Pharmacy
Drug 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Read MoreFDA Releases Draft Guidance on Section 503B Fees for Outsourcing Facilities.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…
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 MoreUnused Medications: What Should I Do With Them?
While many consumers continue throw away medications in the trash or flush medications down the toilet, consumers should be aware of a much safer disposal alternative: community-based “take-back” programs. In February 2007, the Office of National Drug Control Policy (ONDCP), working together with the Food and Drug Administration (FDA), issued the first consumer guidance for proper…
Read MorePharmacists and Social Media
Social media is an online platform where users share information, photos, ideas, personal messages and other content. Some of the most popular social media sites include Facebook, Twitter, Tumblr, Instagram, Pinterest, FourSquare, and LinkedIn. As social media continues to rapidly expand and become more and more popular, the line between personal and professional online personas…
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