Bill Text: FL S1452 | 2019 | Regular Session | Introduced


Bill Title: Prescription Drug Importation Programs

Spectrum: Partisan Bill (Republican 1-0)

Status: (Failed) 2019-05-03 - Died in Health Policy [S1452 Detail]

Download: Florida-2019-S1452-Introduced.html
       Florida Senate - 2019                                    SB 1452
       
       
        
       By Senator Gruters
       
       
       
       
       
       23-01430-19                                           20191452__
    1                        A bill to be entitled                      
    2         An act relating to prescription drug importation
    3         programs; creating s. 381.02035, F.S.; establishing
    4         the Canadian Prescription Drug Importation Program
    5         within the Agency for Health Care Administration for a
    6         specified purpose; defining terms; requiring the
    7         agency to contract with a vendor to facilitate
    8         wholesale prescription drug importation under the
    9         program; providing responsibilities for the vendor;
   10         providing eligibility criteria for prescription drugs,
   11         for Canadian suppliers, and for importers under the
   12         program; requiring participating Canadian suppliers
   13         and importers to comply with specified federal
   14         requirements in distributing prescription drugs
   15         imported under the program; prohibiting Canadian
   16         suppliers and importers from distributing, dispensing,
   17         or selling prescription drugs imported under the
   18         program outside of this state; requiring the agency to
   19         request federal approval of the program; providing
   20         requirements for such request; requiring the agency to
   21         begin operating the program within a specified
   22         timeframe after receiving federal approval; requiring
   23         the agency, in consultation with the vendor, to submit
   24         an annual report to the Governor and the Legislature
   25         by a specified date; providing requirements for such
   26         report; requiring the agency to adopt rules; creating
   27         s. 499.0285, F.S.; requiring the Department of
   28         Business and Professional Regulation to establish the
   29         International Prescription Drug Importation Program
   30         for a specified purpose; defining terms; providing
   31         eligibility criteria for prescription drugs,
   32         exporters, and importers under the program; requiring
   33         participating importers to submit certain
   34         documentation to the department for prescription drugs
   35         imported under the program; requiring the department
   36         to immediately suspend the importation of a specific
   37         prescription drug or the importation by a specific
   38         importer if a violation has occurred under the
   39         program; authorizing the department to revoke such
   40         suspension under certain circumstances; requiring the
   41         department to adopt rules; creating s. 465.0157, F.S.;
   42         establishing an international export pharmacy permit
   43         for participation in the International Prescription
   44         Drug Importation Program; providing requirements for
   45         permit application and renewal; amending s. 465.017,
   46         F.S.; authorizing the department to inspect
   47         international export pharmacy permittees; amending s.
   48         499.01, F.S.; requiring nonresident prescription drug
   49         manufacturers to register with the department to
   50         participate in the program; providing an exception;
   51         establishing an international prescription drug
   52         wholesale distributor permit; providing requirements
   53         for such permit; amending s. 499.012, F.S.; providing
   54         permit application requirements for international
   55         prescription drug wholesale distributors and
   56         nonresident prescription drug manufacturers to
   57         participate in the program; amending ss. 499.005,
   58         499.0051, and 499.015, F.S.; conforming provisions to
   59         changes made by the act; amending s. 499.065, F.S.;
   60         requiring the department to inspect international
   61         prescription drug wholesale distributor establishments
   62         and to require the immediate closure of such
   63         establishments under certain circumstances; requiring
   64         the Department of Business and Professional
   65         Regulation, in collaboration with the Department of
   66         Health, to negotiate a federal arrangement to operate
   67         a pilot program for importing prescription drugs into
   68         this state; providing that implementation of the act
   69         is contingent upon such federal arrangement or
   70         obtaining federal guidance; providing an effective
   71         date.
   72          
   73  Be It Enacted by the Legislature of the State of Florida:
   74  
   75         Section 1. Section 381.02035, Florida Statutes, is created
   76  to read:
   77         381.02035Canadian Prescription Drug Importation Program.—
   78         (1)PROGRAM ESTABLISHED.—The agency shall establish a
   79  program for the importation of safe and effective prescription
   80  drugs from Canada which have the highest potential for cost
   81  savings to the state.
   82         (2)DEFINITIONS.—As used in this section, the term:
   83         (a)“Agency” means the Agency for Health Care
   84  Administration.
   85         (b)“Canadian supplier” means a manufacturer, a wholesale
   86  distributor, or a pharmacy appropriately licensed or permitted
   87  under Canadian law to manufacture, distribute, or dispense
   88  prescription drugs.
   89         (c)“County health department” means a health care facility
   90  established under part I of chapter 154.
   91         (d)“Department” means the Department of Health.
   92         (e)“Free clinic” means a clinic that delivers medical
   93  diagnostic services or nonsurgical medical treatment free of
   94  charge to low-income recipients.
   95         (f)“Medicaid pharmacy” means a pharmacy licensed under
   96  chapter 465 which has a Medicaid provider agreement in effect
   97  with the agency and is in good standing with the agency.
   98         (g)“Pharmacist” means a person who holds an active and
   99  unencumbered license to practice pharmacy pursuant to chapter
  100  465.
  101         (h)“Prescription drug” has the same meaning as in s.
  102  499.003.
  103         (i)“Program” means the Canadian Prescription Drug
  104  Importation Program.
  105         (3)IMPORTATION PROCESS.—
  106         (a)The agency shall contract with a vendor to provide
  107  services under the program.
  108         (b)The vendor shall develop by December 1, 2019, and each
  109  year thereafter revise, a Wholesale Prescription Drug
  110  Importation List identifying the prescription drugs that have
  111  the highest potential for cost savings to the state. In
  112  developing the list, the vendor shall consider, at a minimum,
  113  which prescription drugs will provide the greatest cost savings
  114  to state programs, including prescription drugs for which there
  115  are shortages, specialty prescription drugs, and high-volume
  116  prescription drugs. The agency, in consultation with the
  117  department, shall review the Wholesale Prescription Drug
  118  Importation List every 3 months to ensure that it continues to
  119  meet the requirements of the program, and may direct the vendor
  120  to revise the list, as necessary.
