The 340B ceiling price is defined in statute (section 340B(a)(1) of the Public Health Service Act) and implementing regulations (42 CFR §10.3 and §10.10(a)). The 340B ceiling price is the maximum statutory price a manufacturer can charge a covered entity for the purchase of a covered outpatient drug. The 340B ceiling price is equal to the average manufacturer price (AMP) from the preceding calendar quarter for the smallest unit of measure minus the unit rebate amount (URA). HRSA calculates the 340B ceiling price at six decimal places and then subsequently publishes the price in the 340B OPAIS rounded to two decimal places.
We also publish a package adjusted price for each covered outpatient drug in the 340B OPAIS. HRSA publishes the package adjusted price as a courtesy to assist manufacturers and covered entities in evaluating the 340B ceiling price. The package adjusted price is calculated using the 340B ceiling price, the package size (PS), and the case pack size (CSP) for a covered outpatient drug. This represents the price that the covered entity actually pays for the drug.
Package Adjusted Price = (AMP – URA)* PS *CSP
The PS is the quantity of a unit of measure contained in one package sold by a manufacturer under a particular 11-digit NDC. The CSP is the number of salable units in the shipping container. HRSA publishes the package adjusted price in 340B OPAIS rounded to two decimal places.
The exception to this rounding convention occurs when the 340B ceiling price is less than $0.01. In these cases, the 340B ceiling price rounded to two decimal places will be multiplied by the package size and case pack size to equal the package adjusted price. This is consistent with the Final Rule.