The Drug Supply Chain Security Act (DSCSA) was enacted by the U.S. Congress on November 27, 2013, and aims to build a comprehensive, interoperable system by 2023 to identify and trace prescription drugs as they are distributed in the United States. The four core tenets of DSCSA can be outlined as follows:

1. Product Identification: Requires manufacturers to place a unique product identifier on certain prescription drug packages. This would ideally help in the precise tracking of drug products through the pharmaceutical supply distribution chain.

2. Product Tracing: Obligates wholesale distributors, manufacturers, repackagers, and many dispensers (primarily pharmacies) to provide information about a drug and who handled it each time it is sold in the U.S. market. This aims to maintain a record of the entire drug supply chain.

3. Product Verification: Outlines the steps that need to be taken to properly verify the product identifier on certain prescription drug packages. This allows for the detection and removal of potentially dangerous drugs from the supply chain.

4. Detection and Response: Demands robust systems to quarantine and investigate any drug that is suspected of being counterfeit, unapproved, or potentially dangerous. This is crucial for ensuring the safety and integrity of drugs in the U.S. market.

As for recall improvements, the DSCSA does not directly mention drug recalls. However, the systems and processes it mandates can greatly enhance the efficiency and effectiveness of drug recalls. By having a clear record of where each drug package has been, it becomes much easier to locate and recall potentially dangerous or faulty drugs. This can greatly improve patient safety and public health outcomes.

 

Read the full Act here.

Interested in savings on prescription medications? RxPost can help you buy or sell excess drug inventory to improve your profits and offer better patient service. Learn more about RxPost here.

Get Started