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After consideration of public comments, we are finalizing as proposed to require manufacturers submit reasonable assumptions including documentation of the methodology used to determine FMV for current, new, and renewed contracts

Allergic Reactions: Although rare, some individuals may experience allergic reactions to Glutathione

When a compounded preparation is clinically appropriate, it is prescribed only after an evaluation and labs, dispensed by a licensed 503A or 503B US pharmacy, and limited to substances the FDA currently permits on its 503A bulks list

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Statements Acknowledgments NAA (SFRH/BPD/64690/2009), AD, EP, and IA are grateful to the Portuguese Foundation for Science and Technology (FCT) and the Aveiro University Research Institute/Centre for Environmental and Marine Studies (CESAM) for partial financial supports