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Composition L-glutathione reduced, fructose *, sorbitol *, microcrystalline cellulose *, croscarmellose *, citric acid *, stearic acid **, natural cherry flavor *, silica **, magnesium stearate **
That matters because compounded drugs (whether under FDCA 503A or 503B) may be exempt from certain approval requirements, but they are not FDAapproved and those exemptions are conditioned on meeting specific statutory requirements
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