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For BPC-157, the FDA explicitly classified the compound as an "unapproved drug," and US regulatory authorities issued warnings on so-called "wellness" products containing it

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FDA staff scientists had unanimously opposed every peptide being added to the list, citing a lack of solid clinical trial data, inconsistent recipes from batch to batch and the risk the compounds could trigger harmful immune reactions

For stable responders on established maintenance doses, extended-release formulations offer convenience advantages

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