Florida Senate - 2018 COMMITTEE AMENDMENT
Bill No. SB 1128
Ì446160|Î446160
LEGISLATIVE ACTION
Senate . House
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The Committee on Health Policy (Stargel) recommended the
following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Subsections (7) and (13) of section 465.003,
6 Florida Statutes, are amended, and subsections (21) and (22) are
7 added to that section, to read:
8 465.003 Definitions.—As used in this chapter, the term:
9 (7) “Institutional formulary system” means a method whereby
10 the medical staff evaluates, appraises, and selects those
11 medicinal drugs or proprietary preparations which in the medical
12 staff’s clinical judgment are most useful in patient care, and
13 which are available for dispensing by a practicing pharmacist in
14 a Class II or Class III institutional pharmacy.
15 (13) “Practice of the profession of pharmacy” includes
16 compounding, dispensing, and consulting concerning contents,
17 therapeutic values, and uses of any medicinal drug; consulting
18 concerning therapeutic values and interactions of patent or
19 proprietary preparations, whether pursuant to prescriptions or
20 in the absence and entirely independent of such prescriptions or
21 orders; and conducting other pharmaceutical services. For
22 purposes of this subsection, “other pharmaceutical services”
23 means the monitoring of the patient’s drug therapy and assisting
24 the patient in the management of his or her drug therapy, and
25 includes review of the patient’s drug therapy and communication
26 with the patient’s prescribing health care provider as licensed
27 under chapter 458, chapter 459, chapter 461, or chapter 466, or
28 similar statutory provision in another jurisdiction, or such
29 provider’s agent or such other persons as specifically
30 authorized by the patient, regarding the drug therapy. However,
31 nothing in this subsection may be interpreted to permit an
32 alteration of a prescriber’s directions, the diagnosis or
33 treatment of any disease, the initiation of any drug therapy,
34 the practice of medicine, or the practice of osteopathic
35 medicine, unless otherwise permitted by law. “Practice of the
36 profession of pharmacy” also includes any other act, service,
37 operation, research, or transaction incidental to, or forming a
38 part of, any of the foregoing acts, requiring, involving, or
39 employing the science or art of any branch of the pharmaceutical
40 profession, study, or training, and shall expressly permit a
41 pharmacist to transmit information from persons authorized to
42 prescribe medicinal drugs to their patients. The practice of the
43 profession of pharmacy also includes the administration of
44 vaccines to adults pursuant to s. 465.189 and the preparation of
45 prepackaged drug products in facilities holding Class III
46 institutional pharmacy permits.
47 (21) “Central distribution facility” means a facility under
48 common control with a hospital holding a Class III institutional
49 pharmacy permit that may dispense, distribute, compound, or fill
50 prescriptions for medicinal drugs; prepare prepackaged drug
51 products; and conduct other pharmaceutical services.
52 (22) “Common control” means the power to direct or cause
53 the direction of the management and policies of a person or an
54 organization, whether by ownership of stock, voting rights,
55 contract, or otherwise.
56 Section 2. Subsection (2) of section 465.004, Florida
57 Statutes, is amended to read:
58 465.004 Board of Pharmacy.—
59 (2) Seven members of the board must be licensed pharmacists
60 who are residents of this state and who have been engaged in the
61 practice of the profession of pharmacy in this state for at
62 least 4 years and, to the extent practicable, represent the
63 various pharmacy practice settings. Of the pharmacist members,
64 two must be currently engaged in the practice of pharmacy in a
65 community pharmacy, two must be currently engaged in the
66 practice of pharmacy in a Class II, institutional pharmacy or a
67 Modified Class II, or Class III institutional pharmacy, and
68 three must be pharmacists licensed in this state irrespective of
69 practice setting. The remaining two members must be residents of
70 the state who have never been licensed as pharmacists and who
71 are in no way connected with the practice of the profession of
72 pharmacy. No person may be appointed as a consumer member who is
73 in any way connected with a drug manufacturer or wholesaler. At
74 least one member of the board must be 60 years of age or older.
75 The Governor shall appoint members to the board in accordance
76 with this subsection as members’ terms expire or as a vacancy
77 occurs until the composition of the board complies with the
78 requirements of this subsection.
