Following a series of disputes between drug manufacturers and participants in the 340B program over contract pharmacies, on December 30, 2020, the Health and Resource Service Administration (HRSA) issued Advisory Opinion 20-06, concluding that the plain meaning of the 340B statute requires drug manufacturers to provide 340B discounts for drugs dispensed through contract pharmacies. After undertaking a detailed statutory analysis, HRSA noted that contract pharmacies are a longstanding and integral part of the 340B program, and that the purposes of the 340B program could not be achieved without them. The Advisory Opinion, though definitive in its conclusions, states that it “is not a final agency action . . . and it does not have the force or effect of law.”
