January 6, 2017
On January 5, 2017, the Health Resources and Services Administration within the Department of Health and Human Services (HHS) finalized a rule on how the 340B Drug Program sets ceiling prices for 340B [...]
September 2, 2016
On August 12, 2016, a Notice of Proposed Rulemaking (NPRM) titled, “340B Drug Pricing Administrative Dispute Resolution” was published in the Federal Register.The purpose of the proposed rule is to help Covered Entities [...]
February 25, 2016
340B audits are on the rise while at the same time audit procedures are in flux. The Office of Pharmacy Affairs (OPA) at the Health Resources & Services Administration (HRSA) oversees the 340B [...]
September 9, 2015
On August 28, 2015, the Health Resources and Services Administration (HRSA), which administers 340B Drug Pricing Program, released long-awaited proposed guidance (“Guidance”). The purpose of the Guidance is to assist 340B covered entities [...]
August 28, 2015
Today the Health Resources and Services Administration (HRSA) released guidance for covered entities enrolled in the 340B Drug Pricing Program (340B Program) and for drug manufacturers that participate in the 340B Program. The [...]