Florida Senate - 2012 COMMITTEE AMENDMENT
Bill No. CS for SB 762
Barcode 749074
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
03/01/2012 .
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The Committee on Budget Subcommittee on General Government
Appropriations (Latvala) recommended the following:
1 Senate Amendment to Amendment (657172) (with title
2 amendment)
3
4 Delete line 687
5 and insert:
6 Section 33. Subsections (17), (19), (20), and (43) of
7 section 499.003, Florida Statutes, are amended to read:
8 499.003 Definitions of terms used in this part.—As used in
9 this part, the term:
10 (17) “Distribute” or “distribution” means to sell; offer to
11 sell; give away; transfer, whether by passage of title, physical
12 movement, or both; deliver; or offer to deliver. The term does
13 not mean to administer or dispense and does not include the
14 billing and invoicing activities that commonly follow a
15 wholesale distribution transaction.
16 (19) “Drug” means an article that is:
17 (a) Recognized in the current edition of the United States
18 Pharmacopoeia and National Formulary, official Homeopathic
19 Pharmacopoeia of the United States, or any supplement to any of
20 those publications;
21 (b) Intended for use in the diagnosis, cure, mitigation,
22 treatment, therapy, or prevention of disease in humans or other
23 animals;
24 (c) Intended to affect the structure or any function of the
25 body of humans or other animals; or
26 (d) Intended for use as a component of any article
27 specified in paragraph (a), paragraph (b), or paragraph (c), and
28 includes active pharmaceutical ingredients, but does not include
29 devices or their components, parts, or accessories. For purposes
30 of this paragraph, an “active pharmaceutical ingredient”
31 includes any substance or mixture of substances intended,
32 represented, or labeled for use in drug manufacturing that
33 furnishes or is intended to furnish, in a finished dosage form,
34 any pharmacological activity or other direct effect in the
35 diagnosis, cure, mitigation, treatment, therapy, or prevention
36 of disease in humans or other animals, or to affect the
37 structure or any function of the body of humans or other
38 animals.
39 (20) “Establishment” means a place of business which is at
40 one general physical location and may extend to one or more
41 contiguous suites, units, floors, or buildings operated and
42 controlled exclusively by entities under common operation and
43 control. Where multiple buildings are under common exclusive
44 ownership, operation, and control, an intervening thoroughfare
45 does not affect the contiguous nature of the buildings. For
46 purposes of permitting, each suite, unit, floor, or building
47 must be identified in the most recent permit application.
48 (43) “Prescription drug” means a prescription, medicinal,
49 or legend drug, including, but not limited to, finished dosage
50 forms or active pharmaceutical ingredients subject to, defined
51 by, or described by s. 503(b) of the Federal Food, Drug, and
52 Cosmetic Act or s. 465.003(8), s. 499.007(13), or subsection
53 (11), subsection (46), or subsection (53), except that an active
54 pharmaceutical ingredient is a prescription drug only if
55 substantially all finished dosage forms in which it may be
56 lawfully dispensed or administered in this state are also
57 prescription drugs.
58 Section 34. Paragraphs (c) and (e) of subsection (2) of
59 section 499.01, Florida Statutes, are amended, and subsection
60 (3) is added to that section, to read:
61 499.01 Permits.—
62 (2) The following permits are established:
63 (c) Nonresident prescription drug manufacturer permit.—A
64 nonresident prescription drug manufacturer permit is required
65 for any person that is a manufacturer of prescription drugs,
66 unless permitted as a third party logistics provider, located
67 outside of this state or outside the United States and that
68 engages in the wholesale distribution in this state of such
69 prescription drugs. Each such manufacturer must be permitted by
70 the department and comply with all of the provisions required of
71 a wholesale distributor under this part, except s. 499.01212.
72 1. A person that distributes prescription drugs for which
73 the person is not the manufacturer must also obtain an out-of
74 state prescription drug wholesale distributor permit or third
75 party logistics provider permit pursuant to this section to
76 engage in the wholesale distribution of such prescription drugs.
77 This subparagraph does not apply to a manufacturer as defined in
78 s. 499.003(31)(e).
