Florida Senate - 2020                        COMMITTEE AMENDMENT
       Bill No. CS for CS for SB 230
       
       
       
       
       
       
                                Ì850798`Î850798                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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       The Committee on Rules (Harrell) recommended the following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Between lines 368 and 369
    4  insert:
    5         Section 5. Paragraph (f) of subsection (4) and paragraph
    6  (e) of subsection (8) of section 381.986, Florida Statutes, are
    7  amended to read:
    8         381.986 Medical use of marijuana.—
    9         (4) PHYSICIAN CERTIFICATION.—
   10         (f) A qualified physician may not issue a physician
   11  certification for more than three 70-day supply limits of
   12  marijuana; or more than six 35-day supply limits of marijuana in
   13  a form for smoking; or, to a qualified patient under 21 years of
   14  age, marijuana with a concentration of tetrahydrocannabinol
   15  which exceeds 10 percent, except that a physician may certify
   16  such qualified patient for any concentration of
   17  tetrahydrocannabinol if the qualified patient is diagnosed with
   18  a terminal condition and the qualified physician indicates this
   19  fact on the qualified patient’s certification. The department
   20  shall quantify by rule a daily dose amount with equivalent dose
   21  amounts for each allowable form of marijuana dispensed by a
   22  medical marijuana treatment center. The department shall use the
   23  daily dose amount to calculate a 70-day supply.
   24         1. A qualified physician may request an exception to the
   25  daily dose amount limit, the 35-day supply limit of marijuana in
   26  a form for smoking, and the 4-ounce possession limit of
   27  marijuana in a form for smoking established in paragraph
   28  (14)(a), and the tetrahydrocannabinol concentration limits
   29  established in this paragraph. The request shall be made
   30  electronically on a form adopted by the department in rule and
   31  must include, at a minimum:
   32         a. The qualified patient’s qualifying medical condition.
   33         b. The dosage and route of administration that was
   34  insufficient to provide relief to the qualified patient.
   35         c. A description of how the patient will benefit from an
   36  increased amount.
   37         d. The minimum daily dose amount of marijuana and
   38  tetrahydrocannabinol concentration, as applicable, that would be
   39  sufficient for the treatment of the qualified patient’s
   40  qualifying medical condition.
   41         2. A qualified physician must provide the qualified
   42  patient’s records upon the request of the department.
   43         3. The department shall approve or disapprove the request
   44  within 14 days after receipt of the complete documentation
   45  required by this paragraph. The request shall be deemed approved
   46  if the department fails to act within this time period.
   47         (8) MEDICAL MARIJUANA TREATMENT CENTERS.—
   48         (e) A licensed medical marijuana treatment center shall
   49  cultivate, process, transport, and dispense marijuana for
   50  medical use. A licensed medical marijuana treatment center may
   51  not contract for services directly related to the cultivation,
   52  processing, and dispensing of marijuana or marijuana delivery
   53  devices, except that a medical marijuana treatment center
   54  licensed pursuant to subparagraph (a)1. may contract with a
   55  single entity for the cultivation, processing, transporting, and
   56  dispensing of marijuana and marijuana delivery devices. A
   57  licensed medical marijuana treatment center must, at all times,
   58  maintain compliance with the criteria demonstrated and
   59  representations made in the initial application and the criteria
   60  established in this subsection. Upon request, the department may
   61  grant a medical marijuana treatment center a variance from the
   62  representations made in the initial application. Consideration
   63  of such a request shall be based upon the individual facts and
   64  circumstances surrounding the request. A variance may not be
   65  granted unless the requesting medical marijuana treatment center
   66  can demonstrate to the department that it has a proposed
   67  alternative to the specific representation made in its
   68  application which fulfills the same or a similar purpose as the
   69  specific representation in a way that the department can
   70  reasonably determine will not be a lower standard than the
   71  specific representation in the application. A variance may not
   72  be granted from the requirements in subparagraph 2. and
   73  subparagraphs (b)1. and 2.
   74         1. A licensed medical marijuana treatment center may
   75  transfer ownership to an individual or entity who meets the
   76  requirements of this section. A publicly traded corporation or
   77  publicly traded company that meets the requirements of this
   78  section is not precluded from ownership of a medical marijuana
   79  treatment center. To accommodate a change in ownership:
   80         a. The licensed medical marijuana treatment center shall
   81  notify the department in writing at least 60 days before the
   82  anticipated date of the change of ownership.
   83         b. The individual or entity applying for initial licensure
   84  due to a change of ownership must submit an application that
   85  must be received by the department at least 60 days before the
   86  date of change of ownership.
   87         c. Upon receipt of an application for a license, the
   88  department shall examine the application and, within 30 days
   89  after receipt, notify the applicant in writing of any apparent
   90  errors or omissions and request any additional information
   91  required.
