In notices issued to manufacturers on Monday, HRSA warned that these drug manufacturers were required to sell drugs at the 340B ceiling price to contract pharmacies and that sales could not be conditioned on the collection of additional data. In what could be a significant step forward in protections for 340B covered entities, the agency warned that failure to comply could result in the imposition of civil monetary penalties. On Thursday, one manufacturer responded by filing an emergency motion for stay of any enforcement action that HRSA might take for noncompliance.
