Florida Senate - 2020                        COMMITTEE AMENDMENT
       Bill No. CS for CS for SB 230
       
       
       
       
       
       
                                Ì309044ÊÎ309044                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                   Comm: WD            .                                
                  03/03/2020           .                                
                                       .                                
                                       .                                
                                       .                                
       —————————————————————————————————————————————————————————————————




       —————————————————————————————————————————————————————————————————
       The Committee on Rules (Harrell) recommended the following:
       
    1         Senate Substitute for Amendment (850798) (with title
    2  amendment)
    3  
    4         Between lines 368 and 369
    5  insert:
    6         Section 5. Paragraphs (a) and (f) of subsection (4) and
    7  paragraph (e) of subsection (8) of section 381.986, Florida
    8  Statutes, are amended, and paragraph (i) is added to subsection
    9  (14) of that section, to read:
   10         381.986 Medical use of marijuana.—
   11         (4) PHYSICIAN CERTIFICATION.—
   12         (a) A qualified physician may issue a physician
   13  certification only if the qualified physician:
   14         1. Conducted a physical examination while physically
   15  present in the same room as the patient and a full assessment of
   16  the medical history of the patient.
   17         2. Diagnosed the patient with at least one qualifying
   18  medical condition.
   19         3. Determined that the medical use of marijuana would
   20  likely outweigh the potential health risks for the patient, and
   21  such determination must be documented in the patient’s medical
   22  record. If a patient is younger than 18 years of age, a second
   23  physician must concur with this determination, and such
   24  concurrence must be documented in the patient’s medical record.
   25         4. Determined whether the patient is pregnant and
   26  documented such determination in the patient’s medical record. A
   27  physician may not issue a physician certification, except for
   28  low-THC cannabis, to a patient who is pregnant.
   29         5. Reviewed the patient’s controlled drug prescription
   30  history in the prescription drug monitoring program database
   31  established pursuant to s. 893.055.
   32         6. Reviews the medical marijuana use registry and confirmed
   33  that the patient does not have an active physician certification
   34  from another qualified physician.
   35         7. Registers as the issuer of the physician certification
   36  for the named qualified patient on the medical marijuana use
   37  registry in an electronic manner determined by the department,
   38  and:
   39         a. Enters into the registry the contents of the physician
   40  certification, including all of the patient’s qualifying
   41  conditions for which the qualified physician is issuing the
   42  certification condition and the dosage not to exceed the daily
   43  dose amount determined by the department, the amount and forms
   44  of marijuana authorized for the patient, and any types of
   45  marijuana delivery devices needed by the patient for the medical
   46  use of marijuana.
   47         b. Updates the registry within 7 days after any change is
   48  made to the original physician certification to reflect such
   49  change.
   50         c. Deactivates the registration of the qualified patient
   51  and the patient’s caregiver when the physician no longer
   52  recommends the medical use of marijuana for the patient.
   53         8. Obtains the voluntary and informed written consent of
   54  the patient for medical use of marijuana each time the qualified
   55  physician issues a physician certification for the patient,
   56  which shall be maintained in the patient’s medical record. The
   57  patient, or the patient’s parent or legal guardian if the
   58  patient is a minor, must sign the informed consent acknowledging
   59  that the qualified physician has sufficiently explained its
   60  content. The qualified physician must use a standardized
   61  informed consent form adopted in rule by the Board of Medicine
   62  and the Board of Osteopathic Medicine, which must include, at a
   63  minimum, information related to:
   64         a. The Federal Government’s classification of marijuana as
   65  a Schedule I controlled substance.
   66         b. The approval and oversight status of marijuana by the
   67  Food and Drug Administration.
   68         c. The current state of research on the efficacy of
   69  marijuana to treat the qualifying conditions set forth in this
   70  section.
   71         d. The potential for addiction.
   72         e. The potential effect that marijuana may have on a
   73  patient’s coordination, motor skills, and cognition, including a
   74  warning against operating heavy machinery, operating a motor
   75  vehicle, or engaging in activities that require a person to be
   76  alert or respond quickly.
   77         f. The potential side effects of marijuana use, including
   78  the negative health risks associated with smoking marijuana and
   79  the negative health effects of marijuana use on persons under 21
   80  years of age.