  121         (c)The vendor shall identify Canadian suppliers that are
  122  in full compliance with relevant Canadian federal and provincial
  123  laws and regulations and who have agreed to export prescription
  124  drugs identified on the list. The vendor must verify that such
  125  Canadian suppliers meet all of the requirements of the program
  126  and will export prescription drugs at prices that will provide
  127  cost savings to the state. The vendor shall contract with such
  128  eligible Canadian suppliers, or facilitate contracts between
  129  eligible importers and Canadian suppliers, to import
  130  prescription drugs under the program.
  131         (d)The vendor shall assist the agency with the annual
  132  report required in subsection (9) and shall provide any
  133  information requested by the agency for such report.
  134         (4)ELIGIBLE PRESCRIPTION DRUGS.—Eligible importers may
  135  import a prescription drug from an eligible Canadian supplier
  136  if:
  137         (a)The drug meets the United States Food and Drug
  138  Administration’s standards relating to safety, effectiveness,
  139  misbranding, and adulteration;
  140         (b)Importing the drug would not violate the patent laws of
  141  the United States;
  142         (c)Importing the drug is expected to generate cost
  143  savings; and
  144         (d)The drug is not:
  145         1.A controlled substance as defined in 21 U.S.C. s. 802;
  146         2.A biological product as defined in 42 U.S.C. s. 262;
  147         3.An infused drug;
  148         4.An intravenously injected drug;
  149         5.A drug that is inhaled during surgery; or
  150         6.A drug that is a parenteral drug, the importation of
  151  which is determined by the United States Secretary of Health and
  152  Human Services to pose a threat to the public health.
  153         (5)ELIGIBLE CANADIAN SUPPLIERS.—A Canadian supplier may
  154  export prescription drugs into this state under the program if
  155  the supplier is:
  156         (a)In full compliance with relevant Canadian federal and
  157  provincial laws and regulations; and
  158         (b)Identified by the vendor as eligible to participate in
  159  the program.
  160         (6)ELIGIBLE IMPORTERS.—The following entities may import
  161  prescription drugs from a Canadian supplier under the program:
  162         (a)A pharmacist or wholesaler employed by or under
  163  contract with the department’s central pharmacy, for
  164  distribution to a county health department or free clinic for
  165  dispensing to clients treated in such department or such clinic.
  166         (b)A pharmacist or wholesaler employed by or under
  167  contract with a Medicaid pharmacy, for dispensing to the
  168  pharmacy’s Medicaid recipients.
  169         (c)A pharmacist or wholesaler employed by or under
  170  contract with the Department of Corrections, for dispensing to
  171  inmates in the custody of the Department of Corrections.
  172         (d)A pharmacist or wholesaler employed by or under
  173  contract with a developmental disabilities center, as defined in
  174  s. 393.063, for dispensing to clients treated in such center.
  175         (e)A pharmacist or wholesaler employed by or under
  176  contract with a treatment facility, as defined in s. 394.455,
  177  for dispensing to patients treated in such a facility.
  178         (7)DISTRIBUTION REQUIREMENTS.—Eligible Canadian suppliers
  179  and importers participating under the program:
  180         (a)Must comply with the tracking and tracing requirements
  181  of 21 U.S.C. ss. 360eee et seq.
  182         (b)May not distribute, dispense, or sell prescription
  183  drugs imported under the program outside of this state.
  184         (8)FEDERAL APPROVAL.—By July 1, 2020, the agency shall
  185  submit a request to the United States Secretary of Health and
  186  Human Services for approval of the program under 21 U.S.C. s.
  187  384(l). The agency shall begin operating the program within 6
  188  months after receiving such approval. The request must, at a
  189  minimum:
  190         (a)Describe the agency’s plan for operating the program;
  191         (b)Demonstrate how the prescription drugs imported into
  192  this state under the program will meet the applicable federal
  193  and state standards for safety and effectiveness;
  194         (c)Include a list of prescription drugs that have the
  195  highest potential for cost savings to the state through
  196  importation at the time that the request is submitted;
  197         (d)Estimate the total cost savings attributable to the
  198  program; and
  199         (e)Include a list of potential Canadian suppliers from
  200  which the state would import prescription drugs and demonstrate
  201  that the suppliers are in full compliance with relevant Canadian
  202  federal and provincial laws and regulations.
  203         (9)ANNUAL REPORTING.—By December 1 of each year, the
  204  agency shall submit a report to the Governor, the President of
  205  the Senate, and the Speaker of the House of Representatives on
  206  the operation of the program during the previous fiscal year.
  207  The report must include, at a minimum:
  208         (a)A list of the prescription drugs that were imported
  209  under the program;
  210         (b)The number of participating entities;
  211         (c)The number of prescriptions dispensed through the
  212  program;
  213         (d)The estimated cost savings during the previous fiscal
  214  year and to date;
  215         (e)A description of the methodology used to determine
  216  which prescription drugs may be included on the Wholesale
  217  Prescription Drug Importation List; and
  218         (f)Documentation demonstrating how the program ensures
  219  that:
  220         1.Canadian suppliers participating in the program are of
  221  high quality, of high performance, and in full compliance with
  222  relevant Canadian federal and provincial laws and regulations;
  223         2.Prescription drugs imported under the program are not
  224  shipped, sold, or dispensed outside of this state once in the
  225  possession of the importer;
  226         3.Prescription drugs imported under the program are pure,
  227  unadulterated, potent, and safe;
  228         4.The program does not put consumers at a higher health
  229  and safety risk than if the program did not exist; and
  230         5.The program provides cost savings to the state on
  231  imported prescription drugs.
  232         (10)RULEMAKING AUTHORITY.—The agency shall adopt rules
  233  necessary to implement this section.
