Florida Senate - 2009 CS for SB 574
By the Committee on Health Regulation; and Senator Gaetz
588-02374-09 2009574c1
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31 fee for withdrawn applications or applications that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.; conforming
33 cross-references; amending s. 400.9935, F.S.;
34 assigning responsibilities to a medical director who
35 acts as the qualifying practitioner of a licensed
36 health care clinic; amending ss. 409.9201 and
37 465.0265, F.S.; conforming cross-references; providing
38 an effective date.
39
40 Be It Enacted by the Legislature of the State of Florida:
41
42 Section 1. Present subsections (48) through (54) of section
43 499.003, Florida Statutes, are renumbered as subsections (49)
44 through (55), respectively, and a new subsection (48) is added
45 to that section, to read:
46 499.003 Definitions of terms used in this part.—As used in
47 this part, the term:
48 (48) “Qualifying practitioner” means a licensed health care
49 practitioner as defined in s. 456.001, or a veterinarian
50 licensed under chapter 474, who is authorized under the
51 appropriate practice act to prescribe and administer a
52 prescription drug.
53 Section 2. Subsection (1) and paragraphs (g) and (t) of
54 subsection (2) of section 499.01, Florida Statutes, are amended
55 to read:
56 499.01 Permits.—
57 (1) Prior to operating, a permit is required for each
58 person and establishment that intends to operate as:
59 (a) A prescription drug manufacturer;
60 (b) A prescription drug repackager;
61 (c) A nonresident prescription drug manufacturer;
62 (d) A prescription drug wholesale distributor;
63 (e) An out-of-state prescription drug wholesale
64 distributor;
65 (f) A retail pharmacy drug wholesale distributor;
66 (g) A restricted prescription drug distributor;
67 (h) A complimentary drug distributor;
68 (i) A freight forwarder;
69 (j) A veterinary prescription drug retail establishment;
70 (k) A veterinary prescription drug wholesale distributor;
71 (l) A limited prescription drug veterinary wholesale
72 distributor;
73 (m) A medical oxygen retail establishment;
74 (n) A compressed medical gas wholesale distributor;
75 (o) A compressed medical gas manufacturer;
76 (p) An over-the-counter drug manufacturer;
77 (q) A device manufacturer;
78 (r) A cosmetic manufacturer; or
79 (s) A third party logistics provider.; or
80 (t) A health care clinic establishment.
81 (2) The following permits are established:
82 (g) Restricted prescription drug distributor permit.—A
83 restricted prescription drug distributor permit is required for
84 any person that engages in the distribution of a prescription
85 drug, which distribution is not considered “wholesale
86 distribution” under s. 499.003(54)(a) s. 499.003(53)(a).
87 1. A person who engages in the receipt or distribution of a
88 prescription drug in this state for the purpose of processing
89 its return or its destruction must obtain a permit as a
90 restricted prescription drug distributor if such person is not
91 the person initiating the return, the prescription drug
92 wholesale supplier of the person initiating the return, or the
93 manufacturer of the drug.
94 2. Storage, handling, and recordkeeping of these
95 distributions must comply with the requirements for wholesale
96 distributors under s. 499.0121, but not those set forth in s.
97 499.01212.
98 3. A person who applies for a permit as a restricted
99 prescription drug distributor, or for the renewal of such a
100 permit, must provide to the department the information required
101 under s. 499.012.
102 4. The department may adopt rules regarding the
103 distribution of prescription drugs by hospitals, health care
104 entities, charitable organizations, or other persons not
105 involved in wholesale distribution, which rules are necessary
106 for the protection of the public health, safety, and welfare.
107 (t) Health care clinic establishment permit.—Effective
108 January 1, 2009, a health care clinic establishment permit is
109 required for the purchase of a prescription drug by a place of
110 business at one general physical location owned and operated by
111 a professional corporation or professional limited liability
112 company described in chapter 621, or a corporation that employs
113 a veterinarian as a qualifying practitioner. For the purpose of
114 this paragraph, the term “qualifying practitioner” means a
115 licensed health care practitioner defined in s. 456.001 or a
116 veterinarian licensed under chapter 474, who is authorized under
117 the appropriate practice act to prescribe and administer a
118 prescription drug.
