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 |
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12 | Be It Enacted by the Legislature of the State of Florida: |
13 |
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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 |
42 | distributor must maintain at all times a license or permit to |
43 | engage in the wholesale distribution of prescription drugs in |
44 | compliance with laws of the state in which it is a resident. The |
45 | department shall issue an out-of-state permit by endorsement to |
46 | an applicant who, upon applying to the department and remitting |
47 | a filing fee, set by the board, demonstrates to the board that |
48 | the applicant satisfies the requirements of this chapter and |
49 | holds a valid drug wholesale distributor license or permit from |
50 | another state. An out-of state prescription drug wholesale |
51 | distributor that holds a valid permit under this chapter on the |
52 | effective date of this act may continue to operate under that |
53 | permit until its expiration, after which the distributor may |
54 | apply for a permit by endorsement as provided in this |
55 | subparagraph. |
56 | 2. An out-of-state prescription drug wholesale distributor |
57 | permit is not required for an intracompany sale or transfer of a |
58 | prescription drug from an out-of-state establishment that is |
59 | duly licensed as a prescription drug wholesale distributor, in |
60 | its state of residence, to a licensed prescription drug |
61 | wholesale distributor in this state, if both wholesale |
62 | distributors conduct wholesale distributions of prescription |
63 | drugs under the same business name. The recordkeeping |
64 | requirements of ss. 499.0121(6) and 499.01212 must be followed |
65 | for this transaction. |
66 | Section 2. This act shall take effect July 1, 2012. |