Florida Senate - 2017                                     SB 114
       
       
        
       By Senator Brandes
       
       24-00152-17                                            2017114__
    1                        A bill to be entitled                      
    2         An act relating to cosmetic product registration;
    3         amending s. 499.015, F.S.; deleting the requirement
    4         that a person who manufactures, packages, repackages,
    5         labels, or relabels a cosmetic in this state register
    6         such cosmetic biennially with the Department of
    7         Business and Professional Regulation; amending ss.
    8         499.003, 499.041, and 499.051, F.S.; conforming
    9         provisions to changes made by the act; providing an
   10         appropriation; providing an effective date.
   11          
   12  Be It Enacted by the Legislature of the State of Florida:
   13  
   14         Section 1. Section 499.015, Florida Statutes, is amended to
   15  read:
   16         499.015 Registration of drugs and, devices, and cosmetics;
   17  issuance of certificates of free sale.—
   18         (1)(a) Except for those persons exempted from the
   19  definition of manufacturer in s. 499.003, any person who
   20  manufactures, packages, repackages, labels, or relabels a drug
   21  or, device, or cosmetic in this state must register such drug
   22  or, device, or cosmetic biennially with the department; pay a
   23  fee in accordance with the fee schedule provided by s. 499.041;
   24  and comply with this section. The registrant must list each
   25  separate and distinct drug or, device, or cosmetic at the time
   26  of registration.
   27         (b) The department may not register any product that does
   28  not comply with the Federal Food, Drug, and Cosmetic Act, as
   29  amended, or Title 21 C.F.R. Registration of a product by the
   30  department does not mean that the product does in fact comply
   31  with all provisions of the Federal Food, Drug, and Cosmetic Act,
   32  as amended.
   33         (2) The department may require the submission of a catalog
   34  and specimens of labels at the time of application for
   35  registration of drugs or, devices, and cosmetics packaged and
   36  prepared in compliance with the federal act, which submission
   37  constitutes a satisfactory compliance for registration of the
   38  products. With respect to all other drugs and, devices, and
   39  cosmetics, the department may require the submission of a
   40  catalog and specimens of labels at the time of application for
   41  registration, but the registration will not become effective
   42  until the department has examined and approved the label of the
   43  drug or, device, or cosmetic product. This approval or denial
   44  must include written notification to the manufacturer.
   45         (3) Except for those persons exempted from the definition
   46  of manufacturer in s. 499.003, a person may not sell any product
   47  that he or she has failed to register in conformity with this
   48  section. Such failure to register subjects such drug or, device,
   49  or cosmetic product to seizure and condemnation as provided in
   50  s. 499.062, and subjects such person to the penalties and
   51  remedies provided in this part.
   52         (4) Unless a registration is renewed, it expires 2 years
   53  after the last day of the month in which it was issued. Any
   54  product registration issued or renewed on or after July 1, 2016,
   55  shall expire on the same date as the manufacturer or repackager
   56  permit of the person seeking to register the product. If the
   57  first product registration issued to a person on or after July
   58  1, 2016, expires less than 366 days after issuance, the fee for
   59  product registration shall be $15. If the first product
   60  registration issued to a person on or after July 1, 2016,
   61  expires more than 365 days after issuance, the fee for product
   62  registration shall be $30. The department may issue a stop-sale
   63  notice or order against a person that is subject to the
   64  requirements of this section and that fails to comply with this
   65  section within 31 days after the date the registration expires.
   66  The notice or order shall prohibit such person from selling or
   67  causing to be sold any drugs or, devices, or cosmetics covered
   68  by this part until he or she complies with the requirements of
   69  this section.
   70         (5) A product regulated under this section which is not
   71  included in the biennial registration may not be sold until it
   72  is registered and complies with this section.
   73         (6) The department may issue a certificate of free sale for
   74  any product that is required to be registered under this part.
   75         (7) A product registration is valid only for the company
   76  named on the registration and located at the address on the
   77  registration. A person whose product is registered by the
   78  department under this section must notify the department before
   79  any change in the name or address of the establishment to which
   80  the product is registered. If a person whose product is
   81  registered ceases conducting business, the person must notify
   82  the department before closing the business.
   83         (8) Notwithstanding any requirements set forth in this
   84  part, a manufacturer of medical devices that is registered with
   85  the federal Food and Drug Administration is exempt from this
   86  section and s. 499.041(6) if:
   87         (a) The manufacturer’s medical devices are approved for
   88  marketing by, or listed with the federal Food and Drug
   89  Administration in accordance with federal law for commercial
   90  distribution; or
   91         (b) The manufacturer subcontracts with a manufacturer of
   92  medical devices to manufacture components of such devices.
   93         (9) However, the manufacturer must submit evidence of such
   94  registration, listing, or approval with its initial application
   95  for a permit to do business in this state, as required in s.
   96  499.01, and any changes to such information previously submitted
   97  at the time of renewal of the permit. Evidence of approval,
   98  listing, and registration by the federal Food and Drug
   99  Administration must include:
  100         (a) For Class II devices, a copy of the premarket
  101  notification letter (510K);
  102         (b) For Class III devices, a federal Food and Drug
  103  Administration premarket approval number;
  104         (c) For a manufacturer who subcontracts with a manufacturer
  105  of medical devices to manufacture components of such devices, a
  106  federal Food and Drug Administration registration number; or
  107         (d) For a manufacturer of medical devices whose devices are
  108  exempt from premarket approval by the federal Food and Drug
  109  Administration, a federal Food and Drug Administration
  110  registration number.
  111         Section 2. Subsection (6) of section 499.003, Florida
  112  Statutes, is amended to read:
  113         499.003 Definitions of terms used in this part.—As used in
  114  this part, the term:
  115         (6) “Certificate of free sale” means a document prepared by
  116  the department which certifies a drug or, device, or cosmetic,
  117  that is registered with the department, as one that can be
  118  legally sold in the state.
  119         Section 3. Subsection (6) of section 499.041, Florida
  120  Statutes, is amended to read:
  121         499.041 Schedule of fees for drug, device, and cosmetic
  122  applications and permits, product registrations, and free-sale
  123  certificates.—
  124         (6) A person that is required to register drugs or,
  125  devices, or cosmetic products under s. 499.015 shall pay an
  126  annual product registration fee of not less than $5 or more than
  127  $15 for each separate and distinct product in package form. The
  128  registration fee is in addition to the fee charged for a free
  129  sale certificate.
  130         Section 4. Subsection (2) of section 499.051, Florida
  131  Statutes, is amended to read:
  132         499.051 Inspections and investigations.—
  133         (2) In addition to the authority set forth in subsection
  134  (1), the department and any duly designated officer or employee
  135  of the department may enter and inspect any other establishment
  136  for the purpose of determining compliance with this chapter and
  137  rules adopted under this chapter regarding any drug, device, or
  138  cosmetic product.
  139         Section 5. For the 2017-2018 fiscal year, the sum of
  140  $222,564 in recurring funds is appropriated from the General
  141  Revenue Fund to the Division of Drugs, Devices, and Cosmetics in
  142  the Department of Business and Professional Regulation for the
  143  purpose of implementing this act, and the appropriation from the
  144  Professional Regulation Trust Fund to the division shall be
  145  reduced by $222,564.
  146         Section 6. This act shall take effect July 1, 2017.