FDA issued a June 30 draft guidance document saying, “FDA does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case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 does not intend to take action against manufacturers who do not use a product identifier to verify such product at the package level.”
Called the “Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy, Guidance for Industry,” FDA’s guidance is open for comments and suggestions submitted within 60 days of publication in the Federal Register.
