Florida Senate - 2019                          SENATOR AMENDMENT
       Bill No. CS for CS for SB 1528
       
       
       
       
       
       
                                Ì291576GÎ291576                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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                 Floor: NC/2R          .                                
             04/26/2019 12:09 PM       .                                
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       Senator Bean moved the following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Section 381.02035, Florida Statutes, is created
    6  to read:
    7         381.02035 Canadian Prescription Drug Importation Program.—
    8         (1)PROGRAM ESTABLISHED.—The Agency for Health Care
    9  Administration shall establish the Canadian Prescription Drug
   10  Importation Program for the importation of safe and effective
   11  prescription drugs from Canada which have the highest potential
   12  for cost savings to the state.
   13         (2) DEFINITIONS.—As used in this section, the term:
   14         (a)“Agency” means the Agency for Health Care
   15  Administration.
   16         (b)“Canadian supplier” means a manufacturer, wholesale
   17  distributor, or pharmacy appropriately licensed or permitted
   18  under Canadian law to manufacture, distribute, or dispense
   19  prescription drugs.
   20         (c) “County health department” means a health care facility
   21  established under part I of chapter 154.
   22         (d)“Department” means the Department of Health.
   23         (e)“Drug” or “prescription drug” has the same meaning as
   24  “prescription drug” in s. 499.003, but is limited to drugs
   25  intended for human use.
   26         (f)“Federal act” means the Federal Food, Drug, and
   27  Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
   28  as amended by the Drug Quality and Security Act, 21 U.S.C. 351
   29  et seq.
   30         (g)“Free clinic” means a clinic that delivers only medical
   31  diagnostic services or nonsurgical medical treatment free of
   32  charge to low-income recipients.
   33         (h)“Medicaid pharmacy” means a pharmacy licensed under
   34  chapter 465 that has a Medicaid provider agreement in effect
   35  with the agency and is in good standing with the agency.
   36         (i)“Pharmacist” means a person who holds an active and
   37  unencumbered license to practice pharmacy pursuant to chapter
   38  465.
   39         (j) “Program” means the Canadian Prescription Drug
   40  Importation Program.
   41         (k) “Track-and-trace” means the product-tracing process for
   42  the components of the pharmaceutical distribution supply chain
   43  as described in Title II of the Drug Quality and Security Act,
   44  Drug Supply Chain Security Act, 21 U.S.C. 351 et seq.
   45         (l)“Vendor” means the entity contracted by the agency to
   46  manage specified functions of the program.
   47         (3)IMPORTATION PROCESS.—
   48         (a)The agency shall contract with a vendor to provide
   49  services under the program.
   50         (b)By December 1, 2019, and each year thereafter, the
   51  vendor shall develop a Wholesale Prescription Drug Importation
   52  List identifying the prescription drugs that have the highest
   53  potential for cost savings to the state. In developing the list,
   54  the vendor shall consider, at a minimum, which prescription
   55  drugs will provide the greatest cost savings to state programs,
   56  including prescriptions drugs for which there are shortages,
   57  specialty prescription drugs, and high volume prescription
   58  drugs. The agency, in consultation with the department, shall
   59  review the Wholesale Prescription Drug Importation List every 3
   60  months to ensure that it continues to meet the requirements of
   61  the programs and may direct the vendor to revise the list, as
   62  necessary.
   63         (c)The vendor shall identify Canadian suppliers that are
   64  in full compliance with relevant Canadian federal and provincial
   65  laws and regulations and the federal act and who have agreed to
   66  export drugs identified on the list at prices that will provide
   67  cost savings to the state. The vendor must verify that such
   68  Canadian suppliers meet all of the requirements of the program,
   69  while meeting or exceeding the federal and state track-and-trace
   70  laws and regulations.
   71         (d)The vendor shall contract with such eligible Canadian
   72  suppliers, or facilitate contracts between eligible importers
   73  and Canadian suppliers, to import drugs under the program.
   74         (e)The vendor shall maintain a list of all registered
   75  importers that participate in the program.
   76         (f)The vendor shall ensure compliance with Title II of the
   77  federal Drug Quality and Security Act, Pub. L. No. 113-54, by
   78  all suppliers, importers and other distributors, and
   79  participants in the program.
   80         (g)The vendor shall assist the agency in the preparation
   81  of the annual report required by subsection (12), including the
   82  timely provision of any information requested by the agency.
   83         (h)The vendor shall provide an annual financial audit of
   84  its operations to the agency as required by the agency. The
   85  vendor shall also provide quarterly financial reports specific
   86  to the program and shall include information on the performance
   87  of its subcontractors and vendors. The agency shall determine
   88  the format and contents of the reports.
   89         (4) BOND REQUIREMENT.—The agency shall require a bond from
   90  the vendor to mitigate the financial consequences of potential
   91  acts of malfeasance or misfeasance or fraudulent or dishonest
   92  acts committed by the vendor, any employees of the vendor, or
   93  its subcontractors.
   94         (5) ELIGIBLE PRESCRIPTION DRUGS.—Eligible importers, as
   95  described in subsection (7), may import a drug from an eligible
   96  Canadian supplier, as described in subsection (6), if:
   97         (a)The drug meets the United States Food and Drug
   98  Administration’s standards related to safety, effectiveness,
   99  misbranding, and adulteration;
  100         (b)Importing the drug would not violate federal patent
  101  laws;
  102         (c)Importing the drug is expected to generate cost
  103  savings; and
  104         (d)The drug is not:
  105         1.A controlled substance as defined in 21 U.S.C. s. 802;
  106         2.A biological product as defined in 42 U.S.C. s. 262;
  107         3.An infused drug;
  108         4.An intravenously injected drug;
  109         5.A drug that is inhaled during surgery; or
  110         6.A drug that is a parenteral drug, the importation of
  111  which is determined by the United States Secretary of Health and
  112  Human Services to pose a threat to the public health.
  113         (6) ELIGIBLE CANADIAN SUPPLIERS.—A Canadian supplier may
  114  export prescription drugs into this state under the program if
  115  the supplier:
  116         (a) Is in full compliance with relevant Canadian federal
  117  and provincial laws and regulations;
  118         (b) Is identified by the vendor as eligible to participate
  119  in the program; and
  120         (c)Submits an attestation that the supplier has a
  121  registered agent in the United States, including the name and
  122  United States address of the registered agent.
  123         (7)ELIGIBLE IMPORTERS.—The following entities may import
  124  prescription drugs from an eligible Canadian supplier under the
  125  program:
  126         (a)A pharmacist or wholesaler employed by or under
  127  contract with the department’s central pharmacy, for
  128  distribution to a county health department or free clinic for
  129  dispensing to clients treated in such department or clinic.
  130         (b)A pharmacist or wholesaler employed by or under
  131  contract with a Medicaid pharmacy, for dispensing to the
  132  pharmacy’s Medicaid recipients.
  133         (c)A pharmacist or wholesaler employed by or under
  134  contract with the Department of Corrections, for dispensing to
  135  inmates in the custody of the Department of Corrections.
  136         (d)A pharmacist or wholesaler employed by or under
  137  contract with a developmental disabilities center, as defined in
  138  s. 393.063, for dispensing to clients treated in such center.
  139         (e)A pharmacist or wholesaler employed by or under
  140  contract with a treatment facility, as defined in s. 394.455,
  141  for dispensing to patients treated in such facility.
