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HB 0141 CS

CHAMBER ACTION





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1 The Committee on Health Care recommends the following:
2

3 Committee Substitute
4 Remove the entire bill and insert:
5 A bill to be entitled
6 An act relating to pharmacy; amending s. 465.003, F.S.;
7 defining the term "Internet pharmacy"; amending s.
8 465.0156, F.S.; exempting Internet pharmacies from
9 registration requirements applicable to nonresident
10 pharmacies; requiring a registered nonresident pharmacy
11 and the pharmacist designated by that pharmacy to serve as
12 the prescription department manager or the equivalent to
13 be licensed in the state of location to dispense medicinal
14 drugs into this state; amending s. 465.016, F.S.;
15 providing for disciplinary action for dispensing a
16 medicinal drug when the pharmacist knows or has reason to
17 believe a prescription is not based on a valid
18 practitioner-patient relationship; creating s. 465.0161,
19 F.S.; prohibiting the distribution of medicinal drugs by
20 an Internet pharmacy without a permit; providing
21 penalties; amending s. 465.0196, F.S., relating to special
22 pharmacy permits, to conform; creating s. 465.0197, F.S.;
23 requiring Internet pharmacies to be permitted and
24 providing requirements therefor; requiring the Internet
25 pharmacy and the pharmacist designated by that pharmacy to
26 serve as the prescription department manager or its
27 equivalent to be licensed in the state of location to
28 dispense medicinal drugs into this state; amending s.
29 465.023, F.S.; providing an additional ground for which
30 the Department of Health or the Board of Pharmacy may take
31 action against a permitted pharmacy; amending s. 465.0255,
32 F.S.; revising requirements for certain pharmacists and
33 practitioners to deliver specified disclosures to
34 purchasers when dispensing a medicinal drug; amending s.
35 465.026, F.S.; creating an exception to the requirements
36 for filling or refilling a transferred prescription for a
37 medicinal drug listed in Schedule II under ch. 893, F.S.;
38 amending s. 499.0121, F.S.; providing recordkeeping
39 requirements relating to the storage and handling of
40 prescription drugs which affiliated groups must fulfill;
41 providing for future repeal; amending s. 895.02, F.S.;
42 including violation of s. 465.0161, F.S., in the
43 definition of the term "racketeering activity" for
44 prosecution under ch. 895, F.S.; providing an
45 appropriation and authorizing positions; providing an
46 effective date.
47

