Bill Text: FL S1528 | 2019 | Regular Session | Comm Sub


Bill Title: Prescription Drug Importation Programs

Spectrum: Bipartisan Bill

Status: (Introduced) 2019-04-26 - Laid on Table, refer to CS/HB 19 [S1528 Detail]

Download: Florida-2019-S1528-Comm_Sub.html
       Florida Senate - 2019                      CS for CS for SB 1528
       
       
        
       By the Committees on Appropriations; and Health Policy; and
       Senators Bean and Gruters
       
       
       
       
       576-04599-19                                          20191528c2
    1                        A bill to be entitled                      
    2         An act relating to prescription drug importation
    3         programs; creating s. 381.02035, F.S.; requiring the
    4         Agency for Health Care Administration to establish the
    5         Canadian Prescription Drug Importation Program;
    6         defining terms; requiring the agency to contract with
    7         a vendor to facilitate wholesale prescription drug
    8         importation under the program; providing
    9         responsibilities for the vendor; providing eligibility
   10         criteria for prescription drugs, Canadian suppliers,
   11         and importers under the program; authorizing a
   12         Canadian supplier to export drugs into this state
   13         under the program under certain circumstances;
   14         providing eligibility criteria and requirements for
   15         drug importers; requiring participating Canadian
   16         suppliers and importers to comply with specified
   17         federal requirements for distributing prescription
   18         drugs imported under the program; prohibiting Canadian
   19         suppliers and importers from distributing, dispensing,
   20         or selling prescription drugs imported under the
   21         program outside of this state; requiring the agency to
   22         request federal approval of the program; requiring the
   23         request to include certain information; requiring the
   24         agency to begin operating the program within a
   25         specified timeframe after receiving federal approval;
   26         providing certain documentation requirements;
   27         requiring the agency to suspend the importation of
   28         drugs in violation of this section or any federal or
   29         state law or regulation; authorizing the agency to
   30         revoke the suspension under certain circumstances;
   31         requiring the agency to submit an annual report to the
   32         Governor and the Legislature by a specified date;
   33         providing requirements for such report; requiring the
   34         agency to notify the Legislature upon federal approval
   35         of the program and to submit a proposal to the
   36         Legislature for program implementation and funding
   37         before a certain date; requiring the agency to adopt
   38         necessary rules; creating s. 465.0157, F.S.;
   39         establishing an international export pharmacy permit
   40         for participation in the International Prescription
   41         Drug Importation Program; providing requirements for
   42         permit application and renewal; amending s. 465.017,
   43         F.S.; authorizing the Department of Health to inspect
   44         international export pharmacy permittees; amending s.
   45         499.005, F.S.; providing that the importation of a
   46         prescription drug under the International Prescription
   47         Drug Importation Program is not a prohibited act under
   48         that chapter; amending s. 499.0051, F.S.; providing an
   49         exemption from prosecution as a criminal offense for
   50         the importation of a prescription drug for wholesale
   51         distribution under the International Prescription Drug
   52         Importation Program; amending s. 499.01, F.S.;
   53         requiring an international prescription drug wholesale
   54         distributor to be permitted before operating;
   55         requiring nonresident prescription drug manufacturers
   56         to register with the Department of Business and
   57         Professional Regulation to participate in the program;
   58         providing an exception; establishing an international
   59         prescription drug wholesale distributor drug permit;
   60         providing permit requirements; amending s. 499.012,
   61         F.S.; providing application requirements for
   62         international prescription drug wholesale distributors
   63         and nonresident prescription drug manufacturers to
   64         participate in the program; amending s. 499.015, F.S.;
   65         establishing that prescription drugs imported under
   66         the International Prescription Drug Importation
   67         Program are not required to be registered under a
   68         specified provision; amending s. 499.065, F.S.;
   69         requiring the department to inspect international
   70         prescription drug wholesale distributor
   71         establishments; authorizing the department to
   72         determine that an international prescription drug
   73         wholesale distributor establishment is an imminent
   74         danger to the public and require its immediate closure
   75         under certain conditions; creating s. 499.0285, F.S.;
   76         requiring the Department of Business and Professional
   77         Regulation to establish the International Prescription
   78         Drug Importation Program for a specified purpose;
   79         providing definitions; providing eligibility criteria
   80         for prescription drugs, exporters, and importers under
   81         the program; requiring participating importers to
   82         submit certain documentation to the department for
   83         prescription drugs imported under the program;
   84         requiring the department to immediately suspend the
   85         importation of specific prescription drug or the
   86         importation of prescription drugs by a specific
   87         importer if a violation has occurred under the
   88         program; authorizing the department to revoke such
   89         suspension under certain circumstances; requiring the
   90         department to adopt necessary rules; requiring the
   91         agency, in collaboration with the Department of
   92         Business and Professional Regulation and the
   93         Department of Health, to negotiate a federal
   94         arrangement to operate a pilot program for importing
   95         prescription drugs into this state; providing that
   96         implementation of the act is contingent upon the
   97         federal authorization; requiring the department to
   98         notify the Legislature before implementation of the
   99         pilot program and to submit a proposal for pilot
  100         program implementation and funding; providing an
  101         effective date.
  102          
  103  Be It Enacted by the Legislature of the State of Florida:
  104  
  105         Section 1. Section 381.02035, Florida Statutes, is created
  106  to read:
  107         381.02035 Canadian Prescription Drug Importation Program.—
  108         (1)PROGRAM ESTABLISHED.—The Agency for Health Care
  109  Administration shall establish the Canadian Prescription Drug
  110  Importation Program for the importation of safe and effective
  111  prescription drugs from Canada which have the highest potential
  112  for cost savings to the state.
  113         (2) DEFINITIONS.—As used in this section, the term:
  114         (a)“Agency” means the Agency for Health Care
  115  Administration.
  116         (b)“Canadian supplier” means a manufacturer, wholesale
  117  distributor, or pharmacy appropriately licensed or permitted
  118  under Canadian law to manufacture, distribute, or dispense
  119  prescription drugs.
  120         (c) “County health department” means a health care facility
  121  established under part I of chapter 154.
  122         (d)“Department” means the Department of Health.
  123         (e)“Drug” or “prescription drug” has the same meaning as
  124  “prescription drug” in s. 499.003, but is limited to drugs
  125  intended for human use.
  126         (f)“Federal act” means the Federal Food, Drug, and
  127  Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
  128  as amended by the Drug Quality and Security Act, 21 U.S.C. 351
  129  et seq.
  130         (g)“Free clinic” means a clinic that delivers only medical
  131  diagnostic services or nonsurgical medical treatment free of
  132  charge to low-income recipients.
  133         (h)“Medicaid pharmacy” means a pharmacy licensed under
  134  chapter 465 that has a Medicaid provider agreement in effect
  135  with the agency and is in good standing with the agency.
  136         (i)“Pharmacist” means a person who holds an active and
  137  unencumbered license to practice pharmacy pursuant to chapter
  138  465.
  139         (j) “Program” means the Canadian Prescription Drug
  140  Importation Program.
  141         (k) “Track-and-trace” means the product-tracing process for
  142  the components of the pharmaceutical distribution supply chain
  143  as described in Title II of the Drug Quality and Security Act,
  144  Drug Supply Chain Security Act, 21 U.S.C. 351 et seq.
  145         (l)“Vendor” means the entity contracted by the agency to
  146  manage specified functions of the program.
  147         (3)IMPORTATION PROCESS.—
  148         (a)The agency shall contract with a vendor to provide
  149  services under the program.
  150         (b)By December 1, 2019, and each year thereafter, the
  151  vendor shall develop a Wholesale Prescription Drug Importation
  152  List identifying the prescription drugs that have the highest
  153  potential for cost savings to the state. In developing the list,
  154  the vendor shall consider, at a minimum, which prescription
  155  drugs will provide the greatest cost savings to state programs,
  156  including prescriptions drugs for which there are shortages,
  157  specialty prescription drugs, and high volume prescription
  158  drugs. The agency, in consultation with the department, shall
  159  review the Wholesale Prescription Drug Importation List every 3
  160  months to ensure that it continues to meet the requirements of
  161  the programs and may direct the vendor to revise the list, as
  162  necessary.
  163         (c)The vendor shall submit evidence of a surety bond with
  164  any bid or initial contract negotiation documents and shall
  165  maintain documentation of evidence of such a bond with the
  166  agency throughout the contract term. The surety bond may be from
  167  this state or any other state in the United States for at least
  168  $25,000. The surety bond or comparable security arrangement must
  169  include the State of Florida as a beneficiary. In lieu of the
  170  surety bond, the vendor may provide a comparable security
  171  agreement, such as an irrevocable letter of credit or a deposit
  172  into a trust account or financial institution, which includes
  173  the State of Florida as a beneficiary, payable to the State of
  174  Florida. The purposes of the bond or other security arrangement
  175  for the program are to:
  176         1.Ensure payment of any administrative penalties imposed
  177  by the agency or any other state agency under the contract, if
  178  the vendor fails to pay within 30 days after assessment;
  179         2.Ensure that the vendor meets contractual and statutory
  180  obligations through use of a surety bond or other comparable
  181  security arrangements to pay any other costs or fees incurred by
  182  the agency, the state, or other entities acting on behalf of the
  183  state if the vendor fails to meet its contractual and statutory
  184  obligations. If the vendor is assessed a penalty under the
  185  program and fails to pay within 30 days after that assessment,
  186  the agency, the state, or an entity acting on behalf of the
  187  state may file a claim for reimbursement against the bond or
  188  other comparable security arrangement; and
  189         3.Allow for claims to be made against the bond or other
  190  comparable security arrangements for up to 1 year after the
  191  vendor’s contract under the program has ended with the agency or
  192  the state or the program has ended, whichever occurs last.
