Bill > HB4036

This bill establishes new regulations for the compounding of medications in Arizona, particularly those used for obesity or weight management, by prohibiting the sale, transfer, or distribution of certain drug substances unless specific conditions are met by the compounder. These conditions include using bulk drug substances (meaning any substance intended for incorporation into a finished drug product that provides pharmacological activity or affects the body's structure or function) that meet United States Pharmacopoeia or National Formulary standards, are components of FDA-approved drugs, or are on an FDA list, and confirming they were manufactured according to federal law, are pharmaceutical grade, and are accompanied by a valid certificate of analysis. Compounders must also conduct and document quality control testing of both the bulk drug substance and the finished compounded drug, verify the bulk drug substance was manufactured in an establishment registered with and inspected by the U.S. Food and Drug Administration (FDA) within the last two years and not subject to an FDA import alert, and comply with the federal Food, Drug, and Cosmetic Act. Manufacturers and wholesalers selling bulk drug substances for compounding must provide written verification of pharmaceutical grade and sourcing requirements, along with quality control testing documentation and certificates of analysis. All records related to bulk drug substances must be maintained for at least two years after the expiration date of the last lot of drug containing the substance. The Arizona State Board of Pharmacy, or its agent, is granted authority to inspect entities involved in compounding and their suppliers, with refusal to allow inspection being a violation. The bill also prohibits deceptive advertising of compounded medications, requiring disclosures of potential side effects, risks, and a clear statement that the product is compounded, not FDA-approved, and has not been evaluated for safety or efficacy. Violations can result in civil penalties of $1,000 per dose and suspension or revocation of licenses. The legislature finds these measures necessary due to concerns about the safety and integrity of compounded medications, the exploitation of regulatory gaps by foreign entities, and the proliferation of substandard or contaminated active pharmaceutical ingredients, particularly for weight loss medications, which jeopardize patient health.

Business and Industry, Health and Social Services

https://apps.azleg.gov/BillStatus/BillOverview/85552