Posts Tagged ‘DQSA’
Enhancing FDA Communications: DQSA Update
The Food and Drug Administration (FDA) was granted some new authority this week by the Department of Health and Human Services (DHHS), its parent organization. The new authority, though not unexpected or substantial, pertains to the Drug Quality and Security Act (DQSA) which was passed in late 2013 in response to the deadly New England…
Read MoreDrug Quality and Security Act: Title II – Track and Trace System
The Drug Quality and Security Act (DQSA) was designed to clarify the Food And Drug Administration’s (FDA) oversight authority over drug compounding and update the federal drug tracking and tracing system. Title II of the DQSA seeks to reduce drug shortages, theft, counterfeiting and drug diversion by modernizing existing federal law and replacing current state…
Read MoreDrug Quality and Security Act: Title I – Compounding
On November 23, 2013, the President signed the Drug Quality and Security Act (DQSA) into law. As discussed previously on the Baer Law Blog, the legislation was designed to clarify the Food And Drug Administration’s (FDA) oversight authority over drug compounding and update the federal drug tracking and tracing system. The goal of Title I…
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…
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