The Drug Supply Chain Security Act enacted on November 2013 established a requirement for a Product Identifier to be affixed to each package and homogeneous case of drug introduced into commerce in the USA, from 27th November 2017.
The product identifier includes the product’s standardised numerical identifier, its lot number and expiration date. It should be affixed in both machine-readable data-carrier and human-readable form. The system aims to improve the detection of illegitimate products within the supply chain.
Given the concerns expressed by manufacturers and trading partners about implementation timeline and to avoid supply disruption, FDA decided that no action will be taken against manufacturers who do not affix the product identifier on product introduced into commerce between 27th November 2017 and 27th November 2018.
A draft guidance has been issued on 30th June 2017 to explain the different aspects of the compliance policy for manufacturers, repackagers, Wholesale distributors and dispensers.
Click here to access the FDA statement and guidance.