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