79 Section 3. Subsections (4) and (6) of section 465.019,
80 Florida Statutes, are amended, and paragraph (d) is added to
81 subsection (2) of that section, to read:
82 465.019 Institutional pharmacies; permits.—
83 (2) The following classes of institutional pharmacies are
84 established:
85 (d)1. “Class III institutional pharmacies” are those
86 institutional pharmacies, including central distribution
87 facilities, affiliated with a hospital that provide the same
88 services that are authorized by a Class II institutional
89 pharmacy permit. Class III institutional pharmacies may also:
90 a. Dispense, distribute, compound, and fill prescriptions
91 for medicinal drugs.
92 b. Prepare prepackaged drug products.
93 c. Conduct other pharmaceutical services for the affiliated
94 hospital and for entities under common control that are each
95 permitted under this chapter to possess medicinal drugs.
96 d. Provide the services in sub-subparagraphs a.-c. to an
97 entity under common control which holds an active health care
98 clinic establishment permit as required under s. 499.01(2)(r).
99 2. A Class III institutional pharmacy shall maintain
100 policies and procedures addressing:
101 a. The consultant pharmacist responsible for pharmaceutical
102 services.
103 b. Safe practices for the preparation, dispensing,
104 prepackaging, distribution, and transportation of medicinal
105 drugs and prepackaged drug products.
106 c. Recordkeeping to monitor the movement, distribution, and
107 transportation of medicinal drugs and prepackaged drug products.
108 d. Recordkeeping of pharmacy staff responsible for each
109 step in the preparation, dispensing, prepackaging,
110 transportation, and distribution of medicinal drugs and
111 prepackaged drug products.
112 e. Medicinal drugs and prepackaged drug products that may
113 not be safely distributed among Class III institutional
114 pharmacies.
115 (4) Medicinal drugs shall be dispensed in an institutional
116 pharmacy to outpatients only when that institution has secured a
117 community pharmacy permit from the department. However, an
118 individual licensed to prescribe medicinal drugs in this state
119 may dispense up to a 24-hour supply of a medicinal drug to any
120 patient of an emergency department of a hospital that operates a
121 Class II or Class III institutional pharmacy, provided that the
122 physician treating the patient in such hospital’s emergency
123 department determines that the medicinal drug is warranted and
124 that community pharmacy services are not readily accessible,
125 geographically or otherwise, to the patient. Such dispensing
126 from the emergency department must be in accordance with the
127 procedures of the hospital. For any such patient for whom a
128 medicinal drug is warranted for a period to exceed 24 hours, an
129 individual licensed to prescribe such drug must dispense a 24
130 hour supply of such drug to the patient and must provide the
131 patient with a prescription for such drug for use after the
132 initial 24-hour period. The board may adopt rules necessary to
133 carry out the provisions of this subsection.
134 (6) In a Class II or Class III institutional pharmacy, an
135 institutional formulary system may be adopted with approval of
136 the medical staff for the purpose of identifying those medicinal
137 drugs, proprietary preparations, biologics, biosimilars, and
138 biosimilar interchangeables that may be dispensed by the
139 pharmacists employed in such institution. A facility with a
140 Class II or Class III institutional pharmacy permit which is
141 operating under the formulary system shall establish policies
142 and procedures for the development of the system in accordance
143 with the joint standards of the American Hospital Association
144 and American Society of Hospital Pharmacists for the utilization
145 of a hospital formulary system, which formulary shall be
146 approved by the medical staff.
147 Section 4. Subsection (3) of section 465.0252, Florida
148 Statutes, is amended to read:
149 465.0252 Substitution of interchangeable biosimilar
150 products.—
151 (3) A pharmacist who practices in a Class II, or Modified
152 Class II, or Class III institutional pharmacy shall comply with
153 the notification provisions of paragraph (2)(c) by entering the
154 substitution in the institution’s written medical record system
155 or electronic medical record system.
156 Section 5. Subsection (39) of section 499.003, Florida
157 Statutes, is amended, and paragraphs (w) and (x) are added to
158 subsection (48) of that section, to read:
159 499.003 Definitions of terms used in this part.—As used in
160 this part, the term:
161 (39) “Prepackaged drug product” means a drug that
162 originally was in finished packaged form sealed by a
163 manufacturer and that is placed in a properly labeled container
164 by a pharmacy or practitioner authorized to dispense pursuant to
165 chapter 465 for the purpose of dispensing or by a facility
166 holding a Class III institutional pharmacy permit in the
167 establishment in which the prepackaging occurred.
