Getting Started
HRSAs 
Office of Pharmacy Affairs (OPA) The HRSA office responsible for administering the 340B program. administers the 340B Drug Pricing Program established by Section 340B of the Public Health Service Act (PHSA). Manufacturers participating in Medicaid enter into an agreement with Health and Human Services (HHS) under which they cannot charge covered entities a price that exceeds the 340B ceiling price. It also requires that the Government inform drug manufacturers and State Medicaid agencies of the identity of these entities. In addition, it requires that the Government inform drug manufacturers and State Medicaid agencies of the identity of these entities. The 340B registration and pricing databases collectively known as the 340B Office of Pharmacy Affairs Information System (340B OPAIS The 340B Office of Pharmacy Affairs Information System (OPAIS) is a collection of information submitted by covered entities, contract pharmacies, and manufacturers maintained and verified by HRSA's Office of Pharmacy Affairs (OPA).) has been created to meet these requirements.
The 340B OPAIS public access system allows manufacturers and wholesalers to verify that an organization requesting 340B pricing is an active participant in the 340B program. New registrations from eligible organizations and their contracted pharmacy partners are accepted at published intervals (currently the first two weeks of every quarter). Registration records are reviewed/ validated by OPA staff and approved entities may begin accessing program discounts at the start of the next quarter; once approved participants must recertify their continued eligibility and compliance annually.
Only authorized users can access the internal sites of the Pricing and Registration modules. Public information contained within the registration module is accessible to the public via the application.
These instructions are tailored to users who do not have a 340B user account or who are not currently logged into the 340B OPAIS. They provide information on searching, downloading files, creating a user account, and logging into the system.
