• Track & Trace


What the DSCSA Deadlines Mean for Pharmaceutical Companies

The Drug Supply Chain Security Act (DSCSA) is part of the Drug Quality and Security Act (DQSA).  The first deadline for the DSCSA was January 1, 2015. Pharmaceutical companies must include product transaction information in an electronic or paper record every time ownership is transferred. The document must include transaction data listing lot level information. The documentation must be kept for six years. 

Required Transaction Information:

  • Name of product
  • Strength and dosage of product
  • National Drug Code number of product
  • Container size
  • Number of containers
  • Lot number of product
  • Date of the transaction
  • Date of the shipment, if more than 24 hours after the date of the transaction
  • Business name and address of the person from whom ownership is being transferred
  • Business name and address of the person to whom ownership is being transferred

On November 27, 2017, pharmaceutical transaction information will no longer be allowed on paper. Transaction information must be available electronically. Also in November 2017, a product identifier must be on the label of each case and individual product.  There are more deadlines through 2023.