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As background, the Food and Drug Act in sec 503A provides that bulk drug substances that either 1) lack a USP or NF monograph, or 2) are not components of FDA-approved drug products, cannot be used in compounding unless they appear on a list created under Section 503A

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A limitation of the current review is that it focused on indirect comparisons of 24-h continuous monitoring studies that differed in terms of study population (e.g., obese or not-obese, ambulatory or not-ambulatory), study treatment (e.g., continuous intravenous infusion, or oral administration) and timing of assessment after variable duration of study treatment

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