v. 13 – 2020/01
|Market Executive Summary||
In the USA, the federal law called the Drug Supply Chain Security Act (DSCSA) requires tracing (by lot) and verification (by serialization) of certain prescription drug products. Required is a Product Identifier, uniquely identifying packages and homogenous cases with 4 data elements in both machine and human readable format. Trading partners have different requirements as related to their respective roles in the supply chain.
There have been no new developments, since September 2019, when the FDA issued a guidance document informing the public of an enforcement discretionary period for the requirement for wholesale distributors to verify the Product Identifiers of any product being returned to them intended to be returned to saleable inventory. Where initially wholesale distributors were required to perform this verification starting November 27, 2019, this latest guidance document introduced an enforcement discretionary period to November 27, 2020.