Regulatory Open Forum

Dear all,

I am reading the Guidance: Standards for Securing Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages.

It says, "For the purpose of this guidance, FDA considers the prescription drug package to be the smallest unit placed into interstate commerce by the manufacturer or the repackager that is intended by that manufacturer or repackager, as applicable, for individual sale to the pharmacy or other dispenser of the drug product".

Can anyone shed some light on what FDA's practice is with regards to the SNI? Does it need to appear on both primary and secondary package labels, for example, a vial and its carton?  I've been looking at trade packages, and the SNI only seems to appear on the primary package label.

Thanks,

Heather

Dear all,

I am reading the Guidance: Standards for Securing Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages.

It says, "For the purpose of this guidance, FDA considers the prescription drug package to be the smallest unit placed into interstate commerce by the manufacturer or the repackager that is intended by that manufacturer or repackager, as applicable, for individual sale to the pharmacy or other dispenser of the drug product".

Can anyone shed some light on what FDA's practice is with regards to the SNI? Does it need to appear on both primary and secondary package labels, for example, a vial and its carton?  I've been looking at trade packages, and the SNI only seems to appear on the primary package label.

Thanks,

Heather