   81         g. The risks, benefits, and drug interactions of marijuana.
   82         h. That the patient’s de-identified health information
   83  contained in the physician certification and medical marijuana
   84  use registry may be used for research purposes.
   85         (f) A qualified physician may not issue a physician
   86  certification for more than three 70-day supply limits of
   87  marijuana; or more than six 35-day supply limits of marijuana in
   88  a form for smoking; or, to a qualified patient under 21 years of
   89  age, marijuana with a concentration of tetrahydrocannabinol
   90  which exceeds 10 percent, except that a physician may certify
   91  such qualified patient for any concentration of
   92  tetrahydrocannabinol if the qualified patient is diagnosed with
   93  a terminal condition and the qualified physician indicates this
   94  fact on the qualified patient’s certification. The department
   95  shall quantify by rule a daily dose amount with equivalent dose
   96  amounts for each allowable form of marijuana dispensed by a
   97  medical marijuana treatment center. The department shall use the
   98  daily dose amount to calculate a 70-day supply.
   99         1. A qualified physician may request an exception to the
  100  daily dose amount limit, the 35-day supply limit of marijuana in
  101  a form for smoking, and the 4-ounce possession limit of
  102  marijuana in a form for smoking established in paragraph
  103  (14)(a), and the tetrahydrocannabinol concentration limits
  104  established in this paragraph. The request shall be made
  105  electronically on a form adopted by the department in rule and
  106  must include, at a minimum:
  107         a. The qualified patient’s qualifying medical condition.
  108         b. The dosage and route of administration that was
  109  insufficient to provide relief to the qualified patient.
  110         c. A description of how the patient will benefit from an
  111  increased amount.
  112         d. The minimum daily dose amount of marijuana and
  113  tetrahydrocannabinol concentration, as applicable, that would be
  114  sufficient for the treatment of the qualified patient’s
  115  qualifying medical condition.
  116         2. A qualified physician must provide the qualified
  117  patient’s records upon the request of the department.
  118         3. The department shall approve or disapprove the request
  119  within 14 days after receipt of the complete documentation
  120  required by this paragraph. The request shall be deemed approved
  121  if the department fails to act within this time period.
  122         (8) MEDICAL MARIJUANA TREATMENT CENTERS.—
  123         (e) A licensed medical marijuana treatment center shall
  124  cultivate, process, transport, and dispense marijuana for
  125  medical use. A licensed medical marijuana treatment center may
  126  not contract for services directly related to the cultivation,
  127  processing, and dispensing of marijuana or marijuana delivery
  128  devices, except that a medical marijuana treatment center
  129  licensed pursuant to subparagraph (a)1. may contract with a
  130  single entity for the cultivation, processing, transporting, and
  131  dispensing of marijuana and marijuana delivery devices. A
  132  licensed medical marijuana treatment center must, at all times,
  133  maintain compliance with the criteria demonstrated and
  134  representations made in the initial application and the criteria
  135  established in this subsection. Upon request, the department may
  136  grant a medical marijuana treatment center a variance from the
  137  representations made in the initial application. Consideration
  138  of such a request shall be based upon the individual facts and
  139  circumstances surrounding the request. A variance may not be
  140  granted unless the requesting medical marijuana treatment center
  141  can demonstrate to the department that it has a proposed
  142  alternative to the specific representation made in its
  143  application which fulfills the same or a similar purpose as the
  144  specific representation in a way that the department can
  145  reasonably determine will not be a lower standard than the
  146  specific representation in the application. A variance may not
  147  be granted from the requirements in subparagraph 2. and
  148  subparagraphs (b)1. and 2.
  149         1. A licensed medical marijuana treatment center may
  150  transfer ownership to an individual or entity who meets the
  151  requirements of this section. A publicly traded corporation or
  152  publicly traded company that meets the requirements of this
  153  section is not precluded from ownership of a medical marijuana
  154  treatment center. To accommodate a change in ownership:
  155         a. The licensed medical marijuana treatment center shall
  156  notify the department in writing at least 60 days before the
  157  anticipated date of the change of ownership.
  158         b. The individual or entity applying for initial licensure
  159  due to a change of ownership must submit an application that
  160  must be received by the department at least 60 days before the
  161  date of change of ownership.
