Senate Bill sb0446c1

    Florida Senate - 2004                            CS for SB 446

    By the Committee on Health, Aging, and Long-Term Care; and
    Senator Margolis




    317-954-04

  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; repealing s. 501.0583, F.S.,

  8         relating to selling, delivering, bartering,

  9         furnishing, or giving weight-loss pills to

10         persons under age 18; providing an effective

11         date.

12  

13  Be It Enacted by the Legislature of the State of Florida:

14  

15         Section 1.  Section 499.033, Florida Statutes, is

16  amended to read:

17         499.033  Ephedrine; prescription required.--Ephedrine

18  is declared to be a prescription drug.

19         (1)  Except as provided in subsection (2), a person may

20  not sell or deliver over the counter any product intended for

21  ingestion by humans which that contains any quantity of

22  ephedrine, a salt of ephedrine, an optical isomer of

23  ephedrine, or a salt of an optical isomer of ephedrine,

24  including any part of the plant genus ephedra or the plant

25  genus sida cordifolia, and any species thereof, unless may be

26  dispensed by a duly licensed pharmacist or dispensing

27  practitioner and only upon the prescription of a duly licensed

28  practitioner authorized by the laws of the state to prescribe

29  medicinal drugs.

30         (2)  A product containing ephedrine described in

31  paragraphs (a)-(e) is exempt from subsection (1) if it may

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






    Florida Senate - 2004                            CS for SB 446
    317-954-04




 1  lawfully be sold over the counter without a prescription under

 2  the federal act; is labeled and marketed in a manner

 3  consistent with the pertinent United States Food and Drug

 4  Administration Over-the-Counter Tentative Final or Final

 5  Monograph; and is manufactured and distributed for legitimate

 6  medicinal use in a manner that reduces or eliminates the

 7  likelihood of abuse, when considered in the context with:  the

 8  package sizes and the manner of packaging of the drug product;

 9  the name and labeling of the product; the manner of

10  distribution, advertising, and promotion of the product; the

11  duration, scope, health significance, and societal cost of

12  abuse of the particular product; the need to provide medically

13  important ephedrine-containing therapies to the public for

14  United States Food and Drug Administration approved

15  indications on an unrestricted, over-the-counter basis; and

16  other facts as may be relevant to and consistent with public

17  health and safety.

18         (a)  Solid oral dosage forms that combine active

19  ingredients in the following ranges for each dosage unit:

20         1.  Theophylline (100-130mg), ephedrine (12.5-24mg).

21         2.  Theophylline (60-100mg), ephedrine (12.5-24mg),

22  guaifenesin (200-400mg).

23         3.  Ephedrine (12.5-25mg), guaifenesin (200-400mg).

24         4.  Phenobarbital (not greater than 8mg) in combination

25  with the ingredients of subparagraph 1. or subparagraph 2.

26         (b)  Liquid oral dosage forms that combine active

27  ingredients in the following ranges for each (5ml) dose:

28         1.  Theophylline (not greater than 45mg), ephedrine

29  (not greater than 36mg), guaifenesin (not greater than 100mg),

30  phenobarbital (not greater than 12mg).

31  

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    Florida Senate - 2004                            CS for SB 446
    317-954-04




 1         2.  Phenylephrine (not greater than 5mg), ephedrine

 2  (not greater than 5mg), chlorpheniramine (not greater than

 3  2mg), dextromethorphan (not greater than 10mg), ammonium

 4  chloride (not greater than 40mg), ipecac fluid extract (not

 5  greater than 0.005ml).

 6         (c)  Anorectal preparations containing less than 5

 7  percent ephedrine.

 8         (d)  Nasal decongestant compounds, mixtures, or

 9  preparations containing 0.5 percent or less ephedrine.

10         (e)  Any drug product containing ephedrine that is

11  marketed pursuant to an approved new drug application or legal

12  equivalent under the federal act.

13         (3)  The department may administer implement this

14  section by rule.

15         Section 2.  Section 501.0583, Florida Statutes, as

16  created by section 1 of chapter 2003-24, Laws of Florida, is

17  repealed.

18         Section 3.  This act shall take effect July 1, 2004.

19  

20          STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
                       COMMITTEE SUBSTITUTE FOR
21                         Senate Bill 446

22                                 

23  The committee substitute provides a definition of ephedra and
    sida cordifolia and clarifies that the prohibition on the sale
24  and delivery of ephedra without a prescription only applies to
    products containing ephedra that are intended for ingestion by
25  humans.

26  The bill repeals s.501.0583, F.S., which prohibits the
    selling, delivering, bartering, furnishing, or giving of
27  weight-loss pills to persons under age 18.

28  

29  

30  

31  

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