What is DSCSA?
The Drug Supply Chain Security Act outlines the series of regulations that govern the pharmaceutical supply chain. As products move from manufacturers to distributors to dispensers, each trading partner is required to follow certain laws that protect the integrity of products entering and moving within the supply chain. These laws require trading partners to have provable systems surrounding the products they purchase, sell, dispense or administer, ultimately protecting the patients that receive the product and resulting in a safer pharmaceutical environment for everyone.
Who does DSCSA
Apply to?
The Drug Supply Chain Security Act applies to all trading partners (Authorized Trading Partners) within the pharmaceutical supply chain including Manufacturers and Compounders, Wholesale Drug Distributors, 3PLs, Pharmacies that dispense pharmaceuticals, and Healthcare Facilities that administer pharmaceutical products to patients as part of their practice. Every stage of the pharmaceutical supply chain has its own series of compliance, policy, and procedure requirements in order to ensure the end-to-end quality, safety and integrity of pharmaceutical products.
When is the DSCSA deadline?
DSCSA laws were enacted on November 27, 2013 with ongoing phases for enhancements going forward. The deadline for enhanced requirements are currently in effect for nearly all trading partners within the supply chain. There are limited and specific extensions for Small Business Dispensers as defined by the FDA which mainly provide an extension for certain product tracing requirements. Provable DSCSA compliance systems, company policies and standard procedures are presently subject to audit for all levels of pharmaceutical authorized trading partners.