Bill > HB1801

This bill authorizes an outsourcing facility of legend drugs and controlled substances (a 503B facility registered with the FDA and the Arkansas State Board of Pharmacy) to sell compounded pharmaceutical products, but only to specific entities within Arkansas: licensed retail pharmacies for patient dispensing, licensed healthcare facilities for patient administration, and licensed healthcare providers like physicians or nurse practitioners for patient administration in medical clinics. The bill explicitly prohibits these outsourcing facilities from selling compounded drugs to wholesale distributors, pharmaceutical repackagers, marketing firms, or other entities. The outsourcing facility must comply with Current Good Manufacturing Practices (CGMP) regulations as specified in federal Code of Federal Regulations parts 210, 211, and 212, as of January 1, 2025. Additionally, the Arkansas State Board of Pharmacy is required to develop rules governing how these compounded drugs can be dispensed, including mandating patient education about the compound, disclosure of the outsourcing facility's name, and other dispensing-related requirements deemed necessary by the board. This legislation aims to regulate the production and distribution of specialized pharmaceutical compounds while ensuring patient safety and transparency.

Health and Social Services

https://arkleg.state.ar.us/Bills/Detail?id=hb1801&ddBienniumSession=2025%2F2025R