| 6 | 4 | | 95th General Assembly A Bill 2 |
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| 7 | 5 | | Regular Session, 2025 HOUSE BILL 1801 3 |
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| 8 | 6 | | 4 |
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| 9 | 7 | | By: Representative K. Moore 5 |
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| 10 | 8 | | By: Senator B. Davis 6 |
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| 11 | 9 | | 7 |
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| 12 | 10 | | For An Act To Be Entitled 8 |
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| 13 | 11 | | AN ACT TO AUTHORIZE AN OUTSOURCING FACILITY OF LEGEND 9 |
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| 14 | 12 | | DRUGS AND CONTROLLED SUBSTANCES THAT COMPOUNDS A 10 |
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| 15 | 13 | | PRODUCT TO SELL THE COMPOUNDED PRODUCT TO CERTAIN 11 |
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| 16 | 14 | | ENTITIES; AND FOR OTHER PURPOSES. 12 |
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| 17 | 15 | | 13 |
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| 18 | 16 | | 14 |
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| 19 | 17 | | Subtitle 15 |
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| 20 | 18 | | TO AUTHORIZE AN OUTSOURCING FACILITY OF 16 |
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| 21 | 19 | | LEGEND DRUGS AND CONTROLLED SUBSTANCES 17 |
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| 22 | 20 | | THAT COMPOUNDS A PRODUCT TO SELL THE 18 |
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| 23 | 21 | | COMPOUNDED PRODUCT TO CERTAIN ENTITIES. 19 |
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| 24 | 22 | | 20 |
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| 25 | 23 | | BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF ARKANSAS: 21 |
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| 26 | 24 | | 22 |
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| 27 | 25 | | SECTION 1. Arkansas Code Title 17, Chapter 92, Subchapter 1, is 23 |
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| 28 | 26 | | amended to add an additional section to read as follows: 24 |
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| 29 | 27 | | 17-92-121. Outsourcing facility of legend drugs and controlled 25 |
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| 30 | 28 | | substances. 26 |
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| 31 | 29 | | (a) As used in this section, "outsourcing facility of legend drugs and 27 |
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| 32 | 30 | | controlled substances" means an entity that is registered as a 503B 28 |
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| 33 | 31 | | outsourcing facility with the United States Food and Drug Administration and 29 |
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| 34 | 32 | | has a permit with the Arkansas State Board of Pharmacy. 30 |
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| 35 | 33 | | (b)(1) An outsourcing facility of legend drugs and controlled 31 |
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| 36 | 34 | | substances that compounds a product may sell a compounded product to: 32 |
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| 37 | 35 | | (A) An Arkansas-licensed retail pharmacy for dispensing to 33 |
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| 38 | 36 | | a patient; 34 |
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| 39 | 37 | | (B) An Arkansas-licensed healthcare facility for 35 |
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| 45 | 41 | | (C) An Arkansas-licensed healthcare provider, such as a 1 |
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| 46 | 42 | | physician or nurse practitioner, for administration to a patient in a medical 2 |
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| 47 | 43 | | clinic. 3 |
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| 48 | 44 | | (2) With the exception of the entities listed in subdivision 4 |
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| 49 | 45 | | (b)(1) of this section, an outsourcing facility of legend drugs and 5 |
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| 50 | 46 | | controlled substances shall not sell a compounded drug to a wholesale 6 |
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| 51 | 47 | | distributor, pharmaceutical repackager, pharmaceutical relabeler, marketing 7 |
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| 52 | 48 | | firm, or any other entity. 8 |
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| 53 | 49 | | (c) An outsourcing facility of legend drugs and controlled substances 9 |
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| 54 | 50 | | shall comply with the Current Good Manufacturing Practices regulations in 21 10 |
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| 55 | 51 | | C.F.R. Part 210, 21 C.F.R. Part 211, and 21 C.F.R. Part 212, as existing on 11 |
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| 56 | 52 | | January 1, 2025. 12 |
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| 57 | | - | (d) The board shall adopt rules pertaining to an Arkansas -licensed 13 |
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| 58 | | - | retail pharmacy dispensing a compound obtained from an outsourcing facility 14 |
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| 59 | | - | of legend drugs and controlled substances to a patient, including without 15 |
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| 60 | | - | limitation requiring: 16 |
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| 61 | | - | (1) Patient education on the compound; 17 |
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| 62 | | - | (2) The name of the outsourcing facility of legend drugs and 18 |
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| 63 | | - | controlled substances preparing the compound; and 19 |
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| 64 | | - | (3) Any other item related to the dispensing of a compound by an 20 |
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| 65 | | - | outsourcing facility of legend drugs and controlled substances deemed 21 |
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| 66 | | - | necessary by the board. 22 |
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| 53 | + | 13 |
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| 62 | + | 22 |
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