48 Be It Enacted by the Legislature of the State of Florida:
49

50 Section 1. Paragraph (a) of subsection (11) of section
51 465.003, Florida Statutes, is amended to read:
52 465.003 Definitions.--As used in this chapter, the term:
53 (11)(a) "Pharmacy" includes a community pharmacy, an
54 institutional pharmacy, a nuclear pharmacy, and a special
55 pharmacy, and an Internet pharmacy.
56 1. The term "community pharmacy" includes every location
57 where medicinal drugs are compounded, dispensed, stored, or sold
58 or where prescriptions are filled or dispensed on an outpatient
59 basis.
60 2. The term "institutional pharmacy" includes every
61 location in a hospital, clinic, nursing home, dispensary,
62 sanitarium, extended care facility, or other facility,
63 hereinafter referred to as "health care institutions," where
64 medicinal drugs are compounded, dispensed, stored, or sold.
65 3. The term "nuclear pharmacy" includes every location
66 where radioactive drugs and chemicals within the classification
67 of medicinal drugs are compounded, dispensed, stored, or sold.
68 The term "nuclear pharmacy" does not include hospitals licensed
69 under chapter 395 or the nuclear medicine facilities of such
70 hospitals.
71 4. The term "special pharmacy" includes every location
72 where medicinal drugs are compounded, dispensed, stored, or sold
73 if such locations are not otherwise defined in this subsection.
74 5. The term "Internet pharmacy" includes locations not
75 otherwise licensed or issued a permit under this chapter, within
76 or outside this state, which use the Internet to communicate
77 with or obtain information from consumers in this state and use
78 such communication or information to fill or refill
79 prescriptions or to dispense, distribute, or otherwise engage in
80 the practice of pharmacy in this state. Any act described in
81 this subparagraph constitutes the practice of the profession of
82 pharmacy as defined in subsection (13).
83 Section 2. Subsections (7) and (8) are added to section
84 465.0156, Florida Statutes, to read:
85 465.0156 Registration of nonresident pharmacies.--
86 (7) This section does not apply to Internet pharmacies
87 required to be permitted under s. 465.0197.
88 (8) Notwithstanding s. 465.003(10), for purposes of this
89 section, the registered pharmacy and the pharmacist designated
90 by the registered pharmacy as the prescription department
91 manager or the equivalent must be licensed in the state of
92 location in order to dispense medicinal drugs into this state.
93 Section 3. Paragraph (s) is added to subsection (1) of
94 section 465.016, Florida Statutes, to read:
95 465.016 Disciplinary actions.--
96 (1) The following acts constitute grounds for denial of a
97 license or disciplinary action, as specified in s. 456.072(2):
98 (s) Dispensing any medicinal drug based upon a
99 communication that purports to be a prescription as defined in
100 s. 465.003(14) or s. 893.02(20) when the pharmacist knows or has
101 reason to believe that the purported prescription is not based
102 upon a valid practitioner-patient relationship.
103 Section 4. Section 465.0161, Florida Statutes, is created
104 to read:
105 465.0161 Distribution of medicinal drugs without a
106 permit.--An Internet pharmacy that distributes a medicinal drug
107 to any person in this state without being permitted as a
108 pharmacy under this chapter commits a felony of the second
109 degree, punishable as provided in s. 775.082, s. 775.083, or s.
110 775.084.
111 Section 5. Section 465.0196, Florida Statutes, is amended
112 to read:
113 465.0196 Special pharmacy permits.--Any person desiring a
114 permit to operate a special pharmacy which does not fall within
115 the definitions set forth in s. 465.003(11)(a)1., 2., and 3.
116 shall apply to the department for a special pharmacy permit. If
117 the board certifies that the application complies with the
118 applicable laws and rules of the board governing the practice of
119 the profession of pharmacy, the department shall issue the
120 permit. No permit shall be issued unless a licensed pharmacist
121 is designated to undertake the professional supervision of the
122 compounding and dispensing of all drugs dispensed by the
123 pharmacy. The licensed pharmacist shall be responsible for
124 maintaining all drug records and for providing for the security
125 of the area in the facility in which the compounding, storing,
126 and dispensing of medicinal drugs occurs. The permittee shall
127 notify the department within 10 days of any change of the
128 licensed pharmacist responsible for such duties. Every permittee
129 that employs or otherwise utilizes pharmacy technicians shall
130 have a written policy and procedures manual specifying those
131 duties, tasks, and functions which a pharmacy technician is
132 allowed to perform.
133 Section 6. Section 465.0197, Florida Statutes, is created
134 to read:
135 465.0197 Internet pharmacy permits.--
136 (1) Any person desiring a permit to operate an Internet
137 pharmacy shall apply to the department for an Internet pharmacy
138 permit. If the board certifies that the application complies
139 with the applicable laws and rules of the board governing the
140 practice of the profession of pharmacy, the department shall
141 issue the permit. No permit shall be issued unless a licensed
142 pharmacist is designated as the prescription department manager
143 for dispensing medicinal drugs to persons in this state. The
144 licensed pharmacist shall be responsible for maintaining all
145 drug records and for providing for the security of the area in
146 the facility in which the compounding, storing, and dispensing
147 of medicinal drugs to persons in this state occurs. The
148 permittee shall notify the department within 30 days of any
149 change of the licensed pharmacist responsible for such duties.
150 Every permittee that employs or otherwise utilizes pharmacy
151 technicians shall have a written policy and procedures manual
152 specifying those duties, tasks, and functions which a pharmacy
153 technician is allowed to perform.
154 (2) An Internet pharmacy must obtain a permit under this
155 section to sell medicinal drugs to persons in this state.
156 (3) An Internet pharmacy shall provide pharmacy services
157 at a high level of protection and competence and shall disclose
158 to the board the following specific information:
159 (a) That it maintains at all times a valid, unexpired
160 license, permit, or registration to operate the pharmacy in
161 compliance with the laws of the state in which the dispensing
162 facility is located and from which the medicinal drugs shall be
163 dispensed.
164 (b) The location, names, and titles of all principal
165 corporate officers and the pharmacist who serves as the
166 prescription department manager for dispensing medicinal drugs
167 to persons in this state. This disclosure shall be made within
168 30 days after any change of location, principal corporate
169 officer, or pharmacist serving as the prescription department
170 manager for dispensing medicinal drugs to persons in this state.
171 (c) That it complies with all lawful directions and
172 requests for information from the regulatory or licensing agency
173 of all states in which it is licensed as well as with all
174 requests for information made by the board pursuant to this
175 section. It shall respond directly to all communications from
176 the board concerning emergency circumstances arising from errors
177 in the dispensing of medicinal drugs to persons in this state.
178 (d) That it maintains its records of medicinal drugs
179 dispensed to patients in this state so that the records are
180 readily retrievable from the other business records of the
181 pharmacy and from the records of other medicinal drugs
182 dispensed.
183 (e) That during its regular hours of operation but not
184 less than 6 days per week, for a minimum of 40 hours per week, a
185 toll-free telephone service shall be provided to facilitate
186 communication between patients in this state and a pharmacist at
187 the pharmacy who has access to the patient's records. This toll-
188 free number must be disclosed on the label affixed to each
189 container of dispensed medicinal drugs.
190 (4) Notwithstanding s. 465.003(10), for purposes of this
191 section, the Internet pharmacy and the pharmacist designated by
192 the Internet pharmacy as the prescription department manager or
193 the equivalent must be licensed in the state of location in
194 order to dispense medicinal drugs into this state.
195 Section 7. Subsection (1) of section 465.023, Florida
196 Statutes, is amended to read:
197 465.023 Pharmacy permittee; disciplinary action.--
198 (1) The department or the board may revoke or suspend the
199 permit of any pharmacy permittee, and may fine, place on
200 probation, or otherwise discipline any pharmacy permittee who
201 has:
202 (a) Obtained a permit by misrepresentation or fraud or
203 through an error of the department or the board;
204 (b) Attempted to procure, or has procured, a permit for
205 any other person by making, or causing to be made, any false
206 representation;
207 (c) Violated any of the requirements of this chapter or
208 any of the rules of the Board of Pharmacy; of chapter 499, known
209 as the "Florida Drug and Cosmetic Act"; of 21 U.S.C. ss. 301-
210 392, known as the "Federal Food, Drug, and Cosmetic Act"; of 21
211 U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse
212 Prevention and Control Act; or of chapter 893; or
213 (d) Been convicted or found guilty, regardless of
214 adjudication, of a felony or any other crime involving moral
215 turpitude in any of the courts of this state, of any other
216 state, or of the United States; or
217 (e) Dispensed any medicinal drug based upon a
218 communication that purports to be a prescription as defined in
219 s. 465.003(14) or s. 893.02(20) when the pharmacist knows or has
220 reason to believe that the purported prescription is not based
221 upon a valid practitioner-patient relationship that includes a
222 documented patient evaluation, including history and a physical
223 examination adequate to establish the diagnosis for which any
224 drug is prescribed and any other requirement established by
225 board rule under chapter 458, chapter 459, chapter 461, chapter
226 463, chapter 464, or chapter 466.
227 Section 8. Section 465.0255, Florida Statutes, is amended
228 to read:
229 465.0255 Expiration date of medicinal drugs; display;
230 related use and storage instructions.--
231 (1) The manufacturer, repackager, or other distributor of
232 any medicinal drug shall display the expiration date of each
233 drug in a readable fashion on the container and on its
234 packaging. The term "readable" means conspicuous and bold.
235 (2) Each pharmacist for a community pharmacy dispensing
236 medicinal drugs and each practitioner dispensing medicinal drugs
237 on an outpatient basis shall display on the outside of the
238 container of each medicinal drug dispensed, or in other written
239 form delivered to the purchaser:,
240 (a) The expiration date when provided by the manufacturer,
241 repackager, or other distributor of the drug; or and
242 (b) An earlier beyond-use date for expiration, which may
243 be up to 1 year after the date of dispensing.
244

