Senate Bill sb0874
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Florida Senate - 2005 SB 874
By Senator Peaden
2-593-05
1 A bill to be entitled
2 An act relating to the sale and distribution of
3 prescription drugs; amending s. 499.003, F.S.;
4 redefining the term "pedigree paper"; amending
5 s. 499.0121, F.S.; deleting the expiration
6 dates of provisions governing recordkeeping and
7 reporting which apply to wholesale distributors
8 of prescription drugs, drug repackagers, and
9 chain drug entities that are part of an
10 affiliated group; providing an effective date.
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12 Be It Enacted by the Legislature of the State of Florida:
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14 Section 1. Subsection (31) of section 499.003, Florida
15 Statutes, is amended to read:
16 499.003 Definitions of terms used in ss.
17 499.001-499.081.--As used in ss. 499.001-499.081, the term:
18 (31) "Pedigree paper" means:
19 (a) A document required pursuant to s. 499.0121(6)(d)
20 or (e); or
21 (b) Effective July 1, 2006, a document or electronic
22 in a form approved by the Department of Health and containing
23 information that records each distribution of any given legend
24 drug, from sale by a pharmaceutical manufacturer, through
25 acquisition and sale by any wholesaler or repackager, until
26 final sale to a pharmacy or other person administering or
27 dispensing the drug. The information required to be included
28 on a legend drug's pedigree paper must at least detail the
29 amount of the legend drug, its dosage form and strength, its
30 lot numbers, the name and address of each owner of the legend
31 drug and his or her signature, its shipping information,
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1 including the name and address of each person certifying
2 delivery or receipt of the legend drug, and a certification
3 that the recipient has authenticated the pedigree papers. It
4 must also include the name, address, telephone number and, if
5 available, e-mail contact information of each wholesaler
6 involved in the chain of the legend drug's custody. The
7 department shall adopt rules and a form relating to the
8 requirements of this paragraph no later than 90 days after the
9 effective date of this act.
10 Section 2. Paragraphs (d), (e), and (h) of subsection
11 (6) of section 499.0121, Florida Statutes, are amended to
12 read:
13 499.0121 Storage and handling of prescription drugs;
14 recordkeeping.--The department shall adopt rules to implement
15 this section as necessary to protect the public health,
16 safety, and welfare. Such rules shall include, but not be
17 limited to, requirements for the storage and handling of
18 prescription drugs and for the establishment and maintenance
19 of prescription drug distribution records.
20 (6) RECORDKEEPING.--The department shall adopt rules
21 that require keeping such records of prescription drugs as are
22 necessary for the protection of the public health.
23 (d)1. Each person who is engaged in the wholesale
24 distribution of a prescription drug, and who is not an
25 authorized distributor of record for the drug manufacturer's
26 products, must provide to each wholesale distributor of such
27 drug, before the sale is made to such wholesale distributor, a
28 written statement under oath identifying each previous sale of
29 the drug back to the last authorized distributor of record,
30 the lot number of the drug, and the sales invoice number of
31 the invoice evidencing the sale of the drug. The written
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1 statement must accompany the drug to the next wholesale
2 distributor. The department shall adopt rules relating to the
3 requirements of this written statement. This paragraph does
4 not apply to a manufacturer unless the manufacturer is
5 performing the manufacturing operation of repackaging
6 prescription drugs.
7 2. Each wholesale distributor of prescription drugs
8 must maintain separate and distinct from other required
9 records all statements that are required under subparagraph 1.
10 and paragraph (e).
11 3. Each manufacturer of a prescription drug sold in
12 this state must maintain at its corporate offices a current
13 list of authorized distributors and must make such list
14 available to the department upon request.
15 4. Each manufacturer shall file a written list of all
16 of the manufacturer's authorized distributors of record with
17 the department. A manufacturer shall notify the department not
18 later than 10 days after any change to the list. The
19 department shall publish a list of all authorized distributors
20 of record on its website.
21 5. For the purposes of this subsection, the term
22 "authorized distributors of record" means a wholesale
23 distributor with whom a manufacturer has established an
24 ongoing relationship to distribute the manufacturer's
25 products. Effective March 1, 2004, an ongoing relationship is
26 deemed to exist when a wholesale distributor, including any
27 affiliated group, as defined in s. 1504 of the Internal
28 Revenue Code, of which the wholesale distributor is a member:
29 a. Is listed on the manufacturer's current list of
30 authorized distributors of record.
