Pharma industry groups seeks more time on DSCSA compliance

Two organisations representing pharmaceutical manufacturers, wholesalers and distributors say they need more time to review the FDA's recent block of guidance on the implementation of a track-and-trace system for medicines in the US supply chain.

The requests from the Pharmaceutical Distribution Security Alliance (PDSA) and Healthcare Distribution Alliance (HDA) come shortly after the FDA published four new guidance documents in June to help supply chain partners  phase in the requirements of the 2013 Drug Supply Chain Security Act (DSCSA).

The legislation requires a full track-and-trace system for medicines distributed in the US market to be in place within 10 years – by November 27, 2023, according to the current implementation timeframe.

The HDA and PDSA have asked for an extended comment period on two draft guidances – the Enhanced Drug Distribution Security at the Package Level (EDDS guidance) and Definitions of Suspect Product and Illegitimate Product for Verification Obligations (definitions guidance) – for 60 days beyond the current August 3 deadline.

Both organisations have particular concerns about the EDDS guidance, which covers elements including data architecture, incorporation of the product ID into tracing information, and enhanced verification of distributed and saleable returned products as well as alerts for illegitimate packs.

The definitions guidance lays out the FDA's current understanding of terms like "counterfeit," "diverted," "stolen," "fraudulent transaction" and "unfit for distribution."

The draft "represents a significant departure from what the industry has been developing to meet the 2023 requirements," according to the HDA letter, while the PDSA said "we do not believe that the current comment deadline…provides sufficient time to prepare the necessary feedback that the agency has requested."

At this stage nether organisation has pointed towards the specific problems they have with the drafts.

HDA said that the 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."

"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," it added.

Last month, the Partnership for DSCSA Governance (PDG) industry consortium released the first chapter of its Foundational Blueprint for 2023 Interoperability, intended to help develop "an effective and efficient model for interoperable tracing and verification of prescription pharmaceuticals in the US."