Florida Senate - 2012                                    SB 1006
       
       
       
       By Senator Latvala
       
       
       
       
       16-00907-12                                           20121006__
    1                        A bill to be entitled                      
    2         An act relating to prescription drug wholesale
    3         regulations; amending s. 499.01, F.S.; requiring the
    4         Department of Health to issue a permit by endorsement
    5         to an out-of-state prescription drug wholesale
    6         distributor that meets certain requirements;
    7         authorizing out-of-state wholesale distributors
    8         holding a valid permit to continue to operate under
    9         that permit until its expiration; providing an
   10         effective date.
   11  
   12  Be It Enacted by the Legislature of the State of Florida:
   13  
   14         Section 1. Paragraph (e) of subsection (2) of section
   15  499.01, Florida Statutes, is amended to read:
   16         499.01 Permits.—
   17         (2) The following permits are established:
   18         (e) Out-of-state prescription drug wholesale distributor
   19  permit.—An out-of-state prescription drug wholesale distributor
   20  is a wholesale distributor located outside this state which
   21  engages in the wholesale distribution of prescription drugs into
   22  this state and which must be permitted by the department and
   23  comply with all the provisions required of a wholesale
   24  distributor under this part. An out-of-state prescription drug
   25  wholesale distributor that applies to the department for a new
   26  permit or the renewal of a permit must submit a bond of
   27  $100,000, or other equivalent means of security acceptable to
   28  the department, such as an irrevocable letter of credit or a
   29  deposit in a trust account or financial institution, payable to
   30  the Florida Drug, Device, and Cosmetic Trust Fund. The purpose
   31  of the bond is to secure payment of any administrative penalties
   32  imposed by the department and any fees and costs incurred by the
   33  department regarding that permit which are authorized under
   34  state law and which the permittee fails to pay 30 days after the
   35  fine or costs become final. The department may make a claim
   36  against such bond or security until 1 year after the permittee’s
   37  license ceases to be valid or until 60 days after any
   38  administrative or legal proceeding authorized in this part which
   39  involves the permittee is concluded, including any appeal,
   40  whichever occurs later.
   41         1. The out-of-state prescription drug wholesale distributor
   42  must maintain at all times a license or permit to engage in the
   43  wholesale distribution of prescription drugs in compliance with
   44  laws of the state in which it is a resident. The department
   45  shall issue an out-of-state permit by endorsement to an
   46  applicant who, upon applying to the department and remitting a
   47  filing fee, set by the board, demonstrates to the board that the
   48  applicant satisfies the requirements of this chapter and holds a
   49  valid drug wholesale distributor license or permit from another
   50  state. An out-of state prescription drug wholesale distributor
   51  that holds a valid permit under this chapter on the effective
   52  date of this act may continue to operate under that permit until
   53  its expiration, after which the distributor may apply for a
   54  permit by endorsement as provided in this subparagraph.
   55         2. An out-of-state prescription drug wholesale distributor
   56  permit is not required for an intracompany sale or transfer of a
   57  prescription drug from an out-of-state establishment that is
   58  duly licensed as a prescription drug wholesale distributor, in
   59  its state of residence, to a licensed prescription drug
   60  wholesale distributor in this state, if both wholesale
   61  distributors conduct wholesale distributions of prescription
   62  drugs under the same business name. The recordkeeping
   63  requirements of ss. 499.0121(6) and 499.01212 must be followed
   64  for this transaction.
   65         Section 2. This act shall take effect July 1, 2012.