  142         (8)DISTRIBUTION REQUIREMENTS.—Eligible Canadian suppliers
  143  and eligible importers participating under the program:
  144         (a)Must comply with the tracking and tracing requirements
  145  of 21 U.S.C. ss. 360eee et seq.
  146         (b)May not distribute, dispense, or sell prescription
  147  drugs imported under the program outside of the state.
  148         (9)FEDERAL APPROVAL.—By July 1, 2020, the agency shall
  149  submit a request to the United States Secretary of Health and
  150  Human Services for approval of the program under 21 U.S.C. s.
  151  384(l). The agency shall begin operating the program within 6
  152  months after receiving such approval. The request must, at a
  153  minimum:
  154         (a)Describe the agency’s plan for operating the program.
  155         (b)Demonstrate how the prescription drugs imported into
  156  this state under the program will meet the applicable federal
  157  and state standards for safety and effectiveness.
  158         (c) Demonstrate how the drugs imported into this state
  159  under the program will comply with federal tracing procedures.
  160         (d)Include a list of proposed prescription drugs that have
  161  the highest potential for cost savings to the state through
  162  importation at the time that the request is submitted.
  163         (e)Estimate the total cost savings attributable to the
  164  program.
  165         (f) Provide the costs of program implementation to the
  166  state.
  167         (g)Include a list of potential Canadian suppliers from
  168  which the state would import drugs and demonstrate that the
  169  suppliers are in full compliance with relevant Canadian federal
  170  and provincial laws and regulations as well as all applicable
  171  federal and state laws and regulations.
  172         (10)PRESCRIPTION DRUG SUPPLY CHAIN DOCUMENTATION.—
  173         (a)The vendor shall ensure the safety and quality of drugs
  174  imported under the program. The vendor shall:
  175         1.For an initial imported shipment of a specific drug by
  176  an importer, ensure that each batch of the drug in the shipment
  177  is statistically sampled and tested for authenticity and
  178  degradation in a manner consistent with the federal act.
  179         2.For every subsequent imported shipment of that drug by
  180  that importer, ensure that a statistically valid sample of the
  181  shipment is tested for authenticity and degradation in a manner
  182  consistent with the federal act.
  183         3.Certify that the drug:
  184         a.Is approved for marketing in the United States and is
  185  not adulterated or misbranded; and
  186         b.Meets all of the labeling requirements under 21 U.S.C.
  187  s. 352.
  188         4.Maintain qualified laboratory records, including
  189  complete data derived from all tests necessary to ensure that
  190  the drug is in compliance with the requirements of this section.
  191         5.Maintain documentation demonstrating that the testing
  192  required by this section was conducted at a qualified laboratory
  193  in accordance with the federal act and any other applicable
  194  federal and state laws and regulations governing laboratory
  195  qualifications.
  196         (b)All testing required by this section must be conducted
  197  in a qualified laboratory that meets the standards under the
  198  federal act and any other applicable federal and state laws and
  199  regulations governing laboratory qualifications for drug
  200  testing.
  201         (c)The vendor shall maintain information and documentation
  202  submitted under this section for a period of at least 7 years.
  203         (d)A participating importer must submit the all of
  204  following information to the vendor:
  205         1.The name and quantity of the active ingredient of the
  206  drug.
  207         2.A description of the dosage form of the drug.
  208         3.The date on which the drug is received.
  209         4.The quantity of the drug that is received.
  210         5.The point of origin and destination of the drug.
  211         6.The price paid by the importer for the drug.
  212         (e)A participating Canadian supplier must submit the
  213  following information and documentation to the vendor specifying
  214  all of the following:
  215         1.The original source of the drug, including:
  216         a. The name of the manufacturer of the drug.
  217         b. The date on which the drug was manufactured.
  218         c. The location (country, state or province, and city)
  219  where the drug was manufactured.
  220         2.The date on which the drug is shipped.
  221         3.The quantity of the drug that is shipped.
  222         4.The quantity of each lot of the drug originally received
  223  and the source of the lot.
  224         5.The lot or control number and the batch number assigned
  225  to the drug by the manufacturer.
  226         (f)The agency may require that the vendor collect any
  227  other information necessary to ensure the protection of the
  228  public health.
  229         (11)IMMEDIATE SUSPENSION.—The agency shall immediately
  230  suspend the importation of a specific drug or the importation of
  231  drugs by a specific importer if it discovers that any drug or
  232  activity is in violation of this section or any federal or state
  233  law or regulation. The agency may revoke the suspension if,
  234  after conducting an investigation, it determines that the public
  235  is adequately protected from counterfeit or unsafe drugs being
  236  imported into this state.
  237         (12)ANNUAL REPORT.—By December 1 of each year, the agency
  238  shall submit a report to the Governor, the President of the
  239  Senate, and the Speaker of the House of Representatives on the
  240  operation of the program during the previous fiscal year. The
  241  report must include, at a minimum:
  242         (a)A list of the prescription drugs that were imported
  243  under the program;
  244         (b)The number of participating entities;
  245         (c)The number of prescriptions dispensed through the
  246  program;
  247         (d)The estimated cost savings during the previous fiscal
  248  year and to date attributable the program;
  249         (e)A description of the methodology used to determine
  250  which drugs should be included on the Wholesale Prescription
  251  Drug Importation List; and
  252         (f)Documentation as to how the program ensures the
  253  following:
  254         1.That Canadian suppliers participating in the program are
  255  of high quality, high performance, and in full compliance with
  256  relevant Canadian federal and provincial laws and regulations as
  257  well as all federal laws and regulations and state laws and
  258  rules;
  259         2.That prescription drugs imported under the program are
  260  not shipped, sold, or dispensed outside of this state once in
  261  the possession of the importer;
  262         3.That prescription drugs imported under the program are
  263  pure, unadulterated, potent, and safe;
  264         4.That the program does not put consumers at a higher
  265  health and safety risk than if the consumer did not participate;
  266  and
  267         5.That the program provides cost savings to the state on
  268  imported prescription drugs.
  269         (13)NOTIFICATION OF FEDERAL APPROVAL.—Upon receipt of
  270  federal approval of the program, the agency shall notify the
  271  President of the Senate, the Speaker of the House of
  272  Representatives, and the relevant committees of the Senate and
  273  the House of Representatives. After approval is received and
  274  before the start of the next regular session of the Legislature
  275  in which the proposal could be funded, the agency shall submit
  276  to all parties a proposal for program implementation and program
  277  funding.
  278         (14)RULEMAKING.—The agency shall adopt rules necessary to
  279  implement this section.
  280         Section 2. Section 465.0157, Florida Statutes, is created
  281  to read:
  282         465.0157International export pharmacy permit.—
  283         (1)To participate as an exporter of prescription drugs
  284  into this state under the International Prescription Drug
  285  Importation Program established in s. 499.0285, a pharmacy
  286  located outside of the United States must hold an international
  287  export pharmacy permit.
  288         (2)An international export pharmacy shall maintain at all
  289  times an active and unencumbered license or permit to operate
  290  the pharmacy in compliance with the laws of the jurisdiction in
  291  which the dispensing facility is located and from which the
  292  prescription drugs will be exported. Such jurisdiction must be
  293  in a country with which the United States has a current mutual
  294  recognition agreement, cooperation agreement, memorandum of
  295  understanding, or other federal mechanism recognizing the
  296  country’s adherence to current good manufacturing practices for
  297  pharmaceutical products.
