Florida Senate - 2011 COMMITTEE AMENDMENT
Bill No. SB 1736
Barcode 446694
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
03/22/2011 .
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The Committee on Health Regulation (Gaetz) recommended the
following:
1 Senate Amendment (with title amendment)
2
3 Between lines 3310 and 3311
4 insert:
5 Section 88. Section 381.06014, Florida Statutes, is amended
6 to read:
7 381.06014 Blood establishments.—
8 (1) As used in this section, the term:
9 (a) “Blood establishment” means any person, entity, or
10 organization, operating within the state, which examines an
11 individual for the purpose of blood donation or which collects,
12 processes, stores, tests, or distributes blood or blood
13 components collected from the human body for the purpose of
14 transfusion, for any other medical purpose, or for the
15 production of any biological product. A person, entity, or
16 organization that uses a mobile unit to conduct such activities
17 within the state is also a blood establishment.
18 (b) “Volunteer donor” means a person who does not receive
19 remuneration, other than an incentive, for a blood donation
20 intended for transfusion, and the product container of the
21 donation from the person qualifies for labeling with the
22 statement “volunteer donor” under 21 C.F.R. s. 606.121.
23 (2) Any blood establishment operating in the state may not
24 conduct any activity defined in paragraph (1)(a) subsection (1)
25 unless that blood establishment is operated in a manner
26 consistent with the provisions of Title 21 C.F.R. parts 211 and
27 600-640, Code of Federal Regulations.
28 (3) Any blood establishment determined to be operating in
29 the state in a manner not consistent with the provisions of
30 Title 21 C.F.R. parts 211 and 600-640, Code of Federal
31 Regulations, and in a manner that constitutes a danger to the
32 health or well-being of donors or recipients as evidenced by the
33 federal Food and Drug Administration’s inspection reports and
34 the revocation of the blood establishment’s license or
35 registration is shall be in violation of this chapter and must
36 shall immediately cease all operations in the state.
37 (4) The operation of a blood establishment in a manner not
38 consistent with the provisions of Title 21 C.F.R. parts 211 and
39 600-640, Code of Federal Regulations, and in a manner that
40 constitutes a danger to the health or well-being of blood donors
41 or recipients as evidenced by the federal Food and Drug
42 Administration’s inspection process is declared a nuisance and
43 inimical to the public health, welfare, and safety. The Agency
44 for Health Care Administration or any state attorney may bring
45 an action for an injunction to restrain such operations or
46 enjoin the future operation of the blood establishment.
47 (5) A local government may not restrict the access to or
48 use of any public facility or infrastructure for the collection
49 of blood or blood components from volunteer donors based on
50 whether the blood establishment is operating as a for-profit
51 organization or not-for-profit organization.
52 (6) In determining the service fee of blood or blood
53 components received from volunteer donors and sold to hospitals
54 or other health care providers, a blood establishment may not
55 base the service fee of the blood or blood component solely on
56 whether the purchasing entity is a for-profit organization or
57 not-for-profit organization.
58 (7) A blood establishment that collects blood or blood
59 components from volunteer donors must disclose on the Internet
60 the information required under this subsection to educate and
61 inform donors and the public about the blood establishment’s
62 activities. A hospital that collects blood or blood components
63 to be used only by that hospital’s licensed facilities or by a
64 health care provider that is a part of the hospital’s business
65 entity is exempt from the disclosure requirements in this
66 subsection. The information required to be disclosed under this
67 subsection may be cumulative for all blood establishments within
68 a business entity. A blood establishment must disclose on its
69 website all of the following information:
70 (a) A description of the steps involved in collecting,
71 processing, and distributing volunteer donations.
72 (b) By March 1 of each year, the number of units of blood
73 components which were:
74 1. Produced by the blood establishment during the preceding
75 calendar year;
76 2. Obtained from other sources during the preceding
77 calendar year;
78 3. Distributed during the preceding calendar year to health
79 care providers located outside this state. However, if the blood
80 establishment collects donations in a county outside this state,
81 distributions to health care providers in that county shall be
82 excluded. Such information shall be reported in the aggregate
83 for health care providers located within the United States and
84 its territories or outside the United States and its
85 territories; and
86 4. Distributed during the preceding calendar year to
87 entities that are not health care providers. Such information
88 shall be reported in the aggregate for purchasers located within
89 the United States and its territories or outside the United
90 States and its territories.
91 (c) The blood establishment’s conflict-of-interest policy,
92 policy concerning related-party transactions, whistleblower
93 policy, and policy for determining executive compensation. If a
94 change occurs to any of these documents, the revised document
95 must be available on the blood establishment’s website by the
96 following March 1.
