If a manufacturer determines it overcharged a covered entity for a covered outpatient drug, how soon must the manufacturer refund the affected covered entity?

We require manufacturers to refund covered entities on all drug overcharges and should work with the covered entities in good faith to make repayments. Specifically for new drugs and as outlined in the CMP final rule, manufacturers are required to calculate the actual 340B ceiling price and offer to refund or credit the covered entity the difference between the estimated 340B ceiling price and the actual 340B ceiling price within 120 days of the determination by the manufacturer that an overcharge occurred. For overcharges on other drugs, HRSA expects repayment procedures to follow similar processes that align with standard business practice and be documented in the manufacturer’s policies and procedures.