245 The dispensing pharmacist or practitioner must provide
246 information concerning the expiration date to the purchaser upon
247 request and must provide appropriate instructions regarding the
248 proper use and storage of the drug.
249 (3) Nothing in This section does not shall impose
250 liability on the dispensing pharmacist or practitioner for
251 damages related to, or caused by, a medicinal drug that loses
252 its effectiveness prior to the expiration date displayed by the
253 dispensing pharmacist or practitioner.
254 (4)(3) The provisions of this section are intended to
255 notify the patient receiving a medicinal drug of the information
256 required by this section, and the dispensing pharmacist or
257 practitioner shall not be liable for the patient's failure to
258 heed such notice or to follow the instructions for storage.
259 Section 9. Subsection (7) is added to section 465.026,
260 Florida Statutes, to read:
261 465.026 Filling of certain prescriptions.--Nothing
262 contained in this chapter shall be construed to prohibit a
263 pharmacist licensed in this state from filling or refilling a
264 valid prescription which is on file in a pharmacy located in
265 this state or in another state and has been transferred from one
266 pharmacy to another by any means, including any electronic
267 means, under the following conditions:
268 (7) A community pharmacy licensed under this chapter which
269 only receives and transfers prescriptions for dispensing by
270 another pharmacy may transfer a prescription for a medicinal
271 drug listed in Schedule II under chapter 893. The pharmacy
272 receiving the prescription may ship, mail, or deliver into this
273 state, in any manner, the dispensed Schedule II medicinal drug
274 under the following conditions:
275 (a) The pharmacy receiving and dispensing the transferred
276 prescription maintains at all times a valid, unexpired license,
277 permit, or registration to operate the pharmacy in compliance
278 with the laws of the state in which the pharmacy is located and
279 from which the medicinal drugs are dispensed.
280 (b) The community pharmacy and the receiving pharmacy are
281 owned and operated by the same person and share a centralized
282 database.
283 (c) The community pharmacy assures its compliance with
284 federal laws and subsections (1)-(5).
285 Section 10. Paragraph (h) is added to subsection (6) of
286 section 499.0121, Florida Statutes, to read:
287 499.0121 Storage and handling of prescription drugs;
288 recordkeeping.--The department shall adopt rules to implement
289 this section as necessary to protect the public health, safety,
290 and welfare. Such rules shall include, but not be limited to,
291 requirements for the storage and handling of prescription drugs
292 and for the establishment and maintenance of prescription drug
293 distribution records.
294 (6) RECORDKEEPING.--The department shall adopt rules that
295 require keeping such records of prescription drugs as are
296 necessary for the protection of the public health.
297 (h)1. This paragraph applies only to an affiliated group,
298 as defined in s. 1504 of the Internal Revenue Code of 1986, as
299 amended, which is composed of chain drug entities, including at
300 least 50 retail pharmacies, warehouses, or repackagers, which
301 are members of the same affiliated group if:
302 a. The group discloses to the department the names of all
303 the members of the affiliated group; and
304 b. The affiliated group agrees in writing to provide
305 records on prescription drug purchases by the members of the
306 affiliated group not later than 48 hours after the department
307 requests access to such records, regardless of the location of
308 where the records are stored.
309 2. Each warehouse within the affiliated group must comply
310 with all applicable federal and state drug wholesale permit
311 requirements and must purchase, receive, hold, and distribute
312 prescription drugs only to a retail pharmacy or warehouse within
313 the affiliated group. Such a warehouse is exempt from providing
314 a pedigree paper in accordance with paragraph (d) or paragraph
315 (e) to its affiliated group member warehouse, provided that:
316 a. Any affiliated group member that purchases or receives
317 a prescription drug from outside the affiliated group must
318 receive a pedigree paper if the prescription drug is distributed
319 in or into this state and a pedigree paper is required under
320 this section and must authenticate the documentation as required
321 in subsection (4), regardless of whether the affiliated group
322 member is directly subject to regulation under this chapter; and
323 b. The affiliated group makes available to the department
324 on request all records related to the purchase or acquisition of
325 prescription drugs by members of the affiliated group,
326 regardless of the location where the records are stored, if the
327 prescription drugs were distributed in or into this state.
328 3. If a repackager repackages prescription drugs solely
329 for distribution to its affiliated group members for the
330 exclusive distribution to and among retail pharmacies that are
331 members of the affiliated group to which the repackager is a
332 member:
333 a. The repackager must:
334 (I) In lieu of the written statement required by paragraph
335 (d) or paragraph (e), for all repackaged prescription drugs
336 distributed in or into this state, state in writing under oath
337 with each distribution of a repackaged prescription drug to an
338 affiliated group member warehouse or repackager: "All repackaged