97 (d) Except for a hospital that collects blood or blood
98 components from volunteer donors:
99 1. The most recent 3 years of the Return of Organization
100 Exempt from Income Tax, Internal Revenue Service Form 990, if
101 the business entity for the blood establishment is eligible to
102 file such return. The Form 990 must be available on the blood
103 establishment’s website within 60 calendar days after it is
104 filed with the Internal Revenue Service; or
105 2. If the business entity for the blood establishment is
106 not eligible to file the Form 990 return, a balance sheet,
107 income statement, and statement of changes in cash flow, along
108 with the expression of an opinion thereon by an independent
109 certified public accountant who audited or reviewed such
110 financial statements. Such documents must be available on the
111 blood establishment’s website within 120 days after the end of
112 the blood establishment’s fiscal year and must remain on the
113 blood establishment’s website for at least 36 months.
114 (8) A blood establishment is liable for a civil penalty for
115 failing to make the disclosures required under subsection (7).
116 The Department of Legal Affairs may assess the civil penalty
117 against the blood establishment for each day that it fails to
118 make such required disclosures, but the penalty may not exceed
119 $10,000 per year. If multiple blood establishments operated by a
120 single business entity fail to meet such disclosure
121 requirements, the civil penalty may be assessed against only one
122 of the business entity’s blood establishments. The Department of
123 Legal Affairs may terminate an action if the blood establishment
124 agrees to pay a stipulated civil penalty. A civil penalty so
125 collected accrues to the state and shall be deposited as
126 received into the General Revenue Fund unallocated. The
127 Department of Legal Affairs may terminate the action and waive
128 the civil penalty upon a showing of good cause by the blood
129 establishment as to why the required disclosures were not made.
130 Section 89. Subsection (23) of section 499.003, Florida
131 Statutes, is amended to read:
132 499.003 Definitions of terms used in this part.—As used in
133 this part, the term:
134 (23) “Health care entity” means a closed pharmacy or any
135 person, organization, or business entity that provides
136 diagnostic, medical, surgical, or dental treatment or care, or
137 chronic or rehabilitative care, but does not include any
138 wholesale distributor or retail pharmacy licensed under state
139 law to deal in prescription drugs. However, a blood
140 establishment is a health care entity that may engage in the
141 wholesale distribution of prescription drugs under s.
142 499.01(2)(g)1.c.
143 Section 90. Subsection (21) of section 499.005, Florida
144 Statutes, is amended to read:
145 499.005 Prohibited acts.—It is unlawful for a person to
146 perform or cause the performance of any of the following acts in
147 this state:
148 (21) The wholesale distribution of any prescription drug
149 that was:
150 (a) Purchased by a public or private hospital or other
151 health care entity; or
152 (b) Donated or supplied at a reduced price to a charitable
153 organization,
154
155 unless the wholesale distribution of the prescription drug is
156 authorized in s. 499.01(2)(g)1.c.
157 Section 91. Paragraphs (a) and (g) of subsection (2) of
158 section 499.01, Florida Statutes, are amended to read:
159 499.01 Permits.—
160 (2) The following permits are established:
161 (a) Prescription drug manufacturer permit.—A prescription
162 drug manufacturer permit is required for any person that is a
163 manufacturer of a prescription drug and that manufactures or
164 distributes such prescription drugs in this state.
165 1. A person that operates an establishment permitted as a
166 prescription drug manufacturer may engage in wholesale
167 distribution of prescription drugs manufactured at that
168 establishment and must comply with all of the provisions of this
169 part, except s. 499.01212, and the rules adopted under this
170 part, except s. 499.01212, which that apply to a wholesale
171 distributor.
172 2. A prescription drug manufacturer must comply with all
173 appropriate state and federal good manufacturing practices.
174 3. A blood establishment, as defined in s. 381.06014,
175 operating in a manner consistent with the provisions of Title 21
176 C.F.R. parts 211 and 600-640, and manufacturing only the
177 prescription drugs described in s. 499.003(54)(d) is not
178 required to be permitted as a prescription drug manufacturer
179 under this paragraph or to register products under s. 499.015.
180 (g) Restricted prescription drug distributor permit.—
181 1. A restricted prescription drug distributor permit is
182 required for:
183 a. Any person located in this state that engages in the
184 distribution of a prescription drug, which distribution is not
185 considered “wholesale distribution” under s. 499.003(54)(a).
186 b.1. Any A person located in this state who engages in the
187 receipt or distribution of a prescription drug in this state for
188 the purpose of processing its return or its destruction must
189 obtain a permit as a restricted prescription drug distributor if
190 such person is not the person initiating the return, the
191 prescription drug wholesale supplier of the person initiating
192 the return, or the manufacturer of the drug.
