Hi Everyone,
we are about to build a new phrmaceutical facility to produce generic intravenous IV bag solution ( 0.9% Saline, Dextrose, Lactate ringer's and Sterile water) and would like to know if FDA requirement is to track every single bag, and I was reviewing FDA serilization on
https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-product-tracing-requirements-frequently-asked-questions#q2.
FDA just says:
Certain intravenous IV products don't need serialization.
So my question is do any of my products listed above is subjected to that condition or not ?
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YASSER ESTAFANOUS
Chief Quality & Regulatory officer
Winter Haven FL
United States
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