Florida Senate - 2019              PROPOSED COMMITTEE SUBSTITUTE
       Bill No. CS for SB 1528
       
       
       
       
       
                               Ì7126569Î712656                          
       
       576-04097-19                                                    
       Proposed Committee Substitute by the Committee on Appropriations
       (Appropriations Subcommittee on Health and Human Services)
    1                        A bill to be entitled                      
    2         An act relating to the Canadian Prescription Drug
    3         Importation Program; creating s. 381.02035, F.S.;
    4         requiring the Agency for Health Care Administration to
    5         establish the Canadian Prescription Drug Importation
    6         Program; defining terms; authorizing a Canadian
    7         supplier to export drugs into this state under the
    8         program under certain circumstances; providing
    9         eligibility criteria and requirements for drug
   10         importers; requiring the agency to contract with a
   11         vendor to facilitate wholesale prescription drug
   12         importation under the program; providing
   13         responsibilities for the vendor; providing eligibility
   14         criteria for prescription drugs, Canadian suppliers,
   15         and importers under the program; requiring
   16         participating Canadian suppliers and importers to
   17         comply with specified federal requirements for
   18         distributing prescription drugs imported under the
   19         program; prohibiting Canadian suppliers and importers
   20         from distributing, dispensing, or selling prescription
   21         drugs imported under the program outside of this
   22         state; providing certain documentation requirements;
   23         requiring the agency to suspend the importation of
   24         drugs in violation of this section or any federal or
   25         state law or regulation; authorizing the agency to
   26         revoke the suspension under certain circumstances;
   27         requiring the agency to request federal approval of
   28         the program; requiring the request to include certain
   29         information; requiring the agency to begin operating
   30         the program within a specified timeframe after
   31         receiving federal approval; requiring the agency, in
   32         consultation with the vendor, to submit an annual
   33         report to the Governor and the Legislature by a
   34         specified date; providing requirements for such
   35         report; authorizing the agency to adopt rules;
   36         providing an effective date.
   37          
   38  Be It Enacted by the Legislature of the State of Florida:
   39  
   40         Section 1. Section 381.02035, Florida Statutes, is created
   41  to read:
   42         381.02035 Canadian Prescription Drug Importation Program.—
   43         (1)PROGRAM ESTABLISHED.—The Agency for Health Care
   44  Administration shall establish a program for the importation of
   45  safe and effective prescription drugs from Canada which have the
   46  highest potential for cost savings to the state.
   47         (2) DEFINITIONS.—As used in this section, the term:
   48         (a)“Agency” means the Agency for Health Care
   49  Administration.
   50         (b)“Canadian supplier” means a manufacturer, wholesale
   51  distributor, or pharmacy appropriately licensed or permitted
   52  under Canadian law to manufacture, distribute, or dispense
   53  prescription drugs.
   54         (c)“Drug” or “prescription drug” has the same meaning as
   55  “prescription drug” in s. 499.003.
   56         (d)“Federal act” means the Federal Food, Drug, and
   57  Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
   58  as amended by the Drug Quality and Security Act, 21 U.S.C. 351
   59  et seq.
   60         (e)“Importer” means a wholesale distributor, pharmacy, or
   61  pharmacist importing prescription drugs into this state under
   62  the program.
   63         (f)“Pharmacist” means a person who holds an active and
   64  unencumbered license to practice pharmacy pursuant to chapter
   65  465.
   66         (g)“Program” means the Canadian Prescription Drug
   67  Importation Program.
   68         (h) “Track-and-trace” means the product-tracing process for
   69  the components of the pharmaceutical distribution supply chain
   70  as described in Title II of the Drug Quality and Security Act,
   71  Drug Supply Chain Security Act, 21 U.S.C. 351 et seq.
   72         (i)“Vendor” means the entity contracted by the agency to
   73  manage specified functions of the program.
   74         (3)ELIGIBLE CANADIAN SUPPLIERS.—A Canadian supplier may
   75  export drugs into this state under the program if the supplier
   76  meets all of the following requirements:
   77         (a)Complies fully with relevant Canadian federal and
   78  provincial laws and regulations.