79 2. Any such person must comply with the licensing or
80 permitting requirements of the jurisdiction in which the
81 establishment is located and the federal act, and any product
82 wholesaled into this state must comply with this part. If a
83 person intends to import prescription drugs from a foreign
84 country into this state, the nonresident prescription drug
85 manufacturer must provide to the department a list identifying
86 each prescription drug it intends to import and document
87 approval by the United States Food and Drug Administration for
88 such importation.
89 3. A nonresident prescription drug manufacturer permit is
90 not required for a manufacturer to distribute a prescription
91 drug active pharmaceutical ingredient that it manufactures to a
92 prescription drug manufacturer permitted in this state in
93 limited quantities intended for research and development and not
94 for resale, or human use other than lawful clinical trials and
95 biostudies authorized and regulated by federal law. A
96 manufacturer claiming to be exempt from the permit requirements
97 of this subparagraph and the prescription drug manufacturer
98 purchasing and receiving the active pharmaceutical ingredient
99 shall comply with the recordkeeping requirements of s.
100 499.0121(6), but not the requirements of s. 499.01212. The
101 prescription drug manufacturer purchasing and receiving the
102 active pharmaceutical ingredient shall maintain on file a record
103 of the FDA registration number; the out-of-state license,
104 permit, or registration number; and, if available, a copy of the
105 most current FDA inspection report, for all manufacturers from
106 whom they purchase active pharmaceutical ingredients under this
107 section. The department shall specify by rule the allowable
108 number of transactions within a given period of time and the
109 amount of active pharmaceutical ingredients that qualify as
110 limited quantities for purposes of this exemption. The failure
111 to comply with the requirements of this subparagraph, or rules
112 adopted by the department to administer this subparagraph, for
113 the purchase of prescription drug active pharmaceutical
114 ingredients is a violation of s. 499.005(14).
115 (e) Out-of-state prescription drug wholesale distributor
116 permit.—An out-of-state prescription drug wholesale distributor
117 is a wholesale distributor located outside this state which
118 engages in the wholesale distribution of prescription drugs into
119 this state and which must be permitted by the department and
120 comply with all the provisions required of a wholesale
121 distributor under this part. An out-of-state prescription drug
122 wholesale distributor that applies to the department for a new
123 permit or the renewal of a permit must submit a bond of
124 $100,000, or other equivalent means of security acceptable to
125 the department, such as an irrevocable letter of credit or a
126 deposit in a trust account or financial institution, payable to
127 the Florida Drug, Device, and Cosmetic Trust Fund. The purpose
128 of the bond is to secure payment of any administrative penalties
129 imposed by the department and any fees and costs incurred by the
130 department regarding that permit which are authorized under
131 state law and which the permittee fails to pay 30 days after the
132 fine or costs become final. The department may make a claim
133 against such bond or security until 1 year after the permittee’s
134 license ceases to be valid or until 60 days after any
135 administrative or legal proceeding authorized in this part which
136 involves the permittee is concluded, including any appeal,
137 whichever occurs later.
138 1. The out-of-state prescription drug wholesale distributor
139 must maintain at all times a license or permit to engage in the
140 wholesale distribution of prescription drugs in compliance with
141 laws of the state in which it is a resident.
142 2. An out-of-state prescription drug wholesale distributor
143 permit is not required for an intracompany sale or transfer of a
144 prescription drug from an out-of-state establishment that is
145 duly licensed as a prescription drug wholesale distributor, in
146 its state of residence, to a licensed prescription drug
147 wholesale distributor in this state, if both wholesale
148 distributors conduct wholesale distributions of prescription
149 drugs under the same business name. The recordkeeping
150 requirements of ss. 499.0121(6) and 499.01212 must be followed
151 for this transaction.
152 (3)(a) A permit issued under this part is not required to
153 distribute a prescription drug active pharmaceutical ingredient
154 from an establishment located in the United States to an
155 establishment located in this state permitted as a prescription
156 drug manufacturer under this part for use by the recipient in
157 preparing, deriving, processing, producing, or fabricating a
158 prescription drug finished dosage form at the establishment in
159 this state where the product is received under an approved and
160 otherwise valid New Drug Approval Application, Abbreviated New
161 Drug Application, New Animal Drug Application, or Therapeutic
162 Biologic Application, provided that the application, active
163 pharmaceutical ingredient, or finished dosage form has not been
164 withdrawn or removed from the market in this country for public
165 health reasons.
