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doi: 10.1159/000124200
In simple terms, a substance generally must meet one of these requirements: It has an official USP or National Formulary monograph It is already part of an FDA-approved drug product It appears on the FDAs official 503A Bulks List The important point is this: BPC-157, TB-500, and injectable GHK-Cu are not FDA-approved drugs, and they are not currently on the formal 503A Bulks List
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