Does HRSA authorize covered entities to retroactively change a previous quarter's transactions from a non-340B transaction into a 340B price transaction, or to convert from a GPO purchase into a non-GPO purchase, through a credit and rebill process arranged between the covered entity and the wholesaler?

We do not authorize covered entities to reclassify a purchase as 340B eligible after the fact. Covered entities participating in the 340B Program are responsible for requesting 340B pricing at the time of the original purchase. If a covered entity wishes to reclassify a previous purchase as 340B, it should first notify manufacturers and ensure all processes are fully transparent, with a clear audit trail that reflects the actual timing and facts underlying a transaction. Drug transactions may be credited and rebilled within the wholesaler’s contracted and allowed timeframe according to standard business practices. However, the covered entity retains responsibility for ensuring full compliance, transparency, and integrity of its use of the 340B Program.