FDA Issues One Draft and Two Final DSCSA Guidance Documents
On September 19, 2018, FDA issued the following guidance documents:
• Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (Final Guidance)
• Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry (Final Guidance)
• Product Identifiers under the Drug Supply Chain Security Act – Questions and Answers (Draft Guidance)
The drafts for the first two guidance documents were initially published on November 11, 2017 and on July 3, 2017 respectively.
We recommend that companies thoroughly review the final guidance for Grandfathering Policy and draft guidance for Product Identifiers – Questions and Answers.
Grandfathering Policy for Packages and Homogenous Cases of Product without a Product Identifier
The Grandfathering Policy guidance does an excellent job aligning the requirements for manufacturers and repackagers by providing the following clarification: “For the purposes of this guidance, a package or homogenous case of product is “in the pharmaceutical distribution supply chain” if it was packaged by the product’s manufacturer or repackaged by a repackager before November 27, 2018.” This is an important clarification. As spelled out later in this guidance, the repackager may accept and transfer ownership of such non-serialized grandfathered product on and after November 27, 2018, as long as repackager repackages such product before November 27, 2018.
Product Identifiers under the Drug Supply Chain Security Act - Questions and Answers
The Product Identifiers – Questions and Answers draft guidance contains useful clarifications and recommendations. Question 5 stands out and the answer is not a clarification or recommendation, but rather a requirement. It states that the human-readable portion of the product label must contain NDC and GTIN alone is not sufficient.
Product Identifier Requirements under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry
Product Identifier Requirements for DSCSA – Compliance Policy Guidance for Industry spells out the delay in enforcement of the November 27, 2017 deadline, stating that “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 product as required by section 582(b)(2)(A) of the FD&C Act if the package and homogeneous case of product was packaged by the manufacturer on or after November 27, 2017, but before November 27, 2018.” The compliance policy makes it clear that the enforcement delay is only applicable to products packaged by the manufacturer and does not apply to repackagers.
While these guidance documents are still hot off the press and we will take our time to analyze them thoroughly, we do not see any red flags and are confident that our L2-L3 and L4-L5 products are fully prepared to meet the demands of the industry.