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If a clinical need to compound drug products using the bulk drug substance has not been demonstrated, based on the information submitted by the nominator and any other information considered by the Agency, FDA will not place the bulk drug substance on the 503B Bulks List. In making its decision on which of the nominated drugs are included on the list of permitted bulk drug substances, the FDA does not interpret supply issues, such as backorders, to be within the meaning of clinical need for compounding with a bulk drug substance

GLP-1 can help, but it doesnt fully override biology

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