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1 b. Annually purchases not less than 90 percent of all
2 of its purchases of a manufacturer's prescription drug
3 products, based on dollar volume, directly from that
4 manufacturer and has total annual prescription drug sales of
5 $100 million or more.
6 c. Has reported to the department pursuant to s.
7 499.012(3)(g)2. that the wholesale distributor has total
8 annual prescription drug sales of $100 million or more, and
9 has a verifiable account number issued by the manufacturer
10 authorizing the wholesale distributor to purchase the
11 manufacturer's drug products directly from that manufacturer
12 and that wholesale distributor makes not fewer than 12
13 purchases of that manufacturer's drug products directly from
14 the manufacturer using said verifiable account number in 12
15 months. The provisions of this sub-subparagraph apply with
16 respect to a manufacturer that fails to file a copy of the
17 manufacturer's list of authorized distributors of record with
18 the department by July 1, 2003; that files a list of
19 authorized distributors of record which contains fewer than 10
20 wholesale distributors permitted in this state, excluding the
21 wholesale distributors described in sub-subparagraph b.; or
22 that, as a result of changes to the list of authorized
23 distributors of record filed with the department, has fewer
24 than 10 wholesale distributors permitted in this state as
25 authorized distributors of record, excluding the wholesale
26 distributors described in sub-subparagraph b.
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28 A wholesale distributor that satisfies the requirements of
29 sub-subparagraph b. or sub-subparagraph c. shall submit to the
30 department documentation substantiating its qualification
31 pursuant to sub-subparagraph b. or sub-subparagraph c. The
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1 department shall add those wholesale distributors that the
2 department has determined have met the requirements of
3 sub-subparagraph b. or sub-subparagraph c. to the list of
4 authorized distributors of record on the department's website.
5 6. This paragraph expires July 1, 2006.
6 (e)1. Notwithstanding paragraph (d), each person who
7 is engaged in the wholesale distribution of a specified drug
8 must provide to each wholesale distributor of such specified
9 drug:
10 a. Upon any sale, a written statement that:
11 (I) If the establishment is not a member of an
12 affiliated group: "This establishment purchased the specific
13 unit of the specified drug directly from the manufacturer"; or
14 (II) If the establishment is a member of an affiliated
15 group: "This establishment or a member of my affiliated group
16 purchased the specific unit of the specified drug directly
17 from the manufacturer"; or
18 b. Before the wholesale distribution, a written
19 statement, under oath, that identifies each previous sale of
20 the specific unit of the specified drug back to the
21 manufacturer of the specified drug, the lot number of the
22 specific unit of the specified prescription drug, and the
23 sales invoice number of the invoice evidencing each previous
24 sale of the specific unit of the specified drug. The written
25 statement identifying all sales of such specific unit of the
26 specified drug must accompany the specific unit of the
27 specified drug for each subsequent wholesale distribution of
28 the specific unit of the specified drug to a wholesale
29 distributor.
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1 The department shall adopt rules to administer the
2 requirements of these written statements.
3 2. As used in this paragraph, the term "specified
4 drug" means a specific prescription drug on the list of drugs
5 adopted by the department by rule.
6 3.a. A drug may be placed on the list of specified
7 drugs if the department has seized or issued a stop sale
8 notice on the prescription drug because of the adulteration,
9 counterfeiting, or diversion of the prescription drug from the
10 legal channels of distribution for prescription drugs, or the
11 United States Food and Drug Administration, a manufacturer, a
12 wholesale distributor, a law enforcement agency, or a
13 government agency responsible for regulating the sale or
14 distribution of prescription drugs in another state has
15 notified the department in writing or through a website
16 operated by one of said entities that the prescription drug
17 has been adulterated, counterfeited, or diverted from the
18 legal channels of distribution for prescription drugs; and the
19 prescription drug satisfies one of the following criteria:
20 (I) The prescription drug is included among the top
21 150 prescription drugs for which the state has incurred the
22 highest amount of Medicaid claims in the most recently ended
23 state fiscal year;
24 (II) The prescription drug is available for normal
25 prescription use in dosages or strengths that have a wholesale
26 cost of $200 or more;
27 (III) The prescription drug is used extensively for
28 patients with human immunodeficiency virus, acquired immune
29 deficiency syndrome, cancer, or other serious,
30 life-threatening conditions, where drug nonresponsiveness
31 would not be considered to be medically unusual;
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1 (IV) The prescription drug is an injectable drug;
2 (V) The prescription drug is subject to a special,
3 limited distribution process and is not generally sold to
4 wholesale distributors by the manufacturer of the prescription
5 drug;
6 (VI) The department has found not less than five
7 instances where statements required pursuant to paragraph (d)
8 for the prescription drug were not passed on other than
9 because of unintentional oversight, or have been passed on by
10 or to a wholesale distributor and such statements were
11 fraudulent; or
12 (VII) A shipment of a prescription drug has been
13 reported to a law enforcement agency as having been stolen or
14 as missing.
