The proposed legislation aims to authorize outsourcing facilities that compound legend drugs and controlled substances to sell their compounded products to specific entities in Arkansas. The bill introduces a new section to the Arkansas Code, defining an "outsourcing facility of legend drugs and controlled substances" as an entity registered with the FDA as a 503B outsourcing facility and holding a permit from the Arkansas State Board of Pharmacy. The bill specifies that these facilities may sell compounded products to 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 establish rules for retail pharmacies dispensing compounded products, which will include patient education, disclosure of the outsourcing facility's name, and any other necessary information related to the dispensing process. This legislation seeks to ensure the safe and regulated distribution of compounded medications within the state.