  234         Section 2. Section 499.0285, Florida Statutes, is created
  235  to read:
  236         499.0285International Prescription Drug Importation
  237  Program.—
  238         (1)PROGRAM ESTABLISHED.—The department shall establish a
  239  program for the importation of safe and effective prescription
  240  drugs from foreign nations with whom the United States has
  241  current mutual recognition agreements, cooperation agreements,
  242  memoranda of understanding, or other federal mechanisms
  243  recognizing their adherence to current good manufacturing
  244  practices for pharmaceutical products.
  245         (2)DEFINITIONS.—As used in this section, the term:
  246         (a)“Exporter” means an international prescription drug
  247  wholesale distributor, a nonresident prescription drug
  248  manufacturer registered to participate in the program, or an
  249  international export pharmacy that exports prescription drugs
  250  into this state under the program.
  251         (b)“Foreign recipient” means an entity other than the
  252  original prescription drug manufacturer which receives the
  253  prescription drug before its importation into this state under
  254  the program.
  255         (c)“Good manufacturing practice” refers to the good
  256  manufacturing practice regulations in 21 C.F.R. parts 210 and
  257  211.
  258         (d)“Importer” means a wholesale distributor, a pharmacy,
  259  or a pharmacist importing prescription drugs into this state
  260  under the program.
  261         (e)“International export pharmacy” means a pharmacy
  262  located outside of the United States which holds an active and
  263  unencumbered permit under chapter 465 to export prescription
  264  drugs into this state under the program.
  265         (f)“International prescription drug wholesale distributor”
  266  means a prescription drug wholesale distributor located outside
  267  of the United States which holds an active and unencumbered
  268  permit under this part to export and distribute prescription
  269  drugs into this state under the program.
  270         (g)“Nonresident prescription drug manufacturer” means an
  271  entity located outside of the United States which holds an
  272  active and unencumbered permit under this part to manufacture
  273  prescription drugs and has registered with the department to
  274  export and distribute such prescription drugs into this state
  275  under the program.
  276         (h)“Pharmacist” means a person who holds an active and
  277  unencumbered license to practice pharmacy under chapter 465.
  278         (i)“Pharmacy” means an entity that holds an active and
  279  unencumbered permit under chapter 465.
  280         (j)“Program” means the International Prescription Drug
  281  Importation Program established under this section.
  282         (k)“Qualified laboratory” means a laboratory that has been
  283  approved by the department for the purposes of this section.
  284         (3)ELIGIBLE PRESCRIPTION DRUGS.—An eligible importer may
  285  import a prescription drug from an eligible exporter if:
  286         (a)The drug meets the United States Food and Drug
  287  Administration’s standards relating to safety, effectiveness,
  288  misbranding, and adulteration;
  289         (b)Importing the drug would not violate the patent laws of
  290  the United States; and
  291         (c)The drug is not:
  292         1.A controlled substance as defined in 21 U.S.C. s. 802;
  293         2.A biological product as defined in 42 U.S.C. s. 262;
  294         3.An infused drug;
  295         4.An intravenously injected drug;
  296         5.A drug that is inhaled during surgery; or
  297         6.A drug that is a parenteral drug, the importation of
  298  which is determined by the United States Secretary of Health and
  299  Human Services to pose a threat to the public health.
  300         (4)EXPORTERS.—
  301         (a)The following entities may export prescription drugs
  302  into this state under the program:
  303         1.An international prescription drug wholesale
  304  distributor.
  305         2.A nonresident prescription drug manufacturer.
  306         3.An international export pharmacy.
  307         (b)An eligible exporter shall register with the department
  308  before exporting prescription drugs into this state under the
  309  program.
  310         (c)An exporter may not distribute, sell, or dispense
  311  prescription drugs imported under the program to any person
  312  residing outside of this state.
  313         (5)IMPORTERS.—
  314         (a)The following entities may import prescription drugs
  315  under the program:
  316         1.A wholesale distributor.
  317         2.A pharmacy.
  318         3.A pharmacist.
  319         (b)An eligible importer shall register with the department
  320  before importing prescription drugs into this state under the
  321  program.
  322         (c)An importer may not distribute, sell, or dispense
  323  prescription drugs imported under the program to any person
  324  residing outside of this state.
  325         (6)PRESCRIPTION DRUG SUPPLY CHAIN DOCUMENTATION.—
  326         (a)A participating importer must submit the following
  327  information and documentation to the department:
  328         1.The name and the quantity of the active ingredient of
  329  the prescription drug.
  330         2.A description of the dosage form of the prescription
  331  drug.
  332         3.The date on which the prescription drug is shipped.
  333         4.The quantity of the prescription drug that is shipped.
  334         5.The point of origin and destination of the prescription
  335  drug.
  336         6.The price paid by the importer for the prescription
  337  drug.
  338         7.Documentation from the exporter specifying:
  339         a.The original source of the prescription drug; and
  340         b.The quantity of each lot of the prescription drug
  341  originally received by the seller from such source.
  342         8.The lot or control number assigned to the prescription
  343  drug by the manufacturer.
  344         9.The name, address, telephone number, and professional
  345  license or permit number of the importer.
  346         10.In the case of a prescription drug that is shipped
  347  directly by the first foreign recipient from the manufacturer:
  348         a.Documentation demonstrating that the prescription drug
  349  was received by the recipient from the manufacturer and
  350  subsequently shipped by the first foreign recipient to the
  351  importer.
  352         b.Documentation of the quantity of each lot of the
  353  prescription drug received by the first foreign recipient
  354  demonstrating that the quantity being imported into this state
  355  is not more than the quantity that was received by the first
  356  foreign recipient.
  357         c.For an initial imported shipment, documentation
  358  demonstrating that each batch of the prescription drug in the
  359  shipment was statistically sampled and tested for authenticity
  360  and degradation.
  361         d.For any subsequent imported shipment, documentation
  362  demonstrating that a statistically valid sample of the shipment
  363  was tested for authenticity and degradation.
