Florida Senate - 2017                        COMMITTEE AMENDMENT
       Bill No. SB 406
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  04/04/2017           .                                

       The Committee on Health Policy (Bradley) recommended the
    1         Senate Amendment (with title amendment)
    3         Delete lines 616 - 775
    4  and insert:
    5         2. Have the marijuana tested by an independent testing
    6  laboratory to ensure it meets the standards established by the
    7  department’s quality control program Test the processed low-THC
    8  cannabis and medical cannabis before it is they are dispensed.
    9  Results must be verified and signed by two dispensing
   10  organization employees. Before dispensing low-THC cannabis, the
   11  dispensing organization must determine that the test results
   12  indicate that the low-THC cannabis meets the definition of low
   13  THC cannabis and, for medical cannabis and low-THC cannabis,
   14  that all medical cannabis and low-THC cannabis is safe for human
   15  consumption and free from contaminants that are unsafe for human
   16  consumption. The dispensing organization must retain records of
   17  all testing and samples of each homogenous batch of cannabis and
   18  low-THC cannabis for at least 9 months. The dispensing
   19  organization must contract with an independent testing
   20  laboratory to perform audits on the dispensing organization’s
   21  standard operating procedures, testing records, and samples and
   22  provide the results to the department to confirm that the low
   23  THC cannabis or medical cannabis meets the requirements of this
   24  section and that the medical cannabis and low-THC cannabis is
   25  safe for human consumption.
   26         3. Package the marijuana low-THC cannabis or medical
   27  cannabis in compliance with the United States Poison Prevention
   28  Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.
   29         4. Package the marijuana low-THC cannabis or medical
   30  cannabis in a child-proof receptacle that has a firmly affixed
   31  and legible label stating the following information:
   32         a. A statement that the marijuana low-THC cannabis or
   33  medical cannabis meets the requirements of subparagraph 2.;
   34         b. The name of the MMTC dispensing organization from which
   35  the marijuana medical cannabis or low-THC cannabis originates;
   36  and
   37         c. The batch number and harvest number from which the
   38  marijuana medical cannabis or low-THC cannabis originates; and
   39         d.The concentration of tetrahydrocannabinol and
   40  cannabidiol in the product.
   41         e. Any other information required by department rule
   42         5. Reserve two processed samples from each batch and retain
   43  such samples for at least 9 months for the purpose of testing
   44  pursuant to the audit required under subparagraph 2.
   45         (c) When dispensing marijuana low-THC cannabis, medical
   46  cannabis, or a marijuana cannabis delivery device, an MMTC a
   47  dispensing organization:
   48         1. May not dispense more than the a 45-day supply of
   49  marijuana authorized by a qualifying patient’s physician
   50  certification low-THC cannabis or medical cannabis to a
   51  qualifying patient or caregiver the patient’s legal
   52  representative.
   53         2. Must ensure its have the dispensing organization’s
   54  employee who dispenses the marijuana low-THC cannabis, medical
   55  cannabis, or marijuana a cannabis delivery device enters enter
   56  into the compassionate use registry his or her name or unique
   57  employee identifier.
   58         3. Must verify that the qualifying patient and the
   59  caregiver, if applicable, both have an active and valid
   60  compassionate use registry identification card and that the
   61  amount and type of marijuana dispensed matches the physician’s
   62  certification in the compassionate use registry for that
   63  qualifying patient that a physician has ordered the low-THC
   64  cannabis, medical cannabis, or a specific type of a cannabis
   65  delivery device for the patient.
   66         4.Must label the marijuana with the recommended dose for
   67  the qualifying patient receiving the marijuana.
   68         5.4. May not dispense or sell any other type of marijuana
   69  cannabis, alcohol, or illicit drug-related product, including
   70  pipes, bongs, or wrapping papers, other than a physician-ordered
   71  cannabis delivery device required for the medical use of
   72  marijuana that is specified in a physician certification low-THC
   73  cannabis or medical cannabis, while dispensing low-THC cannabis
   74  or medical cannabis. A registered MMTC may produce and dispense
   75  marijuana as an edible or food product but may not produce such
   76  items in a format designed to be attractive to children. In
   77  addition to the requirements of this section and department
   78  rule, food products produced by an MMTC must meet all food
   79  safety standards established in state and federal law,
   80  including, but not limited to, the identification of the serving
   81  size and the amount of THC in each serving.
   82         5. Must verify that the patient has an active registration
   83  in the compassionate use registry, the patient or patient’s
   84  legal representative holds a valid and active registration card,
   85  the order presented matches the order contents as recorded in
   86  the registry, and the order has not already been filled.
