FDA Issues Draft Guidance on Product Identifiers for Serialization


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 07-06-2017 12:16

  

The US Food and Drug Administration (FDA) has issued draft guidance, Product Identifier Requirements Under the Drug Supply Chain Security Act–Compliance Policy, to describe FDA’s intention with regard to the enforcement of certain requirements related to product identifiers under the Drug Supply Chain Security Act (DSCSA). The DSCSA was signed into law in November 2013 and outlined steps to build an electronic, interoperable system by November 27, 2023 to identify and trace prescription drugs as they are distributed within the US.

Section 202 of the DSCSA added section 582 to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section established product tracing, product identifier, and verification requirements for manufacturers, repackagers, wholesale distributors, and dispensers to facilitate the tracing of a product through the pharmaceutical distribution supply chain.

An important requirement of the product tracing scheme outlined in the DSCSA is the product identifier. Section 582 requires that each package and homogenous case of product in the pharmaceutical distribution supply chain bear a product identifier in both a human-readable form and on a machine-readable data carrier. The product identifier includes the product’s standardized numerical identifier, lot number, and expiration date. Manufacturers are required to begin affixing or imprinting a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce no later than November 27, 2017. Repackagers are required to do the same no later than November 27, 2018. The FDA said in its draft guidance that it has received comments and feedback from manufacturers and other trading partners expressing concern with industry-wide readiness for implementation of the product identifier requirements for manufacturers.

The draft guidance addresses those concerns. Specifically, the draft guidance addresses the requirement in Section 582(b)(2) of the FD&C Act (21 U.S.C. 360eee-1(b)(2)) that manufacturers “affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce” beginning no later than November 27, 2017. According to those provisions, a drug product is misbranded if it fails to bear the product identifier as required by Section 582 of the FD&C Act. The draft guidance also addresses the requirements in Section 582(b)(4) of the FD&C Act that, beginning November 27, 2017, manufacturers must: (1) use the standard numerical identifier, which is part of the product identifier, to verify product at the package level, when investigating suspect product or upon receiving a verification request from the FDA; (2) verify the product identifier of product in the possession or control of an authorized repackager, wholesale distributor, or dispenser who believes that such product was manufactured by the manufacturer and who submits a request for verification to the manufacturer; and (3) verify the product identifier on each package or sealed homogenous case of such product that they intended to further distribute as a saleable return. In addition, the draft guidance addresses the requirements for wholesale distributors, dispensers, and repackagers related to engaging in transactions involving product with a product identifier and product verification. Lastly, the draft guidance addresses the requirements for wholesale distributors and repackagers related to saleable returns.

The compliance policy set forth in the draft guidance applies only to the requirements regarding product identifiers described above. In brief, FDA said it does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of products intended to be introduced in a transaction into commerce before November 26, 2018. This represents a one-year delay in enforcement of the requirement for manufacturers to affix or imprint product identifiers. For the products that manufacturers introduce in a transaction into commerce before November 26, 2018, without a product identifier, FDA also said it does not intend to take action against manufacturers who do not use a product identifier to verify such product at the package level.

FDA said that it recognizes that downstream trading partners of manufacturers may wish to acquire product that was first introduced in a transaction into commerce by the manufacturer between November 27, 2017 and November 26, 2018 and which does not have a product identifier. Therefore, the draft guidance addresses responsibilities of downstream trading partners as well. In that regard. FDA said it does not intend to take action against a repackager, wholesale distributor, or dispenser that engages in a transaction involving such product, regardless of when such a transaction occurs, except where a repackager’s transaction triggers an independent responsibility to affix or imprint a product identifier. Furthermore, FDA said it does not intend to take action against a wholesale distributor, repackager or dispenser who does not verify the product identifier for such product. Lastly, FDA said it does not intend to take action against a repackager or wholesale distributor who does not verify the product identifier on each package or sealed homogenous case of such product that they intended to further distribute as a saleable return.

Source: FDA

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