Archive for April 2014
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 MoreFDA Preparing a List of Bulk Drug Substances for Compound Drug Products
The Food and Drug Administration (FDA) is preparing a list of bulk drug substances that outsourcing facilities may use to compound drug products in accordance with Section 503B of the Food, Drug and Cosmetic Act (FDC Act). Requests for electronic and written nominations ended in early March 2014. Section 503B of the FDC Act defines…
Read MoreFDA Releases Draft Guidance on Section 503B Fees for Outsourcing Facilities.
Section 503B of the Federal Food, Drug and Cosmetic Act (FDCA) created a new Food and Drug Administration (FDA) regulated entity called an ‘outsourcing facility.’ As discussed previously on the Baer Law Blog, a registered outsourcing facility is permitted to compound sterile drugs for human use with or without a prescription after voluntarily registering with…
Read MoreThe 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…
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