Bill Text: FL S1128 | 2018 | Regular Session | Comm Sub
Bill Title: Pharmacies
Spectrum: Bipartisan Bill
Status: (Introduced - Dead) 2018-03-08 - Laid on Table, refer to CS/HB 675 [S1128 Detail]
Download: Florida-2018-S1128-Comm_Sub.html
Florida Senate - 2018 CS for SB 1128
By the Committee on Health Policy; and Senator Stargel
588-02616-18 20181128c1
1 A bill to be entitled
2 An act relating to pharmacies; amending s. 465.003,
3 F.S.; revising and providing definitions; amending s.
4 465.004, F.S.; revising the membership of the Board of
5 Pharmacy; amending s. 465.019, F.S.; establishing
6 Class III institutional pharmacies; providing
7 requirements for such pharmacies; conforming
8 provisions to changes made by the act; amending s.
9 465.0252, F.S.; revising notice requirements to
10 conform to changes made by the act; amending s.
11 499.003, F.S.; providing and revising definitions;
12 amending s. 499.01, F.S.; authorizing the distribution
13 of medicinal drugs and prepackaged drug products
14 without a specified permit under certain conditions;
15 deleting a provision exempting certain drug
16 repackagers from specified permit requirements;
17 providing an effective date.
18
19 Be It Enacted by the Legislature of the State of Florida:
20
21 Section 1. Subsections (7) and (13) of section 465.003,
22 Florida Statutes, are amended, and subsections (21) and (22) are
23 added to that section, to read:
24 465.003 Definitions.—As used in this chapter, the term:
25 (7) “Institutional formulary system” means a method whereby
26 the medical staff evaluates, appraises, and selects those
27 medicinal drugs or proprietary preparations which in the medical
28 staff’s clinical judgment are most useful in patient care, and
29 which are available for dispensing by a practicing pharmacist in
30 a Class II or Class III institutional pharmacy.
31 (13) “Practice of the profession of pharmacy” includes
32 compounding, dispensing, and consulting concerning contents,
33 therapeutic values, and uses of any medicinal drug; consulting
34 concerning therapeutic values and interactions of patent or
35 proprietary preparations, whether pursuant to prescriptions or
36 in the absence and entirely independent of such prescriptions or
37 orders; and conducting other pharmaceutical services. For
38 purposes of this subsection, “other pharmaceutical services”
39 means the monitoring of the patient’s drug therapy and assisting
40 the patient in the management of his or her drug therapy, and
41 includes review of the patient’s drug therapy and communication
42 with the patient’s prescribing health care provider as licensed
43 under chapter 458, chapter 459, chapter 461, or chapter 466, or
44 similar statutory provision in another jurisdiction, or such
45 provider’s agent or such other persons as specifically
46 authorized by the patient, regarding the drug therapy. However,
47 nothing in this subsection may be interpreted to permit an
48 alteration of a prescriber’s directions, the diagnosis or
49 treatment of any disease, the initiation of any drug therapy,
50 the practice of medicine, or the practice of osteopathic
51 medicine, unless otherwise permitted by law. “Practice of the
52 profession of pharmacy” also includes any other act, service,
53 operation, research, or transaction incidental to, or forming a
54 part of, any of the foregoing acts, requiring, involving, or
55 employing the science or art of any branch of the pharmaceutical
56 profession, study, or training, and shall expressly permit a
57 pharmacist to transmit information from persons authorized to
58 prescribe medicinal drugs to their patients. The practice of the
59 profession of pharmacy also includes the administration of
60 vaccines to adults pursuant to s. 465.189 and the preparation of
61 prepackaged drug products in facilities holding Class III
62 institutional pharmacy permits.
63 (21) “Central distribution facility” means a facility under
64 common control with a hospital holding a Class III institutional
65 pharmacy permit that may dispense, distribute, compound, or fill
66 prescriptions for medicinal drugs; prepare prepackaged drug
67 products; and conduct other pharmaceutical services.
68 (22) “Common control” means the power to direct or cause
69 the direction of the management and policies of a person or an
70 organization, whether by ownership of stock, voting rights,
71 contract, or otherwise.
