Bill Text: FL S0612 | 2015 | Regular Session | Introduced

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Cosmetic Product Registration

Spectrum: Bipartisan Bill

Status: (Failed) 2015-05-01 - Died in Appropriations [S0612 Detail]

Download: Florida-2015-S0612-Introduced.html

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       Florida Senate - 2015                                     SB 612
       
       
        
       By Senator Brandes
       
       
       
       
       
       22-00649-15                                            2015612__
    1                        A bill to be entitled                      
    2         An act relating to cosmetic product registration;
    3         amending s. 499.015, F.S.; removing the requirement
    4         that a person who manufactures, packages, repackages,
    5         labels, or relabels a cosmetic in this state must
    6         register such cosmetic biennially with the Department
    7         of Business and Professional Regulation; amending ss.
    8         499.003 and 499.041, F.S.; conforming provisions to
    9         changes made by this act; providing an effective date.
   10          
   11  Be It Enacted by the Legislature of the State of Florida:
   12  
   13         Section 1. Section 499.015, Florida Statutes, is amended to
   14  read:
   15         499.015 Registration of drugs and, devices, and cosmetics;
   16  issuance of certificates of free sale.—
   17         (1)(a) Except for those persons exempted from the
   18  definition of manufacturer in s. 499.003, any person who
   19  manufactures, packages, repackages, labels, or relabels a drug
   20  or, device, or cosmetic in this state must register such drug
   21  or, device, or cosmetic biennially with the department; pay a
   22  fee in accordance with the fee schedule provided by s. 499.041;
   23  and comply with this section. The registrant must list each
   24  separate and distinct drug or, device, or cosmetic at the time
   25  of registration.
   26         (b) The department may not register any product that does
   27  not comply with the Federal Food, Drug, and Cosmetic Act, as
   28  amended, or Title 21 C.F.R. Registration of a product by the
   29  department does not mean that the product does in fact comply
   30  with all provisions of the Federal Food, Drug, and Cosmetic Act,
   31  as amended.
   32         (2) The department may require the submission of a catalog
   33  and specimens of labels at the time of application for
   34  registration of drugs or , devices, and cosmetics packaged and
   35  prepared in compliance with the federal act, which submission
   36  constitutes a satisfactory compliance for registration of the
   37  products. With respect to all other drugs and, devices, and
   38  cosmetics, the department may require the submission of a
   39  catalog and specimens of labels at the time of application for
   40  registration, but the registration will not become effective
   41  until the department has examined and approved the label of the
   42  drug or, device, or cosmetic product. This approval or denial
   43  must include written notification to the manufacturer.
   44         (3) Except for those persons exempted from the definition
   45  of manufacturer in s. 499.003, a person may not sell any product
   46  that he or she has failed to register in conformity with this
   47  section. Such failure to register subjects such drug or, device,
   48  or cosmetic product to seizure and condemnation as provided in
   49  s. 499.062, and subjects such person to the penalties and
   50  remedies provided in this part.
   51         (4) Unless a registration is renewed, it expires 2 years
   52  after the last day of the month in which it was issued. The
   53  department may issue a stop-sale notice or order against a
   54  person that is subject to the requirements of this section and
   55  that fails to comply with this section within 31 days after the
   56  date the registration expires. The notice or order shall
   57  prohibit such person from selling or causing to be sold any
   58  drugs or, devices, or cosmetics covered by this part until he or
   59  she complies with the requirements of this section.
   60         (5) A product regulated under this section which is not
   61  included in the biennial registration may not be sold until it
   62  is registered and complies with this section.
   63         (6) The department may issue a certificate of free sale for
   64  any product that is required to be registered under this part.
   65         (7) A product registration is valid only for the company
   66  named on the registration and located at the address on the
   67  registration. A person whose product is registered by the
   68  department under this section must notify the department before
   69  any change in the name or address of the establishment to which
   70  the product is registered. If a person whose product is
   71  registered ceases conducting business, the person must notify
   72  the department before closing the business.
   73         (8) Notwithstanding any requirements set forth in this
   74  part, a manufacturer of medical devices that is registered with
   75  the federal Food and Drug Administration is exempt from this
   76  section and s. 499.041(6) if:
   77         (a) The manufacturer’s medical devices are approved for
   78  marketing by, or listed with the federal Food and Drug
   79  Administration in accordance with federal law for commercial
   80  distribution; or
   81         (b) The manufacturer subcontracts with a manufacturer of
   82  medical devices to manufacture components of such devices.
   83         (9) However, the manufacturer must submit evidence of such
   84  registration, listing, or approval with its initial application
   85  for a permit to do business in this state, as required in s.
   86  499.01 and any changes to such information previously submitted
   87  at the time of renewal of the permit. Evidence of approval,
   88  listing, and registration by the federal Food and Drug
   89  Administration must include:
   90         (a) For Class II devices, a copy of the premarket
   91  notification letter (510K);
   92         (b) For Class III devices, a federal Food and Federal Drug
   93  Administration premarket approval number;
   94         (c) For a manufacturer who subcontracts with a manufacturer
   95  of medical devices to manufacture components of such devices, a
   96  federal Food and Federal Drug Administration registration
   97  number; or
   98         (d) For a manufacturer of medical devices whose devices are
   99  exempt from premarket approval by the federal Food and Federal
  100  Drug Administration, a federal Food and Federal Drug
  101  Administration registration number.
  102         Section 2. Subsection (6) of section 499.003, Florida
  103  Statutes, is amended to read:
  104         499.003 Definitions of terms used in this part.—As used in
  105  this part, the term:
  106         (6) “Certificate of free sale” means a document prepared by
  107  the department which certifies a drug or, device, or cosmetic,
  108  that is registered with the department, as one that can be
  109  legally sold in the state.
  110         Section 3. Subsection (6) of section 499.041, Florida
  111  Statutes, is amended to read:
  112         499.041 Schedule of fees for drug, device, and cosmetic
  113  applications and permits, product registrations, and free-sale
  114  certificates.—
  115         (6) A person that is required to register drugs or,
  116  devices, or cosmetic products under s. 499.015 shall pay an
  117  annual product registration fee of not less than $5 or more than
  118  $15 for each separate and distinct product in package form. The
  119  registration fee is in addition to the fee charged for a free
  120  sale certificate.
  121         Section 4. This act shall take effect July 1, 2015.