CS for CS for SB 1144 First Engrossed
20091144e1
1 A bill to be entitled
2 An act relating to prescription drugs; amending s.
3 499.003, F.S.; revising the definition of the term
4 “manufacturer” for purposes of the Florida Drug and
5 Cosmetic Act; requiring certain manufacturers to
6 disclose the names of affiliated group members to the
7 Department of Health; amending s. 499.01, F.S.;
8 revising requirements for a prescription drug
9 manufacturer permit, nonresident prescription drug
10 manufacturer permit, and health care clinic
11 establishment permit; amending s. 499.0121, F.S.;
12 clarifying that a wholesale distributor is required to
13 maintain pedigree papers separately from other records
14 of prescription drugs under certain circumstances;
15 amending s. 499.01212, F.S.; revising requirements for
16 a pedigree paper; providing an effective date.
17
18 Be It Enacted by the Legislature of the State of Florida:
19
20 Section 1. Subsection (31) of section 499.003, Florida
21 Statutes, is amended to read:
22 499.003 Definitions of terms used in this part.—As used in
23 this part, the term:
24 (31) “Manufacturer” means:
25 (a) A person who prepares, derives, manufactures, or
26 produces a drug, device, or cosmetic;.
27 (b) The holder or holders of a New Drug Application (NDA),
28 an Abbreviated New Drug Application (ANDA), a Biologics License
29 Application (BLA), or a New Animal Drug Application (NADA),
30 provided such application has become effective or is otherwise
31 approved consistent with s. 499.023;
32 (c) A private label distributor for whom the private label
33 distributor’s prescription drugs are originally manufactured and
34 labeled for the distributor and have not been repackaged; or the
35 distribution point for the manufacturer, contract manufacturer,
36 or private label distributor whether the establishment is a
37 member of the manufacturer’s affiliated group or is a contract
38 distribution site.
39 (d) A person registered under the federal act as a
40 manufacturer of a prescription drug, who is described in
41 paragraph (a), paragraph (b), or paragraph (c), who has entered
42 into a written agreement with another prescription drug
43 manufacturer that authorizes either manufacturer to distribute
44 the prescription drug identified in the agreement as the
45 manufacturer of that drug consistent with the federal act and
46 its implementing regulations;
47 (e) A member of an affiliated group that includes, but is
48 not limited to, persons described in paragraph (a), paragraph
49 (b), paragraph (c), or paragraph (d), which member distributes
50 prescription drugs, whether or not obtaining title to the drugs,
51 only for the manufacturer of the drugs who is also a member of
52 the affiliated group. As used in this paragraph, the term
53 “affiliated group” means an affiliated group as defined in s.
54 1504 of the Internal Revenue Code of 1986, as amended. The
55 manufacturer must disclose the names of all of its affiliated
56 group members to the department; or
57 (f) A person permitted as a third party logistics provider,
58 only while providing warehousing, distribution, or other
59 logistics services on behalf of a person described in paragraph
60 (a), paragraph (b), paragraph (c), paragraph (d), or paragraph
61 (e).
62
63 The term does not include a pharmacy excludes pharmacies that is
64 are operating in compliance with pharmacy practice standards as
65 defined in chapter 465 and rules adopted under that chapter.
66 Section 2. Paragraphs (a), (c), and (t) of subsection (2)
67 of section 499.01, Florida Statutes, are amended to read:
68 499.01 Permits.—
69 (2) The following permits are established:
70 (a) Prescription drug manufacturer permit.—A prescription
71 drug manufacturer permit is required for any person that is a
72 manufacturer of manufactures a prescription drug and that
73 manufactures or distributes such prescription drugs in this
74 state.
75 1. A person that operates an establishment permitted as a
76 prescription drug manufacturer may engage in wholesale
77 distribution of prescription drugs manufactured at that
78 establishment and must comply with all of the provisions of this
79 part, except s. 499.01212, and the rules adopted under this
80 part, except s. 499.01212, that apply to a wholesale
81 distributor.
