1 | The Health & Families Council recommends the following: |
2 |
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3 | Council/Committee Substitute |
4 | Remove the entire bill and insert: |
5 | A bill to be entitled |
6 | An act relating to drug distribution; amending s. 499.003, |
7 | F.S.; amending a definition; requiring the Department of |
8 | Health to approve a document or electronic form relating |
9 | to pedigree papers; providing requirements for pedigree |
10 | papers that record certain distributions of legend drugs; |
11 | amending s. 499.005, F.S.; revising a prohibition relating |
12 | to pedigree papers; amending s. 499.006, F.S.; providing |
13 | that a drug is adulterated if it is a certain prescription |
14 | drug that has been returned by a veterinarian to a limited |
15 | prescription drug veterinary wholesaler; amending s. |
16 | 499.01, F.S.; requiring a limited prescription drug |
17 | veterinary wholesaler to obtain a permit for operation |
18 | from the Department of Health; providing that a permit for |
19 | a limited prescription drug veterinary wholesaler may not |
20 | be issued to the address of certain health care entities; |
21 | amending s. 499.012, F.S.; revising permit requirements |
22 | for a veterinary prescription drug wholesaler that |
23 | distributes prescription drugs; establishing a permit for |
24 | a limited prescription drug veterinary wholesaler; |
25 | providing requirements; providing an exception; amending |
26 | s. 499.0121, F.S.; requiring certain wholesale |
27 | distributors taking title to a prescription drug to |
28 | provide an invoice to the purchaser containing certain |
29 | information; requiring a purchaser of a prescription drug |
30 | to obtain from the manufacturer a shipping document |
31 | containing specified information; requiring a manufacturer |
32 | to make certain information available to the department; |
33 | authorizing the department to adopt certain rules relating |
34 | to the inventory and return of certain prescription drugs; |
35 | amending s. 499.0122, F.S.; redefining the term |
36 | "veterinary legend drug retail establishment"; amending s. |
37 | 499.041, F.S.; requiring the department to assess an |
38 | annual fee within a certain monetary range for a limited |
39 | prescription drug veterinary wholesaler permit; amending |
40 | s. 499.065, F.S.; requiring the department to inspect each |
41 | limited prescription drug veterinary wholesaler |
42 | establishment; authorizing the department to determine |
43 | that a limited prescription drug veterinary wholesaler |
44 | establishment is an imminent danger to the public; |
45 | amending s. 499.0661, F.S.; providing for emergency |
46 | suspension of a permittee if charged with specified |
47 | violations; requiring the department to publish a list of |
48 | certain permittee names; amending s. 499.067, F.S.; |
49 | prohibiting issuance of permits to specified applicants; |
50 | requiring revocation of permits of specified permittees; |
51 | providing an effective date. |
52 |
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53 | Be It Enacted by the Legislature of the State of Florida: |
54 |
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55 | Section 1. Subsection (31) of section 499.003, Florida |
56 | Statutes, is amended to read: |
57 | 499.003 Definitions of terms used in ss. 499.001- |
58 | 499.081.--As used in ss. 499.001-499.081, the term: |
59 | (31) "Pedigree paper" means: |
60 | (a) A document required pursuant to s. 499.0121(6)(d) or |
61 | (e); or |
62 | (b) Effective July 1, 2006, a document or electronic form |
63 | approved by the Department of Health and containing information |
64 | that records each distribution of any given legend drug, from |
65 | sale by a pharmaceutical manufacturer, through acquisition and |
66 | sale by any wholesaler or repackager, until final sale to a |
67 | pharmacy or other person administering or dispensing the drug. |
68 | The information required to be included on a legend drug's |
69 | pedigree paper must at least detail the amount of the legend |
70 | drug; its dosage form and strength; its lot numbers; the name |
71 | and address of each owner of the legend drug and his or her |
72 | signature; its shipping information, including the name and |
