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Compounders Question FDAs Rationale and Evidence Pointing to Safety Concerns On October 27, 2023, APC urged FDA via letter addressed to Gail Bormel, Director of the FDA's Office of Compounding Quality and Compliance, for transparency regarding the recent inclusion of substances into Category 2

Avoiding prescriptive directives

Relationship to Gastric Peptide Sequences The parent protein from which BPC-157 is derivedhuman gastric juice protein BPCis naturally present in gastric mucosa

Self-reported adverse effects from patients who used BPC-157 before the restrictions include injection site pain, joint discomfort, anxiety, heart palpitations, insomnia, fatigue, and mood changes