Office of Pharmacy Affair's Update

Office of Pharmacy Affair's Update

In their update on the final rule, 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation, HRSA's Office of Pharmacy Affairs listed the provisions of the rule, which include:

  • "The requirement that a manufacturer calculate the 340B ceiling price on a quarterly basis;

  • The requirement that a manufacturer charge $0.01 per unit of measure if the 340B ceiling
    price calculation results in a ceiling price that equals zero (penny pricing);

  •  The methodology manufacturers must use when estimating the ceiling price for a new
    covered outpatient drug;

  • An explanation of how a civil monetary penalty (CMP) would be imposed on a
    manufacturer that knowingly and intentionally overcharges a covered entity; and

  • An explanation of what would constitute an instance of overcharging to trigger a CMP."