  298         (3)An application for an international export pharmacy
  299  permit must be submitted on a form developed and provided by the
  300  board. The board may require an applicant to provide any
  301  information it deems reasonably necessary to carry out the
  302  purposes of this section.
  303         (4)An applicant shall submit the following to the board to
  304  obtain an initial permit, or to the department to renew a
  305  permit:
  306         (a)Proof of an active and unencumbered license or permit
  307  to operate the pharmacy in compliance with the laws of the
  308  jurisdiction in which the dispensing facility is located and
  309  from which the prescription drugs will be exported.
  310         (b)Documentation demonstrating that the country in which
  311  the pharmacy operates has a current mutual recognition
  312  agreement, cooperation agreement, memorandum of understanding,
  313  or other federal mechanism recognizing the country’s adherence
  314  to current good manufacturing practices for pharmaceutical
  315  products.
  316         (c)The department shall adopt rules governing the
  317  financial responsibility of the pharmacy permittee. The rules
  318  must establish, at a minimum, financial reporting requirements,
  319  standards for financial capability to perform the functions
  320  governed by the permit, and requirements for ensuring permittees
  321  and their contractors can be held accountable for the financial
  322  consequences of any act of malfeasance or misfeasance or
  323  fraudulent or dishonest act or acts committed by the permittee
  324  or its contractors.
  325         (d)The location, names, and titles of all principal
  326  corporate officers and the pharmacist who serves as the
  327  prescription department manager for prescription drugs exported
  328  into this state under the International Prescription Drug
  329  Importation Program.
  330         (e)Written attestation by an owner or officer of the
  331  applicant, and by the applicant’s prescription department
  332  manager, that:
  333         1.The attestor has read and understands the laws and rules
  334  governing the manufacture, distribution, and dispensing of
  335  prescription drugs in this state.
  336         2.A prescription drug shipped, mailed, or delivered into
  337  this state meets or exceeds this state’s standards for safety
  338  and efficacy.
  339         3.A prescription drug product shipped, mailed, or
  340  delivered into this state must not have been, and may not be,
  341  manufactured or distributed in violation of the laws and rules
  342  of the jurisdiction in which the applicant is located and from
  343  which the prescription drugs shall be exported.
  344         (f)A current inspection report from an inspection
  345  conducted by the regulatory or licensing agency of the
  346  jurisdiction in which the applicant is located. The inspection
  347  report must reflect compliance with this section. An inspection
  348  report is current if the inspection was conducted within 6
  349  months before the date of submitting the application for the
  350  initial permit or within 1 year before the date of submitting an
  351  application for permit renewal. If the applicant is unable to
  352  submit a current inspection report conducted by the regulatory
  353  or licensing agency of the jurisdiction in which the applicant
  354  is located and from which the prescription drugs will be
  355  exported, due to acceptable circumstances, as established by
  356  rule, or if an inspection has not been performed, the department
  357  must:
  358         1.Conduct, or contract with an entity to conduct, an
  359  onsite inspection, with all related costs borne by the
  360  applicant;
  361         2.Accept a current and satisfactory inspection report, as
  362  determined by rule, from an entity approved by the board; or
  363         3.Accept a current inspection report from the United
  364  States Food and Drug Administration conducted pursuant to the
  365  federal Drug Quality and Security Act, Pub. L. No. 113-54.
  366         Section 3. Subsection (2) of section 465.017, Florida
  367  Statutes, is amended to read:
  368         465.017 Authority to inspect; disposal.—
  369         (2) Duly authorized agents and employees of the department
  370  may inspect a nonresident pharmacy registered under s. 465.0156,
  371  an international export pharmacy permittee under s. 465.0157, or
  372  a nonresident sterile compounding permittee under s. 465.0158
  373  pursuant to this section. The costs of such inspections shall be
  374  borne by such pharmacy or permittee.
  375         Section 4. Subsection (20) of section 499.005, Florida
  376  Statutes, is amended to read:
  377         499.005 Prohibited acts.—It is unlawful for a person to
  378  perform or cause the performance of any of the following acts in
  379  this state:
  380         (20) The importation of a prescription drug except as
  381  provided by s. 801(d) of the Federal Food, Drug, and Cosmetic
  382  Act or s. 499.0285.
  383         Section 5. Paragraph (e) of subsection (12) of section
  384  499.0051, Florida Statutes, is amended to read:
  385         499.0051 Criminal acts.—
  386         (12) REFUSAL TO ALLOW INSPECTION; SELLING, PURCHASING, OR
  387  TRADING DRUG SAMPLES; FAILURE TO MAINTAIN RECORDS RELATING TO
  388  PRESCRIPTION DRUGS.—Any person who violates any of the following
  389  provisions commits a felony of the third degree, punishable as
  390  provided in s. 775.082, s. 775.083, or s. 775.084, or as
  391  otherwise provided in this part:
  392         (e) The importation of a prescription drug for wholesale
  393  distribution, except as provided by s. 801(d) of the Federal
  394  Food, Drug, and Cosmetic Act or s. 499.0285.
  395         Section 6. Subsection (1) and paragraph (c) of subsection
  396  (2) of section 499.01, Florida Statutes, are amended, and
  397  paragraph (s) is added to subsection (2) of that section, to
  398  read:
  399         499.01 Permits.—
  400         (1) Before operating, a permit is required for each person
  401  and establishment that intends to operate as:
  402         (a) A prescription drug manufacturer;
  403         (b) A prescription drug repackager;
  404         (c) A nonresident prescription drug manufacturer;
  405         (d) A nonresident prescription drug repackager;
  406         (e) A prescription drug wholesale distributor;
  407         (f) An out-of-state prescription drug wholesale
  408  distributor;
  409         (g) A retail pharmacy drug wholesale distributor;
  410         (h) A restricted prescription drug distributor;
  411         (i) A complimentary drug distributor;
  412         (j) A freight forwarder;
  413         (k) A veterinary prescription drug retail establishment;
  414         (l) A veterinary prescription drug wholesale distributor;
  415         (m) A limited prescription drug veterinary wholesale
  416  distributor;
  417         (n) An over-the-counter drug manufacturer;
  418         (o) A device manufacturer;
  419         (p) A cosmetic manufacturer;
  420         (q) A third party logistics provider; or
  421         (r) A health care clinic establishment; or
  422         (s)An international prescription drug wholesale
  423  distributor.
  424         (2) The following permits are established:
  425         (c) Nonresident prescription drug manufacturer permit.—A
  426  nonresident prescription drug manufacturer permit is required
  427  for any person that is a manufacturer of prescription drugs,
  428  unless permitted as a third party logistics provider, located
  429  outside of this state or outside the United States and that
  430  engages in the distribution in this state of such prescription
  431  drugs. Each such manufacturer must be permitted by the
  432  department and comply with all of the provisions required of a
  433  prescription drug manufacturer under this part. The department
  434  shall adopt rules for issuing a virtual nonresident prescription
  435  drug manufacturer permit to a person who engages in the
  436  manufacture of prescription drugs but does not make or take
  437  physical possession of any prescription drugs. The rules adopted
  438  by the department under this section may exempt virtual
  439  nonresident manufacturers from certain establishment, security,
  440  and storage requirements set forth in s. 499.0121.
