The FDA has issued two final guidances and one draft guidance for implementing the Drug Supply Chain Security Act (DSCSA), a law that specifies requirements for building an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the US. The guidances are designed to help ensure that prescription drug products are identified and traced properly as they move through the supply chain in compliance with the federal law. The guidances seek to clarify the timing related to product identification and verification, reduce confusion in the supply chain, and ensure compliance.

As part of the DSCSA of 2013, a law to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the US, manufacturers and repackagers are required to use unique product identifiers. These product identifiers include the product national drug code (NDC), a serial number, lot number, and an expiration date on each package and case of product in human- and machine-readable form. Industry questions are addressed in the draft guidance, Product Identifiers Under the Drug Supply Chain Security Act, Questions and Answers.

Additionally, the final guidance, Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy, addresses industry-wide readiness for implementation of the new requirements aimed at enhancing the security of the drug supply chain. This guidance document specifies the FDA’s one-year delay in enforcement of manufacturers’ requirement to include product identifier on package or case of product to November 27, 2018 as the agency continues to work with stakeholders to help ensure proper implementation of the law.

In conjunction with the guidance on product-identifier compliance policy, the final guidance, Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier, outlines the circumstances in which packages and cases of product that were not in the supply chain before the November 2018 product-identifier requirement are considered grandfathered. The grandfathering policy describes the circumstances under which products already in the supply chain can remain in distribution without being relabeled with a product identifier. These guidances are designed to help ensure there are no disruptions in the supply chain as manufacturers and repackagers include a product identifier on the package or case.

The agency says in coming weeks it will issue another draft guidance, Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs, to continue the implementation of this framework. The additional guidance document will address the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place under the DSCSA to quarantine and investigate suspect and illegitimate products.

Source: FDA