CS for SB 574 First Engrossed
2009574e1
1 A bill to be entitled
2 An act relating to the purchase of prescription drugs;
3 amending s. 499.003, F.S.; defining the term
4 “qualifying practitioner” as it relates to the Florida
5 Drug and Cosmetic Act; amending s. 499.01, F.S.;
6 deleting provisions requiring a health care clinic
7 establishment permit for the purchase of certain
8 prescription drugs; conforming a cross-reference;
9 amending s. 499.01211, F.S.; conforming a cross
10 reference; amending s. 499.03, F.S.; authorizing
11 certain establishments to possess prescription drugs;
12 creating s. 499.031, F.S.; establishing criteria for
13 certain business entities to purchase and possess
14 prescription drugs; requiring a qualifying
15 practitioner at the establishment; requiring the
16 registration of certain qualifying practitioners;
17 assigning duties and responsibilities to a qualifying
18 practitioner and business entity; providing for
19 expiration of the registration of a qualifying
20 practitioner and for renewal of the registration;
21 requiring the Department of Health to establish an
22 online registration system and post certain
23 information related to qualifying practitioners on its
24 website; providing additional grounds for discipline
25 of a qualifying practitioner; providing recordkeeping
26 requirements; amending s. 499.041, F.S.; deleting
27 provisions requiring a fee for a health care clinic
28 establishment permit to conform to changes made by the
29 act; requiring a fee to register as a qualifying
30 practitioner; authorizing a nonrefundable application
31 fee for withdrawn applications or applications that
32 become void; amending s. 499.05, F.S.; requiring the
33 department to adopt rules regarding record retention
34 requirements and procedures for registering and
35 renewing the registration of certain practitioners;
36 conforming cross-references; amending s. 400.9935,
37 F.S.; assigning responsibilities to a medical director
38 who acts as the qualifying practitioner of a licensed
39 health care clinic; amending ss. 409.9201 and
40 465.0265, F.S.; conforming cross-references; providing
41 an effective date.
42
43 Be It Enacted by the Legislature of the State of Florida:
44
45 Section 1. Present subsections (48) through (54) of section
46 499.003, Florida Statutes, are renumbered as subsections (49)
47 through (55), respectively, and a new subsection (48) is added
48 to that section, to read:
49 499.003 Definitions of terms used in this part.—As used in
50 this part, the term:
51 (48) “Qualifying practitioner” means a licensed health care
52 practitioner as defined in s. 456.001, or a veterinarian
53 licensed under chapter 474, who is authorized under the
54 appropriate practice act to prescribe and administer a
55 prescription drug.
56 Section 2. Subsection (1) and paragraphs (g) and (t) of
57 subsection (2) of section 499.01, Florida Statutes, are amended
58 to read:
59 499.01 Permits.—
60 (1) Prior to operating, a permit is required for each
61 person and establishment that intends to operate as:
62 (a) A prescription drug manufacturer;
63 (b) A prescription drug repackager;
64 (c) A nonresident prescription drug manufacturer;
65 (d) A prescription drug wholesale distributor;
66 (e) An out-of-state prescription drug wholesale
67 distributor;
68 (f) A retail pharmacy drug wholesale distributor;
69 (g) A restricted prescription drug distributor;
70 (h) A complimentary drug distributor;
71 (i) A freight forwarder;
72 (j) A veterinary prescription drug retail establishment;
73 (k) A veterinary prescription drug wholesale distributor;
74 (l) A limited prescription drug veterinary wholesale
75 distributor;
76 (m) A medical oxygen retail establishment;
77 (n) A compressed medical gas wholesale distributor;
78 (o) A compressed medical gas manufacturer;
79 (p) An over-the-counter drug manufacturer;
80 (q) A device manufacturer;
81 (r) A cosmetic manufacturer; or
82 (s) A third party logistics provider.; or
83 (t) A health care clinic establishment.
