HB 0489

1
A bill to be entitled
2An act relating to pedigree papers; amending s. 499.003,
3F.S.; clarifying that a pedigree paper may be in paper or
4electronic form; revising the record requirements for
5pedigree papers; amending s. 499.0121, F.S.; removing the
6expiration dates of certain provisions relating to the
7establishment and maintenance of prescription drug
8distribution records; providing an effective date.
9
10Be It Enacted by the Legislature of the State of Florida:
11
12     Section 1.  Paragraph (b) of subsection (31) of section
13499.003, Florida Statutes, is amended to read:
14     499.003  Definitions of terms used in ss. 499.001-
15499.081.--As used in ss. 499.001-499.081, the term:
16     (31)  "Pedigree paper" means:
17     (b)  Effective July 1, 2006, a document in a paper or
18electronic form approved by the Department of Health and
19containing information that records each distribution of any
20given legend drug, from sale by a pharmaceutical manufacturer,
21through acquisition and sale by any wholesaler or repackager,
22until final sale to a pharmacy or other person administering or
23dispensing the drug. The information required to be included on
24a legend drug's pedigree paper must at least detail the amount
25of the legend drug, its dosage form and strength, its lot
26numbers, the name and address of each owner of the legend drug
27and his or her signature, its shipping information, including
28the name and address of each person certifying delivery or
29receipt of the legend drug, and a certification that the
30recipient has authenticated the pedigree papers. It must also
31include the name, address, telephone number and, if available,
32e-mail contact information of each wholesaler involved in the
33chain of the legend drug's custody. The department shall adopt
34rules and a form relating to the requirements of this paragraph
35no later than 90 days after the effective date of this act.
36     Section 2.  Paragraphs (d), (e), and (h) of subsection (6)
37of section 499.0121, Florida Statutes, are amended to read:
38     499.0121  Storage and handling of prescription drugs;
39recordkeeping.--The department shall adopt rules to implement
40this section as necessary to protect the public health, safety,
41and welfare. Such rules shall include, but not be limited to,
42requirements for the storage and handling of prescription drugs
43and for the establishment and maintenance of prescription drug
44distribution records.
45     (6)  RECORDKEEPING.--The department shall adopt rules that
46require keeping such records of prescription drugs as are
47necessary for the protection of the public health.
48     (d)1.  Each person who is engaged in the wholesale
49distribution of a prescription drug, and who is not an
50authorized distributor of record for the drug manufacturer's
51products, must provide to each wholesale distributor of such
52drug, before the sale is made to such wholesale distributor, a
53written statement under oath identifying each previous sale of
54the drug back to the last authorized distributor of record, the
55lot number of the drug, and the sales invoice number of the
56invoice evidencing the sale of the drug. The written statement
57must accompany the drug to the next wholesale distributor. The
58department shall adopt rules relating to the requirements of
59this written statement. This paragraph does not apply to a
60manufacturer unless the manufacturer is performing the
61manufacturing operation of repackaging prescription drugs.
62     2.  Each wholesale distributor of prescription drugs must
63maintain separate and distinct from other required records all
64statements that are required under subparagraph 1. and paragraph
65(e).
66     3.  Each manufacturer of a prescription drug sold in this
67state must maintain at its corporate offices a current list of
68authorized distributors and must make such list available to the
69department upon request.
70     4.  Each manufacturer shall file a written list of all of
71the manufacturer's authorized distributors of record with the
72department. A manufacturer shall notify the department not later
73than 10 days after any change to the list. The department shall
74publish a list of all authorized distributors of record on its
75website.
76     5.  For the purposes of this subsection, the term
77"authorized distributors of record" means a wholesale
78distributor with whom a manufacturer has established an ongoing
79relationship to distribute the manufacturer's products.
80Effective March 1, 2004, an ongoing relationship is deemed to
81exist when a wholesale distributor, including any affiliated
82group, as defined in s. 1504 of the Internal Revenue Code, of
83which the wholesale distributor is a member:
84     a.  Is listed on the manufacturer's current list of
85authorized distributors of record.
86     b.  Annually purchases not less than 90 percent of all of
87its purchases of a manufacturer's prescription drug products,
88based on dollar volume, directly from that manufacturer and has
89total annual prescription drug sales of $100 million or more.
