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[DOI] [PMC free article] [PubMed] [Google Scholar] 21.Shen J., Wu G., Tsai A.-L., Zhou M

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The Regulatory Reality of 2026: What Actually Changed In late 2023, the FDA moved 19 peptides, including BPC-157, to what's known as "Category 2" status under its framework for bulk drug substances used in compounding, identifying them as substances that "may present significant safety risks." The concern, as stated in FDA guidance, centered on the limited large-scale human data and questions about immunogenicity

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no aspiration) Subcutaneous Drug Injection Review (PMC) Pharmacologic considerations of the subcutaneous route Additional Research and Background These sources provide related context and are not presented as support for a specific statement above