15 b. A prescription drug may be placed on the list of
16 specified drugs if the prescription drug satisfies any three
17 of the seven criteria set forth in sub-sub-subparagraphs
18 (I)-(VII). However, a prescription drug may not be included on
19 the list of specified drugs if the prescription drug is
20 unlikely to be counterfeited or diverted from the legal
21 channels of distribution for prescription drugs.
22 c. Before the department begins the rulemaking process
23 to place a drug on the list of specified drugs, except when
24 the department files a rule under the procedure specified in
25 sub-subparagraph e., the Drug Wholesaler Advisory Council
26 created in s. 499.01211 shall consider whether a prescription
27 drug should be included on or added to the list of specified
28 drugs using the criteria enumerated in sub-subparagraph a. or
29 sub-subparagraph b. and provide a written recommendation
30 adopted by majority vote to the secretary of the department
31 concerning each such drug. This paragraph does not apply to
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1 any list of prescription drugs on which the department has
2 begun rulemaking prior to this paragraph becoming law.
3 d. When a prescription drug is added to the list of
4 specified drugs, the requirements of this paragraph shall be
5 effective as to the prescription drug beginning 60 days after
6 the effective date of the rule adding the prescription drug to
7 the list, except when the department files a rule under the
8 procedure specified in sub-subparagraph e.
9 e.(I) Notwithstanding chapter 120, if the Attorney
10 General or Statewide Prosecutor certifies to the secretary of
11 the department that a prescription drug should be added to the
12 list of specified drugs by emergency rule, the department may
13 proceed to add such drug to the list of specified drugs and
14 the emergency rule shall be effective for a period of 1 year
15 from the date on which the emergency rule is filed, if the
16 department begins the rulemaking process to adopt a permanent
17 rule to place the drug on the list of specified drugs not
18 later than 90 days after the date on which the emergency rule
19 was filed. An emergency rule adding a drug to the list of
20 specified drugs may not be renewed.
21 (II) A prescription drug may be placed on the list of
22 specified drugs through the procedure provided in this
23 sub-subparagraph when:
24 (A) The prescription drug satisfies any two of the
25 criteria specified in sub-subparagraph a. or sub-subparagraph
26 b.; or
27 (B) The prescription drug satisfies any one of the
28 criteria specified in sub-subparagraph a. or sub-subparagraph
29 b. if the prescription drug has not yet become available for
30 wholesale distribution or has been available for wholesale
31 distribution for not more than 60 days.
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1 (III) Notwithstanding chapter 120, any emergency rule
2 that places a prescription drug on the list of specified drugs
3 may be challenged as being an invalid exercise of the
4 delegated legislative authority only if the department lacks
5 any substantial competent evidence that the prescription drug
6 satisfied the criteria required pursuant to
7 sub-sub-subparagraph (I) or sub-sub-subparagraph (II). Not
8 later than 7 days after any request by any person, the
9 department shall provide such person with the substantial
10 competent evidence that justifies the department's adoption of
11 an emergency rule placing a prescription drug on the list of
12 specified drugs.
13 (IV) The department shall notify all prescription drug
14 wholesalers and out-of-state prescription drug wholesalers by
15 electronic means, facsimile, or United States mail and on the
16 bureau's website when any emergency rule is adopted which
17 places a prescription drug on the list of specified drugs. Not
18 later than 7 days after the department adopts an emergency
19 rule placing a prescription drug on the list of specified
20 drugs, wholesalers shall provide the department with the lot
21 numbers and quantities of such prescription drug which the
22 wholesaler owns or has in transit on the date that the
23 department adopted the emergency rule placing the prescription
24 drug on the list of specified drugs.