73 | address of each person certifying delivery or receipt of the |
74 | legend drug; an invoice number, a shipping document number, or |
75 | another number uniquely identifying the transaction; and a |
76 | certification that the recipient wholesaler has authenticated |
77 | the pedigree papers. If the manufacturer or repackager has |
78 | uniquely serialized the individual legend drug unit, that |
79 | identifier must also be included on the pedigree. It must also |
80 | include the name, address, telephone number and, if available, |
81 | e-mail contact information of each wholesaler involved in the |
82 | chain of the legend drug's custody. The department shall adopt |
83 | rules and a form relating to the requirements of this paragraph |
84 | no later than 90 days after the effective date of this act; or. |
85 | (c) Effective July 1, 2006, a document or electronic form |
86 | approved by the Department of Health and containing information |
87 | that records each distribution of any given legend drug, from |
88 | sale by a pharmaceutical manufacturer, through acquisition and |
89 | sale by any wholesaler or repackager, until final sale to a |
90 | pharmacy or other person administering or dispensing the drug; |
91 | or, if a specific unit of the legend drug was purchased by a |
92 | wholesaler, referred to in this paragraph as a "direct purchase |
93 | wholesaler," directly from the manufacturer, an invoice for the |
94 | specific unit of the legend drug together with a certificate |
95 | under oath in written or electronic form stating that: |
96 | 1. If the establishment is not a member of an affiliated |
97 | group: "This establishment purchased the specific unit of the |
98 | legend drug directly from the manufacturer." |
99 | 2. If the establishment is a member of an affiliated |
100 | group: "This establishment or a member of its affiliated group |
101 | purchased the specific unit of the legend drug directly from the |
102 | manufacturer." |
103 |
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104 | A document or electronic form that meets the requirements of |
105 | this paragraph shall constitute a sufficient pedigree paper only |
106 | for the purpose of a single sale or distribution transaction in |
107 | the specific unit of legend drug by the direct purchase |
108 | wholesaler to an entity authorized by law to purchase legend |
109 | drugs. For each transaction of the specific unit of legend drug, |
110 | the direct purchase wholesaler is required to create a separate |
111 | pedigree paper that meets the requirements of this paragraph and |
112 | furnish such pedigree paper to any subsequent purchaser. The |
113 | pedigree paper shall be prepared and updated for every transfer |
114 | following the direct purchase wholesaler's receipt of the |
115 | specific unit of legend drug directly from the manufacturer. The |
116 | information required to be included on the document or |
117 | electronic form approved by the department pursuant to this |
118 | paragraph and required of any subsequent transfers of legend |
119 | drugs received by a direct purchase wholesaler in a transaction |
120 | described in this paragraph must at least detail the amount of |
121 | the legend drug; its dosage form and strength; its lot numbers; |
122 | the name and address of each owner of the legend drug after it |
123 | has left the possession of the manufacturer and his or her |
124 | signature; its shipping information, including the name and |
125 | address of each person certifying delivery or receipt of the |
126 | legend drug after it has left the possession of the |
127 | manufacturer; an invoice number, a shipping document number, or |
128 | another number uniquely identifying the transaction; and a |
129 | certification that the recipient direct purchase wholesaler has |
130 | authenticated the pedigree papers as required in this paragraph. |
131 | If the manufacturer or repackager has uniquely serialized the |
132 | individual legend drug unit, that identifier must also be |
133 | included on the form approved by the department and is required |
134 | of any subsequent transfers of prescription drugs received by a |
135 | direct purchase wholesaler in a transaction governed by this |
136 | paragraph. The pedigree paper must also include the name, |
