HB 199

A bill to be entitled
2An act relating to blood establishments; amending s.
3381.06014, F.S.; redefining the term "blood establishment"
4and defining the term "volunteer donor"; prohibiting local
5governments from restricting access to public facilities
6or infrastructure for certain activities based on whether
7a blood establishment is operating as a for-profit
8organization or not-for-profit organization; prohibiting a
9blood establishment from considering whether certain
10customers are operating as for-profit organizations or
11not-for-profit organizations when determining service fees
12for selling blood or blood components; requiring that
13certain blood establishments disclose specified
14information on the Internet; authorizing the Department of
15Legal Affairs to assess a civil penalty against a blood
16establishment that fails to disclose specified information
17on the Internet; providing that the civil penalty accrues
18to the state and requiring that it be deposited as
19received into the General Revenue Fund; amending s.
20499.003, F.S.; redefining the term "health care entity" to
21clarify that a blood establishment is a health care entity
22that may engage in certain activities; amending s.
23499.005, F.S.; clarifying provisions that prohibit the
24unauthorized wholesale distribution of a prescription drug
25that was purchased by a hospital or other health care
26entity or donated or supplied at a reduced price to a
27charitable organization, to conform to changes made by the
28act; amending s. 499.01, F.S.; exempting certain blood
29establishments from the requirements to be permitted as a
30prescription drug manufacturer and register products;
31requiring that certain blood establishments obtain a
32restricted prescription drug distributor permit under
33specified conditions; limiting the prescription drugs that
34a blood establishment may distribute under a restricted
35prescription drug distributor permit; authorizing the
36Department of Health to adopt rules regarding the
37distribution of prescription drugs by blood
38establishments; providing an effective date.
40Be It Enacted by the Legislature of the State of Florida:
42     Section 1.  Section 381.06014, Florida Statutes, is amended
43to read:
44     381.06014  Blood establishments.-
45     (1)  As used in this section, the term:
46     (a)  "Blood establishment" means any person, entity, or
47organization, operating within the state, which examines an
48individual for the purpose of blood donation or which collects,
49processes, stores, tests, or distributes blood or blood
50components collected from the human body for the purpose of
51transfusion, for any other medical purpose, or for the
52production of any biological product. A person, entity, or
53organization that uses a mobile unit to conduct such activities
54within the state is also a blood establishment.
55     (b)  "Volunteer donor" means a person who does not receive
56remuneration, other than an incentive, for a blood donation
57intended for transfusion, and the product container of the
58donation from the person qualifies for labeling with the
59statement "volunteer donor" under 21 C.F.R. s. 606.121.
60     (2)  Any blood establishment operating in the state may not
61conduct any activity defined in paragraph (1)(a) subsection (1)
62unless that blood establishment is operated in a manner
63consistent with the provisions of Title 21 C.F.R. parts 211 and
64600-640, Code of Federal Regulations.
65     (3)  Any blood establishment determined to be operating in
66the state in a manner not consistent with the provisions of
67Title 21 C.F.R. parts 211 and 600-640, Code of Federal
68Regulations, and in a manner that constitutes a danger to the
69health or well-being of donors or recipients as evidenced by the
70federal Food and Drug Administration's inspection reports and
71the revocation of the blood establishment's license or
72registration is shall be in violation of this chapter and must
73shall immediately cease all operations in the state.
74     (4)  The operation of a blood establishment in a manner not
75consistent with the provisions of Title 21 C.F.R. parts 211 and
76600-640, Code of Federal Regulations, and in a manner that
77constitutes a danger to the health or well-being of blood donors
78or recipients as evidenced by the federal Food and Drug
79Administration's inspection process is declared a nuisance and
80inimical to the public health, welfare, and safety. The Agency
81for Health Care Administration or any state attorney may bring
82an action for an injunction to restrain such operations or
83enjoin the future operation of the blood establishment.
84     (5)  A local government may not restrict the access to or
85use of any public facility or infrastructure for the collection
86of blood or blood components from volunteer donors based on
87whether the blood establishment is operating as a for-profit
88organization or not-for-profit organization.
89     (6)  In determining the service fee of blood or blood
90components received from volunteer donors and sold to hospitals
91or other health care providers, a blood establishment may not
92base the service fee of the blood or blood component solely on
93whether the purchasing entity is a for-profit organization or
94not-for-profit organization.
