New U.S. FDA Product Identifiers for Prescription Drugs (Serialization)
Manufacturers, Packers, and Repackagers of human prescription drug products are required under the Drug Supply Chain Security Act (DSCSA) to affix or imprint a product identifier (often referred to as a serialized National Drug Code, or “sNDC”) to each package and homogenous case of a product that is intended to be introduced in a transaction into commerce by November 28, 2018. This process is known as “serialization”. FDA may consider prescription drug products misbranded if they fail to bear the product identifier after the deadline.
FDA has advised that listings for prescription drugs that do not bear product identifiers should not be certified as unchanged for 2019 during the upcoming renewal period. Industry should submit a new sampling of the labeling incorporating the product identifier as an update to their listing.
Registrar Corp can provide guidance on FDA’s new product identifier requirements and update drug listings on your behalf. Complete the form below for more information: