May 7, 2020
During the COVID-19 outbreak, the U.S. Food and Drug Administration continues to monitor the animal drug supply chain and work closely with animal drug sponsors, to ascertain as early as possible, any shortage or potential shortage that is likely to lead to a disruption in the availability of animal drugs or their components in the United States.
To help animal drug sponsors submit timely and informative notifications, FDA is publishing a guidance for immediate implementation about the importance of these notifications, how sponsors can notify FDA, and the details to provide about the discontinuance or interruption of manufacturing and other factors that may impact availability of animal drug products. The guidance also provides examples of steps FDA’s Center for Veterinary Medicine (CVM) may take to prevent or mitigate animal drug shortages, and information sponsors can provide proactively to help avoid shortages.
Although some supply disruptions and shortages cannot be predicted or prevented, FDA recognizes that early communication and detailed notifications from sponsors to the agency play a significant role in decreasing their incidence, impact, and duration.
The guidance aligns with similar FDA recommendations released in March for sponsors of human drugs and biologics.
This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS) on January 31, 2020 (renewed on April 21, 2020), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service (PHS) Act.
- Guidance for Industry #271: Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency
- Animal Drug Shortages
- Animal Health & Safety and the Coronavirus Disease 2019 (COVID-19)
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.