It's official: DSCSA enforcement will be delayed one year

A long-rumoured delay to the FDA's enforcement of the next Drug Supply Chain Security Act (DSCSA) product identification deadline has now been confirmed.

The US regulator confirmed in a Federal Register notice this morning that its new policy means 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 DSCSA stipulates 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 notice continues: "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."

It is worth emphasising that this does not involve any changes to the law, as any changes to the compliance dates in the DSCSA would require an act of Congress, but is confirmation that the FDA will use its discretion when it comes to enforcement after the November 27 date passes.

It's a pragmatic decision, and reflects what the agency describes as "comments and feedback from manufacturers and other trading partners expressing concern with industry-wide readiness for implementation of the product identifier requirements for manufacturers and describing challenges they face."

It also comes amid concerns that industry is still waiting for various FDA guidance documents intended to flesh out details on the DSCSA requirements.