166 1. Any distributor claiming exemption from permitting
167 requirements pursuant to this paragraph shall maintain a
168 license, permit, or registration to engage in the wholesale
169 distribution of prescription drugs under the laws of the state
170 from which the product is distributed.
171 2. Any distributor claiming exemption from permitting
172 requirements pursuant to this paragraph and the prescription
173 drug manufacturer purchasing and receiving the active
174 pharmaceutical ingredient shall comply with the recordkeeping
175 requirements of s. 499.0121(6), but not the requirements of s.
176 499.01212.
177 (b) A permit issued under this part is not required to
178 distribute limited quantities of a prescription drug that has
179 not been repackaged from an establishment located in the United
180 States to an establishment located in this state permitted as a
181 prescription drug manufacturer under this part for research and
182 development or to a holder of a letter of exemption issued by
183 the department under s. 499.03(4) for research, teaching, or
184 testing. The department shall define “limited quantities” by
185 rule and may include the allowable number of transactions within
186 a given period of time and the amounts of prescription drugs
187 distributed into the state for purposes of this exemption.
188 1. Any distributor claiming exemption from permitting
189 requirements pursuant to this paragraph shall maintain a
190 license, permit, or registration to engage in the wholesale
191 distribution of prescription drugs under the laws of the state
192 from which the product is distributed.
193 2. All purchasers and recipients of any prescription drugs
194 distributed pursuant to this paragraph shall ensure that the
195 products are not resold or used, directly or indirectly, on
196 humans except in lawful clinical trials and biostudies
197 authorized and regulated by federal law.
198 3. Any distributor claiming exemption from permitting
199 requirements pursuant to this paragraph, and the purchaser and
200 recipient of the prescription drug, shall comply with the
201 recordkeeping requirements of s. 499.0121(6), but not the
202 requirements of s. 499.01212.
203 4. The immediate package or container of any active
204 pharmaceutical ingredient distributed into the state that is
205 intended for teaching, testing, research, and development shall
206 bear a label prominently displaying the statement: “Caution:
207 Research, Teaching, or Testing Only – Not for Manufacturing,
208 Compounding, or Resale.”
209 (c) An out-of-state prescription drug wholesale distributor
210 permit is not required for an intracompany sale or transfer of a
211 prescription drug from an out-of-state establishment that is
212 duly licensed as a prescription drug wholesale distributor in
213 its state of residence to a licensed prescription drug wholesale
214 distributor in this state, if both wholesale distributors
215 conduct wholesale distributions of prescription drugs under the
216 same business name. The recordkeeping requirements of ss.
217 499.0121(6) and 499.01212 must be followed for such
218 transactions.
219 (d) Persons receiving prescription drugs from a source
220 claimed to be exempt from permitting requirements under this
221 subsection shall maintain on file:
222 1. A record of the FDA establishment registration number,
223 if any;
224 2. The resident state prescription drug wholesale
225 distribution license, permit, or registration number; and
226 3. A copy of the most recent resident state or FDA
227 inspection report, for all distributors and establishments whom
228 they purchase or receive prescription drugs under this
229 subsection.
230 (e) All persons claiming exemption from permitting
231 requirements pursuant to this subsection who engage in the
232 distribution of prescription drugs within or into the state are
233 subject to this part, including ss. 499.005 and 499.0051, and
234 shall make available, within 48 hours, to the department on
235 request all records related to any prescription drugs
236 distributed under this subsection, including those records
237 described in s. 499.051(4), regardless of the location where the
238 records are stored.
239 (f) A person purchasing and receiving a prescription drug
240 from a person claimed to be exempt from licensing requirements
241 pursuant to this subsection shall report to the department in
242 writing within 14 days after receiving any product that is
243 misbranded or adulterated or that fails to meet minimum
244 standards set forth in the official compendium or state or
245 federal good manufacturing practices for identity, purity,
246 potency, or sterility, regardless of whether the product is
247 thereafter rehabilitated, quarantined, returned, or destroyed.