339 prescription drugs are purchased by the affiliated group
340 directly from the manufacturer or from a prescription drug
341 wholesaler that purchased the prescription drugs directly from
342 the manufacturer.";
343 (II) Purchase all prescription drugs it repackages:
344 (A) Directly from the manufacturer; or
345 (B) From a prescription drug wholesaler that purchased the
346 prescription drugs directly from the manufacturer; and
347 (III) Maintain records in accordance with this section to
348 document that it purchased the prescription drugs directly from
349 the manufacturer or that its prescription drug wholesale
350 supplier purchased the prescription drugs directly from the
351 manufacturer.
352 b. In addition, all members of the affiliated group must
353 provide to agents of the department on request records of
354 purchases by all members of the affiliated group of prescription
355 drugs that have been repackaged, regardless of the location
356 where the records are stored or where the repackager is located.
357 4. This paragraph expires July 1, 2006.
358 Section 11. Paragraph (a) of subsection (1) of section
359 895.02, Florida Statutes, is amended to read:
360 895.02 Definitions.--As used in ss. 895.01-895.08, the
361 term:
362 (1) "Racketeering activity" means to commit, to attempt to
363 commit, to conspire to commit, or to solicit, coerce, or
364 intimidate another person to commit:
365 (a) Any crime which is chargeable by indictment or
366 information under the following provisions of the Florida
367 Statutes:
368 1. Section 210.18, relating to evasion of payment of
369 cigarette taxes.
370 2. Section 403.727(3)(b), relating to environmental
371 control.
372 3.4. Section 409.920, relating to Medicaid provider fraud.
373 4.3. Section 414.39, relating to public assistance fraud.
374 5. Section 440.105 or s. 440.106, relating to workers'
375 compensation.
376 6. Section 465.0161, relating to distribution of medicinal
377 drugs without a permit as an Internet pharmacy.
378 7.6. Sections 499.0051, 499.0052, 499.0053, 499.0054, and
379 499.0691, relating to crimes involving contraband and
380 adulterated drugs.
381 8.7. Part IV of chapter 501, relating to telemarketing.
382 9.8. Chapter 517, relating to sale of securities and
383 investor protection.
384 10.9. Section 550.235, s. 550.3551, or s. 550.3605,
385 relating to dogracing and horseracing.
386 11.10. Chapter 550, relating to jai alai frontons.
387 12.11. Chapter 552, relating to the manufacture,
388 distribution, and use of explosives.
389 13.12. Chapter 560, relating to money transmitters, if the
390 violation is punishable as a felony.
391 14.13. Chapter 562, relating to beverage law enforcement.
392 15.14. Section 624.401, relating to transacting insurance
393 without a certificate of authority, s. 624.437(4)(c)1., relating
394 to operating an unauthorized multiple-employer welfare
395 arrangement, or s. 626.902(1)(b), relating to representing or
396 aiding an unauthorized insurer.
397 16.15. Section 655.50, relating to reports of currency
398 transactions, when such violation is punishable as a felony.
399 17.16. Chapter 687, relating to interest and usurious
400 practices.
401 18.17. Section 721.08, s. 721.09, or s. 721.13, relating
402 to real estate timeshare plans.
403 19.18. Chapter 782, relating to homicide.
404 20.19. Chapter 784, relating to assault and battery.
405 21.20. Chapter 787, relating to kidnapping.
406 22.21. Chapter 790, relating to weapons and firearms.
407 23.22. Section 796.03, s. 796.04, s. 796.05, or s. 796.07,
408 relating to prostitution.
409 24.23. Chapter 806, relating to arson.
410 25.24. Section 810.02(2)(c), relating to specified
411 burglary of a dwelling or structure.
412 26.25. Chapter 812, relating to theft, robbery, and
413 related crimes.
414 27.26. Chapter 815, relating to computer-related crimes.
415 28.27. Chapter 817, relating to fraudulent practices,
416 false pretenses, fraud generally, and credit card crimes.
417 29.28. Chapter 825, relating to abuse, neglect, or
418 exploitation of an elderly person or disabled adult.
419 30.29. Section 827.071, relating to commercial sexual
420 exploitation of children.
421 31.30. Chapter 831, relating to forgery and
422 counterfeiting.
423 32.31. Chapter 832, relating to issuance of worthless
424 checks and drafts.
425 33.32. Section 836.05, relating to extortion.
426 34.33. Chapter 837, relating to perjury.
427 35.34. Chapter 838, relating to bribery and misuse of
428 public office.
429 36.35. Chapter 843, relating to obstruction of justice.
430 37.36. Section 847.011, s. 847.012, s. 847.013, s. 847.06,
431 or s. 847.07, relating to obscene literature and profanity.
432 38.37. Section 849.09, s. 849.14, s. 849.15, s. 849.23, or
433 s. 849.25, relating to gambling.
434 39.38. Chapter 874, relating to criminal street gangs.
435 40.39. Chapter 893, relating to drug abuse prevention and
436 control.
437 41.40. Chapter 896, relating to offenses related to
438 financial transactions.
439 42.41. Sections 914.22 and 914.23, relating to tampering
440 with a witness, victim, or informant, and retaliation against a
441 witness, victim, or informant.
442 43.42. Sections 918.12 and 918.13, relating to tampering
443 with jurors and evidence.
444 Section 12. The sum of $590,051 is appropriated from the
445 Medical Quality Assurance Trust Fund to the Department of
446 Health, and nine full-time equivalent positions are authorized,
447 for the 2004-2005 fiscal year for the purpose of implementing
448 this act.
449 Section 13. This act shall take effect July 1, 2004.


