Some Double Bar-Coding Required After November DSCSA Deadline, US FDA Says
As agency offers further guidance on how and when to begin complying with Drug Supply Chain Security Act requirements, one twist is that some packages will need two barcodes, depending on the circumstances.
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Drug makers must comply with draft FDA guidance on Drug Supply Chain Security Act serialization requirements that took effect Nov. 27 or else “lawyer up” to explain to the agency why their products are not serialized in accordance with it, pharmaceutical lawyer advises.
Serialization Update: Industry Warns Of “Significant Disruptions” If FDA Bars Use Of GSI Global Numbers Under DSCSA
The pharmaceutical industry has already been using GTIN numbers on product packaging to comply with pending serialization requirements and US FDA’s plan to replace the GTIN with the NDC code is drawing much criticism.
Manufacturers need to have robust verification processes in place and actively communicate with their trading partners to handle suspect drugs that are not properly serialized under DSCA, FDA draft guidance document says.