A Resilient Drug Supply Chain Needs More Than DSCSA Compliance
Covectra
There are more current and broader supply chain risks that parallel the challenges the FDA is seeking to address with the DSCSA.
While most pharmaceutical manufacturers are applying serialization to drugs at the unit level, there are contract manufacturers that are still shipping products without any serialization at all. This has been occurring most often when products are shipped directly to dispensers like hospitals or doctor’s offices without any intermediaries (like wholesalers or 3PLs) involved that have Drug Supply Chain Security Act (DSCSA) requirements of their own.
The FDA’s mission is to leverage the DSCSA to enhance its “ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.” DSCSA compliance also serves as a defense from intentional efforts by organized crime and state sponsors to monetize sowing chaos and causing harm by attacking the supply chain.
This article will offer insight into the current, broader supply chain risks that parallel the challenges the FDA is seeking to address with the DSCSA, and how a more comprehensive approach can not only ensure compliance, but also verify that your supply chain partners have implemented sound cyber security practices to safeguard the confidentiality, integrity and availability of your product’s data.
Industry making progress towards DSCSA
