Florida Senate - 2004 CS for CS for CS for SB 446
By the Committees on Agriculture; Governmental Oversight and
Productivity; Health, Aging, and Long-Term Care; and Senators
Margolis and Wasserman Schultz
303-2226-04
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.
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22 Be It Enacted by the Legislature of the State of Florida:
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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
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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 2. Each warehouse within the affiliated group must
12 comply with all applicable federal and state drug wholesale
13 permit requirements and must purchase, receive, hold, and
14 distribute prescription drugs only to a retail pharmacy or
15 warehouse within the affiliated group. Such a warehouse is
16 exempt from providing a pedigree paper in accordance with
17 paragraphs (d) and (e) to its affiliated group member
18 warehouse, provided that:
19 a. Any affiliated group member that purchases or
20 receives a prescription drug from outside the affiliated group
21 must receive a pedigree paper if the prescription drug is
22 distributed in or into this state and a pedigree paper is
23 required under this section and must authenticate the
24 documentation as required in subsection (4), regardless of
25 whether the affiliated group member is directly subject to
26 regulation under this chapter; and
27 b. The affiliated group makes available to the
28 department on request all records related to the purchase or
29 acquisition of prescription drugs by members of the affiliated
30 group, regardless of the location where the records are
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1 stored, if the prescription drugs were distributed in or into
2 this state.
3 3. If a repackager repackages prescription drugs
4 solely for distribution to its affiliated group members for
5 the exclusive distribution to and among retail pharmacies that
6 are members of the affiliated group to which the repackager is
7 a member:
8 a. The repackager must:
9 (I) In lieu of the written statement required by
10 paragraph (d) or paragraph (e), for all repackaged
11 prescription drugs distributed in or into this state, issue
12 the following written statement under oath with each
13 distribution of a repackaged prescription drug to an
14 affiliated group member warehouse or repackager: "All
15 repackaged prescription drugs are purchased by the affiliated
16 group directly from the manufacturer or from a prescription
17 drug wholesaler that purchased the prescription drugs directly
18 from the manufacturer.";
19 (II) Purchase all prescription drugs it repackages:
20 (A) Directly from the manufacturer; or
21 (B) From a prescription drug wholesaler that purchased
22 the prescription drugs directly from the manufacturer; and
23 (III) Maintain records in accordance with this section
24 to document that it purchased the prescription drugs directly
25 from the manufacturer or that its prescription drug wholesale
26 supplier purchased the prescription drugs directly from the
27 manufacturer.
28 b. In addition, all members of the affiliated group
29 must provide to agents of the department on request records of
30 purchases by all members of the affiliated group of
31 prescription drugs that have been repackaged, regardless of
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1 the location where the records are stored or where the
2 repackager is located.
3 4. This paragraph expires July 1, 2006.
4 Section 2. Subsections (1) and (2) of section 499.033,
5 Florida Statutes, are amended to read:
6 499.033 Ephedrine; prescription required.--Ephedrine
7 is declared to be a prescription drug.
8 (1) Except as provided in subsection (2), a person may
9 not sell or deliver over the counter any drug product that
10 contains any quantity of ephedrine, a salt of ephedrine, an
11 optical isomer of ephedrine, or a salt of an optical isomer of
12 ephedrine, including any part of the plant genus ephedra or
13 the plant genus sida cordifolia, and any species thereof,
14 unless may be dispensed by a duly licensed pharmacist or
15 dispensing practitioner and only upon the prescription of a
16 duly licensed practitioner authorized by the laws of the state
17 to prescribe medicinal drugs.
18 (2) A drug product containing ephedrine described in
19 paragraphs (a)-(e) is exempt from subsection (1) if it may
20 lawfully be sold over the counter without a prescription under
21 the federal act; is labeled and marketed in a manner
22 consistent with the pertinent United States Food and Drug
23 Administration Over-the-Counter Tentative Final or Final
24 Monograph; and is manufactured and distributed for legitimate
25 medicinal use in a manner that reduces or eliminates the
26 likelihood of abuse, when considered in the context with: the
27 package sizes and the manner of packaging of the drug product;
28 the name and labeling of the drug product; the manner of
29 distribution, advertising, and promotion of the drug product;
30 the duration, scope, health significance, and societal cost of
31 abuse of the particular drug product; the need to provide
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1 medically important ephedrine-containing therapies to the
2 public for United States Food and Drug Administration approved
3 indications on an unrestricted, over-the-counter basis; and
4 other facts as may be relevant to and consistent with public
5 health and safety.
6 (a) Solid oral dosage forms that combine active
7 ingredients in the following ranges for each dosage unit:
8 1. Theophylline (100-130mg), ephedrine (12.5-24mg).
