Florida Senate - 2012 COMMITTEE AMENDMENT
Bill No. SB 1006
Barcode 416374
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
02/27/2012 .
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The Committee on Health Regulation (Norman) recommended the
following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Subsections (17), (19), (20), and (43) of
6 section 499.003, Florida Statutes, are amended to read:
7 499.003 Definitions of terms used in this part.—As used in
8 this part, the term:
9 (17) “Distribute” or “distribution” means to sell; offer to
10 sell; give away; transfer, whether by passage of title, physical
11 movement, or both; deliver; or offer to deliver. The term does
12 not mean to administer or dispense and does not include the
13 billing and invoicing activities that commonly follow a
14 wholesale distribution transaction.
15 (19) “Drug” means an article that is:
16 (a) Recognized in the current edition of the United States
17 Pharmacopoeia and National Formulary, official Homeopathic
18 Pharmacopoeia of the United States, or any supplement to any of
19 those publications;
20 (b) Intended for use in the diagnosis, cure, mitigation,
21 treatment, therapy, or prevention of disease in humans or other
22 animals;
23 (c) Intended to affect the structure or any function of the
24 body of humans or other animals; or
25 (d) Intended for use as a component of any article
26 specified in paragraph (a), paragraph (b), or paragraph (c), and
27 includes active pharmaceutical ingredients, but does not include
28 devices or their components, parts, or accessories. For purposes
29 of this paragraph, an “active pharmaceutical ingredient”
30 includes any substance or mixture of substances intended,
31 represented, or labeled for use in drug manufacturing that
32 furnishes or is intended to furnish, in a finished dosage form,
33 any pharmacological activity or other direct effect in the
34 diagnosis, cure, mitigation, treatment, therapy, or prevention
35 of disease in humans or other animals, or to affect the
36 structure or any function of the body of humans or other
37 animals.
38 (20) “Establishment” means a place of business which is at
39 one general physical location and may extend to one or more
40 contiguous suites, units, floors, or buildings operated and
41 controlled exclusively by entities under common operation and
42 control. Where multiple buildings are under common exclusive
43 ownership, operation, and control, an intervening thoroughfare
44 does not affect the contiguous nature of the buildings. For
45 purposes of permitting, each suite, unit, floor, or building
46 must be identified in the most recent permit application.
47 (43) “Prescription drug” means a prescription, medicinal,
48 or legend drug, including, but not limited to, finished dosage
49 forms or active pharmaceutical ingredients subject to, defined
50 by, or described by s. 503(b) of the Federal Food, Drug, and
51 Cosmetic Act or s. 465.003(8), s. 499.007(13), or subsection
52 (11), subsection (46), or subsection (53), except that an active
53 pharmaceutical ingredient is a prescription drug only if
54 substantially all finished dosage forms in which it may be
55 lawfully dispensed or administered in this state are also
56 prescription drugs.
57 Section 2. Paragraphs (c) and (e) of subsection (2) of
58 section 499.01, Florida Statutes, are amended, and subsection
59 (3) is added to that section, to read:
60 499.01 Permits.—
61 (2) The following permits are established:
62 (c) Nonresident prescription drug manufacturer permit.—A
63 nonresident prescription drug manufacturer permit is required
64 for any person that is a manufacturer of prescription drugs,
65 unless permitted as a third party logistics provider, located
66 outside of this state or outside the United States and that
67 engages in the wholesale distribution in this state of such
68 prescription drugs. Each such manufacturer must be permitted by
69 the department and comply with all of the provisions required of
70 a wholesale distributor under this part, except s. 499.01212.
71 1. A person that distributes prescription drugs for which
72 the person is not the manufacturer must also obtain an out-of
73 state prescription drug wholesale distributor permit or third
74 party logistics provider permit pursuant to this section to
75 engage in the wholesale distribution of such prescription drugs.
76 This subparagraph does not apply to a manufacturer as defined in
77 s. 499.003(31)(e).
