The US Food and Drug Administration (FDA) has issued draft guidance, Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier, to further detail certain provisions from the Drug Supply Chain Security Act (DSCSA), legislation passed in 2013, which outlines steps to build an electronic, interoperable system that will identify and trace certain prescription drugs distributed within the US.

The draft guidance was written to help trading partners understand their compliance obligations under Section 582 of the DSCSA for packages and homogenous cases of product that are not labeled with a product identifier and that are in the pharmaceutical distribution supply chain at the time of the effective date of the requirements of Section 582. The draft guidance, which is required by Section 582(a)(5)(A) of the DSCSA, specifies whether and under what circumstances such packages and homogenous cases of product shall be exempted, as grandfathered, from certain requirements of section 582. For example, the draft guidance says that a package or homogenous case of product that is not labeled with a product identifier shall be exempted from certain requirements in Section 582 if there is documentation that it was packaged by a manufacturer before November 27, 2018.

Section 582 requires that each package and homogenous case of product in the pharmaceutical distribution supply chain bear a product identifier that is encoded with the product’s standardized numerical identifier, lot number, and expiration date by specific dates. Under the statute, manufacturers are required to begin affixing or imprinting (adding) a product identifier to each package and homogenous case of a product intended to be introduced into commerce no later than November 27, 2017. The draft guidance says that only packages and homogenous cases of product that are “in the pharmaceutical distribution supply chain at the time of the effective date of the requirements of [section 582]” are eligible for an exemption.

Under the guidance, beginning November 27, 2018, repackagers may not receive or transfer ownership of a package or homogenous case of a product that is not encoded with a product identifier. Similar restrictions go into effect for wholesale distributors and dispensers on November 27, 2019, and November 27, 2020, respectively.

The guidance continues to list the specific requirements for exemptions for manufacturers, wholesale distributors, dispensers, and repackagers.

Source: FDA (draft guidance)