340B Office of Pharmacy Affairs Information System

In accordance with Section 340B(d)(1)(B) of the Public Health Service Act, HRSA is required to collect information from manufacturers to verify the accuracy of 340B ceiling prices, and then make ceiling prices available to covered entities. To this end, HRSA has developed a new, integrated information system that focuses on three key priorities: security, user accessibility, and data accuracy.

The 340B registration and pricing databases are collectively known as the 340B Office of Pharmacy Affairs Information System (340B OPAIS). Authorized users of 340B OPAIS must have a user account with appropriate roles and permissions granted by HRSA.

Access the 340B Office of Pharmacy Affairs Information System.

340B OPAIS System Highlights

340B OPAIS GENERAL HIGHLIGHTS

Security	340B OPAIS security requires the user to have an account and to log in to initiate Covered Entity/Manufacturer registrations, change requests, or to respond to annual recertification requests.
Appearance	Changes to the system interface make information easier to view.
Home Page	The functions a user can perform are determined by the user's role. Until the user logs in, the user may only access the Public User Guides, Public Search, Reports/Files, and Login functions.
Help/Reference	All materials are consolidated in one location under the Help link in the 340B OPAIS page header. Logged in users will see help tailored to the user's role and online user guides.

REGISTRATION COMPONENT OF 340B OPAIS – AUTHORIZED USER FUNCTIONS

If the user is not logged into the 340B OPAIS, the user will only have access to a limited selection of the system’s capabilities. When you view the home page, you will only see the Search, Reports/Files, and "I Am a Participant" icons.

Search	Use a variety of search criteria to search for Covered Entities (CE), Contract Pharmacies (CP), and Manufacturers (MFR).
View Search Results	View a table of results that match your search criteria.
View Details	Select an individual Covered Entity, Contract Pharmacy, or Manufacturer to view its detailed information.
Export Search Results to Excel	Select one or more records from the user search results and specify individual fields to export to an Excel spreadsheet.
View Reports and Files	Review and download a variety of available reports and files.
Create a 340B User Account (covered entities and manufacturers)	When you create an account as an Authorizing Official (AO) or Primary Contact (PC) for a covered entity or manufacturer, the 340B system will automatically locate and associate any 340B records associated with that user e-mail address. Upon successful creation of an account, the system will allow users to login to the application using the credentials registered by the user. Logged-in users can associate themselves to a covered entity or manufacturer registration/record as a PC or as an AO.
Log into Your 340B User Account (covered entities and manufacturers)	If the user already has a 340B account or if the user creates an account and logs in as an AO or PC for a Covered Entity or Manufacturer, the user will have access to all associated Covered Entity or Manufacturer 340B records.

PRICING COMPONENT OF 340B OPAIS – AUTHORIZED USER FUNCTIONS

Access to the pricing component of 340B OPAIS is strictly limited to manufacturer and covered entity AOs and PCs with an authenticated and authorized 340B OPAIS user account. All accounts and users are approved by HRSA.

Upload Secure Pricing Data	Provide quarterly pricing data for your labeler codes manually and/or via text file upload.
Perform Quarterly Reconciliation	Reconcile data discrepancies between your data points and HRSA data.
View 340B Ceiling Prices once Published	Once the data is published, manufacturers and authorized covered entity users will have "view only" access to look up 340B ceiling prices. Covered entities may create a favorites list for future reference.