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The FDA's 2022 guidance on bulk drug substances explicitly named BPC-157 as a compound that does not meet the criteria for inclusion in compounded drug preparations under Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act

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The most common side effects are gastrointestinal, including nausea, vomiting, diarrhoea, and abdominal discomfort, affecting up to 40% of patients initially