Florida Senate - 2018 SB 1128
By Senator Stargel
22-00467E-18 20181128__
1 A bill to be entitled
2 An act relating to pharmacy; amending s. 465.003,
3 F.S.; defining and redefining terms; 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; authorizing such
7 pharmacies to dispense, compound, and fill
8 prescriptions, prepare prepackaged drug products, and
9 conduct other pharmaceutical services between certain
10 entities under common control; defining the term
11 “common control”; providing that the lawful dispensing
12 and distribution of medicinal drugs by Class III
13 institutional pharmacies is not considered wholesale
14 distribution; requiring such pharmacies to maintain
15 certain policies and procedures; conforming provisions
16 to changes made by the act; amending s. 465.0252,
17 F.S.; conforming a provision to changes made by the
18 act; amending s. 499.003, F.S.; revising the
19 definition of the term “prepackaged drug product”;
20 amending s. 499.01, F.S.; providing that a
21 prescription drug repackager permit and a restricted
22 prescription drug distributor permit are not required
23 for the distribution of medicinal drugs or prepackaged
24 drug products between entities under common control
25 under certain circumstances; providing that a certain
26 hospital is not required to hold a restricted
27 prescription drug distributor permit under certain
28 circumstances; deleting a provision exempting certain
29 drug repackagers from specified permit requirements;
30 providing an effective date.
31
32 Be It Enacted by the Legislature of the State of Florida:
33
34 Section 1. Subsections (7) and (13) of section 465.003,
35 Florida Statutes, are amended, and subsection (21) is added to
36 that section, to read:
37 465.003 Definitions.—As used in this chapter, the term:
38 (7) “Institutional formulary system” means a method whereby
39 the medical staff evaluates, appraises, and selects those
40 medicinal drugs or proprietary preparations that which in the
41 medical staff’s clinical judgment are most useful in patient
42 care, and that which are available for dispensing by a
43 practicing pharmacist in a Class II or Class III institutional
44 pharmacy.
45 (13) “Practice of the profession of pharmacy” includes
46 compounding, dispensing, and consulting concerning contents,
47 therapeutic values, and uses of any medicinal drug; consulting
48 concerning therapeutic values and interactions of patent or
49 proprietary preparations, whether pursuant to prescriptions or
50 in the absence and entirely independent of such prescriptions or
51 orders; and conducting other pharmaceutical services. For
52 purposes of this subsection, “other pharmaceutical services”
53 means the monitoring of the patient’s drug therapy and assisting
54 the patient in the management of his or her drug therapy, and
55 includes review of the patient’s drug therapy and communication
56 with the patient’s prescribing health care provider as licensed
57 under chapter 458, chapter 459, chapter 461, or chapter 466, or
58 similar statutory provision in another jurisdiction, or such
59 provider’s agent or such other persons as specifically
60 authorized by the patient, regarding the drug therapy. However,
61 nothing in this subsection may be interpreted to permit an
62 alteration of a prescriber’s directions, the diagnosis or
63 treatment of any disease, the initiation of any drug therapy,
64 the practice of medicine, or the practice of osteopathic
65 medicine, unless otherwise permitted by law. “Practice of the
66 profession of pharmacy” also includes any other act, service,
67 operation, research, or transaction incidental to, or forming a
68 part of, any of the foregoing acts, requiring, involving, or
69 employing the science or art of any branch of the pharmaceutical
70 profession, study, or training, and shall expressly permit a
71 pharmacist to transmit information from persons authorized to
72 prescribe medicinal drugs to their patients. The practice of the
73 profession of pharmacy also includes the administration of
74 vaccines to adults pursuant to s. 465.189 and the preparation of
75 prepackaged drug products in facilities holding Class III
76 institutional pharmacy permits.
77 (21) “Central distribution facility” means a facility under
78 common control with a hospital holding a Class III institutional
79 pharmacy permit which may dispense, distribute, compound, or
80 fill prescriptions for medicinal drugs; prepare prepackaged drug
81 products; and conduct other pharmaceutical services.
