Regulations
We understand Drug Supply Chain policies consistently change, with the FDA introducing exemptions and extensions multiple times since the Drug Supply Chain Security Act was adopted in 2013. The DSCSA roadmap introduced by the FDA in 2013 (summarized below) is not as simple as it seems, with updates to legislation and new policies enactments adding some additional twists and turns.
For your convenience, we’ve organized the various different FDA regulations pertaining to Enforcement, Product Verification, and Traceability, making it easy for you to locate and understand the requirements directly from the FDA.
- Enforcement
- Product Verification
- Traceability
