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FDA has consistently held that labeling a product "not for human use" or "for research purposes only" does not exempt it from drug regulations if the product is actually being sold for human use — and the agency evaluates the totality of circumstances, including marketing language, customer communications, and the nature of the product itself

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Bacteriostatic Water is a sterile, non-pyrogenic solution of sterile water containing 0.9% benzyl alcohol (as a bacteriostatic preservative)

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