   92         d. Requested information omitted from an application for
   93  licensure must be filed with the department within 21 days after
   94  the department’s request for omitted information or the
   95  application shall be deemed incomplete and shall be withdrawn
   96  from further consideration and the fees shall be forfeited.
   97  
   98  Within 30 days after the receipt of a complete application, the
   99  department shall approve or deny the application.
  100         2. A medical marijuana treatment center, and any individual
  101  or entity who directly or indirectly owns, controls, or holds
  102  with power to vote 5 percent or more of the voting shares of a
  103  medical marijuana treatment center, may not acquire direct or
  104  indirect ownership or control of any voting shares or other form
  105  of ownership of any other medical marijuana treatment center.
  106         3. A medical marijuana treatment center may not enter into
  107  any form of profit-sharing arrangement with the property owner
  108  or lessor of any of its facilities where cultivation,
  109  processing, storing, or dispensing of marijuana and marijuana
  110  delivery devices occurs.
  111         4. All employees of a medical marijuana treatment center
  112  must be 21 years of age or older and have passed a background
  113  screening pursuant to subsection (9).
  114         5. Each medical marijuana treatment center must adopt and
  115  enforce policies and procedures to ensure employees and
  116  volunteers receive training on the legal requirements to
  117  dispense marijuana to qualified patients.
  118         6. When growing marijuana, a medical marijuana treatment
  119  center:
  120         a. May use pesticides determined by the department, after
  121  consultation with the Department of Agriculture and Consumer
  122  Services, to be safely applied to plants intended for human
  123  consumption, but may not use pesticides designated as
  124  restricted-use pesticides pursuant to s. 487.042.
  125         b. Must grow marijuana within an enclosed structure and in
  126  a room separate from any other plant.
  127         c. Must inspect seeds and growing plants for plant pests
  128  that endanger or threaten the horticultural and agricultural
  129  interests of the state in accordance with chapter 581 and any
  130  rules adopted thereunder.
  131         d. Must perform fumigation or treatment of plants, or
  132  remove and destroy infested or infected plants, in accordance
  133  with chapter 581 and any rules adopted thereunder.
  134         7. Each medical marijuana treatment center must produce and
  135  make available for purchase at least one low-THC cannabis
  136  product.
  137         8. A medical marijuana treatment center that produces
  138  edibles must hold a permit to operate as a food establishment
  139  pursuant to chapter 500, the Florida Food Safety Act, and must
  140  comply with all the requirements for food establishments
  141  pursuant to chapter 500 and any rules adopted thereunder.
  142  Edibles may not contain more than 200 milligrams of
  143  tetrahydrocannabinol, and a single serving portion of an edible
  144  may not exceed 10 milligrams of tetrahydrocannabinol. Edibles
  145  may have a potency variance of no greater than 15 percent.
  146  Edibles may not be attractive to children; be manufactured in
  147  the shape of humans, cartoons, or animals; be manufactured in a
  148  form that bears any reasonable resemblance to products available
  149  for consumption as commercially available candy; or contain any
  150  color additives. To discourage consumption of edibles by
  151  children, the department shall determine by rule any shapes,
  152  forms, and ingredients allowed and prohibited for edibles.
  153  Medical marijuana treatment centers may not begin processing or
  154  dispensing edibles until after the effective date of the rule.
  155  The department shall also adopt sanitation rules providing the
  156  standards and requirements for the storage, display, or
  157  dispensing of edibles.
  158         9. Within 12 months after licensure, a medical marijuana
  159  treatment center must demonstrate to the department that all of
  160  its processing facilities have passed a Food Safety Good
  161  Manufacturing Practices, such as Global Food Safety Initiative
  162  or equivalent, inspection by a nationally accredited certifying
  163  body. A medical marijuana treatment center must immediately stop
  164  processing at any facility which fails to pass this inspection
  165  until it demonstrates to the department that such facility has
  166  met this requirement.
  167         10. A medical marijuana treatment center that produces
  168  prerolled marijuana cigarettes may not use wrapping paper made
  169  with tobacco or hemp.
  170         11. When processing marijuana, a medical marijuana
  171  treatment center must:
  172         a. Process the marijuana within an enclosed structure and
  173  in a room separate from other plants or products.
  174         b. Comply with department rules when processing marijuana
  175  with hydrocarbon solvents or other solvents or gases exhibiting
  176  potential toxicity to humans. The department shall determine by
  177  rule the requirements for medical marijuana treatment centers to
  178  use such solvents or gases exhibiting potential toxicity to
  179  humans.
  180         c. Comply with federal and state laws and regulations and
  181  department rules for solid and liquid wastes. The department
  182  shall determine by rule procedures for the storage, handling,
  183  transportation, management, and disposal of solid and liquid
  184  waste generated during marijuana production and processing. The
  185  Department of Environmental Protection shall assist the
  186  department in developing such rules.