  364         11.In the case of a prescription drug that is not shipped
  365  directly from the first foreign recipient, documentation
  366  demonstrating that each batch in each shipment offered for
  367  importation into the state was statistically sampled and tested
  368  for authenticity and degradation.
  369         12.Certification from the importer or manufacturer that
  370  the prescription drug:
  371         a.Is approved for marketing in the United States and is
  372  not adulterated or misbranded; and
  373         b.Meets all of the labeling requirements under 21 U.S.C.
  374  s. 352.
  375         13.Qualified laboratory records, including complete data
  376  derived from all tests necessary to ensure that the prescription
  377  drug is in compliance with the requirements of this section.
  378         14.Documentation demonstrating that the testing required
  379  by this section was conducted at a qualified laboratory.
  380         15.Any other information the department determines is
  381  necessary to ensure the protection of the public health.
  382         (b)All testing required by this section must be conducted
  383  in a qualified laboratory.
  384         (c)The department shall maintain information and
  385  documentation submitted under this section for a period of at
  386  least 4 years.
  387         (7)IMMEDIATE SUSPENSION.—The department shall immediately
  388  suspend the importation of a specific prescription drug or the
  389  importation of prescription drugs by a specific importer if the
  390  department discovers that any prescription drug or any activity
  391  is in violation of this section. The department may revoke the
  392  suspension if, after conducting an investigation, it determines
  393  that the public is adequately protected from counterfeit or
  394  unsafe prescription drugs being imported into this state.
  395         (8)RULEMAKING AUTHORITY.—The department shall adopt rules
  396  necessary to implement this section.
  397         Section 3. Section 465.0157, Florida Statutes, is created
  398  to read:
  399         465.0157International export pharmacy permit.—
  400         (1)To participate as an exporter of prescription drugs
  401  into this state under the International Prescription Drug
  402  Importation Program established in s. 499.0285, a pharmacy
  403  located outside of the United States must hold an international
  404  export pharmacy permit.
  405         (2)An international export pharmacy must maintain at all
  406  times an active and unencumbered license or a permit to operate
  407  the pharmacy in compliance with the laws of the jurisdiction in
  408  which the dispensing facility is located and from which the
  409  prescription drugs must be exported. Such jurisdiction must be
  410  in a country with whom the United States has a current mutual
  411  recognition agreement, cooperation agreement, memorandum of
  412  understanding, or other federal mechanism recognizing the
  413  country’s adherence to current good manufacturing practices for
  414  pharmaceutical products.
  415         (3)An application for an international export pharmacy
  416  permit must be submitted on a form developed and provided by the
  417  board. The board may require an applicant to provide any
  418  information it deems reasonably necessary to carry out the
  419  purposes of this section.
  420         (4)An applicant must submit the following to the board to
  421  obtain an initial permit, or to the department to renew a
  422  permit:
  423         (a)Proof of an active and unencumbered license or permit
  424  to operate the pharmacy in compliance with the laws of the
  425  jurisdiction in which the dispensing facility is located and
  426  from which the prescription drugs must be exported.
  427         (b)Documentation demonstrating that the country in which
  428  the pharmacy operates has a current mutual recognition
  429  agreement, cooperation agreement, memorandum of understanding,
  430  or other federal mechanism recognizing the country’s adherence
  431  to current good manufacturing practices for pharmaceutical
  432  products.
  433         (c)The locations, names, and titles of all principal
  434  corporate officers and of the pharmacist who serves as the
  435  prescription department manager for prescription drugs exported
  436  into this state under the International Prescription Drug
  437  Importation Program.
  438         (d)Written attestation by an owner or an officer of the
  439  applicant, and by the applicant’s prescription department
  440  manager, that:
  441         1.The attestor has read and understands the laws and rules
  442  governing the manufacturing, distributing, and dispensing of
  443  prescription drugs in this state.
  444         2.A prescription drug shipped, mailed, or delivered into
  445  this state meets or exceeds this state’s standards for safety
  446  and efficacy.
  447         3.A prescription drug product shipped, mailed, or
  448  delivered into this state may not have been, and may not be,
  449  manufactured or distributed in violation of the laws and rules
  450  of the jurisdiction in which the applicant is located and from
  451  which the prescription drugs must be exported.
  452         (e)A current inspection report from an inspection
  453  conducted by the regulatory agency or the licensing agency of
  454  the jurisdiction in which the applicant is located. The
  455  inspection report must reflect compliance with this section. An
  456  inspection report is current if the inspection was conducted
  457  within 6 months before the date of submitting the application
  458  for the initial permit or within 1 year before the date of
  459  submitting an application for the permit renewal. If the
  460  applicant is unable to submit a current inspection report
  461  conducted by the regulatory agency or the licensing agency of
  462  the jurisdiction in which the applicant is located and from
  463  which the prescription drugs must be exported, due to acceptable
  464  circumstances, as established by rule, or if an inspection has
  465  not been performed, the department shall:
  466         1.Conduct, or contract with an entity to conduct, an
  467  onsite inspection for which all costs must be borne by the
  468  applicant;
  469         2.Accept a current and satisfactory inspection report, as
  470  determined by rule, from an entity approved by the board; or
  471         3.Accept a current inspection report from the United
  472  States Food and Drug Administration conducted pursuant to the
  473  federal Drug Quality and Security Act, Pub. L. No. 113-54.
  474         Section 4. Subsection (2) of section 465.017, Florida
  475  Statutes, is amended to read:
  476         465.017 Authority to inspect; disposal.—
  477         (2) Duly authorized agents and employees of the department
  478  may inspect a nonresident pharmacy registered under s. 465.0156,
  479  an international export pharmacy permittee under s. 465.0157, or
  480  a nonresident sterile compounding permittee under s. 465.0158
  481  pursuant to this section. The costs of such inspections shall be
  482  borne by such pharmacy or permittee.
