Final answer:
The 2013 Drug Quality and Security Act (DQSA) improves the safety and security of the pharmaceutical supply chain in the United States. It establishes tracking and tracing systems for prescription drugs and strengthens oversight of compounding pharmacies. The DQSA aims to prevent counterfeit drugs and ensure patient safety.
Step-by-step explanation:
The 2013 Drug Quality and Security Act (DQSA) is a federal law in the United States that aims to improve the safety and security of the pharmaceutical supply chain. It was enacted in response to concerns about counterfeit drugs and other risks to patient safety. The DQSA establishes a system for tracking and tracing prescription drugs as they move through the supply chain, from manufacturers to pharmacies.
One important provision of the DQSA is the requirement for drug manufacturers and repackagers to place unique product identifiers on their packages. These identifiers, known as serial numbers, lot numbers, and expiration dates, help to verify the authenticity and integrity of drugs. This enhances the ability to detect and remove counterfeit or compromised products from the supply chain.
The DQSA also includes provisions to strengthen oversight and regulation of compounding pharmacies, which prepare customized medications for individual patients. It defines the distinction between traditional compounding, which is allowed under state law, and non-traditional compounding, which is subject to more stringent federal regulation. These measures are intended to prevent another incident like the 2012 fungal meningitis outbreak, which was linked to contaminated compounded drugs.