Florida Senate - 2011                                    SB 1860
       
       
       
       By Senator Latvala
       
       
       
       
       16-01645B-11                                          20111860__
    1                        A bill to be entitled                      
    2         An act relating to drugs, cosmetics, and certain
    3         devices; amending s. 499.01, F.S.; requiring that the
    4         Department of Health notify an applicant for an out
    5         of-state prescription drug wholesale distributor
    6         permit of the status of its permit application within
    7         60 days after receipt of all required documentation;
    8         providing an effective date.
    9  
   10  Be It Enacted by the Legislature of the State of Florida:
   11  
   12         Section 1. Paragraph (e) of subsection (2) of section
   13  499.01, Florida Statutes, is amended to read:
   14         499.01 Permits.—
   15         (2) The following permits are established:
   16         (e) Out-of-state prescription drug wholesale distributor
   17  permit.—An out-of-state prescription drug wholesale distributor
   18  is a wholesale distributor located outside this state which
   19  engages in the wholesale distribution of prescription drugs into
   20  this state and which must be permitted by the department and
   21  comply with all the provisions required of a wholesale
   22  distributor under this part. An out-of-state prescription drug
   23  wholesale distributor that applies to the department for a new
   24  permit or the renewal of a permit must submit a bond of
   25  $100,000, or other equivalent means of security acceptable to
   26  the department, such as an irrevocable letter of credit or a
   27  deposit in a trust account or financial institution, payable to
   28  the Florida Drug, Device, and Cosmetic Trust Fund. The purpose
   29  of the bond is to secure payment of any administrative penalties
   30  imposed by the department and any fees and costs incurred by the
   31  department regarding that permit which are authorized under
   32  state law and which the permittee fails to pay 30 days after the
   33  fine or costs become final. The department may make a claim
   34  against such bond or security until 1 year after the permittee’s
   35  license ceases to be valid or until 60 days after any
   36  administrative or legal proceeding authorized in this part which
   37  involves the permittee is concluded, including any appeal,
   38  whichever occurs later.
   39         1. The out-of-state prescription drug wholesale distributor
   40  must maintain at all times a license or permit to engage in the
   41  wholesale distribution of prescription drugs in compliance with
   42  laws of the state in which it is a resident.
   43         2. The department shall notify an out-of-state prescription
   44  drug wholesale distributor that applies for a permit the status
   45  of its permit within 60 days after receipt of all documentation
   46  required by the application.
   47         3.2. An out-of-state prescription drug wholesale
   48  distributor permit is not required for an intracompany sale or
   49  transfer of a prescription drug from an out-of-state
   50  establishment that is duly licensed as a prescription drug
   51  wholesale distributor, in its state of residence, to a licensed
   52  prescription drug wholesale distributor in this state, if both
   53  wholesale distributors conduct wholesale distributions of
   54  prescription drugs under the same business name. The
   55  recordkeeping requirements of ss. 499.0121(6) and 499.01212 must
   56  be followed for this transaction.
   57         Section 2. This act shall take effect July 1, 2011.