  441         1. A person that distributes prescription drugs for which
  442  the person is not the manufacturer must also obtain an out-of
  443  state prescription drug wholesale distributor permit, an
  444  international prescription drug wholesale distributor permit, or
  445  third party logistics provider permit pursuant to this section
  446  to engage in the distribution of such prescription drugs when
  447  required by this part. This subparagraph does not apply to a
  448  manufacturer that distributes prescription drugs only for the
  449  manufacturer of the prescription drugs where both manufacturers
  450  are affiliates.
  451         2. Any such person must comply with the licensing or
  452  permitting requirements of the jurisdiction in which the
  453  establishment is located and the federal act, and any
  454  prescription drug distributed into this state must comply with
  455  this part. If a person intends to import prescription drugs from
  456  a foreign country into this state, the nonresident prescription
  457  drug manufacturer must provide to the department a list
  458  identifying each prescription drug it intends to import and
  459  document approval by the United States Food and Drug
  460  Administration for such importation.
  461         3.a. A nonresident prescription drug manufacturer that has
  462  registered to participate in the International Prescription Drug
  463  Importation Program pursuant to this section is not required to
  464  provide the list and approval required by subparagraph 2. for
  465  prescription drugs imported under that program.
  466         b. To participate as an exporter of prescription drugs into
  467  this state under the International Prescription Drug Importation
  468  Program established under s. 499.0285, a nonresident
  469  prescription drug manufacturer located outside of the United
  470  States must register with the Department of Business and
  471  Professional Regulation before engaging in any activities under
  472  that section. Such manufacturer must be licensed or permitted in
  473  a country with which the United States has a current mutual
  474  recognition agreement, cooperation agreement, memorandum of
  475  understanding, or other federal mechanism recognizing the
  476  country’s adherence to current good manufacturing practices for
  477  pharmaceutical products.
  478         c.The department shall adopt rules governing the financial
  479  responsibility of a nonresident prescription drug manufacturer
  480  licensee or permittee. The rules will establish, at a minimum,
  481  financial reporting requirements, standards for financial
  482  capability to perform the functions governed by the permit, and
  483  requirements for ensuring permittees and their contractors can
  484  be held accountable for the financial consequences of any act of
  485  malfeasance or misfeasance or fraudulent or dishonest act or
  486  acts committed by the permittee or its contractors.
  487         (s)International prescription drug wholesale distributor.
  488         1. A wholesale distributor located outside of the United
  489  States must obtain an international prescription drug wholesale
  490  distributor permit to engage in the wholesale exportation and
  491  distribution of prescription drugs in the state under the
  492  International Prescription Drug Importation Program established
  493  in s. 499.0285. The wholesale distributor must be licensed or
  494  permitted to operate in a country with which the United States
  495  has a mutual recognition agreement, cooperation agreement,
  496  memorandum of understanding, or other federal mechanism
  497  recognizing the country’s adherence to current good
  498  manufacturing practices for pharmaceutical products. The
  499  wholesale distributor must maintain at all times a license or
  500  permit to engage in the wholesale distribution of prescription
  501  drugs in compliance with the laws of the jurisdiction in which
  502  it operates. An international prescription drug wholesale
  503  distributor permit may not be issued to a wholesale distributor
  504  if the jurisdiction in which the wholesale distributor operates
  505  does not require a license to engage in the wholesale
  506  distribution of prescription drugs.
  507         2.The department shall adopt rules governing the financial
  508  responsibility of an international prescription drug wholesale
  509  distributor permittee. The rules will establish, at a minimum,
  510  financial reporting requirements, standards for financial
  511  capability to perform the functions governed by the permit, and
  512  requirements for ensuring permittees and their contractors can
  513  be held accountable for the financial consequences of any act of
  514  malfeasance or misfeasance or fraudulent or dishonest act or
  515  acts committed by the permittee or its contractors.
  516         Section 7. Subsection (2), paragraph (a) of subsection (4),
  517  subsections (8), (10), (11), and (14), and paragraphs (a), (b),
  518  and (f) of subsection (15) of section 499.012, Florida Statutes,
  519  are amended to read:
  520         499.012 Permit application requirements.—
  521         (2) Notwithstanding subsection (6), a permitted person in
  522  good standing may change the type of permit issued to that
  523  person by completing a new application for the requested permit,
  524  paying the amount of the difference in the permit fees if the
  525  fee for the new permit is more than the fee for the original
  526  permit, and meeting the applicable permitting conditions for the
  527  new permit type. The new permit expires on the expiration date
  528  of the original permit being changed; however, a new permit for
  529  a prescription drug wholesale distributor, an out-of-state
  530  prescription drug wholesale distributor, an international
  531  prescription drug wholesale distributor, or a retail pharmacy
  532  drug wholesale distributor shall expire on the expiration date
  533  of the original permit or 1 year after the date of issuance of
  534  the new permit, whichever is earlier. A refund may not be issued
  535  if the fee for the new permit is less than the fee that was paid
  536  for the original permit.
  537         (4)(a) Except for a permit for a prescription drug
  538  wholesale distributor, an international prescription drug
  539  wholesale distributor, or an out-of-state prescription drug
  540  wholesale distributor, an application for a permit must include:
  541         1. The name, full business address, and telephone number of
  542  the applicant;
  543         2. All trade or business names used by the applicant;
  544         3. The address, telephone numbers, and the names of contact
  545  persons for each facility used by the applicant for the storage,
  546  handling, and distribution of prescription drugs;
  547         4. The type of ownership or operation, such as a
  548  partnership, corporation, or sole proprietorship; and
  549         5. The names of the owner and the operator of the
  550  establishment, including:
  551         a. If an individual, the name of the individual;
  552         b. If a partnership, the name of each partner and the name
  553  of the partnership;
  554         c. If a corporation, the name and title of each corporate
  555  officer and director, the corporate names, and the name of the
  556  state of incorporation;
  557         d. If a sole proprietorship, the full name of the sole
  558  proprietor and the name of the business entity;
  559         e. If a limited liability company, the name of each member,
  560  the name of each manager, the name of the limited liability
  561  company, and the name of the state in which the limited
  562  liability company was organized; and
  563         f. Any other relevant information that the department
  564  requires.
  565         (8) An application for a permit or to renew a permit for a
  566  prescription drug wholesale distributor, an international
  567  prescription drug wholesale distributor, or an out-of-state
  568  prescription drug wholesale distributor submitted to the
  569  department must include:
  570         (a) The name, full business address, and telephone number
  571  of the applicant.
  572         (b) All trade or business names used by the applicant.
  573         (c) The address, telephone numbers, and the names of
  574  contact persons for each facility used by the applicant for the
  575  storage, handling, and distribution of prescription drugs.
  576         (d) The type of ownership or operation, such as a
  577  partnership, corporation, or sole proprietorship.
  578         (e) The names of the owner and the operator of the
  579  establishment, including:
  580         1. If an individual, the name of the individual.
  581         2. If a partnership, the name of each partner and the name
  582  of the partnership.
  583         3. If a corporation:
  584         a. The name, address, and title of each corporate officer
  585  and director.
  586         b. The name and address of the corporation, resident agent
  587  of the corporation, the resident agent’s address, and the
  588  corporation’s state of incorporation.
  589         c. The name and address of each shareholder of the
  590  corporation that owns 5 percent or more of the outstanding stock
  591  of the corporation.
  592         4. If a sole proprietorship, the full name of the sole
  593  proprietor and the name of the business entity.
  594         5. If a limited liability company:
  595         a. The name and address of each member.
  596         b. The name and address of each manager.