84 (2) The following permits are established:
85 (g) Restricted prescription drug distributor permit.—A
86 restricted prescription drug distributor permit is required for
87 any person that engages in the distribution of a prescription
88 drug, which distribution is not considered “wholesale
89 distribution” under s. 499.003(54)(a) s. 499.003(53)(a).
90 1. A person who engages in the receipt or distribution of a
91 prescription drug in this state for the purpose of processing
92 its return or its destruction must obtain a permit as a
93 restricted prescription drug distributor if such person is not
94 the person initiating the return, the prescription drug
95 wholesale supplier of the person initiating the return, or the
96 manufacturer of the drug.
97 2. Storage, handling, and recordkeeping of these
98 distributions must comply with the requirements for wholesale
99 distributors under s. 499.0121, but not those set forth in s.
100 499.01212.
101 3. A person who applies for a permit as a restricted
102 prescription drug distributor, or for the renewal of such a
103 permit, must provide to the department the information required
104 under s. 499.012.
105 4. The department may adopt rules regarding the
106 distribution of prescription drugs by hospitals, health care
107 entities, charitable organizations, or other persons not
108 involved in wholesale distribution, which rules are necessary
109 for the protection of the public health, safety, and welfare.
110 (t) Health care clinic establishment permit.—Effective
111 January 1, 2009, a health care clinic establishment permit is
112 required for the purchase of a prescription drug by a place of
113 business at one general physical location owned and operated by
114 a professional corporation or professional limited liability
115 company described in chapter 621, or a corporation that employs
116 a veterinarian as a qualifying practitioner. For the purpose of
117 this paragraph, the term “qualifying practitioner” means a
118 licensed health care practitioner defined in s. 456.001 or a
119 veterinarian licensed under chapter 474, who is authorized under
120 the appropriate practice act to prescribe and administer a
121 prescription drug.
122 1. An establishment must provide, as part of the
123 application required under s. 499.012, designation of a
124 qualifying practitioner who will be responsible for complying
125 with all legal and regulatory requirements related to the
126 purchase, recordkeeping, storage, and handling of the
127 prescription drugs. In addition, the designated qualifying
128 practitioner shall be the practitioner whose name, establishment
129 address, and license number is used on all distribution
130 documents for prescription drugs purchased or returned by the
131 health care clinic establishment. Upon initial appointment of a
132 qualifying practitioner, the qualifying practitioner and the
133 health care clinic establishment shall notify the department on
134 a form furnished by the department within 10 days after such
135 employment. In addition, the qualifying practitioner and health
136 care clinic establishment shall notify the department within 10
137 days after any subsequent change.
138 2. The health care clinic establishment must employ a
139 qualifying practitioner at each establishment.
140 3. In addition to the remedies and penalties provided in
141 this part, a violation of this chapter by the health care clinic
142 establishment or qualifying practitioner constitutes grounds for
143 discipline of the qualifying practitioner by the appropriate
144 regulatory board.
145 4. The purchase of prescription drugs by the health care
146 clinic establishment is prohibited during any period of time
147 when the establishment does not comply with this paragraph.
148 5. A health care clinic establishment permit is not a
149 pharmacy permit or otherwise subject to chapter 465. A health
150 care clinic establishment that meets the criteria of a modified
151 Class II institutional pharmacy under s. 465.019 is not eligible
152 to be permitted under this paragraph.
153 6. This paragraph does not prohibit a qualifying
154 practitioner from purchasing prescription drugs.
155 Section 3. Paragraph (b) of subsection (2) of section
156 499.01211, Florida Statutes, is amended to read:
157 499.01211 Drug Wholesale Distributor Advisory Council.—
158 (2) The State Surgeon General, or his or her designee, and
159 the Secretary of Health Care Administration, or her or his
160 designee, shall be members of the council. The State Surgeon
161 General shall appoint nine additional members to the council who
162 shall be appointed to a term of 4 years each, as follows:
163 (b) One person employed by a prescription drug wholesale
164 distributor licensed under this part which is a secondary
165 wholesale distributor, as defined in s. 499.003(52) s.