119 1. An establishment must provide, as part of the
120 application required under s. 499.012, designation of a
121 qualifying practitioner who will be responsible for complying
122 with all legal and regulatory requirements related to the
123 purchase, recordkeeping, storage, and handling of the
124 prescription drugs. In addition, the designated qualifying
125 practitioner shall be the practitioner whose name, establishment
126 address, and license number is used on all distribution
127 documents for prescription drugs purchased or returned by the
128 health care clinic establishment. Upon initial appointment of a
129 qualifying practitioner, the qualifying practitioner and the
130 health care clinic establishment shall notify the department on
131 a form furnished by the department within 10 days after such
132 employment. In addition, the qualifying practitioner and health
133 care clinic establishment shall notify the department within 10
134 days after any subsequent change.
135 2. The health care clinic establishment must employ a
136 qualifying practitioner at each establishment.
137 3. In addition to the remedies and penalties provided in
138 this part, a violation of this chapter by the health care clinic
139 establishment or qualifying practitioner constitutes grounds for
140 discipline of the qualifying practitioner by the appropriate
141 regulatory board.
142 4. The purchase of prescription drugs by the health care
143 clinic establishment is prohibited during any period of time
144 when the establishment does not comply with this paragraph.
145 5. A health care clinic establishment permit is not a
146 pharmacy permit or otherwise subject to chapter 465. A health
147 care clinic establishment that meets the criteria of a modified
148 Class II institutional pharmacy under s. 465.019 is not eligible
149 to be permitted under this paragraph.
150 6. This paragraph does not prohibit a qualifying
151 practitioner from purchasing prescription drugs.
152 Section 3. Paragraph (b) of subsection (2) of section
153 499.01211, Florida Statutes, is amended to read:
154 499.01211 Drug Wholesale Distributor Advisory Council.—
155 (2) The State Surgeon General, or his or her designee, and
156 the Secretary of Health Care Administration, or her or his
157 designee, shall be members of the council. The State Surgeon
158 General shall appoint nine additional members to the council who
159 shall be appointed to a term of 4 years each, as follows:
160 (b) One person employed by a prescription drug wholesale
161 distributor licensed under this part which is a secondary
162 wholesale distributor, as defined in s. 499.003(52) s.
163 499.003(51).
164 Section 4. Subsection (1) of section 499.03, Florida
165 Statutes, is amended to read:
166 499.03 Possession of certain drugs without prescriptions
167 unlawful; exemptions and exceptions.—
168 (1) A person may not possess, or possess with intent to
169 sell, dispense, or deliver, any habit-forming, toxic, harmful,
170 or new drug subject to s. 499.003(32), or prescription drug as
171 defined in s. 499.003(42), unless the possession of the drug has
172 been obtained by a valid prescription of a practitioner licensed
173 by law to prescribe the drug. However, this section does not
174 apply to the delivery of such drugs to persons included in any
175 of the classes named in this subsection, or to the agents or
176 employees of such persons, for use in the usual course of their
177 businesses or practices or in the performance of their official
178 duties, as the case may be; nor does this section apply to the
179 possession of such drugs by those persons or their agents or
180 employees for such use:
181 (a) A licensed pharmacist or any person under the licensed
182 pharmacist’s supervision while acting within the scope of the
183 licensed pharmacist’s practice;
184 (b) A licensed practitioner authorized by law to prescribe
185 prescription drugs or any person under the licensed
186 practitioner’s supervision while acting within the scope of the
187 licensed practitioner’s practice;
188 (c) A qualified person who uses prescription drugs for
189 lawful research, teaching, or testing, and not for resale;
190 (d) A licensed hospital or other institution that procures
191 such drugs for lawful administration or dispensing by
192 practitioners;
193 (e) An officer or employee of a federal, state, or local
194 government; or
195 (f) A person that holds a valid permit issued by the
196 department pursuant to this part which authorizes that person to
197 possess prescription drugs; or
198 (g) An establishment of a legal business entity at which
199 qualifying practitioners practice their profession under state
200 law if the establishment complies with s. 499.031.