72 Section 2. Subsection (2) of section 465.004, Florida
73 Statutes, is amended to read:
74 465.004 Board of Pharmacy.—
75 (2) Seven members of the board must be licensed pharmacists
76 who are residents of this state and who have been engaged in the
77 practice of the profession of pharmacy in this state for at
78 least 4 years and, to the extent practicable, represent the
79 various pharmacy practice settings. Of the pharmacist members,
80 two must be currently engaged in the practice of pharmacy in a
81 community pharmacy, two must be currently engaged in the
82 practice of pharmacy in a Class II, institutional pharmacy or a
83 Modified Class II, or Class III institutional pharmacy, and
84 three must be pharmacists licensed in this state irrespective of
85 practice setting. The remaining two members must be residents of
86 the state who have never been licensed as pharmacists and who
87 are in no way connected with the practice of the profession of
88 pharmacy. No person may be appointed as a consumer member who is
89 in any way connected with a drug manufacturer or wholesaler. At
90 least one member of the board must be 60 years of age or older.
91 The Governor shall appoint members to the board in accordance
92 with this subsection as members’ terms expire or as a vacancy
93 occurs until the composition of the board complies with the
94 requirements of this subsection.
95 Section 3. Subsections (4) and (6) of section 465.019,
96 Florida Statutes, are amended, and paragraph (d) is added to
97 subsection (2) of that section, to read:
98 465.019 Institutional pharmacies; permits.—
99 (2) The following classes of institutional pharmacies are
100 established:
101 (d)1. “Class III institutional pharmacies” are those
102 institutional pharmacies, including central distribution
103 facilities, affiliated with a hospital that provide the same
104 services that are authorized by a Class II institutional
105 pharmacy permit. Class III institutional pharmacies may also:
106 a. Dispense, distribute, compound, and fill prescriptions
107 for medicinal drugs.
108 b. Prepare prepackaged drug products.
109 c. Conduct other pharmaceutical services for the affiliated
110 hospital and for entities under common control that are each
111 permitted under this chapter to possess medicinal drugs.
112 d. Provide the services in sub-subparagraphs a.-c. to an
113 entity under common control which holds an active health care
114 clinic establishment permit as required under s. 499.01(2)(r).
115 2. A Class III institutional pharmacy shall maintain
116 policies and procedures addressing:
117 a. The consultant pharmacist responsible for pharmaceutical
118 services.
119 b. Safe practices for the preparation, dispensing,
120 prepackaging, distribution, and transportation of medicinal
121 drugs and prepackaged drug products.
122 c. Recordkeeping to monitor the movement, distribution, and
123 transportation of medicinal drugs and prepackaged drug products.
124 d. Recordkeeping of pharmacy staff responsible for each
125 step in the preparation, dispensing, prepackaging,
126 transportation, and distribution of medicinal drugs and
127 prepackaged drug products.
128 e. Medicinal drugs and prepackaged drug products that may
129 not be safely distributed among Class III institutional
130 pharmacies.
131 (4) Medicinal drugs shall be dispensed in an institutional
132 pharmacy to outpatients only when that institution has secured a
133 community pharmacy permit from the department. However, an
134 individual licensed to prescribe medicinal drugs in this state
135 may dispense up to a 24-hour supply of a medicinal drug to any
136 patient of an emergency department of a hospital that operates a
137 Class II or Class III institutional pharmacy, provided that the
138 physician treating the patient in such hospital’s emergency
139 department determines that the medicinal drug is warranted and
140 that community pharmacy services are not readily accessible,
141 geographically or otherwise, to the patient. Such dispensing
142 from the emergency department must be in accordance with the
143 procedures of the hospital. For any such patient for whom a
144 medicinal drug is warranted for a period to exceed 24 hours, an
145 individual licensed to prescribe such drug must dispense a 24
146 hour supply of such drug to the patient and must provide the
147 patient with a prescription for such drug for use after the
148 initial 24-hour period. The board may adopt rules necessary to
149 carry out the provisions of this subsection.
150 (6) In a Class II or Class III institutional pharmacy, an
151 institutional formulary system may be adopted with approval of
152 the medical staff for the purpose of identifying those medicinal
153 drugs, proprietary preparations, biologics, biosimilars, and
154 biosimilar interchangeables that may be dispensed by the
155 pharmacists employed in such institution. A facility with a
156 Class II or Class III institutional pharmacy permit which is
157 operating under the formulary system shall establish policies
158 and procedures for the development of the system in accordance
159 with the joint standards of the American Hospital Association
160 and American Society of Hospital Pharmacists for the utilization
161 of a hospital formulary system, which formulary shall be
162 approved by the medical staff.
