HB 959 2023
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
A bill to be entitled 1
An act relating to dosage form animal health products; 2
creating s. 585.012, F.S.; providing definitions; 3
requiring a manufacturer or distributor of dosage form 4
animal health products to register with the Department 5
of Agriculture and Consumer Services; authorizing the 6
department to waive the registration requirement under 7
certain conditions and to require specified 8
information for registration applications ; providing 9
requirements for product labels; providing conditions 10
under which dosage form animal health products are 11
considered misbranded or adulterated; providing 12
construction; providing an effective date. 13
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Be It Enacted by the Legislature of the State of F lorida: 15
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Section 1. Section 585.012, Florida Statutes, is created 17
to read: 18
585.012 Dosage form animal health products. — 19
(1) As used in this section, the term: 20
(a) "Brand name" means any distinguishing word, name, 21
symbol, or device, or combination thereof, identifying the 22
dosage form animal health product of a manufacturer or 23
distributor. 24
(b) "Distribute" means to offer for sale, sell, barter, or 25
HB 959 2023
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exchange a dosage form animal health product or to supply, 26
furnish, or otherwise provide such a produ ct for use by any 27
consumer or customer in the state. 28
(c) "Distributor" means a person or entity that 29
distributes dosage form animal health products. 30
(d) "Dosage form animal health product" means any product, 31
including oils, tinctures, capsules, tablets , liquids, soft 32
chews, and chewable limited dose products, intended to affect 33
the structure or function of an animal's body other than by 34
providing nutrition to the animal. The term does not include 35
animal feed supplements, products represented as a primar y meal 36
for the intended animal species, products intended as a snack 37
treat or behavioral reward treat, or dental products providing 38
mechanical or abrasive action. 39
(e) "Label" means a display of written, printed, or 40
graphic matter upon or affixed to the c ontainer in which a 41
dosage form animal health product is distributed, or on the 42
invoice or delivery slip with which the product is distributed. 43
(f) "Labeling" means all labels and other written, 44
printed, or graphic matter upon a dosage form animal health 45
product or any of its containers; all wrappers accompanying the 46
product; and all advertisements, brochures, posters, or 47
television or radio announcements used in promoting the sale of 48
the product. 49
(g) "Manufacture" means the grinding, mixing, blending, or 50
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further processing of a dosage form animal health product for 51
distribution. 52
(h) "Manufacturer" means a person or entity that 53
manufactures dosage form animal health products. 54
(i) "Product name" means the name of a dosage form animal 55
health product which identifies the kind, class, or specific use 56
of the product. 57
(2)(a) A manufacturer or distributor that manufactures or 58
distributes the finished form of a dosage form animal health 59
product in the state must submit a registration application to 60
the department every 2 years as prescribed by department rule. 61
The department may waive the registration requirement if a 62
manufacturer or distributor is registered under another federal 63
or state law in compliance with department rule. 64
(b) The department may require a registration application 65
to include a copy of the label and labeling for each dosage form 66
animal health product. 67
(3) A dosage form animal health product label must 68
contain, at a minimum, all of the following information: 69
(a) The net weight or count of the product. 70
(b) The product name and brand name, if any, under which 71
the product is manufactured or distributed. 72
(c) The established name of each active ingredient in the 73
product and the amount of each active ingredient per serving in 74
descending order by predominance of the ingredient in the 75
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product. 76
(d) The established name of each inactive ingredient in 77
the product and the amount of each inactive ingredient per 78
serving in alphabetical order. 79
(e) Adequate directions and precautionary sta tements and 80
warnings necessary to ensure safe and effective use of the 81
product. 82
(f) The name and principal mailing address of the 83
manufacturer or distributor. Only the name, city, state, and zip 84
code are required for a manufacturer or distributor listed in a 85
local telephone directory. 86
(g) A structure-function claim stating the intended non -87
nutritional benefit of the product. 88
(h) The expiration date. 89
(4) A dosage form animal health product is considered 90
misbranded if the product label or labeling: 91
(a) Does not provide the information required in 92
subsection (3) in a prominent and conspicuous manner which can 93
be easily identified and understood under customary conditions 94
of purchase and use. 95
(b) Includes the term "guaranteed analysis." 96
(c) Is false or misleading. 97
(5) A dosage form animal health product is considered 98
adulterated if: 99
(a) The product contains any poisonous or deleterious 100
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substance that may be injurious to animal health. 101
(b) Any valuable ingredient of the product has been in 102
whole or in part omitted or removed. 103
(c) Any valuable ingredient of the product has been in 104
whole or in part substituted by any less valuable ingredient. 105
(d) The composition or quality of the product falls below 106
or differs from what the label or labeling p urports or 107
represents. 108
(e) The methods or controls used to manufacture or package 109
the product do not conform to current good manufacturing 110
practice. 111
(6) Dosage form animal health products may not be 112
considered commercial feed, a drug, or feedstuff as t hose terms 113
are defined in s. 580.031. 114
Section 2. This act shall take effect July 1, 2023. 115