   79         (b)Complies fully with the federal act, including all
   80  other state and federal law and regulations relating to the
   81  track-and-trace requirements at the package level.
   82         (c)Submits evidence at time of contract award and
   83  throughout the contract term of a surety bond or comparable
   84  security arrangement from this state or any other state in the
   85  United States in the minimum amount of $1 million. The agency
   86  shall reevaluate and adjust the amount of the bond annually,
   87  based on program volume. The surety bond or comparable security
   88  arrangement must include the State of Florida as a beneficiary.
   89  In lieu of the surety bond, the supplier may provide a
   90  comparable security arrangement such as an irrevocable letter of
   91  credit or a deposit into a trust account or financial
   92  institution which includes the State of Florida as a
   93  beneficiary. The purposes of the bond or other security
   94  arrangements for the program are to:
   95         1.Ensure payment of any administrative penalties imposed
   96  by the agency or any other state agency under the contract when
   97  the supplier fails to pay within 30 days after assessment;
   98         2.Ensure performance of contractual and statutory
   99  obligations by the supplier through use of a bond or other
  100  comparable security arrangements to receive payment of any other
  101  costs or fees incurred by the agency, the state, or other
  102  entities acting on behalf of the state if the supplier is non
  103  compliant with its contractual and statutory obligations. If the
  104  supplier is assessed a penalty under the program and fails to
  105  pay within 30 days after that assessment, the agency, the state,
  106  or an entity acting on behalf of the state may file a claim for
  107  reimbursement against the bond or other comparable security
  108  arrangement; and
  109         3.Allow for claims to be made against the bond or other
  110  comparable security arrangements for up to 1 year after the
  111  supplier’s contract under the program has ended with the agency
  112  or the state, the supplier’s license is no longer valid, or the
  113  program has ended, whichever occurs last.
  114  
  115  A surety bond or other comparable security arrangement is
  116  required regardless of the type of bid or negotiation process
  117  used by the agency or the type of final contract or agreement
  118  executed for services.
  119         (d)Is identified by the vendor as eligible to participate
  120  in the program.
  121         (e) Submits evidence at the time of contract award and
  122  throughout the contract term of a surety bond or a comparable
  123  security arrangement from this state or any other state in the
  124  United States in the minimum amount of $1 million. The agency
  125  shall reevaluate and adjust the amount of the bond annually,
  126  based on program volume. The surety bond or comparable security
  127  arrangement must include the State of Florida as a beneficiary.
  128  In lieu of the surety bond, the supplier may provide a
  129  comparable security arrangement, such as an irrevocable letter
  130  of credit or a deposit into a trust account or financial
  131  institution which includes the State of Florida as a
  132  beneficiary. The purposes of the bond or other security
  133  arrangement for the program are to:
  134         1.Indemnify the supplier in the event that any civil or
  135  criminal legal action is brought by the state, the agency, any
  136  other state agency, or private individuals or entities against
  137  the supplier because of the supplier’s failure to perform under
  138  the contract, including, but not limited to, causes of action
  139  for personal injury, negligence, and wrongful death;
  140         2.Ensure payment by the supplier of legal judgments and
  141  claims that have been awarded to the state, the agency, other
  142  entities acting on behalf of the state, individuals, or
  143  organizations if the supplier is assessed a final judgment or
  144  other monetary penalty in a court of law for a civil or criminal
  145  action related to participation in the program. The bond or
  146  comparable security arrangement may be accessed if the supplier
  147  fails to pay any judgment or claim within 60 days after final
  148  judgment; and
  149         3.Allow for civil and criminal litigation claims to be
  150  made against the bond or other comparable security arrangement
  151  for up to 1 year after the supplier’s contract under the program
  152  has ended with the agency or the state, the supplier’s license
  153  is no longer valid, or the program has ended, whichever occurs
  154  last.
  155         (4)ELIGIBLE IMPORTERS.—
  156         (a)The following entities or persons may import
  157  prescription drugs from a Canadian supplier under the program:
  158         1.A wholesale distributor.
  159         2.A pharmacy.
