Florida Senate - 2011                          SENATOR AMENDMENT
       Bill No. CS for CS for SB 818
       
       
       
       
       
       
                                Barcode 899940                          
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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               Floor: 14/AD/2R         .                                
             04/28/2011 02:42 PM       .                                
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       Senator Fasano moved the following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete lines 1989 - 2035
    4  and insert:
    5         Section 26. Subsection (9) is added to section 465.025,
    6  Florida Statutes, to read:
    7         465.025 Substitution of drugs.—
    8         (9) The board shall establish by rule a list of opioid
    9  drugs that incorporate tamper-resistant technology. Inclusion of
   10  a drug on the list does not require that the drug bear a
   11  labeling claim with respect to reduction of tampering, abuse, or
   12  abuse potential at the time of listing. The board shall make a
   13  determination whether to include a drug on the list based on a
   14  submission of evidence by the drug manufacturer or distributor
   15  that the drug:
   16         (a) Incorporates a tamper-resistance technology; and
   17         (b) Has been approved by the United States Food and Drug
   18  Administration pursuant to an application that includes at least
   19  one study on human tampering or abuse potential or a laboratory
   20  study comparing the tamper-resistant or abuse-resistant
   21  properties of the drug to one or more opioid drugs that has been
   22  approved by the United States Food and Drug Administration and
   23  serves as a positive control.
   24  
   25  Notwithstanding subsection (2), a pharmacist may not substitute
   26  an opioid analgesic drug, either the brand name drug or generic
   27  drug, for an opioid analgesic drug incorporating a tamper
   28  resistance technology which was originally prescribed and is
   29  listed by the board pursuant to this subsection.
   30  
   31  ================= T I T L E  A M E N D M E N T ================
   32         And the title is amended as follows:
   33         Delete lines 222 - 225
   34  and insert:
   35         clinic may be declared a public nuisance; amending s.
   36         465.025, F.S.; requiring the Board of Pharmacy to
   37         create a list of opioid analgesic drugs; providing
   38         requirements for the list of opioid analgesic drugs;
   39         prohibiting a pharmacist from substituting an opioid
   40         analgesic drug for an opioid analgesic drug that
   41         incorporates a tamper-resistant technology;