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National INAD Program Open for 2025

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National INAD Program Open for 2025

Regulations Guidance

Enrollment is now open for the 2025 Investigational New Animal Drug Program. The U.S. Fish and Wildlife Service’s (Service) Aquatic Animal Drug Approval Partnership (AADAP) Program sponsors a variety of medications through the U.S. Food and Drug Administration’s (FDA) Investigational New Animal Drug pathway. Investigational New Animal Drugs (INADs) are drugs that are in the approval pipeline but are not yet approved by FDA for use in the United States. They are strictly controlled by the FDA’s Center for Veterinary Medicine and AADAP.


AADAP’s National INAD Program is available to all fish culturists, fish biologists, and fishery managers within the United States and U.S. territories and allows participating facilities to have legal access to a broad variety of medications that are still in the approval process. More information for each of the INADs can be found at the following Service website: https://www.fws.gov/find-inad.


INADs available in 2025:


Disease/parasite drugs: Chloramine-T INAD 9321; Diquat INAD 10-969*; Erymicin 200 INAD 12-671**; Florfenicol Medicated Feed INAD 10-697; Hydrogen Peroxide INAD 11-669 (for marine species); Oxytetracycline Medicated Feed INAD 9332; Oxytetracycline Immersion INAD 9033; and SLICE INAD 11-370*

Sedative drugs: Aqui-S 20E INAD 11-741 and Benzoak INAD 11-740

Sex reversal drugs: Estradiol INAD 12-671 (limited species) *; 17 Methyltestosterone INAD 11-236 (tilapia)*; and 17 Methyltestosterone INAD 11-236 (select species) *

Spawning drugs: Common Carp Pituitary INAD 8391**; GnRH IIa INAD 13-345 (female catfish only); LHRHa INAD 8061; Ovaplant-L**; and Ovaplant Pellet Implant (contact Syndel for product availability)

* Some INADs require review by the Food and Drug Administration (FDA) prior to joining the INAD.

                ** Available if product is currently on hand at the facility.


To participate, the approved FDA study protocols must be followed and data forms submitted on time. Non-government facilities will need to sign a cooperative agreement between their organization and the Service. This program is not funded by the Service, but instead funded by enrollment fees collected each year from non-Service participants - $700 per year per facility for each INAD. An online database is used to enroll in the program and to submit data.


If you are interested in participating in this program you may contact Bonnie Johnson for more information or visit the Investigational New Animal Drugs (INADs) University | U.S. Fish & Wildlife Service.


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