HB 475

1
A bill to be entitled
2An act relating to blood establishments; amending s.
3381.06014, F.S.; redefining the term "blood
4establishment" and defining the term "volunteer
5donor"; prohibiting local governments from restricting
6access to public facilities or infrastructure for
7certain activities based on whether a blood
8establishment is operating as a for-profit
9organization or not-for-profit organization;
10prohibiting a blood establishment from considering
11whether certain customers are operating as for-profit
12organizations or not-for-profit organizations when
13determining service fees for selling blood or blood
14components; requiring that certain blood
15establishments disclose specified information on the
16Internet; authorizing the Department of Legal Affairs
17to assess a civil penalty against a blood
18establishment that fails to disclose specified
19information on the Internet; providing that the civil
20penalty accrues to the state and requiring that it be
21deposited as received into the General Revenue Fund;
22amending s. 499.003, F.S.; redefining the term "health
23care entity" to clarify that a blood establishment is
24a health care entity that may engage in certain
25activities; amending s. 499.005, F.S.; clarifying
26provisions that prohibit the unauthorized wholesale
27distribution of a prescription drug that was purchased
28by a hospital or other health care entity or donated
29or supplied at a reduced price to a charitable
30organization, to conform to changes made by the act;
31amending s. 499.01, F.S.; exempting certain blood
32establishments from the requirements to be permitted
33as a prescription drug manufacturer and register
34products; requiring that certain blood establishments
35obtain a restricted prescription drug distributor
36permit under specified conditions; limiting the
37prescription drugs that a blood establishment may
38distribute under a restricted prescription drug
39distributor permit; authorizing the Department of
40Health to adopt rules regarding the distribution of
41prescription drugs by blood establishments; providing
42an effective date.
43
44Be It Enacted by the Legislature of the State of Florida:
45
46     Section 1.  Section 381.06014, Florida Statutes, is amended
47to read:
48     381.06014  Blood establishments.-
49     (1)  As used in this section, the term:
50     (a)  "Blood establishment" means any person, entity, or
51organization, operating within the state, which examines an
52individual for the purpose of blood donation or which collects,
53processes, stores, tests, or distributes blood or blood
54components collected from the human body for the purpose of
55transfusion, for any other medical purpose, or for the
56production of any biological product. A person, entity, or
57organization that uses a mobile unit to conduct such activities
58within the state is also a blood establishment.
59     (b)  "Volunteer donor" means a person who does not receive
60remuneration, other than an incentive, for a blood donation
61intended for transfusion, and the product container of the
62donation from the person qualifies for labeling with the
63statement "volunteer donor" under 21 C.F.R. s. 606.121.
64     (2)  Any blood establishment operating in the state may not
65conduct any activity defined in paragraph (1)(a) subsection (1)
66unless that blood establishment is operated in a manner
67consistent with the provisions of Title 21 C.F.R. parts 211 and
68600-640, Code of Federal Regulations.
69     (3)  Any blood establishment determined to be operating in
70the state in a manner not consistent with the provisions of
71Title 21 C.F.R. parts 211 and 600-640, Code of Federal
72Regulations, and in a manner that constitutes a danger to the
73health or well-being of donors or recipients as evidenced by the
74federal Food and Drug Administration's inspection reports and
75the revocation of the blood establishment's license or
76registration is shall be in violation of this chapter and must
77shall immediately cease all operations in the state.
78     (4)  The operation of a blood establishment in a manner not
79consistent with the provisions of Title 21 C.F.R. parts 211 and
80600-640, Code of Federal Regulations, and in a manner that
81constitutes a danger to the health or well-being of blood donors
82or recipients as evidenced by the federal Food and Drug
83Administration's inspection process is declared a nuisance and
84inimical to the public health, welfare, and safety. The Agency
85for Health Care Administration or any state attorney may bring
86an action for an injunction to restrain such operations or
87enjoin the future operation of the blood establishment.
88     (5)  A local government may not restrict the access to or
89use of any public facility or infrastructure for the collection
90of blood or blood components from volunteer donors based on
91whether the blood establishment is operating as a for-profit
92organization or not-for-profit organization.
93     (6)  In determining the service fee of blood or blood
94components received from volunteer donors and sold to hospitals
95or other health care providers, a blood establishment may not
96base the service fee of the blood or blood component solely on
97whether the purchasing entity is a for-profit organization or
98not-for-profit organization.
