(a) As used in this section, “outsourcing facility of legend drugs and controlled substances” means an entity that is registered as a 503B outsourcing facility with the United States Food and Drug Administration and has a permit with the Arkansas State Board of Pharmacy.
(b) (1) An outsourcing facility of legend drugs and controlled substances that compounds a product may sell a compounded product to:(A) An Arkansas-licensed retail pharmacy for dispensing to a patient;(B) An Arkansas-licensed healthcare facility for administration to a patient; or(C) An Arkansas-licensed healthcare provider, such as a physician or nurse practitioner, for administration to a patient in a medical clinic.(2) With the exception of the entities listed in subdivision (b)(1) of this section, an outsourcing facility of legend drugs and controlled substances shall not sell a compounded drug to a wholesale distributor, pharmaceutical repackager, pharmaceutical relabeler, marketing firm, or any other entity.
(1) An outsourcing facility of legend drugs and controlled substances that compounds a product may sell a compounded product to:(A) An Arkansas-licensed retail pharmacy for dispensing to a patient;(B) An Arkansas-licensed healthcare facility for administration to a patient; or(C) An Arkansas-licensed healthcare provider, such as a physician or nurse practitioner, for administration to a patient in a medical clinic.
(A) An Arkansas-licensed retail pharmacy for dispensing to a patient;
(B) An Arkansas-licensed healthcare facility for administration to a patient; or
(C) An Arkansas-licensed healthcare provider, such as a physician or nurse practitioner, for administration to a patient in a medical clinic.
(2) With the exception of the entities listed in subdivision (b)(1) of this section, an outsourcing facility of legend drugs and controlled substances shall not sell a compounded drug to a wholesale distributor, pharmaceutical repackager, pharmaceutical relabeler, marketing firm, or any other entity.
(c) An outsourcing facility of legend drugs and controlled substances shall comply with the Current Good Manufacturing Practices regulations in 21 C.F.R. Part 210, 21 C.F.R. Part 211, and 21 C.F.R. Part 212, as existing on January 1, 2025.
(d) The board shall adopt rules pertaining to an Arkansas-licensed retail pharmacy dispensing a compound obtained from an outsourcing facility of legend drugs and controlled substances to a patient, including without limitation requiring:(1) Patient education on the compound;(2) The name of the outsourcing facility of legend drugs and controlled substances preparing the compound; and(3) Any other item related to the dispensing of a compound by an outsourcing facility of legend drugs and controlled substances deemed necessary by the board.
(1) Patient education on the compound;
(2) The name of the outsourcing facility of legend drugs and controlled substances preparing the compound; and
(3) Any other item related to the dispensing of a compound by an outsourcing facility of legend drugs and controlled substances deemed necessary by the board.