Florida Senate - 2011 COMMITTEE AMENDMENT
Bill No. SB 94
Barcode 264066
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
01/11/2011 .
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The Committee on Health Regulation (Gaetz) recommended the
following:
1 Senate Amendment (with title amendment)
2
3
4 Delete everything after the enacting clause
5 and insert:
6 Section 1. Section 381.06014, Florida Statutes, is amended
7 to read:
8 381.06014 Blood establishments.—
9 (1) As used in this section, the term:
10 (a) “Blood establishment” means any person, entity, or
11 organization, operating within the state, which examines an
12 individual for the purpose of blood donation or which collects,
13 processes, stores, tests, or distributes blood or blood
14 components collected from the human body for the purpose of
15 transfusion, for any other medical purpose, or for the
16 production of any biological product. A person, entity, or
17 organization that uses a mobile unit to conduct such activities
18 within the state is also a blood establishment.
19 (b) “Volunteer donor” means a person who does not receive
20 remuneration, other than an incentive, for a blood donation
21 intended for transfusion, and the product container of the
22 donation from the person qualifies for labeling with the
23 statement “volunteer donor” under 21 C.F.R. s. 606.121.
24 (2) Any blood establishment operating in the state may not
25 conduct any activity defined in paragraph (1)(a) subsection (1)
26 unless that blood establishment is operated in a manner
27 consistent with the provisions of Title 21 C.F.R. parts 211 and
28 600-640, Code of Federal Regulations.
29 (3) Any blood establishment determined to be operating in
30 the state in a manner not consistent with the provisions of
31 Title 21 C.F.R. parts 211 and 600-640, Code of Federal
32 Regulations, and in a manner that constitutes a danger to the
33 health or well-being of donors or recipients as evidenced by the
34 federal Food and Drug Administration’s inspection reports and
35 the revocation of the blood establishment’s license or
36 registration is shall be in violation of this chapter and must
37 shall immediately cease all operations in the state.
38 (4) The operation of a blood establishment in a manner not
39 consistent with the provisions of Title 21 C.F.R. parts 211 and
40 600-640, Code of Federal Regulations, and in a manner that
41 constitutes a danger to the health or well-being of blood donors
42 or recipients as evidenced by the federal Food and Drug
43 Administration’s inspection process is declared a nuisance and
44 inimical to the public health, welfare, and safety. The Agency
45 for Health Care Administration or any state attorney may bring
46 an action for an injunction to restrain such operations or
47 enjoin the future operation of the blood establishment.
48 (5) A local government may not restrict the access to or
49 use of any public facility or infrastructure for the collection
50 of blood or blood components from volunteer donors based on
51 whether the blood establishment is operating as a for-profit
52 organization or not-for-profit organization.
53 (6) In determining the service fee of blood or blood
54 components received from volunteer donors and sold to hospitals
55 or other health care providers, a blood establishment may not
56 base the service fee of the blood or blood component solely on
57 whether the purchasing entity is a for-profit organization or
58 not-for-profit organization.
59 (7) A blood establishment that collects blood or blood
60 components from volunteer donors must disclose on the Internet
61 the information required under this subsection to educate and
62 inform donors and the public about the blood establishment’s
63 activities. A hospital that collects blood or blood components
64 to be used only by that hospital’s licensed facilities or by a
65 health care provider that is a part of the hospital’s business
66 entity is exempt from the disclosure requirements in this
67 subsection. The information required to be disclosed under this
68 subsection may be cumulative for all blood establishments within
69 a business entity. A blood establishment must disclose on its
70 website all of the following information:
71 (a) A description of the steps involved in collecting,
72 processing, and distributing volunteer donations.
73 (b) By March 1 of each year, the number of units of blood
74 components which were:
75 1. Produced by the blood establishment during the preceding
76 calendar year;
77 2. Obtained from other sources during the preceding
78 calendar year;
79 3. Distributed during the preceding calendar year to health
80 care providers located outside this state. However, if the blood
81 establishment collects donations in a county outside this state,
82 distributions to health care providers in that county shall be
83 excluded. Such information shall be reported in the aggregate
84 for health care providers located within the United States and
85 its territories or outside the United States and its
86 territories; and
87 4. Distributed during the preceding calendar year to
88 entities that are not health care providers. Such information
89 shall be reported in the aggregate for purchasers located within
90 the United States and its territories or outside the United
91 States and its territories.
92 (c) The blood establishment’s conflict-of-interest policy,
93 policy concerning related-party transactions, whistleblower
94 policy, and policy for determining executive compensation. If a
95 change occurs to any of these documents, the revised document
96 must be available on the blood establishment’s website by the
97 following March 1.
