A revision could come in one of two forms: (1) resubmission of data for a claim that the covered entity previously submitted to the 340B repository in error or with errors in the requested data fields, or (2) new submission of data for a claim for a drug that the covered entity had previously determined was not purchased under the 340B Program, but later identified was purchased under such program
Bacteriostatic Water for Injection with benzyl alcohol, USP is: chemically designated H2O and is a sterile, non-pyrogenic preparation of water containing 0.9% (9mg/mL) of benzyl alcohol added as a preservative and has a pH of 5.7 (4.5 to 7.0)
However, on July 23-24, 2026, the FDAs Pharmacy Compounding Advisory Committee (PCAC) voted on inclusion of three of KLOWs peptide compounds for the 503A Bulks List: BPC-157 : 8-6 voted in favor of inclusion, with one abstention TB-500 : 8-6 voted in favor of inclusion, with one abstention KPV : 8-6 voted in favor of inclusion, with one abstention Note: TB-500 is a fragment of the full-length thymosin beta-4 (43 amino acids)
Therapeutic use of oral BPC-157 focuses on comprehensive gut health optimization, treatment of various digestive disorders, support for leaky gut syndrome, and systemic healing enhancement
