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In September 2023, the FDA moved BPC-157 into Category 2 of its 503A bulk substances list, restricting its use in compounding pharmacies pending further review

For the BPC-157 TB-500 regulatory status FDA WADA 2026, TB-500 is WADA-prohibited while BPC-157 is not currently on the WADA prohibited list but both remain research-only compounds without FDA approval

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Notably, certain familial cases of Bells palsy may be associated with increased risk of lasting problems with control of the eyelid, dry eye, and crying when eating