Updated: FDA grants industry 30-day extension to comment on track and trace guidance

Regulatory NewsRegulatory News | 02 August 2021 |  By 

Editor's note: This story has been updated to include the US Food and Drug Administration's notice extending the deadline to comment on its track and trace guidance.

The US Food and Drug Administration (FDA) has agreed to give the pharmaceutical industry more time to comment on a draft guidance calling for the establishment of electronic systems to track products through the supply chain.

Prior to Monday's announcement of the extension, two groups representing pharmaceutical manufacturers, wholesalers and distributors had requested the delay to allow more time for industry to review draft guidance calling for the establishment of electronic systems for tracking products through the supply chain. 
Such systems are called for under the Drug Supply Chain Security Act (DSCSA). One group said industry would have major challenges if the draft was finalized; the groups are calling for the deadline for comments to be extended from 3 August to 4 October.
In June, FDA released its electronic tracking guidance, along with three others related to DSCSA compliance. (RELATED: FDA details plans for DSCSA implementation in four guidances, Regulatory Focus 4 June 2021)The others were a final guidance on identifying suspect products, a final guidance on the format of product identifiers and a revised draft guidance on defining suspect and illegitimate products.
The draft tracking guidance laid the groundwork for the data architecture systems needed to build the electronic, interoperable systems by the 27 November 2023 deadline called for in DSCSA. In the guidance, the agency laid out several data architecture models governing how data can be stored, managed and integrated; firms may employ a centralized or distributed data architecture model, or a hybrid combination of both.
The Pharmaceutical Distribution Security Alliance (PDSA) wrote in its 23 June comment that “we do not believe that the current comment deadline (August 3, 2021) provides sufficient time to prepare the necessary feedback that the agency has requested. Some of our members have submitted requests to extend the comment deadline by 60 days, and we support these requests.”
PDSA members include the Association for Accessible Medicines (AAM), the Pharmaceutical Research and Manufacturers of America (PhRMA), AbbVie, Apotex, AstraZeneca, Pfizer Genentech and Merck. The group also represents wholesale distributors, third-party logistics providers and dispensers.
The Healthcare Distribution Alliance (HDA) made a similar plea in its 15 June comments, saying members needed more time to review the tracking guidance as well as the three others released in June.
“The draft guidances warrant a very thorough review to fully understand their operational implications, as well as a legal analysis of how the guidances align with the DSCSA’s requirements. Moreover, HDA and its members are simultaneously evaluating the two guidelines also issued on June 4. We want to be able to dedicate our best efforts to all these documents, without diluting expertise on, or sacrificing preparations for, compliance with the 2023 requirements.”
HDA also asserts that the 2023 requirements are “complex, resource-intensive, and pose unprecedented challenges.” Further, the draft guidance “represents a significant departure from what the industry has been developing to meet the 2023 requirements.”
If finalized, they say that “wholesale distributors, and likely the entire supply chain, would encounter major challenges.”
An industry consortium has stepped in to help guide efforts in setting up these electronic systems. In July the Partnership for DSCSA Governance (PDG), comprising 60 pharmaceutical supply chain members, developed a blueprint for tracking systems. (RELATED:  Industry consortium releases blueprint for DSCSA tracking systems, Regulatory Focus, 16 July 2021).
Federal Register

PDSA request for extension
HDA request for extension



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