168 (48) “Wholesale distribution” means the distribution of a
169 prescription drug to a person other than a consumer or patient,
170 or the receipt of a prescription drug by a person other than the
171 consumer or patient, but does not include:
172 (w) A hospital covered by s. 340B of the Public Health
173 Service Act, 42 U.S.C. s. 256b, that arranges for a prescription
174 drug wholesale distributor to distribute prescription drugs
175 covered under that act directly to a contract pharmacy. Such
176 hospital is exempt from obtaining a restricted prescription drug
177 distributor permit under s. 499.01(2)(h).
178 (x) The dispensing or distribution of a medicinal drug by a
179 Class III institutional pharmacy pursuant to s. 465.019.
180 Section 6. Paragraphs (b) and (h) of subsection (2) and
181 subsection (5) of section 499.01, Florida Statutes, are amended
182 to read:
183 499.01 Permits.—
184 (2) The following permits are established:
185 (b) Prescription drug repackager permit.—A prescription
186 drug repackager permit is required for any person that
187 repackages a prescription drug in this state.
188 1. A person that operates an establishment permitted as a
189 prescription drug repackager may engage in distribution of
190 prescription drugs repackaged at that establishment and must
191 comply with all of the provisions of this part and the rules
192 adopted under this part that apply to a prescription drug
193 manufacturer.
194 2. A prescription drug repackager must comply with all
195 appropriate state and federal good manufacturing practices.
196 3. A prescription drug repackager permit is not required
197 for distributing medicinal drugs or prepackaged drug products
198 between entities under common control which each hold an active
199 Class III institutional pharmacy permit under chapter 465 or an
200 active health care clinic establishment permit under paragraph
201 (r). For purposes of this subparagraph, the term “common
202 control” has the same meaning as in s. 499.003(48)(a)3.
203 (h) Restricted prescription drug distributor permit.—
204 1. A restricted prescription drug distributor permit is
205 required for:
206 a. Any person located in this state who engages in the
207 distribution of a prescription drug, which distribution is not
208 considered “wholesale distribution” under s. 499.003(48)(a).
209 b. Any person located in this state who engages in the
210 receipt or distribution of a prescription drug in this state for
211 the purpose of processing its return or its destruction if such
212 person is not the person initiating the return, the prescription
213 drug wholesale supplier of the person initiating the return, or
214 the manufacturer of the drug.
215 c. A blood establishment located in this state which
216 collects blood and blood components only from volunteer donors
217 as defined in s. 381.06014 or pursuant to an authorized
218 practitioner’s order for medical treatment or therapy and
219 engages in the wholesale distribution of a prescription drug not
220 described in s. 499.003(48)(j) to a health care entity. A mobile
221 blood unit operated by a blood establishment permitted under
222 this sub-subparagraph is not required to be separately
223 permitted. The health care entity receiving a prescription drug
224 distributed under this sub-subparagraph must be licensed as a
225 closed pharmacy or provide health care services at that
226 establishment. The blood establishment must operate in
227 accordance with s. 381.06014 and may distribute only:
228 (I) Prescription drugs indicated for a bleeding or clotting
229 disorder or anemia;
230 (II) Blood-collection containers approved under s. 505 of
231 the federal act;
232 (III) Drugs that are blood derivatives, or a recombinant or
233 synthetic form of a blood derivative;
234 (IV) Prescription drugs that are identified in rules
235 adopted by the department and that are essential to services
236 performed or provided by blood establishments and authorized for
237 distribution by blood establishments under federal law; or
238 (V) To the extent authorized by federal law, drugs
239 necessary to collect blood or blood components from volunteer
240 blood donors; for blood establishment personnel to perform
241 therapeutic procedures under the direction and supervision of a
242 licensed physician; and to diagnose, treat, manage, and prevent
243 any reaction of a volunteer blood donor or a patient undergoing
244 a therapeutic procedure performed under the direction and
245 supervision of a licensed physician,
246
247 as long as all of the health care services provided by the blood
248 establishment are related to its activities as a registered
249 blood establishment or the health care services consist of
250 collecting, processing, storing, or administering human
251 hematopoietic stem cells or progenitor cells or performing
252 diagnostic testing of specimens if such specimens are tested
253 together with specimens undergoing routine donor testing. The
254 blood establishment may purchase and possess the drugs described
255 in this sub-subparagraph without a health care clinic
256 establishment permit.