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Senate Bill sb1372er
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1

2 An act relating to pharmacy; amending s.

3 465.003, F.S.; defining the term "Internet

4 pharmacy"; amending s. 465.0156, F.S.;

5 exempting Internet pharmacies from registration

6 requirements applicable to nonresident

7 pharmacies; requiring the registered

8 nonresident pharmacy and the pharmacist

9 designated by that pharmacy to serve as the

10 prescription department manager or its

11 equivalent to be licensed in the state of

12 location; amending s. 465.016, F.S.; providing

13 for disciplinary action for dispensing a

14 medicinal drug when the pharmacist knows or has

15 reason to believe the prescription is not based

16 on a valid practitioner-patient relationship;

17 creating s. 465.0161, F.S.; prohibiting the

18 distribution of medicinal drugs by an Internet

19 pharmacy without a permit; providing penalties;

20 amending s. 465.0196, F.S., relating to special

21 pharmacy permits, to conform; creating s.

22 465.0197, F.S.; requiring Internet pharmacies

23 to be permitted and providing requirements

24 therefor; requiring the Internet pharmacy and

25 the pharmacist designated by that pharmacy to

26 serve as the prescription department manager or

27 its equivalent to be licensed in the state of

28 location; amending s. 465.023, F.S.; providing

29 an additional ground for which the Board of

30 Pharmacy may take action against a permitted

31 pharmacy; amending s. 465.0255, F.S.; revising


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1 requirements for pharmacists to deliver

2 specified disclosures to purchasers when

3 dispensing a medicinal drug; amending s.

4 465.026, F.S.; creating an exception to the

5 requirements for filling or refilling a

6 transferred prescription for a medicinal drug

7 listed in Schedule II under ch. 893, F.S.;

8 amending s. 499.0121, F.S.; providing

9 recordkeeping requirements relating to the

10 storage and handling of prescription drugs

11 which certain affiliated groups must fulfill;

12 amending s. 895.02, F.S.; including violation

13 of s. 465.0161, F.S., in the definition of the

14 term "racketeering activity" for prosecution

15 under ch. 895, F.S.; providing an appropriation

16 and authorizing positions; providing an

17 effective date.

18

19 Be It Enacted by the Legislature of the State of Florida:

20

21 Section 1. Paragraph (a) of subsection (11) of section

22 465.003, Florida Statutes, is amended to read:

23 465.003 Definitions.--As used in this chapter, the

24 term:

25 (11)(a) "Pharmacy" includes a community pharmacy, an

26 institutional pharmacy, a nuclear pharmacy, and a special

27 pharmacy, and an Internet pharmacy.

28 1. The term "community pharmacy" includes every

29 location where medicinal drugs are compounded, dispensed,

30 stored, or sold or where prescriptions are filled or dispensed

31 on an outpatient basis.


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1 2. The term "institutional pharmacy" includes every

2 location in a hospital, clinic, nursing home, dispensary,

3 sanitarium, extended care facility, or other facility,

4 hereinafter referred to as "health care institutions," where

5 medicinal drugs are compounded, dispensed, stored, or sold.

6 3. The term "nuclear pharmacy" includes every location

7 where radioactive drugs and chemicals within the

8 classification of medicinal drugs are compounded, dispensed,

9 stored, or sold. The term "nuclear pharmacy" does not include

10 hospitals licensed under chapter 395 or the nuclear medicine

11 facilities of such hospitals.

12 4. The term "special pharmacy" includes every location

13 where medicinal drugs are compounded, dispensed, stored, or

14 sold if such locations are not otherwise defined in this

15 subsection.

16 5. The term "Internet pharmacy" includes locations not

17 otherwise licensed or issued a permit under this chapter,

18 within or outside this state, which use the Internet to

19 communicate with or obtain information from consumers in this

20 state and use such communication or information to fill or

21 refill prescriptions or to dispense, distribute, or otherwise

22 engage in the practice of pharmacy in this state. Any act

23 described in this definition constitutes the practice of

24 pharmacy as defined in subsection (13).

25 Section 2. Subsections (7) and (8) are added to

26 section 465.0156, Florida Statutes, to read:

27 465.0156 Registration of nonresident pharmacies.--

28 (7) This section does not apply to Internet pharmacies

29 required to be permitted under s. 465.0197.

30 (8) Notwithstanding s. 465.003(10), for purposes of

31 this section, the registered pharmacy and the pharmacist


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1 designated by the registered pharmacy as the prescription

2 department manager or the equivalent must be licensed in the

3 state of location in order to dispense into this state.

4 Section 3. Paragraph (s) is added to subsection (1) of

5 section 465.016, Florida Statutes, to read:

6 465.016 Disciplinary actions.--

7 (1) The following acts constitute grounds for denial

8 of a license or disciplinary action, as specified in s.

9 456.072(2):

10 (s) Dispensing any medicinal drug based upon a

11 communication that purports to be a prescription as defined by

12 s. 465.003(14) or s. 893.02(20) when the pharmacist knows or

13 has reason to believe that the purported prescription is not

14 based upon a valid practitioner-patient relationship.

