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Recertification

340B covered entities must annually recertify their eligibility to remain in the 340B Drug Pricing Program and continue purchasing covered outpatient drugs at discounted 340B prices.

Advance email notifications with preliminary information about the recertification process are sent to the following contacts:

  • Primary Contact
  • Authorizing Official

Once the recertification period begins, the Authorizing Official only has access to complete recertification tasks via their 340B user accounts. The Authorizing Official and Primary Contact will be required to log into the 340B OPAIS and update all information. The Authorizing Official must attest to the covered entity’s compliance with all 340B Program requirements and submit to the Office of Pharmacy Affairs.

The covered entity must ensure the contacts listed in the 340B OPAIS are accurate and up-to-date at all times to receive all recertification notifications. To set up user accounts, covered entities can go to https://340bopais.hrsa.gov/ and choose “I am a Participant”.

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