The 340B Program has gained national attention over the last decade, in part due to the opportunities it provides to generate revenue for participating entities without risk of significant enforcement penalties for non-compliance. The 340B Program does not involve payment of federal (or state) funds to participating entities, is not considered a “federal health care program” subject to the False Claims Act, and enforcement tools available to the government are limited. Therefore, participation in the 340B Program is often viewed by participating entities as low-risk, with compliance oversight resources allocated accordingly and often delegated to pharmacy staff.

However, participation in the 340B Program carries more risks than only those that arise under the 340B Statute. Many elements of participation in the 340B Program and decisions related to 340B Program operations do involve federal or state funds or other compliance requirements regulated by entities other than the 340B Program. Participation in the 340B Program also requires an understanding of the related, but non-340B, federal and state laws, as well as oversight by and allocation of legal and compliance resources.