Florida Senate - 2019 SENATOR AMENDMENT Bill No. CS for HB 19 Ì738486VÎ738486 LEGISLATIVE ACTION Senate . House . . . . . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— Senator Bean moved the following: 1 Senate Amendment to Amendment (368506) 2 3 Delete lines 316 - 365 4 and insert: 5 (c) The location, names, and titles of all principal 6 corporate officers and the pharmacist who serves as the 7 prescription department manager for prescription drugs exported 8 into this state under the International Prescription Drug 9 Importation Program. 10 (d) Written attestation by an owner or officer of the 11 applicant, and by the applicant’s prescription department 12 manager, that: 13 1. The attestor has read and understands the laws and rules 14 governing the manufacture, distribution, and dispensing of 15 prescription drugs in this state. 16 2. A prescription drug shipped, mailed, or delivered into 17 this state meets or exceeds this state’s standards for safety 18 and efficacy. 19 3. A prescription drug product shipped, mailed, or 20 delivered into this state must not have been, and may not be, 21 manufactured or distributed in violation of the laws and rules 22 of the jurisdiction in which the applicant is located and from 23 which the prescription drugs shall be exported. 24 (e) A current inspection report from an inspection 25 conducted by the regulatory or licensing agency of the 26 jurisdiction in which the applicant is located. The inspection 27 report must reflect compliance with this section. An inspection 28 report is current if the inspection was conducted within 6 29 months before the date of submitting the application for the 30 initial permit or within 1 year before the date of submitting an 31 application for permit renewal. If the applicant is unable to 32 submit a current inspection report conducted by the regulatory 33 or licensing agency of the jurisdiction in which the applicant 34 is located and from which the prescription drugs will be 35 exported, due to acceptable circumstances, as established by 36 rule, or if an inspection has not been performed, the department 37 must: 38 1. Conduct, or contract with an entity to conduct, an 39 onsite inspection, with all related costs borne by the 40 applicant; 41 2. Accept a current and satisfactory inspection report, as 42 determined by rule, from an entity approved by the board; or 43 3. Accept a current inspection report from the United 44 States Food and Drug Administration conducted pursuant to the 45 federal Drug Quality and Security Act, Pub. L. No. 113-54. 46 (5) The department shall adopt rules governing the 47 financial responsibility of the pharmacy permittee. The rules 48 must establish, at a minimum, financial reporting requirements, 49 standards for financial capability to perform the functions 50 governed by the permit, and requirements for ensuring permittees 51 and their contractors can be held accountable for the financial 52 consequences of any act of malfeasance or misfeasance or 53 fraudulent or dishonest act or acts committed by the permittee 54 or its contractors.