82 Section 2. Subsection (2) of section 465.004, Florida
83 Statutes, is amended to read:
84 465.004 Board of Pharmacy.—
85 (2) Seven members of the board must be licensed pharmacists
86 who are residents of this state and who have been engaged in the
87 practice of the profession of pharmacy in this state for at
88 least 4 years and, to the extent practicable, represent the
89 various pharmacy practice settings. Of the pharmacist members,
90 two must be currently engaged in the practice of pharmacy in a
91 community pharmacy, two must be currently engaged in the
92 practice of pharmacy in a Class II, institutional pharmacy or a
93 modified Class II, or Class III institutional pharmacy, and
94 three must be pharmacists licensed in this state irrespective of
95 practice setting. The remaining two members must be residents of
96 the state who have never been licensed as pharmacists and who
97 are in no way connected with the practice of the profession of
98 pharmacy. No person may be appointed as a consumer member who is
99 in any way connected with a drug manufacturer or wholesaler. At
100 least one member of the board must be 60 years of age or older.
101 The Governor shall appoint members to the board in accordance
102 with this subsection as members’ terms expire or as a vacancy
103 occurs until the composition of the board complies with the
104 requirements of this subsection.
105 Section 3. Subsections (4) and (6) of section 465.019,
106 Florida Statutes, are amended, and paragraph (d) is added to
107 subsection (2) of that section, to read:
108 465.019 Institutional pharmacies; permits.—
109 (2) The following classes of institutional pharmacies are
110 established:
111 (d)1. “Class III institutional pharmacies” are those
112 institutional pharmacies, including central distribution
113 facilities, which are affiliated with a hospital and provide the
114 same services as those authorized for Class II institutional
115 pharmacies in subsection (6). Class III institutional pharmacies
116 may dispense, distribute, compound, and fill prescriptions for
117 medicinal drugs; prepare prepackaged drug products; and conduct
118 other pharmaceutical services for the affiliated hospital and
119 entities under common control, each of which must be permitted
120 under this chapter to possess medicinal drugs. A Class III
121 institutional pharmacy may provide such medicinal drugs, drug
122 products, and pharmaceutical services to an entity under common
123 control that holds an active health care clinic establishment
124 permit as described in s. 499.01(2)(r). For purposes of this
125 chapter, the term “common control” means the power to direct or
126 cause the direction of the management and policies of a person
127 or an organization, whether by ownership of stock, voting
128 rights, contract, or other means. The dispensing or distribution
129 of a medicinal drug by a Class III institutional pharmacy
130 pursuant to this section is not considered wholesale
131 distribution as defined in s. 499.003.
132 2. A Class III institutional pharmacy shall maintain
133 policies and procedures that identify or otherwise address:
134 a. The consultant pharmacist responsible for pharmaceutical
135 services.
136 b. Safe practices for the preparation, dispensing,
137 prepackaging, distribution, and transportation of medicinal
138 drugs and prepackaged drug products.
139 c. Recordkeeping to monitor the movement, distribution, and
140 transportation of medicinal drugs and prepackaged drug products.
141 d. Recordkeeping of pharmacy staff responsible for each
142 step in the preparation, dispensing, prepackaging,
143 transportation, and distribution of medicinal drugs and
144 prepackaged drug products.
145 e. Medicinal drugs and prepackaged drug products that may
146 not be safely distributed among Class III institutional
147 pharmacies.
148 (4) Medicinal drugs shall be dispensed in an institutional
149 pharmacy to outpatients only when that institution has secured a
150 community pharmacy permit from the department. However, an
151 individual licensed to prescribe medicinal drugs in this state
152 may dispense up to a 24-hour supply of a medicinal drug to any
153 patient of an emergency department of a hospital that operates a
154 Class II or Class III institutional pharmacy, provided that the
155 physician treating the patient in such hospital’s emergency
156 department determines that the medicinal drug is warranted and
157 that community pharmacy services are not readily accessible,
158 geographically or otherwise, to the patient. Such dispensing
159 from the emergency department must be in accordance with the
160 procedures of the hospital. For any such patient for whom a
161 medicinal drug is warranted for a period to exceed 24 hours, an
162 individual licensed to prescribe such drug must dispense a 24
163 hour supply of such drug to the patient and must provide the
164 patient with a prescription for such drug for use after the
165 initial 24-hour period. The board may adopt rules necessary to
166 carry out the provisions of this subsection.
167 (6) In a Class II or Class III institutional pharmacy, an
168 institutional formulary system may be adopted with approval of
169 the medical staff for the purpose of identifying those medicinal
170 drugs, proprietary preparations, biologics, biosimilars, and
171 biosimilar interchangeables that may be dispensed by the
172 pharmacists employed in such institution. A facility with a
173 Class II or Class III institutional pharmacy permit which is
174 operating under the formulary system shall establish policies
175 and procedures for the development of the system in accordance
176 with the joint standards of the American Hospital Association
177 and American Society of Hospital Pharmacists for the utilization
178 of a hospital formulary system, which formulary shall be
179 approved by the medical staff.