193 c. A blood establishment located in this state which
194 collects blood and blood components only from volunteer donors
195 as defined in s. 381.06014 or pursuant to an authorized
196 practitioner’s order for medical treatment or therapy and
197 engages in the wholesale distribution of a prescription drug not
198 described in s. 499.003(54)(d) to a health care entity. The
199 health care entity receiving a prescription drug distributed
200 under this sub-subparagraph must be licensed as a closed
201 pharmacy or provide health care services at that establishment.
202 The blood establishment must operate in accordance with s.
203 381.06014 and may distribute only:
204 (I) Prescription drugs indicated for a bleeding or clotting
205 disorder or anemia;
206 (II) Blood-collection containers approved under s. 505 of
207 the federal act;
208 (III) Drugs that are blood derivatives, or a recombinant or
209 synthetic form of a blood derivative;
210 (IV) Prescription drugs that are identified in rules
211 adopted by the department and that are essential to services
212 performed or provided by blood establishments and authorized for
213 distribution by blood establishments under federal law; or
214 (V) To the extent authorized by federal law, drugs
215 necessary to collect blood or blood components from volunteer
216 blood donors; for blood establishment personnel to perform
217 therapeutic procedures under the direction and supervision of a
218 licensed physician; and to diagnose, treat, manage, and prevent
219 any reaction of either a volunteer blood donor or a patient
220 undergoing a therapeutic procedure performed under the direction
221 and supervision of a licensed physician,
222
223 as long as all of the health care services provided by the blood
224 establishment are related to its activities as a registered
225 blood establishment or the health care services consist of
226 collecting, processing, storing, or administering human
227 hematopoietic stem cells or progenitor cells or performing
228 diagnostic testing of specimens if such specimens are tested
229 together with specimens undergoing routine donor testing.
230 2. Storage, handling, and recordkeeping of these
231 distributions by a person required to be permitted as a
232 restricted prescription drug distributor must comply with the
233 requirements for wholesale distributors under s. 499.0121, but
234 not those set forth in s. 499.01212 if the distribution occurs
235 pursuant to sub-subparagraph 1.a. or sub-subparagraph 1.b.
236 3. A person who applies for a permit as a restricted
237 prescription drug distributor, or for the renewal of such a
238 permit, must provide to the department the information required
239 under s. 499.012.
240 4. The department may adopt rules regarding the
241 distribution of prescription drugs by hospitals, health care
242 entities, charitable organizations, or other persons not
243 involved in wholesale distribution, and blood establishments,
244 which rules are necessary for the protection of the public
245 health, safety, and welfare.
246
247 ================= T I T L E A M E N D M E N T ================
248 And the title is amended as follows:
249 Delete lines 263 - 264
250 and insert:
251 by the act; revising a reference; amending s.
252 381.06014, F.S.; redefining the term “blood
253 establishment” and defining the term “volunteer
254 donor”; prohibiting local governments from restricting
255 access to public facilities or infrastructure for
256 certain activities based on whether a blood
257 establishment is operating as a for-profit
258 organization or not-for-profit organization;
259 prohibiting a blood establishment from considering
260 whether certain customers are operating as for-profit
261 organizations or not-for-profit organizations when
262 determining service fees for selling blood or blood
263 components; requiring that certain blood
264 establishments disclose specified information on the
265 Internet; authorizing the Department of Legal Affairs
266 to assess a civil penalty against a blood
267 establishment that fails to disclose specified
268 information on the Internet; providing that the civil
269 penalty accrues to the state and requiring that it be
270 deposited as received into the General Revenue Fund;
271 amending s. 499.003, F.S.; redefining the term “health
272 care entity” to clarify that a blood establishment is
273 a health care entity that may engage in certain
274 activities; amending s. 499.005, F.S.; clarifying
275 provisions that prohibit the unauthorized wholesale
276 distribution of a prescription drug that was purchased
277 by a hospital or other health care entity or donated
278 or supplied at a reduced price to a charitable
279 organization, to conform to changes made by the act;
280 amending s. 499.01, F.S.; exempting certain blood
281 establishments from the requirements to be permitted
282 as a prescription drug manufacturer and register
283 products; requiring that certain blood establishments
284 obtain a restricted prescription drug distributor
285 permit under specified conditions; limiting the
286 prescription drugs that a blood establishment may
287 distribute under a restricted prescription drug
288 distributor permit; authorizing the Department of
289 Health to adopt rules regarding the distribution of
290 prescription drugs by blood establishments; providing
291 an effective date.