Senate Bill sb0446e1

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    CS for CS for CS for SB 446              First Engrossed (ntc)



  1                      A bill to be entitled

  2         An act relating to the sale of products

  3         containing ephedrine or ephedra; amending s.

  4         499.0121, F.S.; providing recordkeeping

  5         requirements relating to the storage and

  6         handling of prescription drugs which affiliated

  7         groups must fulfill; amending s. 499.033, F.S.;

  8         prohibiting the sale or delivery of products

  9         containing ephedrine or ephedra over the

10         counter without a prescription, subject to

11         certain exceptions; amending s. 500.04, F.S.;

12         prohibiting the sale or delivery of dietary

13         supplements or other foods containing ephedrine

14         or ephedra; creating the Weight Loss and

15         Athletic Performance Dietary Supplement Review

16         Committee; providing an appropriations;

17         repealing s. 501.0583, F.S., relating to the

18         sale of weight-loss pills containing ephedrine

19         or ephedra products to minors; providing an

20         effective date.

21  

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

23  

24         Section 1.  Paragraph (h) is added to subsection (6) of

25  section 499.0121, Florida Statutes, to read:

26         499.0121  Storage and handling of prescription drugs;

27  recordkeeping.--The department shall adopt rules to implement

28  this section as necessary to protect the public health,

29  safety, and welfare.  Such rules shall include, but not be

30  limited to, requirements for the storage and handling of

31  


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    CS for CS for CS for SB 446              First Engrossed (ntc)



 1  prescription drugs and for the establishment and maintenance

 2  of prescription drug distribution records.

 3         (6)  RECORDKEEPING.--The department shall adopt rules

 4  that require keeping such records of prescription drugs as are

 5  necessary for the protection of the public health.

 6         (h)1.  This paragraph applies only to an affiliated

 7  group, as defined by s. 1504 of the Internal Revenue Code of

 8  1986, as amended, which is composed of chain drug entities,

 9  including at least 50 retail pharmacies, warehouses, or

10  repackagers, which are members of the same affiliated group

11  if:

12         a.  The group discloses to the department the names of

13  all the members of the affiliated group, and

14         b.  The affiliated group agrees in writing to provide

15  records on prescription drug purchases by the members of the

16  affiliated group not later than 48 hours after the department

17  requests access to such records, regardless of the location of

18  where the records are stored.

19         2.  Each warehouse within the affiliated group must

20  comply with all applicable federal and state drug wholesale

21  permit requirements and must purchase, receive, hold, and

22  distribute prescription drugs only to a retail pharmacy or

23  warehouse within the affiliated group. Such a warehouse is

24  exempt from providing a pedigree paper in accordance with

25  paragraphs (d) and (e) to its affiliated group member

26  warehouse, provided that:

27         a.  Any affiliated group member that purchases or

28  receives a prescription drug from outside the affiliated group

29  must receive a pedigree paper if the prescription drug is

30  distributed in or into this state and a pedigree paper is

31  required under this section and must authenticate the


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    CS for CS for CS for SB 446              First Engrossed (ntc)



 1  documentation as required in subsection (4), regardless of

 2  whether the affiliated group member is directly subject to

 3  regulation under this chapter; and

 4         b.  The affiliated group makes available to the

 5  department on request all records related to the purchase or

 6  acquisition of prescription drugs by members of the affiliated

 7  group, regardless of the location where the records are

 8  stored, if the prescription drugs were distributed in or into

 9  this state.

10         3.  If a repackager repackages prescription drugs

11  solely for distribution to its affiliated group members for

12  the exclusive distribution to and among retail pharmacies that

13  are members of the affiliated group to which the repackager is

14  a member:

15         a.  The repackager must:

16         (I)  In lieu of the written statement required by

17  paragraph (d) or paragraph (e), for all repackaged

18  prescription drugs distributed in or into this state, issue

19  the following written statement under oath with each

20  distribution of a repackaged prescription drug to an

21  affiliated group member warehouse or repackager: "All

22  repackaged prescription drugs are purchased by the affiliated

23  group directly from the manufacturer or from a prescription

24  drug wholesaler that purchased the prescription drugs directly

25  from the manufacturer.";

26         (II)  Purchase all prescription drugs it repackages:

27         (A)  Directly from the manufacturer; or

28         (B)  From a prescription drug wholesaler that purchased

29  the prescription drugs directly from the manufacturer; and

30         (III)  Maintain records in accordance with this section

31  to document that it purchased the prescription drugs directly


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    CS for CS for CS for SB 446              First Engrossed (ntc)



 1  from the manufacturer or that its prescription drug wholesale

 2  supplier purchased the prescription drugs directly from the

 3  manufacturer.

