1 | A bill to be entitled |
2 | An act relating to blood establishments; amending s. |
3 | 381.06014, F.S.; redefining the term "blood |
4 | establishment" and defining the term "volunteer |
5 | donor"; prohibiting local governments from restricting |
6 | access to public facilities or infrastructure for |
7 | certain activities based on whether a blood |
8 | establishment is operating as a for-profit |
9 | organization or not-for-profit organization; |
10 | prohibiting a blood establishment from considering |
11 | whether certain customers are operating as for-profit |
12 | organizations or not-for-profit organizations when |
13 | determining service fees for selling blood or blood |
14 | components; requiring that certain blood |
15 | establishments disclose specified information on the |
16 | Internet; authorizing the Department of Legal Affairs |
17 | to assess a civil penalty against a blood |
18 | establishment that fails to disclose specified |
19 | information on the Internet; providing that the civil |
20 | penalty accrues to the state and requiring that it be |
21 | deposited as received into the General Revenue Fund; |
22 | amending s. 499.003, F.S.; redefining the term "health |
23 | care entity" to clarify that a blood establishment is |
24 | a health care entity that may engage in certain |
25 | activities; amending s. 499.005, F.S.; clarifying |
26 | provisions that prohibit the unauthorized wholesale |
27 | distribution of a prescription drug that was purchased |
28 | by a hospital or other health care entity or donated |
29 | or supplied at a reduced price to a charitable |
30 | organization, to conform to changes made by the act; |
31 | amending s. 499.01, F.S.; exempting certain blood |
32 | establishments from the requirements to be permitted |
33 | as a prescription drug manufacturer and register |
34 | products; requiring that certain blood establishments |
35 | obtain a restricted prescription drug distributor |
36 | permit under specified conditions; limiting the |
37 | prescription drugs that a blood establishment may |
38 | distribute under a restricted prescription drug |
39 | distributor permit; authorizing the Department of |
40 | Health to adopt rules regarding the distribution of |
41 | prescription drugs by blood establishments; providing |
42 | an effective date. |
43 |
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44 | Be It Enacted by the Legislature of the State of Florida: |
45 |
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46 | Section 1. Section 381.06014, Florida Statutes, is amended |
47 | to read: |
48 | 381.06014 Blood establishments.- |
49 | (1) As used in this section, the term: |
50 | (a) "Blood establishment" means any person, entity, or |
51 | organization, operating within the state, which examines an |
52 | individual for the purpose of blood donation or which collects, |
53 | processes, stores, tests, or distributes blood or blood |
54 | components collected from the human body for the purpose of |
55 | transfusion, for any other medical purpose, or for the |
56 | production of any biological product. A person, entity, or |
57 | organization that uses a mobile unit to conduct such activities |
58 | within the state is also a blood establishment. |
59 | (b) "Volunteer donor" means a person who does not receive |
60 | remuneration, other than an incentive, for a blood donation |
61 | intended for transfusion, and the product container of the |
62 | donation from the person qualifies for labeling with the |
63 | statement "volunteer donor" under 21 C.F.R. s. 606.121. |
64 | (2) Any blood establishment operating in the state may not |
65 | conduct any activity defined in paragraph (1)(a) subsection (1) |
66 | unless that blood establishment is operated in a manner |
67 | consistent with the provisions of Title 21 C.F.R. parts 211 and |
68 | 600-640, Code of Federal Regulations. |
69 | (3) Any blood establishment determined to be operating in |
70 | the state in a manner not consistent with the provisions of |
71 | Title 21 C.F.R. parts 211 and 600-640, Code of Federal |
72 | Regulations, and in a manner that constitutes a danger to the |
73 | health or well-being of donors or recipients as evidenced by the |
74 | federal Food and Drug Administration's inspection reports and |
75 | the revocation of the blood establishment's license or |
76 | registration is shall be in violation of this chapter and must |
77 | shall immediately cease all operations in the state. |
78 | (4) The operation of a blood establishment in a manner not |
79 | consistent with the provisions of Title 21 C.F.R. parts 211 and |
80 | 600-640, Code of Federal Regulations, and in a manner that |
81 | constitutes a danger to the health or well-being of blood donors |
82 | or recipients as evidenced by the federal Food and Drug |
83 | Administration's inspection process is declared a nuisance and |
84 | inimical to the public health, welfare, and safety. The Agency |
85 | for Health Care Administration or any state attorney may bring |
86 | an action for an injunction to restrain such operations or |
87 | enjoin the future operation of the blood establishment. |
88 | (5) A local government may not restrict the access to or |
89 | use of any public facility or infrastructure for the collection |
90 | of blood or blood components from volunteer donors based on |
91 | whether the blood establishment is operating as a for-profit |
92 | organization or not-for-profit organization. |
93 | (6) In determining the service fee of blood or blood |
94 | components received from volunteer donors and sold to hospitals |
95 | or other health care providers, a blood establishment may not |
96 | base the service fee of the blood or blood component solely on |
