Posts Tagged ‘compounding’
The Drug Quality and Security Act: Compounding Guidance
In November 2013, President Obama signed the Drug Quality and Security Act (DQSA), a law that aims to address and improve the safety of the United States pharmaceutical supply and contains updates to the oversight systems for pharmaceutical compounding. In December 2013, the United States Food and Drug Administration (FDA) released (for public comment) six…
Read MoreCompounding Update: Drug Quality and Security Act – Outsourcing Facilities
The Drug Quality and Security Act establishes and regulates a new class of compounding pharmacies called “outsourcing facilities.” What qualifies as an outsourcing facility? To qualify as an outsourcing facility, an entity must compound sterile drugs with or without patient specific prescriptions and comply with the Drug Quality and Security Act’s new rules, which include…
Read MoreCompounding Pharmacy Update: Drug Quality and Security Act
This week, Congress took the final step in approving the Drug Quality and Security Act, a bill that amends the Federal Food, Drug and Cosmetic Act with respect to the regulation of human drug compounding and drug supply chain security. The bill addresses the practice of compounding which has expanded drastically over the past two decades…
Read MoreCompounding and Nonresident Pharmacies
In late 2012, an outbreak of fungal meningitis brought national attention to compounding pharmacies, the sterility and regulation of their compounded products, and the potential patient risks associated with compounded medications. At the heart of the outbreak was a medication called methylprednisolone acetate, a preservative free injectable steroid that was produced at the New England…
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