DSCSA: FDA Finalizes 2 Guidances and Offers New Draft Q&A
With an aim to offer more guidance on the Drug Supply Chain and Security Act (DSCSA), the US Food and Drug Administration (FDA) on Wednesday finalized two guidances and drafted a question and answer document on product identifiers.The guidance follows FDA’s decision to delay by one year – until 26 November – its enforcement of the requirement for manufacturers to affix or imprint product identifiers.
One of the final guidances, based on a draft issued in July 2017, makes this delay clear. As far as what’s new from the draft to final version, FDA noted three distinct changes: a streamlining of the guidance to remove information that was repetitive of information in the final guidance entitled, “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.”
In addition, FDA “removed the language in the draft version of this guidance on wholesale distributor and dispenser responsibilities to ensure product purchased from repackagers after November 27, 2018, is affixed or imprinted with a product identifier. Finally, FDA removed the recommendations in the draft version of this guidance related to the documentation for determining when a product without a product identifier was introduced in a transaction into commerce by a manufacturer. The topic of documentation is addressed in the final grandfathering policy guidance,” the agency said.
That final grandfathering guidance, also released Wednesday and first drafted in November 2017, 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).
In terms of changes between the draft and final, FDA said the “most significant change” was to “revise the grandfathering exemption to include products repackaged by a repackager before November 27, 2018. FDA made this change in response to comments indicating that repackagers will need time beyond November 27, 2018, to sell such product.”
The draft Q&A, meanwhile, is intended to assist manufacturers and repackagers in understanding the requirements to affix or imprint a product identifier on each package and homogenous case of product that they introduce in a transaction into commerce to satisfy the product identifier requirement under the DSCSA.
While clarifying that the requirements do not change the linear barcode requirements, the recommendations in this draft Q&A are intended to assist manufacturers and repackagers in standardizing both the human-readable and machine-readable format of the information that is contained in the product identifier.
The 19 questions and answers focus on such topics as “is my product package required to have both a linear barcode and a 2D matrix barcode?” (it depends, FDA says), or “can manufacturers and repackagers request a waiver, exemption, or exception from the DSCSA requirement to include a product identifier?” (yes, FDA says).
Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers
Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier Guidance for Industry
Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry