In September 2023, the FDA classified BPC-157 as a Category 2 bulk substance, prohibiting its inclusion in compounded medications
Genetic testing not standard but may explain differential peptide responses
The FDAs own language makes it clear: Compounded drugs containing BPC-157 may pose risk for immunogenicity and may have complexities with regard to peptide-related impurities and API characterization. In plain terms, the FDA is worried about shady, unregulated research-use-only peptides sold online not about what happens when BPC-157 is responsibly compounded, tested for purity, and dispensed under medical supervision
Recalls & Warnings October 09, 2023 Orgain Protein Powder Recalled Due to Allergen Risk On October 4, 2023, Orgain LLC issued a recall of four lots of the companys Organic Protein Powder + Superfoods, Creamy Chocolate Fudge flavor protein powder after a co-manufacturer informed the company that the product contained undeclared sesame, which is now one of nine food
This synthetic peptide is derived from a partial sequence of a naturally occurring protein in gastric juice
No published data exists for treatment periods extending beyond six months