180 Section 4. Subsection (3) of section 465.0252, Florida
181 Statutes, is amended to read:
182 465.0252 Substitution of interchangeable biosimilar
183 products.—
184 (3) A pharmacist who practices in a Class II, or modified
185 Class II, or Class III institutional pharmacy shall comply with
186 the notification provisions of paragraph (2)(c) by entering the
187 substitution in the institution’s written medical record system
188 or electronic medical record system.
189 Section 5. Subsection (39) of section 499.003, Florida
190 Statutes, is amended to read:
191 499.003 Definitions of terms used in this part.—As used in
192 this part, the term:
193 (39) “Prepackaged drug product” means a drug that
194 originally was in finished packaged form sealed by a
195 manufacturer and that is placed in a properly labeled container
196 by a pharmacy or practitioner authorized to dispense pursuant to
197 chapter 465 for the purpose of dispensing in the establishment
198 in which the prepackaging occurred.
199 Section 6. Paragraphs (b) and (h) of subsection (2) and
200 subsection (5) of section 499.01, Florida Statutes, are amended
201 to read:
202 499.01 Permits.—
203 (2) The following permits are established:
204 (b) Prescription drug repackager permit.—A prescription
205 drug repackager permit is required for any person that
206 repackages a prescription drug in this state.
207 1. A person that operates an establishment permitted as a
208 prescription drug repackager may engage in distribution of
209 prescription drugs repackaged at that establishment and must
210 comply with all of the provisions of this part and the rules
211 adopted under this part that apply to a prescription drug
212 manufacturer.
213 2. A prescription drug repackager must comply with all
214 appropriate state and federal good manufacturing practices.
215 3. A prescription drug repackager permit is not required
216 for the distribution of medicinal drugs or prepackaged drug
217 products between entities under common control if each entity
218 holds an active Class III institutional pharmacy permit under
219 chapter 465 or an active health care clinic establishment permit
220 under paragraph (r). For purposes of this subparagraph, the term
221 “common control” means the same as in s. 465.019(2).
222 (h) Restricted prescription drug distributor permit.—
223 1. A restricted prescription drug distributor permit is
224 required for:
225 a. Any person located in this state who engages in the
226 distribution of a prescription drug, which distribution is not
227 considered “wholesale distribution” under s. 499.003(48)(a).
228 b. Any person located in this state who engages in the
229 receipt or distribution of a prescription drug in this state for
230 the purpose of processing its return or its destruction if such
231 person is not the person initiating the return, the prescription
232 drug wholesale supplier of the person initiating the return, or
233 the manufacturer of the drug.
234 c. A blood establishment located in this state which
235 collects blood and blood components only from volunteer donors
236 as defined in s. 381.06014 or pursuant to an authorized
237 practitioner’s order for medical treatment or therapy and
238 engages in the wholesale distribution of a prescription drug not
239 described in s. 499.003(48)(j) to a health care entity. A mobile
240 blood unit operated by a blood establishment permitted under
241 this sub-subparagraph is not required to be separately
242 permitted. The health care entity receiving a prescription drug
243 distributed under this sub-subparagraph must be licensed as a
244 closed pharmacy or provide health care services at that
245 establishment. The blood establishment must operate in
246 accordance with s. 381.06014 and may distribute only:
247 (I) Prescription drugs indicated for a bleeding or clotting
248 disorder or anemia;
249 (II) Blood-collection containers approved under s. 505 of
250 the federal act;
251 (III) Drugs that are blood derivatives, or a recombinant or
252 synthetic form of a blood derivative;
253 (IV) Prescription drugs that are identified in rules
254 adopted by the department and that are essential to services
255 performed or provided by blood establishments and authorized for
256 distribution by blood establishments under federal law; or
257 (V) To the extent authorized by federal law, drugs
258 necessary to collect blood or blood components from volunteer
259 blood donors; for blood establishment personnel to perform
260 therapeutic procedures under the direction and supervision of a
261 licensed physician; and to diagnose, treat, manage, and prevent
262 any reaction of a volunteer blood donor or a patient undergoing
263 a therapeutic procedure performed under the direction and
264 supervision of a licensed physician,
265
266 as long as all of the health care services provided by the blood
267 establishment are related to its activities as a registered
268 blood establishment or the health care services consist of
269 collecting, processing, storing, or administering human
270 hematopoietic stem cells or progenitor cells or performing
271 diagnostic testing of specimens if such specimens are tested
272 together with specimens undergoing routine donor testing. The
273 blood establishment may purchase and possess the drugs described
274 in this sub-subparagraph without a health care clinic
275 establishment permit.