137 | address, telephone number, and, if available, e-mail contact |
138 | information of each wholesaler involved in the chain of custody |
139 | of the legend drug. The department shall adopt rules and a form |
140 | relating to the requirements of this paragraph. |
141 | Section 2. Subsection (29) of section 499.005, Florida |
142 | Statutes, is amended to read: |
143 | 499.005 Prohibited acts.--It is unlawful for a person to |
144 | perform or cause the performance of any of the following acts in |
145 | this state: |
146 | (29) The receipt of a prescription drug pursuant to a |
147 | wholesale distribution without either first receiving a pedigree |
148 | paper that was attested to as accurate and complete by the |
149 | wholesale distributor or complying with the provisions of s. |
150 | 499.0121(6)(f)6. |
151 | Section 3. Section 499.006, Florida Statutes, is amended |
152 | to read: |
153 | 499.006 Adulterated drug or device.--A drug or device is |
154 | adulterated: |
155 | (1) If it consists in whole or in part of any filthy, |
156 | putrid, or decomposed substance; |
157 | (2) If it has been produced, prepared, packed, or held |
158 | under conditions whereby it could have been contaminated with |
159 | filth or rendered injurious to health; |
160 | (3) If it is a drug and the methods used in, or the |
161 | facilities or controls used for, its manufacture, processing, |
162 | packing, or holding do not conform to, or are not operated or |
163 | administered in conformity with, current good manufacturing |
164 | practices to assure that the drug meets the requirements of ss. |
165 | 499.001-499.081 and that the drug has the identity and strength, |
166 | and meets the standard of quality and purity, which it purports |
167 | or is represented to possess; |
168 | (4) If it is a drug and its container is composed, in |
169 | whole or in part, of any poisonous or deleterious substance |
170 | which could render the contents injurious to health; |
171 | (5) If it is a drug and it bears or contains, for the |
172 | purpose of coloring only, a color additive that is unsafe within |
173 | the meaning of the federal act; or, if it is a color additive, |
174 | the intended use of which in or on drugs is for the purpose of |
175 | coloring only, and it is unsafe within the meaning of the |
176 | federal act; |
177 | (6) If it purports to be, or is represented as, a drug the |
178 | name of which is recognized in the official compendium, and its |
179 | strength differs from, or its quality or purity falls below, the |
180 | standard set forth in such compendium. The determination as to |
181 | strength, quality, or purity must be made in accordance with the |
182 | tests or methods of assay set forth in such compendium, or, when |
183 | such tests or methods of assay are absent or inadequate, in |
184 | accordance with those tests or methods of assay prescribed under |
185 | authority of the federal act. A drug defined in the official |
186 | compendium is not adulterated under this subsection merely |
187 | because it differs from the standard of strength, quality, or |
188 | purity set forth for that drug in such compendium if its |
189 | difference in strength, quality, or purity from such standard is |
190 | plainly stated on its label; |
191 | (7) If it is not subject to subsection (6) and its |
192 | strength differs from, or its purity or quality falls below the |
193 | standard of, that which it purports or is represented to |
194 | possess; |
195 | (8) If it is a drug: |
196 | (a) With which any substance has been mixed or packed so |
197 | as to reduce the quality or strength of the drug; or |
198 | (b) For which any substance has been substituted wholly or |
199 | in part; |
200 | (9) If it is a drug or device for which the expiration |
201 | date has passed; or |
202 | (10) If it is a legend drug for which the required |
203 | pedigree paper is nonexistent, fraudulent, or incomplete under |
204 | the requirements of ss. 499.001-499.081 or applicable rules, or |
205 | that has been purchased, held, sold, or distributed at any time |
206 | by a person not authorized under federal or state law to do so; |
207 | or. |
208 | (11) If it is a prescription drug subject to, defined by, |
209 | or described by s. 503(b) of the Federal Food, Drug, and |
