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For all four peptides on Thursday's agenda BPC-157, TB-500, KPV, and MOTS-C FDA staff reviewed the evidence under the agency's four-part balancing test and reached the same conclusion for each: do not add them to the 503A Bulk Drug Substances List, the only legal pathway for compounding pharmacies to dispense these compounds to patients
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The most common side effect is irritation at the site of injection which could last up to 5-10 minutes
The cost of the initial vial is $200. For batch/lot variance testing, all vials must be identical in every aspectincluding compound, label claim (strength in mg), manufacturer, cap color, and any other distinguishing featuresas the results are combined into a single Certificate of Analysis (COA)
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