  597         c. The name and address of the limited liability company,
  598  the resident agent of the limited liability company, and the
  599  name of the state in which the limited liability company was
  600  organized.
  601         (f) If applicable, the name and address of each affiliate
  602  of the applicant.
  603         (g) The applicant’s gross annual receipts attributable to
  604  prescription drug wholesale distribution activities for the
  605  previous tax year.
  606         (h) The tax year of the applicant.
  607         (i) A copy of the deed for the property on which
  608  applicant’s establishment is located, if the establishment is
  609  owned by the applicant, or a copy of the applicant’s lease for
  610  the property on which applicant’s establishment is located that
  611  has an original term of not less than 1 calendar year, if the
  612  establishment is not owned by the applicant.
  613         (j) A list of all licenses and permits issued to the
  614  applicant by any other state or jurisdiction which authorize the
  615  applicant to purchase or possess prescription drugs.
  616         (k) The name of the manager of the establishment that is
  617  applying for the permit or to renew the permit, the next four
  618  highest ranking employees responsible for prescription drug
  619  wholesale operations for the establishment, and the name of all
  620  affiliated parties for the establishment, together with the
  621  personal information statement and fingerprints required
  622  pursuant to subsection (9) for each of such persons.
  623         (l) The name of each of the applicant’s designated
  624  representatives as required by subsection (15), together with
  625  the personal information statement and fingerprints required
  626  pursuant to subsection (9) for each such person.
  627         (m) Evidence of a surety bond in this state or any other
  628  state in the United States in the amount of $100,000. If the
  629  annual gross receipts of the applicant’s previous tax year are
  630  $10 million or less, evidence of a surety bond in the amount of
  631  $25,000. The specific language of the surety bond must include
  632  the State of Florida as a beneficiary, payable to the
  633  Professional Regulation Trust Fund. In lieu of the surety bond,
  634  the applicant may provide other equivalent security such as an
  635  irrevocable letter of credit, or a deposit in a trust account or
  636  financial institution, which includes the State of Florida as a
  637  beneficiary, payable to the Professional Regulation Trust Fund.
  638  The purpose of the bond or other security is to secure payment
  639  of any administrative penalties imposed by the department and
  640  any fees and costs incurred by the department regarding that
  641  permit which are authorized under state law and which the
  642  permittee fails to pay 30 days after the fine or costs become
  643  final. The department may make a claim against such bond or
  644  security until 1 year after the permittee’s license ceases to be
  645  valid or until 60 days after any administrative or legal
  646  proceeding authorized in this part which involves the permittee
  647  is concluded, including any appeal, whichever occurs later.
  648         (n) For establishments used in wholesale distribution,
  649  proof of an inspection conducted by the department, the United
  650  States Food and Drug Administration, or another governmental
  651  entity charged with the regulation of good manufacturing
  652  practices related to wholesale distribution of prescription
  653  drugs, within timeframes set forth by the department in
  654  departmental rules, which demonstrates substantial compliance
  655  with current good manufacturing practices applicable to
  656  wholesale distribution of prescription drugs. The department may
  657  recognize another state’s or jurisdiction’s inspection of a
  658  wholesale distributor located in that state or jurisdiction if
  659  such state’s or jurisdiction’s laws are deemed to be
  660  substantially equivalent to the law of this state by the
  661  department. The department may accept an inspection by a third
  662  party accreditation or inspection service which meets the
  663  criteria set forth in department rule.
  664         (o) Any other relevant information that the department
  665  requires.
  666         (p) Documentation of the credentialing policies and
  667  procedures required by s. 499.0121(15).
  668         (q)For international prescription drug wholesale
  669  distributors and nonresident prescription drug manufacturers to
  670  participate in the International Prescription Drug Importation
  671  Program established under s. 499.0285, documentation
  672  demonstrating that the applicant is appropriately licensed or
  673  permitted by a country with which the United States has a mutual
  674  recognition agreement, cooperation agreement, memorandum of
  675  understanding, or other mechanism recognizing the country’s
  676  adherence to current good manufacturing practices for
  677  pharmaceutical products.
  678         (10) The department may deny an application for a permit or
  679  refuse to renew a permit for a prescription drug wholesale
  680  distributor, an international prescription drug wholesale
  681  distributor, or an out-of-state prescription drug wholesale
  682  distributor if:
  683         (a) The applicant has not met the requirements for the
  684  permit.
  685         (b) The management, officers, or directors of the applicant
  686  or any affiliated party are found by the department to be
  687  incompetent or untrustworthy.
  688         (c) The applicant is so lacking in experience in managing a
  689  wholesale distributor as to make the issuance of the proposed
  690  permit hazardous to the public health.
  691         (d) The applicant is so lacking in experience in managing a
  692  wholesale distributor as to jeopardize the reasonable promise of
  693  successful operation of the wholesale distributor.
  694         (e) The applicant is lacking in experience in the
  695  distribution of prescription drugs.
  696         (f) The applicant’s past experience in manufacturing or
  697  distributing prescription drugs indicates that the applicant
  698  poses a public health risk.
  699         (g) The applicant is affiliated directly or indirectly
  700  through ownership, control, or other business relations, with
  701  any person or persons whose business operations are or have been
  702  detrimental to the public health.
  703         (h) The applicant, or any affiliated party, has been found
  704  guilty of or has pleaded guilty or nolo contendere to any felony
  705  or crime punishable by imprisonment for 1 year or more under the
  706  laws of the United States, any state, or any other country,
  707  regardless of whether adjudication of guilt was withheld.
  708         (i) The applicant or any affiliated party has been charged
  709  with a felony in a state or federal court and the disposition of
  710  that charge is pending during the application review or renewal
  711  review period.
  712         (j) The applicant has furnished false or fraudulent
  713  information or material in any application made in this state or
  714  any other state in connection with obtaining a permit or license
  715  to manufacture or distribute drugs, devices, or cosmetics.
  716         (k) That a federal, state, or local government permit
  717  currently or previously held by the applicant, or any affiliated
  718  party, for the manufacture or distribution of any drugs,
  719  devices, or cosmetics has been disciplined, suspended, or
  720  revoked and has not been reinstated.
  721         (l) The applicant does not possess the financial or
  722  physical resources to operate in compliance with the permit
  723  being sought, this chapter, and the rules adopted under this
  724  chapter.
  725         (m) The applicant or any affiliated party receives,
  726  directly or indirectly, financial support and assistance from a
  727  person who was an affiliated party of a permittee whose permit
  728  was subject to discipline or was suspended or revoked, other
  729  than through the ownership of stock in a publicly traded company
  730  or a mutual fund.
  731         (n) The applicant or any affiliated party receives,
  732  directly or indirectly, financial support and assistance from a
  733  person who has been found guilty of any violation of this part
  734  or chapter 465, chapter 501, or chapter 893, any rules adopted
  735  under this part or those chapters, any federal or state drug
  736  law, or any felony where the underlying facts related to drugs,
  737  regardless of whether the person has been pardoned, had her or
  738  his civil rights restored, or had adjudication withheld, other
  739  than through the ownership of stock in a publicly traded company
  740  or a mutual fund.
  741         (o) The applicant for renewal of a permit under s.
  742  499.01(2)(e) or (f) has not actively engaged in the wholesale
  743  distribution of prescription drugs, as demonstrated by the
  744  regular and systematic distribution of prescription drugs
  745  throughout the year as evidenced by not fewer than 12 wholesale
  746  distributions in the previous year and not fewer than three
  747  wholesale distributions in the previous 6 months.