90     c.  Has reported to the department pursuant to s.
91499.012(3)(g)2. that the wholesale distributor has total annual
92prescription drug sales of $100 million or more, and has a
93verifiable account number issued by the manufacturer authorizing
94the wholesale distributor to purchase the manufacturer's drug
95products directly from that manufacturer and that wholesale
96distributor makes not fewer than 12 purchases of that
97manufacturer's drug products directly from the manufacturer
98using said verifiable account number in 12 months. The
99provisions of this sub-subparagraph apply with respect to a
100manufacturer that fails to file a copy of the manufacturer's
101list of authorized distributors of record with the department by
102July 1, 2003; that files a list of authorized distributors of
103record which contains fewer than 10 wholesale distributors
104permitted in this state, excluding the wholesale distributors
105described in sub-subparagraph b.; or that, as a result of
106changes to the list of authorized distributors of record filed
107with the department, has fewer than 10 wholesale distributors
108permitted in this state as authorized distributors of record,
109excluding the wholesale distributors described in sub-
110subparagraph b.
111
112A wholesale distributor that satisfies the requirements of sub-
113subparagraph b. or sub-subparagraph c. shall submit to the
114department documentation substantiating its qualification
115pursuant to sub-subparagraph b. or sub-subparagraph c. The
116department shall add those wholesale distributors that the
117department has determined have met the requirements of sub-
118subparagraph b. or sub-subparagraph c. to the list of authorized
119distributors of record on the department's website.
120     6.  This paragraph expires July 1, 2006.
121     (e)1.  Notwithstanding paragraph (d), each person who is
122engaged in the wholesale distribution of a specified drug must
123provide to each wholesale distributor of such specified drug:
124     a.  Upon any sale, a written statement that:
125     (I)  If the establishment is not a member of an affiliated
126group: "This establishment purchased the specific unit of the
127specified drug directly from the manufacturer"; or
128     (II)  If the establishment is a member of an affiliated
129group: "This establishment or a member of my affiliated group
130purchased the specific unit of the specified drug directly from
131the manufacturer"; or
132     b.  Before the wholesale distribution, a written statement,
133under oath, that identifies each previous sale of the specific
134unit of the specified drug back to the manufacturer of the
135specified drug, the lot number of the specific unit of the
136specified prescription drug, and the sales invoice number of the
137invoice evidencing each previous sale of the specific unit of
138the specified drug. The written statement identifying all sales
139of such specific unit of the specified drug must accompany the
140specific unit of the specified drug for each subsequent
141wholesale distribution of the specific unit of the specified
142drug to a wholesale distributor.
143
144The department shall adopt rules to administer the requirements
145of these written statements.
146     2.  As used in this paragraph, the term "specified drug"
147means a specific prescription drug on the list of drugs adopted
148by the department by rule.
149     3.a.  A drug may be placed on the list of specified drugs
150if the department has seized or issued a stop sale notice on the
151prescription drug because of the adulteration, counterfeiting,
152or diversion of the prescription drug from the legal channels of
153distribution for prescription drugs, or the United States Food
154and Drug Administration, a manufacturer, a wholesale
155distributor, a law enforcement agency, or a government agency
156responsible for regulating the sale or distribution of
157prescription drugs in another state has notified the department
158in writing or through a website operated by one of said entities
159that the prescription drug has been adulterated, counterfeited,
160or diverted from the legal channels of distribution for
161prescription drugs; and the prescription drug satisfies one of
162the following criteria:
163     (I)  The prescription drug is included among the top 150
164prescription drugs for which the state has incurred the highest
165amount of Medicaid claims in the most recently ended state
166fiscal year;
167     (II)  The prescription drug is available for normal
168prescription use in dosages or strengths that have a wholesale
169cost of $200 or more;
170     (III)  The prescription drug is used extensively for
171patients with human immunodeficiency virus, acquired immune
172deficiency syndrome, cancer, or other serious, life-threatening
173conditions, where drug nonresponsiveness would not be considered
174to be medically unusual;
175     (IV)  The prescription drug is an injectable drug;
176     (V)  The prescription drug is subject to a special, limited
177distribution process and is not generally sold to wholesale
178distributors by the manufacturer of the prescription drug;
179     (VI)  The department has found not less than five instances
180where statements required pursuant to paragraph (d) for the
181prescription drug were not passed on other than because of
182unintentional oversight, or have been passed on by or to a
183wholesale distributor and such statements were fraudulent; or
184     (VII)  A shipment of a prescription drug has been reported
185to a law enforcement agency as having been stolen or as missing.