98 (d) Except for a hospital that collects blood or blood
99 components from volunteer donors:
100 1. The most recent 3 years of the Return of Organization
101 Exempt from Income Tax, Internal Revenue Service Form 990, if
102 the business entity for the blood establishment is eligible to
103 file such return. The Form 990 must be available on the blood
104 establishment’s website within 60 calendar days after it is
105 filed with the Internal Revenue Service; or
106 2. If the business entity for the blood establishment is
107 not eligible to file the Form 990 return, a balance sheet,
108 income statement, and statement of changes in cash flow, along
109 with the expression of an opinion thereon by an independent
110 certified public accountant who audited or reviewed such
111 financial statements. Such documents must be available on the
112 blood establishment’s website within 120 days after the end of
113 the blood establishment’s fiscal year and must remain on the
114 blood establishment’s website for at least 36 months.
115 (8) A blood establishment is liable for a civil penalty for
116 failing to make the disclosures required under subsection (7).
117 The Department of Legal Affairs may assess the civil penalty
118 against the blood establishment for each day that it fails to
119 make such required disclosures, but the penalty may not exceed
120 $10,000 per year. If multiple blood establishments operated by a
121 single business entity fail to meet such disclosure
122 requirements, the civil penalty may be assessed against only one
123 of the business entity’s blood establishments. The Department of
124 Legal Affairs may terminate an action if the blood establishment
125 agrees to pay a stipulated civil penalty. A civil penalty so
126 collected accrues to the state and shall be deposited as
127 received into the General Revenue Fund unallocated. The
128 Department of Legal Affairs may terminate the action and waive
129 the civil penalty upon a showing of good cause by the blood
130 establishment as to why the required disclosures were not made.
131 Section 2. Subsection (23) of section 499.003, Florida
132 Statutes, is amended to read:
133 499.003 Definitions of terms used in this part.—As used in
134 this part, the term:
135 (23) “Health care entity” means a closed pharmacy or any
136 person, organization, or business entity that provides
137 diagnostic, medical, surgical, or dental treatment or care, or
138 chronic or rehabilitative care, but does not include any
139 wholesale distributor or retail pharmacy licensed under state
140 law to deal in prescription drugs. However, a blood
141 establishment is a health care entity that may engage in the
142 wholesale distribution of prescription drugs under s.
143 499.01(2)(g)1.c.
144 Section 3. Subsection (21) of section 499.005, Florida
145 Statutes, is amended to read:
146 499.005 Prohibited acts.—It is unlawful for a person to
147 perform or cause the performance of any of the following acts in
148 this state:
149 (21) The wholesale distribution of any prescription drug
150 that was:
151 (a) Purchased by a public or private hospital or other
152 health care entity; or
153 (b) Donated or supplied at a reduced price to a charitable
154 organization,
155
156 unless the wholesale distribution of the prescription drug is
157 authorized in s. 499.01(2)(g)1.c.
158 Section 4. Paragraphs (a) and (g) of subsection (2) of
159 section 499.01, Florida Statutes, are amended to read:
160 499.01 Permits.—
161 (2) The following permits are established:
162 (a) Prescription drug manufacturer permit.—A prescription
163 drug manufacturer permit is required for any person that is a
164 manufacturer of a prescription drug and that manufactures or
165 distributes such prescription drugs in this state.
166 1. A person that operates an establishment permitted as a
167 prescription drug manufacturer may engage in wholesale
168 distribution of prescription drugs manufactured at that
169 establishment and must comply with all of the provisions of this
170 part, except s. 499.01212, and the rules adopted under this
171 part, except s. 499.01212, which that apply to a wholesale
172 distributor.
173 2. A prescription drug manufacturer must comply with all
174 appropriate state and federal good manufacturing practices.
175 3. A blood establishment, as defined in s. 381.06014,
176 operating in a manner consistent with the provisions of Title 21
177 C.F.R. parts 211 and 600-640, and manufacturing only the
178 prescription drugs described in s. 499.003(54)(d) is not
179 required to be permitted as a prescription drug manufacturer
180 under this paragraph or to register products under s. 499.015.
181 (g) Restricted prescription drug distributor permit.—
182 1. A restricted prescription drug distributor permit is
183 required for:
184 a. Any person located in this state that engages in the
185 distribution of a prescription drug, which distribution is not
186 considered “wholesale distribution” under s. 499.003(54)(a).
187 b.1. Any A person located in this state who engages in the
188 receipt or distribution of a prescription drug in this state for
189 the purpose of processing its return or its destruction must
190 obtain a permit as a restricted prescription drug distributor if
191 such person is not the person initiating the return, the
192 prescription drug wholesale supplier of the person initiating
193 the return, or the manufacturer of the drug.
