Bill Amendment: FL H0019 | 2019 | Regular Session

Florida House Bill 19 (Prior Session Legislation)

NOTE: For additional amemendments please see the Bill Drafting List

Bill Title: Prescription Drug Importation Programs

Status: 2019-06-11 - Chapter No. 2019-99 [H0019 Detail]

Download: Florida-2019-H0019-Senate_Floor_Amendment_738486_to_Amendment_368506_.html

       Florida Senate - 2019                          SENATOR AMENDMENT
       Bill No. CS for HB 19
       
       
       
       
       
       
                                Ì738486VÎ738486                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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       Senator Bean moved the following:
       
    1         Senate Amendment to Amendment (368506) 
    2  
    3         Delete lines 316 - 365
    4  and insert:
    5         (c) The location, names, and titles of all principal
    6  corporate officers and the pharmacist who serves as the
    7  prescription department manager for prescription drugs exported
    8  into this state under the International Prescription Drug
    9  Importation Program.
   10         (d) Written attestation by an owner or officer of the
   11  applicant, and by the applicant’s prescription department
   12  manager, that:
   13         1. The attestor has read and understands the laws and rules
   14  governing the manufacture, distribution, and dispensing of
   15  prescription drugs in this state.
   16         2. A prescription drug shipped, mailed, or delivered into
   17  this state meets or exceeds this state’s standards for safety
   18  and efficacy.
   19         3. A prescription drug product shipped, mailed, or
   20  delivered into this state must not have been, and may not be,
   21  manufactured or distributed in violation of the laws and rules
   22  of the jurisdiction in which the applicant is located and from
   23  which the prescription drugs shall be exported.
   24         (e) A current inspection report from an inspection
   25  conducted by the regulatory or licensing agency of the
   26  jurisdiction in which the applicant is located. The inspection
   27  report must reflect compliance with this section. An inspection
   28  report is current if the inspection was conducted within 6
   29  months before the date of submitting the application for the
   30  initial permit or within 1 year before the date of submitting an
   31  application for permit renewal. If the applicant is unable to
   32  submit a current inspection report conducted by the regulatory
   33  or licensing agency of the jurisdiction in which the applicant
   34  is located and from which the prescription drugs will be
   35  exported, due to acceptable circumstances, as established by
   36  rule, or if an inspection has not been performed, the department
   37  must:
   38         1. Conduct, or contract with an entity to conduct, an
   39  onsite inspection, with all related costs borne by the
   40  applicant;
   41         2. Accept a current and satisfactory inspection report, as
   42  determined by rule, from an entity approved by the board; or
   43         3. Accept a current inspection report from the United
   44  States Food and Drug Administration conducted pursuant to the
   45  federal Drug Quality and Security Act, Pub. L. No. 113-54.
   46         (5) The department shall adopt rules governing the
   47  financial responsibility of the pharmacy permittee. The rules
   48  must establish, at a minimum, financial reporting requirements,
   49  standards for financial capability to perform the functions
   50  governed by the permit, and requirements for ensuring permittees
   51  and their contractors can be held accountable for the financial
   52  consequences of any act of malfeasance or misfeasance or
   53  fraudulent or dishonest act or acts committed by the permittee
   54  or its contractors.