Florida Senate - 2019                              CS for SB 182
       By the Committee on Health Policy; and Senator Brandes
       588-02162-19                                           2019182c1
    1                        A bill to be entitled                      
    2         An act relating to smoking marijuana for medical use;
    3         amending s. 381.986, F.S.; redefining the term
    4         “medical use” to include the possession, use, or
    5         administration of marijuana in a form for smoking;
    6         conforming a provision to changes made by the act;
    7         requiring a patient’s informed consent form to include
    8         the risks specifically associated with smoking
    9         marijuana; requiring a certifying physician to make a
   10         determination in concurrence with a second physician
   11         who meets specified requirements before certifying a
   12         patient not diagnosed with a terminal condition to
   13         smoke marijuana for medical use; deleting a provision
   14         prohibiting a medical marijuana treatment center from
   15         dispensing or selling specified products; providing an
   16         effective date.
   18  Be It Enacted by the Legislature of the State of Florida:
   20         Section 1. Paragraph (j) of subsection (1), paragraph (a)
   21  of subsection (4), and paragraph (e) of subsection (8) of
   22  section 381.986, Florida Statutes, are amended to read:
   23         381.986 Medical use of marijuana.—
   24         (1) DEFINITIONS.—As used in this section, the term:
   25         (j) “Medical use” means the acquisition, possession, use,
   26  delivery, transfer, or administration of marijuana authorized by
   27  a physician certification. The term does not include:
   28         1. Possession, use, or administration of marijuana that was
   29  not purchased or acquired from a medical marijuana treatment
   30  center.
   31         2. Possession, use, or administration of marijuana in a
   32  form for smoking, in the form of commercially produced food
   33  items other than edibles, or of marijuana seeds or flower,
   34  except for flower in a sealed, tamper-proof receptacle for
   35  vaping.
   36         3. Use or administration of any form or amount of marijuana
   37  in a manner that is inconsistent with the qualified physician’s
   38  directions or physician certification.
   39         4. Transfer of marijuana to a person other than the
   40  qualified patient for whom it was authorized or the qualified
   41  patient’s caregiver on behalf of the qualified patient.
   42         5. Use or administration of marijuana in the following
   43  locations:
   44         a. On any form of public transportation, except for low-THC
   45  cannabis.
   46         b. In any public place, except for low-THC cannabis.
   47         c. In a qualified patient’s place of employment, except
   48  when permitted by his or her employer.
   49         d. In a state correctional institution, as defined in s.
   50  944.02, or a correctional institution, as defined in s. 944.241.
   51         e. On the grounds of a preschool, primary school, or
   52  secondary school, except as provided in s. 1006.062.
   53         f. In a school bus, a vehicle, an aircraft, or a motorboat,
   54  except for low-THC cannabis.
   56  For the purposes of this subparagraph, the exceptions for low
   57  THC cannabis do not include the smoking of low-THC cannabis.
   59         (a) A qualified physician may issue a physician
   60  certification only if the qualified physician:
   61         1. Conducted a physical examination while physically
   62  present in the same room as the patient and a full assessment of
   63  the medical history of the patient.
   64         2. Diagnosed the patient with at least one qualifying
   65  medical condition.
   66         3. Determined that the medical use of marijuana would
   67  likely outweigh the potential health risks for the patient, and
   68  such determination must be documented in the patient’s medical
   69  record. If a patient is younger than 18 years of age, a second
   70  physician must concur with this determination, and such
   71  concurrence must be documented in the patient’s medical record.
   72         4. Determined whether the patient is pregnant and
   73  documented such determination in the patient’s medical record. A
   74  physician may not issue a physician certification, except for
   75  low-THC cannabis, to a patient who is pregnant.
   76         5. Reviewed the patient’s controlled drug prescription
   77  history in the prescription drug monitoring program database
   78  established pursuant to s. 893.055.
   79         6. Reviews the medical marijuana use registry and confirmed
   80  that the patient does not have an active physician certification
   81  from another qualified physician.