166 499.003(51).
167 Section 4. Subsection (1) of section 499.03, Florida
168 Statutes, is amended to read:
169 499.03 Possession of certain drugs without prescriptions
170 unlawful; exemptions and exceptions.—
171 (1) A person may not possess, or possess with intent to
172 sell, dispense, or deliver, any habit-forming, toxic, harmful,
173 or new drug subject to s. 499.003(32), or prescription drug as
174 defined in s. 499.003(42), unless the possession of the drug has
175 been obtained by a valid prescription of a practitioner licensed
176 by law to prescribe the drug. However, this section does not
177 apply to the delivery of such drugs to persons included in any
178 of the classes named in this subsection, or to the agents or
179 employees of such persons, for use in the usual course of their
180 businesses or practices or in the performance of their official
181 duties, as the case may be; nor does this section apply to the
182 possession of such drugs by those persons or their agents or
183 employees for such use:
184 (a) A licensed pharmacist or any person under the licensed
185 pharmacist’s supervision while acting within the scope of the
186 licensed pharmacist’s practice;
187 (b) A licensed practitioner authorized by law to prescribe
188 prescription drugs or any person under the licensed
189 practitioner’s supervision while acting within the scope of the
190 licensed practitioner’s practice;
191 (c) A qualified person who uses prescription drugs for
192 lawful research, teaching, or testing, and not for resale;
193 (d) A licensed hospital or other institution that procures
194 such drugs for lawful administration or dispensing by
195 practitioners;
196 (e) An officer or employee of a federal, state, or local
197 government; or
198 (f) A person that holds a valid permit issued by the
199 department pursuant to this part which authorizes that person to
200 possess prescription drugs; or
201 (g) An establishment of a legal business entity at which
202 qualifying practitioners practice their profession under state
203 law if the establishment complies with s. 499.031.
204 Section 5. Section 499.031, Florida Statutes, is created to
205 read:
206 499.031 Medical and veterinary clinics; purchase and
207 possession of prescription drugs; registration and duties of
208 qualifying practitioners.—
209 (1) An establishment of a legal business entity that has
210 been issued a federal tax identification number and through
211 which qualifying practitioners practice their profession under
212 state law and that:
213 (a) Has a qualifying practitioner registered with the
214 department who is an owner or member of the entity or an
215 employee of the entity at that establishment; or
216 (b) Is a health care clinic licensed under part X of
217 chapter 400 which has included in the medical director’s written
218 agreement the responsibility to serve as the qualifying
219 practitioner for the clinic,
220
221 may purchase and possess prescription drugs in the name of the
222 business entity in accordance with this section.
223 (2) A health care clinic licensed under part X of chapter
224 400 which does not have a medical director as provided in
225 subsection (1) for more than 10 days must register a qualifying
226 practitioner who meets the requirements of paragraph (1)(a) with
227 the department in order to purchase and possess prescription
228 drugs.
229 (3) A qualifying practitioner who is registered with the
230 department for an establishment and the business entity must
231 each notify the department, and any person from whom the
232 business entity has purchased prescription drugs for that
233 establishment in the previous 6 months, within 10 days after the
234 qualifying practitioner ceases serving as the qualifying
235 practitioner for that establishment. An establishment that is
236 required to have a qualifying practitioner registered with the
237 department must have a new qualifying practitioner registered
238 with the department within 10 days after a registered qualifying
239 practitioner ceases serving in that capacity.
240 (4) The business entity may purchase only prescription
241 drugs that the registered qualifying practitioner or medical
242 director serving as the qualifying practitioner of the
243 establishment is authorized to prescribe. The authorization to
244 purchase prescription drugs under this section is not a permit
245 that authorizes the purchase and possession of controlled
246 substances, and the business entity and establishment must
247 comply with chapter 893 and applicable federal law related to
248 controlled substances.
