Florida Senate - 2009                          SENATOR AMENDMENT
       Bill No. CS for CS for SB 1144
       
       
       
       
       
       
                                Barcode 312402                          
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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                Floor: 1/AD/2R         .                                
             04/23/2009 04:28 PM       .                                
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       Senator Peaden moved the following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete lines 936 - 1262
    4  and insert:
    5         Section 6. Paragraph (e) of subsection (6) of section
    6  499.0121, Florida Statutes, is amended to read:
    7         499.0121 Storage and handling of prescription drugs;
    8  recordkeeping.—The department shall adopt rules to implement
    9  this section as necessary to protect the public health, safety,
   10  and welfare. Such rules shall include, but not be limited to,
   11  requirements for the storage and handling of prescription drugs
   12  and for the establishment and maintenance of prescription drug
   13  distribution records.
   14         (6) RECORDKEEPING.—The department shall adopt rules that
   15  require keeping such records of prescription drugs as are
   16  necessary for the protection of the public health.
   17         (e) When pedigree papers are required by this part, a
   18  wholesale distributor must maintain the pedigree papers separate
   19  and distinct from other records required under this part
   20  chapter.
   21         Section 7. Paragraph (b) of subsection (2) of section
   22  499.01212, Florida Statutes, is amended to read:
   23         499.01212 Pedigree paper.—
   24         (2) FORMAT.—A pedigree paper must contain the following
   25  information:
   26         (b) For all other wholesale distributions of prescription
   27  drugs:
   28         1. The quantity, dosage form, and strength of the
   29  prescription drugs.
   30         2. The lot numbers of the prescription drugs.
   31         3. The name and address of each owner of the prescription
   32  drug and his or her signature.
   33         4. Shipping information, including the name and address of
   34  each person certifying delivery or receipt of the prescription
   35  drug.
   36         5. An invoice number, a shipping document number, or
   37  another number uniquely identifying the transaction.
   38         6. A certification that the recipient wholesale distributor
   39  has authenticated the pedigree papers.
   40         7. The unique serialization of the prescription drug, if
   41  the manufacturer or repackager has uniquely serialized the
   42  individual prescription drug unit.
   43         8. The name, address, telephone number, and, if available,
   44  e-mail contact information of each wholesale distributor
   45  involved in the chain of the prescription drug’s custody.
   46  
   47  When an affiliated group member obtains title to a prescription
   48  drug before distributing the prescription drug as the
   49  manufacturer under s. 499.003(31)(e), information regarding the
   50  distribution between those affiliated group members may be
   51  omitted from a pedigree paper required under this paragraph for
   52  subsequent distributions of that prescription drug.
   53  
   54  ================= T I T L E  A M E N D M E N T ================
   55         And the title is amended as follows:
   56         Delete lines 14 - 30
   57  and insert:
   58         clarifying that a wholesale distributor is required to
   59         maintain pedigree papers separately from other records
   60         of prescription drugs under certain circumstances;
   61         amending s. 499.01212, F.S.; revising requirements for
   62         a pedigree paper;