Drug Supply Chain Security Act (DSCSA)

As part of the Drug Quality and Secutity Act (DQSA), the Drug Supply Chain Security Act addresses wholesale distribution security controls that, as noted above, were largely seen as ineffective as defined in the original PDMA.  It defines critical steps that will be required of manufacturers, wholesale distributors, re-packagers, and pharmacies over the next ten years.

The DSCSA provides an over-arching objective of ensuring drugs are legitimate, safe, and effective as they move from manufacturer to patient. It also serves to help identify illegitimate and counterfeit drug products and facilitate the recall of potentially dangerous product.