Read the full article: The FDA Considers PI a Closed Issue – So Why the Confusion? - LSPediA
I hope this doesn't come as a surprise.
According to the article:
"It’s been 14 months since the FDA advised manufacturers, wholesalers, and repackagers on Product Identifier (PI) requirements. You’ll remember that it came as a bit of a shock to most in the industry that what they’d been doing—following the GS1 standard of a GTIN with an embedded 10-digit National Drug Code (NDC) number, plus the serial number, lot number, and expiration date—was insufficient for PI purposes.
The FDA’s draft guidance said that was close to what they wanted, but not close enough. They dismissed the GTIN and confirmed the requirement of using the NDC number as one of the building blocks of a PI. The exact language was found in the answers to questions 4 and 5 of the guidance."
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