Discussion: View Thread

Serilization requirement

  • 1.  Serilization requirement

    Posted 08-Dec-2022 09:25
    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 ?

    --


    ------------------------------
    YASSER ESTAFANOUS
    Chief Quality & Regulatory officer
    Winter Haven FL
    United States
    ------------------------------