9 2. Theophylline (60-100mg), ephedrine (12.5-24mg),
10 guaifenesin (200-400mg).
11 3. Ephedrine (12.5-25mg), guaifenesin (200-400mg).
12 4. Phenobarbital (not greater than 8mg) in combination
13 with the ingredients of subparagraph 1. or subparagraph 2.
14 (b) Liquid oral dosage forms that combine active
15 ingredients in the following ranges for each (5ml) dose:
16 1. Theophylline (not greater than 45mg), ephedrine
17 (not greater than 36mg), guaifenesin (not greater than 100mg),
18 phenobarbital (not greater than 12mg).
19 2. Phenylephrine (not greater than 5mg), ephedrine
20 (not greater than 5mg), chlorpheniramine (not greater than
21 2mg), dextromethorphan (not greater than 10mg), ammonium
22 chloride (not greater than 40mg), ipecac fluid extract (not
23 greater than 0.005ml).
24 (c) Anorectal preparations containing less than 5
25 percent ephedrine.
26 (d) Nasal decongestant compounds, mixtures, or
27 preparations containing 0.5 percent or less ephedrine.
28 (e) Any drug product containing ephedrine that is
29 marketed pursuant to an approved new drug application or legal
30 equivalent under the federal act.
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1 Section 3. Subsection (12) is added to section 500.04,
2 Florida Statutes, to read:
3 500.04 Prohibited acts.--The following acts and the
4 causing thereof within the state are prohibited:
5 (12) The sale or delivery of any dietary supplement or
6 any other food that contains any quantity of ephedrine, a salt
7 of epherdrine, an optical isomer of ephedrine, or a salt of
8 any optical isomer of ephedrine, including any part of the
9 plant genus ephedra or the plant genus sida cordifolia, and
10 any species thereof.
11 Section 4. Weight Loss and Athletic Performance
12 Dietary Supplement Review Committee.--
13 (1) The Weight Loss and Athletic Performance Dietary
14 Supplement Review Committee is created for the purpose of
15 evaluating the safety of ingredients contained in dietary
16 supplements that are sold in Florida and that claim to promote
17 weight loss and athletic performance. The committee shall be
18 established by August 1, 2004, and its evaluation process
19 shall include reviewing scientific research and adverse
20 incident reports relating to weight loss and athletic
21 performance dietary supplements. The committee shall draft a
22 report that summarizes its findings and provides
23 recommendations for future legislative and executive branch
24 action that may be taken to protect the public from dangerous
25 weight loss and athletic performance dietary supplements. This
26 report shall be submitted to the President of the Senate and
27 the Speaker of the House of Representatives by August 1, 2005.
28 (2) The committee shall consist of:
29 (a) The Commissioner of Agriculture, or his or her
30 designee;
31 (b) The Secretary of Health, or his or her designee;
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1 (c) Two members who are health care practitioners as
2 defined in section 456.001, Florida Statutes, or scientists,
3 who possess expertise in the area of weight loss and athletic
4 performance dietary supplements, to be appointed by the
5 Secretary of Health;
6 (d) Two members who possess expertise in the area of
7 dietary supplement regulation, to be appointed by the
8 Commissioner of Agriculture; and
9 (e) Two members who represent the weight loss and
10 athletic performance dietary supplement industry, to be
11 appointed by the Commissioner of Agriculture.
12 (3) The sum of $10,000 is appropriated from the
13 General Revenue Fund for fiscal year 2004-2005 for use in
14 payment of costs associated with meeting attendance for
15 appointees of this committee. Additional administrative
16 support shall be provided by the Department of Agriculture and
17 Consumer Services.
18 Section 5. Section 501.0583, Florida Statutes, as
19 created by section 1 of chapter 2003-24, Laws of Florida, is
20 repealed.
21 Section 6. This act shall take effect July 1, 2004.
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Florida Senate - 2004 CS for CS for CS for SB 446
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1 STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
COMMITTEE SUBSTITUTE FOR
2 CS/CS Senate Bill 446
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4 CS for CS for CS for SB 446 is different from CS for CS SB 446
in that it:
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1. Changes recordkeeping requirements for affiliated groups
6 concerning the storage and handling of prescription
drugs;
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2. Prohibits the sale or delivery of dietary supplements or
8 foods containing ephedrine or ephedra;
9 3. Appropriates $10,000 to the Department of Agriculture and
Consumer Services from General Revenue for fiscal year
10 2004-2005 for costs associated with the Weight Loss and
Athletic Performance Dietary Supplement Review Committee.
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