Florida Senate - 2016                        COMMITTEE AMENDMENT
       Bill No. PCS (141410) for CS for SB 1604
       
       
       
       
       
       
                                Ì847704.Î847704                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  02/26/2016           .                                
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       The Committee on Appropriations (Grimsley) recommended the
       following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete lines 2374 - 2421
    4  and insert:
    5         (a) The following persons must maintain business records
    6  that include the information specified in paragraph (b)
    7  Wholesale distributors must establish and maintain inventories
    8  and records of all transactions regarding the receipt and
    9  distribution or other disposition of prescription drugs. These
   10  records must provide a complete audit trail from receipt to sale
   11  or other disposition, be readily retrievable for inspection, and
   12  include, at a minimum, the following information:
   13         1. Persons permitted or required to be permitted under
   14  chapter 499 to engage in the manufacture, repackaging, or
   15  distribution of active pharmaceutical ingredients or
   16  prescription drugs. The source of the drugs, including the name
   17  and principal address of the seller or transferor, and the
   18  address of the location from which the drugs were shipped;
   19         2. Persons other than those set forth in subparagraph 1.
   20  that engage in the receipt of active pharmaceutical ingredients
   21  or prescription drugs. The name, principal address, and state
   22  license permit or registration number of the person authorized
   23  to purchase prescription drugs;
   24         3. The name, strength, dosage form, and quantity of the
   25  drugs received and distributed or disposed of;
   26         4. The dates of receipt and distribution or other
   27  disposition of the drugs; and
   28         5. Any financial documentation supporting the transaction.
   29         (b) Business records for persons specified in paragraph (a)
   30  must include:
   31         1.The name and address of the seller, and the Florida
   32  permit number of the seller if such seller is not exempt from
   33  Florida permitting requirements, of the active pharmaceutical
   34  ingredient or prescription drug.
   35         2.The address of the location the active pharmaceutical
   36  ingredient or prescription drug was shipped from.
   37         3.The distribution date of the active pharmaceutical
   38  ingredient or prescription drug.
   39         4.The name, strength, and quantity, and the National Drug
   40  Code if such code has been assigned, of the distributed active
   41  pharmaceutical ingredient or prescription drug.
   42         5.The name and Florida permit number of the person that
   43  purchased the active pharmaceutical ingredient or prescription
   44  drug.
   45         6.The financial data, including the unit type and unit
   46  price, for the distributions involving active pharmaceutical
   47  ingredients or prescription drugs.
   48         7.The date and method of disposition of the active
   49  pharmaceutical ingredient or prescription drug. Inventories and
   50  records must be made available for inspection and photocopying
   51  by authorized federal, state, or local officials for a period of
   52  2 years following disposition of the drugs or 3 years after the
   53  creation of the records, whichever period is longer.
   54         (c) Each manufacturer or repackager of medical devices,
   55  over-the-counter drugs, or cosmetics must maintain business
   56  records that include:
   57         1.The name and address of the seller or transferor of the
   58  product.
   59         2.The address of the location the product was shipped
   60  from.
   61         3.The date of the sale or distribution of the product.
   62         4.The name and quantity of the product involved.
   63         5.The name and address of the person who purchased the
   64  product Records described in this section that are kept at the
   65  inspection site or that can be immediately retrieved by computer
   66  or other electronic means must be readily available for
   67  authorized inspection during the retention period. Records that
   68  are kept at a central location outside of this state and that
   69  are not electronically retrievable must be made available for
   70  inspection within 2 working days after a request by an
   71  authorized official of a federal, state, or local law
   72  enforcement agency. Records that are maintained at a central
   73  location within this state must be maintained at an
   74  establishment that is permitted pursuant to this part and must
   75  be readily available.
   76         (d) Persons permitted, or required to be permitted, under
   77  this chapter to engage in the manufacture, repackaging, or
   78  distribution of active pharmaceutical ingredients or
   79  prescription drugs; or the manufacture or repackaging of medical
   80  devices, over-the-counter drugs, and cosmetics; must establish,
   81  maintain, or have the capability to create a current inventory
   82  of the active pharmaceutical ingredients, prescription drugs,
   83  over-the-counter drugs, cosmetics, and devices at an
   84  establishment where activities specified in this paragraph are
   85  undertaken and must be able to produce such inventory for
   86  inspection by the department within 2 business days Each
   87  manufacturer or repackager of medical devices, over-the-counter
   88  drugs, or cosmetics must maintain records that include the name
   89  and principal address of the seller or transferor of the
   90  product, the address of the location from which the product was
   91  shipped, the date of the transaction, the name and quantity of
   92  the product involved, and the name and principal address of the
   93  person who purchased the product.
   94         (e) Business records required to be kept pursuant to this
   95  section, and that are kept at the inspection site or can be
   96  immediately retrieved by computer or other electronic means,
   97  must be readily available for authorized inspection during the
   98  retention period. Records kept at a central location outside of
   99  this state which are not electronically retrievable must be made
  100  available for inspection within 2 working days after a request
  101  by an authorized official of a federal, state, or local law
  102  enforcement agency. Records maintained at a central location
  103  within this state must be maintained at an establishment that is
  104  permitted pursuant to this part and such records must be readily
  105  available for inspection When pedigree papers are required by
  106  this part, a wholesale distributor must maintain the pedigree
  107  papers separate and distinct from other records required under
  108  this part.
  109         (f)Records required to be kept pursuant to this subsection
  110  must be maintained as specified for a period of not less than 6
  111  years from the date of disposition of the active pharmaceutical
  112  ingredients, prescription drugs, over-the-counter drugs, medical
  113  devices, or cosmetics.
  114         (g)To the extent that prescription drugs are also products
  115  as defined in the federal act, as amended, and the information
  116  required by the business records requirements of this section
  117  are also included in the tracking and tracing requirements of
  118  the federal act, as amended, and departmental rules, the
  119  manufacturer, wholesale distributor, repackager, or dispenser
  120  must follow both the requirements of the federal act, as
  121  amended, and departmental rules.
  122  
  123  ================= T I T L E  A M E N D M E N T ================
  124  And the title is amended as follows:
  125         Delete lines 64 - 66
  126  and insert:
  127         recordkeeping requirements; specifying recordkeeping
  128         requirements for manufacturers and repackagers of
  129         medical devices, over-the-counter drugs, and
  130         cosmetics; increasing the quantity of unit doses of