  748         (p) Information obtained in response to s. 499.01(2)(e) or
  749  (f) demonstrates it would not be in the best interest of the
  750  public health, safety, and welfare to issue a permit.
  751         (q) The applicant does not possess the financial standing
  752  and business experience for the successful operation of the
  753  applicant.
  754         (r) The applicant or any affiliated party has failed to
  755  comply with the requirements for manufacturing or distributing
  756  prescription drugs under this part, similar federal laws,
  757  similar laws in other states, or the rules adopted under such
  758  laws.
  759         (11) Upon approval of the application by the department and
  760  payment of the required fee, the department shall issue or renew
  761  a prescription drug wholesale distributor, an international
  762  prescription drug wholesale distributor, or an out-of-state
  763  prescription drug wholesale distributor permit to the applicant.
  764         (14) The name of a permittee or establishment on a
  765  prescription drug wholesale distributor permit, an international
  766  prescription drug wholesale distributor permit, or an out-of
  767  state prescription drug wholesale distributor permit may not
  768  include any indicia of attainment of any educational degree, any
  769  indicia that the permittee or establishment possesses a
  770  professional license, or any name or abbreviation that the
  771  department determines is likely to cause confusion or mistake or
  772  that the department determines is deceptive, including that of
  773  any other entity authorized to purchase prescription drugs.
  774         (15)(a) Each establishment that is issued an initial or
  775  renewal permit as a prescription drug wholesale distributor, an
  776  international prescription drug wholesale distributor, or an
  777  out-of-state prescription drug wholesale distributor must
  778  designate in writing to the department at least one natural
  779  person to serve as the designated representative of the
  780  wholesale distributor. Such person must have an active
  781  certification as a designated representative from the
  782  department.
  783         (b) To be certified as a designated representative, a
  784  natural person must:
  785         1. Submit an application on a form furnished by the
  786  department and pay the appropriate fees.
  787         2. Be at least 18 years of age.
  788         3. Have at least 2 years of verifiable full-time:
  789         a. Work experience in a pharmacy licensed in this state or
  790  another state or jurisdiction, where the person’s
  791  responsibilities included, but were not limited to,
  792  recordkeeping for prescription drugs;
  793         b. Managerial experience with a prescription drug wholesale
  794  distributor licensed in this state or in another state or
  795  jurisdiction; or
  796         c. Managerial experience with the United States Armed
  797  Forces, where the person’s responsibilities included, but were
  798  not limited to, recordkeeping, warehousing, distributing, or
  799  other logistics services pertaining to prescription drugs.
  800         4. Receive a passing score of at least 75 percent on an
  801  examination given by the department regarding federal laws
  802  governing distribution of prescription drugs and this part and
  803  the rules adopted by the department governing the wholesale
  804  distribution of prescription drugs. This requirement shall be
  805  effective 1 year after the results of the initial examination
  806  are mailed to the persons that took the examination. The
  807  department shall offer such examinations at least four times
  808  each calendar year.
  809         5. Provide the department with a personal information
  810  statement and fingerprints pursuant to subsection (9).
  811         (f) A wholesale distributor may not operate under a
  812  prescription drug wholesale distributor permit, an international
  813  prescription drug wholesale distributor permit, or an out-of
  814  state prescription drug wholesale distributor permit for more
  815  than 10 business days after the designated representative leaves
  816  the employ of the wholesale distributor, unless the wholesale
  817  distributor employs another designated representative and
  818  notifies the department within 10 business days of the identity
  819  of the new designated representative.
  820         Section 8. Subsection (1) of section 499.015, Florida
  821  Statutes, is amended to read:
  822         499.015 Registration of drugs and devices; issuance of
  823  certificates of free sale.—
  824         (1)(a) Except for those persons exempted from the
  825  definition of manufacturer in s. 499.003, any person who
  826  manufactures, packages, repackages, labels, or relabels a drug
  827  or device in this state must register such drug or device
  828  biennially with the department; pay a fee in accordance with the
  829  fee schedule provided by s. 499.041; and comply with this
  830  section. The registrant must list each separate and distinct
  831  drug or device at the time of registration.
  832         (b) The department may not register any product that does
  833  not comply with the Federal Food, Drug, and Cosmetic Act, as
  834  amended, or Title 21 C.F.R. Registration of a product by the
  835  department does not mean that the product does in fact comply
  836  with all provisions of the Federal Food, Drug, and Cosmetic Act,
  837  as amended.
  838         (c)Registration under this section is not required for
  839  prescription drugs imported under the International Prescription
  840  Drug Importation Program established in s. 499.0285.
  841         Section 9. Subsections (1) and (3) of section 499.065,
  842  Florida Statutes, are amended to read:
  843         499.065 Inspections; imminent danger.—
  844         (1) Notwithstanding s. 499.051, the department shall
  845  inspect each prescription drug wholesale distributor
  846  establishment, international prescription drug wholesale
  847  distributor establishment, prescription drug repackager
  848  establishment, veterinary prescription drug wholesale
  849  distributor establishment, limited prescription drug veterinary
  850  wholesale distributor establishment, and retail pharmacy drug
  851  wholesale distributor establishment that is required to be
  852  permitted under this part as often as necessary to ensure
  853  compliance with applicable laws and rules. The department shall
  854  have the right of entry and access to these facilities at any
  855  reasonable time.
  856         (3) The department may determine that a prescription drug
  857  wholesale distributor establishment, international prescription
  858  drug wholesale distributor establishment, prescription drug
  859  repackager establishment, veterinary prescription drug wholesale
  860  distributor establishment, limited prescription drug veterinary
  861  wholesale distributor establishment, or retail pharmacy drug
  862  wholesale distributor establishment that is required to be
  863  permitted under this part is an imminent danger to the public
  864  health and shall require its immediate closure if the
  865  establishment fails to comply with applicable laws and rules
  866  and, because of the failure, presents an imminent threat to the
  867  public’s health, safety, or welfare. Any establishment so deemed
  868  and closed shall remain closed until allowed by the department
  869  or by judicial order to reopen.
  870         Section 10. Section 499.0285, Florida Statutes, is created
  871  to read:
  872         499.0285International Prescription Drug Importation
  873  Program.—
  874         (1)PROGRAM ESTABLISHED.—The department shall establish a
  875  program for the importation of safe and effective prescription
  876  drugs from foreign nations with which the United States has
  877  current mutual recognition agreements, cooperation agreements,
  878  memoranda of understanding, or other federal mechanisms
  879  recognizing their adherence to current good manufacturing
  880  practices for pharmaceutical products.
  881         (2)DEFINITIONS.—As used in this section, the term:
  882         (a)“Exporter” means an international prescription drug
  883  wholesale distributor, a nonresident prescription drug
  884  manufacturer registered to participate in the program, or an
  885  international export pharmacy that exports prescription drugs
  886  into this state under the program.
  887         (b)“Federal Act” means the Federal Food, Drug, and
  888  Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
  889  as amended by the Drug Quality and Security Act, 21 U.S.C. 351
  890  et seq.
  891         (c)“Foreign recipient” means an entity other than the
  892  original prescription drug manufacturer which receives the
  893  prescription drug before its importation into this state under
  894  the program.
  895         (d)“Good manufacturing practice” refers to the good
  896  manufacturing practice regulations in 21 C.F.R. parts 210 and
  897  211.