249 (5) The qualifying practitioner is responsible for
250 complying with all legal and regulatory requirements related to
251 the purchase, recordkeeping, storage, and handling of the
252 prescription drugs purchased by the business entity of the
253 establishment for which the health care practitioner or
254 veterinarian is the qualifying practitioner. A qualifying
255 practitioner must ensure that there are policies and procedures
256 for handling prescription drugs at an establishment which
257 protect the integrity of the drugs at the establishment and the
258 public health upon the termination of the qualifying
259 practitioner from serving in that capacity at the establishment.
260 (6) One qualifying practitioner at an establishment for
261 which a business entity wishes to purchase prescription drugs,
262 other than the medical director of a health care clinic as
263 described in paragraph (1)(b), must:
264 (a) Register with the department his or her name and
265 practitioner license number, the name of the business entity
266 that will be purchasing prescription drugs, and the address of
267 the establishment for which he or she is the qualifying
268 practitioner;
269 (b) Certify acceptance of the responsibilities of a
270 qualifying practitioner; and
271 (c) Pay the registration fee required in s. 499.041(10).
272 (7) A registration under this section automatically expires
273 upon the licensure renewal date of the qualifying practitioner’s
274 professional license, unless the qualifying practitioner has
275 previously notified the department that he or she has
276 discontinued serving as the qualifying practitioner for an
277 establishment of a business entity or the registration has been
278 previously revoked. The department shall provide for a
279 qualifying practitioner to renew his or her registration as a
280 qualifying practitioner for an establishment of a business
281 entity by a:
282 (a) Health care practitioner as defined in s. 456.001, as a
283 part of the renewal of the practitioner’s professional license;
284 or
285 (b) Veterinarian through an online registration system.
286 (8) The department shall establish an online system for the
287 registration of qualifying practitioners. Until the online
288 system is operational, the department must accept any written
289 document that provides the information required in subsection
290 (6), along with the registration fee. The name of the purchasing
291 business entity; the address of the establishment; and the name,
292 license number, and registration number of the qualifying
293 practitioner must be published on the department’s website.
294 (9) In addition to the remedies and penalties provided in
295 this part, a violation of this part constitutes grounds for
296 discipline against the qualifying practitioner by the
297 appropriate regulatory board.
298 (10) In addition to other recordkeeping requirements,
299 distribution documents for prescription drugs purchased or
300 returned by:
301 (a) An establishment that has a registered qualifying
302 practitioner must include the registration number of the
303 qualifying practitioner; or
304 (b) A health care clinic that has a medical director
305 serving as the qualifying practitioner must include the health
306 care clinic license number,
307
308 in order to comply with the requirement under s.
309 499.0121(6)(a)2. that records include the state license, permit,
310 or registration number of the person authorized to purchase
311 prescription drugs.
312 (11) This section does not prohibit a licensed practitioner
313 whose professional license authorizes the practitioner to
314 prescribe prescription drugs from purchasing prescription drugs
315 under his or her practice license.
316 Section 6. Section 499.041, Florida Statutes, is amended to
317 read:
318 499.041 Schedule of fees for drug, device, and cosmetic
319 applications and permits, product registrations, and free-sale
320 certificates.—
321 (1) The department shall assess applicants requiring a
322 manufacturing permit an annual fee within the ranges established
323 in this section for the specific type of manufacturer.
324 (a) The fee for a prescription drug manufacturer permit may
325 not be less than $500 or more than $750 annually.
326 (b) The fee for a device manufacturer permit may not be
327 less than $500 or more than $600 annually.
328 (c) The fee for a cosmetic manufacturer permit may not be
329 less than $250 or more than $400 annually.
330 (d) The fee for an over-the-counter drug manufacturer
331 permit may not be less than $300 or more than $400 annually.
332 (e) The fee for a compressed medical gas manufacturer
333 permit may not be less than $400 or more than $500 annually.
334 (f) The fee for a prescription drug repackager permit may
335 not be less than $500 or more than $750 annually.
