HB 0247

CS

CHAMBER ACTION

1	The Committee on Health Care recommends the following:
2
3	Committee Substitute
4	Remove the entire bill and insert:
5	A bill to be entitled
6	An act relating to the sale of products containing
7	ephedrine or ephedra; amending s. 499.033, F.S.;
8	prohibiting the sale or delivery of products containing
9	ephedrine or ephedra over the counter without a
10	prescription, subject to certain exceptions; amending s.
11	500.04, F.S.; prohibiting the sale or delivery of dietary
12	supplements or other foods containing ephedrine or
13	ephedra; reenacting and amending s. 500.177(1), F.S., to
14	incorporate the amendment to s. 500.04, F.S., in
15	references thereto; providing penalties; creating the
16	Weight Loss and Athletic Performance Dietary Supplement
17	Review Committee; providing duties; requiring a report to
18	the Legislature; providing for membership; providing an
19	appropriation for meeting attendance; providing for
20	administrative support; repealing s. 501.0583, F.S.,
21	relating to selling, delivering, bartering, furnishing, or
22	giving weight-loss pills to persons under age 18;
23	providing an effective date.
24
25	Be It Enacted by the Legislature of the State of Florida:
26
27	Section 1.  Subsections (1) and (2) of section 499.033,
28	Florida Statutes, are amended to read:
29	499.033  Ephedrine; prescription required.--Ephedrine is
30	declared to be a prescription drug.
31	(1)  Except as provided in subsection (2), a person may not
32	sell or deliver over the counter any drug product that contains
33	any quantity of ephedrine, a salt of ephedrine, an optical
34	isomer of ephedrine, or a salt of an optical isomer of
35	ephedrine, including any part of the plant genus ephedra or the
36	plant genus sida cordifolia, and any species thereof, unless may
37	be dispensed by a duly licensed pharmacist or dispensing
38	practitioner and only upon the prescription of a duly licensed
39	practitioner authorized by the laws of the state to prescribe
40	medicinal drugs.
41	(2)  A drug product containing ephedrine described in
42	paragraphs (a)-(e) is exempt from subsection (1) if it may
43	lawfully be sold over the counter without a prescription under
44	the federal act; is labeled and marketed in a manner consistent
45	with the pertinent United States Food and Drug Administration
46	Over-the-Counter Tentative Final or Final Monograph; and is
47	manufactured and distributed for legitimate medicinal use in a
48	manner that reduces or eliminates the likelihood of abuse, when
49	considered in the context with: the package sizes and the manner
50	of packaging of the drug product; the name and labeling of the
51	drug product; the manner of distribution, advertising, and
52	promotion of the drug product; the duration, scope, health
53	significance, and societal cost of abuse of the particular drug
54	product; the need to provide medically important ephedrine-
55	containing therapies to the public for United States Food and
56	Drug Administration approved indications on an unrestricted,
57	over-the-counter basis; and other facts as may be relevant to
58	and consistent with public health and safety.
59	(a)  Solid oral dosage forms that combine active
60	ingredients in the following ranges for each dosage unit:
61	1.  Theophylline (100-130mg), ephedrine (12.5-24mg).
62	2.  Theophylline (60-100mg), ephedrine (12.5-24mg),
63	guaifenesin (200-400mg).
64	3.  Ephedrine (12.5-25mg), guaifenesin (200-400mg).
65	4.  Phenobarbital (not greater than 8mg) in combination
66	with the ingredients of subparagraph 1. or subparagraph 2.
67	(b)  Liquid oral dosage forms that combine active
68	ingredients in the following ranges for each (5ml) dose:
69	1.  Theophylline (not greater than 45mg), ephedrine (not
70	greater than 36mg), guaifenesin (not greater than 100mg),
71	phenobarbital (not greater than 12mg).
72	2.  Phenylephrine (not greater than 5mg), ephedrine (not
73	greater than 5mg), chlorpheniramine (not greater than 2mg),
74	dextromethorphan (not greater than 10mg), ammonium chloride (not
75	greater than 40mg), ipecac fluid extract (not greater than
76	0.005ml).
77	(c)  Anorectal preparations containing less than 5 percent
78	ephedrine.
79	(d)  Nasal decongestant compounds, mixtures, or
80	preparations containing 0.5 percent or less ephedrine.
81	(e)  Any drug product containing ephedrine that is marketed
82	pursuant to an approved new drug application or legal equivalent
83	under the federal act.
84	Section 2.  Subsection (12) is added to section 500.04,
85	Florida Statutes, to read:
86	500.04  Prohibited acts.--The following acts and the
87	causing thereof within the state are prohibited:
88	(12)  The sale or delivery of any dietary supplement or any
89	other food which contains any quantity of ephedrine, a salt of
90	ephedrine, an optical isomer of ephedrine, or a salt of any
91	optical isomer of ephedrine, including any part of the plant
92	genus ephedra or the plant genus sida cordifolia, and any
93	species thereof.
94	Section 3.  For the purpose of incorporating the amendment
95	to section 500.04, Florida Statutes, in references thereto,
96	subsection (1) of section 500.177, Florida Statutes, is
97	reenacted and amended to read:
98	500.177  Penalty for violation of s. 500.04; dissemination
99	of false advertisement.--
100	(1)  Any person who violates any provision of s. 500.04
101	commits is guilty of a misdemeanor of the second degree,
102	punishable as provided in s. 775.082 or s. 775.083; but, if the
103	violation is committed after a conviction of such person under
104	this section has become final, such person commits is guilty of
105	a misdemeanor of the first degree, punishable as provided in s.
106	775.082 or s. 775.083.
107	Section 4.  Weight Loss and Athletic Performance Dietary
108	Supplement Review Committee.--
109	(1)  The Weight Loss and Athletic Performance Dietary
110	Supplement Review Committee is created for the purpose of
111	evaluating the safety of ingredients contained in dietary
112	supplements that are sold in Florida and that claim to promote
113	weight loss and athletic performance. The committee shall be
114	established by August 1, 2004, and its evaluation process shall
115	include reviewing scientific research and adverse incident
116	reports relating to weight loss and athletic performance dietary
117	supplements. The committee shall draft a report that summarizes
118	its findings and provides recommendations for future legislative
119	and executive branch action that may be taken to protect the
120	public from dangerous weight loss and athletic performance
121	dietary supplements. This report shall be submitted to the
122	President of the Senate and the Speaker of the House of
123	Representatives by August 1, 2005.
124	(2)  The committee shall consist of:
125	(a)  The Commissioner of Agriculture, or his or her
126	designee.
127	(b)  The Secretary of Health, or his or her designee.
128	(c)  Two members who are health care practitioners, as
129	defined in s. 456.001, Florida Statutes, or scientists, who
130	possess expertise in the area of weight loss and athletic
131	performance dietary supplements, to be appointed by the
132	Secretary of Health.
133	(d)  Two members who possess expertise in the area of
134	dietary supplement regulation, to be appointed by the
135	Commissioner of Agriculture.
136	(e)  Two members who represent the weight loss and athletic
137	performance dietary supplement industry, to be appointed by the
138	Commissioner of Agriculture.
139	(3)  There is appropriated $10,000 from general revenue for
140	fiscal year 2004-2005 for use in payment of costs associated
141	with meeting attendance for appointees to the committee.
142	Additional administrative support shall be provided by the
143	Department of Agriculture and Consumer Services.
144	Section 5.  Section 501.0583, Florida Statutes, as created
145	by section 1 of chapter 2003-24, Laws of Florida, is repealed.
146	Section 6.  This act shall take effect July 1, 2004.

CODING: Words stricken are deletions; words underlined are additions.