At industry request, FDA says it will extend DSCSA comment time

The FDA has agreed to give the pharmaceutical industry more time to review and comment on a piece of draft guidance published in June on the implementation of a track-and-trace system for medicines in the US supply chain.

In a federal register notice, the FDA said it was extending the comment period on the Enhanced Drug Distribution Security at the Package Level (EDDS guidance) by 30 days to September 2, a shorter extension than had been sought by two industry organisations representing pharmaceutical manufacturers, wholesalers and distributors.

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.

Both organisations said in comments submitted to the regulator that they had 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 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."

The HDA also wanted more time to review another draft guidance entitled Definitions of Suspect Product and Illegitimate Product for Verification Obligations (definitions guidance), but so far the FDA hasn't budged on its timeline for that document.