  160         3.A pharmacist.
  161         (b)An eligible importer must meet all of the following
  162  requirements at the time of contract award and throughout the
  163  contract term:
  164         1.Register with the vendor before importing drugs into
  165  this state under the program and be deemed in compliance with
  166  all requirements, including any relevant provisions of the
  167  federal act.
  168         2.Submit evidence at the time of contract award and
  169  throughout the contract term of a surety bond or other
  170  comparable security arrangement from this state or any other
  171  state in the United States in the minimum amount of $1 million.
  172  The surety bond or comparable security arrangement must include
  173  the State of Florida as a beneficiary. In lieu of the surety
  174  bond, the importer may provide a comparable security agreement,
  175  such as an irrevocable letter of credit or a deposit into a
  176  trust account or financial institution which includes the State
  177  of Florida as a beneficiary, payable to the State of Florida.
  178  The purposes of the bond or other security arrangement for the
  179  program are to:
  180         a.Ensure payment of any administrative penalties imposed
  181  by the agency or any other state agency under the contract when
  182  the importer fails to pay within 30 days after assessment;
  183         b.Ensure that the importer meets contractual and statutory
  184  obligations through use of a bond or other comparable security
  185  arrangements to pay any other costs or fees incurred by the
  186  agency, the state, or other entities acting on behalf of the
  187  state if the importer fails to meet its contractual and
  188  statutory obligations. If the importer is assessed a penalty
  189  under the program and fails to pay within 30 days after that
  190  assessment, the agency, the state, or an entity acting on behalf
  191  of the state may file a claim for reimbursement against the bond
  192  or other comparable security arrangement; and
  193         c.Allow for claims to be made against the bond or other
  194  comparable security arrangements for up to 1 year after the
  195  importer’s contract under the program has ended with the agency
  196  or the state, the importer’s license is no longer valid, or the
  197  program has ended, whichever occurs last.
  198  
  199  A surety bond or comparable document is required, regardless of
  200  the type of bid or negotiation process the agency used or the
  201  type of final contract or agreement executed for services.
  202         (c) An eligible importer must submit evidence at the time
  203  of contract award and throughout the contract term of a surety
  204  bond or comparable security arrangement from this state or any
  205  other state in the United States in the minimum amount of $1
  206  million. The agency shall reevaluate and adjust the amount of
  207  the bond annually, based on program volume. The surety bond or
  208  comparable security arrangement must include the State of
  209  Florida as a beneficiary. In lieu of the surety bond, the
  210  importer may provide a comparable security agreement, such as an
  211  irrevocable letter of credit or a deposit into a trust account
  212  or financial institution which includes the State of Florida as
  213  a beneficiary, payable to the State of Florida. The purposes of
  214  the bond or other security arrangement for the program are to:
  215         1.Ensure the importer’s participation in any civil or
  216  criminal legal action by the state, the agency, any other state
  217  agency, or private individuals or entities against the importer
  218  because of the importer’s failure to perform under the contract,
  219  including, but not limited to causes of action for personal
  220  injury, negligence, and wrongful death;
  221         2.Ensure payment by the importer through the use of a bond
  222  or other comparable security arrangements of legal judgments and
  223  claims that have been awarded to the agency, the state, other
  224  entities acting on behalf of the state, individuals, or
  225  organizations if the importer is assessed a final judgment or
  226  other monetary penalty in a court of law for a civil or criminal
  227  action under the program. The bond or comparable security
  228  arrangement may be accessed if the importer fails to pay any
  229  judgment or claim within 60 days after final judgment; and
  230         3.Allow for civil and criminal litigation claims to be
  231  made against the bond or other comparable security arrangements
  232  for up to 1 year after the importer’s contract under the program
  233  has ended with the agency or the state, the importer’s license
  234  is no longer valid, or the program has ended, whichever occurs
  235  last.