  187         d. Test the processed marijuana using a medical marijuana
  188  testing laboratory before it is dispensed. Results must be
  189  verified and signed by two medical marijuana treatment center
  190  employees. Before dispensing, the medical marijuana treatment
  191  center must determine that the test results indicate that low
  192  THC cannabis meets the definition of low-THC cannabis, the
  193  concentration of tetrahydrocannabinol meets the potency
  194  requirements of this section, the labeling of the concentration
  195  of tetrahydrocannabinol and cannabidiol is accurate, and all
  196  marijuana is safe for human consumption and free from
  197  contaminants that are unsafe for human consumption. The
  198  department shall determine by rule which contaminants must be
  199  tested for and the maximum levels of each contaminant which are
  200  safe for human consumption. The Department of Agriculture and
  201  Consumer Services shall assist the department in developing the
  202  testing requirements for contaminants that are unsafe for human
  203  consumption in edibles. The department shall also determine by
  204  rule the procedures for the treatment of marijuana that fails to
  205  meet the testing requirements of this section, s. 381.988, or
  206  department rule. The department may select a random sample from
  207  edibles available for purchase in a dispensing facility which
  208  shall be tested by the department to determine that the edible
  209  meets the potency requirements of this section, is safe for
  210  human consumption, and the labeling of the tetrahydrocannabinol
  211  and cannabidiol concentration is accurate. A medical marijuana
  212  treatment center may not require payment from the department for
  213  the sample. A medical marijuana treatment center must recall
  214  edibles, including all edibles made from the same batch of
  215  marijuana, which fail to meet the potency requirements of this
  216  section, which are unsafe for human consumption, or for which
  217  the labeling of the tetrahydrocannabinol and cannabidiol
  218  concentration is inaccurate. The medical marijuana treatment
  219  center must retain records of all testing and samples of each
  220  homogenous batch of marijuana for at least 9 months. The medical
  221  marijuana treatment center must contract with a marijuana
  222  testing laboratory to perform audits on the medical marijuana
  223  treatment center’s standard operating procedures, testing
  224  records, and samples and provide the results to the department
  225  to confirm that the marijuana or low-THC cannabis meets the
  226  requirements of this section and that the marijuana or low-THC
  227  cannabis is safe for human consumption. A medical marijuana
  228  treatment center shall reserve two processed samples from each
  229  batch and retain such samples for at least 9 months for the
  230  purpose of such audits. A medical marijuana treatment center may
  231  use a laboratory that has not been certified by the department
  232  under s. 381.988 until such time as at least one laboratory
  233  holds the required certification, but in no event later than
  234  July 1, 2018.
  235         e. Package the marijuana in compliance with the United
  236  States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss.
  237  1471 et seq.
  238         f. Package the marijuana in a receptacle that has a firmly
  239  affixed and legible label stating the following information:
  240         (I) The marijuana or low-THC cannabis meets the
  241  requirements of sub-subparagraph d.
  242         (II) The name of the medical marijuana treatment center
  243  from which the marijuana originates.
  244         (III) The batch number and harvest number from which the
  245  marijuana originates and the date dispensed.
  246         (IV) The name of the physician who issued the physician
  247  certification.
  248         (V) The name of the patient.
  249         (VI) The product name, if applicable, and dosage form,
  250  including concentration of tetrahydrocannabinol and cannabidiol.
  251  The product name may not contain wording commonly associated
  252  with products marketed by or to children.
  253         (VII) The recommended dose.
  254         (VIII) A warning that it is illegal to transfer medical
  255  marijuana to another person.
  256         (IX) A marijuana universal symbol developed by the
  257  department.
  258         12. The medical marijuana treatment center shall include in
  259  each package a patient package insert with information on the
  260  specific product dispensed related to:
  261         a. Clinical pharmacology.
  262         b. Indications and use.
  263         c. Dosage and administration.
  264         d. Dosage forms and strengths.
  265         e. Contraindications.
  266         f. Warnings and precautions.
  267         g. Adverse reactions.
  268         13. In addition to the packaging and labeling requirements
  269  specified in subparagraphs 11. and 12., marijuana in a form for
  270  smoking must be packaged in a sealed receptacle with a legible
  271  and prominent warning to keep away from children and a warning
  272  that states marijuana smoke contains carcinogens and may
  273  negatively affect health. Such receptacles for marijuana in a
  274  form for smoking must be plain, opaque, and white without
  275  depictions of the product or images other than the medical
  276  marijuana treatment center’s department-approved logo and the
  277  marijuana universal symbol.
  278         14. The department shall adopt rules to regulate the types,
  279  appearance, and labeling of marijuana delivery devices dispensed
  280  from a medical marijuana treatment center. The rules must
  281  require marijuana delivery devices to have an appearance
  282  consistent with medical use.