186     b.  A prescription drug may be placed on the list of
187specified drugs if the prescription drug satisfies any three of
188the seven criteria set forth in sub-sub-subparagraphs (I)-(VII).
189However, a prescription drug may not be included on the list of
190specified drugs if the prescription drug is unlikely to be
191counterfeited or diverted from the legal channels of
192distribution for prescription drugs.
193     c.  Before the department begins the rulemaking process to
194place a drug on the list of specified drugs, except when the
195department files a rule under the procedure specified in sub-
196subparagraph e., the Drug Wholesaler Advisory Council created in
197s. 499.01211 shall consider whether a prescription drug should
198be included on or added to the list of specified drugs using the
199criteria enumerated in sub-subparagraph a. or sub-subparagraph
200b. and provide a written recommendation adopted by majority vote
201to the secretary of the department concerning each such drug.
202This paragraph does not apply to any list of prescription drugs
203on which the department has begun rulemaking prior to this
204paragraph becoming law.
205     d.  When a prescription drug is added to the list of
206specified drugs, the requirements of this paragraph shall be
207effective as to the prescription drug beginning 60 days after
208the effective date of the rule adding the prescription drug to
209the list, except when the department files a rule under the
210procedure specified in sub-subparagraph e.
211     e.(I)  Notwithstanding chapter 120, if the Attorney General
212or Statewide Prosecutor certifies to the secretary of the
213department that a prescription drug should be added to the list
214of specified drugs by emergency rule, the department may proceed
215to add such drug to the list of specified drugs and the
216emergency rule shall be effective for a period of 1 year from
217the date on which the emergency rule is filed, if the department
218begins the rulemaking process to adopt a permanent rule to place
219the drug on the list of specified drugs not later than 90 days
220after the date on which the emergency rule was filed. An
221emergency rule adding a drug to the list of specified drugs may
222not be renewed.
223     (II)  A prescription drug may be placed on the list of
224specified drugs through the procedure provided in this sub-
225subparagraph when:
226     (A)  The prescription drug satisfies any two of the
227criteria specified in sub-subparagraph a. or sub-subparagraph
228b.; or
229     (B)  The prescription drug satisfies any one of the
230criteria specified in sub-subparagraph a. or sub-subparagraph b.
231if the prescription drug has not yet become available for
232wholesale distribution or has been available for wholesale
233distribution for not more than 60 days.
234     (III)  Notwithstanding chapter 120, any emergency rule that
235places a prescription drug on the list of specified drugs may be
236challenged as being an invalid exercise of the delegated
237legislative authority only if the department lacks any
238substantial competent evidence that the prescription drug
239satisfied the criteria required pursuant to sub-sub-subparagraph
240(I) or sub-sub-subparagraph (II). Not later than 7 days after
241any request by any person, the department shall provide such
242person with the substantial competent evidence that justifies
243the department's adoption of an emergency rule placing a
244prescription drug on the list of specified drugs.
245     (IV)  The department shall notify all prescription drug
246wholesalers and out-of-state prescription drug wholesalers by
247electronic means, facsimile, or United States mail and on the
248bureau's website when any emergency rule is adopted which places
249a prescription drug on the list of specified drugs. Not later
250than 7 days after the department adopts an emergency rule
251placing a prescription drug on the list of specified drugs,
252wholesalers shall provide the department with the lot numbers
253and quantities of such prescription drug which the wholesaler
254owns or has in transit on the date that the department adopted
255the emergency rule placing the prescription drug on the list of
256specified drugs.
