HB 0247 2004
1	A bill to be entitled
2	An act relating to the sale of products containing
3	ephedrine or ephedra; amending s. 499.033, F.S.;
4	prohibiting the sale or delivery of products containing
5	ephedrine or ephedra over the counter without a
6	prescription, subject to certain exceptions, for which
7	there are penalties; providing rulemaking authority;
8	providing an effective date.
9
10	Be It Enacted by the Legislature of the State of Florida:
11
12	Section 1. Section 499.033, Florida Statutes, is amended
13	to read:
14	499.033 Ephedrine; prescription required.--Ephedrine is
15	declared to be a prescription drug.
16	(1) Except as provided in subsection (2), a person may not
17	sell or deliver over the counter without a prescription any
18	product that contains any quantity of ephedrine or ephedra, a
19	salt of ephedrine, an optical isomer of ephedrine, or a salt of
20	any optical isomer of ephedrine.Any product that contains any
21	quantity of ephedrine or ephedra, a salt of ephedrine, an
22	optical isomer of ephedrine, or a salt of an optical isomer of
23	ephedrine may be dispensed only upon the prescription of a duly
24	licensed practitioner authorized by the laws of the state to
25	prescribe medicinal drugs.
26	(2) A product containing ephedrine described in paragraphs
27	(a)-(e) is exempt from subsection (1) if it may lawfully be sold
28	over the counter without a prescription under the federal act;
29	is labeled and marketed in a manner consistent with the
30	pertinent United States Food and Drug Administration Over-the-
31	Counter Tentative Final or Final Monograph; and is manufactured
32	and distributed for legitimate medicinal use in a manner that
33	reduces or eliminates the likelihood of abuse, when considered
34	in the context with: the package sizes and the manner of
35	packaging of the drug product; the name and labeling of the
36	product; the manner of distribution, advertising, and promotion
37	of the product; the duration, scope, health significance, and
38	societal cost of abuse of the particular product; the need to
39	provide medically important ephedrine-containing therapies to
40	the public for United States Food and Drug Administration
41	approved indications on an unrestricted, over-the-counter basis;
42	and other facts as may be relevant to and consistent with public
43	health and safety.
44	(a) Solid oral dosage forms that combine active
45	ingredients in the following ranges for each dosage unit:
46	1. Theophylline (100-130mg), ephedrine (12.5-24mg).
47	2. Theophylline (60-100mg), ephedrine (12.5-24mg),
48	guaifenesin(200-400mg).
49	3. Ephedrine (12.5-25mg), guaifenesin (200-400mg).
50	4. Phenobarbital (not greater than 8mg) in combination
51	with the ingredients of subparagraph 1. or subparagraph 2.
52	(b) Liquid oral dosage forms that combine active
53	ingredients in the following ranges for each (5ml) dose:
54	1. Theophylline (not greater than 45mg), ephedrine (not
55	greater than 36mg), guaifenesin (not greater than 100mg),
56	phenobarbital (not greater than 12mg).
57	2. Phenylephrine (not greater than 5mg), ephedrine (not
58	greater than 5mg), chlorpheniramine (not greater than 2mg),
59	dextromethorphan (not greater than 10mg), ammonium chloride (not
60	greater than 40mg), ipecac fluid extract (not greater than
61	0.005ml).
62	(c) Anorectal preparations containing less than 5 percent
63	ephedrine.
64	(d) Nasal decongestant compounds, mixtures, or
65	preparations containing 0.5 percent or less ephedrine.
66	(e) Any drug product containing ephedrine that is marketed
67	pursuant to an approved new drug application or legal equivalent
68	under the federal act.
69	(3) The department may administer implementthis section
70	by rule.
71	Section 2. This act shall take effect July 1, 2004.