257 2. Storage, handling, and recordkeeping of these
258 distributions by a person required to be permitted as a
259 restricted prescription drug distributor must be in accordance
260 with the requirements for wholesale distributors under s.
261 499.0121.
262 3. A person who applies for a permit as a restricted
263 prescription drug distributor, or for the renewal of such a
264 permit, must provide to the department the information required
265 under s. 499.012.
266 4. The department may adopt rules regarding the
267 distribution of prescription drugs by hospitals, health care
268 entities, charitable organizations, other persons not involved
269 in wholesale distribution, and blood establishments, which rules
270 are necessary for the protection of the public health, safety,
271 and welfare.
272 5. A restricted prescription drug distributor permit is not
273 required for distributions between pharmacies that each hold an
274 active permit under chapter 465, have a common ownership, and
275 are operating in a freestanding end-stage renal dialysis clinic,
276 if such distributions are made to meet the immediate emergency
277 medical needs of specifically identified patients and do not
278 occur with such frequency as to amount to the regular and
279 systematic supplying of that drug between the pharmacies. The
280 department shall adopt rules establishing when the distribution
281 of a prescription drug under this subparagraph amounts to the
282 regular and systematic supplying of that drug.
283 6. A restricted prescription drug distributor permit is not
284 required for distributing medicinal drugs or prepackaged drug
285 products between entities under common control that each hold
286 either an active Class III institutional pharmacy permit under
287 chapter 465 or an active health care clinic establishment permit
288 under paragraph (2)(r). For purposes of this subparagraph, the
289 term “common control” has the same meaning as in s.
290 499.003(48)(a)3.
291 (5) A prescription drug repackager permit issued under this
292 part is not required for a restricted prescription drug
293 distributor permitholder that is a health care entity to
294 repackage prescription drugs in this state for its own use or
295 for distribution to hospitals or other health care entities in
296 the state for their own use, pursuant to s. 499.003(48)(a)3.,
297 if:
298 (a) The prescription drug distributor notifies the
299 department, in writing, of its intention to engage in
300 repackaging under this exemption, 30 days before engaging in the
301 repackaging of prescription drugs at the permitted
302 establishment;
303 (b) The prescription drug distributor is under common
304 control with the hospitals or other health care entities to
305 which the prescription drug distributor is distributing
306 prescription drugs. As used in this paragraph, “common control”
307 means the power to direct or cause the direction of the
308 management and policies of a person or an organization, whether
309 by ownership of stock, voting rights, contract, or otherwise;
310 (c) The prescription drug distributor repackages the
311 prescription drugs in accordance with current state and federal
312 good manufacturing practices; and
313 (d) The prescription drug distributor labels the
314 prescription drug it repackages in accordance with state and
315 federal laws and rules.
316
317 The prescription drug distributor is exempt from the product
318 registration requirements of s. 499.015 with regard to the
319 prescription drugs that it repackages and distributes under this
320 subsection. A prescription drug distributor that repackages and
321 distributes prescription drugs under this subsection to a not
322 for-profit rural hospital, as defined in s. 395.602, is not
323 required to comply with paragraph (c) or paragraph (d), but must
324 provide to each health care entity for which it repackages, for
325 each prescription drug that is repackaged and distributed, the
326 information required by department rule for labeling
327 prescription drugs. The department shall adopt rules to ensure
328 the safety and integrity of prescription drugs repackaged and
329 distributed under this subsection, including rules regarding
330 prescription drug manufacturing and labeling requirements.
331 Section 7. This act shall take effect July 1, 2018.
332
333 ================= T I T L E A M E N D M E N T ================
334 And the title is amended as follows:
335 Delete everything before the enacting clause
336 and insert:
337 A bill to be entitled
338 An act relating to pharmacies; amending s. 465.003,
339 F.S.; revising and providing definitions; amending s.
340 465.004, F.S.; revising the membership of the Board of
341 Pharmacy; amending s. 465.019, F.S.; establishing
342 Class III institutional pharmacies; providing
343 requirements for such pharmacies; conforming
344 provisions to changes made by the act; amending s.
345 465.0252, F.S.; revising notice requirements to
346 conform to changes made by the act; amending s.
347 499.003, F.S.; providing and revising definitions;
348 amending s. 499.01, F.S.; authorizing the distribution
349 of medicinal drugs and prepackaged drug products
350 without a specified permit under certain conditions;
351 deleting a provision exempting certain drug
352 repackagers from specified permit requirements;
353 providing an effective date.