BPC-157 is prohibited for compounding under the FDA's 503A Category 2 classification
This follows its role as a cytoprotection mediator transmitting the mucosal integrity maintenance to other organs therapy [1,2,3,4,5,6,7,8,9,10,11,15,27,28,29,30,33,109,124,125] in consideration of the regular dietary taking (dietary nitrate as an important source of NO in mammals [252]), and nitrate-nitrite-NO pathway (and swallowed nitrite) resulting with high NO concentration in the stomach [253]
Remove the vial, withdraw what's needed, and return to refrigeration promptly
They prepare individualized medications for patients with valid prescriptions, follow USP standards for sterility and potency, and are inspected by state boards of pharmacy
Much of the safety data comes from animal studies, where researchers report on tolerance and effects in those models
enforcement action typically focuses on supply and intent to distribute, though personal importation of unlicensed products remains legally complex and is not without risk