HRSA Says It Has Limited Authority To Enforce 340B Guidance

The Health Resources and Services Administration no longer aims to put out new guidance on the 340B program, shifting away from its earlier plans. HRSA says its authority to enforce program guidance is “limited unless there is a clear violation of 340B statute,” and guidance doesn’t give HRSA the right enforcement capability. “Without comprehensive regulatory authority, HRSA is unable to develop enforceable policy that ensures program requirements across all the interdependent aspects of the Program are met,” officials at the...