210 | Cosmetic Act which has been returned by a veterinarian to a |
211 | limited prescription drug veterinary wholesaler. |
212 | Section 4. Subsection (1) and paragraph (d) of subsection |
213 | (2) of section 499.01, Florida Statutes, are amended to read: |
214 | 499.01 Permits; applications; renewal; general |
215 | requirements.-- |
216 | (1) Prior to operating, a permit is required for each |
217 | person and establishment that intends to operate as: |
218 | (a) A prescription drug manufacturer; |
219 | (b) A prescription drug repackager; |
220 | (c) An over-the-counter drug manufacturer; |
221 | (d) A compressed medical gas manufacturer; |
222 | (e) A device manufacturer; |
223 | (f) A cosmetic manufacturer; |
224 | (g) A prescription drug wholesaler; |
225 | (h) A veterinary prescription drug wholesaler; |
226 | (i) A compressed medical gas wholesaler; |
227 | (j) An out-of-state prescription drug wholesaler; |
228 | (k) A nonresident prescription drug manufacturer; |
229 | (l) A freight forwarder; |
230 | (m) A retail pharmacy drug wholesaler; |
231 | (n) A veterinary legend drug retail establishment; |
232 | (o) A medical oxygen retail establishment; |
233 | (p) A complimentary drug distributor; or |
234 | (q) A restricted prescription drug distributor; or. |
235 | (r) A limited prescription drug veterinary wholesaler. |
236 | (2) |
237 | (d) A permit for a prescription drug manufacturer, |
238 | prescription drug repackager, prescription drug wholesaler, |
239 | limited prescription drug veterinary wholesaler, or retail |
240 | pharmacy wholesaler may not be issued to the address of a health |
241 | care entity or to a pharmacy licensed under chapter 465, except |
242 | as provided in this paragraph. The department may issue a |
243 | prescription drug manufacturer permit to an applicant at the |
244 | same address as a licensed nuclear pharmacy, which is a health |
245 | care entity, for the purpose of manufacturing prescription drugs |
246 | used in positron emission tomography or other |
247 | radiopharmaceuticals, as listed in a rule adopted by the |
248 | department pursuant to this paragraph. The purpose of this |
249 | exemption is to assure availability of state-of-the-art |
250 | pharmaceuticals that would pose a significant danger to the |
251 | public health if manufactured at a separate establishment |
252 | address from the nuclear pharmacy from which the prescription |
253 | drugs are dispensed. The department may also issue a retail |
254 | pharmacy wholesaler permit to the address of a community |
255 | pharmacy licensed under chapter 465 which does not meet the |
256 | definition of a closed pharmacy in s. 499.003. |
257 | Section 5. Paragraph (g) of subsection (2) of section |
258 | 499.012, Florida Statutes, is amended, and paragraph (h) is |
259 | added to that subsection, to read: |
260 | 499.012 Wholesale distribution; definitions; permits; |
261 | applications; general requirements.-- |
262 | (2) The following types of wholesaler permits are |
263 | established: |
264 | (g) A veterinary prescription drug wholesaler permit.--A |
265 | veterinary prescription drug wholesaler permit is required for |
266 | any person that engages in the distribution of veterinary |
267 | prescription drugs in or into this state. A veterinary |
268 | prescription drug wholesaler that also distributes prescription |
269 | drugs subject to, defined by, or described by s. 503(b) of the |
270 | Federal Food, Drug, and Cosmetic Act which it did not |
271 | manufacture must obtain a permit as a prescription drug |
272 | wholesaler, an or out-of-state prescription drug wholesaler, or |
273 | a limited prescription drug veterinary wholesaler in lieu of the |
274 | veterinary prescription drug wholesaler permit. A veterinary |
275 | prescription drug wholesaler must comply with the requirements |
276 | for wholesale distributors under s. 499.0121, except those set |
277 | forth in s. 499.0121(6)(d), (e), or (f). |
278 | (h) Limited prescription drug veterinary wholesaler |
279 | permit.--Unless engaging in the activities of and permitted as a |
280 | prescription drug manufacturer, nonresident prescription drug |
281 | manufacturer, prescription drug wholesaler, or out-of-state |
282 | prescription drug wholesaler, a limited prescription drug |
283 | veterinary wholesaler permit is required for any person that |
