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Therefore, your 'Bacteriostatic Water' is a drug." The legal mechanism is "intended use" doctrine, codified at 21 CFR 201.128

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If this response is strong enough to cause inflammation, the function of the tissues may be disrupted

Our results indicate that molecular oxygen, superoxide, and hydrogen peroxide are very poor oxidants of N-acetylcysteine and of the protein thiols of alkaline phosphatase in vitro

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[DOI] [PMC free article] [PubMed] [Google Scholar] 79.Fan D., Fan T.J