Emergency use authorizations for three animal drugs — the framework better known from human medicine, applied to livestock and pets
The Food and Drug Administration issued three emergency use authorizations for animal products to prevent and treat infestations by New World screwworm larvae. The authority better known from human medicine extends to animal products as well.
Document overview (primary data)
- Document typeNotice
- AgencyDepartment of Health and Human Services
- Citation91 FR 55861
Key points
- The FDA issued three emergency use authorizations for animal products against infestations by New World screwworm larvae.
- They cover prevention and treatment in dairy cattle, horses, swine, sheep and deer; treatment in dogs and cats; and short-term prevention in horses.
- Section 564 of the Federal Food, Drug, and Cosmetic Act, the basis for emergency use authorization, covers animal products as well as human medicines.
- They follow an August 18, 2025 determination that the screwworm poses significant potential to affect national security or citizens abroad.
- An authorization differs from approval: it applies where no adequate approved alternative exists, carries conditions and ends with the declaration.
1Emergency authorization is not only for people
The mechanism allowing an unapproved medical product to be used in an emergency is the emergency use authorization, widely known from its use for human medicines during disease outbreaks. Section 564 of the Federal Food, Drug, and Cosmetic Act, its statutory basis, also covers animal products. This notice is an instance of that.
2The three authorizations
| Requesting company | Animals covered | Scope |
|---|---|---|
| Zoetis Inc. | Dairy cattle, horses, swine, sheep, deer | Prevention and treatment, effective May 19, 2026 |
| Felix Pharmaceuticals Pvt. Ltd. | Dogs, puppies, cats, kittens | Treatment, effective June 11, 2026 |
| Alberta Vet Labs Ltd | Horses | Short-term prevention, effective July 15, 2026 |
The animals split across livestock, pets and horses. One infestation requires separate products and separate authorizations by species, and the three effective dates differ, showing that each request and review proceeded on its own.
3Why a public health emergency
- 1August 18, 2025The Secretary of Health and Human Services determines a significant potential for a public health emergency involving the screwworm
- 2The same dayThe Secretary declares circumstances exist justifying emergency use authorization of animal drugs
- 3Basis of the determinationSignificant potential to affect national security or the health and security of U.S. citizens living abroad
- 4AfterwardThree authorizations issued individually between May and July 2026 on request
An animal disease treated as a public health emergency is the striking part. New World screwworm larvae infest the tissue of living animals, so effects on livestock reach the food supply. That is why the determination speaks of national security.
4Authorization is not approval
An emergency use authorization is a separate mechanism from ordinary approval. Section 564 permits use of an unapproved product, or an unapproved use of an approved product, where there is no adequate, approved and available alternative, among other criteria. It is an emergency measure, the authorizations carry conditions on use, and it ends when the declaration ends.
5The full text appears in the Federal Register
This notice takes the form of a notice of availability, and the authorizations, including an explanation of the reasons for issuance, are reprinted in the document. Even an emergency measure leaves its basis and conditions on the public record. This site also holds recall records from the same agency, so approval, authorization and recall can each be followed through published data.
Why it matters
That emergency use authority extends to animal drugs shows food supply treated as part of public health. Because authorizations carry conditions and expire, they must be read together with the status of the underlying declaration.
FAQ
Are emergency use authorizations only for human medicines?
Why is an animal disease a public health emergency?
Sources (primary)
Source: Federal Register (federal documents, public domain). Links go to the official site.