95     (7)  A blood establishment that collects blood or blood
96components from volunteer donors must disclose on the Internet
97the information required under this subsection to educate and
98inform donors and the public about the blood establishment's
99activities. A hospital that collects blood or blood components
100to be used only by that hospital's licensed facilities or by a
101health care provider that is a part of the hospital's business
102entity is exempt from the disclosure requirements in this
103subsection. The information required to be disclosed under this
104subsection may be cumulative for all blood establishments within
105a business entity. A blood establishment must disclose on its
106website all of the following information:
107     (a)  A description of the steps involved in collecting,
108processing, and distributing volunteer donations.
109     (b)  By March 1 of each year, the number of units of blood
110components which were:
111     1.  Produced by the blood establishment during the
112preceding calendar year;
113     2.  Obtained from other sources during the preceding
114calendar year;
115     3.  Distributed during the preceding calendar year to
116health care providers located outside this state. However, if
117the blood establishment collects donations in a county outside
118this state, distributions to health care providers in that
119county shall be excluded. Such information shall be reported in
120the aggregate for health care providers located within the
121United States and its territories or outside the United States
122and its territories; and
123     4.  Distributed during the preceding calendar year to
124entities that are not health care providers. Such information
125shall be reported in the aggregate for purchasers located within
126the United States and its territories or outside the United
127States and its territories.
128     (c)  The blood establishment's conflict-of-interest policy,
129policy concerning related-party transactions, whistleblower
130policy, and policy for determining executive compensation. If a
131change occurs to any of these documents, the revised document
132must be available on the blood establishment's website by the
133following March 1.
134     (d)  Except for a hospital that collects blood or blood
135components from volunteer donors:
136     1.  The most recent 3 years of the Return of Organization
137Exempt from Income Tax, Internal Revenue Service Form 990, if
138the business entity for the blood establishment is eligible to
139file such return. The Form 990 must be available on the blood
140establishment's website within 60 calendar days after it is
141filed with the Internal Revenue Service; or
142     2.  If the business entity for the blood establishment is
143not eligible to file the Form 990 return, a balance sheet,
144income statement, and statement of changes in cash flow, along
145with the expression of an opinion thereon by an independent
146certified public accountant who audited or reviewed such
147financial statements. Such documents must be available on the
148blood establishment's website within 120 days after the end of
149the blood establishment's fiscal year and must remain on the
150blood establishment's website for at least 36 months.
151     (8)  A blood establishment is liable for a civil penalty
152for failing to make the disclosures required under subsection
153(7). The Department of Legal Affairs may assess the civil
154penalty against the blood establishment for each day that it
155fails to make such required disclosures, but the penalty may not
156exceed $10,000 per year. If multiple blood establishments
157operated by a single business entity fail to meet such
158disclosure requirements, the civil penalty may be assessed
159against only one of the business entity's blood establishments.
160The Department of Legal Affairs may terminate an action if the
161blood establishment agrees to pay a stipulated civil penalty. A
162civil penalty so collected accrues to the state and shall be
163deposited as received into the General Revenue Fund unallocated.
164The Department of Legal Affairs may terminate the action and
165waive the civil penalty upon a showing of good cause by the
166blood establishment as to why the required disclosures were not
168     Section 2.  Subsection (23) of section 499.003, Florida
169Statutes, is amended to read:
170     499.003  Definitions of terms used in this part.-As used in
171this part, the term:
172     (23)  "Health care entity" means a closed pharmacy or any
173person, organization, or business entity that provides
174diagnostic, medical, surgical, or dental treatment or care, or
175chronic or rehabilitative care, but does not include any
176wholesale distributor or retail pharmacy licensed under state
177law to deal in prescription drugs. However, a blood
178establishment is a health care entity that may engage in the
179wholesale distribution of prescription drugs under s.
181     Section 3.  Subsection (21) of section 499.005, Florida
182Statutes, is amended to read:
183     499.005  Prohibited acts.-It is unlawful for a person to
184perform or cause the performance of any of the following acts in
185this state:
186     (21)  The wholesale distribution of any prescription drug
187that was:
188     (a)  Purchased by a public or private hospital or other
189health care entity; or
190     (b)  Donated or supplied at a reduced price to a charitable
193unless the wholesale distribution of the prescription drug is
194authorized in s. 499.01(2)(g)1.c.