99     (7)  A blood establishment that collects blood or blood
100components from volunteer donors must disclose on the Internet
101the information required under this subsection to educate and
102inform donors and the public about the blood establishment's
103activities. A hospital that collects blood or blood components
104to be used only by that hospital's licensed facilities or by a
105health care provider that is a part of the hospital's business
106entity is exempt from the disclosure requirements in this
107subsection. The information required to be disclosed under this
108subsection may be cumulative for all blood establishments within
109a business entity. A blood establishment must disclose on its
110website all of the following information:
111     (a)  A description of the steps involved in collecting,
112processing, and distributing volunteer donations.
113     (b)  By March 1 of each year, the number of units of blood
114components which were:
115     1.  Produced by the blood establishment during the
116preceding calendar year;
117     2.  Obtained from other sources during the preceding
118calendar year;
119     3.  Distributed during the preceding calendar year to
120health care providers located outside this state. However, if
121the blood establishment collects donations in a county outside
122this state, distributions to health care providers in that
123county shall be excluded. Such information shall be reported in
124the aggregate for health care providers located within the
125United States and its territories or outside the United States
126and its territories; and
127     4.  Distributed during the preceding calendar year to
128entities that are not health care providers. Such information
129shall be reported in the aggregate for purchasers located within
130the United States and its territories or outside the United
131States and its territories.
132     (c)  The blood establishment's conflict-of-interest policy,
133policy concerning related-party transactions, whistleblower
134policy, and policy for determining executive compensation. If a
135change occurs to any of these documents, the revised document
136must be available on the blood establishment's website by the
137following March 1.
138     (d)  Except for a hospital that collects blood or blood
139components from volunteer donors:
140     1.  The most recent 3 years of the Return of Organization
141Exempt from Income Tax, Internal Revenue Service Form 990, if
142the business entity for the blood establishment is eligible to
143file such return. The Form 990 must be available on the blood
144establishment's website within 60 calendar days after it is
145filed with the Internal Revenue Service; or
146     2.  If the business entity for the blood establishment is
147not eligible to file the Form 990 return, a balance sheet,
148income statement, and statement of changes in cash flow, along
149with the expression of an opinion thereon by an independent
150certified public accountant who audited or reviewed such
151financial statements. Such documents must be available on the
152blood establishment's website within 120 days after the end of
153the blood establishment's fiscal year and must remain on the
154blood establishment's website for at least 36 months.
155     (8)  A blood establishment is liable for a civil penalty
156for failing to make the disclosures required under subsection
157(7). The Department of Legal Affairs may assess the civil
158penalty against the blood establishment for each day that it
159fails to make such required disclosures, but the penalty may not
160exceed $10,000 per year. If multiple blood establishments
161operated by a single business entity fail to meet such
162disclosure requirements, the civil penalty may be assessed
163against only one of the business entity's blood establishments.
164The Department of Legal Affairs may terminate an action if the
165blood establishment agrees to pay a stipulated civil penalty. A
166civil penalty so collected accrues to the state and shall be
167deposited as received into the General Revenue Fund unallocated.
168The Department of Legal Affairs may terminate the action and
169waive the civil penalty upon a showing of good cause by the
170blood establishment as to why the required disclosures were not
171made.
172     Section 2.  Subsection (23) of section 499.003, Florida
173Statutes, is amended to read:
174     499.003  Definitions of terms used in this part.-As used in
175this part, the term:
176     (23)  "Health care entity" means a closed pharmacy or any
177person, organization, or business entity that provides
178diagnostic, medical, surgical, or dental treatment or care, or
179chronic or rehabilitative care, but does not include any
180wholesale distributor or retail pharmacy licensed under state
181law to deal in prescription drugs. However, a blood
182establishment is a health care entity that may engage in the
183wholesale distribution of prescription drugs under s.
184499.01(2)(g)1.c.
185     Section 3.  Subsection (21) of section 499.005, Florida
186Statutes, is amended to read:
187     499.005  Prohibited acts.-It is unlawful for a person to
188perform or cause the performance of any of the following acts in
189this state:
190     (21)  The wholesale distribution of any prescription drug
191that was:
192     (a)  Purchased by a public or private hospital or other
193health care entity; or
194     (b)  Donated or supplied at a reduced price to a charitable
195organization,
196
197unless the wholesale distribution of the prescription drug is
198authorized in s. 499.01(2)(g)1.c.