  193  
  194  A surety bond or comparable document is required, regardless of
  195  the type of bid or negotiation process the agency used or the
  196  type of final contract or agreement executed for services.
  197         (d)The vendor must submit evidence at the time of contract
  198  award and throughout the contract term of a surety bond or
  199  comparable security arrangement from this state or any other
  200  state in the United States in an amount no less than $25,000.
  201  The surety bond or comparable security arrangement must include
  202  the State of Florida as a beneficiary. In lieu of the surety
  203  bond, the vendor may provide a comparable security arrangement
  204  such as an irrevocable letter of credit or a deposit into a
  205  trust account or financial institution which names the State of
  206  Florida as a beneficiary. The purposes of the bond or other
  207  security arrangements for the program are to:
  208         1.Ensure participation of the vendor in any civil or
  209  criminal legal action by the state, the agency, any other state
  210  agency, or private individuals or entities against the vendor
  211  because of the vendor’s failure to perform under the contract,
  212  including, but not limited to causes of actions for personal
  213  injury, negligence, and wrongful death;
  214         2.Ensure payment by the vendor through the use of a bond
  215  or other comparable security arrangements of legal judgements
  216  and claims that have been awarded to the agency, the state,
  217  other entities acting on behalf of the state, individuals, or
  218  organizations if the vendor is assessed a final judgement or
  219  other monetary penalty in a court of law for a civil or criminal
  220  action under the program. The bond or comparable security
  221  arrangement will be accessed if the vendor fails to pay any
  222  judgement or claim within 60 days after final judgement; and
  223         3.Allow for civil and criminal litigation claims to be
  224  made against the bond or other comparable security arrangements
  225  for up to 1 year after the vendor’s contract under the program
  226  has ended with the agency or the state, the vendor’s license is
  227  no longer valid, or the program has ended, whichever occurs
  228  last.
  229         (e)The vendor shall identify Canadian suppliers that are
  230  in full compliance with relevant Canadian federal and provincial
  231  laws and regulations and the federal act and who have agreed to
  232  export drugs identified on the list at prices that will provide
  233  cost savings to the state. The vendor must verify that such
  234  Canadian suppliers meet all of the requirements of the program,
  235  while meeting or exceeding the federal and state track-and-trace
  236  laws and regulations.
  237         (f)The vendor shall contract with such eligible Canadian
  238  suppliers, or facilitate contracts between eligible importers
  239  and Canadian suppliers, to import drugs under the program.
  240         (g)The vendor shall maintain a list of all registered
  241  importers that participate in the program.
  242         (h)The vendor shall ensure compliance with Title II of the
  243  federal Drug Quality and Security Act, Pub. L. No. 113-54, by
  244  all suppliers, importers and other distributors, and
  245  participants in the program.
  246         (i)The vendor shall assist the agency in the preparation
  247  of the annual report required by subsection (11), including the
  248  timely provision of any information requested by the agency.
  249         (j)The vendor shall provide an annual financial audit of
  250  its operations to the agency as required by the agency. The
  251  vendor shall also provide quarterly financial reports specific
  252  to the program and shall include information on the performance
  253  of its subcontractors and vendors. The agency shall determine
  254  the format and contents of the reports.
  255         (4) ELIGIBLE PRESCRIPTION DRUGS.—Eligible importers, as
  256  described in subsection (6), may import a drug from an eligible
  257  Canadian supplier, as described in subsection (5), if:
  258         (a)The drug meets the United States Food and Drug
  259  Administration’s standards related to safety, effectiveness,
  260  misbranding, and adulteration;
  261         (b)Importing the drug would not violate federal patent
  262  laws;
  263         (c)Importing the drug is expected to generate cost
  264  savings; and
  265         (d)The drug is not:
  266         1.A controlled substance as defined in 21 U.S.C. s. 802;
  267         2.A biological product as defined in 42 U.S.C. s. 262;
  268         3.An infused drug;
  269         4.An intravenously injected drug;
  270         5.A drug that is inhaled during surgery; or
  271         6.A drug that is a parenteral drug, the importation of
  272  which is determined by the United States Secretary of Health and
  273  Human Services to pose a threat to the public health.
  274         (5) ELIGIBLE CANADIAN SUPPLIERS.—A Canadian supplier may
  275  export prescription drugs into this state under the program if
  276  the supplier:
  277         (a) Is in full compliance with relevant Canadian federal
  278  and provincial laws and regulations;
  279         (b) Is identified by the vendor as eligible to participate
  280  in the program; and
  281         (c)Submits an attestation that the supplier has a
  282  registered agent in the United States, including the name and
  283  United States address of the registered agent.
  284         (6)ELIGIBLE IMPORTERS.—The following entities may import
  285  prescription drugs from an eligible Canadian supplier under the
  286  program:
  287         (a)A pharmacist or wholesaler employed by or under
  288  contract with the department’s central pharmacy, for
  289  distribution to a county health department or free clinic for
  290  dispensing to clients treated in such department or clinic.
  291         (b)A pharmacist or wholesaler employed by or under
  292  contract with a Medicaid pharmacy, for dispensing to the
  293  pharmacy’s Medicaid recipients.
  294         (c)A pharmacist or wholesaler employed by or under
  295  contract with the Department of Corrections, for dispensing to
  296  inmates in the custody of the Department of Corrections.
  297         (d)A pharmacist or wholesaler employed by or under
  298  contract with a developmental disabilities center, as defined in
  299  s. 393.063, for dispensing to clients treated in such center.
  300         (e)A pharmacist or wholesaler employed by or under
  301  contract with a treatment facility, as defined in s. 394.455,
  302  for dispensing to patients treated in such facility.
  303         (7)DISTRIBUTION REQUIREMENTS.—Eligible Canadian suppliers
  304  and eligible importers participating under the program:
  305         (a)Must comply with the tracking and tracing requirements
  306  of 21 U.S.C. ss. 360eee et seq.
  307         (b)May not distribute, dispense, or sell prescription
  308  drugs imported under the program outside of the state.
  309         (8)FEDERAL APPROVAL.—By July 1, 2020, the agency shall
  310  submit a request to the United States Secretary of Health and
  311  Human Services for approval of the program under 21 U.S.C. s.
  312  384(l). The agency shall begin operating the program within 6
  313  months after receiving such approval. The request must, at a
  314  minimum:
  315         (a)Describe the agency’s plan for operating the program.
  316         (b)Demonstrate how the prescription drugs imported into
  317  this state under the program will meet the applicable federal
  318  and state standards for safety and effectiveness.
  319         (c) Demonstrate how the drugs imported into this state
  320  under the program will comply with federal tracing procedures.
  321         (d)Include a list of proposed prescription drugs that have
  322  the highest potential for cost savings to the state through
  323  importation at the time that the request is submitted.
  324         (e)Estimate the total cost savings attributable to the
  325  program.
  326         (f) Provide the costs of program implementation to the
  327  state.
  328         (g)Include a list of potential Canadian suppliers from
  329  which the state would import drugs and demonstrate that the
  330  suppliers are in full compliance with relevant Canadian federal
  331  and provincial laws and regulations as well as all applicable
  332  federal and state laws and regulations.
  333         (9)PRESCRIPTION DRUG SUPPLY CHAIN DOCUMENTATION.—
  334         (a)The vendor shall ensure the safety and quality of drugs
  335  imported under the program. The vendor shall:
  336         1.For an initial imported shipment, ensure that each batch
  337  of the drug in the shipment is statistically sampled and tested
  338  for authenticity and degradation in a manner consistent with the
  339  federal act.
  340         2.For any subsequent imported shipment, ensure that a
  341  statistically valid sample of the shipment is tested for
  342  authenticity and degradation in a manner consistent with the
  343  federal act.
  344         3.Certify that the drug:
  345         a.Is approved for marketing in the United States and is
  346  not adulterated or misbranded; and
  347         b.Meets all of the labeling requirements under 21 U.S.C.
  348  s. 352.
  349         4.Maintain qualified laboratory records, including
  350  complete data derived from all tests necessary to ensure that
  351  the drug is in compliance with the requirements of this section.
  352         5.Maintain documentation demonstrating that the testing
  353  required by this section was conducted at a qualified laboratory
  354  in accordance with the federal act and any other applicable
  355  federal and state laws and regulations governing laboratory
  356  qualifications.