  283         15. Each edible shall be individually sealed in plain,
  284  opaque wrapping marked only with the marijuana universal symbol.
  285  Where practical, each edible shall be marked with the marijuana
  286  universal symbol. In addition to the packaging and labeling
  287  requirements in subparagraphs 11. and 12., edible receptacles
  288  must be plain, opaque, and white without depictions of the
  289  product or images other than the medical marijuana treatment
  290  center’s department-approved logo and the marijuana universal
  291  symbol. The receptacle must also include a list of all the
  292  edible’s ingredients, storage instructions, an expiration date,
  293  a legible and prominent warning to keep away from children and
  294  pets, and a warning that the edible has not been produced or
  295  inspected pursuant to federal food safety laws.
  296         16. When dispensing marijuana or a marijuana delivery
  297  device, a medical marijuana treatment center:
  298         a. May dispense any active, valid order for low-THC
  299  cannabis, medical cannabis and cannabis delivery devices issued
  300  pursuant to former s. 381.986, Florida Statutes 2016, which was
  301  entered into the medical marijuana use registry before July 1,
  302  2017.
  303         b. May not dispense more than a 70-day supply of marijuana
  304  within any 70-day period to a qualified patient or caregiver.
  305  May not dispense more than one 35-day supply of marijuana in a
  306  form for smoking within any 35-day period to a qualified patient
  307  or caregiver. A 35-day supply of marijuana in a form for smoking
  308  may not exceed 2.5 ounces unless an exception to this amount is
  309  approved by the department pursuant to paragraph (4)(f).
  310         c. Must have the medical marijuana treatment center’s
  311  employee who dispenses the marijuana or a marijuana delivery
  312  device enter into the medical marijuana use registry his or her
  313  name or unique employee identifier.
  314         d. Must verify that the qualified patient and the
  315  caregiver, if applicable, each have an active registration in
  316  the medical marijuana use registry and an active and valid
  317  medical marijuana use registry identification card, the amount
  318  and type of marijuana dispensed matches the physician
  319  certification in the medical marijuana use registry for that
  320  qualified patient, and the physician certification has not
  321  already been filled.
  322         e. May not dispense marijuana to a qualified patient who is
  323  younger than 18 years of age. If the qualified patient is
  324  younger than 18 years of age, marijuana may only be dispensed to
  325  the qualified patient’s caregiver.
  326         f.May not dispense marijuana with a concentration of
  327  tetrahydrocannabinol which exceeds 10 percent to a qualified
  328  patient 18 to 21 years of age, to his or her caregiver, or to
  329  the caregiver of a qualified patient under 18 years of age for
  330  the qualified patient’s medical use. However, if a qualified
  331  patient younger than 21 years of age has an exception approved
  332  by the department under paragraph (4)(f) relating to the
  333  concentration of tetrahydrocannabinol or the qualified patient’s
  334  certification indicates that he or she is diagnosed with a
  335  terminal condition, marijuana with a concentration of
  336  tetrahydrocannabinol which exceeds 10 percent may be dispensed
  337  to such a qualified patient who is 18 years of age or older or
  338  to his or her caregiver or to such a qualified patient’s
  339  caregiver if the patient is younger than 18 years of age, for
  340  the qualified patient’s medical use.
  341         g.f. May not dispense or sell any other type of cannabis,
  342  alcohol, or illicit drug-related product, including pipes or
  343  wrapping papers made with tobacco or hemp, other than a
  344  marijuana delivery device required for the medical use of
  345  marijuana and which is specified in a physician certification.
  346         h.g. Must, upon dispensing the marijuana or marijuana
  347  delivery device, record in the registry the date, time,
  348  quantity, and form of marijuana dispensed; the type of marijuana
  349  delivery device dispensed; and the name and medical marijuana
  350  use registry identification number of the qualified patient or
  351  caregiver to whom the marijuana delivery device was dispensed.
  352         i.h. Must ensure that patient records are not visible to
  353  anyone other than the qualified patient, his or her caregiver,
  354  and authorized medical marijuana treatment center employees.
  355  
  356  ================= T I T L E  A M E N D M E N T ================
  357  And the title is amended as follows:
  358         Delete line 19
  359  and insert:
  360         Program; amending s. 381.986, F.S.; prohibiting
  361         qualified physicians from certifying for certain
  362         qualified patients marijuana with concentration of
  363         tetrahydrocannabinol exceeding a certain amount;
  364         providing exceptions; prohibiting medical marijuana
  365         treatment centers from dispensing for certain
  366         qualified patients marijuana with a concentration of
  367         tetrahydrocannabinol exceeding a certain amount;
  368         providing exceptions; amending s. 401.35, F.S.;
  369         clarifying