284 | engages in the distribution in or into this state of veterinary |
285 | prescription drugs and prescription drugs subject to, defined |
286 | by, or described by s. 503(b) of the Federal Food, Drug, and |
287 | Cosmetic Act to veterinarians under the following conditions: |
288 | 1. The person is engaged in the business of wholesaling |
289 | prescription and veterinary legend drugs to persons: |
290 | a. Licensed as veterinarians practicing on a full-time |
291 | basis; |
292 | b. Regularly and lawfully engaged in instruction in |
293 | veterinary medicine; |
294 | c. Regularly and lawfully engaged in law enforcement; |
295 | d. For use in research, not involving clinical use; or |
296 | e. For use in chemical analysis or physical testing, for |
297 | the purposes of instruction in law enforcement, research, or |
298 | testing. |
299 | 2. No more than 30 percent of prescription drug sales may |
300 | be prescription drugs approved for human use which are subject |
301 | to, defined by, or described by s. 503(b) of the Federal Food, |
302 | Drug, and Cosmetic Act. |
303 | 3. The person is not permitted, licensed, or otherwise |
304 | authorized in any state to wholesale prescription drugs subject |
305 | to, defined by, or described by s. 503(b) of the Federal Food, |
306 | Drug, and Cosmetic Act to any person who is authorized to sell, |
307 | distribute, purchase, trade, or use these drugs on or for |
308 | humans. |
309 | 4. A limited prescription drug veterinary wholesaler that |
310 | applies to the department for a new permit or the renewal of a |
311 | permit must submit a bond of $20,000, or other equivalent means |
312 | of security acceptable to the department, such as an irrevocable |
313 | letter of credit or a deposit in a trust account or financial |
314 | institution, payable to the Florida Drug, Device, and Cosmetic |
315 | Trust Fund. The purpose of the bond is to secure payment of any |
316 | administrative penalties imposed by the department and any fees |
317 | and costs incurred by the department regarding that permit which |
318 | are authorized under state law and which the permittee fails to |
319 | pay 30 days after the fine or costs become final. The department |
320 | may make a claim against such bond or security until 1 year |
321 | after the permittee's license ceases to be valid or until 60 |
322 | days after any administrative or legal proceeding authorized in |
323 | ss. 499.001-499.081 which involves the permittee is concluded, |
324 | including any appeal, whichever occurs later. |
325 | 5. A limited prescription drug veterinary wholesaler must |
326 | maintain at all times a license or permit to engage in the |
327 | wholesale distribution of prescription drugs in compliance with |
328 | laws of the state in which it is a resident. |
329 | 6. A limited prescription drug veterinary wholesaler must |
330 | comply with the requirements for wholesale distributors under s. |
331 | 499.0121, except that a limited prescription drug veterinary |
332 | wholesaler is not required to provide a pedigree paper as |
333 | required by s. 499.0121(6)(f) upon the wholesale distribution of |
334 | a prescription drug to a veterinarian. |
335 | 7. A limited prescription drug veterinary wholesaler may |
336 | not return to inventory for subsequent wholesale distribution |
337 | any prescription drug subject to, defined by, or described by s. |
338 | 503(b) of the Federal Food, Drug, and Cosmetic Act which has |
339 | been returned by a veterinarian. |
340 | 8. An out-of-state prescription drug wholesaler's permit |
341 | or a limited prescription drug veterinary wholesaler permit is |
342 | not required for an intracompany sale or transfer of a |
343 | prescription drug from an out-of-state establishment that is |
344 | duly licensed to engage in the wholesale distribution of |
345 | prescription drugs in its state of residence to a licensed |
346 | limited prescription drug veterinary wholesaler in this state if |
347 | both wholesalers conduct wholesale distributions of prescription |
348 | drugs under the same business name. The recordkeeping |
349 | requirements of s. 499.0121(6) must be followed for this |
350 | transaction. |
351 | Section 6. Paragraph (f) of subsection (6) of section |
