Florida Senate - 2022 SB 1096



By Senator Brodeur





9-01070-22 20221096__
1 A bill to be entitled
2 An act relating to regulation of compounded drug
3 products; providing legislative intent; requiring the
4 Surgeon General, on behalf of the Department of
5 Health, to sign and become a party to the United
6 States Food and Drug Administration’s Memorandum of
7 Understanding Addressing Certain Distributions of
8 Compounded Human Drug Products; requiring the Surgeon
9 General to notify the Division of Law Revision within
10 a specified timeframe after signing the memorandum;
11 creating s. 465.036, F.S.; requiring certain pharmacy
12 permittees to annually report information to the
13 National Association of Boards of Pharmacy’s
14 information sharing network as required by the
15 memorandum; requiring the department to ensure such
16 permittees comply with the reporting requirements;
17 providing effective dates.
18
19 Be It Enacted by the Legislature of the State of Florida:
20
21 Section 1. (1) It is the intent of the Legislature to
22 enhance communication and maximize federal and state resources
23 for the oversight of compounded drug products produced and
24 shipped by pharmacies in this state, and to enact an information
25 sharing agreement with the United States Food and Drug
26 Administration for the purpose of monitoring compounded drug
27 products produced in this state which are shipped outside of
28 this state.
29 (2) Upon release of the United States Food and Drug
30 Administration’s Memorandum of Understanding Addressing Certain
31 Distributions of Compounded Human Drug Products, as provided for
32 in section 503A(b)(3)(B)(i) of the Federal Food, Drug, and
33 Cosmetic Act, 21 U.S.C. s. 353a, the Surgeon General, on behalf
34 of the Department of Health, shall sign and become a party to
35 the memorandum. The Surgeon General must notify the Division of
36 Law Revision within 5 days after signing the memorandum.
37 Section 2. Effective upon the date the Surgeon General
38 signs the United States Food and Drug Administration’s
39 Memorandum of Understanding Addressing Certain Distributions of
40 Compounded Human Drug Products, section 465.036, Florida
41 Statutes, is created to read:
42 465.036 Annual reporting on shipments of compounded drug
43 products.—By April 1 of each year, permittees that ship
44 compounded drug products to another state shall report
45 information to the National Association of Boards of Pharmacy’s
46 information sharing network as required by the Memorandum of
47 Understanding Addressing Certain Distributions of Compounded
48 Human Drug Products between the department and the United States
49 Food and Drug Administration. The department shall ensure that
50 permittees comply with this section.
51 Section 3. Except as otherwise expressly provided in this
52 act, this act shall take effect upon becoming a law.