  483         Section 5. Subsection (1) and paragraph (c) of subsection
  484  (2) of section 499.01, Florida Statutes, are amended, and
  485  paragraph (s) is added to subsection (2) of that section, to
  486  read:
  487         499.01 Permits.—
  488         (1) Before operating, a permit is required for each person
  489  and establishment that intends to operate as:
  490         (a) A prescription drug manufacturer;
  491         (b) A prescription drug repackager;
  492         (c) A nonresident prescription drug manufacturer;
  493         (d) A nonresident prescription drug repackager;
  494         (e) A prescription drug wholesale distributor;
  495         (f) An out-of-state prescription drug wholesale
  496  distributor;
  497         (g) A retail pharmacy drug wholesale distributor;
  498         (h) A restricted prescription drug distributor;
  499         (i) A complimentary drug distributor;
  500         (j) A freight forwarder;
  501         (k) A veterinary prescription drug retail establishment;
  502         (l) A veterinary prescription drug wholesale distributor;
  503         (m) A limited prescription drug veterinary wholesale
  504  distributor;
  505         (n) An over-the-counter drug manufacturer;
  506         (o) A device manufacturer;
  507         (p) A cosmetic manufacturer;
  508         (q) A third party logistics provider; or
  509         (r) A health care clinic establishment; or
  510         (s)An international prescription drug wholesale
  511  distributor.
  512         (2) The following permits are established:
  513         (c) Nonresident prescription drug manufacturer permit.—A
  514  nonresident prescription drug manufacturer permit is required
  515  for any person that is a manufacturer of prescription drugs,
  516  unless permitted as a third party logistics provider, located
  517  outside of this state or outside the United States and that
  518  engages in the distribution in this state of such prescription
  519  drugs. Each such manufacturer must be permitted by the
  520  department and comply with all of the provisions required of a
  521  prescription drug manufacturer under this part. To participate
  522  as an exporter of prescription drugs into this state under the
  523  International Prescription Drug Importation Program established
  524  in s. 499.0285, a nonresident prescription drug manufacturer
  525  located outside of the United States must register with the
  526  department before engaging in any activities under that section.
  527  Such manufacturer must be licensed or permitted in a country
  528  with whom the United States has a current mutual recognition
  529  agreement, cooperation agreement, memorandum of understanding,
  530  or other federal mechanism recognizing the country’s adherence
  531  to current good manufacturing practices for pharmaceutical
  532  products. The department shall adopt rules for issuing a virtual
  533  nonresident prescription drug manufacturer permit to a person
  534  who engages in the manufacture of prescription drugs but does
  535  not make or take physical possession of any prescription drugs.
  536  The rules adopted by the department under this section may
  537  exempt virtual nonresident manufacturers from certain
  538  establishment, security, and storage requirements set forth in
  539  s. 499.0121.
  540         1. A person that distributes prescription drugs for which
  541  the person is not the manufacturer must also obtain an out-of
  542  state prescription drug wholesale distributor permit,
  543  international prescription drug wholesale distributor permit, or
  544  third party logistics provider permit pursuant to this section
  545  to engage in the distribution of such prescription drugs when
  546  required by this part. This subparagraph does not apply to a
  547  manufacturer that distributes prescription drugs only for the
  548  manufacturer of the prescription drugs where both manufacturers
  549  are affiliates.
  550         2. Any such person must comply with the licensing or
  551  permitting requirements of the jurisdiction in which the
  552  establishment is located and the federal act, and any
  553  prescription drug distributed into this state must comply with
  554  this part. If a person intends to import prescription drugs from
  555  a foreign country into this state, the nonresident prescription
  556  drug manufacturer must provide to the department a list
  557  identifying each prescription drug it intends to import and
  558  document approval by the United States Food and Drug
  559  Administration for such importation. A nonresident prescription
  560  drug manufacturer that has registered to participate in the
  561  International Prescription Drug Importation Program pursuant to
  562  this section is not required to provide such documentation for
  563  prescription drugs imported under that program.
  564         (s)International prescription drug wholesale distributor.
  565  A wholesale distributor located outside of the United States
  566  must obtain an international prescription drug wholesale
  567  distributor permit to engage in the wholesale exportation and
  568  the distribution of prescription drugs in this state under the
  569  International Prescription Drug Importation Program established
  570  in s. 499.0285. The wholesale distributor must be licensed or
  571  permitted to operate in a country with whom the United States
  572  has a mutual recognition agreement, cooperation agreement,
  573  memorandum of understanding, or other federal mechanism
  574  recognizing the country’s adherence to current good
  575  manufacturing practices for pharmaceutical products. The
  576  wholesale distributor must maintain at all times a license or
  577  permit to engage in the wholesale distribution of prescription
  578  drugs in compliance with the laws of the jurisdiction in which
  579  it operates. An international prescription drug wholesale
  580  distributor permit may not be issued to a wholesale distributor
  581  if the jurisdiction in which the wholesale distributor operates
  582  does not require a license to engage in the wholesale
  583  distribution of prescription drugs.
  584         Section 6. Subsection (2), paragraph (a) of subsection (4),
  585  subsections (8), (10), (11), and (14), and paragraphs (a), (b),
  586  and (f) of subsection (15) of section 499.012, Florida Statutes,
  587  are amended to read:
  588         499.012 Permit application requirements.—
  589         (2) Notwithstanding subsection (6), a permitted person in
  590  good standing may change the type of permit issued to that
  591  person by completing a new application for the requested permit,
  592  paying the amount of the difference in the permit fees if the
  593  fee for the new permit is more than the fee for the original
  594  permit, and meeting the applicable permitting conditions for the
  595  new permit type. The new permit expires on the expiration date
  596  of the original permit being changed; however, a new permit for
  597  a prescription drug wholesale distributor, an out-of-state
  598  prescription drug wholesale distributor, an international
  599  prescription drug wholesale distributor, or a retail pharmacy
  600  drug wholesale distributor shall expire on the expiration date
  601  of the original permit or 1 year after the date of issuance of
  602  the new permit, whichever is earlier. A refund may not be issued
  603  if the fee for the new permit is less than the fee that was paid
  604  for the original permit.
