What You Need to Know
7/3/2017–The FDA released guidance to apply a one year enforcement discretion for the Drug Supply Chain Security Act’s 2017 product identification deadline. The full guidance is available here.
The DSCSA is requiring that all medicine packs sold in the US must be marked with a product identifier, serial number, lot number and expiration date using a 2D datamatrix barcode. The original deadline for US companies to have this completed was November 27, 2017. The FDA issued a notice on June 30, 2017 stating that it “does not intend to take action against manufacturers who do not affix or imprint a product identifier to their packages and homogenous cases of product that are intended to be introduced in a transaction into commerce between November 27, 2017, and November 26, 2018.“
The law itself is not changing, but this notice is stating that no action will be taken if this year’s deadline is not met. The notice also states the following:
“For such product that does not contain a product identifier and was first introduced in a transaction into commerce by the manufacturer between November 27, 2017, and November 26, 2018, FDA also does not intend to take action against manufacturers who do not use the product identifier to verify a product at the package level when investigating suspect product, upon receiving a verification request from FDA, after receiving a request from an authorized trading partner, or for a saleable returned product.“
Please contact Adept Packaging with any questions or concerns regarding this deadline.