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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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Transition to Weekly Administration After the first phase, shots are given weekly

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