This bill proposes significant updates to the current statutes regarding the regulation of compounded medications and bulk drug substances. Under the new provisions, it would be unlawful for any person or entity to sell, transfer, or distribute compounded drugs that utilize specific drug substances related to obesity or weight management unless they meet stringent criteria, including compliance with United States pharmacopoeia standards and federal manufacturing processes. The bill also mandates that manufacturers and wholesalers provide written verification of the pharmaceutical grade of bulk drug substances and maintain detailed records of their sourcing and quality control testing for at least two years.

Additionally, the bill enhances the authority of the Arizona State Board of Pharmacy to inspect entities involved in drug compounding and imposes civil penalties for violations, including fines and potential license suspensions. It emphasizes the importance of truthful advertising for compounded medications and outlines specific requirements for such advertisements. The legislation aims to protect public health by ensuring that only safe and compliant ingredients are used in compounded medications, particularly those intended for weight loss, addressing concerns about the integrity of the pharmaceutical supply chain.

Statutes affected:
Introduced Version: 32-1971.01