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.