15 Section 4. Section 465.0161, Florida Statutes, is

16 created to read:

17 465.0161 Distribution of medicinal drugs without a

18 permit.--An Internet pharmacy that distributes a medicinal

19 drug to any person in this state without being permitted as a

20 pharmacy under this chapter commits a felony of the second

21 degree, punishable as provided in s. 775.082, s. 775.083, or

22 s. 775.084.

23 Section 5. Section 465.0196, Florida Statutes, is

24 amended to read:

25 465.0196 Special pharmacy permits.--Any person

26 desiring a permit to operate a special pharmacy which does not

27 fall within the definitions set forth in s. 465.003(11)(a)1.,

28 2., and 3. shall apply to the department for a special

29 pharmacy permit. If the board certifies that the application

30 complies with the applicable laws and rules of the board

31 governing the practice of the profession of pharmacy, the


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1 department shall issue the permit. No permit shall be issued

2 unless a licensed pharmacist is designated to undertake the

3 professional supervision of the compounding and dispensing of

4 all drugs dispensed by the pharmacy. The licensed pharmacist

5 shall be responsible for maintaining all drug records and for

6 providing for the security of the area in the facility in

7 which the compounding, storing, and dispensing of medicinal

8 drugs occurs. The permittee shall notify the department within

9 10 days of any change of the licensed pharmacist responsible

10 for such duties. Every permittee that employs or otherwise

11 utilizes pharmacy technicians shall have a written policy and

12 procedures manual specifying those duties, tasks, and

13 functions which a pharmacy technician is allowed to perform.

14 Section 6. Section 465.0197, Florida Statutes, is

15 created to read:

16 465.0197 Internet pharmacy permits.--

17 (1) Any person desiring a permit to operate an

18 Internet pharmacy shall apply to the department for an

19 Internet pharmacy permit. If the board certifies that the

20 application complies with the applicable laws and rules of the

21 board governing the practice of the profession of pharmacy,

22 the department shall issue the permit. No permit shall be

23 issued unless a licensed pharmacist is designated as the

24 prescription department manager for dispensing medicinal drugs

25 to persons in this state. The licensed pharmacist shall be

26 responsible for maintaining all drug records and for providing

27 for the security of the area in the facility in which the

28 compounding, storing, and dispensing of medicinal drugs to

29 persons in this state occurs. The permittee shall notify the

30 department within 30 days of any change of the licensed

31 pharmacist responsible for such duties. Every permittee that


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1 employs or otherwise utilizes pharmacy technicians shall have

2 a written policy and procedures manual specifying those

3 duties, tasks, and functions which a pharmacy technician is

4 allowed to perform.

5 (2) An Internet pharmacy must obtain a permit under

6 this section to sell medicinal drugs to persons in this state.

7 (3) An Internet pharmacy shall provide pharmacy

8 services at a high level of protection and competence and

9 shall disclose to the board the following specific

10 information:

11 (a) That it maintains at all times a valid, unexpired

12 license, permit, or registration to operate the pharmacy in

13 compliance with the laws of the state in which the dispensing

14 facility is located and from which the medicinal drugs shall

15 be dispensed.

16 (b) The location, names, and titles of all principal

17 corporate officers and the pharmacist who serves as the

18 prescription department manager for dispensing medicinal drugs

19 to persons in this state. This disclosure shall be made within

20 30 days after any change of location, principal corporate

21 officer, or pharmacist serving as the prescription department

22 manager for dispensing medicinal drugs to persons in this

23 state.

24 (c) That it complies with all lawful directions and

25 requests for information from the regulatory or licensing

26 agency of all states in which it is licensed as well as with

27 all requests for information made by the board pursuant to

28 this section. It shall respond directly to all communications

29 from the board concerning emergency circumstances arising from

30 errors in the dispensing of medicinal drugs to persons in this

31 state.


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1 (d) That it maintains its records of medicinal drugs

2 dispensed to patients in this state so that the records are

3 readily retrievable from the other business records of the

4 pharmacy and from the records of other medicinal drugs

5 dispensed.

6 (e) That during its regular hours of operation but not

7 less than 6 days per week, for a minimum of 40 hours per week,

8 a toll-free telephone service shall be provided to facilitate

9 communication between patients in this state and a pharmacist

10 at the pharmacy who has access to the patient's records. This

11 toll-free number must be disclosed on the label affixed to

12 each container of dispensed medicinal drugs.

13 (4) Notwithstanding s. 465.003(10), for purposes of

14 this section, the Internet pharmacy and the pharmacist

15 designated by the Internet pharmacy as the prescription

16 department manager or the equivalent must be licensed in the

17 state of location in order to dispense into this state.

18 Section 7. Subsection (1) of section 465.023, Florida

19 Statutes, is amended to read:

20 465.023 Pharmacy permittee; disciplinary action.--

21 (1) The department or the board may revoke or suspend

22 the permit of any pharmacy permittee, and may fine, place on

23 probation, or otherwise discipline any pharmacy permittee who

24 has:

25 (a) Obtained a permit by misrepresentation or fraud or

26 through an error of the department or the board;

27 (b) Attempted to procure, or has procured, a permit

28 for any other person by making, or causing to be made, any

29 false representation;

30 (c) Violated any of the requirements of this chapter

31 or any of the rules of the Board of Pharmacy; of chapter 499,


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1 known as the "Florida Drug and Cosmetic Act"; of 21 U.S.C. ss.

