FDA Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

On November 27, 2017, FDA issued a draft guidance to help trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) understand their compliance obligations under section 582 of the Food, Drug and Cosmetic (FD&C) Act for packages and homogeneous 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.  This draft guidance specifies whether and under what circumstances such packages and homogenous cases of product shall be exempted, as grandfathered, from certain requirements of section 582.  It also briefly discusses the distinctions between the grandfathering policy provisions of the guidance with the draft guidance Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy.

Download Resource