FDA Delays Enforcement of Supply Chain Identifier Requirements for One Year

The FDA will give manufacturers an extra year before it begins enforcing new requirements for individual serial codes in drug packaging, according to a new draft guidance.

The Drug Supply Chain Security Act, passed in November 2013, required manufacturers to apply product identifiers to all of their packaging, beginning Nov. 27 this year.

Responding to industry’s concerns over their ability to comply with the November deadline, the agency said it does not intend to take action against manufacturers that do not affix a product identifier to new packages between Nov. 27 and Nov. 26, 2018.