   82         7. Registers as the issuer of the physician certification
   83  for the named qualified patient on the medical marijuana use
   84  registry in an electronic manner determined by the department,
   85  and:
   86         a. Enters into the registry the contents of the physician
   87  certification, including the patient’s qualifying condition and
   88  the dosage not to exceed the daily dose amount determined by the
   89  department, the amount and forms of marijuana authorized for the
   90  patient, and any types of marijuana delivery devices needed by
   91  the patient for the medical use of marijuana.
   92         b. Updates the registry within 7 days after any change is
   93  made to the original physician certification to reflect such
   94  change.
   95         c. Deactivates the registration of the qualified patient
   96  and the patient’s caregiver when the physician no longer
   97  recommends the medical use of marijuana for the patient.
   98         8. Obtains the voluntary and informed written consent of
   99  the patient for medical use of marijuana each time the qualified
  100  physician issues a physician certification for the patient,
  101  which shall be maintained in the patient’s medical record. The
  102  patient, or the patient’s parent or legal guardian if the
  103  patient is a minor, must sign the informed consent acknowledging
  104  that the qualified physician has sufficiently explained its
  105  content. The qualified physician must use a standardized
  106  informed consent form adopted in rule by the Board of Medicine
  107  and the Board of Osteopathic Medicine, which must include, at a
  108  minimum, information related to:
  109         a. The Federal Government’s classification of marijuana as
  110  a Schedule I controlled substance.
  111         b. The approval and oversight status of marijuana by the
  112  Food and Drug Administration.
  113         c. The current state of research on the efficacy of
  114  marijuana to treat the qualifying conditions set forth in this
  115  section.
  116         d. The potential for addiction.
  117         e. The potential effect that marijuana may have on a
  118  patient’s coordination, motor skills, and cognition, including a
  119  warning against operating heavy machinery, operating a motor
  120  vehicle, or engaging in activities that require a person to be
  121  alert or respond quickly.
  122         f. The potential side effects of marijuana use.
  123         g. The risks, benefits, and drug interactions of marijuana.
  124         h. The risks specifically associated with smoking
  125  marijuana.
  126         i.h. That the patient’s de-identified health information
  127  contained in the physician certification and medical marijuana
  128  use registry may be used for research purposes.
  130  For a patient not diagnosed with a terminal condition, if the
  131  certifying physician intends to certify the patient’s medical
  132  use of marijuana by way of smoking, the certifying physician
  133  must determine that smoking is the only means of administering
  134  medical marijuana that is likely to benefit the patient and a
  135  second physician must concur with that determination. The second
  136  physician must not be registered with the department as a
  137  certifying physician for any qualified patients. Such
  138  determination and concurrence must be documented in the
  139  patient’s medical record.
  141         (e) A licensed medical marijuana treatment center shall
  142  cultivate, process, transport, and dispense marijuana for
  143  medical use. A licensed medical marijuana treatment center may
  144  not contract for services directly related to the cultivation,
  145  processing, and dispensing of marijuana or marijuana delivery
  146  devices, except that a medical marijuana treatment center
  147  licensed pursuant to subparagraph (a)1. may contract with a
  148  single entity for the cultivation, processing, transporting, and
  149  dispensing of marijuana and marijuana delivery devices. A
  150  licensed medical marijuana treatment center must, at all times,
  151  maintain compliance with the criteria demonstrated and
  152  representations made in the initial application and the criteria
  153  established in this subsection. Upon request, the department may
  154  grant a medical marijuana treatment center a variance from the
  155  representations made in the initial application. Consideration
  156  of such a request shall be based upon the individual facts and
  157  circumstances surrounding the request. A variance may not be
  158  granted unless the requesting medical marijuana treatment center
  159  can demonstrate to the department that it has a proposed
  160  alternative to the specific representation made in its
  161  application which fulfills the same or a similar purpose as the
  162  specific representation in a way that the department can
  163  reasonably determine will not be a lower standard than the
  164  specific representation in the application. A variance may not
  165  be granted from the requirements in subparagraph 2. and
  166  subparagraphs (b)1. and 2.