97 | whether the purchasing entity is a for-profit organization or |
98 | not-for-profit organization. |
99 | (7) A blood establishment that collects blood or blood |
100 | components from volunteer donors must disclose on the Internet |
101 | the information required under this subsection to educate and |
102 | inform donors and the public about the blood establishment's |
103 | activities. A hospital that collects blood or blood components |
104 | to be used only by that hospital's licensed facilities or by a |
105 | health care provider that is a part of the hospital's business |
106 | entity is exempt from the disclosure requirements in this |
107 | subsection. The information required to be disclosed under this |
108 | subsection may be cumulative for all blood establishments within |
109 | a business entity. A blood establishment must disclose on its |
110 | website all of the following information: |
111 | (a) A description of the steps involved in collecting, |
112 | processing, and distributing volunteer donations. |
113 | (b) By March 1 of each year, the number of units of blood |
114 | components which were: |
115 | 1. Produced by the blood establishment during the |
116 | preceding calendar year; |
117 | 2. Obtained from other sources during the preceding |
118 | calendar year; |
119 | 3. Distributed during the preceding calendar year to |
120 | health care providers located outside this state. However, if |
121 | the blood establishment collects donations in a county outside |
122 | this state, distributions to health care providers in that |
123 | county shall be excluded. Such information shall be reported in |
124 | the aggregate for health care providers located within the |
125 | United States and its territories or outside the United States |
126 | and its territories; and |
127 | 4. Distributed during the preceding calendar year to |
128 | entities that are not health care providers. Such information |
129 | shall be reported in the aggregate for purchasers located within |
130 | the United States and its territories or outside the United |
131 | States and its territories. |
132 | (c) The blood establishment's conflict-of-interest policy, |
133 | policy concerning related-party transactions, whistleblower |
134 | policy, and policy for determining executive compensation. If a |
135 | change occurs to any of these documents, the revised document |
136 | must be available on the blood establishment's website by the |
137 | following March 1. |
138 | (d) Except for a hospital that collects blood or blood |
139 | components from volunteer donors: |
140 | 1. The most recent 3 years of the Return of Organization |
141 | Exempt from Income Tax, Internal Revenue Service Form 990, if |
142 | the business entity for the blood establishment is eligible to |
143 | file such return. The Form 990 must be available on the blood |
144 | establishment's website within 60 calendar days after it is |
145 | filed with the Internal Revenue Service; or |
146 | 2. If the business entity for the blood establishment is |
147 | not eligible to file the Form 990 return, a balance sheet, |
148 | income statement, and statement of changes in cash flow, along |
149 | with the expression of an opinion thereon by an independent |
150 | certified public accountant who audited or reviewed such |
151 | financial statements. Such documents must be available on the |
152 | blood establishment's website within 120 days after the end of |
153 | the blood establishment's fiscal year and must remain on the |
154 | blood establishment's website for at least 36 months. |
155 | (8) A blood establishment is liable for a civil penalty |
156 | for failing to make the disclosures required under subsection |
157 | (7). The Department of Legal Affairs may assess the civil |
158 | penalty against the blood establishment for each day that it |
159 | fails to make such required disclosures, but the penalty may not |
160 | exceed $10,000 per year. If multiple blood establishments |
161 | operated by a single business entity fail to meet such |
162 | disclosure requirements, the civil penalty may be assessed |
163 | against only one of the business entity's blood establishments. |
164 | The Department of Legal Affairs may terminate an action if the |
165 | blood establishment agrees to pay a stipulated civil penalty. A |
166 | civil penalty so collected accrues to the state and shall be |
167 | deposited as received into the General Revenue Fund unallocated. |
168 | The Department of Legal Affairs may terminate the action and |
169 | waive the civil penalty upon a showing of good cause by the |
170 | blood establishment as to why the required disclosures were not |
171 | made. |
172 | Section 2. Subsection (23) of section 499.003, Florida |
173 | Statutes, is amended to read: |
174 | 499.003 Definitions of terms used in this part.-As used in |
175 | this part, the term: |
176 | (23) "Health care entity" means a closed pharmacy or any |
177 | person, organization, or business entity that provides |
178 | diagnostic, medical, surgical, or dental treatment or care, or |
179 | chronic or rehabilitative care, but does not include any |
180 | wholesale distributor or retail pharmacy licensed under state |
181 | law to deal in prescription drugs. However, a blood |
182 | establishment is a health care entity that may engage in the |
183 | wholesale distribution of prescription drugs under s. |
184 | 499.01(2)(g)1.c. |
185 | Section 3. Subsection (21) of section 499.005, Florida |
186 | Statutes, is amended to read: |
187 | 499.005 Prohibited acts.-It is unlawful for a person to |
188 | perform or cause the performance of any of the following acts in |
189 | this state: |
190 | (21) The wholesale distribution of any prescription drug |