201 Section 5. Section 499.031, Florida Statutes, is created to
202 read:
203 499.031 Medical and veterinary clinics; purchase and
204 possession of prescription drugs; registration and duties of
205 qualifying practitioners.—
206 (1) An establishment of a legal business entity that has
207 been issued a federal tax identification number and through
208 which qualifying practitioners practice their profession under
209 state law and that:
210 (a) Has a qualifying practitioner registered with the
211 department who is an owner or member of the entity or an
212 employee of the entity at that establishment; or
213 (b) Is a health care clinic licensed under part X of
214 chapter 400 which has included in the medical director’s written
215 agreement the responsibility to serve as the qualifying
216 practitioner for the clinic,
217
218 may purchase and possess prescription drugs in the name of the
219 business entity in accordance with this section.
220 (2) A health care clinic licensed under part X of chapter
221 400 which does not have a medical director as provided in
222 subsection (1) for more than 10 days must register a qualifying
223 practitioner who meets the requirements of paragraph (1)(a) with
224 the department in order to purchase and possess prescription
225 drugs.
226 (3) A qualifying practitioner who is registered with the
227 department for an establishment and the business entity must
228 each notify the department, and any person from whom the
229 business entity has purchased prescription drugs for that
230 establishment in the previous 6 months, within 10 days after the
231 qualifying practitioner ceases serving as the qualifying
232 practitioner for that establishment. An establishment that is
233 required to have a qualifying practitioner registered with the
234 department must have a new qualifying practitioner registered
235 with the department within 10 days after a registered qualifying
236 practitioner ceases serving in that capacity.
237 (4) The business entity may purchase only prescription
238 drugs that the registered qualifying practitioner or medical
239 director serving as the qualifying practitioner of the
240 establishment is authorized to prescribe. The authorization to
241 purchase prescription drugs under this section is not a permit
242 that authorizes the purchase and possession of controlled
243 substances, and the business entity and establishment must
244 comply with chapter 893 and applicable federal law related to
245 controlled substances.
246 (5) The qualifying practitioner is responsible for
247 complying with all legal and regulatory requirements related to
248 the purchase, recordkeeping, storage, and handling of the
249 prescription drugs purchased by the business entity of the
250 establishment for which the health care practitioner or
251 veterinarian is the qualifying practitioner. A qualifying
252 practitioner must ensure that there are policies and procedures
253 for handling prescription drugs at an establishment which
254 protect the integrity of the drugs at the establishment and the
255 public health upon the termination of the qualifying
256 practitioner from serving in that capacity at the establishment.
257 (6) One qualifying practitioner at an establishment for
258 which a business entity wishes to purchase prescription drugs,
259 other than the medical director of a health care clinic as
260 described in paragraph (1)(b), must:
261 (a) Register with the department his or her name and
262 practitioner license number, the name of the business entity
263 that will be purchasing prescription drugs, and the address of
264 the establishment for which he or she is the qualifying
265 practitioner;
266 (b) Certify acceptance of the responsibilities of a
267 qualifying practitioner; and
268 (c) Pay the registration fee required in s. 499.041(10).
269 (7) A registration under this section automatically expires
270 upon the licensure renewal date of the qualifying practitioner’s
271 professional license, unless the qualifying practitioner has
272 previously notified the department that he or she has
273 discontinued serving as the qualifying practitioner for an
274 establishment of a business entity or the registration has been
275 previously revoked. The department shall provide for a
276 qualifying practitioner to renew his or her registration as a
277 qualifying practitioner for an establishment of a business
278 entity as a part of the renewal of the practitioner’s
279 professional license.
280 (8) The department shall establish an online system for the
281 registration of qualifying practitioners. Until the online
282 system is operational, the department must accept any written
283 document that provides the information required in subsection
284 (6), along with the registration fee. The name of the purchasing
285 business entity; the address of the establishment; and the name,
286 license number, and registration number of the qualifying
287 practitioner must be published on the department’s website.