  162         c. Upon receipt of an application for a license, the
  163  department shall examine the application and, within 30 days
  164  after receipt, notify the applicant in writing of any apparent
  165  errors or omissions and request any additional information
  166  required.
  167         d. Requested information omitted from an application for
  168  licensure must be filed with the department within 21 days after
  169  the department’s request for omitted information or the
  170  application shall be deemed incomplete and shall be withdrawn
  171  from further consideration and the fees shall be forfeited.
  172  
  173  Within 30 days after the receipt of a complete application, the
  174  department shall approve or deny the application.
  175         2. A medical marijuana treatment center, and any individual
  176  or entity who directly or indirectly owns, controls, or holds
  177  with power to vote 5 percent or more of the voting shares of a
  178  medical marijuana treatment center, may not acquire direct or
  179  indirect ownership or control of any voting shares or other form
  180  of ownership of any other medical marijuana treatment center.
  181         3. A medical marijuana treatment center may not enter into
  182  any form of profit-sharing arrangement with the property owner
  183  or lessor of any of its facilities where cultivation,
  184  processing, storing, or dispensing of marijuana and marijuana
  185  delivery devices occurs.
  186         4. All employees of a medical marijuana treatment center
  187  must be 21 years of age or older and have passed a background
  188  screening pursuant to subsection (9).
  189         5. Each medical marijuana treatment center must adopt and
  190  enforce policies and procedures to ensure employees and
  191  volunteers receive training on the legal requirements to
  192  dispense marijuana to qualified patients.
  193         6. When growing marijuana, a medical marijuana treatment
  194  center:
  195         a. May use pesticides determined by the department, after
  196  consultation with the Department of Agriculture and Consumer
  197  Services, to be safely applied to plants intended for human
  198  consumption, but may not use pesticides designated as
  199  restricted-use pesticides pursuant to s. 487.042.
  200         b. Must grow marijuana within an enclosed structure and in
  201  a room separate from any other plant.
  202         c. Must inspect seeds and growing plants for plant pests
  203  that endanger or threaten the horticultural and agricultural
  204  interests of the state in accordance with chapter 581 and any
  205  rules adopted thereunder.
  206         d. Must perform fumigation or treatment of plants, or
  207  remove and destroy infested or infected plants, in accordance
  208  with chapter 581 and any rules adopted thereunder.
  209         7. Each medical marijuana treatment center must produce and
  210  make available for purchase at least one low-THC cannabis
  211  product.
  212         8. A medical marijuana treatment center that produces
  213  edibles must hold a permit to operate as a food establishment
  214  pursuant to chapter 500, the Florida Food Safety Act, and must
  215  comply with all the requirements for food establishments
  216  pursuant to chapter 500 and any rules adopted thereunder.
  217  Edibles may not contain more than 200 milligrams of
  218  tetrahydrocannabinol, and a single serving portion of an edible
  219  may not exceed 10 milligrams of tetrahydrocannabinol. Edibles
  220  may have a potency variance of no greater than 15 percent of the
  221  10 milligrams of tetrahydrocannabinol per single serving limit
  222  or the 200 milligrams of tetrahydrocannabinol per product limit.
  223  Edibles may not be attractive to children; be manufactured in
  224  the shape of humans, cartoons, or animals; be manufactured in a
  225  form that bears any reasonable resemblance to products available
  226  for consumption as commercially available candy; or contain any
  227  color additives. To discourage consumption of edibles by
  228  children, the department shall determine by rule any shapes,
  229  forms, and ingredients allowed and prohibited for edibles.
  230  Medical marijuana treatment centers may not begin processing or
  231  dispensing edibles until after the effective date of the rule.
  232  The department shall also adopt sanitation rules providing the
  233  standards and requirements for the storage, display, or
  234  dispensing of edibles.
  235         9. Within 12 months after licensure, a medical marijuana
  236  treatment center must demonstrate to the department that all of
  237  its processing facilities have passed a Food Safety Good
  238  Manufacturing Practices, such as Global Food Safety Initiative
  239  or equivalent, inspection by a nationally accredited certifying
  240  body. A medical marijuana treatment center must immediately stop
  241  processing at any facility which fails to pass this inspection
  242  until it demonstrates to the department that such facility has
  243  met this requirement.
