The Drug Quality and Security Act (DQSA), enacted in 2013, addresses the safety, traceability, and regulation of compounded drugs in the U.S. and strengthens the nation's drug supply chain. It consists of two key titles:

Title I: Compounding Quality Act – This title was established in response to the 2012 fungal meningitis outbreak linked to contaminated compounded drugs. It clarifies the FDA's authority to regulate and oversee compounded drugs. The law distinguishes between traditional compounding pharmacies and outsourcing facilities. Outsourcing facilities can compound sterile drugs in bulk, but they are subject to FDA oversight, while traditional compounding pharmacies follow state regulations and are more limited in scope.

Title II: Drug Supply Chain Security Act (DSCSA) – This title aims to create a national system for tracking and tracing prescription drugs as they move through the supply chain. It establishes standards for manufacturers, wholesalers, and dispensers to verify and trace the source of drugs from production to the end consumer. Full implementation of the DSCSA will allow for enhanced drug traceability and prevent counterfeit or unsafe drugs from reaching patients.

The DQSA promotes the safety and integrity of compounded drugs and the overall pharmaceutical supply chain.

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An article can be found on NHIA's website. NHIA.org