   87         6. Must, upon dispensing the marijuana low-THC cannabis,
   88  medical cannabis, or marijuana cannabis delivery device, record
   89  in the registry the date, time, quantity, and form of marijuana
   90  low-THC cannabis or medical cannabis dispensed; and the type of
   91  marijuana cannabis delivery device dispensed; and the name and
   92  compassionate use registry identification number of the
   93  qualifying patient or caregiver to whom the marijuana delivery
   94  device was dispensed.
   95         (d) To ensure the safety and security of its premises and
   96  any off-site storage facilities, and to maintain adequate
   97  controls against the diversion, theft, and loss of marijuana
   98  low-THC cannabis, medical cannabis, or marijuana cannabis
   99  delivery devices, an MMTC a dispensing organization shall:
  100         1.a. Maintain a fully operational security alarm system
  101  that secures all entry points and perimeter windows and is
  102  equipped with motion detectors; pressure switches; and duress,
  103  panic, and hold-up alarms; or
  104         b. Maintain a video surveillance system that records
  105  continuously 24 hours each day and meets at least one of the
  106  following criteria:
  107         (I) Cameras are fixed in a place that allows for the clear
  108  identification of persons and activities in controlled areas of
  109  the premises. Controlled areas include grow rooms, processing
  110  rooms, storage rooms, disposal rooms or areas, and point-of-sale
  111  rooms;
  112         (II) Cameras are fixed in entrances and exits to the
  113  premises, which shall record from both indoor and outdoor, or
  114  ingress and egress, vantage points;
  115         (III) Recorded images must clearly and accurately display
  116  the time and date; or
  117         (IV) Retain video surveillance recordings for a minimum of
  118  45 days, or longer upon the request of a law enforcement agency.
  119         2. Ensure that the MMTC’s organization’s outdoor premises
  120  have sufficient lighting from dusk until dawn.
  121         3. Implement Establish and maintain a tracking system using
  122  a vendor approved by the department which that traces the
  123  marijuana low-THC cannabis or medical cannabis from seed to
  124  sale. The tracking system must shall include notification of key
  125  events as determined by the department, including when cannabis
  126  seeds are planted, when cannabis plants are harvested and
  127  destroyed, and when marijuana low-THC cannabis or medical
  128  cannabis is transported, sold, stolen, diverted, or lost.
  129         4. Not dispense from its premises marijuana low-THC
  130  cannabis, medical cannabis, or a cannabis delivery device
  131  between the hours of 9 p.m. and 7 a.m., but may perform all
  132  other operations and deliver marijuana low-THC cannabis and
  133  medical cannabis to qualifying qualified patients 24 hours each
  134  day.
  135         5. Store marijuana low-THC cannabis or medical cannabis in
  136  a secured, locked room or a vault.
  137         6. Require at least two of its employees, or two employees
  138  of a security agency with whom it contracts, to be on the
  139  premises at all times.
  140         7. Require each employee or contractor to wear a photo
  141  identification badge at all times while on the premises.
  142         8. Require each visitor to wear a visitor’s pass at all
  143  times while on the premises.
  144         9. Implement an alcohol and drug-free workplace policy.
  145         10. Report to local law enforcement within 24 hours after
  146  it is notified or becomes aware of the theft, diversion, or loss
  147  of marijuana low-THC cannabis or medical cannabis.
  148         (e) To ensure the safe transport of marijuana low-THC
  149  cannabis or medical cannabis to MMTC dispensing organization
  150  facilities, independent testing laboratories, or qualifying
  151  patients, the MMTC dispensing organization must:
  152         1. Maintain a transportation manifest, which must be
  153  retained for at least 1 year. A copy of the manifest must be in
  154  the vehicle at all times when transporting marijuana.
  155         2. Ensure only vehicles in good working order are used to
  156  transport marijuana low-THC cannabis or medical cannabis.
  157         3. Lock marijuana low-THC cannabis or medical cannabis in a
  158  separate compartment or container within the vehicle.
  159         4. Require at least two persons to be in a vehicle
  160  transporting marijuana low-THC cannabis or medical cannabis, and
  161  require at least one person to remain in the vehicle while the
  162  marijuana low-THC cannabis or medical cannabis is being
  163  delivered.
  164         5. Provide specific safety and security training to
  165  employees transporting or delivering marijuana low-THC cannabis
  166  or medical cannabis.
  169         (a)The department shall establish a quality control
  170  program requiring marijuana to be tested by an independent
  171  testing laboratory for potency and contaminants before sale to
  172  qualifying patients and caregivers.
  173         1. The quality control program must require MMTCs to submit
  174  samples from each batch or lot of marijuana harvested or
  175  manufactured to an independent testing laboratory for testing to
  176  ensure, at a minimum, that the labeling of the potency of
  177  tetrahydrocannabinol and all other marketed cannabinoids or
  178  terpenes is accurate and that the medical cannabis dispensed to
  179  qualifying patients is safe for human consumption.