  244         10. A medical marijuana treatment center that produces
  245  prerolled marijuana cigarettes may not use wrapping paper made
  246  with tobacco or hemp.
  247         11. When processing marijuana, a medical marijuana
  248  treatment center must:
  249         a. Process the marijuana within an enclosed structure and
  250  in a room separate from other plants or products.
  251         b. Comply with department rules when processing marijuana
  252  with hydrocarbon solvents or other solvents or gases exhibiting
  253  potential toxicity to humans. The department shall determine by
  254  rule the requirements for medical marijuana treatment centers to
  255  use such solvents or gases exhibiting potential toxicity to
  256  humans.
  257         c. Comply with federal and state laws and regulations and
  258  department rules for solid and liquid wastes. The department
  259  shall determine by rule procedures for the storage, handling,
  260  transportation, management, and disposal of solid and liquid
  261  waste generated during marijuana production and processing. The
  262  Department of Environmental Protection shall assist the
  263  department in developing such rules.
  264         12.d.A medical marijuana treatment center must test the
  265  processed marijuana using a medical marijuana testing laboratory
  266  before it is dispensed. Results must be verified and signed by
  267  two medical marijuana treatment center employees. Before
  268  dispensing, the medical marijuana treatment center must
  269  determine that the test results indicate that low-THC cannabis
  270  meets the definition of low-THC cannabis, the concentration of
  271  tetrahydrocannabinol meets the potency requirements of this
  272  section, the labeling of the concentration of
  273  tetrahydrocannabinol and cannabidiol is accurate, and all
  274  marijuana is safe for human consumption and free from
  275  contaminants that are unsafe for human consumption. The
  276  department shall determine by rule which contaminants must be
  277  tested for and the maximum levels of each contaminant which are
  278  safe for human consumption. The Department of Agriculture and
  279  Consumer Services shall assist the department in developing the
  280  testing requirements for contaminants that are unsafe for human
  281  consumption in edibles. The department shall also determine by
  282  rule the procedures for the treatment of marijuana that fails to
  283  meet the testing requirements of this section, s. 381.988, or
  284  department rule. The department may select a random samples of
  285  marijuana, sample from edibles available in a cultivation
  286  facility, processing facility, or for purchase in a dispensing
  287  facility which shall be tested by the department to determine
  288  that the marijuana edible meets the potency requirements of this
  289  section, is safe for human consumption, and the labeling of the
  290  tetrahydrocannabinol and cannabidiol concentration is accurate.
  291  A medical marijuana treatment center may not require payment
  292  from the department for the sample. A medical marijuana
  293  treatment center must recall edibles, including all edibles made
  294  from the same batch of marijuana, which fail to meet the potency
  295  requirements of this section, which are unsafe for human
  296  consumption, or for which the labeling of the
  297  tetrahydrocannabinol and cannabidiol concentration is
  298  inaccurate. The medical marijuana treatment center must retain
  299  records of all testing and samples of each homogenous batch of
  300  marijuana for at least 9 months. The medical marijuana treatment
  301  center must contract with a marijuana testing laboratory to
  302  perform audits on the medical marijuana treatment center’s
  303  standard operating procedures, testing records, and samples and
  304  provide the results to the department to confirm that the
  305  marijuana or low-THC cannabis meets the requirements of this
  306  section and that the marijuana or low-THC cannabis is safe for
  307  human consumption. A medical marijuana treatment center shall
  308  reserve two processed samples from each batch and retain such
  309  samples for at least 9 months for the purpose of such audits. A
  310  medical marijuana treatment center may use a laboratory that has
  311  not been certified by the department under s. 381.988 until such
  312  time as at least one laboratory holds the required
  313  certification, but in no event later than July 1, 2021 2018.
  314         13.When packaging marijuana, a medical marijuana treatment
  315  center must:
  316         a.e. Package the marijuana in compliance with the United
  317  States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss.
  318  1471 et seq.
  319         b.f. Package the marijuana in a receptacle that has a
  320  firmly affixed and legible label stating the following
  321  information:
  322         (I) The marijuana or low-THC cannabis meets the
  323  requirements of subparagraph 12 sub-subparagraph d.