352 | 499.0121, Florida Statutes, is amended to read: |
353 | 499.0121 Storage and handling of prescription drugs; |
354 | recordkeeping.--The department shall adopt rules to implement |
355 | this section as necessary to protect the public health, safety, |
356 | and welfare. Such rules shall include, but not be limited to, |
357 | requirements for the storage and handling of prescription drugs |
358 | and for the establishment and maintenance of prescription drug |
359 | distribution records. |
360 | (6) RECORDKEEPING.--The department shall adopt rules that |
361 | require keeping such records of prescription drugs as are |
362 | necessary for the protection of the public health. |
363 | (f)1. Effective July 1, 2006, each person who is engaged |
364 | in the wholesale distribution of a prescription drug and who is |
365 | not the manufacturer of that drug must, before each wholesale |
366 | distribution of such drug, provide to the person who receives |
367 | the drug a pedigree paper as defined in s. 499.003(31). |
368 | 2. A repackager must comply with this paragraph. |
369 | 3. The pedigree paper requirements in this paragraph do |
370 | not apply to compressed medical gases or veterinary legend |
371 | drugs. |
372 | 4. Each wholesale distributor of prescription drugs must |
373 | maintain separate and distinct from other required records all |
374 | statements that are required under subparagraph 1. |
375 | 5. In order to verify compliance with subparagraph (d)1., |
376 | each manufacturer of a prescription drug sold in this state must |
377 | make available upon request distribution documentation related |
378 | to its sales of prescription drugs, regardless of whether the |
379 | prescription drug was sold directly by the manufacturer to a |
380 | person in Florida. |
381 | 6. Subparagraph 1. does not apply to a wholesale |
382 | distributor that takes title to, but not possession of, a |
383 | prescription drug and the prescription drug's manufacturer ships |
384 | the prescription drug directly to a person authorized by law to |
385 | administer or dispense prescription drugs or a member of an |
386 | affiliated group, except a repackager, described in paragraph |
387 | (h). |
388 | a. The wholesale distributor must send an invoice to the |
389 | purchaser of the prescription drug that contains a clear cross- |
390 | reference to the shipping document sent by the manufacturer to |
391 | the purchaser of the prescription drug. |
392 | b. The purchaser of the prescription drug must obtain a |
393 | shipping document from the manufacturer that contains, at a |
394 | minimum: |
395 | (I) The name and address of the manufacturer, including |
396 | the point of origin of the shipment; the wholesaler; and the |
397 | purchaser. |
398 | (II) The name of the prescription drug as it appears on |
399 | the label. |
400 | (III) The quantity, dosage form, and strength of the |
401 | prescription drug. |
402 | (IV) The date of the shipment. |
403 | c. The manufacturer must also make available to the |
404 | department, upon request, the lot number of the prescription |
405 | drug if the lot number is not contained in the shipping document |
406 | received by the purchaser. |
407 | 7. The department may by rule define alternatives to |
408 | compliance with subparagraph 1. for a prescription drug in the |
409 | inventory of a permitted prescription drug wholesaler as of June |
410 | 30, 2006, and the return of a prescription drug purchased prior |
411 | to July 1, 2006. The department may specify time limits for such |
412 | alternatives. |
413 | Section 7. Paragraph (d) of subsection (1) of section |
414 | 499.0122, Florida Statutes, is amended to read: |
415 | 499.0122 Medical oxygen and veterinary legend drug retail |
416 | establishments; definitions, permits, general requirements.-- |
417 | (1) As used in this section, the term: |
418 | (d) "Veterinary legend drug retail establishment" means a |
419 | person permitted to sell veterinary legend drugs to the public |
420 | or to veterinarians, but does not include a pharmacy licensed |
421 | under chapter 465. |
422 | 1. The sale to the public must be based on a valid written |
423 | order from a veterinarian licensed in this state who has a valid |
424 | client-veterinarian relationship with the purchaser's animal. |