288 (9) In addition to the remedies and penalties provided in
289 this part, a violation of this part constitutes grounds for
290 discipline against the qualifying practitioner by the
291 appropriate regulatory board.
292 (10) In addition to other recordkeeping requirements,
293 distribution documents for prescription drugs purchased or
294 returned by:
295 (a) An establishment that has a registered qualifying
296 practitioner must include the registration number of the
297 qualifying practitioner; or
298 (b) A health care clinic that has a medical director
299 serving as the qualifying practitioner must include the health
300 care clinic license number.
301 (11) This section does not prohibit a licensed practitioner
302 whose professional license authorizes the practitioner to
303 prescribe prescription drugs from purchasing prescription drugs
304 under his or her practice license.
305 Section 6. Section 499.041, Florida Statutes, is amended to
306 read:
307 499.041 Schedule of fees for drug, device, and cosmetic
308 applications and permits, product registrations, and free-sale
309 certificates.—
310 (1) The department shall assess applicants requiring a
311 manufacturing permit an annual fee within the ranges established
312 in this section for the specific type of manufacturer.
313 (a) The fee for a prescription drug manufacturer permit may
314 not be less than $500 or more than $750 annually.
315 (b) The fee for a device manufacturer permit may not be
316 less than $500 or more than $600 annually.
317 (c) The fee for a cosmetic manufacturer permit may not be
318 less than $250 or more than $400 annually.
319 (d) The fee for an over-the-counter drug manufacturer
320 permit may not be less than $300 or more than $400 annually.
321 (e) The fee for a compressed medical gas manufacturer
322 permit may not be less than $400 or more than $500 annually.
323 (f) The fee for a prescription drug repackager permit may
324 not be less than $500 or more than $750 annually.
325 (g) A manufacturer may not be required to pay more than one
326 fee per establishment to obtain an additional manufacturing
327 permit, but each manufacturer must pay the highest fee
328 applicable to his or her operation in each establishment.
329 (2) The department shall assess an applicant that is
330 required to have a wholesaling permit an annual fee within the
331 ranges established in this section for the specific type of
332 wholesaling.
333 (a) The fee for a prescription drug wholesale distributor
334 permit may not be less than $300 or more than $800 annually.
335 (b) The fee for a compressed medical gas wholesale
336 distributor permit may not be less than $200 or more than $300
337 annually.
338 (c) The fee for an out-of-state prescription drug wholesale
339 distributor permit may not be less than $300 or more than $800
340 annually.
341 (d) The fee for a nonresident prescription drug
342 manufacturer permit may not be less than $300 or more than $500
343 annually.
344 (e) The fee for a retail pharmacy drug wholesale
345 distributor permit may not be less than $35 or more than $50
346 annually.
347 (f) The fee for a freight forwarder permit may not be less
348 than $200 or more than $300 annually.
349 (g) The fee for a veterinary prescription drug wholesale
350 distributor permit may not be less than $300 or more than $500
351 annually.
352 (h) The fee for a limited prescription drug veterinary
353 wholesale distributor permit may not be less than $300 or more
354 than $500 annually.
355 (i) The fee for a third party logistics provider permit may
356 not be less than $200 or more than $300 annually.
357 (3) The department shall assess an applicant that is
358 required to have a retail establishment permit an annual fee
359 within the ranges established in this section for the specific
360 type of retail establishment.
361 (a) The fee for a veterinary prescription drug retail
362 establishment permit may not be less than $200 or more than $300
363 annually.
364 (b) The fee for a medical oxygen retail establishment
365 permit may not be less than $200 or more than $300 annually.
366 (c) The fee for a health care clinic establishment permit
367 may not be less than $125 or more than $250 annually.
368 (4) The department shall assess an applicant that is
369 required to have a restricted prescription drug distributor
370 permit an annual fee of not less than $200 or more than $300.
