An act TO AUTHORIZE AN OUTSOURCING FACILITY OF LEGEND 10 DRUGS AND CONTROLLED SUBSTANCES THAT COMPOUNDS A 11 PRODUCT TO SELL THE COMPOUNDED PRODUCT TO CERTAIN 12 ENTITIES, the official text

Stricken language would be deleted from and underlined language would be added to present law.

1 State of Arkansas            As Engrossed: S4/9/25
2 95th General Assembly
                                    A Bill

3 Regular Session, 2025                                            HOUSE BILL 1801

4

5 By: Representative K. Moore

6 By: Senator B. Davis

7

8                              For An Act To Be Entitled

9               AN ACT TO AUTHORIZE AN OUTSOURCING FACILITY OF LEGEND

10              DRUGS AND CONTROLLED SUBSTANCES THAT COMPOUNDS A

11              PRODUCT TO SELL THE COMPOUNDED PRODUCT TO CERTAIN

12              ENTITIES; AND FOR OTHER PURPOSES.

13

14

15                                  Subtitle

16                       TO AUTHORIZE AN OUTSOURCING FACILITY OF

17                       LEGEND DRUGS AND CONTROLLED SUBSTANCES

18                       THAT COMPOUNDS A PRODUCT TO SELL THE

19                       COMPOUNDED PRODUCT TO CERTAIN ENTITIES.

20

21 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF ARKANSAS:

22

23  SECTION 1. Arkansas Code Title 17, Chapter 92, Subchapter 1, is

24 amended to add an additional section to read as follows:

25  17-92-121. Outsourcing facility of legend drugs and controlled

26 substances.

27  (a) As used in this section, "outsourcing facility of legend drugs and

28 controlled substances" means an entity that is registered as a 503B

29 outsourcing facility with the United States Food and Drug Administration and

30 has a permit with the Arkansas State Board of Pharmacy.

31  (b)(1) An outsourcing facility of legend drugs and controlled

32 substances that compounds a product may sell a compounded product to:

33                       (A) An Arkansas-licensed retail pharmacy for dispensing to

34 a patient;

35                       (B) An Arkansas-licensed healthcare facility for

36 administration to a patient; or

    *JMB495*                                                      04-09-2025 18:29:06 JMB495
    As Engrossed: S4/9/25                                                 HB1801

1                    (C) An Arkansas-licensed healthcare provider, such as a

2 physician or nurse practitioner, for administration to a patient in a medical

3 clinic.

4          (2) With the exception of the entities listed in subdivision

5 (b)(1) of this section, an outsourcing facility of legend drugs and

6 controlled substances shall not sell a compounded drug to a wholesale

7 distributor, pharmaceutical repackager, pharmaceutical relabeler, marketing

8 firm, or any other entity.

9   (c) An outsourcing facility of legend drugs and controlled substances

10 shall comply with the Current Good Manufacturing Practices regulations in 21

11 C.F.R. Part 210, 21 C.F.R. Part 211, and 21 C.F.R. Part 212, as existing on

12 January 1, 2025.

13  (d) The board shall adopt rules pertaining to an Arkansas-licensed

14 retail pharmacy dispensing a compound obtained from an outsourcing facility

15 of legend drugs and controlled substances to a patient, including without

16 limitation requiring:

17         (1) Patient education on the compound;

18         (2) The name of the outsourcing facility of legend drugs and

19 controlled substances preparing the compound; and

20         (3) Any other item related to the dispensing of a compound by an

21 outsourcing facility of legend drugs and controlled substances deemed

22 necessary by the board.

23

24                            /s/K. Moore

25

26

27

28

29

30

31

32

33

34

35

36

                              2                       04-09-2025 18:29:06 JMB495