163 Section 4. Subsection (3) of section 465.0252, Florida
164 Statutes, is amended to read:
165 465.0252 Substitution of interchangeable biosimilar
166 products.—
167 (3) A pharmacist who practices in a Class II, or Modified
168 Class II, or Class III institutional pharmacy shall comply with
169 the notification provisions of paragraph (2)(c) by entering the
170 substitution in the institution’s written medical record system
171 or electronic medical record system.
172 Section 5. Subsection (39) of section 499.003, Florida
173 Statutes, is amended, and paragraphs (w) and (x) are added to
174 subsection (48) of that section, to read:
175 499.003 Definitions of terms used in this part.—As used in
176 this part, the term:
177 (39) “Prepackaged drug product” means a drug that
178 originally was in finished packaged form sealed by a
179 manufacturer and that is placed in a properly labeled container
180 by a pharmacy or practitioner authorized to dispense pursuant to
181 chapter 465 for the purpose of dispensing or by a facility
182 holding a Class III institutional pharmacy permit in the
183 establishment in which the prepackaging occurred.
184 (48) “Wholesale distribution” means the distribution of a
185 prescription drug to a person other than a consumer or patient,
186 or the receipt of a prescription drug by a person other than the
187 consumer or patient, but does not include:
188 (w) A hospital covered by s. 340B of the Public Health
189 Service Act, 42 U.S.C. s. 256b, that arranges for a prescription
190 drug wholesale distributor to distribute prescription drugs
191 covered under that act directly to a contract pharmacy. Such
192 hospital is exempt from obtaining a restricted prescription drug
193 distributor permit under s. 499.01(2)(h).
194 (x) The dispensing or distribution of a medicinal drug by a
195 Class III institutional pharmacy pursuant to s. 465.019.
196 Section 6. Paragraphs (b) and (h) of subsection (2) and
197 subsection (5) of section 499.01, Florida Statutes, are amended
198 to read:
199 499.01 Permits.—
200 (2) The following permits are established:
201 (b) Prescription drug repackager permit.—A prescription
202 drug repackager permit is required for any person that
203 repackages a prescription drug in this state.
204 1. A person that operates an establishment permitted as a
205 prescription drug repackager may engage in distribution of
206 prescription drugs repackaged at that establishment and must
207 comply with all of the provisions of this part and the rules
208 adopted under this part that apply to a prescription drug
209 manufacturer.
210 2. A prescription drug repackager must comply with all
211 appropriate state and federal good manufacturing practices.
212 3. A prescription drug repackager permit is not required
213 for distributing medicinal drugs or prepackaged drug products
214 between entities under common control which each hold an active
215 Class III institutional pharmacy permit under chapter 465 or an
216 active health care clinic establishment permit under paragraph
217 (r). For purposes of this subparagraph, the term “common
218 control” has the same meaning as in s. 499.003(48)(a)3.
219 (h) Restricted prescription drug distributor permit.—
220 1. A restricted prescription drug distributor permit is
221 required for:
222 a. Any person located in this state who engages in the
223 distribution of a prescription drug, which distribution is not
224 considered “wholesale distribution” under s. 499.003(48)(a).
225 b. Any person located in this state who engages in the
226 receipt or distribution of a prescription drug in this state for
227 the purpose of processing its return or its destruction if such
228 person is not the person initiating the return, the prescription
229 drug wholesale supplier of the person initiating the return, or
230 the manufacturer of the drug.
231 c. A blood establishment located in this state which
232 collects blood and blood components only from volunteer donors
233 as defined in s. 381.06014 or pursuant to an authorized
234 practitioner’s order for medical treatment or therapy and
235 engages in the wholesale distribution of a prescription drug not
236 described in s. 499.003(48)(j) to a health care entity. A mobile
237 blood unit operated by a blood establishment permitted under
238 this sub-subparagraph is not required to be separately
239 permitted. The health care entity receiving a prescription drug
240 distributed under this sub-subparagraph must be licensed as a
241 closed pharmacy or provide health care services at that
242 establishment. The blood establishment must operate in
243 accordance with s. 381.06014 and may distribute only:
244 (I) Prescription drugs indicated for a bleeding or clotting
245 disorder or anemia;
246 (II) Blood-collection containers approved under s. 505 of
247 the federal act;
248 (III) Drugs that are blood derivatives, or a recombinant or
249 synthetic form of a blood derivative;
250 (IV) Prescription drugs that are identified in rules
251 adopted by the department and that are essential to services
252 performed or provided by blood establishments and authorized for
253 distribution by blood establishments under federal law; or
254 (V) To the extent authorized by federal law, drugs
255 necessary to collect blood or blood components from volunteer
256 blood donors; for blood establishment personnel to perform
257 therapeutic procedures under the direction and supervision of a
258 licensed physician; and to diagnose, treat, manage, and prevent
259 any reaction of a volunteer blood donor or a patient undergoing
260 a therapeutic procedure performed under the direction and
261 supervision of a licensed physician,
262
263 as long as all of the health care services provided by the blood
264 establishment are related to its activities as a registered
265 blood establishment or the health care services consist of
266 collecting, processing, storing, or administering human
267 hematopoietic stem cells or progenitor cells or performing
268 diagnostic testing of specimens if such specimens are tested
269 together with specimens undergoing routine donor testing. The
270 blood establishment may purchase and possess the drugs described
271 in this sub-subparagraph without a health care clinic
272 establishment permit.
