The DSCSA seeks to further enhance the security of the supply chain through the serialization of drug products. Serialization is accomplished by affixing to packages and cases a “product identifier,” which is a standardized graphic (i.e., a two-dimensional dot matrix) that carries, among other data, the product’s standardized numerical identifier (SNI), lot number, and expiration date in both human- and machine-readable format.
As of November 27, 2018 (delayed one year by FDA), manufacturers must affix a “product identifier” to each individual package and homogenous case of product. Repackagers must also affix product identifiers to repackaged product. Wholesale distributors and dispensers must only accept products that contain the required product identifier as of November 27, 2019 and November 27, 2020, respectively. The intersection of these obligations create important questions about the grandfathering unserialized product. Certain exemptions, waivers, and exceptions are also available. For more information about grandfathering, exceptions, exemptions, and waivers, see these two PDSA letters – letter 1 | letter 2. In addition, please see the September 2018 final guidance on Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier here and the May 2018 draft guidance on Waivers, Exceptions, Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act here.
Enhanced verification requirements also went into effect, incrementally, beginning November 27, 2018 (delayed by one year based on feedback from manufacturers and trading partners on concerns with industry readiness). Contemporaneous with the obligation to affix and/or receive product identifiers, manufacturers (2018), repackagers (2018), wholesale distributors (2019), and dispensers (2020) were expected to have systems and processes in place to verify the SNI of suspect products upon request by a trading partner. Such verification became an explicit operational requirement for saleable returns—an important operational issue, especially for wholesale distributors—in 2019. Wholesale distributors are now required to verify the saleable product identifiers for any salable products that have been returned before they can be restocked and resold.
Since 2020, FDA has continued to refine expectations for verification systems and interoperable electronic tracing. In December 2023 the FDA issued final guidance, Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs available here, clarifying verification, quarantine, investigation, disposition, and notification expectations for trading partners.