  167         1. A licensed medical marijuana treatment center may
  168  transfer ownership to an individual or entity who meets the
  169  requirements of this section. A publicly traded corporation or
  170  publicly traded company that meets the requirements of this
  171  section is not precluded from ownership of a medical marijuana
  172  treatment center. To accommodate a change in ownership:
  173         a. The licensed medical marijuana treatment center shall
  174  notify the department in writing at least 60 days before the
  175  anticipated date of the change of ownership.
  176         b. The individual or entity applying for initial licensure
  177  due to a change of ownership must submit an application that
  178  must be received by the department at least 60 days before the
  179  date of change of ownership.
  180         c. Upon receipt of an application for a license, the
  181  department shall examine the application and, within 30 days
  182  after receipt, notify the applicant in writing of any apparent
  183  errors or omissions and request any additional information
  184  required.
  185         d. Requested information omitted from an application for
  186  licensure must be filed with the department within 21 days after
  187  the department’s request for omitted information or the
  188  application shall be deemed incomplete and shall be withdrawn
  189  from further consideration and the fees shall be forfeited.
  191  Within 30 days after the receipt of a complete application, the
  192  department shall approve or deny the application.
  193         2. A medical marijuana treatment center, and any individual
  194  or entity who directly or indirectly owns, controls, or holds
  195  with power to vote 5 percent or more of the voting shares of a
  196  medical marijuana treatment center, may not acquire direct or
  197  indirect ownership or control of any voting shares or other form
  198  of ownership of any other medical marijuana treatment center.
  199         3. A medical marijuana treatment center may not enter into
  200  any form of profit-sharing arrangement with the property owner
  201  or lessor of any of its facilities where cultivation,
  202  processing, storing, or dispensing of marijuana and marijuana
  203  delivery devices occurs.
  204         4. All employees of a medical marijuana treatment center
  205  must be 21 years of age or older and have passed a background
  206  screening pursuant to subsection (9).
  207         5. Each medical marijuana treatment center must adopt and
  208  enforce policies and procedures to ensure employees and
  209  volunteers receive training on the legal requirements to
  210  dispense marijuana to qualified patients.
  211         6. When growing marijuana, a medical marijuana treatment
  212  center:
  213         a. May use pesticides determined by the department, after
  214  consultation with the Department of Agriculture and Consumer
  215  Services, to be safely applied to plants intended for human
  216  consumption, but may not use pesticides designated as
  217  restricted-use pesticides pursuant to s. 487.042.
  218         b. Must grow marijuana within an enclosed structure and in
  219  a room separate from any other plant.
  220         c. Must inspect seeds and growing plants for plant pests
  221  that endanger or threaten the horticultural and agricultural
  222  interests of the state in accordance with chapter 581 and any
  223  rules adopted thereunder.
  224         d. Must perform fumigation or treatment of plants, or
  225  remove and destroy infested or infected plants, in accordance
  226  with chapter 581 and any rules adopted thereunder.
  227         7. Each medical marijuana treatment center must produce and
  228  make available for purchase at least one low-THC cannabis
  229  product.
  230         8. A medical marijuana treatment center that produces
  231  edibles must hold a permit to operate as a food establishment
  232  pursuant to chapter 500, the Florida Food Safety Act, and must
  233  comply with all the requirements for food establishments
  234  pursuant to chapter 500 and any rules adopted thereunder.
  235  Edibles may not contain more than 200 milligrams of
  236  tetrahydrocannabinol, and a single serving portion of an edible
  237  may not exceed 10 milligrams of tetrahydrocannabinol. Edibles
  238  may have a potency variance of no greater than 15 percent.
  239  Edibles may not be attractive to children; be manufactured in
  240  the shape of humans, cartoons, or animals; be manufactured in a
  241  form that bears any reasonable resemblance to products available
  242  for consumption as commercially available candy; or contain any
  243  color additives. To discourage consumption of edibles by
  244  children, the department shall determine by rule any shapes,
  245  forms, and ingredients allowed and prohibited for edibles.
  246  Medical marijuana treatment centers may not begin processing or
  247  dispensing edibles until after the effective date of the rule.
  248  The department shall also adopt sanitation rules providing the
  249  standards and requirements for the storage, display, or
  250  dispensing of edibles.