78 2. Any such person must comply with the licensing or
79 permitting requirements of the jurisdiction in which the
80 establishment is located and the federal act, and any product
81 wholesaled into this state must comply with this part. If a
82 person intends to import prescription drugs from a foreign
83 country into this state, the nonresident prescription drug
84 manufacturer must provide to the department a list identifying
85 each prescription drug it intends to import and document
86 approval by the United States Food and Drug Administration for
87 such importation.
88 3. A nonresident prescription drug manufacturer permit is
89 not required for a manufacturer to distribute a prescription
90 drug active pharmaceutical ingredient that it manufactures to a
91 prescription drug manufacturer permitted in this state in
92 limited quantities intended for research and development and not
93 for resale, or human use other than lawful clinical trials and
94 biostudies authorized and regulated by federal law. A
95 manufacturer claiming to be exempt from the permit requirements
96 of this subparagraph and the prescription drug manufacturer
97 purchasing and receiving the active pharmaceutical ingredient
98 shall comply with the recordkeeping requirements of s.
99 499.0121(6), but not the requirements of s. 499.01212. The
100 prescription drug manufacturer purchasing and receiving the
101 active pharmaceutical ingredient shall maintain on file a record
102 of the FDA registration number; the out-of-state license,
103 permit, or registration number; and, if available, a copy of the
104 most current FDA inspection report, for all manufacturers from
105 whom they purchase active pharmaceutical ingredients under this
106 section. The department shall specify by rule the allowable
107 number of transactions within a given period of time and the
108 amount of active pharmaceutical ingredients that qualify as
109 limited quantities for purposes of this exemption. The failure
110 to comply with the requirements of this subparagraph, or rules
111 adopted by the department to administer this subparagraph, for
112 the purchase of prescription drug active pharmaceutical
113 ingredients is a violation of s. 499.005(14).
114 (e) Out-of-state prescription drug wholesale distributor
115 permit.—An out-of-state prescription drug wholesale distributor
116 is a wholesale distributor located outside this state which
117 engages in the wholesale distribution of prescription drugs into
118 this state and which must be permitted by the department and
119 comply with all the provisions required of a wholesale
120 distributor under this part. An out-of-state prescription drug
121 wholesale distributor that applies to the department for a new
122 permit or the renewal of a permit must submit a bond of
123 $100,000, or other equivalent means of security acceptable to
124 the department, such as an irrevocable letter of credit or a
125 deposit in a trust account or financial institution, payable to
126 the Florida Drug, Device, and Cosmetic Trust Fund. The purpose
127 of the bond is to secure payment of any administrative penalties
128 imposed by the department and any fees and costs incurred by the
129 department regarding that permit which are authorized under
130 state law and which the permittee fails to pay 30 days after the
131 fine or costs become final. The department may make a claim
132 against such bond or security until 1 year after the permittee’s
133 license ceases to be valid or until 60 days after any
134 administrative or legal proceeding authorized in this part which
135 involves the permittee is concluded, including any appeal,
136 whichever occurs later.
137 1. The out-of-state prescription drug wholesale distributor
138 must maintain at all times a license or permit to engage in the
139 wholesale distribution of prescription drugs in compliance with
140 laws of the state in which it is a resident.
141 2. An out-of-state prescription drug wholesale distributor
142 permit is not required for an intracompany sale or transfer of a
143 prescription drug from an out-of-state establishment that is
144 duly licensed as a prescription drug wholesale distributor, in
145 its state of residence, to a licensed prescription drug
146 wholesale distributor in this state, if both wholesale
147 distributors conduct wholesale distributions of prescription
148 drugs under the same business name. The recordkeeping
149 requirements of ss. 499.0121(6) and 499.01212 must be followed
150 for this transaction.
151 (3)(a) A permit issued under this part is not required to
152 distribute a prescription drug active pharmaceutical ingredient
153 from an establishment located in the United States to an
154 establishment located in this state permitted as a prescription
155 drug manufacturer under this part for use by the recipient in
156 preparing, deriving, processing, producing, or fabricating a
157 prescription drug finished dosage form at the establishment in
158 this state where the product is received under an approved and
159 otherwise valid New Drug Approval Application, Abbreviated New
160 Drug Application, New Animal Drug Application, or Therapeutic
161 Biologic Application, provided that the application, active
162 pharmaceutical ingredient, or finished dosage form has not been
163 withdrawn or removed from the market in this country for public
164 health reasons.
