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.