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As such, it is sold strictly as a research chemical and labeled not for human consumption. United States Legal Status BPC-157 is not FDA-approved for any medical or therapeutic use It is legal to buy and possess for research purposes It cannot be marketed or sold for human use , which includes claims related to healing or supplementation Companies distributing it for human use risk FDA enforcement actions , including warning letters and product seizures FDA considers products like BPC-157 that are sold for use in humans without proper approval to be unapproved new drugs, subject to regulatory enforcement. U.S

Ongoing challenges to trial conduct include the substances short half-life, the availability of unregulated commercial products, and ensuring protocol compliance

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Further investigations can include a validation study of the genes involved in the skin irritation mechanism following direct treatment to cells