What to consider before renewing your serialization contract

As we kickstart the last quarter of 2021, the federal deadline for full interoperability in pharmaceutical serialization, as dictated by the DSCSA (Drug Supply Chain Security Act), will soon reach its two-year countdown on November 27. Since November 2018, all manufacturers, including virtual manufacturers and brand owners, have been required to serialize products at the lowest salable unit. Products that do not contain a unique serial number on the packaging, along with other required information (GTIN, serial, lot and expiry date), are not authorized to be sold or purchased. As stated in the guidelines, “Failure to comply with DSCSA can lead to fines, suspension or revocation of license, and even potential imprisonment or civil penalties.”

Technical challenges coupled with a global pandemic have hindered the roadmap towards serialization compliance. Pressured by the supply chain amidst the COVID-19 outbreak, the FDA announced an enforcement discretion on verifying s…

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