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This way, inspectors can verify manufacturing practices, and doctors can maintain accurate records of batches, dosages, and any side effects

We thank our Data and Safety Monitoring Committee, our TSC and Trial Management Group members, and our patient and public involvement and engagement representatives who reviewed the trial protocol and participated in our TSC and Monitoring Committees

The FDA will continue to review the panels recommendation before making a final determination on whether BPC-157 and six other peptides under consideration can be added to the 503A list

The FDA in early 2026 highlighted enforcement actions targeting non-approved GLP-1 active ingredients in compounded drugs, which underscores the quality-control concern