  898         (e)“Importer” means a wholesale distributor, pharmacy, or
  899  pharmacist importing prescription drugs into this state under
  900  the program.
  901         (f)“International export pharmacy” means a pharmacy
  902  located outside of the United States which holds an active and
  903  unencumbered permit under chapter 465 to export prescription
  904  drugs into this state under the program.
  905         (g)“International prescription drug wholesale distributor”
  906  means a prescription drug wholesale distributor located outside
  907  of the United States which holds an active and unencumbered
  908  permit under this part to export and distribute prescription
  909  drugs into this state under the program.
  910         (h)“Nonresident prescription drug manufacturer” means an
  911  entity located outside of the United States which holds an
  912  active and unencumbered permit under this part to manufacture
  913  prescription drugs and has registered with the department to
  914  export and distribute such prescription drugs into this state
  915  under the program.
  916         (i)“Pharmacist” means a person who holds an active and
  917  unencumbered license to practice pharmacy under chapter 465.
  918         (j)“Pharmacy” means an entity that holds an active and
  919  unencumbered permit under chapter 465.
  920         (k)“Prescription drug” has the same meaning as defined in
  921  this part, but is limited to drugs intended for human use.
  922         (l)“Program” means the International Prescription Drug
  923  Importation Program established under this section.
  924         (m)“Qualified laboratory” means a laboratory that has been
  925  approved by the department for the purposes of this section.
  926         (3)ELIGIBLE PRESCRIPTION DRUGS.—An eligible importer may
  927  import a prescription drug from an eligible exporter if:
  928         (a)The drug meets the United States Food and Drug
  929  Administration’s standards related to safety, effectiveness,
  930  misbranding, and adulteration;
  931         (b)Importing the drug would not violate the patent laws of
  932  the United States; and
  933         (c)The drug is not:
  934         1.A controlled substance as defined in 21 U.S.C. s. 802;
  935         2.A biological product as defined in 42 U.S.C. s. 262;
  936         3.An infused drug;
  937         4.An intravenously injected drug;
  938         5.A drug that is inhaled during surgery; or
  939         6. A drug that is a parenteral drug, the importation of
  940  which is determined by the United States Secretary of Health and
  941  Human Services to pose a threat to the public health.
  942         (4)EXPORTERS.—
  943         (a)The following entities may export prescription drugs
  944  into this state under the program:
  945         1.An international prescription drug wholesale
  946  distributor.
  947         2.A nonresident prescription drug manufacturer.
  948         3.An international export pharmacy.
  949         (b)An eligible exporter must register with the department
  950  before exporting prescription drugs into this state under the
  951  program.
  952         (c)An exporter may not distribute, sell, or dispense
  953  prescription drugs imported under the program to any person
  954  residing outside of the state.
  955         (5)IMPORTERS.—
  956         (a)The following entities may import prescription drugs
  957  under the program:
  958         1.A wholesale distributor.
  959         2.A pharmacy.
  960         3.A pharmacist.
  961         (b)An eligible importer must register with the department
  962  before importing prescription drugs into this state under the
  963  program.
  964         (c)An importer may not distribute, sell, or dispense
  965  prescription drugs imported under the program to any person
  966  residing outside of the state.
  967         (6)PRESCRIPTION DRUG SUPPLY CHAIN DOCUMENTATION.—
  968         (a)A participating importer must submit the following
  969  information and documentation to the department:
  970         1.The name and quantity of the active ingredient of the
  971  prescription drug.
  972         2.A description of the dosage form of the prescription
  973  drug.
  974         3.The date on which the prescription drug is shipped.
  975         4.The quantity of the prescription drug that is shipped.
  976         5.The point of origin and destination of the prescription
  977  drug.
  978         6.The price paid by the importer for the prescription
  979  drug.
  980         7.Documentation from the exporter specifying:
  981         a.The original source of the prescription drug; and
  982         b.The quantity of each lot of the prescription drug
  983  originally received by the seller from that source.
  984         8.The lot or control number assigned to the prescription
  985  drug by the manufacturer.
  986         9.The name, address, telephone number, and professional
  987  license or permit number of the importer.
  988         10.In the case of a prescription drug that is shipped
  989  directly by the first foreign recipient from the manufacturer:
  990         a.Documentation demonstrating that the prescription drug
  991  was received by the recipient from the manufacturer and
  992  subsequently shipped by the first foreign recipient to the
  993  importer.
  994         b.Documentation of the quantity of each lot of the
  995  prescription drug received by the first foreign recipient
  996  demonstrating that the quantity being imported into this state
  997  is not more than the quantity that was received by the first
  998  foreign recipient.
  999         c.For an initial imported shipment, documentation
 1000  demonstrating that each batch of the prescription drug in the
 1001  shipment was statistically sampled and tested for authenticity
 1002  and degradation.
 1003         11.In the case of a prescription drug that is not shipped
 1004  directly from the first foreign recipient, documentation
 1005  demonstrating that each batch in each shipment offered for
 1006  importation into this state was statistically sampled and tested
 1007  for authenticity and degradation.
 1008         12.For an initial imported shipment of a specific drug by
 1009  an importer, the department shall ensure that each batch of the
 1010  drug in the shipment is statistically sampled and tested for
 1011  authenticity and degradation in a manner consistent with the
 1012  federal act. The agency may contract with a vendor for these
 1013  functions.
 1014         13.For every subsequent imported shipment of that drug by
 1015  that importer, the department shall ensure that a statistically
 1016  valid sample of the shipment was tested for authenticity and
 1017  degradation in a manner consistent with the federal act.
 1018         14.Certify that the drug:
 1019         a.Is approved for marketing in the United States and is
 1020  not adulterated or misbranded; and
 1021         b.Meets all of the labeling requirements under 21 U.S.C.
 1022  s. 352.
 1023         15.Maintain qualified laboratory records, including
 1024  complete data derived from all tests necessary to ensure that
 1025  the drug is in compliance with the requirements of this section.
 1026         16.Maintain documentation demonstrating that the testing
 1027  required by this section was conducted at a qualified laboratory
 1028  in accordance with the federal act and any other applicable
 1029  federal and state laws and regulations governing laboratory
 1030  qualifications.
 1031         (b)All testing required by this section must be conducted
 1032  in a qualified laboratory that meets the standards under the
 1033  federal act and any other applicable federal and state laws and
 1034  regulations governing laboratory qualifications for drug
 1035  testing.
 1036         (c)The vendor shall maintain information and documentation
 1037  submitted under this section for a period of at least 7 years.
 1038         (d)A participating importer must submit the all of
 1039  following information to the department:
 1040         1.The name and quantity of the active ingredient of the
 1041  drug.
 1042         2.A description of the dosage form of the drug.
 1043         3.The date on which the drug is received.
 1044         4.The quantity of the drug that is received.
 1045         5.The point of origin and destination of the drug.
 1046         6.The price paid by the importer for the drug.
 1047         (e)A participating International Importation Drug supplier
 1048  must submit the following information and documentation to the
 1049  agency or the agency’s designated vendor specifying all of the
 1050  following:
 1051         1.The original source of the drug, including:
 1052         a. The name of the manufacturer of the drug.
 1053         b. The date on which the drug was manufactured.
 1054         c. The location (country, state or province, and city)
 1055  where the drug was manufactured.
 1056         2.The date on which the drug is shipped.
 1057         3.The quantity of the drug that is shipped.
