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FDA applies four factors to determine whether a compounded drug is essentially a copy of a commercially available product: Same active ingredient semaglutide or tirzepatide Same route of administration subcutaneous injection Same dosage form injectable solution Same strength matching FDA-approved doses (0.25mg, 0.5mg, 1mg, 1.7mg, 2.4mg, etc.) If your compounded product meets these four criteria, it is essentially a copy of Ozempic, Wegovy, Mounjaro, or Zepbound and it is illegal to compound, prescribe, or dispense

doi: 10.1016/s0924-977x(99)00063-2 22 BorisovaT