  324         (II) The name of the medical marijuana treatment center
  325  from which the marijuana originates.
  326         (III) The batch number and harvest number from which the
  327  marijuana originates and the date dispensed.
  328         (IV) The name of the physician who issued the physician
  329  certification.
  330         (V) The name of the patient.
  331         (VI) The product name, if applicable, and dosage form,
  332  including concentration of tetrahydrocannabinol and cannabidiol.
  333  The product name may not contain wording commonly associated
  334  with products marketed by or to children.
  335         (VII) The recommended dose.
  336         (VIII) A warning that it is illegal to transfer medical
  337  marijuana to another person.
  338         (IX) A marijuana universal symbol developed by the
  339  department.
  340         14.12. The medical marijuana treatment center shall include
  341  in each package a patient package insert with information on the
  342  specific product dispensed related to:
  343         a. Clinical pharmacology.
  344         b. Indications and use.
  345         c. Dosage and administration.
  346         d. Dosage forms and strengths.
  347         e. Contraindications.
  348         f. Warnings and precautions.
  349         g. Adverse reactions.
  350         15.13. In addition to the packaging and labeling
  351  requirements specified in subparagraphs 11. and 14. 12.,
  352  marijuana in a form for smoking must be packaged in a sealed
  353  receptacle with a legible and prominent warning to keep away
  354  from children and a warning that states marijuana smoke contains
  355  carcinogens and may negatively affect health. Such receptacles
  356  for marijuana in a form for smoking must be plain, opaque, and
  357  white without depictions of the product or images other than the
  358  medical marijuana treatment center’s department-approved logo
  359  and the marijuana universal symbol.
  360         16.14. The department shall adopt rules to regulate the
  361  types, appearance, and labeling of marijuana delivery devices
  362  dispensed from a medical marijuana treatment center. The rules
  363  must require marijuana delivery devices to have an appearance
  364  consistent with medical use.
  365         17.15. Each edible shall be individually sealed in plain,
  366  opaque wrapping marked only with the marijuana universal symbol.
  367  Where practical, each edible shall be marked with the marijuana
  368  universal symbol. In addition to the packaging and labeling
  369  requirements in subparagraphs 11. and 14. 12., edible
  370  receptacles must be plain, opaque, and white without depictions
  371  of the product or images other than the medical marijuana
  372  treatment center’s department-approved logo and the marijuana
  373  universal symbol. The receptacle must also include a list of all
  374  the edible’s ingredients, storage instructions, an expiration
  375  date, a legible and prominent warning to keep away from children
  376  and pets, and a warning that the edible has not been produced or
  377  inspected pursuant to federal food safety laws.
  378         18.16. When dispensing marijuana or a marijuana delivery
  379  device, a medical marijuana treatment center:
  380         a. May dispense any active, valid order for low-THC
  381  cannabis, medical cannabis and cannabis delivery devices issued
  382  pursuant to former s. 381.986, Florida Statutes 2016, which was
  383  entered into the medical marijuana use registry before July 1,
  384  2017.
  385         b. May not dispense more than a 70-day supply of marijuana
  386  within any 70-day period to a qualified patient or caregiver.
  387  May not dispense more than one 35-day supply of marijuana in a
  388  form for smoking within any 35-day period to a qualified patient
  389  or caregiver. A 35-day supply of marijuana in a form for smoking
  390  may not exceed 2.5 ounces unless an exception to this amount is
  391  approved by the department pursuant to paragraph (4)(f).
  392         c. Must have the medical marijuana treatment center’s
  393  employee who dispenses the marijuana or a marijuana delivery
  394  device enter into the medical marijuana use registry his or her
  395  name or unique employee identifier.
  396         d. Must verify that the qualified patient and the
  397  caregiver, if applicable, each have an active registration in
  398  the medical marijuana use registry and an active and valid
  399  medical marijuana use registry identification card, the amount
  400  and type of marijuana dispensed matches the physician
  401  certification in the medical marijuana use registry for that
  402  qualified patient, and the physician certification has not
  403  already been filled.