194 c. A blood establishment located in this state which
195 collects blood and blood components only from volunteer donors
196 as defined in s. 381.06014 or pursuant to an authorized
197 practitioner’s order for medical treatment or therapy and
198 engages in the wholesale distribution of a prescription drug not
199 described in s. 499.003(54)(d) to a health care entity. The
200 health care entity receiving a prescription drug distributed
201 under this sub-subparagraph must be licensed as a closed
202 pharmacy or provide health care services at that establishment.
203 The blood establishment must operate in accordance with s.
204 381.06014 and may distribute only:
205 (I) Prescription drugs indicated for a bleeding or clotting
206 disorder or anemia;
207 (II) Blood-collection containers approved under s. 505 of
208 the federal act;
209 (III) Drugs that are blood derivatives, or a recombinant or
210 synthetic form of a blood derivative;
211 (IV) Prescription drugs that are identified in rules
212 adopted by the department and that are essential to services
213 performed or provided by blood establishments and authorized for
214 distribution by blood establishments under federal law; or
215 (V) To the extent authorized by federal law, drugs
216 necessary to collect blood or blood components from volunteer
217 blood donors; for blood establishment personnel to perform
218 therapeutic procedures under the direction and supervision of a
219 licensed physician; and to diagnose, treat, manage, and prevent
220 any reaction of either a volunteer blood donor or a patient
221 undergoing a therapeutic procedure performed under the direction
222 and supervision of a licensed physician,
223
224 as long as all of the health care services provided by the blood
225 establishment are related to its activities as a registered
226 blood establishment or the health care services consist of
227 collecting, processing, storing, or administering human
228 hematopoietic stem cells or progenitor cells or performing
229 diagnostic testing of specimens if such specimens are tested
230 together with specimens undergoing routine donor testing.
231 2. Storage, handling, and recordkeeping of these
232 distributions by a person required to be permitted as a
233 restricted prescription drug distributor must comply with the
234 requirements for wholesale distributors under s. 499.0121, but
235 not those set forth in s. 499.01212 if the distribution occurs
236 pursuant to sub-subparagraph 1.a. or sub-subparagraph 1.b.
237 3. A person who applies for a permit as a restricted
238 prescription drug distributor, or for the renewal of such a
239 permit, must provide to the department the information required
240 under s. 499.012.
241 4. The department may adopt rules regarding the
242 distribution of prescription drugs by hospitals, health care
243 entities, charitable organizations, or other persons not
244 involved in wholesale distribution, and blood establishments,
245 which rules are necessary for the protection of the public
246 health, safety, and welfare.
247 Section 5. This act shall take effect July 1, 2011.
248
249 ================= T I T L E A M E N D M E N T ================
250 And the title is amended as follows:
251 Delete everything before the enacting clause
252 and insert:
253 A bill to be entitled
254 An act relating to blood establishments; amending s.
255 381.06014, F.S.; redefining the term “blood
256 establishment” and defining the term “volunteer
257 donor”; prohibiting local governments from restricting
258 access to public facilities or infrastructure for
259 certain activities based on whether a blood
260 establishment is operating as a for-profit
261 organization or not-for-profit organization;
262 prohibiting a blood establishment from considering
263 whether certain customers are operating as for-profit
264 organizations or not-for-profit organizations when
265 determining service fees for selling blood or blood
266 components; requiring that certain blood
267 establishments disclose specified information on the
268 Internet; authorizing the Department of Legal Affairs
269 to assess a civil penalty against a blood
270 establishment that fails to disclose specified
271 information on the Internet; providing that the civil
272 penalty accrues to the state and requiring that it be
273 deposited as received into the General Revenue Fund;
274 amending s. 499.003, F.S.; redefining the term “health
275 care entity” to clarify that a blood establishment is
276 a health care entity that may engage in certain
277 activities; amending s. 499.005, F.S.; clarifying
278 provisions that prohibit the unauthorized wholesale
279 distribution of a prescription drug that was purchased
280 by a hospital or other health care entity or donated
281 or supplied at a reduced price to a charitable
282 organization, to conform to changes made by the act;
283 amending s. 499.01, F.S.; exempting certain blood
284 establishments from the requirements to be permitted
285 as a prescription drug manufacturer and register
286 products; requiring that certain blood establishments
287 obtain a restricted prescription drug distributor
288 permit under specified conditions; limiting the
289 prescription drugs that a blood establishment may
290 distribute under a restricted prescription drug
291 distributor permit; authorizing the Department of
292 Health to adopt rules regarding the distribution of
293 prescription drugs by blood establishments; providing
294 an effective date.