  605  possess, sell, deliver, distribute, dispense, and lawfully
  606  dispose of marijuana or a marijuana delivery device as provided
  607  in this section, s. 381.988, and by department rule. For the
  608  purposes of this subsection, the terms “manufacture,”
  609  “possession,” “deliver,” “distribute,” and “dispense” have the
  610  same meanings as provided in s. 893.02.
  611         (d)(c) Notwithstanding s. 893.13, s. 893.135, s. 893.147,
  612  or any other provision of law, but subject to the requirements
  613  of this section, a certified marijuana testing laboratory,
  614  including an employee of a certified marijuana testing
  615  laboratory acting within the scope of his or her employment, may
  616  acquire, possess, test, transport, and lawfully dispose of
  617  marijuana as provided in this section, in s. 381.988, and by
  618  department rule.
  619         (e)(d) A licensed medical marijuana treatment center and
  620  its owners, managers, and employees are not subject to licensure
  621  or regulation under chapter 465 or chapter 499 for
  622  manufacturing, possessing, selling, delivering, distributing,
  623  dispensing, or lawfully disposing of marijuana or a marijuana
  624  delivery device, as provided in this section, in s. 381.988, and
  625  by department rule.
  626         (f)(e) This subsection does not exempt a person from
  627  prosecution for a criminal offense related to impairment or
  628  intoxication resulting from the medical use of marijuana or
  629  relieve a person from any requirement under law to submit to a
  630  breath, blood, urine, or other test to detect the presence of a
  631  controlled substance.
  632         (g)(f) Notwithstanding s. 893.13, s. 893.135, s. 893.147,
  633  or any other provision of law, but subject to the requirements
  634  of this section and pursuant to policies and procedures
  635  established pursuant to s. 1006.62(8), school personnel may
  636  possess marijuana that is obtained for medical use pursuant to
  637  this section by a student who is a qualified patient.
  638         (h)(g) Notwithstanding s. 893.13, s. 893.135, s. 893.147,
  639  or any other provision of law, but subject to the requirements
  640  of this section, a research institute established by a public
  641  postsecondary educational institution, such as the H. Lee
  642  Moffitt Cancer Center and Research Institute, Inc., established
  643  under s. 1004.43, or a state university that has achieved the
  644  preeminent state research university designation under s.
  645  1001.7065 may possess, test, transport, and lawfully dispose of
  646  marijuana for research purposes as provided by this section.
  647         (15) APPLICABILITY.—
  648         (a) This section does not limit the ability of an employer
  649  to establish, continue, or enforce a drug-free workplace program
  650  or policy.
  651         (b) This section does not require an employer to
  652  accommodate the medical use of marijuana in any workplace or any
  653  employee working while under the influence of marijuana.
  654         (c) This section does not create a cause of action against
  655  an employer for wrongful discharge or discrimination.
  656         (d) This section does not impair the ability of any party
  657  to restrict or limit smoking or vaping marijuana on his or her
  658  private property.
  659         (e) This section does not prohibit the medical use of
  660  marijuana or a caregiver assisting with the medical use of
  661  marijuana in a nursing home facility licensed under part II of
  662  chapter 400, a hospice facility licensed under part IV of
  663  chapter 400, or an assisted living facility licensed under part
  664  I of chapter 429, if the medical use of marijuana is not
  665  prohibited in the facility’s policies.
  666         (f) Marijuana, as defined in this section, is not
  667  reimbursable under chapter 440.
  668         Section 2. Section 1004.4351, Florida Statutes, is amended
  669  to read:
  670         1004.4351 Medical marijuana research and education.—
  671         (1) SHORT TITLE.—This section shall be known and may be
  672  cited as the “Medical Marijuana Research and Education Act.”
  673         (2) LEGISLATIVE FINDINGS.—The Legislature finds that:
  674         (a) The present state of knowledge concerning the use of
  675  marijuana to alleviate pain and treat illnesses is limited
  676  because permission to perform clinical studies on marijuana is
  677  difficult to obtain, with access to research-grade marijuana so
  678  restricted that little or no unbiased studies have been
  679  performed.
