Tag Archives: DQSA

FDA Extends Oversight of Large Compounders

Moving fast to bolster its authority over compounding pharmacies that operate as manufacturers of prescription drugs, FDA is urging “outsourcers” to register, seeking state support, and moving to issue more rules and guidance. The agency is pleased that 14 outsourcers registered through mid-January. The number is small, considering that an estimated 3000 compounding pharmacies make […]
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Provider Demand to Drive Compounder Registration with FDA

The Food and Drug Administration is moving fast to implement the drug compounding provisions of new Drug Quality and Security Act (DQSA), issuing new guidance to spur registration by outsourcing facilities just days after President Obama signed the new bill into law. But because FDA cannot compel compounders to opt for agency regulation, implementation will […]
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