  605         (4)(a) Except for a permit for a prescription drug
  606  wholesale distributor, an international prescription drug
  607  wholesale distributor, or an out-of-state prescription drug
  608  wholesale distributor, an application for a permit must include:
  609         1. The name, full business address, and telephone number of
  610  the applicant;
  611         2. All trade or business names used by the applicant;
  612         3. The address, telephone numbers, and the names of contact
  613  persons for each facility used by the applicant for the storage,
  614  handling, and distribution of prescription drugs;
  615         4. The type of ownership or operation, such as a
  616  partnership, corporation, or sole proprietorship; and
  617         5. The names of the owner and the operator of the
  618  establishment, including:
  619         a. If an individual, the name of the individual;
  620         b. If a partnership, the name of each partner and the name
  621  of the partnership;
  622         c. If a corporation, the name and title of each corporate
  623  officer and director, the corporate names, and the name of the
  624  state of incorporation;
  625         d. If a sole proprietorship, the full name of the sole
  626  proprietor and the name of the business entity;
  627         e. If a limited liability company, the name of each member,
  628  the name of each manager, the name of the limited liability
  629  company, and the name of the state in which the limited
  630  liability company was organized; and
  631         f. Any other relevant information that the department
  632  requires.
  633         (8) An application for a permit or to renew a permit for a
  634  prescription drug wholesale distributor, an international
  635  prescription drug wholesale distributor, or an out-of-state
  636  prescription drug wholesale distributor submitted to the
  637  department must include:
  638         (a) The name, full business address, and telephone number
  639  of the applicant.
  640         (b) All trade or business names used by the applicant.
  641         (c) The address, telephone numbers, and the names of
  642  contact persons for each facility used by the applicant for the
  643  storage, handling, and distribution of prescription drugs.
  644         (d) The type of ownership or operation, such as a
  645  partnership, corporation, or sole proprietorship.
  646         (e) The names of the owner and the operator of the
  647  establishment, including:
  648         1. If an individual, the name of the individual.
  649         2. If a partnership, the name of each partner and the name
  650  of the partnership.
  651         3. If a corporation:
  652         a. The name, address, and title of each corporate officer
  653  and director.
  654         b. The name and address of the corporation, resident agent
  655  of the corporation, the resident agent’s address, and the
  656  corporation’s state of incorporation.
  657         c. The name and address of each shareholder of the
  658  corporation that owns 5 percent or more of the outstanding stock
  659  of the corporation.
  660         4. If a sole proprietorship, the full name of the sole
  661  proprietor and the name of the business entity.
  662         5. If a limited liability company:
  663         a. The name and address of each member.
  664         b. The name and address of each manager.
  665         c. The name and address of the limited liability company,
  666  the resident agent of the limited liability company, and the
  667  name of the state in which the limited liability company was
  668  organized.
  669         (f) If applicable, the name and address of each affiliate
  670  of the applicant.
  671         (g) The applicant’s gross annual receipts attributable to
  672  prescription drug wholesale distribution activities for the
  673  previous tax year.
  674         (h) The tax year of the applicant.
  675         (i) A copy of the deed for the property on which
  676  applicant’s establishment is located, if the establishment is
  677  owned by the applicant, or a copy of the applicant’s lease for
  678  the property on which applicant’s establishment is located that
  679  has an original term of not less than 1 calendar year, if the
  680  establishment is not owned by the applicant.
  681         (j) A list of all licenses and permits issued to the
  682  applicant by any other state or other jurisdiction which
  683  authorize the applicant to purchase or possess prescription
  684  drugs.
  685         (k) The name of the manager of the establishment that is
  686  applying for the permit or to renew the permit, the next four
  687  highest ranking employees responsible for prescription drug
  688  wholesale operations for the establishment, and the name of all
  689  affiliated parties for the establishment, together with the
  690  personal information statement and fingerprints required
  691  pursuant to subsection (9) for each of such persons.
  692         (l) The name of each of the applicant’s designated
  693  representatives as required by subsection (15), together with
  694  the personal information statement and fingerprints required
  695  pursuant to subsection (9) for each such person.
  696         (m) Evidence of a surety bond in this state or any other
  697  state in the United States in the amount of $100,000. If the
  698  annual gross receipts of the applicant’s previous tax year are
  699  $10 million or less, evidence of a surety bond in the amount of
  700  $25,000. The specific language of the surety bond must include
  701  the State of Florida as a beneficiary, payable to the
  702  Professional Regulation Trust Fund. In lieu of the surety bond,
  703  the applicant may provide other equivalent security such as an
  704  irrevocable letter of credit, or a deposit in a trust account or
  705  financial institution, which includes the State of Florida as a
  706  beneficiary, payable to the Professional Regulation Trust Fund.
  707  The purpose of the bond or other security is to secure payment
  708  of any administrative penalties imposed by the department and
  709  any fees and costs incurred by the department regarding that
  710  permit which are authorized under state law and which the
  711  permittee fails to pay 30 days after the fine or costs become
  712  final. The department may make a claim against such bond or
  713  security until 1 year after the permittee’s license ceases to be
  714  valid or until 60 days after any administrative or legal
  715  proceeding authorized in this part which involves the permittee
  716  is concluded, including any appeal, whichever occurs later.
  717         (n) For establishments used in wholesale distribution,
  718  proof of an inspection conducted by the department, the United
  719  States Food and Drug Administration, or another governmental
  720  entity charged with the regulation of good manufacturing
  721  practices related to wholesale distribution of prescription
  722  drugs, within timeframes set forth by the department in
  723  departmental rules, which demonstrates substantial compliance
  724  with current good manufacturing practices applicable to
  725  wholesale distribution of prescription drugs. The department may
  726  recognize another state’s or jurisdiction’s inspection of a
  727  wholesale distributor located in that state or jurisdiction if
  728  such state’s or jurisdiction’s laws are deemed to be
  729  substantially equivalent to the law of this state by the
  730  department. The department may accept an inspection by a third
  731  party accreditation or inspection service which meets the
  732  criteria set forth in department rule.
