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| 3 | 3 | | HB 1109 2022 |
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| 7 | 7 | | CODING: Words stricken are deletions; words underlined are additions. |
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| 8 | 8 | | hb1109-00 |
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| 9 | 9 | | Page 1 of 2 |
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| 10 | 10 | | F L O R I D A H O U S E O F R E P R E S E N T A T I V E S |
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| 14 | 14 | | A bill to be entitled 1 |
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| 15 | 15 | | An act relating to distributions of compounded human 2 |
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| 16 | 16 | | drug products; creating s. 465.41, F.S.; providing 3 |
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| 17 | 17 | | legislative intent; requiring the State Surgeon 4 |
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| 18 | 18 | | General to sign and become a party to a specified 5 |
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| 19 | 19 | | memorandum of understanding on behalf of the 6 |
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| 20 | 20 | | Department of Health; providing reporting requirements 7 |
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| 21 | 21 | | for certain persons who ship compounded human drug 8 |
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| 22 | 22 | | products interstate; providing an effective date. 9 |
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| 24 | 24 | | Be It Enacted by the Legislature of the State of Florida: 11 |
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| 25 | 25 | | 12 |
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| 26 | 26 | | Section 1. Section 465.41, Florida Statutes, is created to 13 |
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| 27 | 27 | | read: 14 |
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| 28 | 28 | | 465.41 Distribution of compounded human drug products. — 15 |
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| 29 | 29 | | (1) It is the intent of the Legislature to enhance 16 |
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| 30 | 30 | | communication and maximize federal and state resources for 17 |
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| 31 | 31 | | oversight of compounded drugs produced by traditional pharmacies 18 |
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| 32 | 32 | | and to enact an information sharing agreement with the federal 19 |
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| 33 | 33 | | Food and Drug Administration as a tool to monitor such drug 20 |
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| 34 | 34 | | products. 21 |
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| 35 | 35 | | (2) Upon release of the standard Memorandum of 22 |
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| 36 | 36 | | Understanding Addressing Certain Distributions of Compounded 23 |
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| 37 | 37 | | Human Drug Products, as provided for in s. 503A(b)(3)(i) of the 24 |
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| 38 | 38 | | Federal Food, Drug, and Cosmetic Act, 21 U.S.C. s. 353a, the 25 |
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| 40 | 40 | | HB 1109 2022 |
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| 44 | 44 | | CODING: Words stricken are deletions; words underlined are additions. |
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| 45 | 45 | | hb1109-00 |
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| 46 | 46 | | Page 2 of 2 |
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| 47 | 47 | | F L O R I D A H O U S E O F R E P R E S E N T A T I V E S |
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| 51 | 51 | | State Surgeon General shall sign and become a party to the 26 |
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| 52 | 52 | | memorandum on behalf of the department. 27 |
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| 53 | 53 | | (3) On an annual basis, and within 90 days after the 28 |
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| 54 | 54 | | beginning of the calendar year, all licensed persons who ship 29 |
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| 55 | 55 | | compounded human drug products interstate shall report to the 30 |
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| 56 | 56 | | National Association of Boards of Pharmacy Information -Sharing 31 |
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| 57 | 57 | | Network the information required by the Memorandum of 32 |
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| 58 | 58 | | Understanding Addressing Certain Distributions of Compounded 33 |
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| 59 | 59 | | Human Drug Products between the department and the United States 34 |
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| 60 | 60 | | Food and Drug Administration as provided by the federal Food and 35 |
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| 61 | 61 | | Drug Administration. 36 |
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| 62 | 62 | | Section 2. This act shall take effect July 1, 2022. 37 |
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