248 (g) The department may adopt rules to administer this
249 subsection which are necessary for the protection of the public
250 health, safety, and welfare. Failure to comply with the
251 requirements of this subsection, or rules adopted by the
252 department to administer this subsection, is a violation of s.
253 499.005(14), and a knowing failure is a violation of s.
254 499.0051(4).
255 (h) This subsection does not relieve any person from any
256 requirement prescribed by law with respect to controlled
257 substances as defined in the applicable federal and state laws.
258 Section 35. This act shall take effect July 1, 2012.
259
260 ================= T I T L E A M E N D M E N T ================
261 And the title is amended as follows:
262
263 Delete line 757
264 and insert:
265
266 amending s. 499.003, F.S.; revising the definitions of
267 the terms “distribute” or “distribution,” “drug,”
268 “establishment,” and “prescription drug”; amending s.
269 499.01, F.S.; deleting provisions relating to an
270 exemption from nonresident prescription drug
271 manufacturer permit requirements; deleting provisions
272 relating to an exemption from out-of-state
273 prescription drug wholesale distributor permit
274 requirements for intracompany sale or transfer of
275 prescription drugs; providing an exemption from permit
276 requirements for the distribution into this state of
277 prescription drug active pharmaceutical ingredients
278 for incorporation into prescription drugs in finished
279 dosage form; requiring a distributor claiming such
280 exemption to maintain a valid license, permit, or
281 registration in the state from which the prescription
282 drug was distributed; requiring compliance with
283 certain recordkeeping requirements; exempting
284 compliance with pedigree paper requirements; providing
285 an exemption from permit requirements for distribution
286 into this state of limited quantities of a
287 prescription drug that has not been repackaged, for
288 research and development or to a holder of a letter of
289 exemption issued by the Department of Business and
290 Professional Regulation for research, teaching, or
291 testing; granting the department authority to define
292 “limited quantities” by rule and limit therein the
293 number of transactions and amount of prescription
294 drugs distributed into the state; requiring a
295 distributor claiming such exemption to maintain a
296 valid license, permit, or registration in the state
297 from which the prescription drug was distributed;
298 requiring all purchasers and recipients of such
299 prescription drugs to ensure the products are not
300 resold or used on humans except in lawful clinical
301 trials and biostudies; requiring compliance with
302 certain recordkeeping requirements; exempting
303 compliance from pedigree paper requirements; providing
304 labeling requirements for active pharmaceutical
305 ingredients distributed within the state for teaching,
306 testing, research, and development; exempting from
307 out-of-state prescription drug wholesale distributor
308 permit requirements intracompany transactions or the
309 sale of prescription drugs from an out-of-state
310 distributor to a distributor in this state if both
311 distributors conduct wholesale distributions under the
312 same business name; requiring compliance with
313 recordkeeping and pedigree paper requirements;
314 allowing distributors and recipients of prescription
315 drugs claiming exemption from certain permitting
316 requirements to maintain on file their FDA
317 registration number, resident state distributor
318 license or permit number, and most recent resident
319 state or FDA inspection report; providing that persons
320 claiming such exemptions are subject to part I of
321 chapter 499, F.S., the Florida Drug and Cosmetic Act;
322 requiring persons claiming such exemptions to make all
323 records regarding prescription drug distribution
324 available to the department, upon request, within 48
325 hours; requiring submission of a report of mishandled
326 or adulterated prescription drugs within 14 days after
327 receipt of such drugs; authorizing the department to
328 adopt rules; providing that failure to comply with
329 requirements or rules governing such exemptions
330 constitutes unlawful purchase or receipt of a
331 prescription drug from a person not authorized to
332 distribute prescription drugs to that purchaser or
333 recipient; providing that knowing failure to comply
334 with such requirements constitutes unlawful sale,
335 distribution, purchase, trade, holding, or offering of
336 a drug; providing penalties; providing construction
337 with respect to federal and state laws relating to
338 controlled substances; providing an effective date.