  680         (b) Under the State Constitution, marijuana is available
  681  for the treatment of certain debilitating medical conditions.
  682         (c) Additional clinical studies are needed to ensure that
  683  the residents of this state obtain the correct dosing,
  684  formulation, route, modality, frequency, quantity, and quality
  685  of marijuana for specific illnesses.
  686         (d) An effective medical marijuana research and education
  687  program would mobilize the scientific, educational, and medical
  688  resources that presently exist in this state to determine the
  689  appropriate and best use of marijuana to treat illness.
  690         (3) DEFINITIONS.—As used in this section, the term:
  691         (a) “Board” means the Medical Marijuana Research and
  692  Education Board.
  693         (b) “Consortium” “Coalition” means the Consortium Coalition
  694  for Medical Marijuana Clinical Outcomes Research and Education.
  695         (c) “Marijuana” has the same meaning as provided in s. 29,
  696  Art. X of the State Constitution.
  697         (4) CONSORTIUM COALITION FOR MEDICAL MARIJUANA CLINICAL
  698  OUTCOMES RESEARCH AND EDUCATION.—
  699         (a) There is established within a state university
  700  designated by the Board of Governors the H. Lee Moffitt Cancer
  701  Center and Research Institute, Inc., the Consortium Coalition
  702  for Medical Marijuana Clinical Outcomes Research which shall
  703  consist of public and private universities and Education. The
  704  purpose of the consortium coalition is to conduct rigorous
  705  scientific research and, provide education, disseminate such
  706  research, and guide policy for the adoption of a statewide
  707  policy on ordering and dosing practices for the medical use of
  708  marijuana. The coalition shall be physically located at the H.
  709  Lee Moffitt Cancer Center and Research Institute, Inc.
  710         (b) The Medical Marijuana Research and Education Board is
  711  established to direct the operations of the consortium
  712  coalition. The board shall be composed of seven members
  713  representing each participating university appointed by the
  714  president of each participating university the chief executive
  715  officer of the H. Lee Moffitt Cancer Center and Research
  716  Institute, Inc. Board members must have experience in a variety
  717  of scientific and medical fields, including, but not limited to,
  718  oncology, neurology, psychology, pediatrics, nutrition, and
  719  addiction. Members shall be appointed to 4-year terms and may be
  720  reappointed to serve additional terms. The chair shall be
  721  elected by the board from among its members to serve a 2-year
  722  term. The board shall meet at least semiannually at the call of
  723  the chair or, in his or her absence or incapacity, the vice
  724  chair. Four members constitute a quorum. A majority vote of the
  725  members present is required for all actions of the board. The
  726  board may prescribe, amend, and repeal a charter governing the
  727  manner in which it conducts its business. A board member shall
  728  serve without compensation but is entitled to be reimbursed for
  729  travel expenses by the consortium coalition or the organization
  730  he or she represents in accordance with s. 112.061.
  731         (c) The consortium coalition shall be administered by a
  732  coalition director, who shall be appointed by and serve at the
  733  pleasure of the board. The coalition director shall, subject to
  734  the approval of the board:
  735         1. Propose a budget for the consortium coalition.
  736         2. Foster the collaboration of scientists, researchers, and
  737  other appropriate personnel in accordance with the consortium’s
  738  coalition’s charter.
  739         3. Engage individuals in public and private university
  740  programs relevant to the consortium’s work to participate in the
  741  consortium.
  742         4.3. Identify and prioritize the research to be conducted
  743  by the consortium coalition.
  744         5.4. Prepare a plan for medical marijuana research the
  745  Medical Marijuana Research and Education Plan for submission to
  746  the board.
  747         6.5. Apply for grants to obtain funding for research
  748  conducted by the consortium coalition.
  749         7.6. Perform other duties as determined by the board.
  750         (d) The board shall advise the Board of Governors, the
  751  State Surgeon General, the Governor, and the Legislature with
  752  respect to medical marijuana research and education in this
  753  state. The board shall explore methods of implementing and
  754  enforcing medical marijuana laws in relation to cancer control,
  755  research, treatment, and education.
