Pharmacy Compounding Quality Act of 2013: Problem Solved or Confusion Compounded? Webinar

Pharmacy Compounding Quality Act of 2013

Problem Solved or Confusion Compounded?

Thursday, February 20, 2014

Time: 1:00 pm EST - 2:00 pm EST

Cost: $200.00

Webinar

Since ancient times, when apothecaries began using mortar and pestle to create mixtures tailored for individual patients, drug “compounding” has been an established part of pharmacy practice. Over time, however, pharmacy compounding has often come to resemble full scale drug manufacturing rather than preparation of tailored mixtures for specific patients. Congress has stepped into the fray through the recent enactment of the Compounding Quality Act, which is part of the broader Drug Quality and Security Act that also addresses track and trace requirements in the pharmaceutical distribution chain. This webinar is for business owners, drug companies, corporate regulatory and compliance personnel and organization executives.
Key Topics

• FDA’s Historic Approach to Compounding
• Supreme Court’s Decision in Thompson vs. Western States
• Distinguishing between drug “compounding” and “manufacturing” 
• New England Compounding Center Crisis
• The Compounding Quality Act of 2013

Our Speakers
ARNOLD (ARNIE) FRIEDE has practiced food and drug law for more than 35 years and has successfully represented clients in virtually every FDA-regulated industry.  He brings a breadth and depth of experience in the field that began with his service as an associate chief counsel in the Office of Chief Counsel at FDA.  While there, Arnie represented the agency in a wide array of significant judicial and administrative proceedings and also worked as counsel to the then-Bureau of Radiological Health.  He recently taught the first-ever food and drug law course as an adjunct professor at the University of Miami School of Law.
SHELLY GARG is an attorney with ST&R’s Food and Drug Law Practice Group.  She represents clients across a broad range of FDA-regulated product categories, including  food and dietary supplements, prescription and over-the-counter drugs, biologics, medical devices, and cosmetics.  Her keen insights into FDA and its inner workings have proved to be of significant value to her clients in successfully resolving matters before the agency.

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