This bill amends Arkansas Code Title 17, Chapter 92, Subchapter 1, to establish regulations for outsourcing facilities that compound legend drugs and controlled substances. It introduces a new section, 17-92-121, which defines an "outsourcing facility of legend drugs and controlled substances" as an entity registered with the FDA as a 503B outsourcing facility and permitted by the Arkansas State Board of Pharmacy. The bill allows these facilities to sell compounded products to specific entities, including Arkansas-licensed retail pharmacies, healthcare facilities, and healthcare providers, while prohibiting sales to wholesale distributors and other entities.
Additionally, the bill mandates that outsourcing facilities comply with Current Good Manufacturing Practices as outlined in federal regulations. It also requires the Arkansas State Board of Pharmacy to adopt rules regarding the dispensing of compounded products by retail pharmacies, which must include patient education, disclosure of the outsourcing facility's name, and any other necessary information related to the dispensing process.