The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.'' This guidance specifies whether and under what circumstances packages and homogenous cases of product not labeled with a product identifier shall be grandfathered from certain requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance issued on November 27, 2017.
Document
Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Grandfathering Policy for Packages and Homogenous Cas...
Legal Citation
Federal Register Citation
Use this for formal legal and research references to the published document.
83 FR 47622
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Guidance for Industry; Availability,” thefederalregister.org (September 20, 2018), https://thefederalregister.org/documents/2018-20503/grandfathering-policy-for-packages-and-homogenous-cases-of-product-without-a-product-identifier-guidance-for-industry-av.