Select drug manufacturers have begun deploying restrictions or limitations on the sale of their products through the 340B program. There are a variety of quality assurance exercises to complete that will ensure 340B ESP is facilitating the manufacturer restrictions appropriately.

Since 2020, select drug manufacturers have begun deploying restrictions or limitations on the sale of their products through the 340B program. This has proven to be a marketplace disruptor that has shifted the landscape of the 340B contract pharmacy program, as covered entities have experienced a loss of savings and have had to increasingly rely on entity-owned retail and/or specialty pharmacy operations to help in their mission. The issue of manufacturer restrictions has endured several legal challenges as well with some states, such as Arkansas, Louisiana, and West Virginia, having measurable success with combating the manufacturer restrictions.