Florida Senate - 2009 SENATOR AMENDMENT
Bill No. CS for CS for SB 1144
Barcode 894876
LEGISLATIVE ACTION
Senate . House
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Floor: WD/2R .
04/23/2009 09:16 AM .
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Senator Peaden moved the following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Subsection (31) of section 499.003, Florida
6 Statutes, is amended to read:
7 499.003 Definitions of terms used in this part.—As used in
8 this part, the term:
9 (31) “Manufacturer” means:
10 (a) A person who prepares, derives, manufactures, or
11 produces a drug, device, or cosmetic;.
12 (b) The holder or holders of a New Drug Application (NDA),
13 an Abbreviated New Drug Application (ANDA), a Biologics License
14 Application (BLA), or a New Animal Drug Application (NADA),
15 provided such application has become effective or is otherwise
16 approved consistent with s. 499.023;
17 (c) A private label distributor for whom the private label
18 distributor’s prescription drugs are originally manufactured and
19 labeled for the distributor and have not been repackaged; or the
20 distribution point for the manufacturer, contract manufacturer,
21 or private label distributor whether the establishment is a
22 member of the manufacturer’s affiliated group or is a contract
23 distribution site.
24 (d) A person registered under the federal act as a
25 manufacturer of a precription drug, who is described in
26 paragraph (a), paragraph (b), or paragraph (c), who has entered
27 into a written agreement with another prescription drug
28 manufacturer that authorizes either manufacturer to distribute
29 the prescription drug identified in the agreement as the
30 manufacturer of that drug consistent with the federal act and
31 its implementing regulations;
32 (e) A member of an affiliated group that includes, but is
33 not limited to, persons described in paragraph (a), paragraph
34 (b), paragraph (c), or paragraph (d), which member distributes
35 prescription drugs, whether or not obtaining title to the drugs,
36 only for the manufacturer of the drugs who is also a member of
37 the affiliated group. As used in this paragraph, the term
38 “affiliated group” means an affiliated group as defined in s.
39 1504 of the Internal Revenue Code of 1986, as amended. The
40 manufacturer must disclose the names of all of its affiliated
41 group members to the department; or
42 (f) A person permitted as a third party logistics provider,
43 only while providing warehousing, distribution, or other
44 logistics services on behalf of a person described in paragraph
45 (a), paragraph (b), paragraph (c), paragraph (d), or paragraph
46 (e).
47 The term does not include a pharmacy excludes pharmacies
48 that is are operating in compliance with pharmacy practice
49 standards as defined in chapter 465 and rules adopted under that
50 chapter.
51 Section 2. Paragraphs (a), (c), and (t) of subsection (2)
52 of section 499.01, Florida Statutes, are amended to read:
53 499.01 Permits.—
54 (2) The following permits are established:
55 (a) Prescription drug manufacturer permit.—A prescription
56 drug manufacturer permit is required for any person that is a
57 manufacturer of manufactures a prescription drug and that
58 manufactures or distributes such prescription drugs in this
59 state.
60 1. A person that operates an establishment permitted as a
61 prescription drug manufacturer may engage in wholesale
62 distribution of prescription drugs manufactured at that
63 establishment and must comply with all of the provisions of this
64 part, except s. 499.01212, and the rules adopted under this
65 part, except s. 499.01212, that apply to a wholesale
66 distributor.
67 2. A prescription drug manufacturer must comply with all
68 appropriate state and federal good manufacturing practices.
69 (c) Nonresident prescription drug manufacturer permit.—A
70 nonresident prescription drug manufacturer permit is required
71 for any person that is a manufacturer of prescription drugs, or
72 the distribution point for a manufacturer of prescription drugs
73 unless permitted as a third party logistics provider, and
74 located outside of this state, or that is an entity to whom an
75 approved new drug application has been issued by the United
76 States Food and Drug Administration, or the contracted
77 manufacturer of the approved new drug application holder, and
78 located outside the United States and that, which engages in the
79 wholesale distribution in this state of such the prescription
80 drugs it manufactures or is responsible for manufacturing. Each
81 such manufacturer or entity must be permitted by the department
82 and comply with all of the provisions required of a wholesale
83 distributor under this part, except s. 499.01212.
