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BPC-157 and TB-500 are not FDA-approved drugs They are not: Approved prescription medications Approved compounded drugs Dietary supplements Because they are unapproved , they do not have: An FDA-approved indication An FDA-recognized dosing standard A lawful prescription pathway for routine treatment This matters because off-label prescribing does not apply to unapproved substances

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Iyer KS, McCann SM

Serum B12 at 7 days post-injection is equivalent (Andrs et al., 2018)