  236         (5)IMPORTATION PROCESS.—
  237         (a)The agency shall contract with a vendor to provide
  238  services under the program. The vendor shall submit evidence of
  239  a surety bond with any bid or initial contract negotiation
  240  documents and shall maintain documentation of evidence of such a
  241  bond with the agency throughout the contract term. The surety
  242  bond may be from this state or any other state in the United
  243  States in the minimum amount of $1 million. The surety bond or
  244  comparable security arrangement must include the State of
  245  Florida as a beneficiary. In lieu of the surety bond, the vendor
  246  may provide a comparable security agreement, such as an
  247  irrevocable letter of credit or a deposit into a trust account
  248  or financial institution which includes the State of Florida as
  249  a beneficiary, payable to the State of Florida. The purposes of
  250  the bond or other security arrangement for the program are to:
  251         1.Ensure payment of any administrative penalties imposed
  252  by the agency or any other state agency under the contract when
  253  the vendor fails to pay within 30 days after assessment;
  254         2.Ensure that the vendor meets contractual and statutory
  255  obligations through use of a surety bond or other comparable
  256  security arrangements to pay any other costs or fees incurred by
  257  the agency, the state, or other entities acting on behalf of the
  258  state if the vendor fails to meet its contractual and statutory
  259  obligations. If the vendor is assessed a penalty under the
  260  program and fails to pay within 30 days after that assessment,
  261  the agency, the state, or an entity acting on behalf of the
  262  state may file a claim for reimbursement against the bond or
  263  other comparable security arrangement; and
  264         3.Allow for claims to be made against the bond or other
  265  comparable security arrangements for up to 1 year after the
  266  vendor’s contract under the program has ended with the agency or
  267  the state or the program has ended, whichever occurs last.
  268  
  269  A surety bond or comparable document is required, regardless of
  270  the type of bid or negotiation process the agency used or the
  271  type of final contract or agreement executed for services.
  272         (b)The eligible vendor must submit evidence at the time of
  273  contract award and throughout the contract term of a surety bond
  274  or comparable security arrangement from this state or any other
  275  state in the United States in the minimum amount of $1 million.
  276  The agency shall reevaluate and adjust the amount of the bond
  277  annually, based on program volume. The surety bond or comparable
  278  security arrangement must include the State of Florida as a
  279  beneficiary. In lieu of the surety bond, the vendor may provide
  280  a comparable security arrangement such as an irrevocable letter
  281  of credit or a deposit into a trust account or financial
  282  institution which names the State of Florida as a beneficiary.
  283  The purposes of the bond or other security arrangements for the
  284  program are to:
  285         1.Ensure participation of the vendor in any civil or
  286  criminal legal action by the state, the agency, any other state
  287  agency, or private individuals or entities against the vendor
  288  because of the vendor’s failure to perform under the contract,
  289  including, but not limited to causes of actions for personal
  290  injury, negligence, and wrongful death;
  291         2.Ensure payment by the vendor through the use of a bond
  292  or other comparable security arrangements of legal judgements
  293  and claims that have been awarded to the agency, the state,
  294  other entities acting on behalf of the state, individuals, or
  295  organizations if the vendor is assessed a final judgement or
  296  other monetary penalty in a court of law for a civil or criminal
  297  action under the program. The bond or comparable security
  298  arrangement will be accessed if the vendor fails to pay any
  299  judgement or claim within 60 days after final judgement; and
  300         3.Allow for civil and criminal litigation claims to be
  301  made against the bond or other comparable security arrangements
  302  for up to 1 year after the vendor’s contract under the program
  303  has ended with the agency or the state, the vendor’s license is
  304  no longer valid, or the program has ended, whichever occurs
  305  last.
  306         (c)The vendor shall provide all of the following services
  307  at a minimum:
  308         1.Develop a list every 3 months of drugs that have the
  309  highest potential for cost savings to the state if imported from
  310  Canada. In developing the list, the vendor shall consider, at a
  311  minimum, which drugs will provide the greatest cost savings to
  312  the state, including drugs for which there are shortages,
  313  specialty drugs, and high-volume drugs. The agency may direct
  314  the vendor to revise the list, as necessary.
