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Gerda Vitamin B12 1000 µg/4 mL for Vitamin B12 Deficiencies

FDA routinely conducts similar, web-based inspections, which are well suited to reveal a product’s “ intended use ” – often the determining factor in whether a product is a “drug.” See 21 CFR § 201.128 (intended use can be derived from a broad array of “objective” factors, including “labeling claims, advertising matter, or oral or written statements.”) See also 21 USC § 321(g) (defining “drug” based on, inter alia, its intended use)

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Also at risk are people who’ve undergone gastrointestinal (GI) surgery that involved removing parts of the pancreas or stomach