Senate Bill sb0446
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Florida Senate - 2004 SB 446
By Senator Margolis
35-88A-04
1 A bill to be entitled
2 An act relating to the sale of products
3 containing ephedrine; amending s. 499.033,
4 F.S.; prohibiting the sale or delivery of
5 products containing ephedrine over the counter
6 without a prescription, subject to certain
7 exceptions; providing an effective date.
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9 Be It Enacted by the Legislature of the State of Florida:
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11 Section 1. Section 499.033, Florida Statutes, is
12 amended to read:
13 499.033 Ephedrine; prescription required.--Ephedrine
14 is declared to be a prescription drug.
15 (1) Except as provided in subsection (2), a person may
16 not sell or deliver over the counter without a prescription
17 any product that contains any quantity of ephedrine or
18 ephedra, a salt of ephedrine, an optical isomer of ephedrine,
19 or a salt of any optical isomer of ephedrine. Any product that
20 contains any quantity of ephedrine or ephedra, a salt of
21 ephedrine, an optical isomer of ephedrine, or a salt of an
22 optical isomer of ephedrine may be dispensed only upon the
23 prescription of a duly licensed practitioner authorized by the
24 laws of the state to prescribe medicinal drugs.
25 (2) A product containing ephedrine described in
26 paragraphs (a)-(e) is exempt from subsection (1) if it may
27 lawfully be sold over the counter without a prescription under
28 the federal act; is labeled and marketed in a manner
29 consistent with the pertinent United States Food and Drug
30 Administration Over-the-Counter Tentative Final or Final
31 Monograph; and is manufactured and distributed for legitimate
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Florida Senate - 2004 SB 446
35-88A-04
1 medicinal use in a manner that reduces or eliminates the
2 likelihood of abuse, when considered in the context with: the
3 package sizes and the manner of packaging of the drug product;
4 the name and labeling of the product; the manner of
5 distribution, advertising, and promotion of the product; the
6 duration, scope, health significance, and societal cost of
7 abuse of the particular product; the need to provide medically
8 important ephedrine-containing therapies to the public for
9 United States Food and Drug Administration approved
10 indications on an unrestricted, over-the-counter basis; and
11 other facts as may be relevant to and consistent with public
12 health and safety.
13 (a) Solid oral dosage forms that combine active
14 ingredients in the following ranges for each dosage unit:
15 1. Theophylline (100-130mg), ephedrine (12.5-24mg).
16 2. Theophylline (60-100mg), ephedrine (12.5-24mg),
17 guaifenesin (200-400mg).
18 3. Ephedrine (12.5-25mg), guaifenesin (200-400mg).
19 4. Phenobarbital (not greater than 8mg) in combination
20 with the ingredients of subparagraph 1. or subparagraph 2.
21 (b) Liquid oral dosage forms that combine active
22 ingredients in the following ranges for each (5ml) dose:
23 1. Theophylline (not greater than 45mg), ephedrine
24 (not greater than 36mg), guaifenesin (not greater than 100mg),
25 phenobarbital (not greater than 12mg).
26 2. Phenylephrine (not greater than 5mg), ephedrine
27 (not greater than 5mg), chlorpheniramine (not greater than
28 2mg), dextromethorphan (not greater than 10mg), ammonium
29 chloride (not greater than 40mg), ipecac fluid extract (not
30 greater than 0.005ml).
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Florida Senate - 2004 SB 446
35-88A-04
1 (c) Anorectal preparations containing less than 5
2 percent ephedrine.
3 (d) Nasal decongestant compounds, mixtures, or
4 preparations containing 0.5 percent or less ephedrine.
5 (e) Any drug product containing ephedrine that is
6 marketed pursuant to an approved new drug application or legal
7 equivalent under the federal act.
8 (3) The department may administer implement this
9 section by rule.
10 Section 2. This act shall take effect July 1, 2004.
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13 SENATE SUMMARY
14 Prohibits the sale or delivery of products containing
ephedrine over the counter without a prescription.
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