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doi: 10.1002/1529-0131(200102)44:2 3.0.CO;2-S

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Key Regulatory Points as of 2026: Not FDA-approved for any medical indication Cannot legally be sold as a drug, food, or dietary supplement for human consumption Legally sold as a "research chemical," not intended for human use Not a DEA-scheduled substance, so possession is not illegal (unlike anabolic steroids) Many medical clinics offer BPC-157 treatments despite lack of approval The FDA has expressed safety concerns due to the lack of human clinical trial data and the potential for adverse effects from unregulated manufacturing