425 | 2. Veterinary legend drugs may not be sold in excess of |
426 | the amount clearly indicated on the order or beyond the date |
427 | indicated on the order. |
428 | 3. An order may not be valid for more than 1 year. |
429 | 4. A veterinary legend drug retail establishment may not |
430 | purchase, sell, trade, or possess human prescription drugs or |
431 | any controlled substance as defined in chapter 893. |
432 | 5. A veterinary legend drug retail establishment must sell |
433 | a veterinary legend drug in the original, sealed manufacturer's |
434 | container with all labeling intact and legible. The department |
435 | may adopt by rule additional labeling requirements for the sale |
436 | of a veterinary legend drug. |
437 | Section 8. Paragraph (h) is added to subsection (2) of |
438 | section 499.041, Florida Statutes, to read: |
439 | 499.041 Schedule of fees for drug, device, and cosmetic |
440 | applications and permits, product registrations, and free-sale |
441 | certificates.-- |
442 | (2) The department shall assess an applicant that is |
443 | required to have a wholesaling permit an annual fee within the |
444 | ranges established in this section for the specific type of |
445 | wholesaling. |
446 | (h) The fee for a limited prescription drug veterinary |
447 | wholesaler's permit may not be less than $300 or more than $500 |
448 | annually. |
449 | Section 9. Subsections (1) and (3) of section 499.065, |
450 | Florida Statutes, are amended to read: |
451 | 499.065 Imminent danger.-- |
452 | (1) Notwithstanding s. 499.051, the department shall |
453 | inspect each prescription drug wholesale establishment, |
454 | prescription drug repackager establishment, veterinary |
455 | prescription drug wholesale establishment, limited prescription |
456 | drug veterinary wholesaler establishment, and retail pharmacy |
457 | drug wholesaler establishment that is required to be permitted |
458 | under this chapter as often as necessary to ensure compliance |
459 | with applicable laws and rules. The department shall have the |
460 | right of entry and access to these facilities at any reasonable |
461 | time. |
462 | (3) The department may determine that a prescription drug |
463 | wholesale establishment, prescription drug repackager |
464 | establishment, veterinary prescription drug wholesale |
465 | establishment, limited prescription drug veterinary wholesaler |
466 | establishment, or retail pharmacy drug wholesaler establishment |
467 | that is required to be permitted under this chapter is an |
468 | imminent danger to the public health and shall require its |
469 | immediate closure if the establishment fails to comply with |
470 | applicable laws and rules and, because of the failure, presents |
471 | an imminent threat to the public's health, safety, or welfare. |
472 | Any establishment so deemed and closed shall remain closed until |
473 | allowed by the department or by judicial order to reopen. |
474 |
|
475 | For purposes of this section, a refusal to allow entry to the |
476 | department for inspection at reasonable times, or a failure or |
477 | refusal to provide the department with required documentation |
478 | for purposes of inspection, constitutes an imminent danger to |
479 | the public health. |
480 | Section 10. Paragraph (e) of subsection (3) of section |
481 | 499.0661, Florida Statutes, is amended to read: |
482 | 499.0661 Cease and desist orders; removal of certain |
483 | persons.-- |
484 | (3) REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.-- |
485 | (e)1. The chief executive officer, designated |
486 | representative, or the person holding the equivalent office, of |
487 | a permittee shall promptly notify the department if she or he |
488 | has actual knowledge that any affiliated party is charged with a |
489 | felony in a state or federal court. |
490 | 2. Whenever any affiliated party is charged with a felony |
491 | in a state or federal court or with the equivalent of a felony |
492 | in the courts of any foreign country with which the United |
493 | States maintains diplomatic relations, and the charge alleges |
494 | violation of any law involving prescription drugs, |
495 | pharmaceuticals, fraud, theft, or moral turpitude, the |
496 | department may enter an emergency order suspending the |
497 | affiliated party or restricting or prohibiting participation by |