  315         2.Identify Canadian suppliers that are in full compliance
  316  with relevant Canadian federal and provincial laws and
  317  regulations and the federal act and who have agreed to export
  318  drugs identified on the list. The vendor must verify that such
  319  Canadian suppliers meet all of the requirements of the program,
  320  while meeting or exceeding the federal and state track-and-trace
  321  laws and regulations.
  322         3.Contract with such eligible Canadian suppliers, or
  323  facilitate contracts between eligible importers and Canadian
  324  suppliers, to import drugs under the program.
  325         4.Maintain a list of all registered importers that
  326  participate in the program.
  327         5.Ensure compliance with Title II of the federal Drug
  328  Quality and Security Act, Pub. L. No. 113-54, by all suppliers,
  329  importers and other distributors, and participants in the
  330  program.
  331         6.Assist the agency in the preparation of the annual
  332  report required by subsection (12) and timely provide any
  333  information requested by the agency for the report.
  334         (6)ELIGIBLE PRESCRIPTION DRUGS.—Eligible importers may
  335  import a drug from an eligible Canadian supplier if:
  336         (a)The drug meets the United States Food and Drug
  337  Administration’s standards related to safety, effectiveness,
  338  misbranding, and adulteration;
  339         (b)Importing the drug would not violate the patent laws of
  340  the United States;
  341         (c)Importing the drug is expected to generate cost
  342  savings; and
  343         (d)The drug is not:
  344         1.A controlled substance as defined in 21 U.S.C. s. 802;
  345         2.A biological product as defined in 42 U.S.C. s. 262;
  346         3.An infused drug;
  347         4.An intravenously injected drug;
  348         5.A drug that is inhaled during surgery; or
  349         6.A drug that is a parenteral drug, the importation of
  350  which is determined by the United States Secretary of Health and
  351  Human Services to pose a threat to the public health.
  352         (7)DISTRIBUTION REQUIREMENTS.—Eligible Canadian suppliers
  353  and importers participating under the program:
  354         (a)Must comply with the tracking and tracing requirements
  355  of 21 U.S.C. ss. 360eee et seq.
  356         (b)May not distribute, dispense, or sell drugs imported
  357  under the program outside of the program or outside of this
  358  state.
  359         (8)PRESCRIPTION DRUG SUPPLY CHAIN DOCUMENTATION.—
  360         (a)The vendor shall ensure the safety and quality of drugs
  361  imported under the program. The vendor shall:
  362         1.For an initial imported shipment, ensure that each batch
  363  of the drug in the shipment is statistically sampled and tested
  364  for authenticity and degradation in a manner consistent with the
  365  federal act.
  366         2.For any subsequent imported shipment, ensure that a
  367  statistically valid sample of the shipment was tested for
  368  authenticity and degradation in a manner consistent with the
  369  federal act.
  370         3.Certify that the drug:
  371         a.Is approved for marketing in the United States and is
  372  not adulterated or misbranded; and
  373         b.Meets all of the labeling requirements under 21 U.S.C.
  374  s. 352.
  375         4.Maintain qualified laboratory records, including
  376  complete data derived from all tests necessary to ensure that
  377  the drug is in compliance with the requirements of this section.
  378         5.Maintain documentation demonstrating that the testing
  379  required by this section was conducted at a qualified laboratory
  380  in accordance with the federal act and any other applicable
  381  federal and state laws and regulations governing laboratory
  382  qualifications.
  383         (b)All testing required by this section must be conducted
  384  in a qualified laboratory that meets the standards under the
  385  federal act and any other applicable federal and state laws and
  386  regulations governing laboratory qualifications for drug
  387  testing.
  388         (c)The vendor shall maintain information and documentation
  389  submitted under this section for a period of at least 7 years.
  390         (d)A participating importer must submit the all of
  391  following information to the vendor:
  392         1.The name and quantity of the active ingredient of the
  393  drug.
  394         2.A description of the dosage form of the drug.
  395         3.The date on which the drug is received.
  396         4.The quantity of the drug that is received.
  397         5.The point of origin and destination of the drug.
  398         6.The price paid by the importer for the drug.
  399         (e)A participating Canadian supplier must submit the
  400  following information and documentation to the vendor specifying
  401  all of the following:
  402         1.The original source of the drug, including:
  403         a. The name of the manufacturer of the drug.