2 301-392, known as the "Federal Food, Drug, and Cosmetic Act";

3 of 21 U.S.C. ss. 821 et seq., known as the Comprehensive Drug

4 Abuse Prevention and Control Act; or of chapter 893; or

5 (d) Been convicted or found guilty, regardless of

6 adjudication, of a felony or any other crime involving moral

7 turpitude in any of the courts of this state, of any other

8 state, or of the United States; or.

9 (e) Dispensed any medicinal drug based upon a

10 communication that purports to be a prescription as defined by

11 s. 465.003(14) or s. 893.02(20) when the pharmacist knows or

12 has reason to believe that the purported prescription is not

13 based upon a valid practitioner-patient relationship that

14 includes a documented patient evaluation, including history

15 and a physical examination adequate to establish the diagnosis

16 for which any drug is prescribed and any other requirement

17 established by board rule under chapter 458, chapter 459,

18 chapter 461, chapter 463, chapter 464, or chapter 466.

19 Section 8. Section 465.0255, Florida Statutes, is

20 amended to read:

21 465.0255 Expiration date of medicinal drugs; display;

22 related use and storage instructions.--

23 (1) The manufacturer, repackager, or other distributor

24 of any medicinal drug shall display the expiration date of

25 each drug in a readable fashion on the container and on its

26 packaging. The term "readable" means conspicuous and bold.

27 (2) Each pharmacist for a community pharmacy

28 dispensing medicinal drugs and each practitioner dispensing

29 medicinal drugs on an outpatient basis shall display on the

30 outside of the container of each medicinal drug dispensed, or

31 in other written form delivered to the purchaser:,


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1 (a) The expiration date when provided by the

2 manufacturer, repackager, or other distributor of the drug; or

3 and

4 (b) An earlier beyond-use date for expiration, which

5 may be up to 1 year after the date of dispensing.

6

7 The dispensing pharmacist or practitioner must provide

8 information concerning the expiration date to the purchaser

9 upon request and must provide appropriate instructions

10 regarding the proper use and storage of the drug.

11 (3) Nothing in This section does not shall impose

12 liability on the dispensing pharmacist or practitioner for

13 damages related to, or caused by, a medicinal drug that loses

14 its effectiveness prior to the expiration date displayed by

15 the dispensing pharmacist or practitioner.

16 (4)(3) The provisions of this section are intended to

17 notify the patient receiving a medicinal drug of the

18 information required by this section, and the dispensing

19 pharmacist or practitioner shall not be liable for the

20 patient's failure to heed such notice or to follow the

21 instructions for storage.

22 Section 9. Subsection (7) is added to section 465.026,

23 Florida Statutes, to read:

24 465.026 Filling of certain prescriptions.--Nothing

25 contained in this chapter shall be construed to prohibit a

26 pharmacist licensed in this state from filling or refilling a

27 valid prescription which is on file in a pharmacy located in

28 this state or in another state and has been transferred from

29 one pharmacy to another by any means, including any electronic

30 means, under the following conditions:

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1 (7) A community pharmacy licensed under this chapter

2 which only receives and transfers prescriptions for dispensing

3 by another pharmacy may transfer a prescription for a

4 medicinal drug listed in Schedule II under chapter 893. The

5 pharmacy receiving the prescription may ship, mail, or deliver

6 into this state, in any manner, the dispensed Schedule II

7 medicinal drug under the following conditions:

8 (a) The pharmacy receiving and dispensing the

9 transferred prescription maintains at all times a valid,

10 unexpired license, permit, or registration to operate the

11 pharmacy in compliance with the laws of the state in which the

12 pharmacy is located and from which the medicinal drugs are

13 dispensed;

14 (b) The community pharmacy and the receiving pharmacy

15 are owned and operated by the same person and share a

16 centralized database; and

17 (c) The community pharmacy assures its compliance with

18 federal laws and subsections (1)-(5).

19 Section 10. Paragraph (h) is added to subsection (6)

20 of section 499.0121, Florida Statutes, to read:

21 499.0121 Storage and handling of prescription drugs;

22 recordkeeping.--The department shall adopt rules to implement

23 this section as necessary to protect the public health,

24 safety, and welfare. Such rules shall include, but not be

25 limited to, requirements for the storage and handling of

26 prescription drugs and for the establishment and maintenance

27 of prescription drug distribution records.

28 (6) RECORDKEEPING.--The department shall adopt rules

29 that require keeping such records of prescription drugs as are

30 necessary for the protection of the public health.

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1 (h)1. This paragraph applies only to an affiliated

2 group, as defined by s. 1504 of the Internal Revenue Code of

3 1986, as amended, which is composed of chain drug entities,

4 including at least 50 retail pharmacies, warehouses, or

5 repackagers, which are members of the same affiliated group,

6 if the affiliated group:

7 a. Discloses to the department the names of all its

8 members; and

9 b. Agrees in writing to provide records on

10 prescription drug purchases by members of the affiliated group

11 not later than 48 hours after the department requests such

12 records, regardless of the location where the records are

13 stored.

14 2. Each warehouse within the affiliated group must

15 comply with all applicable federal and state drug wholesale

16 permit requirements and must purchase, receive, hold, and

17 distribute prescription drugs only to a retail pharmacy or

18 warehouse within the affiliated group. Such a warehouse is

19 exempt from providing a pedigree paper in accordance with

20 paragraphs (d) and (e) to its affiliated group member

21 warehouse, provided that:

22 a. Any affiliated group member that purchases or

23 receives a prescription drug from outside the affiliated group

24 must receive a pedigree paper if the prescription drug is

25 distributed in or into this state and a pedigree paper is

26 required under this section and must authenticate the

27 documentation as required in subsection (4), regardless of

28 whether the affiliated group member is directly subject to

29 regulation under this chapter; and

30 b. The affiliated group makes available to the

31 department on request all records related to the purchase or


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1 acquisition of prescription drugs by members of the affiliated

2 group, regardless of the location where the records are

3 stored, if the prescription drugs were distributed in or into

4 this state.