165 1. Any distributor claiming exemption from permitting
166 requirements pursuant to this paragraph shall maintain a
167 license, permit, or registration to engage in the wholesale
168 distribution of prescription drugs under the laws of the state
169 from which the product is distributed.
170 2. Any distributor claiming exemption from permitting
171 requirements pursuant to this paragraph and the prescription
172 drug manufacturer purchasing and receiving the active
173 pharmaceutical ingredient shall comply with the recordkeeping
174 requirements of s. 499.0121(6), but not the requirements of s.
175 499.01212.
176 (b) A permit issued under this part is not required to
177 distribute limited quantities of a prescription drug that has
178 not been repackaged from an establishment located in the United
179 States to an establishment located in this state permitted as a
180 prescription drug manufacturer under this part for research and
181 development or to a holder of a letter of exemption issued by
182 the department under s. 499.03(4) for research, teaching, or
183 testing. The department shall define “limited quantities” by
184 rule and may include the allowable number of transactions within
185 a given period of time and the amounts of prescription drugs
186 distributed into the state for purposes of this exemption.
187 1. Any distributor claiming exemption from permitting
188 requirements pursuant to this paragraph shall maintain a
189 license, permit, or registration to engage in the wholesale
190 distribution of prescription drugs under the laws of the state
191 from which the product is distributed.
192 2. All purchasers and recipients of any prescription drugs
193 distributed pursuant to this paragraph shall ensure that the
194 products are not resold or used, directly or indirectly, on
195 humans except in lawful clinical trials and biostudies
196 authorized and regulated by federal law.
197 3. Any distributor claiming exemption from permitting
198 requirements pursuant to this paragraph, and the purchaser and
199 recipient of the prescription drug, shall comply with the
200 recordkeeping requirements of s. 499.0121(6), but not the
201 requirements of s. 499.01212.
202 4. The immediate package or container of any active
203 pharmaceutical ingredient distributed into the state that is
204 intended for teaching, testing, research, and development shall
205 bear a label prominently displaying the statement: “Caution:
206 Research, Teaching, or Testing Only – Not for Manufacturing,
207 Compounding, or Resale.”
208 (c) An out-of-state prescription drug wholesale distributor
209 permit is not required for an intracompany sale or transfer of a
210 prescription drug from an out-of-state establishment that is
211 duly licensed as a prescription drug wholesale distributor in
212 its state of residence to a licensed prescription drug wholesale
213 distributor in this state, if both wholesale distributors
214 conduct wholesale distributions of prescription drugs under the
215 same business name. The recordkeeping requirements of ss.
216 499.0121(6) and 499.01212 must be followed for such
217 transactions.
218 (d) Persons receiving prescription drugs from a source
219 claimed to be exempt from permitting requirements under this
220 subsection shall maintain on file:
221 1. A record of the FDA establishment registration number,
222 if any;
223 2. The resident state prescription drug wholesale
224 distribution license, permit, or registration number; and
225 3. A copy of the most recent resident state or FDA
226 inspection report, for all distributors and establishments whom
227 they purchase or receive prescription drugs under this
228 subsection.
229 (e) All persons claiming exemption from permitting
230 requirements pursuant to this subsection who engage in the
231 distribution of prescription drugs within or into the state are
232 subject to this part, including ss. 499.005 and 499.0051, and
233 shall make available, within 48 hours, to the department on
234 request all records related to any prescription drugs
235 distributed under this subsection, including those records
236 described in s. 499.051(4), regardless of the location where the
237 records are stored.
238 (f) A person purchasing and receiving a prescription drug
239 from a person claimed to be exempt from licensing requirements
240 pursuant to this subsection shall report to the department in
241 writing within 14 days after receiving any product that is
242 misbranded or adulterated or that fails to meet minimum
243 standards set forth in the official compendium or state or
244 federal good manufacturing practices for identity, purity,
245 potency, or sterility, regardless of whether the product is
246 thereafter rehabilitated, quarantined, returned, or destroyed.