  357         (b)All testing required by this section must be conducted
  358  in a qualified laboratory that meets the standards under the
  359  federal act and any other applicable federal and state laws and
  360  regulations governing laboratory qualifications for drug
  361  testing.
  362         (c)The vendor shall maintain information and documentation
  363  submitted under this section for a period of at least 7 years.
  364         (d)A participating importer must submit the all of
  365  following information to the vendor:
  366         1.The name and quantity of the active ingredient of the
  367  drug.
  368         2.A description of the dosage form of the drug.
  369         3.The date on which the drug is received.
  370         4.The quantity of the drug that is received.
  371         5.The point of origin and destination of the drug.
  372         6.The price paid by the importer for the drug.
  373         (e)A participating Canadian supplier must submit the
  374  following information and documentation to the vendor specifying
  375  all of the following:
  376         1.The original source of the drug, including:
  377         a. The name of the manufacturer of the drug.
  378         b. The date on which the drug was manufactured.
  379         c. The location (country, state or province, and city)
  380  where the drug was manufactured.
  381         2.The date on which the drug is shipped.
  382         3.The quantity of the drug that is shipped.
  383         4.The quantity of each lot of the drug originally received
  384  and the source of the lot.
  385         5.The lot or control number and the batch number assigned
  386  to the drug by the manufacturer.
  387         (f)The agency may require that the vendor collect any
  388  other information necessary to ensure the protection of the
  389  public health.
  390         (10)IMMEDIATE SUSPENSION.—The agency shall immediately
  391  suspend the importation of a specific drug or the importation of
  392  drugs by a specific importer if it discovers that any drug or
  393  activity is in violation of this section or any federal or state
  394  law or regulation. The agency may revoke the suspension if,
  395  after conducting an investigation, it determines that the public
  396  is adequately protected from counterfeit or unsafe drugs being
  397  imported into this state.
  398         (11)ANNUAL REPORT.—By December 1 of each year, the agency
  399  shall submit a report to the Governor, the President of the
  400  Senate, and the Speaker of the House of Representatives on the
  401  operation of the program during the previous fiscal year. The
  402  report must include, at a minimum:
  403         (a)A list of the prescription drugs that were imported
  404  under the program;
  405         (b)The number of participating entities;
  406         (c)The number of prescriptions dispensed through the
  407  program;
  408         (d)The estimated cost savings during the previous fiscal
  409  year and to date attributable the program;
  410         (e)A description of the methodology used to determine
  411  which drugs should be included on the Wholesale Prescription
  412  Drug Importation List; and
  413         (f)Documentation as to how the program ensures the
  414  following:
  415         1.That Canadian suppliers participating in the program are
  416  of high quality, high performance, and in full compliance with
  417  relevant Canadian federal and provincial laws and regulations as
  418  well as all federal laws and regulations and state laws and
  419  rules;
  420         2.That prescription drugs imported under the program are
  421  not shipped, sold, or dispensed outside of this state once in
  422  the possession of the importer;
  423         3.That prescription drugs imported under the program are
  424  pure, unadulterated, potent, and safe;
  425         4.That the program does not put consumers at a higher
  426  health and safety risk than if the consumer did not participate;
  427  and
  428         5.That the program provides cost savings to the state on
  429  imported prescription drugs.
  430         (12)NOTIFICATION OF FEDERAL APPROVAL.—Upon receipt of
  431  federal approval of the program, the agency shall notify the
  432  President of the Senate, the Speaker of the House of
  433  Representatives, and the relevant committees of the Senate and
  434  the House of Representatives. After approval is received and
  435  before the start of the next regular session of the Legislature
  436  in which the proposal could be funded, the agency shall submit
  437  to all parties a proposal for program implementation and program
  438  funding.
  439         (13)RULEMAKING.—The agency shall adopt rules necessary to
  440  implement this section.
  441         Section 2. Section 465.0157, Florida Statutes, is created
  442  to read:
  443         465.0157International export pharmacy permit.—
  444         (1)To participate as an exporter of prescription drugs
  445  into this state under the International Prescription Drug
  446  Importation Program established in s. 499.0285, a pharmacy
  447  located outside of the United States must hold an international
  448  export pharmacy permit.
  449         (2)An international export pharmacy shall maintain at all
  450  times an active and unencumbered license or permit to operate
  451  the pharmacy in compliance with the laws of the jurisdiction in
  452  which the dispensing facility is located and from which the
  453  prescription drugs will be exported. Such jurisdiction must be
  454  in a country with which the United States has a current mutual
  455  recognition agreement, cooperation agreement, memorandum of
  456  understanding, or other federal mechanism recognizing the
  457  country’s adherence to current good manufacturing practices for
  458  pharmaceutical products.
  459         (3)An application for an international export pharmacy
  460  permit must be submitted on a form developed and provided by the
  461  board. The board may require an applicant to provide any
  462  information it deems reasonably necessary to carry out the
  463  purposes of this section.
  464         (4)An applicant shall submit the following to the board to
  465  obtain an initial permit, or to the department to renew a
  466  permit:
  467         (a)Proof of an active and unencumbered license or permit
  468  to operate the pharmacy in compliance with the laws of the
  469  jurisdiction in which the dispensing facility is located and
  470  from which the prescription drugs will be exported.
  471         (b)Documentation demonstrating that the country in which
  472  the pharmacy operates has a current mutual recognition
  473  agreement, cooperation agreement, memorandum of understanding,
  474  or other federal mechanism recognizing the country’s adherence
  475  to current good manufacturing practices for pharmaceutical
  476  products.
  477         (c)Evidence of a surety bond with any application or
  478  filing for pharmacy permit under this section and shall maintain
  479  documentation of evidence of such a bond with the Department of
  480  Business and Professional Regulation throughout the permit term.
  481  The surety bond may be from this state or any other state in the
  482  United States for no less than $25,000. The surety bond or
  483  comparable security arrangement must include the State of
  484  Florida as a beneficiary. In lieu of the surety bond, the
  485  pharmacy may provide a comparable security agreement, such as an
  486  irrevocable letter of credit or a deposit into a trust account
  487  or financial institution which includes the State of Florida as
  488  a beneficiary, payable to the State of Florida. The purposes of
  489  the bond or other security arrangement for the program are to:
  490         1.Ensure payment of any administrative penalties imposed
  491  by the department or any other state agency under the contract
  492  when the pharmacy fails to pay within 30 days after assessment;
  493         2.Ensure that the pharmacy meets contractual and statutory
  494  obligations through use of a surety bond or other comparable
  495  security arrangements to pay any other costs or fees incurred by
  496  the Department of Business of Professional Regulation, the
  497  state, or other entities acting on behalf of the state if the
  498  pharmacy fails to meet its obligations. If the pharmacy is
  499  assessed a penalty under the program and fails to pay within 30
  500  days after that assessment, the Department of Business and
  501  Professional Regulation, the state, or an entity acting on
  502  behalf of the state may file a claim for reimbursement against
  503  the bond or other comparable security arrangement; and
  504         3.Allow for claims to be made against the bond or other
  505  comparable security arrangements for up to 1 year after the
  506  pharmacy’s permit under the program has ended with this section
  507  or the program has ended, whichever occurs last.
  508         (d)The eligible pharmacy must submit evidence at the time
  509  of application and throughout the permit term of a surety bond
  510  or comparable security arrangement from this state or any other
  511  state in the United States in an amount no less than $25,000.
  512  The surety bond or comparable security arrangement must include
  513  the State of Florida as a beneficiary. In lieu of the surety
  514  bond, the pharmacy may provide a comparable security arrangement
  515  such as an irrevocable letter of credit or a deposit into a
  516  trust account or financial institution which names the State of
  517  Florida as a beneficiary. The purposes of the bond or other
  518  security arrangements for the program are to:
  519         1.Ensure participation of the pharmacy in any civil or
  520  criminal legal action by the state, the Department of Business
  521  of Professional Regulation, any other state agency, or private
  522  individuals or entities against the pharmacy or because of the
  523  pharmacy’s failure to perform under the contract, including, but
  524  not limited to causes of actions for personal injury,
  525  negligence, and wrongful death;
  526         2.Ensure payment by the pharmacy through the use of a bond
  527  or other comparable security arrangements of legal judgements
  528  and claims that have been awarded to the Department of Business
  529  and Professional Regulation, the state, other entities acting on
  530  behalf of the state, individuals, or organizations if the
  531  pharmacy is assessed a final judgement or other monetary penalty
  532  in a court of law for a civil or criminal action under the
  533  program. The bond or comparable security arrangement will be
  534  accessed if the pharmacy fails to pay any judgement or claim
  535  within 60 days after final judgement; and
  536         3.Allow for civil and criminal litigation claims to be
  537  made against the bond or other comparable security arrangements
  538  for up to 1 year after the pharmacy’s contract under the program
  539  has ended with the agency or the state, the pharmacy’s license
  540  is no longer valid, or the program has ended, whichever occurs
  541  last.
