When we consider 340B in relation to DSCSA compliance, two questions apply:

                                1) were you charged the appropriate price

                                2) did you charge the patient the appropriate price

 

In the DSCSA, a “shared responsibility” exists between the bill-to organization and the contract pharmacy. If your facility is a not-for-profit hospital that has a number of 340B contract pharmacies, from a DSCSA perspective, your hospital is required to be compliant. The data for each drug pedigree go to your hospital but accountability for the dose goes to each contract pharmacy.

 

What’s the requirement for reporting on each end?

According to an OIG report on 340B, “to comply with the DCSCA, wholesalers send drug product tracing information to the 340B-covered entities because the 340B-covered entities maintain ownership of the drug product.”