  404         b. The date on which the drug was manufactured.
  405         c. The location (country, state or province, and city)
  406  where the drug was manufactured.
  407         2.The date on which the drug is shipped.
  408         3.The quantity of the drug that is shipped.
  409         4.The quantity of each lot of the drug originally received
  410  and from which source.
  411         5.The lot or control number and the batch number assigned
  412  to the drug by the manufacturer.
  413         (f)The agency may require that the vendor collect any
  414  other information necessary to ensure the protection of the
  415  public health.
  416         (9)IMMEDIATE SUSPENSION.—The agency shall immediately
  417  suspend the importation of a specific drug or the importation of
  418  drugs by a specific importer if it discovers that any drug or
  419  activity is in violation of this section or any federal or state
  420  law or regulation. The agency may revoke the suspension if,
  421  after conducting an investigation, it determines that the public
  422  is adequately protected from counterfeit or unsafe drugs being
  423  imported into this state.
  424         (10)FEDERAL APPROVAL.—By July 1, 2020, the agency shall
  425  submit a request to the United States Secretary of Health and
  426  Human Services for approval of the program under 21 U.S.C. s.
  427  384(l). At a minimum, the request must do all of the following:
  428         (a)Describe the agency’s plan for operating the program.
  429         (b)Demonstrate how the drugs imported into this state
  430  under the program will meet the applicable federal and state
  431  standards for safety and effectiveness.
  432         (c) Demonstrate how the drugs imported into this state
  433  under the program will comply with federal tracing procedures.
  434         (d)Include a list of proposed drugs that have the highest
  435  potential for cost savings to the state through importation at
  436  the time that the request is submitted.
  437         (e)Estimate the total cost savings attributable to the
  438  program.
  439         (f) Provide the costs of program implementation to the
  440  state.
  441         (g)Include a list of potential Canadian suppliers from
  442  which the state would import drugs and demonstrate that the
  443  suppliers are in full compliance with relevant Canadian federal
  444  and provincial laws and regulations as well as all applicable
  445  federal and state laws and regulations.
  446         (11)NOTIFICATION OF FEDERAL APPROVAL.—Upon receipt of
  447  federal approval of the program, the agency shall notify the
  448  President of the Senate, the Speaker of the House of
  449  Representatives, and the relevant committees of the Senate and
  450  the House of Representatives. The program may not be implemented
  451  until the Legislature approves the program as authorized by the
  452  federal government. As part of its review process for
  453  implementation approval, the Legislature shall consider the
  454  estimated cost savings to the state and whether the program has
  455  met the required safety standards.
  456         (12)ANNUAL REPORT.—By December 1 of each year, the agency
  457  shall submit a report to the Governor, the President of the
  458  Senate, and the Speaker of the House of Representatives on the
  459  operation of the program during the previous fiscal year. The
  460  report must include, at a minimum:
  461         (a)A list of the drugs that were imported under the
  462  program;
  463         (b)The number of participating entities;
  464         (c)The number of prescriptions dispensed through the
  465  program;
  466         (d)The estimated cost savings during the previous fiscal
  467  year and to date in the program;
  468         (e)A description of the methodology used to determine
  469  which drugs should be included; and
  470         (f)Documentation of how the program ensures the following
  471  criteria:
  472         1.Canadian suppliers participating in the program are of
  473  high quality, high performance, and in full compliance with
  474  relevant Canadian federal and provincial laws and regulations as
  475  well as all United States and Florida laws and regulations;
  476         2.Drugs imported under the program are not shipped, sold,
  477  or dispensed outside of this state or the program once in the
  478  possession of the importer;
  479         3.Drugs imported under the program are unadulterated,
  480  potent, and safe;
  481         4.The program does not put consumers at a higher health
  482  and safety risk than if the consumer did not participate; and
  483         5.The program provides cost savings to the state.
  484         (13)RULEMAKING.—The agency may adopt rules necessary to
  485  implement this section.
  486         Section 2. This act shall take effect July 1, 2019.