  542         (e)The location, names, and titles of all principal
  543  corporate officers and the pharmacist who serves as the
  544  prescription department manager for prescription drugs exported
  545  into this state under the International Prescription Drug
  546  Importation Program.
  547         (f)Written attestation by an owner or officer of the
  548  applicant, and by the applicant’s prescription department
  549  manager, that:
  550         1.The attestor has read and understands the laws and rules
  551  governing the manufacture, distribution, and dispensing of
  552  prescription drugs in this state.
  553         2.A prescription drug shipped, mailed, or delivered into
  554  this state meets or exceeds this state’s standards for safety
  555  and efficacy.
  556         3.A prescription drug product shipped, mailed, or
  557  delivered into this state must not have been, and may not be,
  558  manufactured or distributed in violation of the laws and rules
  559  of the jurisdiction in which the applicant is located and from
  560  which the prescription drugs shall be exported.
  561         (g)A current inspection report from an inspection
  562  conducted by the regulatory or licensing agency of the
  563  jurisdiction in which the applicant is located. The inspection
  564  report must reflect compliance with this section. An inspection
  565  report is current if the inspection was conducted within 6
  566  months before the date of submitting the application for the
  567  initial permit or within 1 year before the date of submitting an
  568  application for permit renewal. If the applicant is unable to
  569  submit a current inspection report conducted by the regulatory
  570  or licensing agency of the jurisdiction in which the applicant
  571  is located and from which the prescription drugs will be
  572  exported, due to acceptable circumstances, as established by
  573  rule, or if an inspection has not been performed, the department
  574  must:
  575         1.Conduct, or contract with an entity to conduct, an
  576  onsite inspection, with all related costs borne by the
  577  applicant;
  578         2.Accept a current and satisfactory inspection report, as
  579  determined by rule, from an entity approved by the board; or
  580         3.Accept a current inspection report from the United
  581  States Food and Drug Administration conducted pursuant to the
  582  federal Drug Quality and Security Act, Pub. L. No. 113-54.
  583         Section 3. Subsection (2) of section 465.017, Florida
  584  Statutes, is amended to read:
  585         465.017 Authority to inspect; disposal.—
  586         (2) Duly authorized agents and employees of the department
  587  may inspect a nonresident pharmacy registered under s. 465.0156,
  588  an international export pharmacy permittee under s. 465.0157, or
  589  a nonresident sterile compounding permittee under s. 465.0158
  590  pursuant to this section. The costs of such inspections shall be
  591  borne by such pharmacy or permittee.
  592         Section 4. Subsection (20) of section 499.005, Florida
  593  Statutes, is amended to read:
  594         499.005 Prohibited acts.—It is unlawful for a person to
  595  perform or cause the performance of any of the following acts in
  596  this state:
  597         (20) The importation of a prescription drug except as
  598  provided by s. 801(d) of the Federal Food, Drug, and Cosmetic
  599  Act or s. 499.0285.
  600         Section 5. Paragraph (e) of subsection (12) of section
  601  499.0051, Florida Statutes, is amended to read:
  602         499.0051 Criminal acts.—
  603         (12) REFUSAL TO ALLOW INSPECTION; SELLING, PURCHASING, OR
  604  TRADING DRUG SAMPLES; FAILURE TO MAINTAIN RECORDS RELATING TO
  605  PRESCRIPTION DRUGS.—Any person who violates any of the following
  606  provisions commits a felony of the third degree, punishable as
  607  provided in s. 775.082, s. 775.083, or s. 775.084, or as
  608  otherwise provided in this part:
  609         (e) The importation of a prescription drug for wholesale
  610  distribution, except as provided by s. 801(d) of the Federal
  611  Food, Drug, and Cosmetic Act or s. 499.0285.
  612         Section 6. Subsection (1) and paragraph (c) of subsection
  613  (2) of section 499.01, Florida Statutes, are amended, and
  614  paragraph (s) is added to subsection (2) of that section, to
  615  read:
  616         499.01 Permits.—
  617         (1) Before operating, a permit is required for each person
  618  and establishment that intends to operate as:
  619         (a) A prescription drug manufacturer;
  620         (b) A prescription drug repackager;
  621         (c) A nonresident prescription drug manufacturer;
  622         (d) A nonresident prescription drug repackager;
  623         (e) A prescription drug wholesale distributor;
  624         (f) An out-of-state prescription drug wholesale
  625  distributor;
  626         (g) A retail pharmacy drug wholesale distributor;
  627         (h) A restricted prescription drug distributor;
  628         (i) A complimentary drug distributor;
  629         (j) A freight forwarder;
  630         (k) A veterinary prescription drug retail establishment;
  631         (l) A veterinary prescription drug wholesale distributor;
  632         (m) A limited prescription drug veterinary wholesale
  633  distributor;
  634         (n) An over-the-counter drug manufacturer;
  635         (o) A device manufacturer;
  636         (p) A cosmetic manufacturer;
  637         (q) A third party logistics provider; or
  638         (r) A health care clinic establishment; or
  639         (s)An international prescription drug wholesale
  640  distributor.
  641         (2) The following permits are established:
  642         (c) Nonresident prescription drug manufacturer permit.—A
  643  nonresident prescription drug manufacturer permit is required
  644  for any person that is a manufacturer of prescription drugs,
  645  unless permitted as a third party logistics provider, located
  646  outside of this state or outside the United States and that
  647  engages in the distribution in this state of such prescription
  648  drugs. Each such manufacturer must be permitted by the
  649  department and comply with all of the provisions required of a
  650  prescription drug manufacturer under this part. The department
  651  shall adopt rules for issuing a virtual nonresident prescription
  652  drug manufacturer permit to a person who engages in the
  653  manufacture of prescription drugs but does not make or take
  654  physical possession of any prescription drugs. The rules adopted
  655  by the department under this section may exempt virtual
  656  nonresident manufacturers from certain establishment, security,
  657  and storage requirements set forth in s. 499.0121.
  658         1. A person that distributes prescription drugs for which
  659  the person is not the manufacturer must also obtain an out-of
  660  state prescription drug wholesale distributor permit, an
  661  international prescription drug wholesale distributor permit, or
  662  third party logistics provider permit pursuant to this section
  663  to engage in the distribution of such prescription drugs when
  664  required by this part. This subparagraph does not apply to a
  665  manufacturer that distributes prescription drugs only for the
  666  manufacturer of the prescription drugs where both manufacturers
  667  are affiliates.
  668         2. Any such person must comply with the licensing or
  669  permitting requirements of the jurisdiction in which the
  670  establishment is located and the federal act, and any
  671  prescription drug distributed into this state must comply with
  672  this part. If a person intends to import prescription drugs from
  673  a foreign country into this state, the nonresident prescription
  674  drug manufacturer must provide to the department a list
  675  identifying each prescription drug it intends to import and
  676  document approval by the United States Food and Drug
  677  Administration for such importation.
  678         3.a. A nonresident prescription drug manufacturer that has
  679  registered to participate in the International Prescription Drug
  680  Importation Program pursuant to this section is not required to
  681  provide the list and approval required by subparagraph 2. for
  682  prescription drugs imported under that program.
  683         b. To participate as an exporter of prescription drugs into
  684  this state under the International Prescription Drug Importation
  685  Program established under s. 499.0285, a nonresident
  686  prescription drug manufacturer located outside of the United
  687  States must register with the Department of Business and
  688  Professional Regulation before engaging in any activities under
  689  that section. Such manufacturer must be licensed or permitted in
  690  a country with which the United States has a current mutual
  691  recognition agreement, cooperation agreement, memorandum of
  692  understanding, or other federal mechanism recognizing the
  693  country’s adherence to current good manufacturing practices for
  694  pharmaceutical products.
  695         c.The nonresident prescription drug manufacturer shall
  696  submit evidence of a surety bond with any application or filing
  697  for registration under this section and shall maintain
  698  documentation of evidence of such a bond with the Department of
  699  Business and Professional Regulation throughout the registration
  700  term. The surety bond may be from this state or any other state
  701  in the United States in an amount equal to 10 percent of the
  702  manufacturer’s annual sales or $1 million, whichever is higher.
  703  The surety bond or comparable security arrangement must include
  704  the State of Florida as a beneficiary. In lieu of the surety
  705  bond, the manufacturer may provide a comparable security
  706  agreement, such as an irrevocable letter of credit or a deposit
  707  into a trust account or financial institution which includes the
  708  State of Florida as a beneficiary, payable to the State of
  709  Florida. The purposes of the bond or other security arrangement
  710  for the program are to:
  711         (I)Ensure payment of any administrative penalties imposed
  712  by the Department of Business and Professional Regulation or any
  713  other state agency under the contract when the manufacturer
  714  fails to pay within 30 days after assessment;
  715         (II)Ensure that if the manufacturer fails to meets its
  716  obligations through use of a surety bond or other comparable
  717  security arrangements to pay any other costs or fees incurred by
  718  the Department of Business of Professional Regulation, the
  719  state, or other entities acting on behalf of the state if the
  720  manufacturer fails to meet its obligations. If the manufacturer
  721  is assessed a penalty under the program and fails to pay within
  722  30 days after that assessment, the Department of Business and
  723  Professional Regulation, the state, or an entity acting on
  724  behalf of the state may file a claim for reimbursement against
  725  the bond or other comparable security arrangement; and
  726         (III)Allow for claims to be made against the bond or other
  727  comparable security arrangements for up to 1 year after the
  728  manufacturer’s permit under the program has ended with this
  729  section or the program has ended, whichever occurs last.
