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Category 1 Bulk substance the FDA considers eligible for use in compounding pending final rulemaking Generally permitted Category 2 Bulk substance the FDA has significant safety, identity, or quality concerns about Not permitted during review Category 3 Substance requiring further evaluation Case-by-case Critically, Category 1 status is not FDA approval

Patients with Duchenne dystrophy and Becker dystrophy showed lower carnitine levels in muscle biopsies than controls [131] though these levels were higher than in patients suffering primary carnitine deficiency as a result of severe muscle damage [1]

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