Yasser,
Per the applicable part of the law (21 USC §360eee(24)(B), Pharmaceutical Distribution Supply Chain - Transaction - Exemptions), the following products are excluded from definition of transaction and, therefore, application of the DSCSA requirements (note that these are a subset from the overall list; emphasis added):
(xiv) the distribution of an intravenous product that, by its formulation, is intended for the replenishment of fluids and electrolytes (such as sodium, chloride, and potassium) or calories (such as dextrose and amino acids);
(xv) the distribution of an intravenous product used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions;
(xvi) the distribution of a product that is intended for irrigation, or sterile water, whether intended for such purposes or for injection;
Therefore, based on my reading, the products you listed (normal saline, dextrose, Ringer's, and sterile water) would be exempt. You can confirm by contacting FDA at the email address listed on their DSCSA webpage.
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Jonathan Amaya-Hodges
Director, Technical Services
Sharon MA
United States
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Original Message:
Sent: 08-Dec-2022 09:13
From: YASSER ESTAFANOUS
Subject: Serilization requirement for drug
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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