  730         4.The eligible manufacturer must submit evidence at the
  731  time of application and throughout the permit term of a surety
  732  bond or comparable security arrangement from this state or any
  733  other state in the United States in an amount equal to 10
  734  percent of the manufacturer’s annual sales or $1 million,
  735  whichever is greater. The surety bond or comparable security
  736  arrangement must include the State of Florida as a beneficiary.
  737  In lieu of the surety bond, the manufacturer may provide a
  738  comparable security arrangement such as an irrevocable letter of
  739  credit or a deposit into a trust account or financial
  740  institution which names the State of Florida as a beneficiary.
  741  The purposes of the bond or other security arrangements for the
  742  program are to:
  743         a.Ensure participation of the manufacturer in any civil or
  744  criminal legal action by the state, the Department of Business
  745  of Professional Regulation, any other state agency, or private
  746  individuals or entities against the manufacturer or because of
  747  the manufacturer’s failure to perform according to the contract,
  748  permit, or federal or state law and regulations, including, but
  749  not limited to causes of actions for personal injury,
  750  negligence, and wrongful death;
  751         b.Ensure payment by the manufacturer through the use of a
  752  bond or other comparable security arrangements of legal
  753  judgements and claims that have been awarded to the Department
  754  of Business and Professional Regulation, the state, other
  755  entities acting on behalf of the state, individuals, or
  756  organizations if the pharmacy is assessed a final judgement or
  757  other monetary penalty in a court of law for a civil or criminal
  758  action under the program. The bond or comparable security
  759  arrangement will be accessed if the manufacturer fails to pay
  760  any judgement or claim within 60 days after final judgement; and
  761         c. Allow for civil and criminal litigation claims to be
  762  made against the bond or other comparable security arrangements
  763  for up to 1 year after the manufacturer’s permit under the
  764  program has ended with the Department of Professional and
  765  Business Regulation or the state, the manufacturer’s permit or
  766  comparable legal document is no longer valid, or the program has
  767  ended, whichever occurs last.
  768         (s)International prescription drug wholesale distributor.
  769         1. A wholesale distributor located outside of the United
  770  States must obtain an international prescription drug wholesale
  771  distributor permit to engage in the wholesale exportation and
  772  distribution of prescription drugs in the state under the
  773  International Prescription Drug Importation Program established
  774  in s. 499.0285. The wholesale distributor must be licensed or
  775  permitted to operate in a country with which the United States
  776  has a mutual recognition agreement, cooperation agreement,
  777  memorandum of understanding, or other federal mechanism
  778  recognizing the country’s adherence to current good
  779  manufacturing practices for pharmaceutical products. The
  780  wholesale distributor must maintain at all times a license or
  781  permit to engage in the wholesale distribution of prescription
  782  drugs in compliance with the laws of the jurisdiction in which
  783  it operates. An international prescription drug wholesale
  784  distributor permit may not be issued to a wholesale distributor
  785  if the jurisdiction in which the wholesale distributor operates
  786  does not require a license to engage in the wholesale
  787  distribution of prescription drugs.
  788         2.In order to participate in the International
  789  Prescription Drug Importation Program established under s.
  790  499.0285, the international wholesale distributor shall submit
  791  evidence of a surety bond with any application or filing for a
  792  permit under this section and shall maintain documentation of
  793  evidence of such a bond with the Department of Business and
  794  Professional Regulation throughout the permit term. The surety
  795  bond may be from this state or any other state in the United
  796  States in an amount equal to 10 percent of the international
  797  wholesale distributor’s annual sales or $1 million, whichever is
  798  greater. The surety bond or comparable security arrangement must
  799  include the State of Florida as a beneficiary. In lieu of the
  800  surety bond, the wholesale distributor may provide a comparable
  801  security agreement, such as an irrevocable letter of credit or a
  802  deposit into a trust account or financial institution which
  803  names the State of Florida as a beneficiary. The purposes of the
  804  bond or other security arrangement for the program are to:
  805         a.Ensure payment of any administrative penalties imposed
  806  by the Department of Business and Professional Regulation or any
  807  other state agency under the contract when the wholesale
  808  distributor fails to pay within 30 days after assessment;
  809         b.Ensure that the wholesale distributor meets contractual
  810  and statutory obligations through use of a surety bond or other
  811  comparable security arrangements to pay any other costs or fees
  812  incurred by the Department of Business of Professional
  813  Regulation, the state, or other entities acting on behalf of the
  814  state if the wholesale distributor fails to meet its
  815  obligations. If the wholesale distributor is assessed a penalty
  816  under the program and fails to pay within 30 days after that
  817  assessment, the Department of Business and Professional
  818  Regulation, the state, or an entity acting on behalf of the
  819  state may file a claim for reimbursement against the bond or
  820  other comparable security arrangement; and
  821         c.Allow for claims to be made against the bond or other
  822  comparable security arrangements for up to 1 year after the
  823  wholesale distributor’s permit under the program has ended with
  824  this section or the program has ended, whichever occurs last.
  825         3.The eligible wholesale distributor must submit evidence
  826  at the time of application and throughout the permit term of a
  827  surety bond or comparable security arrangement from this state
  828  or any other state in the United States in an amount equal to 10
  829  percent of the international wholesale distributor’s annual
  830  sales or $1 million, whichever is greater. The surety bond or
  831  comparable security arrangement must include the State of
  832  Florida as a beneficiary. In lieu of the surety bond, the
  833  wholesale distributor may provide a comparable security
  834  arrangement such as an irrevocable letter of credit or a deposit
  835  into a trust account or financial institution which names the
  836  State of Florida as a beneficiary. The purposes of the bond or
  837  other security arrangements for the program are to:
  838         a.Ensure participation of the wholesale distributor in any
  839  civil or criminal legal action by the state, the Department of
  840  Business of Professional Regulation, any other state agency, or
  841  private individuals or entities against the wholesale
  842  distributor or because of the wholesale distributor’s failure to
  843  perform under the contract, including, but not limited to causes
  844  of actions for personal injury, negligence, and wrongful death;
  845         b.Ensure payment by the wholesale distributor through the
  846  use of a bond or other comparable security arrangements of legal
  847  judgements and claims that have been awarded to the Department
  848  of Business and Professional Regulation, the state, other
  849  entities acting on behalf of the state, individuals, or
  850  organizations if the wholesale distributor is assessed a final
  851  judgement or other monetary penalty in a court of law for a
  852  civil or criminal action under the program. The bond or
  853  comparable security arrangement will be accessed if the
  854  wholesale distributor fails to pay any judgement or claim within
  855  60 days after final judgement; and
  856         c.Allow for civil and criminal litigation claims to be
  857  made against the bond or other comparable security arrangements
  858  for up to 1 year after the wholesale distributor’s permit under
  859  the program has ended with the agency or the state, the
  860  pharmacy’s permit or comparable legal document is no longer
  861  valid, or the program has ended, whichever occurs last.
  862         Section 7. Subsection (2), paragraph (a) of subsection (4),
  863  subsections (8), (10), (11), and (14), and paragraphs (a), (b),
  864  and (f) of subsection (15) of section 499.012, Florida Statutes,
  865  are amended to read:
  866         499.012 Permit application requirements.—
  867         (2) Notwithstanding subsection (6), a permitted person in
  868  good standing may change the type of permit issued to that
  869  person by completing a new application for the requested permit,
  870  paying the amount of the difference in the permit fees if the
  871  fee for the new permit is more than the fee for the original
  872  permit, and meeting the applicable permitting conditions for the
  873  new permit type. The new permit expires on the expiration date
  874  of the original permit being changed; however, a new permit for
  875  a prescription drug wholesale distributor, an out-of-state
  876  prescription drug wholesale distributor, an international
  877  prescription drug wholesale distributor, or a retail pharmacy
  878  drug wholesale distributor shall expire on the expiration date
  879  of the original permit or 1 year after the date of issuance of
  880  the new permit, whichever is earlier. A refund may not be issued
  881  if the fee for the new permit is less than the fee that was paid
  882  for the original permit.
