| 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. |