Bill Text: FL S0114 | 2017 | Regular Session | Introduced
Bill Title: Cosmetic Product Registration
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2017-04-27 - Laid on Table, companion bill(s) passed, see CS/HB 211 (Ch. 2017-51) [S0114 Detail]
Download: Florida-2017-S0114-Introduced.html
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.