  756         (d)(e) The board shall annually adopt a plan for medical
  757  marijuana research. The plan must organize a program of research
  758  that contributes to the body of scientific knowledge on the
  759  effects of the medical use of marijuana and informs both policy
  760  and medical practice related to the treatment of debilitating
  761  medical conditions with marijuana. Research much include
  762  tracking clinical outcomes, certification standards, dosing
  763  standards, routes of administration, efficacy, and side effects.
  764  Research must also include the study of the effects of smoking
  765  marijuana to treat debilitating medical conditions. The board
  766  must award funds to members of the consortium and to perform
  767  research consistent with the plan. The board may also award
  768  funds to teaching nursing homes, as defined in s. 430.08, for
  769  research on medical use of marijuana to alleviate conditions
  770  related to chronic disease and aging, known as the “Medical
  771  Marijuana Research and Education Plan,” which must be in
  772  accordance with state law and coordinate with existing programs
  773  in this state. The plan must include recommendations for the
  774  coordination and integration of medical, pharmacological,
  775  nursing, paramedical, community, and other resources connected
  776  with the treatment of debilitating medical conditions; research
  777  related to the treatment of such medical conditions; and
  778  education.
  779         (e)(f) By February 15 of each year, the board shall issue a
  780  report to the Governor, the President of the Senate, and the
  781  Speaker of the House of Representatives on research projects,
  782  research findings, community outreach initiatives, and future
  783  plans for the consortium coalition.
  784         (f)(g) Beginning August 1, 2019 January 15, 2018, and
  785  quarterly thereafter, the Department of Health shall submit to
  786  the board a data set that includes, for each patient registered
  787  in the medical marijuana use registry, the patient’s qualifying
  788  medical condition and the daily dose amount, routes of
  789  administration, and forms of marijuana certified for the
  790  patient. The department shall also provide the board with such
  791  data for all patients registered in the medical marijuana use
  792  registry before August 1, 2019.
  793         (5) RESPONSIBILITIES OF THE H. LEE MOFFITT CANCER CENTER
  794  AND RESEARCH INSTITUTE, INC.—The H. Lee Moffitt Cancer Center
  795  and Research Institute, Inc., shall allocate staff and provide
  796  information and assistance, as the coalition’s budget permits,
  797  to assist the board in fulfilling its responsibilities.
  798         Section 3. Paragraph (h) of subsection (2) and paragraph
  799  (b) of subsection (3) of section 381.987, Florida Statutes, are
  800  amended to read:
  801         381.987 Public records exemption for personal identifying
  802  information relating to medical marijuana held by the
  803  department.—
  804         (2) The department shall allow access to the confidential
  805  and exempt information in the medical marijuana use registry to:
  806         (h) The Consortium Coalition for Medical Marijuana Clinical
  807  Outcomes Research and Education established in s. 1004.4351(4).
  808         (3) The department shall allow access to the confidential
  809  and exempt information pertaining to the physician certification
  810  for marijuana and the dispensing thereof, whether in the
  811  registry or otherwise held by the department, to:
  812         (b) The Consortium Coalition for Medical Marijuana Clinical
  813  Outcomes Research and Education pursuant to s. 381.986 for the
  814  purpose of conducting research regarding the medical use of
  815  marijuana.
  816         Section 4. (1) For the 2019-2020 fiscal year, the sum of
  817  $1.5 million in recurring funds is appropriated from the General
  818  Revenue Fund to the Board of Governors for the Consortium for
  819  Medical Marijuana Clinical Outcomes Research established under
  820  s. 1004.4351, Florida Statutes.
  821         (2) For the 2018-2019 fiscal year, the sum of $391,333 in
  822  nonrecurring funds is appropriated from the Grants and Donations
  823  Trust Fund to the Department of Health for the purpose of
  824  implementing the requirements of this act.
  825         (3) For the 2019-2020 fiscal year, the sum of $705,331 in
  826  recurring funds is appropriated from the Grants and Donations
  827  Trust Fund to the Department of Health for the purpose of
  828  implementing the requirements of this act.
