Critical 340B Drug Discount Program Strictures Placed on Manufacturers as Obama Team Departs -

On January 5, 2016, the Health Resources and Services Administration (“HRSA”) published in the Federal Register a final rule entitled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation” (“Final Rule”). See 82 Fed. Reg. 1210 (January 5, 2017).

The Final Rule revises and amends all subparts of 42 C.F.R. Part 10 (the “340B Program”).