199     Section 4.  Paragraphs (a) and (g) of subsection (2) of
200section 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
204drug manufacturer permit is required for any person that is a
205manufacturer of a prescription drug and that manufactures or
206distributes such prescription drugs in this state.
207     1.  A person that operates an establishment permitted as a
208prescription drug manufacturer may engage in wholesale
209distribution of prescription drugs manufactured at that
210establishment and must comply with all of the provisions of this
211part, except s. 499.01212, and the rules adopted under this
212part, except s. 499.01212, which that apply to a wholesale
213distributor.
214     2.  A prescription drug manufacturer must comply with all
215appropriate state and federal good manufacturing practices.
216     3.  A blood establishment, as defined in s. 381.06014,
217operating in a manner consistent with the provisions of 21
218C.F.R. parts 211 and 600-640, and manufacturing only the
219prescription drugs described in s. 499.003(54)(d) is not
220required to be permitted as a prescription drug manufacturer
221under 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
224required for:
225     a.  Any person located in this state who that engages in
226the distribution of a prescription drug, which distribution is
227not considered "wholesale distribution" under s. 499.003(54)(a).
228     b.1.  Any A person located in this state who engages in the
229receipt or distribution of a prescription drug in this state for
230the purpose of processing its return or its destruction must
231obtain a permit as a restricted prescription drug distributor if
232such person is not the person initiating the return, the
233prescription drug wholesale supplier of the person initiating
234the return, or the manufacturer of the drug.
235     c.  A blood establishment located in this state which
236collects blood and blood components only from volunteer donors
237as defined in s. 381.06014 or pursuant to an authorized
238practitioner's order for medical treatment or therapy and
239engages in the wholesale distribution of a prescription drug not
240described in s. 499.003(54)(d) to a health care entity. The
241health care entity receiving a prescription drug distributed
242under this sub-subparagraph must be licensed as a closed
243pharmacy or provide health care services at that establishment.
244The blood establishment must operate in accordance with s.
245381.06014 and may distribute only:
246     (I)  Prescription drugs indicated for a bleeding or
247clotting disorder or anemia;
248     (II)  Blood-collection containers approved under s. 505 of
249the federal act;
250     (III)  Drugs that are blood derivatives, or a recombinant
251or synthetic form of a blood derivative;
252     (IV)  Prescription drugs that are identified in rules
253adopted by the department and that are essential to services
254performed or provided by blood establishments and authorized for
255distribution by blood establishments under federal law; or
256     (V)  To the extent authorized by federal law, drugs
257necessary to collect blood or blood components from volunteer
258blood donors; for blood establishment personnel to perform
259therapeutic procedures under the direction and supervision of a
260licensed physician; and to diagnose, treat, manage, and prevent
261any reaction of a volunteer blood donor or a patient undergoing
262a therapeutic procedure performed under the direction and
263supervision of a licensed physician,
264
265as long as all of the health care services provided by the blood
266establishment are related to its activities as a registered
267blood establishment or the health care services consist of
268collecting, processing, storing, or administering human
269hematopoietic stem cells or progenitor cells or performing
270diagnostic testing of specimens if such specimens are tested
271together with specimens undergoing routine donor testing.
272     2.  Storage, handling, and recordkeeping of these
273distributions by a person required to be permitted as a
274restricted prescription drug distributor must be in accordance
275comply with the requirements for wholesale distributors under s.
276499.0121, but not those set forth in s. 499.01212 if the
277distribution occurs pursuant to sub-subparagraph 1.a. or sub-
278subparagraph 1.b.
279     3.  A person who applies for a permit as a restricted
280prescription drug distributor, or for the renewal of such a
281permit, must provide to the department the information required
282under s. 499.012.
283     4.  The department may adopt rules regarding the
284distribution of prescription drugs by hospitals, health care
285entities, charitable organizations, or other persons not
286involved in wholesale distribution, and blood establishments,
287which rules are necessary for the protection of the public
288health, safety, and welfare.
289     Section 5.  This act shall take effect July 1, 2012.


CODING: Words stricken are deletions; words underlined are additions.