 1058         4.The quantity of each lot of the drug originally received
 1059  and from which source.
 1060         5.The lot or control number and the batch number assigned
 1061  to the drug by the manufacturer.
 1062         6.The name, address, and telephone number, and
 1063  professional license or permit number of the importer.
 1064         (f)The department may require any other information
 1065  necessary to ensure the protection of the public health.
 1066         (7)IMMEDIATE SUSPENSION.—The department shall immediately
 1067  suspend the importation of a specific prescription drug or the
 1068  importation of prescription drugs by a specific importer if it
 1069  discovers that any prescription drug or activity is in violation
 1070  of this section. The department may revoke the suspension if,
 1071  after conducting an investigation, it determines that the public
 1072  is adequately protected from counterfeit or unsafe prescription
 1073  drugs being imported into this state.
 1074         (8)RULEMAKING AUTHORITY.—The department shall adopt rules
 1075  necessary to implement this section.
 1076         Section 11. Notwithstanding the Federal Food, Drug, and
 1077  Cosmetic Act, the Department of Business and Professional
 1078  Regulation, in collaboration with the Department of Health,
 1079  shall negotiate a federal arrangement to operate a pilot program
 1080  for importing prescription drugs into this state. The proposal
 1081  to operate such a pilot program shall demonstrate that the
 1082  program sets safety standards consistent with the current
 1083  federal requirements for the manufacturing and distribution of
 1084  prescription drugs; limits the importation of prescription drugs
 1085  under the program to entities licensed or permitted by the state
 1086  to manufacture, distribute, or dispense prescription drugs; and
 1087  includes inspection and enforcement authority. Implementation of
 1088  sections 2 through 10 of this act is contingent upon
 1089  authorization granted under federal law, rule, or approval. The
 1090  department shall notify the President of the Senate, the Speaker
 1091  of the House of Representatives, and the relevant committees of
 1092  the Senate and the House of Representatives before
 1093  implementation of the pilot program. The department shall submit
 1094  to all parties a proposal for program implementation and program
 1095  funding.
 1096         Section 12. This act shall take effect July 1, 2019.
 1097  
 1098  ================= T I T L E  A M E N D M E N T ================
 1099  And the title is amended as follows:
 1100         Delete everything before the enacting clause
 1101  and insert:
 1102                        A bill to be entitled                      
 1103         An act relating to prescription drug importation
 1104         programs; creating s. 381.02035, F.S.; requiring the
 1105         Agency for Health Care Administration to establish the
 1106         Canadian Prescription Drug Importation Program;
 1107         defining terms; requiring the agency to contract with
 1108         a vendor to facilitate wholesale prescription drug
 1109         importation under the program; providing
 1110         responsibilities for the vendor, including the payment
 1111         of a bond; providing eligibility criteria for
 1112         prescription drugs, Canadian suppliers, and importers
 1113         under the program; authorizing a Canadian supplier to
 1114         export drugs into this state under the program under
 1115         certain circumstances; providing eligibility criteria
 1116         and requirements for drug importers; requiring
 1117         participating Canadian suppliers and importers to
 1118         comply with specified federal requirements for
 1119         distributing prescription drugs imported under the
 1120         program; prohibiting Canadian suppliers and importers
 1121         from distributing, dispensing, or selling prescription
 1122         drugs imported under the program outside of this
 1123         state; requiring the agency to request federal
 1124         approval of the program; requiring the request to
 1125         include certain information; requiring the agency to
 1126         begin operating the program within a specified
 1127         timeframe after receiving federal approval; providing
 1128         certain documentation requirements; requiring the
 1129         agency to suspend the importation of drugs in
 1130         violation of this section or any federal or state law
 1131         or regulation; authorizing the agency to revoke the
 1132         suspension under certain circumstances; requiring the
 1133         agency to submit an annual report to the Governor and
 1134         the Legislature by a specified date; providing
 1135         requirements for such report; requiring the agency to
 1136         notify the Legislature upon federal approval of the
 1137         program and to submit a proposal to the Legislature
 1138         for program implementation and funding before a
 1139         certain date; requiring the agency to adopt necessary
 1140         rules; creating s. 465.0157, F.S.; establishing an
 1141         international export pharmacy permit for participation
 1142         in the International Prescription Drug Importation
 1143         Program; providing requirements for permit application
 1144         and renewal; requiring the Department of Health to
 1145         adopt certain rules governing the financial
 1146         responsibility of the pharmacy permittee; amending s.
 1147         465.017, F.S.; authorizing the department to inspect
 1148         international export pharmacy permittees; amending s.
 1149         499.005, F.S.; providing that the importation of a
 1150         prescription drug under the International Prescription
 1151         Drug Importation Program is not a prohibited act under
 1152         that chapter; amending s. 499.0051, F.S.; providing an
 1153         exemption from prosecution as a criminal offense for
 1154         the importation of a prescription drug for wholesale
 1155         distribution under the International Prescription Drug
 1156         Importation Program; amending s. 499.01, F.S.;
 1157         requiring an international prescription drug wholesale
 1158         distributor to be permitted before operating;
 1159         requiring nonresident prescription drug manufacturers
 1160         to register with the Department of Business and
 1161         Professional Regulation to participate in the program;
 1162         providing an exception; establishing an international
 1163         prescription drug wholesale distributor drug permit;
 1164         providing permit requirements; requiring the
 1165         Department of Business and Professional Regulation to
 1166         adopt certain rules governing the financial
 1167         responsibility of nonresident prescription drug
 1168         manufacturer licensee or permittee and international
 1169         prescription drug wholesale distributor permittees;
 1170         amending s. 499.012, F.S.; providing application
 1171         requirements for international prescription drug
 1172         wholesale distributors and nonresident prescription
 1173         drug manufacturers to participate in the program;
 1174         amending s. 499.015, F.S.; establishing that
 1175         prescription drugs imported under the International
 1176         Prescription Drug Importation Program are not required
 1177         to be registered under a specified provision; amending
 1178         s. 499.065, F.S.; requiring the department to inspect
 1179         international prescription drug wholesale distributor
 1180         establishments; authorizing the department to
 1181         determine that an international prescription drug
 1182         wholesale distributor establishment is an imminent
 1183         danger to the public and require its immediate closure
 1184         under certain conditions; creating s. 499.0285, F.S.;
 1185         requiring the department to establish the
 1186         International Prescription Drug Importation Program
 1187         for a specified purpose; providing definitions;
 1188         providing eligibility criteria for prescription drugs,
 1189         exporters, and importers under the program; requiring
 1190         participating importers to submit certain
 1191         documentation to the department for prescription drugs
 1192         imported under the program; requiring the department
 1193         to immediately suspend the importation of specific
 1194         prescription drug or the importation of prescription
 1195         drugs by a specific importer if a violation has
 1196         occurred under the program; authorizing the department
 1197         to revoke such suspension under certain circumstances;
 1198         requiring the department to adopt necessary rules;
 1199         requiring the agency, in collaboration with the
 1200         Department of Business and Professional Regulation and
 1201         the Department of Health, to negotiate a federal
 1202         arrangement to operate a pilot program for importing
 1203         prescription drugs into this state; providing that
 1204         implementation of the act is contingent upon the
 1205         federal authorization; requiring the department to
 1206         notify the Legislature before implementation of the
 1207         pilot program and to submit a proposal for pilot
 1208         program implementation and funding; providing an
 1209         effective date.