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.