  251         9. Within 12 months after licensure, a medical marijuana
  252  treatment center must demonstrate to the department that all of
  253  its processing facilities have passed a Food Safety Good
  254  Manufacturing Practices, such as Global Food Safety Initiative
  255  or equivalent, inspection by a nationally accredited certifying
  256  body. A medical marijuana treatment center must immediately stop
  257  processing at any facility which fails to pass this inspection
  258  until it demonstrates to the department that such facility has
  259  met this requirement.
  260         10. When processing marijuana, a medical marijuana
  261  treatment center must:
  262         a. Process the marijuana within an enclosed structure and
  263  in a room separate from other plants or products.
  264         b. Comply with department rules when processing marijuana
  265  with hydrocarbon solvents or other solvents or gases exhibiting
  266  potential toxicity to humans. The department shall determine by
  267  rule the requirements for medical marijuana treatment centers to
  268  use such solvents or gases exhibiting potential toxicity to
  269  humans.
  270         c. Comply with federal and state laws and regulations and
  271  department rules for solid and liquid wastes. The department
  272  shall determine by rule procedures for the storage, handling,
  273  transportation, management, and disposal of solid and liquid
  274  waste generated during marijuana production and processing. The
  275  Department of Environmental Protection shall assist the
  276  department in developing such rules.
  277         d. Test the processed marijuana using a medical marijuana
  278  testing laboratory before it is dispensed. Results must be
  279  verified and signed by two medical marijuana treatment center
  280  employees. Before dispensing, the medical marijuana treatment
  281  center must determine that the test results indicate that low
  282  THC cannabis meets the definition of low-THC cannabis, the
  283  concentration of tetrahydrocannabinol meets the potency
  284  requirements of this section, the labeling of the concentration
  285  of tetrahydrocannabinol and cannabidiol is accurate, and all
  286  marijuana is safe for human consumption and free from
  287  contaminants that are unsafe for human consumption. The
  288  department shall determine by rule which contaminants must be
  289  tested for and the maximum levels of each contaminant which are
  290  safe for human consumption. The Department of Agriculture and
  291  Consumer Services shall assist the department in developing the
  292  testing requirements for contaminants that are unsafe for human
  293  consumption in edibles. The department shall also determine by
  294  rule the procedures for the treatment of marijuana that fails to
  295  meet the testing requirements of this section, s. 381.988, or
  296  department rule. The department may select a random sample from
  297  edibles available for purchase in a dispensing facility which
  298  shall be tested by the department to determine that the edible
  299  meets the potency requirements of this section, is safe for
  300  human consumption, and the labeling of the tetrahydrocannabinol
  301  and cannabidiol concentration is accurate. A medical marijuana
  302  treatment center may not require payment from the department for
  303  the sample. A medical marijuana treatment center must recall
  304  edibles, including all edibles made from the same batch of
  305  marijuana, which fail to meet the potency requirements of this
  306  section, which are unsafe for human consumption, or for which
  307  the labeling of the tetrahydrocannabinol and cannabidiol
  308  concentration is inaccurate. The medical marijuana treatment
  309  center must retain records of all testing and samples of each
  310  homogenous batch of marijuana for at least 9 months. The medical
  311  marijuana treatment center must contract with a marijuana
  312  testing laboratory to perform audits on the medical marijuana
  313  treatment center’s standard operating procedures, testing
  314  records, and samples and provide the results to the department
  315  to confirm that the marijuana or low-THC cannabis meets the
  316  requirements of this section and that the marijuana or low-THC
  317  cannabis is safe for human consumption. A medical marijuana
  318  treatment center shall reserve two processed samples from each
  319  batch and retain such samples for at least 9 months for the
  320  purpose of such audits. A medical marijuana treatment center may
  321  use a laboratory that has not been certified by the department
  322  under s. 381.988 until such time as at least one laboratory
  323  holds the required certification, but in no event later than
  324  July 1, 2018.
  325         e. Package the marijuana in compliance with the United
  326  States Poison Prevention Packaging Act of 1970, 15 U.S.C. ss.
  327  1471 et seq.
