Exclusion of orphan drugs for certain covered entities under 340B Program. Final rule.

HHS is issuing this final rule to clarify how section 340B(e) of the Public Health Service Act (PHSA) will be implemented. The final rule applies section 340B(e) of the PHSA only to drugs transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the orphan drug was designated under section 526 of the Federal Food, Drug, and Cosmetic Act (FFDCA). The final rule also sets forth that it is the responsibility of the 340B covered entity to maintain auditable records that demonstrate compliance with the terms of the orphan drug exclusion requirements. This rule will provide clarity in the marketplace, maintain the 340B savings for newly-eligible covered entities, and protect the financial incentives for manufacturing orphan drugs designated for a rare disease or condition as indicated in the Affordable Care Act and intended by Congress.