Senate Bill sb0446e1
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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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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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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).
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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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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.
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