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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

The safety profile in humans is not established

In recent years, the biophysical and biochemical properties of both enzymes have been extensively studied

Skin Aging Claims Versus Systemic Anti-Aging Claims Skin aging claims can point to topical studies on photoaging and wrinkle parameters, but systemic anti-aging claims often rely on gene expression, oxidative stress, inflammation, or animal data [2], [10], 17