5 3. If a repackager repackages prescription drugs

6 solely for distribution to its affiliated group members for

7 the exclusive distribution to and among retail pharmacies that

8 are members of the affiliated group to which the repackager is

9 a member:

10 a. The repackager must:

11 (I) In lieu of the written statement required by

12 paragraph (d) or paragraph (e), for all repackaged

13 prescription drugs distributed in or into this state, state in

14 writing under oath with each distribution of a repackaged

15 prescription drug to an affiliated group member warehouse or

16 repackager: "All repackaged prescription drugs are purchased

17 by the affiliated group directly from the manufacturer or from

18 a prescription drug wholesaler that purchased the prescription

19 drugs directly from the manufacturer.";

20 (II) Purchase all prescription drugs it repackages:

21 (A) Directly from the manufacturer; or

22 (B) From a prescription drug wholesaler that purchased

23 the prescription drugs directly from the manufacturer; and

24 (III) Maintain records in accordance with this section

25 to document that it purchased the prescription drugs directly

26 from the manufacturer or that its prescription drug wholesale

27 supplier purchased the prescription drugs directly from the

28 manufacturer.

29 b. All members of the affiliated group must provide to

30 agents of the department on request records of purchases by

31 all members of the affiliated group of prescription drugs that


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1 have been repackaged, regardless of the location where the

2 records are stored or where the repackager is located.

3 4. This paragraph expires July 1, 2006.

4 Section 11. Paragraph (a) of subsection (1) of section

5 895.02, Florida Statutes, is amended to read:

6 895.02 Definitions.--As used in ss. 895.01-895.08, the

7 term:

8 (1) "Racketeering activity" means to commit, to

9 attempt to commit, to conspire to commit, or to solicit,

10 coerce, or intimidate another person to commit:

11 (a) Any crime which is chargeable by indictment or

12 information under the following provisions of the Florida

13 Statutes:

14 1. Section 210.18, relating to evasion of payment of

15 cigarette taxes.

16 2. Section 403.727(3)(b), relating to environmental

17 control.

18 3.4. Section 409.920, relating to Medicaid provider

19 fraud.

20 4.3. Section 414.39, relating to public assistance

21 fraud.

22 5. Section 440.105 or s. 440.106, relating to workers'

23 compensation.

24 6. Section 465.0161, relating to distribution of

25 medicinal drugs without a permit as an Internet pharmacy.

26 7.6. Sections 499.0051, 499.0052, 499.0053, 499.0054,

27 and 499.0691, relating to crimes involving contraband and

28 adulterated drugs.

29 8.7. Part IV of chapter 501, relating to

30 telemarketing.

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1 9.8. Chapter 517, relating to sale of securities and

2 investor protection.

3 10.9. Section 550.235, s. 550.3551, or s. 550.3605,

4 relating to dogracing and horseracing.

5 11.10. Chapter 550, relating to jai alai frontons.

6 12.11. Chapter 552, relating to the manufacture,

7 distribution, and use of explosives.

8 13.12. Chapter 560, relating to money transmitters, if

9 the violation is punishable as a felony.

10 14.13. Chapter 562, relating to beverage law

11 enforcement.

12 15.14. Section 624.401, relating to transacting

13 insurance without a certificate of authority, s.

14 624.437(4)(c)1., relating to operating an unauthorized

15 multiple-employer welfare arrangement, or s. 626.902(1)(b),

16 relating to representing or aiding an unauthorized insurer.

17 16.15. Section 655.50, relating to reports of currency

18 transactions, when such violation is punishable as a felony.

19 17.16. Chapter 687, relating to interest and usurious

20 practices.

21 18.17. Section 721.08, s. 721.09, or s. 721.13,

22 relating to real estate timeshare plans.

23 19.18. Chapter 782, relating to homicide.

24 20.19. Chapter 784, relating to assault and battery.

25 21.20. Chapter 787, relating to kidnapping.

26 22.21. Chapter 790, relating to weapons and firearms.

27 23.22. Section 796.03, s. 796.04, s. 796.05, or s.

28 796.07, relating to prostitution.

29 24.23. Chapter 806, relating to arson.

30 25.24. Section 810.02(2)(c), relating to specified

31 burglary of a dwelling or structure.


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1 26.25. Chapter 812, relating to theft, robbery, and

2 related crimes.

3 27.26. Chapter 815, relating to computer-related

4 crimes.

5 28.27. Chapter 817, relating to fraudulent practices,

6 false pretenses, fraud generally, and credit card crimes.

7 29.28. Chapter 825, relating to abuse, neglect, or

8 exploitation of an elderly person or disabled adult.

9 30.29. Section 827.071, relating to commercial sexual

10 exploitation of children.

11 31.30. Chapter 831, relating to forgery and

12 counterfeiting.

13 32.31. Chapter 832, relating to issuance of worthless

14 checks and drafts.

15 33.32. Section 836.05, relating to extortion.

16 34.33. Chapter 837, relating to perjury.

17 35.34. Chapter 838, relating to bribery and misuse of

18 public office.

19 36.35. Chapter 843, relating to obstruction of

20 justice.

21 37.36. Section 847.011, s. 8

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"Whosoever is spared personal pain must feel himself called to help in diminishing the pain of others." Dr Albert Schweitzer

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