Drug Compounding: Manufacturing Standards Announced for Outsourcing Facilities

In late 2013, Congress passed the Drug Quality and Security Act (DQSA) in response to a deadly fungal meningitis outbreak linked to a sterile compounded injectable drug shipped across the country and responsible for more than 750 confirmed infections and 60 deaths. A key component of the DQSA is the recognition of a new type of drug compounding entity—outsourcing facilities—that can provide a source of high-quality compounded drugs for hospitals and providers. Unlike traditional state-regulated compounding pharmacies, outsourcing facilities are regulated by the U.S. Food and Drug Administration (FDA) and subject to manufacturing standards for the production of sterile compounds. This week, FDA released draft guidance explaining how the agency intends to apply current Good Manufacturing Practices (cGMPs) to these outsourcing facilities.
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