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or identical or nearly identical A drug, a component of which is a bulk drug substance (i.e., active pharmaceutical ingredient) that is a component of an approved drug, unless there is a change that produces for an , between the compounded drug and the comparable approved drug. individual patient a clinical difference , as determined by the prescribing practitioner See Section 503B(d)(2)(A)-(B) (codified at 21 U.S.C
For ligament work, the canonical reference is Cerovecki and colleagues 2010 study of medial collateral ligament transection in rats, in which intraperitoneal, oral (drinking water), and topical BPC-157 administration each produced consistent improvements in functional, biomechanical, macroscopic, and histological healing endpoints over a 90-day window (Cerovecki et al., 2010)
Wang J, Johnson T, Sahin L, Tassinari MS, Anderson PO, Baker TE, et al