  404         e. May not dispense marijuana to a qualified patient who is
  405  younger than 18 years of age. If the qualified patient is
  406  younger than 18 years of age, marijuana may only be dispensed to
  407  the qualified patient’s caregiver.
  408         f.May not dispense marijuana with a concentration of
  409  tetrahydrocannabinol which exceeds 10 percent to a qualified
  410  patient 18 to 21 years of age, to his or her caregiver, or to
  411  the caregiver of a qualified patient under 18 years of age for
  412  the qualified patient’s medical use. However, if a qualified
  413  patient younger than 21 years of age has an exception approved
  414  by the department under paragraph (4)(f) relating to the
  415  concentration of tetrahydrocannabinol or the qualified patient’s
  416  certification indicates that he or she is diagnosed with a
  417  terminal condition, marijuana with a concentration of
  418  tetrahydrocannabinol which exceeds 10 percent may be dispensed
  419  to such a qualified patient who is 18 years of age or older or
  420  to his or her caregiver or to such a qualified patient’s
  421  caregiver if the patient is younger than 18 years of age, for
  422  the qualified patient’s medical use.
  423         g.f. May not dispense or sell any other type of cannabis,
  424  alcohol, or illicit drug-related product, including pipes or
  425  wrapping papers made with tobacco or hemp, other than a
  426  marijuana delivery device required for the medical use of
  427  marijuana and which is specified in a physician certification.
  428         h.g. Must, upon dispensing the marijuana or marijuana
  429  delivery device, record in the registry the date, time,
  430  quantity, and form of marijuana dispensed; the type of marijuana
  431  delivery device dispensed; and the name and medical marijuana
  432  use registry identification number of the qualified patient or
  433  caregiver to whom the marijuana delivery device was dispensed.
  434         i.h. Must ensure that patient records are not visible to
  435  anyone other than the qualified patient, his or her caregiver,
  436  and authorized medical marijuana treatment center employees.
  437         (14) EXCEPTIONS TO OTHER LAWS.—
  438         (i)Notwithstanding s. 893.13, s. 893.135, s. 893.147, or
  439  any other provision of law, but subject to the requirements of
  440  this section, the department, including an employee of the
  441  department acting within the scope of his or her employment, may
  442  acquire, possess, test, transport, and lawfully dispose of
  443  marijuana as provided in this section.
  444         Section 6. Present subsection (11) of section 381.988,
  445  Florida Statutes, is redesignated as subsection (12), and a new
  446  subsection (11) is added to that section, to read:
  447         381.988 Medical marijuana testing laboratories; marijuana
  448  tests conducted by a certified laboratory.—
  449         (11) A certified medical marijuana testing laboratory and
  450  its officers, directors, and employees may not have a direct or
  451  indirect economic interest in, or a financial relationship with,
  452  a medical marijuana treatment center. Nothing in this subsection
  453  may be construed to prohibit a certified medical marijuana
  454  testing laboratory from contracting with a medical marijuana
  455  treatment center to provide testing services.
  456  
  457  ================= T I T L E  A M E N D M E N T ================
  458  And the title is amended as follows:
  459         Delete line 19
  460  and insert:
  461         Program; amending s. 381.986, F.S.; revising
  462         requirements for qualified physicians who issue
  463         physician certifications for the medical use of
  464         marijuana; prohibiting qualified physicians from
  465         certifying for certain qualified patients marijuana
  466         with concentration of tetrahydrocannabinol exceeding a
  467         specified amount; providing exceptions; revising a
  468         provision related to the tetrahydrocannabinol limits
  469         for edibles; revising provisions related to the
  470         testing, processing, and packaging of marijuana for
  471         medical use; prohibiting medical marijuana treatment
  472         centers from dispensing for certain qualified patients
  473         marijuana with a concentration of tetrahydrocannabinol
  474         exceeding a certain amount; providing exceptions;
  475         authorizing the department and its employees to
  476         acquire, possess, test, transport, and lawfully
  477         dispose of marijuana under certain circumstances;
  478         amending s. 381.988, F.S.; prohibiting certified
  479         medical marijuana testing laboratories and their
  480         officers, directors, and employees from having an
  481         economic interest in, or a financial relationship
  482         with, a medical marijuana treatment center; providing
  483         construction; amending s. 401.35, F.S.; clarifying