273 2. Storage, handling, and recordkeeping of these
274 distributions by a person required to be permitted as a
275 restricted prescription drug distributor must be in accordance
276 with the requirements for wholesale distributors under s.
277 499.0121.
278 3. A person who applies for a permit as a restricted
279 prescription drug distributor, or for the renewal of such a
280 permit, must provide to the department the information required
281 under s. 499.012.
282 4. The department may adopt rules regarding the
283 distribution of prescription drugs by hospitals, health care
284 entities, charitable organizations, other persons not involved
285 in wholesale distribution, and blood establishments, which rules
286 are necessary for the protection of the public health, safety,
287 and welfare.
288 5. A restricted prescription drug distributor permit is not
289 required for distributions between pharmacies that each hold an
290 active permit under chapter 465, have a common ownership, and
291 are operating in a freestanding end-stage renal dialysis clinic,
292 if such distributions are made to meet the immediate emergency
293 medical needs of specifically identified patients and do not
294 occur with such frequency as to amount to the regular and
295 systematic supplying of that drug between the pharmacies. The
296 department shall adopt rules establishing when the distribution
297 of a prescription drug under this subparagraph amounts to the
298 regular and systematic supplying of that drug.
299 6. A restricted prescription drug distributor permit is not
300 required for distributing medicinal drugs or prepackaged drug
301 products between entities under common control that each hold
302 either an active Class III institutional pharmacy permit under
303 chapter 465 or an active health care clinic establishment permit
304 under paragraph (2)(r). For purposes of this subparagraph, the
305 term “common control” has the same meaning as in s.
306 499.003(48)(a)3.
307 (5) A prescription drug repackager permit issued under this
308 part is not required for a restricted prescription drug
309 distributor permitholder that is a health care entity to
310 repackage prescription drugs in this state for its own use or
311 for distribution to hospitals or other health care entities in
312 the state for their own use, pursuant to s. 499.003(48)(a)3.,
313 if:
314 (a) The prescription drug distributor notifies the
315 department, in writing, of its intention to engage in
316 repackaging under this exemption, 30 days before engaging in the
317 repackaging of prescription drugs at the permitted
318 establishment;
319 (b) The prescription drug distributor is under common
320 control with the hospitals or other health care entities to
321 which the prescription drug distributor is distributing
322 prescription drugs. As used in this paragraph, “common control”
323 means the power to direct or cause the direction of the
324 management and policies of a person or an organization, whether
325 by ownership of stock, voting rights, contract, or otherwise;
326 (c) The prescription drug distributor repackages the
327 prescription drugs in accordance with current state and federal
328 good manufacturing practices; and
329 (d) The prescription drug distributor labels the
330 prescription drug it repackages in accordance with state and
331 federal laws and rules.
332
333 The prescription drug distributor is exempt from the product
334 registration requirements of s. 499.015 with regard to the
335 prescription drugs that it repackages and distributes under this
336 subsection. A prescription drug distributor that repackages and
337 distributes prescription drugs under this subsection to a not
338 for-profit rural hospital, as defined in s. 395.602, is not
339 required to comply with paragraph (c) or paragraph (d), but must
340 provide to each health care entity for which it repackages, for
341 each prescription drug that is repackaged and distributed, the
342 information required by department rule for labeling
343 prescription drugs. The department shall adopt rules to ensure
344 the safety and integrity of prescription drugs repackaged and
345 distributed under this subsection, including rules regarding
346 prescription drug manufacturing and labeling requirements.
347 Section 7. This act shall take effect July 1, 2018.
