Regulatory Spotlight: FDA Delays Enforcement of Serialization Mandate

In late September, the U.S. Food and Drug Administration (FDA) issued a pair of draft guidances related to the implementation of product identifiers as mandated by the Drug Supply Chain Security Act (DSCSA).1,2 These new guidances come in response to continuing indications across the industry that the start date of November 27, 2017 was not feasible because of an industry-wide lack of readiness to meet the requirements. In the guidances — which had previously been issued in draft form — the FDA states that it will exercise enforcement discretion for an additional year and not take action against manufacturers who fail to implement the requirement to apply product identifiers on packages and cases of product before November 27, 2018.

The Drug Supply Chain Security Act

The DSCSA was signed into law on November 27, 2013, establishing requirements for product tracing, product identifier, trading partner authorization and verification for manufacturers, wholesale distributors, repackagers and dispensers, with the goal of facilitating tracking and tracing of a product throughout the pharmaceutical supply chain. The ultimate goal was to build an electronic, interoperable system by 2023 that can comprehensively identify and trace prescription drugs distributed in the United States.

The most critical requirement in the DSCSA involves product identifiers. Under the law, each package — down to the smallest individual saleable unit — and homogenous case of product in the supply chain must bear a product identifier, in both human- and machine-readable forms, that includes the product’s standardized numerical identifier (the National Drug Code [NDC], which identifies the labeler, product and package size and type), lot number and expiration date.

According to the law’s provisions, manufacturers are required to affix or imprint a product identifier to each package and case of product to be introduced into a commercial transaction no later than November 27, 2017, with repackagers required to do the same no later than November 27, 2018. Product under the provision of the DSCSA includes any “prescription drug in a finished dosage form" for administration to a patient without substantial further manufacturing (such as capsules, tablets and lyophilized products before reconstitution).1

Concerns About Industry Readiness

Ever since passage of the DSCSA, pharmaceutical companies and CDMOs have pressed the FDA with concerns about their ability to implement the significant changes needed across the supply chain to ensure compliance with the act, owing to a limited number of vendors with the capabilities to provide needed information technology and data management systems, issues surrounding new manufacturing and packaging equipment and a lack of readiness on the part of CDMOs to meet all requirements.

In light of these concerns, the FDA recognized that many manufacturers needed additional time to introduce fully compliant product identifiers to all products and that initiating enforcement actions on companies that are not yet complaint with the DSCSA could introduce significant disruptions in the pharmaceutical supply chain in the United States, potentially creating shortages of life-saving drugs.

As a result, the FDA announced that they would not take action against manufacturers or packagers who fail to affix or imprint product identifiers on packages and cases or products that are packaged between November 27, 2017 and November 27, 2018, essentially grandfathering such products as exempt from the law’s provisions.

While FDA guidance documents are not legally binding, they describe the agency’s consensus thinking on a topic and its intentions with regard to its enforcement capabilities. The guidance documents do not change the law’s provisions, but state the FDA’s discretionary choice to not pursue enforcement for manufacturers that are noncompliant until November 27, 2018.

Beyond the exemption for implementation of product identifiers outlined in the guidances, they do not affect requirements for compliance with other provisions of the DSCSA. The release of the new guidances on enforcement was accompanied by a new question-and-answer document further clarifying the product identifier requirements aimed at facilitating standardization of both the human- and machine-readable formats.3

It remains to be seen whether enforcement will truly begin after November 27. Many in the industry continue to express concerns about meeting that deadline without disruptions to drug distribution networks, and there may yet be further delays before the FDA begins aggressively enforcing the track-and-trace requirements.


  1. Product Identifier Requirements Under the Drug Supply Chain Security Act: Guidance for Industry. U.S. Food and Drug Administration. 20 Sep. 2018.
  2. Grandfathering Policy for Packages and Homogenous Cases of Product Without A Product Identifier: Guidance for Industry. U.S. Food and Drug Administration. 20 Sep. 2018.
  3. Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers: Guidance for Industry. U.S. Food and Drug Administration. 20 Sep. 2018.

KshitiJ (TJ) Ladage

Kshitij (TJ) has been a part of Nice Insight since 2014. TJ’s role involves research design and operations, developing and maintaining syndicated studies, business intelligence data analysis, content development and article writing on the latest developments in the biopharmaceutical industry. Prior to market research, TJ spent time in academia research working on a broad range of subject matter, including pharmacoeconomics, drug delivery and genetics. TJ holds a masters of biotechnology degree from the University of Pennsylvania.