340B Guidance Documents Removed from HHS Public Database

Nearly all 340B-related program guidance documents have been taken down from an online database that the Trump administration launched last summer to underscore its position that federal government guidance documents are non-binding. The U.S. Health Resources and Services Administration’s (HRSA) ability to enforce its 340B guidance—its 1996 and 2010 contract pharmacy guidance in particular—is central to four drug manufacturers’ lawsuits asking federal courts court to strike down the U.S. Health and Human Services Department (HHS) general counsel’s Dec. 30 advisory opinion that drug makers must provide 340B discounts when covered entities use contract pharmacies to dispense drugs. The four drug companies say the advisory opinion contradicts HRSA’s previous statements that its 340B guidance is non-binding.