Florida Senate - 2024 SB 1406
By Senator Calatayud
38-01176-24 20241406__
1 A bill to be entitled
2 An act relating to restricted prescription drug
3 distributors; amending s. 499.01, F.S.; exempting
4 certain persons who engage in the receipt or
5 distribution of prescription drugs for the sole
6 purpose of processing the drugs’ destruction from
7 specified inventory and vehicle security requirements;
8 amending s. 499.05, F.S.; requiring the Department of
9 Business and Professional Regulation to adopt less
10 stringent rules for certain persons who engage in the
11 receipt or distribution of prescription drugs for the
12 sole purpose of processing the drugs’ destruction;
13 providing requirements for such rules; providing an
14 effective date.
15
16 Be It Enacted by the Legislature of the State of Florida:
17
18 Section 1. Paragraph (h) of subsection (2) of section
19 499.01, Florida Statutes, is amended to read:
20 499.01 Permits.—
21 (2) The following permits are established:
22 (h) Restricted prescription drug distributor permit.—
23 1. A restricted prescription drug distributor permit is
24 required for:
25 a. Any person located in this state who engages in the
26 distribution of a prescription drug, which distribution is not
27 considered “wholesale distribution” under s. 499.003(48)(a).
28 b. Any person located in this state who engages in the
29 receipt or distribution of a prescription drug in this state for
30 the purpose of processing its return or its destruction if such
31 person is not the person initiating the return, the prescription
32 drug wholesale supplier of the person initiating the return, or
33 the manufacturer of the drug.
34 c. A blood establishment located in this state which
35 collects blood and blood components only from volunteer donors
36 as defined in s. 381.06014 or pursuant to an authorized
37 practitioner’s order for medical treatment or therapy and
38 engages in the wholesale distribution of a prescription drug not
39 described in s. 499.003(48)(j) to a health care entity. A mobile
40 blood unit operated by a blood establishment permitted under
41 this sub-subparagraph is not required to be separately
42 permitted. The health care entity receiving a prescription drug
43 distributed under this sub-subparagraph must be licensed as a
44 closed pharmacy or provide health care services at that
45 establishment. The blood establishment must operate in
46 accordance with s. 381.06014 and may distribute only:
47 (I) Prescription drugs indicated for a bleeding or clotting
48 disorder or anemia;
49 (II) Blood-collection containers approved under s. 505 of
50 the federal act;
51 (III) Drugs that are blood derivatives, or a recombinant or
52 synthetic form of a blood derivative;
53 (IV) Prescription drugs that are identified in rules
54 adopted by the department and that are essential to services
55 performed or provided by blood establishments and authorized for
56 distribution by blood establishments under federal law; or
57 (V) To the extent authorized by federal law, drugs
58 necessary to collect blood or blood components from volunteer
59 blood donors; for blood establishment personnel to perform
60 therapeutic procedures under the direction and supervision of a
61 licensed physician; and to diagnose, treat, manage, and prevent
62 any reaction of a volunteer blood donor or a patient undergoing
63 a therapeutic procedure performed under the direction and
64 supervision of a licensed physician,
65
66 as long as all of the health care services provided by the blood
67 establishment are related to its activities as a registered
68 blood establishment or the health care services consist of
69 collecting, processing, storing, or administering human
70 hematopoietic stem cells or progenitor cells or performing
71 diagnostic testing of specimens if such specimens are tested
72 together with specimens undergoing routine donor testing. The
73 blood establishment may purchase and possess the drugs described
74 in this sub-subparagraph without a health care clinic
75 establishment permit.
76 2.a. Except as provided in sub-subparagraph b., the
77 storage, handling, and recordkeeping of these distributions by a
78 person required to be permitted as a restricted prescription
79 drug distributor must be in accordance with the requirements for
80 wholesale distributors under s. 499.0121.
81 b. A person who is required to be permitted as a restricted
82 prescription drug distributor and who engages in the receipt or
83 distribution of a prescription drug in this state for the sole
84 purpose of processing its destruction is not required to comply
85 with the inventory requirements of s. 499.0121(6)(d) or (8) or
86 the vehicle security requirements of s. 499.0121(2)(c).
87 3. A person who applies for a permit as a restricted
88 prescription drug distributor, or for the renewal of such a
89 permit, must provide to the department the information required
90 under s. 499.012.
91 4. The department may adopt rules regarding the
92 distribution of prescription drugs by hospitals, health care
93 entities, charitable organizations, other persons not involved
94 in wholesale distribution, and blood establishments, which rules
95 are necessary for the protection of the public health, safety,
96 and welfare.
97 5. A restricted prescription drug distributor permit is not
98 required for distributions between pharmacies that each hold an
99 active permit under chapter 465, have a common ownership, and
100 are operating in a freestanding end-stage renal dialysis clinic,
101 if such distributions are made to meet the immediate emergency
102 medical needs of specifically identified patients and do not
103 occur with such frequency as to amount to the regular and
104 systematic supplying of that drug between the pharmacies. The
105 department shall adopt rules establishing when the distribution
106 of a prescription drug under this subparagraph amounts to the
107 regular and systematic supplying of that drug.
108 6. A restricted prescription drug distributor permit is not
109 required for distributing medicinal drugs or prepackaged drug
110 products between entities under common control that each hold
111 either an active Class III institutional pharmacy permit under
112 chapter 465 or an active health care clinic establishment permit
113 under paragraph (r). For purposes of this subparagraph, the term
114 “common control” has the same meaning as in s. 499.003(48)(a)3.
115 Section 2. Subsection (3) of section 499.05, Florida
116 Statutes, is amended to read:
117 499.05 Rules.—
118 (3) The department shall adopt rules regulating
119 recordkeeping for and the storage, handling, and distribution of
120 medical devices and over-the-counter drugs to protect the public
121 from adulterated products; however, rules regulating persons who
122 engage in the receipt or distribution of a prescription drug in
123 this state for the sole purpose of processing its destruction
124 must be less stringent than the requirements for wholesale
125 distributors under s. 499.0121 and may not include the inventory
126 requirements in s. 499.0121(6)(d) or (8) or the vehicle security
127 requirements in s. 499.0121(2)(c).
128 Section 3. This act shall take effect July 1, 2024.