82 2. A prescription drug manufacturer must comply with all
83 appropriate state and federal good manufacturing practices.
84 (c) Nonresident prescription drug manufacturer permit.—A
85 nonresident prescription drug manufacturer permit is required
86 for any person that is a manufacturer of prescription drugs, or
87 the distribution point for a manufacturer of prescription drugs
88 unless permitted as a third party logistics provider, and
89 located outside of this state, or that is an entity to whom an
90 approved new drug application has been issued by the United
91 States Food and Drug Administration, or the contracted
92 manufacturer of the approved new drug application holder, and
93 located outside the United States and that, which engages in the
94 wholesale distribution in this state of such the prescription
95 drugs it manufactures or is responsible for manufacturing. Each
96 such manufacturer or entity must be permitted by the department
97 and comply with all of the provisions required of a wholesale
98 distributor under this part, except s. 499.01212.
99 1. A person that distributes prescription drugs for which
100 the person is not the manufacturer that it did not manufacture
101 must also obtain an out-of-state prescription drug wholesale
102 distributor permit or third party logistics provider permit
103 pursuant to this section to engage in the wholesale distribution
104 of such the prescription drugs manufactured by another person
105 and comply with the requirements of an out-of-state prescription
106 drug wholesale distributor. This subparagraph does not apply to
107 a manufacturer as defined in s. 499.003(31)(e).
108 2. Any such person must comply with the licensing or
109 permitting requirements of the jurisdiction in which the
110 establishment is located and the federal act, and any product
111 wholesaled into this state must comply with this part. If a
112 person intends to import prescription drugs from a foreign
113 country into this state, the nonresident prescription drug
114 manufacturer must provide to the department a list identifying
115 each prescription drug it intends to import and document
116 approval by the United States Food and Drug Administration for
117 such importation.
118 3. A nonresident prescription drug manufacturer permit is
119 not required for a manufacturer to distribute a prescription
120 drug active pharmaceutical ingredient that it manufactures to a
121 prescription drug manufacturer permitted in this state in
122 limited quantities intended for research and development and not
123 for resale, or human use other than lawful clinical trials and
124 biostudies authorized and regulated by federal law. A
125 manufacturer claiming to be exempt from the permit requirements
126 of this subparagraph and the prescription drug manufacturer
127 purchasing and receiving the active pharmaceutical ingredient
128 shall comply with the recordkeeping requirements of s.
129 499.0121(6), but not the requirements of s. 499.01212. The
130 prescription drug manufacturer purchasing and receiving the
131 active pharmaceutical ingredient shall maintain on file a record
132 of the FDA registration number; the out-of-state license,
133 permit, or registration number; and, if available, a copy of the
134 most current FDA inspection report, for all manufacturers from
135 whom they purchase active pharmaceutical ingredients under this
136 section. The department shall specify by rule the allowable
137 number of transactions within a given period of time and the
138 amount of active pharmaceutical ingredients that qualify as
139 limited quantities for purposes of this exemption. The failure
140 to comply with the requirements of this subparagraph, or rules
141 adopted by the department to administer this subparagraph, for
142 the purchase of prescription drug active pharmaceutical
143 ingredients is a violation of s. 499.005(14).
144 (t) Health care clinic establishment permit.—Effective
145 January 1, 2009, a health care clinic establishment permit is
146 required for the purchase of a prescription drug by a place of
147 business at one general physical location that provides health
148 care or veterinary services, which is owned and operated by a
149 business entity that has been issued a federal employer tax
150 identification number professional corporation or professional
151 limited liability company described in chapter 621, or a
152 corporation that employs a veterinarian as a qualifying
153 practitioner. For the purpose of this paragraph, the term
154 “qualifying practitioner” means a licensed health care
155 practitioner defined in s. 456.001, or a veterinarian licensed
156 under chapter 474, who is authorized under the appropriate
157 practice act to prescribe and administer a prescription drug.
