Compounding Quality Act

The Compounding Quality Act, enacted in 2013, aims to enhance the safety and quality of compounded drugs, which are custom-made medications tailored to individual patient needs. The law establishes stricter regulations for large-scale compounding pharmacies, requiring them to follow good manufacturing practices and register with the FDA. It also creates a new category of compounding facilities known as "outsourcing facilities," which must adhere to rigorous oversight. The goal is to prevent incidents of contamination and ensure that patients receive safe, effective medications tailored to their specific health needs.