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.
The 340B OPAIS pricing module is the sole official federal source for 340B ceiling prices; it calculates those prices based on information supplied by pharmaceutical manufacturers, the Centers for Medicare and Medicaid Services (CMS Centers for Medicare and Medicaid Services, the federal agency within Health and Human Services (HHS) that administers the Medicare and Medicaid programs, including the Medicaid drug rebate program and the Medicare Part D prescription drug benefit.), and a commercial data broker. The calculated prices are considered non-public information due to the proprietary nature of some of the underlying data. Calculated ceiling prices can only be viewed by selected OPA staff and authorized staff at manufactures/covered entities currently participating in the 340B Program The federal drug discount program authorized under section 340B of the Public Health Service Act and established by Congress under the Veterans Health Care Act of 1992 (Public Law 102-585, codified at 42 USC § 256b). The 340B program requires drug manufacturers to enter into pharmaceutical pricing agreements with the HHS Secretary, under which manufacturers agree not to sell covered outpatient drugs to covered entities above 340B ceiling prices. with secure access.
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 are logged into the 340B OPAIS as an Authorizing Official or Primary Contact. They provide information on account management; searching; registering, and changing labeler codes; downloading reports and files; and attesting to registrations and changes prior to submission to OPA for approval.
