Florida Senate - 2012 COMMITTEE AMENDMENT
Bill No. SB 1006
Barcode 942294
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
02/27/2012 .
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The Committee on Health Regulation (Norman) recommended the
following:
1 Senate Amendment to Amendment (416374) (with directory and
2 title amendments)
3
4 Between lines 56 and 57
5 insert:
6 (54) “Wholesale distribution” means distribution of
7 prescription drugs to persons other than a consumer or patient,
8 but does not include:
9 (a) Any of the following activities, which is not a
10 violation of s. 499.005(21) if such activity is conducted in
11 accordance with s. 499.01(2)(g):
12 1. The purchase or other acquisition by a hospital or other
13 health care entity that is a member of a group purchasing
14 organization of a prescription drug for its own use from the
15 group purchasing organization or from other hospitals or health
16 care entities that are members of that organization.
17 2. The sale, purchase, or trade of a prescription drug or
18 an offer to sell, purchase, or trade a prescription drug by a
19 charitable organization described in s. 501(c)(3) of the
20 Internal Revenue Code of 1986, as amended and revised, to a
21 nonprofit affiliate of the organization to the extent otherwise
22 permitted by law.
23 3. The sale, purchase, or trade of a prescription drug or
24 an offer to sell, purchase, or trade a prescription drug among
25 hospitals or other health care entities that are under common
26 control. For purposes of this subparagraph, “common control”
27 means the power to direct or cause the direction of the
28 management and policies of a person or an organization, whether
29 by ownership of stock, by voting rights, by contract, or
30 otherwise.
31 4. The sale, purchase, trade, or other transfer of a
32 prescription drug from or for any federal, state, or local
33 government agency or any entity eligible to purchase
34 prescription drugs at public health services prices pursuant to
35 Pub. L. No. 102-585, s. 602 to a contract provider or its
36 subcontractor for eligible patients of the agency or entity
37 under the following conditions:
38 a. The agency or entity must obtain written authorization
39 for the sale, purchase, trade, or other transfer of a
40 prescription drug under this subparagraph from the State Surgeon
41 General or his or her designee.
42 b. The contract provider or subcontractor must be
43 authorized by law to administer or dispense prescription drugs.
44 c. In the case of a subcontractor, the agency or entity
45 must be a party to and execute the subcontract.
46 d. A contract provider or subcontractor must maintain
47 separate and apart from other prescription drug inventory any
48 prescription drugs of the agency or entity in its possession.
49 d.e. The contract provider and subcontractor must maintain
50 and produce immediately for inspection all records of movement
51 or transfer of all the prescription drugs belonging to the
52 agency or entity, including, but not limited to, the records of
53 receipt and disposition of prescription drugs. Each contractor
54 and subcontractor dispensing or administering these drugs must
55 maintain and produce records documenting the dispensing or
56 administration. Records that are required to be maintained
57 include, but are not limited to, a perpetual inventory itemizing
58 drugs received and drugs dispensed by prescription number or
59 administered by patient identifier, which must be submitted to
60 the agency or entity quarterly.
61 e.f. The contract provider or subcontractor may administer
62 or dispense the prescription drugs only to the eligible patients
63 of the agency or entity or must return the prescription drugs
64 for or to the agency or entity. The contract provider or
65 subcontractor must require proof from each person seeking to
66 fill a prescription or obtain treatment that the person is an
67 eligible patient of the agency or entity and must, at a minimum,
68 maintain a copy of this proof as part of the records of the
69 contractor or subcontractor required under sub-subparagraph d
70 sub-subparagraph e.
71 f.g. In addition to the departmental inspection authority
72 set forth in s. 499.051, the establishment of the contract
73 provider and subcontractor and all records pertaining to
74 prescription drugs subject to this subparagraph shall be subject
75 to inspection by the agency or entity. All records relating to
76 prescription drugs of a manufacturer under this subparagraph
77 shall be subject to audit by the manufacturer of those drugs,
78 without identifying individual patient information.
79
80 ====== D I R E C T O R Y C L A U S E A M E N D M E N T ======
81 And the directory clause is amended as follows:
82 Delete line 5
83 and insert:
84 Section 1. Subsections (17), (19), (20), and (43), and
85 paragraph (a) of subsection (54) of
86
87 ================= T I T L E A M E N D M E N T ================
88 And the title is amended as follows:
89 Delete lines 267 - 268
90 and insert:
91 “distribution,” “drug,” “establishment,” “prescription
92 drug,” and “wholesale distribution”; amending s.
93 499.01, F.S.;