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),33 lot number, and expiration date in both human- and machine-readable format.
No later than November 27, 2017 (i.e., four years after enactment), manufacturers must begin affixing a “product identifier” to each individual package and homogenous case of product. Repackagers must affix product identifiers within five years of enactment. Wholesale distributors and dispensers must only accept products that contain the required product identifier beginning six and seven years after enactment, 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.
Enhanced verification requirements also go into effect, incrementally, beginning November 27, 2017. Contemporaneous with the obligation to affix and/or receive product identifiers, manufacturers (2017), repackagers (2018), wholesale distributors (2019), and dispensers (2020) must have systems and processes in place to verify the SNI of suspect products upon request by a trading partner. Such verification must also be done for saleable returns—an important operational issues, especially for wholesale distributors in 2019.