Own Use (340B)
Definition
The own use doctrine in the 340B program refers to the requirement that covered entities purchase 340B drugs for use in their own institutional operations—specifically, for the care of their eligible patients. This concept is closely related to the prohibition on diversion and is the basis for patient eligibility requirements.
Own use means that 340B drugs must be used in the care of patients who have an established relationship with the covered entity. The drugs must be used as part of the entity’s intended institutional operation, not resold on the open market or provided to individuals who are not the entity’s patients.
The own use principle is the conceptual foundation for patient eligibility determinations. When a covered entity ensures that 340B drugs are only dispensed to its eligible patients, it is operationalizing the own use requirement. Violations of own use—such as dispensing 340B drugs to patients without an established care relationship—constitute diversion.
Frequently Asked Questions
Why Own Use (340B) Matters
Own use is the conceptual anchor for patient eligibility and diversion prevention. Covered entities that do not clearly understand or operationalize this principle are at risk of inadvertent diversion violations, particularly in contract pharmacy arrangements where the dispensing site may not have direct access to patient eligibility data.
How Virtue 340B Uses It
Virtue 340B evaluates whether a covered entity's patient eligibility policies and operational controls effectively implement the own use requirement across all dispensing channels, including contract pharmacies.