336 (g) A manufacturer may not be required to pay more than one
337 fee per establishment to obtain an additional manufacturing
338 permit, but each manufacturer must pay the highest fee
339 applicable to his or her operation in each establishment.
340 (2) The department shall assess an applicant that is
341 required to have a wholesaling permit an annual fee within the
342 ranges established in this section for the specific type of
343 wholesaling.
344 (a) The fee for a prescription drug wholesale distributor
345 permit may not be less than $300 or more than $800 annually.
346 (b) The fee for a compressed medical gas wholesale
347 distributor permit may not be less than $200 or more than $300
348 annually.
349 (c) The fee for an out-of-state prescription drug wholesale
350 distributor permit may not be less than $300 or more than $800
351 annually.
352 (d) The fee for a nonresident prescription drug
353 manufacturer permit may not be less than $300 or more than $500
354 annually.
355 (e) The fee for a retail pharmacy drug wholesale
356 distributor permit may not be less than $35 or more than $50
357 annually.
358 (f) The fee for a freight forwarder permit may not be less
359 than $200 or more than $300 annually.
360 (g) The fee for a veterinary prescription drug wholesale
361 distributor permit may not be less than $300 or more than $500
362 annually.
363 (h) The fee for a limited prescription drug veterinary
364 wholesale distributor permit may not be less than $300 or more
365 than $500 annually.
366 (i) The fee for a third party logistics provider permit may
367 not be less than $200 or more than $300 annually.
368 (3) The department shall assess an applicant that is
369 required to have a retail establishment permit an annual fee
370 within the ranges established in this section for the specific
371 type of retail establishment.
372 (a) The fee for a veterinary prescription drug retail
373 establishment permit may not be less than $200 or more than $300
374 annually.
375 (b) The fee for a medical oxygen retail establishment
376 permit may not be less than $200 or more than $300 annually.
377 (c) The fee for a health care clinic establishment permit
378 may not be less than $125 or more than $250 annually.
379 (4) The department shall assess an applicant that is
380 required to have a restricted prescription drug distributor
381 permit an annual fee of not less than $200 or more than $300.
382 (5) In addition to the fee charged for a permit required by
383 this part, the department shall assess applicants an initial
384 application fee of $150 for each new permit issued by the
385 department which requires an onsite inspection.
386 (6) A person that is required to register drugs, devices,
387 or cosmetic products under s. 499.015 shall pay an annual
388 product registration fee of not less than $5 or more than $15
389 for each separate and distinct product in package form. The
390 registration fee is in addition to the fee charged for a free
391 sale certificate.
392 (7) The department shall assess an applicant that requests
393 a free-sale certificate a fee of $25. A fee of $2 will be
394 charged for each signature copy of a free-sale certificate that
395 is obtained at the same time the free-sale certificate is
396 issued.
397 (8) The department shall assess an out-of-state
398 prescription drug wholesale distributor applicant or permittee
399 an onsite inspection fee of not less than $1,000 or more than
400 $3,000 annually, to be based on the actual cost of the
401 inspection if an onsite inspection is performed by agents of the
402 department.
403 (9) The department shall assess each person applying for
404 certification as a designated representative a fee of $150, plus
405 the cost of processing the criminal history record check.
406 (10) The department shall assess a person registering as a
407 qualifying practitioner for an establishment under s. 499.031 a
408 fee of $25 for each establishment.
409 (11) The department shall assess each person applying for a
410 permit or certification as a designated representative a
411 nonrefundable application fee of $150 or 50 percent of the
412 permit or certification fee, whichever is less, if the
413 application is withdrawn or it becomes void.
414 (12)(10) The department shall assess other fees as provided
415 in this part.
416 Section 7. Subsection (1) of section 499.05, Florida
417 Statutes, is amended to read:
418 499.05 Rules.—
419 (1) The department shall adopt rules to implement and
420 enforce this part with respect to:
421 (a) The definition of terms used in this part, and used in
422 the rules adopted under this part, when the use of the term is
423 not its usual and ordinary meaning.
