Register a new covered entity in HRSA's 340B OPAIS system during an open registration window

Verified steps

1. Confirm entity eligibility: verify the organization meets a statutory 340B-eligible grantee or entity type (e.g., FQHC, Ryan White program, disproportionate share hospital meeting DSH threshold); gather the required documentation including DSH adjustment percentage for hospitals
2. Access 340B OPAIS at 340bopais.hrsa.gov during an open registration window (currently: January 1–15, April 1–15, July 1–15, October 1–15); create or log in with an existing HRSA ORCA account
3. Complete the covered entity registration form: enter organization legal name, TIN (Tax Identification Number), physical address, primary contact information, and designate an Authorizing Official (AO) who must be a senior organizational officer such as CEO, CFO, or COO—not a consultant or contractor
4. Submit and await HRSA verification; if registration is returned with deficiencies, the entity has 5 business days to correct and resubmit before the registration is rejected and must be restarted in the next window
5. Upon approval, record the 340B ID number assigned by HRSA; this ID is required for all subsequent OPAIS actions including adding outpatient facilities, contract pharmacies, and annual recertification
6. Conduct annual recertification each year during the January registration window; update all active outpatient facility and contract pharmacy registrations for accuracy