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According to FDA communications, the agency has distinguished between mass-marketed compounded products and patient-specific compounding performed under Section 503A of the FD&C Act, which may remain permissible in narrow circumstances where a patient's medical needs cannot be met by an FDA-approved drug

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[98, 99] advised that DPP-4i will only be beneficial in instances where serum DPP-4 is extremely upregulated, 625 ng/ml or higher