  328         f. Package the marijuana in a receptacle that has a firmly
  329  affixed and legible label stating the following information:
  330         (I) The marijuana or low-THC cannabis meets the
  331  requirements of sub-subparagraph d.
  332         (II) The name of the medical marijuana treatment center
  333  from which the marijuana originates.
  334         (III) The batch number and harvest number from which the
  335  marijuana originates and the date dispensed.
  336         (IV) The name of the physician who issued the physician
  337  certification.
  338         (V) The name of the patient.
  339         (VI) The product name, if applicable, and dosage form,
  340  including concentration of tetrahydrocannabinol and cannabidiol.
  341  The product name may not contain wording commonly associated
  342  with products marketed by or to children.
  343         (VII) The recommended dose.
  344         (VIII) A warning that it is illegal to transfer medical
  345  marijuana to another person.
  346         (IX) A marijuana universal symbol developed by the
  347  department.
  348         11. The medical marijuana treatment center shall include in
  349  each package a patient package insert with information on the
  350  specific product dispensed related to:
  351         a. Clinical pharmacology.
  352         b. Indications and use.
  353         c. Dosage and administration.
  354         d. Dosage forms and strengths.
  355         e. Contraindications.
  356         f. Warnings and precautions.
  357         g. Adverse reactions.
  358         12. Each edible shall be individually sealed in plain,
  359  opaque wrapping marked only with the marijuana universal symbol.
  360  Where practical, each edible shall be marked with the marijuana
  361  universal symbol. In addition to the packaging and labeling
  362  requirements in subparagraphs 10. and 11., edible receptacles
  363  must be plain, opaque, and white without depictions of the
  364  product or images other than the medical marijuana treatment
  365  center’s department-approved logo and the marijuana universal
  366  symbol. The receptacle must also include a list all of the
  367  edible’s ingredients, storage instructions, an expiration date,
  368  a legible and prominent warning to keep away from children and
  369  pets, and a warning that the edible has not been produced or
  370  inspected pursuant to federal food safety laws.
  371         13. When dispensing marijuana or a marijuana delivery
  372  device, a medical marijuana treatment center:
  373         a. May dispense any active, valid order for low-THC
  374  cannabis, medical cannabis and cannabis delivery devices issued
  375  pursuant to former s. 381.986, Florida Statutes 2016, which was
  376  entered into the medical marijuana use registry before July 1,
  377  2017.
  378         b. May not dispense more than a 70-day supply of marijuana
  379  to a qualified patient or caregiver.
  380         c. Must have the medical marijuana treatment center’s
  381  employee who dispenses the marijuana or a marijuana delivery
  382  device enter into the medical marijuana use registry his or her
  383  name or unique employee identifier.
  384         d. Must verify that the qualified patient and the
  385  caregiver, if applicable, each have an active registration in
  386  the medical marijuana use registry and an active and valid
  387  medical marijuana use registry identification card, the amount
  388  and type of marijuana dispensed matches the physician
  389  certification in the medical marijuana use registry for that
  390  qualified patient, and the physician certification has not
  391  already been filled.
  392         e. May not dispense marijuana to a qualified patient who is
  393  younger than 18 years of age. If the qualified patient is
  394  younger than 18 years of age, marijuana may only be dispensed to
  395  the qualified patient’s caregiver.
  396         f. May not dispense or sell any other type of cannabis,
  397  alcohol, or illicit drug-related product, including pipes,
  398  bongs, or wrapping papers, other than a marijuana delivery
  399  device required for the medical use of marijuana and which is
  400  specified in a physician certification.
  401         g. Must, upon dispensing the marijuana or marijuana
  402  delivery device, record in the registry the date, time,
  403  quantity, and form of marijuana dispensed; the type of marijuana
  404  delivery device dispensed; and the name and medical marijuana
  405  use registry identification number of the qualified patient or
  406  caregiver to whom the marijuana delivery device was dispensed.
  407         h. Must ensure that patient records are not visible to
  408  anyone other than the qualified patient, his or her caregiver,
  409  and authorized medical marijuana treatment center employees.
  410         Section 2. This act shall take effect upon becoming a law.