  883         (4)(a) Except for a permit for a prescription drug
  884  wholesale distributor, an international prescription drug
  885  wholesale distributor, or an out-of-state prescription drug
  886  wholesale distributor, an application for a permit must include:
  887         1. The name, full business address, and telephone number of
  888  the applicant;
  889         2. All trade or business names used by the applicant;
  890         3. The address, telephone numbers, and the names of contact
  891  persons for each facility used by the applicant for the storage,
  892  handling, and distribution of prescription drugs;
  893         4. The type of ownership or operation, such as a
  894  partnership, corporation, or sole proprietorship; and
  895         5. The names of the owner and the operator of the
  896  establishment, including:
  897         a. If an individual, the name of the individual;
  898         b. If a partnership, the name of each partner and the name
  899  of the partnership;
  900         c. If a corporation, the name and title of each corporate
  901  officer and director, the corporate names, and the name of the
  902  state of incorporation;
  903         d. If a sole proprietorship, the full name of the sole
  904  proprietor and the name of the business entity;
  905         e. If a limited liability company, the name of each member,
  906  the name of each manager, the name of the limited liability
  907  company, and the name of the state in which the limited
  908  liability company was organized; and
  909         f. Any other relevant information that the department
  910  requires.
  911         (8) An application for a permit or to renew a permit for a
  912  prescription drug wholesale distributor, an international
  913  prescription drug wholesale distributor, or an out-of-state
  914  prescription drug wholesale distributor submitted to the
  915  department must include:
  916         (a) The name, full business address, and telephone number
  917  of the applicant.
  918         (b) All trade or business names used by the applicant.
  919         (c) The address, telephone numbers, and the names of
  920  contact persons for each facility used by the applicant for the
  921  storage, handling, and distribution of prescription drugs.
  922         (d) The type of ownership or operation, such as a
  923  partnership, corporation, or sole proprietorship.
  924         (e) The names of the owner and the operator of the
  925  establishment, including:
  926         1. If an individual, the name of the individual.
  927         2. If a partnership, the name of each partner and the name
  928  of the partnership.
  929         3. If a corporation:
  930         a. The name, address, and title of each corporate officer
  931  and director.
  932         b. The name and address of the corporation, resident agent
  933  of the corporation, the resident agent’s address, and the
  934  corporation’s state of incorporation.
  935         c. The name and address of each shareholder of the
  936  corporation that owns 5 percent or more of the outstanding stock
  937  of the corporation.
  938         4. If a sole proprietorship, the full name of the sole
  939  proprietor and the name of the business entity.
  940         5. If a limited liability company:
  941         a. The name and address of each member.
  942         b. The name and address of each manager.
  943         c. The name and address of the limited liability company,
  944  the resident agent of the limited liability company, and the
  945  name of the state in which the limited liability company was
  946  organized.
  947         (f) If applicable, the name and address of each affiliate
  948  of the applicant.
  949         (g) The applicant’s gross annual receipts attributable to
  950  prescription drug wholesale distribution activities for the
  951  previous tax year.
  952         (h) The tax year of the applicant.
  953         (i) A copy of the deed for the property on which
  954  applicant’s establishment is located, if the establishment is
  955  owned by the applicant, or a copy of the applicant’s lease for
  956  the property on which applicant’s establishment is located that
  957  has an original term of not less than 1 calendar year, if the
  958  establishment is not owned by the applicant.
  959         (j) A list of all licenses and permits issued to the
  960  applicant by any other state or jurisdiction which authorize the
  961  applicant to purchase or possess prescription drugs.
  962         (k) The name of the manager of the establishment that is
  963  applying for the permit or to renew the permit, the next four
  964  highest ranking employees responsible for prescription drug
  965  wholesale operations for the establishment, and the name of all
  966  affiliated parties for the establishment, together with the
  967  personal information statement and fingerprints required
  968  pursuant to subsection (9) for each of such persons.
  969         (l) The name of each of the applicant’s designated
  970  representatives as required by subsection (15), together with
  971  the personal information statement and fingerprints required
  972  pursuant to subsection (9) for each such person.
  973         (m) Evidence of a surety bond in this state or any other
  974  state in the United States in the amount of $100,000. If the
  975  annual gross receipts of the applicant’s previous tax year are
  976  $10 million or less, evidence of a surety bond in the amount of
  977  $25,000. The specific language of the surety bond must include
  978  the State of Florida as a beneficiary, payable to the
  979  Professional Regulation Trust Fund. In lieu of the surety bond,
  980  the applicant may provide other equivalent security such as an
  981  irrevocable letter of credit, or a deposit in a trust account or
  982  financial institution, which includes the State of Florida as a
  983  beneficiary, payable to the Professional Regulation Trust Fund.
  984  The purpose of the bond or other security is to secure payment
  985  of any administrative penalties imposed by the department and
  986  any fees and costs incurred by the department regarding that
  987  permit which are authorized under state law and which the
  988  permittee fails to pay 30 days after the fine or costs become
  989  final. The department may make a claim against such bond or
  990  security until 1 year after the permittee’s license ceases to be
  991  valid or until 60 days after any administrative or legal
  992  proceeding authorized in this part which involves the permittee
  993  is concluded, including any appeal, whichever occurs later.
  994         (n) For establishments used in wholesale distribution,
  995  proof of an inspection conducted by the department, the United
  996  States Food and Drug Administration, or another governmental
  997  entity charged with the regulation of good manufacturing
  998  practices related to wholesale distribution of prescription
  999  drugs, within timeframes set forth by the department in
 1000  departmental rules, which demonstrates substantial compliance
 1001  with current good manufacturing practices applicable to
 1002  wholesale distribution of prescription drugs. The department may
 1003  recognize another state’s or jurisdiction’s inspection of a
 1004  wholesale distributor located in that state or jurisdiction if
 1005  such state’s or jurisdiction’s laws are deemed to be
 1006  substantially equivalent to the law of this state by the
 1007  department. The department may accept an inspection by a third
 1008  party accreditation or inspection service which meets the
 1009  criteria set forth in department rule.
 1010         (o) Any other relevant information that the department
 1011  requires.
 1012         (p) Documentation of the credentialing policies and
 1013  procedures required by s. 499.0121(15).
 1014         (q)For international prescription drug wholesale
 1015  distributors and nonresident prescription drug manufacturers to
 1016  participate in the International Prescription Drug Importation
 1017  Program established under s. 499.0285, documentation
 1018  demonstrating that the applicant is appropriately licensed or
 1019  permitted by a country with which the United States has a mutual
 1020  recognition agreement, cooperation agreement, memorandum of
 1021  understanding, or other mechanism recognizing the country’s
 1022  adherence to current good manufacturing practices for
 1023  pharmaceutical products.
 1024         (10) The department may deny an application for a permit or
 1025  refuse to renew a permit for a prescription drug wholesale
 1026  distributor, an international prescription drug wholesale
 1027  distributor, or an out-of-state prescription drug wholesale
 1028  distributor if:
 1029         (a) The applicant has not met the requirements for the
 1030  permit.
 1031         (b) The management, officers, or directors of the applicant
 1032  or any affiliated party are found by the department to be
 1033  incompetent or untrustworthy.
 1034         (c) The applicant is so lacking in experience in managing a
 1035  wholesale distributor as to make the issuance of the proposed
 1036  permit hazardous to the public health.
 1037         (d) The applicant is so lacking in experience in managing a
 1038  wholesale distributor as to jeopardize the reasonable promise of
 1039  successful operation of the wholesale distributor.
 1040         (e) The applicant is lacking in experience in the
 1041  distribution of prescription drugs.
 1042         (f) The applicant’s past experience in manufacturing or
 1043  distributing prescription drugs indicates that the applicant
 1044  poses a public health risk.
 1045         (g) The applicant is affiliated directly or indirectly
 1046  through ownership, control, or other business relations, with
 1047  any person or persons whose business operations are or have been
 1048  detrimental to the public health.
 1049         (h) The applicant, or any affiliated party, has been found
 1050  guilty of or has pleaded guilty or nolo contendere to any felony
 1051  or crime punishable by imprisonment for 1 year or more under the
 1052  laws of the United States, any state, or any other country,
 1053  regardless of whether adjudication of guilt was withheld.
 1054         (i) The applicant or any affiliated party has been charged
 1055  with a felony in a state or federal court and the disposition of
 1056  that charge is pending during the application review or renewal
 1057  review period.
 1058         (j) The applicant has furnished false or fraudulent
 1059  information or material in any application made in this state or
 1060  any other state in connection with obtaining a permit or license
 1061  to manufacture or distribute drugs, devices, or cosmetics.
 1062         (k) That a federal, state, or local government permit
 1063  currently or previously held by the applicant, or any affiliated
 1064  party, for the manufacture or distribution of any drugs,
 1065  devices, or cosmetics has been disciplined, suspended, or
 1066  revoked and has not been reinstated.
 1067         (l) The applicant does not possess the financial or
 1068  physical resources to operate in compliance with the permit
 1069  being sought, this chapter, and the rules adopted under this
 1070  chapter.
 1071         (m) The applicant or any affiliated party receives,
 1072  directly or indirectly, financial support and assistance from a
 1073  person who was an affiliated party of a permittee whose permit
 1074  was subject to discipline or was suspended or revoked, other
 1075  than through the ownership of stock in a publicly traded company
 1076  or a mutual fund.
 1077         (n) The applicant or any affiliated party receives,
 1078  directly or indirectly, financial support and assistance from a
 1079  person who has been found guilty of any violation of this part
 1080  or chapter 465, chapter 501, or chapter 893, any rules adopted
 1081  under this part or those chapters, any federal or state drug
 1082  law, or any felony where the underlying facts related to drugs,
 1083  regardless of whether the person has been pardoned, had her or
 1084  his civil rights restored, or had adjudication withheld, other
 1085  than through the ownership of stock in a publicly traded company
 1086  or a mutual fund.