276 2. Storage, handling, and recordkeeping of these
277 distributions by a person required to be permitted as a
278 restricted prescription drug distributor must be in accordance
279 with the requirements for wholesale distributors under s.
280 499.0121.
281 3. A person who applies for a permit as a restricted
282 prescription drug distributor, or for the renewal of such a
283 permit, must provide to the department the information required
284 under s. 499.012.
285 4. The department may adopt rules regarding the
286 distribution of prescription drugs by hospitals, health care
287 entities, charitable organizations, other persons not involved
288 in wholesale distribution, and blood establishments, which rules
289 are necessary for the protection of the public health, safety,
290 and welfare.
291 5. A restricted prescription drug distributor permit is not
292 required for distributions between pharmacies that each hold an
293 active permit under chapter 465, have a common ownership, and
294 are operating in a freestanding end-stage renal dialysis clinic,
295 if such distributions are made to meet the immediate emergency
296 medical needs of specifically identified patients and do not
297 occur with such frequency as to amount to the regular and
298 systematic supplying of that drug between the pharmacies. The
299 department shall adopt rules establishing when the distribution
300 of a prescription drug under this subparagraph amounts to the
301 regular and systematic supplying of that drug.
302 6. A restricted prescription drug distributor permit is not
303 required for the distribution of medicinal drugs or prepackaged
304 drug products between entities under common control if each
305 entity holds an active Class III institutional pharmacy permit
306 under chapter 465 or an active health care clinic establishment
307 permit under paragraph (r). For purposes of this subparagraph,
308 the term “common control” means the same as in s. 465.019(2).
309 7. A restricted prescription drug distributor permit is not
310 required for a hospital covered by s. 340B of the Public Health
311 Service Act, 42 U.S.C. s. 256b, if such hospital arranges for a
312 prescription drug wholesale distributor to distribute
313 prescription drugs covered under that act directly to a contract
314 pharmacy.
315 (5) A prescription drug repackager permit issued under this
316 part is not required for a restricted prescription drug
317 distributor permitholder that is a health care entity to
318 repackage prescription drugs in this state for its own use or
319 for distribution to hospitals or other health care entities in
320 the state for their own use, pursuant to s. 499.003(48)(a)3.,
321 if:
322 (a) The prescription drug distributor notifies the
323 department, in writing, of its intention to engage in
324 repackaging under this exemption, 30 days before engaging in the
325 repackaging of prescription drugs at the permitted
326 establishment;
327 (b) The prescription drug distributor is under common
328 control with the hospitals or other health care entities to
329 which the prescription drug distributor is distributing
330 prescription drugs. As used in this paragraph, “common control”
331 means the power to direct or cause the direction of the
332 management and policies of a person or an organization, whether
333 by ownership of stock, voting rights, contract, or otherwise;
334 (c) The prescription drug distributor repackages the
335 prescription drugs in accordance with current state and federal
336 good manufacturing practices; and
337 (d) The prescription drug distributor labels the
338 prescription drug it repackages in accordance with state and
339 federal laws and rules.
340
341 The prescription drug distributor is exempt from the product
342 registration requirements of s. 499.015 with regard to the
343 prescription drugs that it repackages and distributes under this
344 subsection. A prescription drug distributor that repackages and
345 distributes prescription drugs under this subsection to a not
346 for-profit rural hospital, as defined in s. 395.602, is not
347 required to comply with paragraph (c) or paragraph (d), but must
348 provide to each health care entity for which it repackages, for
349 each prescription drug that is repackaged and distributed, the
350 information required by department rule for labeling
351 prescription drugs. The department shall adopt rules to ensure
352 the safety and integrity of prescription drugs repackaged and
353 distributed under this subsection, including rules regarding
354 prescription drug manufacturing and labeling requirements.
355 Section 7. This act shall take effect July 1, 2018.