With a background in biopharma manufacturing, I'm used to communicating only what has already been verified by lab results, batch records, etc., so I’ll begin by explaining that this article is based on some mere rumblings heard around the industry. At this point, this information is not substantiated, but after coming back from interpack, a few different sources have hinted at the potential for a delay in the November 2017 serialization deadline.
Sources have said that some industry players have communicated with the FDA about the state of readiness among pharma manufacturers, and expressed concern that companies will need more time to become compliant.
Possible Implications
The details are still up in the air and no official word has come from FDA. If the sources are correct, there is a possibility that more time—beyond the November 2017 deadline—could be granted to manufacturers in meeting DSCSA requirements.
Stay tuned.
