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The injectable form was placed on the FDA's Category 2 bulk drug substances list in 2023, restricting compounding pharmacies from preparing it under Section 503A

After a contentious, seven-hour meeting punctuated with numerous scathing public comments, the Board decided to press pause, as one member put it

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Both AO and APXs are responsible for the conversion of reduced form of ascorbate to an oxidized form (dehydro-ascorbate) which is then transported to cytoplasm for subsequent glutathione mediated reduction to ascorbate finally recycled back to cell apoplast

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Compounding pharmacies take labeling seriously because it directly impacts patient safety and treatment effectiveness