191 | that was: |
192 | (a) Purchased by a public or private hospital or other |
193 | health care entity; or |
194 | (b) Donated or supplied at a reduced price to a charitable |
195 | organization, |
196 |
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197 | unless the wholesale distribution of the prescription drug is |
198 | authorized in s. 499.01(2)(g)1.c. |
199 | Section 4. Paragraphs (a) and (g) of subsection (2) of |
200 | section 499.01, Florida Statutes, are amended to read: |
201 | 499.01 Permits.- |
202 | (2) The following permits are established: |
203 | (a) Prescription drug manufacturer permit.-A prescription |
204 | drug manufacturer permit is required for any person that is a |
205 | manufacturer of a prescription drug and that manufactures or |
206 | distributes such prescription drugs in this state. |
207 | 1. A person that operates an establishment permitted as a |
208 | prescription drug manufacturer may engage in wholesale |
209 | distribution of prescription drugs manufactured at that |
210 | establishment and must comply with all of the provisions of this |
211 | part, except s. 499.01212, and the rules adopted under this |
212 | part, except s. 499.01212, which that apply to a wholesale |
213 | distributor. |
214 | 2. A prescription drug manufacturer must comply with all |
215 | appropriate state and federal good manufacturing practices. |
216 | 3. A blood establishment, as defined in s. 381.06014, |
217 | operating in a manner consistent with the provisions of 21 |
218 | C.F.R. parts 211 and 600-640, and manufacturing only the |
219 | prescription drugs described in s. 499.003(54)(d) is not |
220 | required to be permitted as a prescription drug manufacturer |
221 | under this paragraph or to register products under s. 499.015. |
222 | (g) 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 that engages in |
226 | the distribution of a prescription drug, which distribution is |
227 | not considered "wholesale distribution" under s. 499.003(54)(a). |
228 | b.1. Any A 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 must |
231 | obtain a permit as a restricted prescription drug distributor if |
232 | such person is not the person initiating the return, the |
233 | prescription drug wholesale supplier of the person initiating |
234 | the return, or the manufacturer of the drug. |
235 | c. A blood establishment located in this state which |
236 | collects blood and blood components only from volunteer donors |
237 | as defined in s. 381.06014 or pursuant to an authorized |
238 | practitioner's order for medical treatment or therapy and |
239 | engages in the wholesale distribution of a prescription drug not |
240 | described in s. 499.003(54)(d) to a health care entity. The |
241 | health care entity receiving a prescription drug distributed |
242 | under this sub-subparagraph must be licensed as a closed |
243 | pharmacy or provide health care services at that establishment. |
244 | The blood establishment must operate in accordance with s. |
245 | 381.06014 and may distribute only: |
246 | (I) Prescription drugs indicated for a bleeding or |
247 | clotting disorder or anemia; |
248 | (II) Blood-collection containers approved under s. 505 of |
249 | the federal act; |
250 | (III) Drugs that are blood derivatives, or a recombinant |
251 | or synthetic form of a blood derivative; |
252 | (IV) Prescription drugs that are identified in rules |
253 | adopted by the department and that are essential to services |
254 | performed or provided by blood establishments and authorized for |
255 | distribution by blood establishments under federal law; or |
256 | (V) To the extent authorized by federal law, drugs |
257 | necessary to collect blood or blood components from volunteer |
258 | blood donors; for blood establishment personnel to perform |
259 | therapeutic procedures under the direction and supervision of a |
260 | licensed physician; and to diagnose, treat, manage, and prevent |
261 | any reaction of a volunteer blood donor or a patient undergoing |
262 | a therapeutic procedure performed under the direction and |
263 | supervision of a licensed physician, |
264 |
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265 | as long as all of the health care services provided by the blood |
266 | establishment are related to its activities as a registered |
267 | blood establishment or the health care services consist of |
268 | collecting, processing, storing, or administering human |
269 | hematopoietic stem cells or progenitor cells or performing |
270 | diagnostic testing of specimens if such specimens are tested |
271 | together with specimens undergoing routine donor testing. |
272 | 2. Storage, handling, and recordkeeping of these |
273 | distributions by a person required to be permitted as a |
274 | restricted prescription drug distributor must be in accordance |
275 | comply with the requirements for wholesale distributors under s. |
276 | 499.0121, but not those set forth in s. 499.01212 if the |
277 | distribution occurs pursuant to sub-subparagraph 1.a. or sub- |
278 | subparagraph 1.b. |
279 | 3. A person who applies for a permit as a restricted |
280 | prescription drug distributor, or for the renewal of such a |
281 | permit, must provide to the department the information required |
282 | under s. 499.012. |
283 | 4. The department may adopt rules regarding the |
284 | distribution of prescription drugs by hospitals, health care |
285 | entities, charitable organizations, or other persons not |
286 | involved in wholesale distribution, and blood establishments, |
287 | which rules are necessary for the protection of the public |
288 | health, safety, and welfare. |
289 | Section 5. This act shall take effect July 1, 2012. |