498 | the affiliated party in the affairs of the particular permittee |
499 | or of any other permittee upon service of the order upon the |
500 | permittee and the affiliated party charged. The order must |
501 | contain notice of opportunity for a hearing pursuant to ss. |
502 | 120.569 and 120.57, where the affiliated party may request a |
503 | postsuspension hearing to show that continued service to or |
504 | participation in the affairs of the permittee does not pose a |
505 | threat to the public health or the interests of the permittee |
506 | and does not threaten to impair public confidence in the |
507 | permittee. In accordance with applicable departmental rules, the |
508 | department shall notify the affiliated party whether the order |
509 | suspending or prohibiting the person from participation in the |
510 | affairs of a permittee will be rescinded or otherwise modified. |
511 | The emergency order remains in effect, unless otherwise modified |
512 | by the department, until the criminal charge is disposed of. The |
513 | acquittal of the person charged, or the final, unappealed |
514 | dismissal of all charges against the person, dissolves the |
515 | emergency order but does not prohibit the department from |
516 | instituting proceedings under paragraph (a). If the person |
517 | charged is convicted or pleads guilty or nolo contendere, |
518 | whether or not an adjudication of guilt is entered by the court, |
519 | the emergency order shall become final. |
520 | 3. Whenever a permittee is charged with violation of s. |
521 | 499.0051 or s. 499.0052, the department may enter an emergency |
522 | order suspending the permittee's permit. The order must contain |
523 | notice of opportunity for a hearing pursuant to ss. 120.569 and |
524 | 120.57, where a permittee may request a postsuspension hearing |
525 | to show that continued operation by the permittee under his or |
526 | her permit does not pose a threat to the public health and does |
527 | not threaten to impair public confidence in the permittee. In |
528 | accordance with applicable departmental rules, the department |
529 | shall notify the permittee whether the order suspending the |
530 | permit of the permittee will be rescinded or otherwise modified. |
531 | The emergency order remains in effect, unless otherwise modified |
532 | by the department, until the criminal charge is disposed of. The |
533 | acquittal of the permittee charged, or the final, unappealed |
534 | dismissal of all charges against the permittee, dissolves the |
535 | emergency order but does not prohibit the department from |
536 | instituting proceedings under paragraph (a). If a permittee |
537 | charged with a violation of s. 499.0051 or s. 499.0052 is |
538 | convicted or pleads guilty or nolo contendere, whether or not an |
539 | adjudication of guilt is entered by the court, the emergency |
540 | order shall become final. |
541 | 4. The department shall publish on its website a list of |
542 | all permittees against whom an emergency order or a permanent |
543 | order under this section is entered. |
544 | Section 11. Subsections (8) and (9) are added to section |
545 | 499.067, Florida Statutes, to read: |
546 | 499.067 Denial, suspension, or revocation of permit, |
547 | certification, or registration.-- |
548 | (8) The department shall deny an application for a permit |
549 | for an establishment if the applicant, any person named pursuant |
550 | to s. 499.012(3)(k) in the applicant's application, or the |
551 | person designated pursuant to s. 499.012(11) by the applicant |
552 | has been convicted or pleaded guilty or nolo contendere to a |
553 | violation of s. 499.0051 or s. 499.0052, whether or not an |
554 | adjudication of guilt is entered by the court. |
555 | (9) The department shall revoke the permit of an |
556 | establishment if the permittee, any person named pursuant to s. |
557 | 499.012(3)(k) in the permittee's application, or the person |
558 | designated pursuant to s. 499.012(11) by the permittee has been |
559 | convicted or pleaded guilty or nolo contendere to a violation of |
560 | s. 499.0051 or s. 499.0052, whether or not an adjudication of |
561 | guilt is entered by the court. |
562 | Section 12. This act shall take effect July 1, 2006. |