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The Federal Food, Drug, and Cosmetic Act (FDCA) is clear: new drugs may not be introduced into interstate commerce unless they have received FDA approval

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Bacteriostatic Water (Reconstitution Solutions) - 5 mL A sterile, nonpyrogenic aqueous solution containing 0.9% benzyl alcohol as a preservative, commonly utilized in laboratory preparation workflows requiring a preserved aqueous vehicle for compatible research materials and reconstitution procedures