bulk drug substances; prohibitions

HB 4036 regulates the use of specific bulk drug substances in compounded medications, primarily targeting drugs for obesity or weight management. It requires compounders to use only pharmaceutical-grade bulk substances meeting U.S. Pharmacopeia standards, conduct rigorous quality testing, verify supplier compliance with FDA registration, and maintain detailed records for two years. The bill also mandates truthful advertising disclosures, including clear statements that compounded medications are not FDA-approved. These provisions directly affect pharmacies and compounding facilities that create custom medications, with violations subject to $1,000 per dose penalties or license suspension.