As part of this, manufacturers and repackagers have to put a product identifier on drug packages. This includes the product national drug code (NDC), serial number, lot number and expiration date on each package and homogenous case of product, in human- and machine-readable form. The machine-readable form is generally a two-dimensional data matrix barcode. Industry questions are clarified in the 20-page final guidance Product Identifiers Under the Drug Supply Chain Security Act, Q&As.
The second 20-page final guidance Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification is intended to aid certain trading partners in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. The guidance also describes how trading partners should notify the FDA of illegitimate product and sets forth a process for terminating notifications of illegitimate product in consultation with the FDA. In addition, this guidance describes when manufacturers should notify the FDA of a high risk that a product is illegitimate.
These two final guidances come along with two draft documents on the same subject:
The drafts are open for public consultation until 3 August 2021.
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