 1087         (o) The applicant for renewal of a permit under s.
 1088  499.01(2)(e) or (f) has not actively engaged in the wholesale
 1089  distribution of prescription drugs, as demonstrated by the
 1090  regular and systematic distribution of prescription drugs
 1091  throughout the year as evidenced by not fewer than 12 wholesale
 1092  distributions in the previous year and not fewer than three
 1093  wholesale distributions in the previous 6 months.
 1094         (p) Information obtained in response to s. 499.01(2)(e) or
 1095  (f) demonstrates it would not be in the best interest of the
 1096  public health, safety, and welfare to issue a permit.
 1097         (q) The applicant does not possess the financial standing
 1098  and business experience for the successful operation of the
 1099  applicant.
 1100         (r) The applicant or any affiliated party has failed to
 1101  comply with the requirements for manufacturing or distributing
 1102  prescription drugs under this part, similar federal laws,
 1103  similar laws in other states, or the rules adopted under such
 1104  laws.
 1105         (11) Upon approval of the application by the department and
 1106  payment of the required fee, the department shall issue or renew
 1107  a prescription drug wholesale distributor, an international
 1108  prescription drug wholesale distributor, or an out-of-state
 1109  prescription drug wholesale distributor permit to the applicant.
 1110         (14) The name of a permittee or establishment on a
 1111  prescription drug wholesale distributor permit, an international
 1112  prescription drug wholesale distributor permit, or an out-of
 1113  state prescription drug wholesale distributor permit may not
 1114  include any indicia of attainment of any educational degree, any
 1115  indicia that the permittee or establishment possesses a
 1116  professional license, or any name or abbreviation that the
 1117  department determines is likely to cause confusion or mistake or
 1118  that the department determines is deceptive, including that of
 1119  any other entity authorized to purchase prescription drugs.
 1120         (15)(a) Each establishment that is issued an initial or
 1121  renewal permit as a prescription drug wholesale distributor, an
 1122  international prescription drug wholesale distributor, or an
 1123  out-of-state prescription drug wholesale distributor must
 1124  designate in writing to the department at least one natural
 1125  person to serve as the designated representative of the
 1126  wholesale distributor. Such person must have an active
 1127  certification as a designated representative from the
 1128  department.
 1129         (b) To be certified as a designated representative, a
 1130  natural person must:
 1131         1. Submit an application on a form furnished by the
 1132  department and pay the appropriate fees.
 1133         2. Be at least 18 years of age.
 1134         3. Have at least 2 years of verifiable full-time:
 1135         a. Work experience in a pharmacy licensed in this state or
 1136  another state or jurisdiction, where the person’s
 1137  responsibilities included, but were not limited to,
 1138  recordkeeping for prescription drugs;
 1139         b. Managerial experience with a prescription drug wholesale
 1140  distributor licensed in this state or in another state or
 1141  jurisdiction; or
 1142         c. Managerial experience with the United States Armed
 1143  Forces, where the person’s responsibilities included, but were
 1144  not limited to, recordkeeping, warehousing, distributing, or
 1145  other logistics services pertaining to prescription drugs.
 1146         4. Receive a passing score of at least 75 percent on an
 1147  examination given by the department regarding federal laws
 1148  governing distribution of prescription drugs and this part and
 1149  the rules adopted by the department governing the wholesale
 1150  distribution of prescription drugs. This requirement shall be
 1151  effective 1 year after the results of the initial examination
 1152  are mailed to the persons that took the examination. The
 1153  department shall offer such examinations at least four times
 1154  each calendar year.
 1155         5. Provide the department with a personal information
 1156  statement and fingerprints pursuant to subsection (9).
 1157         (f) A wholesale distributor may not operate under a
 1158  prescription drug wholesale distributor permit, an international
 1159  prescription drug wholesale distributor permit, or an out-of
 1160  state prescription drug wholesale distributor permit for more
 1161  than 10 business days after the designated representative leaves
 1162  the employ of the wholesale distributor, unless the wholesale
 1163  distributor employs another designated representative and
 1164  notifies the department within 10 business days of the identity
 1165  of the new designated representative.
 1166         Section 8. Subsection (1) of section 499.015, Florida
 1167  Statutes, is amended to read:
 1168         499.015 Registration of drugs and devices; issuance of
 1169  certificates of free sale.—
 1170         (1)(a) Except for those persons exempted from the
 1171  definition of manufacturer in s. 499.003, any person who
 1172  manufactures, packages, repackages, labels, or relabels a drug
 1173  or device in this state must register such drug or device
 1174  biennially with the department; pay a fee in accordance with the
 1175  fee schedule provided by s. 499.041; and comply with this
 1176  section. The registrant must list each separate and distinct
 1177  drug or device at the time of registration.
 1178         (b) The department may not register any product that does
 1179  not comply with the Federal Food, Drug, and Cosmetic Act, as
 1180  amended, or Title 21 C.F.R. Registration of a product by the
 1181  department does not mean that the product does in fact comply
 1182  with all provisions of the Federal Food, Drug, and Cosmetic Act,
 1183  as amended.
 1184         (c)Registration under this section is not required for
 1185  prescription drugs imported under the International Prescription
 1186  Drug Importation Program established in s. 499.0285.
 1187         Section 9. Subsections (1) and (3) of section 499.065,
 1188  Florida Statutes, are amended to read:
 1189         499.065 Inspections; imminent danger.—
 1190         (1) Notwithstanding s. 499.051, the department shall
 1191  inspect each prescription drug wholesale distributor
 1192  establishment, international prescription drug wholesale
 1193  distributor establishment, prescription drug repackager
 1194  establishment, veterinary prescription drug wholesale
 1195  distributor establishment, limited prescription drug veterinary
 1196  wholesale distributor establishment, and retail pharmacy drug
 1197  wholesale distributor establishment that is required to be
 1198  permitted under this part as often as necessary to ensure
 1199  compliance with applicable laws and rules. The department shall
 1200  have the right of entry and access to these facilities at any
 1201  reasonable time.
 1202         (3) The department may determine that a prescription drug
 1203  wholesale distributor establishment, international prescription
 1204  drug wholesale distributor establishment, prescription drug
 1205  repackager establishment, veterinary prescription drug wholesale
 1206  distributor establishment, limited prescription drug veterinary
 1207  wholesale distributor establishment, or retail pharmacy drug
 1208  wholesale distributor establishment that is required to be
 1209  permitted under this part is an imminent danger to the public
 1210  health and shall require its immediate closure if the
 1211  establishment fails to comply with applicable laws and rules
 1212  and, because of the failure, presents an imminent threat to the
 1213  public’s health, safety, or welfare. Any establishment so deemed
 1214  and closed shall remain closed until allowed by the department
 1215  or by judicial order to reopen.
 1216         Section 10. Section 499.0285, Florida Statutes, is created
 1217  to read:
 1218         499.0285International Prescription Drug Importation
 1219  Program.—
 1220         (1)PROGRAM ESTABLISHED.—The department shall establish a
 1221  program for the importation of safe and effective prescription
 1222  drugs from foreign nations with which the United States has
 1223  current mutual recognition agreements, cooperation agreements,
 1224  memoranda of understanding, or other federal mechanisms
 1225  recognizing their adherence to current good manufacturing
 1226  practices for pharmaceutical products. The program shall be open
 1227  to individual Florida residents and to those participating in
 1228  the Canadian Drug Importation Program under s. 381.02035.
 1229         (2)DEFINITIONS.—As used in this section, the term:
 1230         (a)“Exporter” means an international prescription drug
 1231  wholesale distributor, a nonresident prescription drug
 1232  manufacturer registered to participate in the program, or an
 1233  international export pharmacy that exports prescription drugs
 1234  into this state under the program.
 1235         (b)“Federal Act” means the Federal Food, Drug, and
 1236  Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
 1237  as amended by the Drug Quality and Security Act, 21 U.S.C. 351
 1238  et seq.
 1239         (c)“Foreign recipient” means an entity other than the
 1240  original prescription drug manufacturer which receives the
 1241  prescription drug before its importation into this state under
 1242  the program.
 1243         (d)“Good manufacturing practice” refers to the good
 1244  manufacturing practice regulations in 21 C.F.R. parts 210 and
 1245  211.
 1246         (e)“Importer” means a wholesale distributor, pharmacy, or
 1247  pharmacist importing prescription drugs into this state under
 1248  the program.
 1249         (f)“International export pharmacy” means a pharmacy
 1250  located outside of the United States which holds an active and
 1251  unencumbered permit under chapter 465 to export prescription
 1252  drugs into this state under the program.
 1253         (g)“International prescription drug wholesale distributor”
 1254  means a prescription drug wholesale distributor located outside
 1255  of the United States which holds an active and unencumbered
 1256  permit under this part to export and distribute prescription
 1257  drugs into this state under the program.
