Bill Text: FL S7050 | 2010 | Regular Session | Introduced

---

Bill Title: Blood Establishments

Spectrum: Unknown

Status: (N/A - Dead) 2010-02-03 - Submit as committee bill by Health Regulation (SB 1818) [S7050 Detail]

Download: Florida-2010-S7050-Introduced.html

---

 
Florida Senate - 2010         (PROPOSED COMMITTEE BILL) SPB 7050 
 
FOR CONSIDERATION By the Committee on Health Regulation 
588-01616A-10                                         20107050__ 
1                        A bill to be entitled 
2         An act relating to blood establishments; amending s. 
3         381.06014, F.S.; prohibiting local governments from 
4         restricting access to public facilities or 
5         infrastructure for certain activities based on whether 
6         a blood establishment is operating as a for-profit 
7         organization or not-for-profit organization; 
8         prohibiting a blood establishment from considering 
9         whether certain customers are operating as a for 
10         profit organization or not-for-profit organization 
11         when determining prices for selling blood or blood 
12         components; amending s. 499.005, F.S.; clarifying 
13         provisions prohibiting the unauthorized wholesale 
14         distribution of a prescription drug that was purchased 
15         by a hospital or other health care entity, to conform 
16         to changes made by the act; amending s. 499.01, F.S.; 
17         requiring certain blood establishments to obtain a 
18         restricted prescription drug distributor permit under 
19         specified conditions; providing an effective date. 
20 
21  Be It Enacted by the Legislature of the State of Florida: 
22 
23         Section 1. Subsections (5) and (6) are added to section 
24  381.06014, Florida Statutes, to read: 
25         381.06014 Blood establishments.— 
26         (5) A local government may not restrict the access to or 
27  use of any public facility or infrastructure for the collection 
28  of blood or blood components from volunteer donors based on 
29  whether the blood establishment is operating as a for-profit 
30  organization or not-for-profit organization. 
31         (6) In determining the price of blood or blood components 
32  that are received from volunteer donors and sold to hospitals or 
33  other health care providers, a blood establishment may not base 
34  the price of the blood or blood component solely on whether the 
35  purchasing entity is a for-profit organization or not-for-profit 
36  organization. 
37         Section 2. Subsection (21) of section 499.005, Florida 
38  Statutes, is amended to read: 
39         499.005 Prohibited acts.—It is unlawful for a person to 
40  perform or cause the performance of any of the following acts in 
41  this state: 
42         (21) The wholesale distribution of any prescription drug 
43  that was: 
44         (a) Purchased by a public or private hospital or other 
45  health care entity, except as authorized in s. 499.01(2)(g); or 
46         (b) Donated or supplied at a reduced price to a charitable 
47  organization. 
48         Section 3. Paragraph (g) of subsection (2) of section 
49  499.01, Florida Statutes, is amended to read: 
50         499.01 Permits.— 
51         (2) The following permits are established: 
52         (g) Restricted prescription drug distributor permit.— 
53         1. A restricted prescription drug distributor permit is 
54  required for: 
55         a. Any person that engages in the distribution of a 
56  prescription drug, which distribution is not considered 
57  “wholesale distribution” under s. 499.003(53)(a). 
58         b.1. Any A person who engages in the receipt or 
59  distribution of a prescription drug in this state for the 
60  purpose of processing its return or its destruction must obtain 
61  a permit as a restricted prescription drug distributor if such 
62  person is not the person initiating the return, the prescription 
63  drug wholesale supplier of the person initiating the return, or 
64  the manufacturer of the drug. 
65         c. A blood establishment located in this state which 
66  collects blood and blood components only from volunteer donors 
67  and which engages in the wholesale distribution of a 
68  prescription drug to a health care entity. The blood 
69  establishment must operate in accordance with s. 381.06014. The 
70  blood establishment shall distribute only: 
71         (I) Prescription drugs indicated for a bleeding or clotting 
72  disorder or anemia; 
73         (II) Blood-collection containers approved under s. 505 of 
74  the federal act; or 
75         (III) Drugs that are blood derivatives, blood recombinants, 
76  or synthetic forms of a blood derivative, 
77 
78  as long as all of the health care services that the blood 
79  establishment provides are related to its activities as a 
80  registered blood establishment or the health care services 
81  consist of collecting, processing, storing, or administering 
82  human hematopoietic stem cells or progenitor cells or performing 
83  diagnostic testing of specimens if these specimens are tested 
84  together with specimens undergoing routine donor testing. 
85         2. Storage, handling, and recordkeeping of these 
86  distributions by a person permitted as a restricted prescription 
87  drug distributor must comply with the requirements for wholesale 
88  distributors under s. 499.0121, but not those set forth in s. 
89  499.01212 if the distribution occurs pursuant to sub 
90  subparagraph 1.a. or sub-subparagraph 1.b. 
91         3. A person who applies for a permit as a restricted 
92  prescription drug distributor, or for the renewal of such a 
93  permit, must provide to the department the information required 
94  under s. 499.012. 
95         4. The department may adopt rules regarding the 
96  distribution of prescription drugs by hospitals, health care 
97  entities, charitable organizations, or other persons not 
98  involved in wholesale distribution, which rules are necessary 
99  for the protection of the public health, safety, and welfare. 
100         Section 4. This act shall take effect July 1, 2010.