  733         (o) Any other relevant information that the department
  734  requires.
  735         (p) Documentation of the credentialing policies and
  736  procedures required by s. 499.0121(15).
  737         (q)For international prescription drug wholesale
  738  distributors and nonresident prescription drug manufacturers to
  739  participate in the International Prescription Drug Importation
  740  Program established under s. 499.0285, documentation
  741  demonstrating that the applicant is appropriately licensed or
  742  permitted by a country with whom the United States has a mutual
  743  recognition agreement, cooperation agreement, memorandum of
  744  understanding, or other mechanism recognizing the country’s
  745  adherence to current good manufacturing practices for
  746  pharmaceutical products.
  747         (10) The department may deny an application for a permit or
  748  refuse to renew a permit for a prescription drug wholesale
  749  distributor, an international prescription drug wholesale
  750  distributor, or an out-of-state prescription drug wholesale
  751  distributor if:
  752         (a) The applicant has not met the requirements for the
  753  permit.
  754         (b) The management, officers, or directors of the applicant
  755  or any affiliated party are found by the department to be
  756  incompetent or untrustworthy.
  757         (c) The applicant is so lacking in experience in managing a
  758  wholesale distributor as to make the issuance of the proposed
  759  permit hazardous to the public health.
  760         (d) The applicant is so lacking in experience in managing a
  761  wholesale distributor as to jeopardize the reasonable promise of
  762  successful operation of the wholesale distributor.
  763         (e) The applicant is lacking in experience in the
  764  distribution of prescription drugs.
  765         (f) The applicant’s past experience in manufacturing or
  766  distributing prescription drugs indicates that the applicant
  767  poses a public health risk.
  768         (g) The applicant is affiliated directly or indirectly
  769  through ownership, control, or other business relations, with
  770  any person or persons whose business operations are or have been
  771  detrimental to the public health.
  772         (h) The applicant, or any affiliated party, has been found
  773  guilty of or has pleaded guilty or nolo contendere to any felony
  774  or crime punishable by imprisonment for 1 year or more under the
  775  laws of the United States, any state, or any other country,
  776  regardless of whether adjudication of guilt was withheld.
  777         (i) The applicant or any affiliated party has been charged
  778  with a felony in a state or federal court and the disposition of
  779  that charge is pending during the application review or renewal
  780  review period.
  781         (j) The applicant has furnished false or fraudulent
  782  information or material in any application made in this state or
  783  any other state in connection with obtaining a permit or license
  784  to manufacture or distribute drugs, devices, or cosmetics.
  785         (k) That a federal, state, or local government permit
  786  currently or previously held by the applicant, or any affiliated
  787  party, for the manufacture or distribution of any drugs,
  788  devices, or cosmetics has been disciplined, suspended, or
  789  revoked and has not been reinstated.
  790         (l) The applicant does not possess the financial or
  791  physical resources to operate in compliance with the permit
  792  being sought, this chapter, and the rules adopted under this
  793  chapter.
  794         (m) The applicant or any affiliated party receives,
  795  directly or indirectly, financial support and assistance from a
  796  person who was an affiliated party of a permittee whose permit
  797  was subject to discipline or was suspended or revoked, other
  798  than through the ownership of stock in a publicly traded company
  799  or a mutual fund.
  800         (n) The applicant or any affiliated party receives,
  801  directly or indirectly, financial support and assistance from a
  802  person who has been found guilty of any violation of this part
  803  or chapter 465, chapter 501, or chapter 893, any rules adopted
  804  under this part or those chapters, any federal or state drug
  805  law, or any felony where the underlying facts related to drugs,
  806  regardless of whether the person has been pardoned, had her or
  807  his civil rights restored, or had adjudication withheld, other
  808  than through the ownership of stock in a publicly traded company
  809  or a mutual fund.
  810         (o) The applicant for renewal of a permit under s.
  811  499.01(2)(e) or (f) has not actively engaged in the wholesale
  812  distribution of prescription drugs, as demonstrated by the
  813  regular and systematic distribution of prescription drugs
  814  throughout the year as evidenced by not fewer than 12 wholesale
  815  distributions in the previous year and not fewer than three
  816  wholesale distributions in the previous 6 months.
  817         (p) Information obtained in response to s. 499.01(2)(e) or
  818  (f) demonstrates it would not be in the best interest of the
  819  public health, safety, and welfare to issue a permit.
  820         (q) The applicant does not possess the financial standing
  821  and business experience for the successful operation of the
  822  applicant.
  823         (r) The applicant or any affiliated party has failed to
  824  comply with the requirements for manufacturing or distributing
  825  prescription drugs under this part, similar federal laws,
  826  similar laws in other states, or the rules adopted under such
  827  laws.
  828         (11) Upon approval of the application by the department and
  829  payment of the required fee, the department shall issue or renew
  830  a prescription drug wholesale distributor, an international
  831  prescription drug wholesale distributor, or an out-of-state
  832  prescription drug wholesale distributor permit to the applicant.
  833         (14) The name of a permittee or establishment on a
  834  prescription drug wholesale distributor permit, an international
  835  prescription drug wholesale distributor permit, or an out-of
  836  state prescription drug wholesale distributor permit may not
  837  include any indicia of attainment of any educational degree, any
  838  indicia that the permittee or establishment possesses a
  839  professional license, or any name or abbreviation that the
  840  department determines is likely to cause confusion or mistake or
  841  that the department determines is deceptive, including that of
  842  any other entity authorized to purchase prescription drugs.