25 (V) The requirements of subparagraph 1. do not apply
26 to those lot numbers and quantities of a prescription drug
27 which are included on a report filed pursuant to
28 sub-sub-subparagraph (IV), and paragraph (d) shall apply to
29 those lot numbers and quantities of the prescription drug. In
30 addition to the requirements of paragraph (d), any wholesale
31 distributor selling a prescription drug included on a report
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1 filed pursuant to sub-sub-subparagraph (IV) shall provide any
2 wholesaler purchasing the prescription drugs with a statement
3 under oath that the prescription drugs are among those
4 included on a report filed pursuant to sub-sub-subparagraph
5 (IV) and with a copy of the report filed by the wholesale
6 distributor with the department for those prescription drugs.
7 f. Not less than annually, the council and department
8 shall evaluate whether each prescription drug included on the
9 list of specified drugs should remain on the list. In
10 determining whether a prescription drug should remain on the
11 list of specified drugs, the council and department must
12 consider:
13 (I) The availability of generic forms of the drug.
14 (II) Changes in the price of the drug since the
15 prescription drug was placed on the list.
16 (III) The current status of the drug that caused the
17 department to place the prescription drug on the list of
18 specified drugs.
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20 The council shall provide a written recommendation adopted by
21 majority vote to the secretary of the department concerning
22 each drug that the council recommends be removed from the list
23 of specified drugs.
24 4. This paragraph does not apply to a manufacturer;
25 however, a repackager must comply with this paragraph.
26 5. This paragraph expires July 1, 2006.
27 (h)1. This paragraph applies only to an affiliated
28 group, as defined by s. 1504 of the Internal Revenue Code of
29 1986, as amended, which is composed of chain drug entities,
30 including at least 50 retail pharmacies, warehouses, or
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1 repackagers, which are members of the same affiliated group,
2 if the affiliated group:
3 a. Discloses to the department the names of all its
4 members; and
5 b. Agrees in writing to provide records on
6 prescription drug purchases by members of the affiliated group
7 not later than 48 hours after the department requests such
8 records, regardless of the location where the records are
9 stored.
10 2. Each warehouse within the affiliated group must
11 comply with all applicable federal and state drug wholesale
12 permit requirements and must purchase, receive, hold, and
13 distribute prescription drugs only to a retail pharmacy or
14 warehouse within the affiliated group. Such a warehouse is
15 exempt from providing a pedigree paper in accordance with
16 paragraphs (d) and (e) to its affiliated group member
17 warehouse, provided that:
18 a. Any affiliated group member that purchases or
19 receives a prescription drug from outside the affiliated group
20 must receive a pedigree paper if the prescription drug is
21 distributed in or into this state and a pedigree paper is
22 required under this section and must authenticate the
23 documentation as required in subsection (4), regardless of
24 whether the affiliated group member is directly subject to
25 regulation under this chapter; and
26 b. The affiliated group makes available to the
27 department on request all records related to the purchase or
28 acquisition of prescription drugs by members of the affiliated
29 group, regardless of the location where the records are
30 stored, if the prescription drugs were distributed in or into
31 this state.
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1 3. If a repackager repackages prescription drugs
2 solely for distribution to its affiliated group members for
3 the exclusive distribution to and among retail pharmacies that
4 are members of the affiliated group to which the repackager is
5 a member:
6 a. The repackager must:
7 (I) In lieu of the written statement required by
8 paragraph (d) or paragraph (e), for all repackaged
9 prescription drugs distributed in or into this state, state in
10 writing under oath with each distribution of a repackaged
11 prescription drug to an affiliated group member warehouse or
12 repackager: "All repackaged prescription drugs are purchased
13 by the affiliated group directly from the manufacturer or from
14 a prescription drug wholesaler that purchased the prescription
15 drugs directly from the manufacturer.";
16 (II) Purchase all prescription drugs it repackages:
17 (A) Directly from the manufacturer; or
18 (B) From a prescription drug wholesaler that purchased
19 the prescription drugs directly from the manufacturer; and
20 (III) Maintain records in accordance with this section
21 to document that it purchased the prescription drugs directly
22 from the manufacturer or that its prescription drug wholesale
23 supplier purchased the prescription drugs directly from the
24 manufacturer.
25 b. All members of the affiliated group must provide to
26 agents of the department on request records of purchases by
27 all members of the affiliated group of prescription drugs that
28 have been repackaged, regardless of the location where the
29 records are stored or where the repackager is located.
30 4. This paragraph expires July 1, 2006.
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1 Section 3. This act shall take effect upon becoming a
2 law.
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5 SENATE SUMMARY
6 Redefines the term "pedigree paper" for purposes of the
Florida Drug and Cosmetic Act. Deletes the expiration
7 dates of provisions governing the wholesale distribution
of prescription drugs.
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