By what criteria are drugs classified as eligible under the 340B Program?

Drugs are classified as eligible under the 340B Program primarily based on federal regulatory compliance. The 340B Program is designed to provide discounted prescription drugs to eligible healthcare organizations, but only for drugs manufactured by companies that participate in the program and meet specific federal guidelines. This compliance ensures that the drugs are used in settings that meet the program's criteria, specifically serving vulnerable populations in a manner that aligns with the program's intent.

While patient insurance status and clinical effectiveness are important aspects of healthcare delivery, they do not directly determine whether a drug qualifies under the 340B Program. Similarly, manufacturer subsidies are not a criterion for eligibility; rather, the focus is on the manufacturers' agreements with the federal government regarding participation in the 340B Program. Thus, regulatory compliance is the foundation upon which the eligibility of drugs is built within this program.