84 1. A person that distributes prescription drugs for which
85 the person is not the manufacturer that it did not manufacture
86 must also obtain an out-of-state prescription drug wholesale
87 distributor permit or third party logistics provider permit
88 pursuant to this section to engage in the wholesale distribution
89 of such the prescription drugs manufactured by another person
90 and comply with the requirements of an out-of-state prescription
91 drug wholesale distributor. This subparagraph does not apply to
92 a manufacturer as defined in s. 499.003(31)(e).
93 2. Any such person must comply with the licensing or
94 permitting requirements of the jurisdiction in which the
95 establishment is located and the federal act, and any product
96 wholesaled into this state must comply with this part. If a
97 person intends to import prescription drugs from a foreign
98 country into this state, the nonresident prescription drug
99 manufacturer must provide to the department a list identifying
100 each prescription drug it intends to import and document
101 approval by the United States Food and Drug Administration for
102 such importation.
103 3. A nonresident prescription drug manufacturer permit is
104 not required for a manufacturer to distribute a prescription
105 drug active pharmaceutical ingredient that it manufactures to a
106 prescription drug manufacturer permitted in this state in
107 limited quantities intended for research and development and not
108 for resale, or human use other than lawful clinical trials and
109 biostudies authorized and regulated by federal law. A
110 manufacturer claiming to be exempt from the permit requirements
111 of this subparagraph and the prescription drug manufacturer
112 purchasing and receiving the active pharmaceutical ingredient
113 shall comply with the recordkeeping requirements of s.
114 499.0121(6), but not the requirements of s. 499.01212. The
115 prescription drug manufacturer purchasing and receiving the
116 active pharmaceutical ingredient shall maintain on file a record
117 of the FDA registration number; the out-of-state license,
118 permit, or registration number; and, if available, a copy of the
119 most current FDA inspection report, for all manufacturers from
120 whom they purchase active pharmaceutical ingredients under this
121 section. The department shall specify by rule the allowable
122 number of transactions within a given period of time and the
123 amount of active pharmaceutical ingredients that qualify as
124 limited quantities for purposes of this exemption. The failure
125 to comply with the requirements of this subparagraph, or rules
126 adopted by the department to administer this subparagraph, for
127 the purchase of prescription drug active pharmaceutical
128 ingredients is a violation of s. 499.005(14).
129 (t) Health care clinic establishment permit.—Effective
130 January 1, 2009, a health care clinic establishment permit is
131 required for the purchase of a prescription drug by a place of
132 business at one general physical location that provides health
133 care or veterinary services, which is owned and operated by a
134 business entity that has been issued a federal employer tax
135 identification number professional corporation or professional
136 limited liability company described in chapter 621, or a
137 corporation that employs a veterinarian as a qualifying
138 practitioner. For the purpose of this paragraph, the term
139 “qualifying practitioner” means a licensed health care
140 practitioner defined in s. 456.001, or a veterinarian licensed
141 under chapter 474, who is authorized under the appropriate
142 practice act to prescribe and administer a prescription drug.
143 1. An establishment must provide, as part of the
144 application required under s. 499.012, designation of a
145 qualifying practitioner who will be responsible for complying
146 with all legal and regulatory requirements related to the
147 purchase, recordkeeping, storage, and handling of the
148 prescription drugs. In addition, the designated qualifying
149 practitioner shall be the practitioner whose name, establishment
150 address, and license number is used on all distribution
151 documents for prescription drugs purchased or returned by the
152 health care clinic establishment. Upon initial appointment of a
153 qualifying practitioner, the qualifying practitioner and the
154 health care clinic establishment shall notify the department on
155 a form furnished by the department within 10 days after such
156 employment. In addition, the qualifying practitioner and health
157 care clinic establishment shall notify the department within 10
158 days after any subsequent change.
