Bill > HB2613

This bill establishes new safety and regulatory requirements for compounded medications, which are drugs prepared by a pharmacist or physician for a specific patient based on a prescription. The bill aims to protect public health by ensuring that the active pharmaceutical ingredients (APIs), also known as bulk drug substances, used in these compounded medications meet strict quality and safety standards. Specifically, it mandates that APIs must comply with official pharmacopoeia monographs, be components of FDA-approved drugs, or be on an FDA list for use in compounding. Compounders must also confirm the API is pharmaceutical-grade, obtain a certificate of analysis detailing its origin and impurities, conduct quality control testing, and verify that the API was manufactured in an establishment registered with and inspected by the FDA within the last two years for compliance with current good manufacturing practices. Failure to comply can result in a $1,000 fine per illegally compounded drug dose and revocation of a pharmacy license. The bill also requires record-keeping for two years after the expiration date of the last lot of compounded drug and grants the commission authority to inspect compounding facilities and suppliers.

Health and Social Services

https://app.leg.wa.gov/billsummary?BillNumber=2613&Year=2025&Initiative=false