  829         Section 5. This act shall take effect upon becoming a law.
  830  
  831  ================= T I T L E  A M E N D M E N T ================
  832  And the title is amended as follows:
  833         Delete everything before the enacting clause
  834  and insert:
  835                        A bill to be entitled                      
  836         An act relating to the medical use of marijuana;
  837         amending s. 381.986, F.S.; redefining the term
  838         “marijuana delivery device” to eliminate the
  839         requirement that such devices must be purchased from a
  840         medical marijuana treatment center; redefining the
  841         term “medical use” to include the possession, use, or
  842         administration of marijuana in a form for smoking;
  843         conforming provisions to changes made by the act;
  844         restricting the smoking of marijuana in enclosed
  845         indoor workplaces; requiring a patient’s informed
  846         consent form to include the negative health risks
  847         associated with smoking marijuana; conforming a
  848         provision to changes made by the act; requiring a
  849         qualified physician to submit specified documentation
  850         to the Board of Medicine and the Board of Osteopathic
  851         Medicine upon determining that smoking is an
  852         appropriate route of administration for a qualified
  853         patient, other than a patient diagnosed with a
  854         terminal condition; prohibiting a physician from
  855         certifying a patient under 18 years of age to smoke
  856         marijuana for medical use unless the patient is
  857         diagnosed with a terminal condition and the physician
  858         makes a certain determination in concurrence with a
  859         second physician who is a pediatrician; requiring a
  860         qualified physician to obtain the written informed
  861         consent of the such patient’s parent or legal guardian
  862         before certifying the patient to smoke marijuana for
  863         medical use; requiring the qualified physician to use
  864         a certain informed consent form adopted in rule by the
  865         boards; requiring the boards to review specified
  866         documentation and adopt certain practice standards by
  867         rule by a specified date; establishing a supply limit
  868         for a physician certification for marijuana in a form
  869         for smoking; authorizing a qualified physician to
  870         request an exception to the supply limit and
  871         possession limit for marijuana in a form for smoking;
  872         authorizing more than one caregiver to assist with a
  873         qualified patient’s medical use of marijuana if the
  874         patient is participating in a certain research program
  875         in a teaching nursing home; authorizing a caregiver to
  876         be listed in the medical marijuana use registry as a
  877         designated caregiver for qualified patients who are
  878         participating in a certain research program in a
  879         teaching nursing home; prohibiting a medical marijuana
  880         treatment center that produces prerolled marijuana
  881         cigarettes from using wrapping paper made with tobacco
  882         or hemp; requiring that marijuana in a form for
  883         smoking meet certain packaging and labeling
  884         requirements; requiring the Department of Health to
  885         adopt rules regulating the types, appearance, and
  886         labeling of marijuana delivery devices; prohibiting a
  887         medical marijuana treatment center from dispensing
  888         more than a specified supply limit of marijuana in a
  889         form for smoking; revising a provision prohibiting a
  890         medical marijuana treatment center from dispensing or
  891         selling specified products; establishing possession
  892         limits on marijuana in a form for smoking for a
  893         qualified patient; allowing marijuana delivery devices
  894         to be purchased from a vendor other than a medical
  895         marijuana treatment center; providing applicability;
  896         amending s. 1004.4351, F.S.; renaming the Coalition
  897         for Medical Marijuana Research and Education as the
  898         Consortium for Medical Marijuana Clinical Outcomes
  899         Research; establishing the consortium for a specified
  900         purpose; renaming the Medical Marijuana Research and
  901         Education Board as the Medical Marijuana Research
  902         Board; requiring the board to direct the operations of
  903         the consortium; providing membership of the board;
  904         providing for the appointment of a consortium
  905         director; providing duties of the consortium director;
  906         requiring the board to annually adopt a plan for
  907         medical marijuana research; requiring the plan to
  908         include specified information; providing research
  909         requirements for the plan; requiring the board to
  910         award funds to members of the consortium; authorizing
  911         the board to award funds to teaching nursing homes for
  912         certain research; requiring the board to issue an
  913         annual report to the Governor and Legislature by a
  914         specified date; requiring the department to submit
  915         certain data sets to the board; amending s. 381.987,
  916         F.S.; conforming provisions to changes made by the
  917         act; providing appropriations; providing an effective
  918         date.