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The FDA distinguishes the categories explicitly: a generic is approved under section 505(j) and must establish therapeutic equivalence to a brand-name drug, while a compounded drug is not FDA-approved and the agency does not verify its safety, effectiveness or quality before marketing

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doi: 10.3390/ijms22020733 151 Parra-MedinaRPayn-GmezCAcosta-VegaNLRamrez-ClavijoS

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