  843         (15)(a) Each establishment that is issued an initial or
  844  renewal permit as a prescription drug wholesale distributor, an
  845  international prescription drug wholesale distributor, or an
  846  out-of-state prescription drug wholesale distributor must
  847  designate in writing to the department at least one natural
  848  person to serve as the designated representative of the
  849  wholesale distributor. Such person must have an active
  850  certification as a designated representative from the
  851  department.
  852         (b) To be certified as a designated representative, a
  853  natural person must:
  854         1. Submit an application on a form furnished by the
  855  department and pay the appropriate fees.
  856         2. Be at least 18 years of age.
  857         3. Have at least 2 years of verifiable full-time:
  858         a. Work experience in a pharmacy licensed in this state or
  859  another state or jurisdiction, where the person’s
  860  responsibilities included, but were not limited to,
  861  recordkeeping for prescription drugs;
  862         b. Managerial experience with a prescription drug wholesale
  863  distributor licensed in this state or in another state or
  864  another jurisdiction; or
  865         c. Managerial experience with the United States Armed
  866  Forces, where the person’s responsibilities included, but were
  867  not limited to, recordkeeping, warehousing, distributing, or
  868  other logistics services pertaining to prescription drugs.
  869         4. Receive a passing score of at least 75 percent on an
  870  examination given by the department regarding federal laws
  871  governing distribution of prescription drugs and this part and
  872  the rules adopted by the department governing the wholesale
  873  distribution of prescription drugs. This requirement shall be
  874  effective 1 year after the results of the initial examination
  875  are mailed to the persons that took the examination. The
  876  department shall offer such examinations at least four times
  877  each calendar year.
  878         5. Provide the department with a personal information
  879  statement and fingerprints pursuant to subsection (9).
  880         (f) A wholesale distributor may not operate under a
  881  prescription drug wholesale distributor permit, an international
  882  prescription drug wholesale distributor permit, or an out-of
  883  state prescription drug wholesale distributor permit for more
  884  than 10 business days after the designated representative leaves
  885  the employ of the wholesale distributor, unless the wholesale
  886  distributor employs another designated representative and
  887  notifies the department within 10 business days after of the
  888  identity of the new designated representative.
  889         Section 7. Subsection (20) of section 499.005, Florida
  890  Statutes, is amended to read:
  891         499.005 Prohibited acts.—It is unlawful for a person to
  892  perform or cause the performance of any of the following acts in
  893  this state:
  894         (20) The importation of a prescription drug except as
  895  provided by s. 801(d) of the Federal Food, Drug, and Cosmetic
  896  Act or s. 499.0285.
  897         Section 8. Paragraph (e) of subsection (12) of section
  898  499.0051, Florida Statutes, is amended to read:
  899         499.0051 Criminal acts.—
  900         (12) REFUSAL TO ALLOW INSPECTION; SELLING, PURCHASING, OR
  901  TRADING DRUG SAMPLES; FAILURE TO MAINTAIN RECORDS RELATING TO
  902  PRESCRIPTION DRUGS.—Any person who violates any of the following
  903  provisions commits a felony of the third degree, punishable as
  904  provided in s. 775.082, s. 775.083, or s. 775.084, or as
  905  otherwise provided in this part:
  906         (e) The importation of a prescription drug for wholesale
  907  distribution, except as provided by s. 801(d) of the Federal
  908  Food, Drug, and Cosmetic Act or s. 499.0285.
  909         Section 9. Paragraph (c) is added to subsection (1) of
  910  section 499.015, Florida Statutes, to read:
  911         499.015 Registration of drugs and devices; issuance of
  912  certificates of free sale.—
  913         (1)
  914         (c)Registration under this section is not required for
  915  prescription drugs imported under the International Prescription
  916  Drug Importation Program established in s. 499.0285.
  917         Section 10. Subsections (1) and (3) of section 499.065,
  918  Florida Statutes, are amended to read:
  919         499.065 Inspections; imminent danger.—
  920         (1) Notwithstanding s. 499.051, the department shall
  921  inspect each prescription drug wholesale distributor
  922  establishment, international prescription drug wholesale
  923  distributor establishment, prescription drug repackager
  924  establishment, veterinary prescription drug wholesale
  925  distributor establishment, limited prescription drug veterinary
  926  wholesale distributor establishment, and retail pharmacy drug
  927  wholesale distributor establishment that is required to be
  928  permitted under this part as often as necessary to ensure
  929  compliance with applicable laws and rules. The department shall
  930  have the right of entry and access to these facilities at any
  931  reasonable time.
  932         (3) The department may determine that a prescription drug
  933  wholesale distributor establishment, international prescription
  934  drug wholesale distributor establishment, prescription drug
  935  repackager establishment, veterinary prescription drug wholesale
  936  distributor establishment, limited prescription drug veterinary
  937  wholesale distributor establishment, or retail pharmacy drug
  938  wholesale distributor establishment that is required to be
  939  permitted under this part is an imminent danger to the public
  940  health and shall require its immediate closure if the
  941  establishment fails to comply with applicable laws and rules
  942  and, because of the failure, presents an imminent threat to the
  943  public’s health, safety, or welfare. Any establishment so deemed
  944  and closed shall remain closed until allowed by the department
  945  or by judicial order to reopen.
  946         Section 11. Notwithstanding the Federal Food, Drug, and
  947  Cosmetic Act, the Department of Business and Professional
  948  Regulation, in collaboration with the Department of Health,
  949  shall negotiate a federal arrangement to operate a pilot program
  950  for importing prescription drugs into this state. The proposal
  951  to operate such a pilot program must demonstrate that the
  952  program sets safety standards consistent with the current
  953  federal requirements for the manufacturing and distributing of
  954  prescription drugs; limits the importation of prescription drugs
  955  to entities licensed or permitted by the state to manufacture,
  956  distribute, or dispense prescription drugs; and includes
  957  inspection and enforcement authority. Implementation of sections
  958  2 through 11 of this act is contingent upon such federal
  959  arrangement or upon obtaining federal guidance.
  960         Section 12. This act shall take effect July 1, 2019.

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