On June 30, 2017, FDA issued a draft guidance for industry, Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. This guidance informs manufacturers and other supply chain stakeholders that although manufacturers are to begin including a product identifier on prescription drug packages and cases on November 27, 2017, the FDA is delaying enforcement of those requirements until November 2018 to provide manufacturers additional time and avoid supply disruptions.
What is a product identifier?
The compliance policy outlined in the draft guidance applies solely to products without a product identifier that are introduced into commerce by a manufacturer between November 27, 2017 and November 26, 2018.
While manufacturers work to meet product identifier requirements, they must comply with other DSCSA requirements.
SOURCE: U.S. Food and Drug Administration