195     Section 4.  Paragraphs (a) and (g) of subsection (2) of
196section 499.01, Florida Statutes, are amended to read:
197     499.01  Permits.-
198     (2)  The following permits are established:
199     (a)  Prescription drug manufacturer permit.-A prescription
200drug manufacturer permit is required for any person that is a
201manufacturer of a prescription drug and that manufactures or
202distributes such prescription drugs in this state.
203     1.  A person that operates an establishment permitted as a
204prescription drug manufacturer may engage in wholesale
205distribution of prescription drugs manufactured at that
206establishment and must comply with all of the provisions of this
207part, except s. 499.01212, and the rules adopted under this
208part, except s. 499.01212, which that apply to a wholesale
210     2.  A prescription drug manufacturer must comply with all
211appropriate state and federal good manufacturing practices.
212     3.  A blood establishment, as defined in s. 381.06014,
213operating in a manner consistent with the provisions of Title 21
214C.F.R. parts 211 and 600-640, and manufacturing only the
215prescription drugs described in s. 499.003(54)(d) is not
216required to be permitted as a prescription drug manufacturer
217under this paragraph or to register products under s. 499.015.
218     (g)  Restricted prescription drug distributor permit.-
219     1.  A restricted prescription drug distributor permit is
220required for:
221     a.  Any person located in this state that engages in the
222distribution of a prescription drug, which distribution is not
223considered "wholesale distribution" under s. 499.003(54)(a).
224     b.1.  Any A person located in this state who engages in the
225receipt or distribution of a prescription drug in this state for
226the purpose of processing its return or its destruction must
227obtain a permit as a restricted prescription drug distributor if
228such person is not the person initiating the return, the
229prescription drug wholesale supplier of the person initiating
230the return, or the manufacturer of the drug.
231     c.  A blood establishment located in this state which
232collects blood and blood components only from volunteer donors
233as defined in s. 381.06014 or pursuant to an authorized
234practitioner's order for medical treatment or therapy and
235engages in the wholesale distribution of a prescription drug not
236described in s. 499.003(54)(d) to a health care entity. The
237health care entity receiving a prescription drug distributed
238under this sub-subparagraph must be licensed as a closed
239pharmacy or provide health care services at that establishment.
240The blood establishment must operate in accordance with s.
241381.06014 and may distribute only:
242     (I)  Prescription drugs indicated for a bleeding or
243clotting disorder or anemia;
244     (II)  Blood-collection containers approved under s. 505 of
245the federal act;
246     (III)  Drugs that are blood derivatives, or a recombinant
247or synthetic form of a blood derivative;
248     (IV)  Prescription drugs that are identified in rules
249adopted by the department and that are essential to services
250performed or provided by blood establishments and authorized for
251distribution by blood establishments under federal law; or
252     (V)  To the extent authorized by federal law, drugs
253necessary to collect blood or blood components from volunteer
254blood donors; for blood establishment personnel to perform
255therapeutic procedures under the direction and supervision of a
256licensed physician; and to diagnose, treat, manage, and prevent
257any reaction of either a volunteer blood donor or a patient
258undergoing a therapeutic procedure performed under the direction
259and supervision of a licensed physician,
261as long as all of the health care services provided by the blood
262establishment are related to its activities as a registered
263blood establishment or the health care services consist of
264collecting, processing, storing, or administering human
265hematopoietic stem cells or progenitor cells or performing
266diagnostic testing of specimens if such specimens are tested
267together with specimens undergoing routine donor testing.
268     2.  Storage, handling, and recordkeeping of these
269distributions by a person required to be permitted as a
270restricted prescription drug distributor must comply with the
271requirements for wholesale distributors under s. 499.0121, but
272not those set forth in s. 499.01212 if the distribution occurs
273pursuant to sub-subparagraph 1.a. or sub-subparagraph 1.b.
274     3.  A person who applies for a permit as a restricted
275prescription drug distributor, or for the renewal of such a
276permit, must provide to the department the information required
277under s. 499.012.
278     4.  The department may adopt rules regarding the
279distribution of prescription drugs by hospitals, health care
280entities, charitable organizations, or other persons not
281involved in wholesale distribution, and blood establishments,
282which rules are necessary for the protection of the public
283health, safety, and welfare.
284     Section 5.  This act shall take effect July 1, 2011.

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