247 (g) The department may adopt rules to administer this
248 subsection which are necessary for the protection of the public
249 health, safety, and welfare. Failure to comply with the
250 requirements of this subsection, or rules adopted by the
251 department to administer this subsection, is a violation of s.
252 499.005(14), and a knowing failure is a violation of s.
253 499.0051(4).
254 (h) This subsection does not relieve any person from any
255 requirement prescribed by law with respect to controlled
256 substances as defined in the applicable federal and state laws.
257 Section 3. This act shall take effect July 1, 2012.
258
259 ================= T I T L E A M E N D M E N T ================
260 And the title is amended as follows:
261 Delete everything before the enacting clause
262 and insert:
263 A bill to be entitled
264 An act relating to prescription drug wholesale
265 regulations; amending s. 499.003, F.S.; revising the
266 definitions of the terms “distribute” or
267 “distribution,” “drug,” “establishment,” and
268 “prescription drug”; amending s. 499.01, F.S.;
269 deleting provisions relating to an exemption from
270 nonresident prescription drug manufacturer permit
271 requirements; deleting provisions relating to an
272 exemption from out-of-state prescription drug
273 wholesale distributor permit requirements for
274 intracompany sale or transfer of prescription drugs;
275 providing an exemption from permit requirements for
276 the distribution into this state of prescription drug
277 active pharmaceutical ingredients for incorporation
278 into prescription drugs in finished dosage form;
279 requiring a distributor claiming such exemption to
280 maintain a valid license, permit, or registration in
281 the state from which the prescription drug was
282 distributed; requiring compliance with certain
283 recordkeeping requirements; exempting compliance with
284 pedigree paper requirements; providing an exemption
285 from permit requirements for distribution into this
286 state of limited quantities of a prescription drug
287 that has not been repackaged, for research and
288 development or to a holder of a letter of exemption
289 issued by the Department of Business and Professional
290 Regulation for research, teaching, or testing;
291 granting the department authority to define “limited
292 quantities” by rule and limit therein the number of
293 transactions and amount of prescription drugs
294 distributed into the state; requiring a distributor
295 claiming such exemption to maintain a valid license,
296 permit, or registration in the state from which the
297 prescription drug was distributed; requiring all
298 purchasers and recipients of such prescription drugs
299 to ensure the products are not resold or used on
300 humans except in lawful clinical trials and
301 biostudies; requiring compliance with certain
302 recordkeeping requirements; exempting compliance from
303 pedigree paper requirements; providing labeling
304 requirements for active pharmaceutical ingredients
305 distributed within the state for teaching, testing,
306 research, and development; exempting from out-of-state
307 prescription drug wholesale distributor permit
308 requirements intracompany transactions or the sale of
309 prescription drugs from an out-of-state distributor to
310 a distributor in this state if both distributors
311 conduct wholesale distributions under the same
312 business name; requiring compliance with recordkeeping
313 and pedigree paper requirements; allowing distributors
314 and recipients of prescription drugs claiming
315 exemption from certain permitting requirements to
316 maintain on file their FDA registration number,
317 resident state distributor license or permit number,
318 and most recent resident state or FDA inspection
319 report; providing that persons claiming such
320 exemptions are subject to part I of chapter 499, F.S.,
321 the Florida Drug and Cosmetic Act; requiring persons
322 claiming such exemptions to make all records regarding
323 prescription drug distribution available to the
324 department, upon request, within 48 hours; requiring
325 submission of a report of mishandled or adulterated
326 prescription drugs within 14 days after receipt of
327 such drugs; authorizing the department to adopt rules;
328 providing that failure to comply with requirements or
329 rules governing such exemptions constitutes unlawful
330 purchase or receipt of a prescription drug from a
331 person not authorized to distribute prescription drugs
332 to that purchaser or recipient; providing that knowing
333 failure to comply with such requirements constitutes
334 unlawful sale, distribution, purchase, trade, holding,
335 or offering of a drug; providing penalties; providing
336 construction with respect to federal and state laws
337 relating to controlled substances; providing an
338 effective date.