Stricken language would be deleted from and underlined language would be added to present law.
Act 961 of the Regular Session
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State of Arkansas As Engrossed: S4/9/25 1
95th General Assembly A Bill 2
Regular Session, 2025 HOUSE BILL 1801 3
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By: Representative K. Moore 5
By: Senator B. Davis 6
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For An Act To Be Entitled 8
AN ACT TO AUTHORIZE AN OUTSOURCING FACILITY OF LEGEND 9
DRUGS AND CONTROLLED SUBSTANCES THAT COMPOUNDS A 10
PRODUCT TO SELL THE COMPOUNDED PRODUCT TO CERTAIN 11
ENTITIES; AND FOR OTHER PURPOSES. 12
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Subtitle 15
TO AUTHORIZE AN OUTSOURCING FACILITY OF 16
LEGEND DRUGS AND CONTROLLED SUBSTANCES 17
THAT COMPOUNDS A PRODUCT TO SELL THE 18
COMPOUNDED PRODUCT TO CERTAIN ENTITIES. 19
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BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF ARKANSAS: 21
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SECTION 1. Arkansas Code Title 17, Chapter 92, Subchapter 1, is 23
amended to add an additional section to read as follows: 24
17-92-121. Outsourcing facility of legend drugs and controlled 25
substances. 26
(a) As used in this section, "outsourcing facility of legend drugs and 27
controlled substances" means an entity that is registered as a 503B 28
outsourcing facility with the United States Food and Drug Administration and 29
has a permit with the Arkansas State Board of Pharmacy. 30
(b)(1) An outsourcing facility of legend drugs and controlled 31
substances that compounds a product may sell a compounded product to: 32
(A) An Arkansas-licensed retail pharmacy for dispensing to 33
a patient; 34
(B) An Arkansas-licensed healthcare facility for 35
administration to a patient; or 36 As Engrossed: S4/9/25 HB1801
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(C) An Arkansas-licensed healthcare provider, such as a 1
physician or nurse practitioner, for administration to a patient in a medical 2
clinic. 3
(2) With the exception of the entities listed in subdivision 4
(b)(1) of this section, an outsourcing facility of legend drugs and 5
controlled substances shall not sell a compounded drug to a wholesale 6
distributor, pharmaceutical repackager, pharmaceutical relabeler, marketing 7
firm, or any other entity. 8
(c) An outsourcing facility of legend drugs and controlled substances 9
shall comply with the Current Good Manufacturing Practices regulations in 21 10
C.F.R. Part 210, 21 C.F.R. Part 211, and 21 C.F.R. Part 212, as existing on 11
January 1, 2025. 12
(d) The board shall adopt rules pertaining to an Arkansas -licensed 13
retail pharmacy dispensing a compound obtained from an outsourcing facility 14
of legend drugs and controlled substances to a patient, including without 15
limitation requiring: 16
(1) Patient education on the compound; 17
(2) The name of the outsourcing facility of legend drugs and 18
controlled substances preparing the compound; and 19
(3) Any other item related to the dispensing of a compound by an 20
outsourcing facility of legend drugs and controlled substances deemed 21
necessary by the board. 22
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/s/K. Moore 24
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APPROVED: 4/21/25 27
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