When was the Compounding Quality Act established?

When was the Compounding Quality Act established?

• A. 2013
• B. 2010
• C. 2015
• D. 2008

Answer: (A)

The Compounding Quality Act was established in 2013 as part of the Drug Quality and Security Act to strengthen safety and oversight of pharmaceutical compounding. It arose in response to the 2012 fungal meningitis outbreak and created a framework that distinguishes traditional compounding from manufacturing, with FDA oversight expanded for outsourcing facilities under 503B and continued state oversight for traditional compounding under 503A. Because the law was signed in 2013, that year is the correct one. The other dates don’t fit since the act wasn’t enacted in 2008, 2010, or 2015.

The Compounding Quality Act was established in 2013 as part of the Drug Quality and Security Act to strengthen safety and oversight of pharmaceutical compounding. It arose in response to the 2012 fungal meningitis outbreak and created a framework that distinguishes traditional compounding from manufacturing, with FDA oversight expanded for outsourcing facilities under 503B and continued state oversight for traditional compounding under 503A. Because the law was signed in 2013, that year is the correct one. The other dates don’t fit since the act wasn’t enacted in 2008, 2010, or 2015.