371 (5) In addition to the fee charged for a permit required by
372 this part, the department shall assess applicants an initial
373 application fee of $150 for each new permit issued by the
374 department which requires an onsite inspection.
375 (6) A person that is required to register drugs, devices,
376 or cosmetic products under s. 499.015 shall pay an annual
377 product registration fee of not less than $5 or more than $15
378 for each separate and distinct product in package form. The
379 registration fee is in addition to the fee charged for a free
380 sale certificate.
381 (7) The department shall assess an applicant that requests
382 a free-sale certificate a fee of $25. A fee of $2 will be
383 charged for each signature copy of a free-sale certificate that
384 is obtained at the same time the free-sale certificate is
385 issued.
386 (8) The department shall assess an out-of-state
387 prescription drug wholesale distributor applicant or permittee
388 an onsite inspection fee of not less than $1,000 or more than
389 $3,000 annually, to be based on the actual cost of the
390 inspection if an onsite inspection is performed by agents of the
391 department.
392 (9) The department shall assess each person applying for
393 certification as a designated representative a fee of $150, plus
394 the cost of processing the criminal history record check.
395 (10) The department shall assess a person registering as a
396 qualifying practitioner for an establishment under s. 499.031 a
397 fee of $25 for each establishment.
398 (11) The department shall assess each person applying for a
399 permit or certification as a designated representative a
400 nonrefundable application fee of $150 or 50 percent of the
401 permit or certification fee, whichever is less, if the
402 application is withdrawn or it becomes void.
403 (12)(10) The department shall assess other fees as provided
404 in this part.
405 Section 7. Paragraphs (i) and (m) of subsection (1) of
406 section 499.05, Florida Statutes, are amended to read:
407 499.05 Rules.—
408 (1) The department shall adopt rules to implement and
409 enforce this part with respect to:
410 (i) Additional conditions that qualify as an emergency
411 medical reason under s. 499.003(54)(b)2. s. 499.003(53)(b)2.
412 (m) The recordkeeping, storage, and handling with respect
413 to each of the distributions of prescription drugs specified in
414 s. 499.003(54)(a)-(d) s. 499.003(53)(a)-(d).
415 Section 8. Paragraph (i) is added to subsection (1) of
416 section 400.9935, Florida Statutes, to read:
417 400.9935 Clinic responsibilities.—
418 (1) Each clinic shall appoint a medical director or clinic
419 director who shall agree in writing to accept legal
420 responsibility for the following activities on behalf of the
421 clinic. The medical director or the clinic director shall:
422 (i) Be responsible for complying with all legal and
423 regulatory requirements related to the purchase, recordkeeping,
424 storage, and handling of prescription drugs that have been sold
425 to the clinic using the medical director as the qualifying
426 practitioner under ss. 499.03 and 499.031.
427 Section 9. Paragraph (a) of subsection (1) of section
428 409.9201, Florida Statutes, is amended to read:
429 409.9201 Medicaid fraud.—
430 (1) As used in this section, the term:
431 (a) “Prescription drug” means any drug, including, but not
432 limited to, finished dosage forms or active ingredients that are
433 subject to, defined by, or described by s. 503(b) of the Federal
434 Food, Drug, and Cosmetic Act or by s. 465.003(8), s. 499.003(45)
435 or (53) (52), or s. 499.007(13).
436
437 The value of individual items of the legend drugs or goods or
438 services involved in distinct transactions committed during a
439 single scheme or course of conduct, whether involving a single
440 person or several persons, may be aggregated when determining
441 the punishment for the offense.
442 Section 10. Subsection (3) of section 465.0265, Florida
443 Statutes, is amended to read:
444 465.0265 Centralized prescription filling.—
445 (3) The filling, delivery, and return of a prescription by
446 one pharmacy for another pursuant to this section shall not be
447 construed as the filling of a transferred prescription as set
448 forth in s. 465.026 or as a wholesale distribution as set forth
449 in s. 499.003(54) s. 499.003(53).
450 Section 11. This act shall take effect July 1, 2009.