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In a formal review, the agency concluded that BPC-157: Lacks sufficient safety data and has not been shown to be safe or effective in humans FDA Compounding Memorandum, 2023 The FDA also lists BPC-157 as ineligible for 503B compounding , which prohibits it from being added to compounded medications by outsourcing facilities

Most commonly, patients will present with a variety of generalized symptoms including, but not limited to, nausea/vomiting, dehydration, hypoglycemia, diarrhea and abdominal pain

Some of these studies were conducted using liver biopsy in human [10,11]