257     (V)  The requirements of subparagraph 1. do not apply to
258those lot numbers and quantities of a prescription drug which
259are included on a report filed pursuant to sub-sub-subparagraph
260(IV), and paragraph (d) shall apply to those lot numbers and
261quantities of the prescription drug. In addition to the
262requirements of paragraph (d), any wholesale distributor selling
263a prescription drug included on a report filed pursuant to sub-
264sub-subparagraph (IV) shall provide any wholesaler purchasing
265the prescription drugs with a statement under oath that the
266prescription drugs are among those included on a report filed
267pursuant to sub-sub-subparagraph (IV) and with a copy of the
268report filed by the wholesale distributor with the department
269for those prescription drugs.
270     f.  Not less than annually, the council and department
271shall evaluate whether each prescription drug included on the
272list of specified drugs should remain on the list. In
273determining whether a prescription drug should remain on the
274list of specified drugs, the council and department must
275consider:
276     (I)  The availability of generic forms of the drug.
277     (II)  Changes in the price of the drug since the
278prescription drug was placed on the list.
279     (III)  The current status of the drug that caused the
280department to place the prescription drug on the list of
281specified drugs.
282
283The council shall provide a written recommendation adopted by
284majority vote to the secretary of the department concerning each
285drug that the council recommends be removed from the list of
286specified drugs.
287     4.  This paragraph does not apply to a manufacturer;
288however, a repackager must comply with this paragraph.
289     5.  This paragraph expires July 1, 2006.
290     (h)1.  This paragraph applies only to an affiliated group,
291as defined by s. 1504 of the Internal Revenue Code of 1986, as
292amended, which is composed of chain drug entities, including at
293least 50 retail pharmacies, warehouses, or repackagers, which
294are members of the same affiliated group, if the affiliated
295group:
296     a.  Discloses to the department the names of all its
297members; and
298     b.  Agrees in writing to provide records on prescription
299drug purchases by members of the affiliated group not later than
30048 hours after the department requests such records, regardless
301of the location where the records are stored.
302     2.  Each warehouse within the affiliated group must comply
303with all applicable federal and state drug wholesale permit
304requirements and must purchase, receive, hold, and distribute
305prescription drugs only to a retail pharmacy or warehouse within
306the affiliated group. Such a warehouse is exempt from providing
307a pedigree paper in accordance with paragraphs (d) and (e) to
308its affiliated group member warehouse, provided that:
309     a.  Any affiliated group member that purchases or receives
310a prescription drug from outside the affiliated group must
311receive a pedigree paper if the prescription drug is distributed
312in or into this state and a pedigree paper is required under
313this section and must authenticate the documentation as required
314in subsection (4), regardless of whether the affiliated group
315member is directly subject to regulation under this chapter; and
316     b.  The affiliated group makes available to the department
317on request all records related to the purchase or acquisition of
318prescription drugs by members of the affiliated group,
319regardless of the location where the records are stored, if the
320prescription drugs were distributed in or into this state.
321     3.  If a repackager repackages prescription drugs solely
322for distribution to its affiliated group members for the
323exclusive distribution to and among retail pharmacies that are
324members of the affiliated group to which the repackager is a
325member:
326     a.  The repackager must:
327     (I)  In lieu of the written statement required by paragraph
328(d) or paragraph (e), for all repackaged prescription drugs
329distributed in or into this state, state in writing under oath
330with each distribution of a repackaged prescription drug to an
331affiliated group member warehouse or repackager: "All repackaged
332prescription drugs are purchased by the affiliated group
333directly from the manufacturer or from a prescription drug
334wholesaler that purchased the prescription drugs directly from
335the manufacturer.";
336     (II)  Purchase all prescription drugs it repackages:
337     (A)  Directly from the manufacturer; or
338     (B)  From a prescription drug wholesaler that purchased the
339prescription drugs directly from the manufacturer; and
340     (III)  Maintain records in accordance with this section to
341document that it purchased the prescription drugs directly from
342the manufacturer or that its prescription drug wholesale
343supplier purchased the prescription drugs directly from the
344manufacturer.
345     b.  All members of the affiliated group must provide to
346agents of the department on request records of purchases by all
347members of the affiliated group of prescription drugs that have
348been repackaged, regardless of the location where the records
349are stored or where the repackager is located.
350     4.  This paragraph expires July 1, 2006.
351     Section 3.  This act shall take effect July 1, 2005.


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