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
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
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.