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Under Section 503B of the Federal Food, Drug, and Cosmetic Act, outsourcing facilities can compound sterile drugs like this without individual prescriptions, and these products are exempt from FDA approval requirements (though they must be made under stringent quality standards)

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It is gluten-free, lactose-free, and zero-carb, making it compatible with most dietary plans

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For instance, a Phase III clinical trial evaluated the efficacy and safety of NTLA-2001, a CRISPR-Cas9-based therapy, in participants with ATTR-CM

Sterile water for research contains no preservative and is typically intended for single-use applications