159 2. The health care clinic establishment must employ a
160 qualifying practitioner at each establishment.
161 3. In addition to the remedies and penalties provided in
162 this part, a violation of this chapter by the health care clinic
163 establishment or qualifying practitioner constitutes grounds for
164 discipline of the qualifying practitioner by the appropriate
165 regulatory board.
166 4. The purchase of prescription drugs by the health care
167 clinic establishment is prohibited during any period of time
168 when the establishment does not comply with this paragraph.
169 5. A health care clinic establishment permit is not a
170 pharmacy permit or otherwise subject to chapter 465. A health
171 care clinic establishment that meets the criteria of a modified
172 Class II institutional pharmacy under s. 465.019 is not eligible
173 to be permitted under this paragraph.
174 6. This paragraph does not apply to the purchase of a
175 prescription drug by prohibit a licensed qualifying practitioner
176 under his or her license from purchasing prescription drugs.
177 Section 3. Paragraph (e) of subsection (6) of section
178 499.0121, Florida Statutes, is amended to read:
179 499.0121 Storage and handling of prescription drugs;
180 recordkeeping.—The department shall adopt rules to implement
181 this section as necessary to protect the public health, safety,
182 and welfare. Such rules shall include, but not be limited to,
183 requirements for the storage and handling of prescription drugs
184 and for the establishment and maintenance of prescription drug
185 distribution records.
186 (6) RECORDKEEPING.—The department shall adopt rules that
187 require keeping such records of prescription drugs as are
188 necessary for the protection of the public health.
189 (e) When pedigree papers are required by this part, a
190 wholesale distributor must maintain the pedigree papers separate
191 and distinct from other records required under this part
192 chapter.
193 Section 4. Paragraph (b) of subsection (2) of section
194 499.01212, Florida Statutes, is amended to read:
195 499.01212 Pedigree paper.—
196 (2) FORMAT.—A pedigree paper must contain the following
197 information:
198 (b) For all other wholesale distributions of prescription
199 drugs:
200 1. The quantity, dosage form, and strength of the
201 prescription drugs.
202 2. The lot numbers of the prescription drugs.
203 3. The name and address of each owner of the prescription
204 drug and his or her signature.
205 4. Shipping information, including the name and address of
206 each person certifying delivery or receipt of the prescription
207 drug.
208 5. An invoice number, a shipping document number, or
209 another number uniquely identifying the transaction.
210 6. A certification that the recipient wholesale distributor
211 has authenticated the pedigree papers.
212 7. The unique serialization of the prescription drug, if
213 the manufacturer or repackager has uniquely serialized the
214 individual prescription drug unit.
215 8. The name, address, telephone number, and, if available,
216 e-mail contact information of each wholesale distributor
217 involved in the chain of the prescription drug’s custody.
218
219 When an affiliated group member obtains title to a prescription
220 drug prior to distributing the prescription drug as the
221 manufacturer under s. 499.003(31)(e), information regarding the
222 distribution between those affiliated group members may be
223 omitted from a pedigree paper required under this paragraph for
224 subsequent distributions of that prescription drug.
225 Section 5. This act shall take effect October 1, 2009.
226
227 ================= T I T L E A M E N D M E N T ================
228 And the title is amended as follows:
229 Delete everything before the enacting clause
230 and insert:
231 A bill to be entitled
232 An act relating to prescription drugs; amending s.
233 499.003, F.S.; revising the definition of the term
234 “manufacturer” for purposes of the Florida Drug and
235 Cosmetic Act; requiring certain manufacturers to
236 disclose the names of affiliated group members to the
237 Department of Health; amending s. 499.01, F.S.;
238 revising requirements for a prescription drug
239 manufacturer permit, nonresident prescription drug
240 manufacturer permit, and health care clinic
241 establishment permit; amending s. 499.0121, F.S.;
242 requiring a wholesale distributor to maintain pedigree
243 papers separately from other records of prescription
244 drugs under certain circumstances; amending
245 s. 499.01212, F.S.; revising requirements for a
246 pedigree paper; providing an effective date.