Following increased regulatory scrutiny and safety incidents linked to inconsistent oversight by state boards of pharmacy, the FDA established two designations for compounding facilities: 503A and 503B. This guide explains the defining features of each designation, the key differences between them, and what 503A compounding pharmacies and 503B outsourcing facilities need to know to remain compliant with evolving FDA and state regulations.
Read MoreA 503B outsourcing facility is a type of drug manufacturing establishment authorized to compound medications in bulk, with or without patient-specific prescriptions, for distribution to healthcare facilities for office or “office-administered” use. These facilities are regulated by the U.S. Food and Drug Administration (FDA) and must comply with stringent quality and safety standards. Learn more about the definitions & regulations in this post.
Read MoreThe information below represents material from the conference and includes data from the 503B Market Landscape Study conducted by the FDA in 2022. These points include emerging compounding trends and key industry insights shared by FDA.
Read MoreLast week, the Food and Drug Administration announced the release of a revised draft guidance describing current good manufacturing practice (CGMP) requirements for 503B outsourcing facilities. The document provides direction and details as to how 503B’s can stay compliant with the Agency. Are you compliant?
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