 1258         (h)“Nonresident prescription drug manufacturer” means an
 1259  entity located outside of the United States which holds an
 1260  active and unencumbered permit under this part to manufacture
 1261  prescription drugs and has registered with the department to
 1262  export and distribute such prescription drugs into this state
 1263  under the program.
 1264         (i)“Pharmacist” means a person who holds an active and
 1265  unencumbered license to practice pharmacy under chapter 465.
 1266         (j)“Pharmacy” means an entity that holds an active and
 1267  unencumbered permit under chapter 465.
 1268         (k)“Prescription drug” has the same meaning as defined in
 1269  this part, but is limited to drugs intended for human use.
 1270         (l)“Program” means the International Prescription Drug
 1271  Importation Program established under this section.
 1272         (m)“Qualified laboratory” means a laboratory that has been
 1273  approved by the department for the purposes of this section.
 1274         (3)ELIGIBLE PRESCRIPTION DRUGS.—An eligible importer may
 1275  import a prescription drug from an eligible exporter if:
 1276         (a)The drug meets the United States Food and Drug
 1277  Administration’s standards related to safety, effectiveness,
 1278  misbranding, and adulteration;
 1279         (b)Importing the drug would not violate the patent laws of
 1280  the United States; and
 1281         (c)The drug is not:
 1282         1.A controlled substance as defined in 21 U.S.C. s. 802;
 1283         2.A biological product as defined in 42 U.S.C. s. 262;
 1284         3.An infused drug;
 1285         4.An intravenously injected drug;
 1286         5.A drug that is inhaled during surgery; or
 1287         6. A drug that is a parenteral drug, the importation of
 1288  which is determined by the United States Secretary of Health and
 1289  Human Services to pose a threat to the public health.
 1290         (4)EXPORTERS.—
 1291         (a)The following entities may export prescription drugs
 1292  into this state under the program:
 1293         1.An international prescription drug wholesale
 1294  distributor.
 1295         2.A nonresident prescription drug manufacturer.
 1296         3.An international export pharmacy.
 1297         (b)An eligible exporter must register with the department
 1298  before exporting prescription drugs into this state under the
 1299  program.
 1300         (c)An exporter may not distribute, sell, or dispense
 1301  prescription drugs imported under the program to any person
 1302  residing outside of the state.
 1303         (5)IMPORTERS.—
 1304         (a)The following entities may import prescription drugs
 1305  under the program:
 1306         1.A wholesale distributor.
 1307         2.A pharmacy.
 1308         3.A pharmacist.
 1309         (b)An eligible importer must register with the department
 1310  before importing prescription drugs into this state under the
 1311  program.
 1312         (c)An importer may not distribute, sell, or dispense
 1313  prescription drugs imported under the program to any person
 1314  residing outside of the state.
 1315         (6)PRESCRIPTION DRUG SUPPLY CHAIN DOCUMENTATION.—
 1316         (a)A participating importer must submit the following
 1317  information and documentation to the department:
 1318         1.The name and quantity of the active ingredient of the
 1319  prescription drug.
 1320         2.A description of the dosage form of the prescription
 1321  drug.
 1322         3.The date on which the prescription drug is shipped.
 1323         4.The quantity of the prescription drug that is shipped.
 1324         5.The point of origin and destination of the prescription
 1325  drug.
 1326         6.The price paid by the importer for the prescription
 1327  drug.
 1328         7.Documentation from the exporter specifying:
 1329         a.The original source of the prescription drug; and
 1330         b.The quantity of each lot of the prescription drug
 1331  originally received by the seller from that source.
 1332         8.The lot or control number assigned to the prescription
 1333  drug by the manufacturer.
 1334         9.The name, address, telephone number, and professional
 1335  license or permit number of the importer.
 1336         10.In the case of a prescription drug that is shipped
 1337  directly by the first foreign recipient from the manufacturer:
 1338         a.Documentation demonstrating that the prescription drug
 1339  was received by the recipient from the manufacturer and
 1340  subsequently shipped by the first foreign recipient to the
 1341  importer.
 1342         b.Documentation of the quantity of each lot of the
 1343  prescription drug received by the first foreign recipient
 1344  demonstrating that the quantity being imported into this state
 1345  is not more than the quantity that was received by the first
 1346  foreign recipient.
 1347         c.For an initial imported shipment, documentation
 1348  demonstrating that each batch of the prescription drug in the
 1349  shipment was statistically sampled and tested for authenticity
 1350  and degradation.
 1351         11.In the case of a prescription drug that is not shipped
 1352  directly from the first foreign recipient, documentation
 1353  demonstrating that each batch in each shipment offered for
 1354  importation into this state was statistically sampled and tested
 1355  for authenticity and degradation.
 1356         12.For an initial imported shipment, the agency shall
 1357  ensure that each batch of the drug in the shipment is
 1358  statistically sampled and tested for authenticity and
 1359  degradation in a manner consistent with the federal act. The
 1360  agency may contract with a vendor for these functions.
 1361         13.For any subsequent imported shipment, the department
 1362  shall ensure that a statistically valid sample of the shipment
 1363  was tested for authenticity and degradation in a manner
 1364  consistent with the federal act.
 1365         14.Certify that the drug:
 1366         a.Is approved for marketing in the United States and is
 1367  not adulterated or misbranded; and
 1368         b.Meets all of the labeling requirements under 21 U.S.C.
 1369  s. 352.
 1370         15.Maintain qualified laboratory records, including
 1371  complete data derived from all tests necessary to ensure that
 1372  the drug is in compliance with the requirements of this section.
 1373         16.Maintain documentation demonstrating that the testing
 1374  required by this section was conducted at a qualified laboratory
 1375  in accordance with the federal act and any other applicable
 1376  federal and state laws and regulations governing laboratory
 1377  qualifications.
 1378         (b)All testing required by this section must be conducted
 1379  in a qualified laboratory that meets the standards under the
 1380  federal act and any other applicable federal and state laws and
 1381  regulations governing laboratory qualifications for drug
 1382  testing.
 1383         (c)The vendor shall maintain information and documentation
 1384  submitted under this section for a period of at least 7 years.
 1385         (d)A participating importer must submit the all of
 1386  following information to the department:
 1387         1.The name and quantity of the active ingredient of the
 1388  drug.
 1389         2.A description of the dosage form of the drug.
 1390         3.The date on which the drug is received.
 1391         4.The quantity of the drug that is received.
 1392         5.The point of origin and destination of the drug.
 1393         6.The price paid by the importer for the drug.
 1394         (e)A participating International Importation Drug supplier
 1395  must submit the following information and documentation to the
 1396  agency or the agency’s designated vendor specifying all of the
 1397  following:
 1398         1.The original source of the drug, including:
 1399         a. The name of the manufacturer of the drug.
 1400         b. The date on which the drug was manufactured.
 1401         c. The location (country, state or province, and city)
 1402  where the drug was manufactured.
 1403         2.The date on which the drug is shipped.
 1404         3.The quantity of the drug that is shipped.
 1405         4.The quantity of each lot of the drug originally received
 1406  and from which source.
 1407         5.The lot or control number and the batch number assigned
 1408  to the drug by the manufacturer.
 1409         6.The name, address, and telephone number, and
 1410  professional license or permit number of the importer.
 1411         (f)The department may require any other information
 1412  necessary to ensure the protection of the public health.
 1413         (7)IMMEDIATE SUSPENSION.—The department shall immediately
 1414  suspend the importation of a specific prescription drug or the
 1415  importation of prescription drugs by a specific importer if it
 1416  discovers that any prescription drug or activity is in violation
 1417  of this section. The department may revoke the suspension if,
 1418  after conducting an investigation, it determines that the public
 1419  is adequately protected from counterfeit or unsafe prescription
 1420  drugs being imported into this state.
 1421         (8)RULEMAKING AUTHORITY.—The department shall adopt rules
 1422  necessary to implement this section.
 1423         Section 11. Notwithstanding the Federal Food, Drug, and
 1424  Cosmetic Act, the Department of Business and Professional
 1425  Regulation, in collaboration with the Department of Health,
 1426  shall negotiate a federal arrangement to operate a pilot program
 1427  for importing prescription drugs into this state. The proposal
 1428  to operate such a pilot program shall demonstrate that the
 1429  program sets safety standards consistent with the current
 1430  federal requirements for the manufacturing and distribution of
 1431  prescription drugs; limits the importation of prescription drugs
 1432  under the program to entities licensed or permitted by the state
 1433  to manufacture, distribute, or dispense prescription drugs; and
 1434  includes inspection and enforcement authority. Implementation of
 1435  sections 2 through 10 of this act is contingent upon
 1436  authorization granted under federal law or rule. The department
 1437  shall notify the President of the Senate, the Speaker of the
 1438  House of Representatives, and the relevant committees of the
 1439  Senate and the House of Representatives before implementation of
 1440  the pilot program. The department shall submit to all parties a
 1441  proposal for program implementation and program funding.
 1442         Section 12. This act shall take effect July 1, 2019.

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