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