Tamiflu (oseltamivir): EUA Conditions

As described in the Food and Drug Administration (FDA) final guidance entitled “Emergency Use Authorization of Medical Products” (dated July 2007), Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act, or “the Act”) requires the FDA Commissioner (to the extent practicable given the circumstances of the emergency) to establish certain conditions on an EUA authorization that the Commissioner finds necessary or appropriate to protect the public health, and permits the Commissioner to establish other conditions that s/he finds necessary or appropriate to protect the public health.

Pursuant to section 564 of the Act, the following conditions¹ impacting public health authority(ies) and entities that are not public health authorities have been established on the EUA authorization issued for Tamiflu (oseltamivir):

Public Health Authority(ies)²

Public Health Authority(ies) will:

• Ensure that authorized oseltamivir phosphate products are distributed to recipients in accordance with applicable state and local laws and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered countermeasures, and their officials, agents, employees, contractors, or volunteers following a declaration of an emergency³. However, the appropriate public health authorities will ensure that authorized oseltamivir phosphate products are distributed, dispensed, and/or administered to patients less than 1 year old only under the supervision of a licensed health care provider.
• Make available through appropriate means authorized Fact Sheet for Health Care Providers, Fact Sheet for Patients and Parents/Caregivers, and at least one representative FDA-approved package insert that covers the dosage forms and strengths of authorized oseltamivir phosphate products.

Public Health Authority(ies) are authorized to:

• Make available additional information relating to the emergency use of authorized oseltamivir phosphate products that is consistent with, and does not exceed, the terms of this letter of authorization.
• Label the oseltamivir phosphate products that are (i) identified by FDA, (ii) deployed from the SNS, and (iii) have passed SLEP testing with the SLEP-tested expiry, should the appropriate public health authority(ies) choose to do so.

Entities that are not Public Health Authorities

Entities that are not Public Health Authorities are defined as those who are: neither (a) public health authorities nor (b) acting in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered countermeasures, and that dispense authorized oseltamivir products (i) identified by FDA and (ii) are beyond or will be beyond their expiration dates before the declaration of emergency underlying this EUA has terminated.

Entities that are not Public Health Authorities will:

• Ensure that authorized oseltamivir phosphate capsules are prescribed and dispensed to recipients in accordance with applicable laws that are consistent with the letter of authorization and with applicable federal public health guidelines that are consistent with the letter of authorization.
• Make available through appropriate means the authorized Fact Sheet for Health Care Providers, Fact Sheet for Patients and Parents/Caregivers, and at least one representative FDA-approved package insert that covers the dosage forms and strengths of authorized oseltamivir phosphate capsules.
• Verify that the oseltamivir phosphate products that are beyond or will be beyond their expiration dates before the termination of the Secretary's declaration of emergency have been identified by FDA as described above.

1. For questions regarding EUA conditions, please contact: EUA.OCET@fda.hhs.gov.
2. Conditions apply to entities that are not public health authorities, but are acting under the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered countermeasures.
3. For more information about the terms “Authority Having Jurisdiction” and “covered countermeasures,” see Public Readiness and Emergency Preparedness (PREP) Act, sections 319F-3 and 319F-4 of the Public Health Service Act (codified at 42 U.S.C. §§247d-6d, 247d-6e), and the PREP Act declaration regarding pandemic influenza antivirals.