Drug manufacturer AstraZeneca has notified covered entities on August 17 that it will cease providing 340B pricing for 340B-eligible drugs dispensed by contract pharmacies on October 1. This represents a significant development in the recent trend of drug manufacturers restricting access to 340B drugs for contract pharmacy arrangements.
The language in the letter suggests that AstraZeneca views the longstanding 2010 Health Resources and Services Administration (HRSA) contract pharmacy guidance as a proposal, not a binding regulatory requirement. AstraZeneca's position is the most aggressive test to date of the anecdotal evidence that HRSA no longer considers itself to have authority to issue 340B Program directives outside of the narrow confines of the 340B program statute.