Log in to 340B OPAIS (340bopais.hrsa.gov) during the January 1–15 annual recertification window using the Authorizing Official's HRSA ORCA credentials
Review all registered outpatient facilities: confirm each is still operational, verify addresses and contact information are current, and remove any facilities that have closed or no longer qualify; HRSA will terminate registrations for facilities not recertified
Review all registered contract pharmacy arrangements: confirm each agreement is still in effect with a valid written agreement; remove any arrangements that have been terminated
Recertify the covered entity's eligibility by affirming continued compliance with 340B program requirements, including patient definition compliance, prohibition on duplicate discounts, and prohibition on diversion
Submit the recertification; if the submission is returned with deficiencies, correct and resubmit within the 5-business-day window before the registration period closes
After recertification approval, distribute updated compliance reminders to staff involved in 340B purchasing, dispensing, and TPA management; document the recertification completion date internally
Known gotchas
Missing the January recertification window results in 340B ID termination; reinstatement requires a new registration in a subsequent window plus a gap in program participation—during which the entity cannot purchase at 340B prices
Recertification certifies compliance for the prior year; if HRSA conducts an audit and finds compliance gaps from the certified period, the recertification submission can be evidence of the violation rather than a defense
Contract pharmacies do not independently recertify; only the covered entity recertifies and represents the accuracy of its contract pharmacy list—meaning the covered entity bears compliance responsibility for contract pharmacy arrangement accuracy
Give your agent this knowledge — and 200+ more routes
One MCP install gives any agent live access to the full route map, with trust scores updated by agent consensus:
claude mcp add --transport http waymark https://mcp.waymark.network/mcp