 4         b.  In addition, all members of the affiliated group

 5  must provide to agents of the department on request records of

 6  purchases by all members of the affiliated group of

 7  prescription drugs that have been repackaged, regardless of

 8  the location where the records are stored or where the

 9  repackager is located.

10         4.  This paragraph expires July 1, 2006.

11         Section 2.  Subsections (1) and (2) of section 499.033,

12  Florida Statutes, are 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 any drug product that

17  contains any quantity of ephedrine, a salt of ephedrine, an

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

19  ephedrine, including any part of the plant genus ephedra or

20  the plant genus sida cordifolia, and any species thereof,

21  unless may be dispensed by a duly licensed pharmacist or

22  dispensing practitioner and only upon the prescription of a

23  duly licensed practitioner authorized by the laws of the state

24  to prescribe medicinal drugs.

25         (2)  A drug 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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    CS for CS for CS for SB 446              First Engrossed (ntc)



 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 drug product; the manner of

 5  distribution, advertising, and promotion of the drug product;

 6  the duration, scope, health significance, and societal cost of

 7  abuse of the particular drug product; the need to provide

 8  medically important ephedrine-containing therapies to the

 9  public for 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).

31  


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    CS for CS for CS for SB 446              First Engrossed (ntc)



 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         Section 3.  Subsection (12) is added to section 500.04,

 9  Florida Statutes, to read:

10         500.04  Prohibited acts.--The following acts and the

11  causing thereof within the state are prohibited:

12         (12)  The sale or delivery of any dietary supplement or

13  any other food that contains any quantity of ephedrine, a salt

14  of epherdrine, an optical isomer of ephedrine, or a salt of

15  any optical isomer of ephedrine, including any part of the

16  plant genus ephedra or the plant genus sida cordifolia, and

17  any species thereof.

18         Section 4.  Weight Loss and Athletic Performance

19  Dietary Supplement Review Committee.--

20         (1)  The Weight Loss and Athletic Performance Dietary

21  Supplement Review Committee is created for the purpose of

22  evaluating the safety of ingredients contained in dietary

23  supplements that are sold in Florida and that claim to promote

24  weight loss and athletic performance. The committee shall be

25  established by August 1, 2004, and its evaluation process

26  shall include reviewing scientific research and adverse

27  incident reports relating to weight loss and athletic

28  performance dietary supplements. The committee shall draft a

29  report that summarizes its findings and provides

30  recommendations for future legislative and executive branch

31  action that may be taken to protect the public from dangerous


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    CS for CS for CS for SB 446              First Engrossed (ntc)



 1  weight loss and athletic performance dietary supplements. This

 2  report shall be submitted to the President of the Senate and

 3  the Speaker of the House of Representatives by August 1, 2005.

 4         (2)  The committee shall consist of:

 5         (a)  The Commissioner of Agriculture, or his or her

 6  designee;

 7         (b)  The Secretary of Health, or his or her designee;

 8         (c)  Two members who are health care practitioners as

 9  defined in section 456.001, Florida Statutes, or scientists,

10  who possess expertise in the area of weight loss and athletic

11  performance dietary supplements, to be appointed by the

12  Secretary of Health;

13         (d)  Two members who possess expertise in the area of

14  dietary supplement regulation, to be appointed by the

15  Commissioner of Agriculture; and

16         (e)  Two members who represent the weight loss and

17  athletic performance dietary supplement industry, to be

18  appointed by the Commissioner of Agriculture.

19         (3)  The sum of $10,000 is appropriated from the

20  General Revenue Fund for fiscal year 2004-2005 for use in

21  payment of costs associated with meeting attendance for

22  appointees of this committee. Additional administrative

23  support shall be provided by the Department of Agriculture and

24  Consumer Services.

25         Section 5.  Section 501.0583, Florida Statutes, as

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

27  repealed.

28         Section 6.  This act shall take effect July 1, 2004.

29  

30  

31  


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