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Its banned in and out of competition with no exceptions

10.1007/s43032-022-01038-2 76 ZhangH.YangB.ZhangP.CaoJ.ZhangX.GahallahS.et al (2025)

The briefing materials now state that FDA proposes not to include any of the following on the 503A Bulks List: BPC-157 free base and BPC-157 acetate KPV free base and KPV acetate TB-500 free base and TB-500 acetate MOTS-c free base and MOTS-c acetate Emideltide free base and emideltide acetate Epitalon free base and Epitalon acetate Semax free base and Semax acetate FDA has framed these as 14 separate questions

Realistically, you're looking at 3 months before you'd see early signs of response, and 6 months for a meaningful assessment