| 1 | Representative Bean offered the following: |
| 2 |
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| 3 | Amendment |
| 4 | Between lines 1507 and 1508, insert: |
| 5 | 3. A nonresident prescription drug manufacturer permit is |
| 6 | not required for a manufacturer to distribute an active |
| 7 | pharmaceutical ingredient that it manufactures to a Florida |
| 8 | permitted prescription drug manufacturer in limited quantities |
| 9 | intended for research and development and not for resale or |
| 10 | human use other than lawful clinical trials and biostudies |
| 11 | authorized and regulated by federal law. A manufacturer claiming |
| 12 | to be exempt from the permit requirements of this paragraph and |
| 13 | the prescription drug manufacturer purchasing and receiving the |
| 14 | active pharmaceutical ingredient must comply with the |
| 15 | recordkeeping requirements of s. 499.0121(6), and rules adopted |
| 16 | thereunder. The department shall specify by rule the allowable |
| 17 | number of transactions within a given period of time and the |
| 18 | amount of active pharmaceutical ingredients that qualify as |
| 19 | limited quantities for purposes of this exemption. |