DSCSA Unit-Level Serialization:
The Clock Is Ticking
There is no time to lose since the transition to unit-level
serialization is not a quick fix.
By Peter Sturtevant, GS1 US
Pharmaceutical companies are now required to embed a standardized product identifier, serial number, lot number, and expiration date in a 2D barcode, on all individual
The pressure is on for companies to comply
with the FDA’s Drug Supply Chain Security Act
(DSCSA) lowest saleable unit and homogeneous
case serialization requirements with the November
27, 2017 deadline now passed.
A barcode assessment conducted last May at
two of largest wholesalers’ distribution centers
showed that a meager single-digit percentage of
packages that were scanned carried the necessary
data—raising concerns that the industry was far
from ready for compliance in November. This past
summer, the FDA announced an enforcement delay
giving companies an additional year to become
compliant before any penalties will be levied.
The one-year reprieve gives pharmaceutical
manufacturers the opportunity to implement proper
sterilization solutions, with concerted effort to meet
the requirements before November 27, 2018.
There is no time to lose since the transition to
unit-level serialization is not a quick fix. Forward
action must begin in earnest, if it hasn’t already.
The mandatory product identifier can be a GS1
Global Trade Item Number (GTIN) or an FDA
National Drug Code (NDC).
Working together as members of the GS1
Healthcare US Initiative, the voluntary industry
group implementing global standards to address
patient safety and deliver supply-chain efficiencies,
industry stakeholders have learned that common
questions and ambiguities have contributed to
the companies’ delays in implementing DSCSA
Answering some of these questions, they offer
some clarity and guidelines to help.
Difference Between GTINs and NDCs
The NDC is a 10-digit number used to identify
pharmaceutical products that are subject to U.S.
A GTIN is an 8-, 12-, 13-, or 14-digit number
used to identify all types of trade items, including
pharmaceutical products, medical devices,
consumer products outside of the healthcare sector,
and non-consumer trade items across all sectors.