Florida Senate - 2016              PROPOSED COMMITTEE SUBSTITUTE
       Bill No. SB 176
       Proposed Committee Substitute by the Committee on Appropriations
       (Appropriations Subcommittee on General Government)
    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, 499.041, and 499.051, F.S.; conforming
    9         provisions to changes made by this act; providing an
   10         appropriation; providing an effective date.
   12  Be It Enacted by the Legislature of the State of Florida:
   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. The
   54  department may issue a stop-sale notice or order against a
   55  person that is subject to the requirements of this section and
   56  that fails to comply with this section within 31 days after the
   57  date the registration expires. The notice or order shall
   58  prohibit such person from selling or causing to be sold any
   59  drugs or, devices, or cosmetics covered by this part until he or
   60  she complies with the requirements of this section.
   61         (5) A product regulated under this section which is not
   62  included in the biennial registration may not be sold until it
   63  is registered and complies with this section.
   64         (6) The department may issue a certificate of free sale for
   65  any product that is required to be registered under this part.
   66         (7) A product registration is valid only for the company
   67  named on the registration and located at the address on the
   68  registration. A person whose product is registered by the
   69  department under this section must notify the department before
   70  any change in the name or address of the establishment to which
   71  the product is registered. If a person whose product is
   72  registered ceases conducting business, the person must notify
   73  the department before closing the business.
   74         (8) Notwithstanding any requirements set forth in this
   75  part, a manufacturer of medical devices that is registered with
   76  the federal Food and Drug Administration is exempt from this
   77  section and s. 499.041(6) if:
   78         (a) The manufacturer’s medical devices are approved for
   79  marketing by, or listed with the federal Food and Drug
   80  Administration in accordance with federal law for commercial
   81  distribution; or
   82         (b) The manufacturer subcontracts with a manufacturer of
   83  medical devices to manufacture components of such devices.
   84         (9) However, the manufacturer must submit evidence of such
   85  registration, listing, or approval with its initial application
   86  for a permit to do business in this state, as required in s.
   87  499.01 and any changes to such information previously submitted
   88  at the time of renewal of the permit. Evidence of approval,
   89  listing, and registration by the federal Food and Drug
   90  Administration must include:
   91         (a) For Class II devices, a copy of the premarket
   92  notification letter (510K);
   93         (b) For Class III devices, a federal Food and Federal Drug
   94  Administration premarket approval number;
   95         (c) For a manufacturer who subcontracts with a manufacturer
   96  of medical devices to manufacture components of such devices, a
   97  federal Food and Federal Drug Administration registration
   98  number; or
   99         (d) For a manufacturer of medical devices whose devices are
  100  exempt from premarket approval by the federal Food and Federal
  101  Drug Administration, a federal Food and Federal Drug
  102  Administration registration number.
  103         Section 2. Subsection (6) of section 499.003, Florida
  104  Statutes, is amended to read:
  105         499.003 Definitions of terms used in this part.—As used in
  106  this part, the term:
  107         (6) “Certificate of free sale” means a document prepared by
  108  the department which certifies a drug or, device, or cosmetic,
  109  that is registered with the department, as one that can be
  110  legally sold in the state.
  111         Section 3. Subsection (6) of section 499.041, Florida
  112  Statutes, is amended to read:
  113         499.041 Schedule of fees for drug, device, and cosmetic
  114  applications and permits, product registrations, and free-sale
  115  certificates.—
  116         (6) A person that is required to register drugs or,
  117  devices, or cosmetic products under s. 499.015 shall pay an
  118  annual product registration fee of not less than $5 or more than
  119  $15 for each separate and distinct product in package form. The
  120  registration fee is in addition to the fee charged for a free
  121  sale certificate.
  122         Section 4. Subsection (2) of section 499.051, Florida
  123  Statutes, is amended to read:
  124         499.051 Inspections and investigations.—
  125         (2) In addition to the authority set forth in subsection
  126  (1), the department and any duly designated officer or employee
  127  of the department may enter and inspect any other establishment
  128  for the purpose of determining compliance with this chapter and
  129  rules adopted under this chapter regarding any drug, device, or
  130  cosmetic product.
  131         Section 5. For the 2016-2017 fiscal year, the sum of
  132  $222,564 in recurring funds is appropriated from the General
  133  Revenue Fund to the Division of Drugs, Devices, and Cosmetics in
  134  the Department of Business and Professional Regulation for the
  135  purpose of implementing this act, and the appropriation from the
  136  Professional Regulation Trust Fund to the division shall be
  137  reduced by $222,564.
  138         Section 6. This act shall take effect July 1, 2016.