How does HRSA determine 340B ceiling prices and covered outpatient drug status?

HRSA defines a 'covered outpatient drug' by referencing section 1927(k) of the Social Security Act, using Medicaid’s rebate definitions that exclude inpatient bundles and non‑FDA‑approved supplies. Ceiling prices are calculated from the Average Manufacturer Price minus the Medicaid Unit Rebate Amount, with HRSA posting quarterly updates in its secure portal.