Florida Senate - 2013                        COMMITTEE AMENDMENT
       Bill No. SB 966
                                Barcode 541434                          
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  03/15/2013           .                                

       The Committee on Health Policy (Bean) recommended the following:
    1         Senate Amendment to Amendment (373656) (with title
    2  amendment)
    4         Between lines 737 and 738
    5  insert:
    6         Section 23. Paragraph (b) of subsection (54) of section
    7  499.003, Florida Statutes, is amended to read:
    8         499.003 Definitions of terms used in this part.—As used in
    9  this part, the term:
   10         (54) “Wholesale distribution” means distribution of
   11  prescription drugs to persons other than a consumer or patient,
   12  but does not include:
   13         (b) Any of the following activities, which is not a
   14  violation of s. 499.005(21) if such activity is conducted in
   15  accordance with rules established by the department:
   16         1. The sale, purchase, or trade of a prescription drug
   17  among federal, state, or local government health care entities
   18  that are under common control and are authorized to purchase
   19  such prescription drug.
   20         2. The sale, purchase, or trade of a prescription drug or
   21  an offer to sell, purchase, or trade a prescription drug for
   22  emergency medical reasons. For purposes of this subparagraph,
   23  the term “emergency medical reasons” includes transfers of
   24  prescription drugs by a retail pharmacy to another retail
   25  pharmacy to alleviate a temporary shortage.
   26         3. The transfer of a prescription drug acquired by a
   27  medical director on behalf of a licensed emergency medical
   28  services provider to that emergency medical services provider
   29  and its transport vehicles for use in accordance with the
   30  provider’s license under chapter 401.
   31         4. The revocation of a sale or the return of a prescription
   32  drug to the person’s prescription drug wholesale supplier.
   33         5. The donation of a prescription drug by a health care
   34  entity to a charitable organization that has been granted an
   35  exemption under s. 501(c)(3) of the Internal Revenue Code of
   36  1986, as amended, and that is authorized to possess prescription
   37  drugs.
   38         6. The transfer of a prescription drug by a person
   39  authorized to purchase or receive prescription drugs to a person
   40  licensed or permitted to handle reverse distributions or
   41  destruction under the laws of the jurisdiction in which the
   42  person handling the reverse distribution or destruction receives
   43  the drug.
   44         7. The transfer of a prescription drug by a hospital or
   45  other health care entity, either directly or through the
   46  hospital's or health care entity's supplier, to a person
   47  licensed under this part to repackage prescription drugs for the
   48  purpose of repackaging the prescription drug for use by that
   49  hospital, or other health care entity and other health care
   50  entities that are under common control, if ownership of the
   51  prescription drugs remains with the hospital or other health
   52  care entity at all times. In addition to the recordkeeping
   53  requirements of s. 499.0121(6) and the requirements for
   54  repackagers in s. 499.01212(2), the hospital or health care
   55  entity that transfers prescription drugs pursuant to this
   56  subparagraph must reconcile all drugs transferred and returned
   57  and resolve any discrepancies in a timely manner.
   58         Section 24. Paragraph (b) of subsection (2) of section
   59  499.01, Florida Statutes, is amended to read
   60         499.01 Permits.—
   61         (2) The following permits are established:
   62         (b) Prescription drug repackager permit.—A prescription
   63  drug repackager permit is required for any person that
   64  repackages a prescription drug in this state or any person
   65  located in another state that repackages and distributes
   66  prescription drugs in or into this state that are received in a
   67  transfer pursuant to s. 499.003(54)(b)7.
   68         1. A person that operates an establishment permitted as a
   69  prescription drug repackager may engage in wholesale
   70  distribution of prescription drugs repackaged at that
   71  establishment and must comply with all the provisions of this
   72  part and the rules adopted under this part that apply to a
   73  wholesale distributor.
   74         2. A prescription drug repackager must comply with all
   75  appropriate state and federal good manufacturing practices.
   76         Section 25. Paragraph (a) of subsection (2) of section
   77  499.01212, Florida Statutes, is amended to read:
   78         499.01212 Pedigree paper.—
   79         (2) FORMAT.—A pedigree paper must contain the following
   80  information:
   81         (a) For the wholesale distribution of a prescription drug
   82  within the normal distribution chain or pursuant to a transfer
   83  described in s. 499.003(54)(b)7:
   84         1. The following statement: “This wholesale distributor
   85  purchased the specific unit of the prescription drug directly
   86  from the manufacturer.”
   87         2. The manufacturer’s national drug code identifier and the
   88  name and address of the wholesale distributor and the purchaser
   89  of the prescription drug.
   90         3. The name of the prescription drug as it appears on the
   91  label.
   92         4. The quantity, dosage form, and strength of the
   93  prescription drug.
   95         The wholesale distributor must also maintain and make
   96  available to the department, upon request, the point of origin
   97  of the prescription drugs, including intracompany transfers, the
   98  date of the shipment from the manufacturer to the wholesale
   99  distributor, the lot numbers of such drugs, and the invoice
  100  numbers from the manufacturer. When a repackager further
  101  distributes prescription drugs to a hospital or other health
  102  care entity pursuant to s. 499.003(54)(b)7, the pedigree paper
  103  must contain the statement from the wholesale distributor in
  104  this subsection, along with the lot numbers of the prescription
  105  drugs, the name and address of the repackager and his or her
  106  signature, the date of receipt, and the name and address of the
  107  person authorized by law to purchase prescription drugs for the
  108  purpose of administering or dispensing the drug, as defined in
  109  s. 465.003.
  111  ================= T I T L E  A M E N D M E N T ================
  112         And the title is amended as follows:
  113         Delete line 1024
  114  and insert:
  115         Rules to develop and implement the program; amending
  116         s. 499.003, F.S.; exempting prescription drugs
  117         transferred either directly or through a hospital’s or
  118         health care entity’s supplier for the purpose of
  119         repackaging from the definition of “wholesale
  120         distribution”; amending s. 499.01, F.S.; requiring a
  121         permit for prescription drug repackagers located in
  122         other states that repackage and distribute drugs for
  123         limited purposes into this state; amending s.
  124         499.01212, F.S.; requiring pedigree papers for
  125         transfers pursuant to s. 499.03(54)(b)7, F.S., to
  126         include specified information; amending