158 1. An establishment must provide, as part of the
159 application required under s. 499.012, designation of a
160 qualifying practitioner who will be responsible for complying
161 with all legal and regulatory requirements related to the
162 purchase, recordkeeping, storage, and handling of the
163 prescription drugs. In addition, the designated qualifying
164 practitioner shall be the practitioner whose name, establishment
165 address, and license number is used on all distribution
166 documents for prescription drugs purchased or returned by the
167 health care clinic establishment. Upon initial appointment of a
168 qualifying practitioner, the qualifying practitioner and the
169 health care clinic establishment shall notify the department on
170 a form furnished by the department within 10 days after such
171 employment. In addition, the qualifying practitioner and health
172 care clinic establishment shall notify the department within 10
173 days after any subsequent change.
174 2. The health care clinic establishment must employ a
175 qualifying practitioner at each establishment.
176 3. In addition to the remedies and penalties provided in
177 this part, a violation of this chapter by the health care clinic
178 establishment or qualifying practitioner constitutes grounds for
179 discipline of the qualifying practitioner by the appropriate
180 regulatory board.
181 4. The purchase of prescription drugs by the health care
182 clinic establishment is prohibited during any period of time
183 when the establishment does not comply with this paragraph.
184 5. A health care clinic establishment permit is not a
185 pharmacy permit or otherwise subject to chapter 465. A health
186 care clinic establishment that meets the criteria of a modified
187 Class II institutional pharmacy under s. 465.019 is not eligible
188 to be permitted under this paragraph.
189 6. This paragraph does not apply to the purchase of a
190 prescription drug by prohibit a licensed qualifying practitioner
191 under his or her license from purchasing prescription drugs.
192 Section 3. Paragraph (e) of subsection (6) of section
193 499.0121, Florida Statutes, is amended to read:
194 499.0121 Storage and handling of prescription drugs;
195 recordkeeping.—The department shall adopt rules to implement
196 this section as necessary to protect the public health, safety,
197 and welfare. Such rules shall include, but not be limited to,
198 requirements for the storage and handling of prescription drugs
199 and for the establishment and maintenance of prescription drug
200 distribution records.
201 (6) RECORDKEEPING.—The department shall adopt rules that
202 require keeping such records of prescription drugs as are
203 necessary for the protection of the public health.
204 (e) When pedigree papers are required by this part, a
205 wholesale distributor must maintain the pedigree papers separate
206 and distinct from other records required under this part
207 chapter.
208 Section 4. Paragraph (b) of subsection (2) of section
209 499.01212, Florida Statutes, is amended to read:
210 499.01212 Pedigree paper.—
211 (2) FORMAT.—A pedigree paper must contain the following
212 information:
213 (b) For all other wholesale distributions of prescription
214 drugs:
215 1. The quantity, dosage form, and strength of the
216 prescription drugs.
217 2. The lot numbers of the prescription drugs.
218 3. The name and address of each owner of the prescription
219 drug and his or her signature.
220 4. Shipping information, including the name and address of
221 each person certifying delivery or receipt of the prescription
222 drug.
223 5. An invoice number, a shipping document number, or
224 another number uniquely identifying the transaction.
225 6. A certification that the recipient wholesale distributor
226 has authenticated the pedigree papers.
227 7. The unique serialization of the prescription drug, if
228 the manufacturer or repackager has uniquely serialized the
229 individual prescription drug unit.
230 8. The name, address, telephone number, and, if available,
231 e-mail contact information of each wholesale distributor
232 involved in the chain of the prescription drug’s custody.
233
234 When an affiliated group member obtains title to a prescription
235 drug before distributing the prescription drug as the
236 manufacturer under s. 499.003(31)(e), information regarding the
237 distribution between those affiliated group members may be
238 omitted from a pedigree paper required under this paragraph for
239 subsequent distributions of that prescription drug.
240 Section 5. This act shall take effect October 1, 2009.