424 (b) Labeling requirements for drugs, devices, and
425 cosmetics.
426 (c) The establishment of fees authorized in this part.
427 (d) The identification of permits that require an initial
428 application and onsite inspection or other prerequisites for
429 permitting which demonstrate that the establishment and person
430 are in compliance with the requirements of this part.
431 (e) The application processes and forms for product
432 registration.
433 (f) Procedures for requesting and issuing certificates of
434 free sale.
435 (g) Inspections and investigations conducted under s.
436 499.051, and the identification of information claimed to be a
437 trade secret and exempt from the public records law as provided
438 in s. 499.051(7).
439 (h) The establishment of a range of penalties, as provided
440 in s. 499.066; requirements for notifying persons of the
441 potential impact of a violation of this part; and a process for
442 the uncontested settlement of alleged violations.
443 (i) Additional conditions that qualify as an emergency
444 medical reason under s. 499.003(54)(b)2 s. 499.003(53)(b)2.
445 (j) Procedures and forms relating to the pedigree paper
446 requirement of s. 499.01212.
447 (k) The protection of the public health, safety, and
448 welfare regarding good manufacturing practices that
449 manufacturers and repackagers must follow to ensure the safety
450 of the products.
451 (l) Information required from each retail establishment
452 pursuant to s. 499.012(3), including requirements for
453 prescriptions or orders.
454 (m) The recordkeeping, storage, and handling with respect
455 to each of the distributions of prescription drugs specified in
456 s. 499.003(54)(a)-(d) s. 499.003(53)(a)-(d).
457 (n) Alternatives to compliance with s. 499.01212 for a
458 prescription drug in the inventory of a permitted prescription
459 drug wholesale distributor as of June 30, 2006, and the return
460 of a prescription drug purchased prior to July 1, 2006. The
461 department may specify time limits for such alternatives.
462 (o) Record retention requirements and procedures for
463 registering and renewing the registration of a qualifying
464 practitioner related to a business entity purchasing and
465 possessing prescription drugs under s. 499.031.
466 Section 8. Paragraph (i) is added to subsection (1) of
467 section 400.9935, Florida Statutes, to read:
468 400.9935 Clinic responsibilities.—
469 (1) Each clinic shall appoint a medical director or clinic
470 director who shall agree in writing to accept legal
471 responsibility for the following activities on behalf of the
472 clinic. The medical director or the clinic director shall:
473 (i) Be responsible for complying with all legal and
474 regulatory requirements related to the purchase, recordkeeping,
475 storage, and handling of prescription drugs that have been sold
476 to the clinic using the medical director as the qualifying
477 practitioner under ss. 499.03 and 499.031.
478 Section 9. Paragraph (a) of subsection (1) of section
479 409.9201, Florida Statutes, is amended to read:
480 409.9201 Medicaid fraud.—
481 (1) As used in this section, the term:
482 (a) “Prescription drug” means any drug, including, but not
483 limited to, finished dosage forms or active ingredients that are
484 subject to, defined by, or described by s. 503(b) of the Federal
485 Food, Drug, and Cosmetic Act or by s. 465.003(8), s. 499.003(45)
486 or (53) (52), or s. 499.007(13).
487
488 The value of individual items of the legend drugs or goods or
489 services involved in distinct transactions committed during a
490 single scheme or course of conduct, whether involving a single
491 person or several persons, may be aggregated when determining
492 the punishment for the offense.
493 Section 10. Subsection (3) of section 465.0265, Florida
494 Statutes, is amended to read:
495 465.0265 Centralized prescription filling.—
496 (3) The filling, delivery, and return of a prescription by
497 one pharmacy for another pursuant to this section shall not be
498 construed as the filling of a transferred prescription as set
499 forth in s. 465.026 or as a wholesale distribution as set forth
500 in s. 499.003(54) s. 499.003(53).
501 Section 11. This act shall take effect July 1, 2009.