  180         2. An MMTC must maintain records of all tests conducted,
  181  including the results of each test and any additional
  182  information, as required by the department.
  183         3. The department shall adopt all rules necessary to create
  184  and oversee the quality control program, which must include, at
  185  a minimum:
  186         a.Permissible levels of variation in potency labeling and
  187  standards requiring tetrahydrocannabinol in edible marijuana
  188  products to be distributed consistently throughout the product;
  189         b. Permissible levels of contaminants and mandatory testing
  190  for contaminants to confirm that the tested marijuana is safe
  191  for human consumption. This testing must include, but is not
  192  limited to, testing for microbiological impurity, residual
  193  solvents, and pesticide residues;
  194         c.The destruction of medical cannabis determined to be
  195  inaccurately labeled or unsafe for human consumption after the
  196  MMTC has an opportunity to take remedial action;
  197         d.The collection, storage, handling, recording, and
  198  destruction of samples of marijuana by independent testing
  199  laboratories; and
  200         e.Security, inventory tracking, and record retention.
  201         (b) The department must license all independent testing
  202  laboratories to ensure that all marijuana is tested for potency
  203  and contaminants in accordance with the department’s quality
  204  control program. An independent testing laboratory may collect
  205  and accept samples of, and possess, store, transport, and test
  206  marijuana. An independent testing laboratory may not be owned by
  207  a person who also possesses an ownership interest in an MMTC. A
  208  clinical laboratory licensed by the agency pursuant to Part I of
  209  chapter 483 and that performs non-waived clinical tests is
  210  exempt from the requirement to be licensed by the department
  211  pursuant to this paragraph but must be certified to perform all
  212  required tests pursuant to subparagraph 2.
  213         1. The department shall develop rules establishing
  214  independent testing laboratory license requirements and a
  215  process for licensing independent testing laboratories; develop
  216  an application form for an independent testing laboratory
  217  license; and impose an initial application fee and a biennial
  218  renewal fee sufficient to cover the costs of administering this
  219  subsection.
  220         2. In addition to licensure, an independent testing
  221  laboratory must be certified to perform all required tests by
  222  the department. The department must issue a certification to an
  223  independent testing laboratory that has been certified by a
  224  third-party laboratory certification body approved by the
  225  department. The department shall establish reasonable rules for
  226  the certification and operation of independent testing
  227  laboratories. Rules for certification must, at a minimum,
  228  address standards relating to:
  229         a.Personnel qualifications;
  230         b.Equipment and methodology;
  231         c.Proficiency testing;
  232         d.Tracking;
  233         e.Sampling;
  234         f.Chain of custody;
  235         g.Record and sample retention;
  236         h.Reporting;
  237         i.Audit and inspection; and
  238         j.Security.
  239         3. The department shall suspend or reduce any mandatory
  240  testing requirement specified in its quality control program if
  241  the number of licensed and certified independent testing
  242  laboratories is insufficient to process the tests necessary to
  243  meet the patient demand for MMTCs.
  244         4. An independent testing laboratory may accept only
  245  samples composed of marijuana which are obtained from a sample
  246  source approved by the department. At a minimum, these sources
  247  must include an MMTC, a researcher affiliated with an accredited
  248  university or research hospital, a qualifying patient, and a
  249  caregiver.
  251  ================= T I T L E  A M E N D M E N T ================
  252  And the title is amended as follows:
  253         Delete line 53
  254  and insert:
  255         times; requiring the department to establish a quality
  256         control program that requires medical marijuana
  257         treatment centers to submit samples from each batch or
  258         lot of marijuana to an independent testing laboratory;
  259         requiring a medical marijuana treatment center to
  260         maintain records of all tests conducted; requiring the
  261         department to adopt rules to create and oversee the
  262         quality control program; providing that the department
  263         must license independent testing laboratories;
  264         authorizing an independent testing laboratory to
  265         collect and accept samples of, possess, store,
  266         transport, and test marijuana; prohibiting a person
  267         with an ownership interest in a medical marijuana
  268         treatment center from owning an independent testing
  269         laboratory; requiring the department to develop rules
  270         and a process for licensing requirements; authorizing
  271         the department to impose application and renewal fees;
  272         specifying that an independent testing laboratory must
  273         be certified to perform required tests; requiring the
  274         department to suspend or reduce any mandatory testing
  275         if the number of licensed and certified independent
  276         testing laboratories is insufficient to process the
  277         tests necessary to meet the patient demand for medical
  278         marijuana treatment centers; providing that an
  279         independent testing laboratory may only accept certain
  280         samples; requiring the department to adopt rules
  281         related