CS/HB 509

1
A bill to be entitled
2An act relating to blood establishments; amending s.
3381.06014, F.S.; prohibiting a local government from
4restricting access to or use of public facilities or
5infrastructure for the collection of blood or blood
6components from volunteer donors based on certain
7criteria; prohibiting blood establishments from
8determining the price of blood or blood components based
9on certain criteria; amending s. 499.003, F.S.; revising
10the definition of the term "wholesale distribution" to
11exclude certain drugs and products distributed by blood
12establishments; amending s. 499.01, F.S.; excluding
13certain blood establishments from the requirement to
14obtain a prescription drug manufacturer permit; providing
15an effective date.
16
17Be It Enacted by the Legislature of the State of Florida:
18
19     Section 1.  Subsections (5) and (6) are added to section
20381.06014, Florida Statutes, to read:
21     381.06014  Blood establishments.-
22     (5)  A local government may not restrict the access to or
23use of any public facility or infrastructure for the collection
24of blood or blood components from volunteer donors based on
25whether the blood establishment is operating as a for-profit
26organization or a not-for-profit organization.
27     (6)  In determining the price of blood or blood components
28that are received from volunteer donors and sold to hospitals or
29other health care providers, a blood establishment may not base
30the price of the blood or blood component solely on whether the
31purchasing entity is a for-profit organization or a not-for-
32profit organization.
33     Section 2.  Paragraphs (e) and (f) of subsection (53) of
34section 499.003, Florida Statutes, are redesignated as
35paragraphs (f) and (g), respectively, and a new paragraph (e) is
36added to that subsection to read:
37     499.003  Definitions of terms used in this part.-As used in
38this part, the term:
39     (53)  "Wholesale distribution" means distribution of
40prescription drugs to persons other than a consumer or patient,
41but does not include:
42     (e)  The sale, purchase, or trade or the offer to sell,
43purchase, or trade, by a registered blood establishment that
44qualifies as a health care entity of any:
45     1.  Drug indicated for a bleeding or clotting disorder or
46anemia;
47     2.  Blood collection container approved under section 505
48of the Prescription Drug Marketing Act;
49     3.  Drug that is a blood derivative, or a recombinant or
50synthetic form of a blood derivative, as long as the health care
51services provided by the blood establishment are related to its
52activities as a registered blood establishment or the health
53care services provided by the blood establishment consist of
54collecting, processing, storing, or administering human
55hematopoietic stem or progenitor cells or performing diagnostic
56testing of specimens that are tested together with specimens
57undergoing routine donor testing; or
58     4.  Drug necessary to collect blood or blood components
59from volunteer blood donors; for blood establishment personnel
60to perform therapeutic procedures under the direction and
61supervision of a licensed physician; and to diagnose, treat,
62manage, and prevent any reaction of either a volunteer blood
63donor or a patient undergoing a therapeutic procedure performed
64under the direction and supervision of a licensed physician.
65
66A blood establishment whose distribution of products is excluded
67under this paragraph must satisfy all other requirements of this
68part applicable to a wholesale distributor or retail pharmacy.
69     Section 3.  Paragraph (a) of subsection (2) of section
70499.01, Florida Statutes, is amended to read:
71     499.01  Permits.-
72     (2)  The following permits are established:
73     (a)  Prescription drug manufacturer permit.-A prescription
74drug manufacturer permit is required for any person that is a
75manufacturer of a prescription drug and that manufactures or
76distributes such prescription drugs in this state.
77     1.  A person that operates an establishment permitted as a
78prescription drug manufacturer may engage in wholesale
79distribution of prescription drugs manufactured at that
80establishment and must comply with all of the provisions of this
81part, except s. 499.01212, and the rules adopted under this
82part, except s. 499.01212, that apply to a wholesale
83distributor.
84     2.  A prescription drug manufacturer must comply with all
85appropriate state and federal good manufacturing practices.
86     3.  A blood establishment, as defined in s. 381.06014,
87operating in a manner consistent with 21 C.F.R. parts 211 and
88660-640 and manufacturing only the prescription drugs described
89in s. 499.003(53)(d) and (e) is not required to obtain a permit
90as a prescription drug manufacturer under this paragraph or
91register products under s. 499.015.
92     Section 4.  This act shall take effect upon becoming a law.


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