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It is not an FDA-approved finished product, and the FDA states that it does not verify the safety, effectiveness or quality of compounded drugs before they are marketed, and that compounded drugs are not the same as generic drugs, which must establish therapeutic equivalence under section 505(j)

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Furthermore, the investigation revealed serious deficiencies in quality, safety, and regulatory compliance, including: The illegal importation of Semaglutide and Tirzepatide active pharmaceutical ingredients (APIs)

The gradual supportive nature of micro-dosing aligns with what these conditions require

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