Animal Drug Shortage Information
Coronavirus Disease (COVID-19): The FDA continues to take steps to monitor the supply chain. The drug shortage staff within the FDA’s Center for Veterinary Medicine (CVM) has asked manufacturers to evaluate their entire supply chain, including active pharmaceutical ingredients, finished dose forms, and any components that may be impacted in any area of the supply chain due to the COVID-19 outbreak. For FDA’s current thinking on shortages of animal drugs during the COVID-19 pandemic, please see Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency.
Report Animal Drug Shortages to CVM:
What Is a Medically Necessary Veterinary Product?
What are CVM's Roles during an Animal Drug Shortage?
What Causes Animal Drug Shortages?
What Can Veterinarians Do During an Animal Drug Shortage?
What about Human Drug Shortages?
What about Animal Vaccine Shortages?
Current Animal Drug Shortages (Medically Necessary Veterinary Products)
Resolved Animal Drug Shortages (Medically Necessary Veterinary Products)
CVM Drug Shortage Updates:
A drug shortage may involve either an actual or a potential shortage of a drug product. When drug shortages involve medically necessary veterinary products, it is FDA’s policy to help prevent or alleviate them. FDA works with drug manufacturers in the U.S. and, when necessary, other countries, to find ways to resolve shortages of medically necessary veterinary products. FDA does not have the authority to require a company to make any product, even if it is medically necessary.
What Is a Medically Necessary Veterinary Product?
A Medically Necessary Veterinary Product (MNVP) is a product that is:
- Used to treat or prevent a serious animal disease or condition, or
- Is needed to assure the availability of safe food products of animal origin, and
- No other available source of that product or adequate alternative drug substitute exists.
Owner inconvenience and non-therapeutic uses are inappropriate reasons for classifying a product as an MNVP.
What Are CVM’s Roles during an Animal Drug Shortage?
CVM’s roles in managing animal drug shortages include:
- Reviewing all animal drug shortage reports to determine if a shortage truly exists.
- Determining if the shortage involves a Medically Necessary Veterinary Product (MNVP).
- Creating an action plan to prevent or alleviate an animal drug shortage. The action plan may include:
- Holding discussions with drug manufacturers and others in the animal health industry;
- Speeding up the animal drug review and approval process; and
- Exercising enforcement discretion (certain situations when the FDA decides not to strictly enforce approval requirements found in the Federal Food, Drug, and Cosmetic Act).
What Causes Animal Drug Shortages?
Many reasons for animal drug shortages exist. Some of these include:
- Unavailable raw materials
- Unavailable packaging materials
- Marketing decisions by manufacturers
- FDA enforcement issues
What Can Veterinarians Do During an Animal Drug Shortage?
CVM encourages veterinarians to report a shortage of any animal drug to the center by emailing [email protected].
The American Society of Health Systems Pharmacists (ASHP) has a helpful article, ASHP Guidelines on Managing Drug Shortages, that describes factors that contribute to drug shortages and ways veterinarians can manage their drug inventory so they’re prepared for shortages.
What about Human Drug Shortages?
FDA’s Center Drug and Evaluation and Research (CDER) is responsible for addressing human drug shortages. Veterinarians, especially those in the companion animal field, often use FDA-approved human drugs in their patients in an extra-label manner. Therefore, shortages of human drugs can affect veterinary medicine. (The Animal Medicinal Drug Use Clarification Act gives veterinarians the legal ability—with certain restrictions—to use approved human and animal drugs in a way that isn’t listed on the drug’s labeling. This is called extra-label drug use, or sometimes “off-label use” because the use is “off the label.”)
When a human drug shortage affects veterinary medicine, CVM works with CDER to respond to the shortage. For example, in 2018, there was a shortage of certain injectable opioids for people that veterinarians often relied on to control pain in their patients. Both FDA centers, as well as the drug company Pfizer Inc., collaborated to keep a limited amount of these products available to treat pain in animals during the shortage.
More Information about Human Drug Shortages
- Drug Shortages
- Drug Safety and Availability
- Drug Shortages: Root Causes and Potential Solutions
- Current Drug Shortages (American Society of Health-System Pharmacists)
What about Animal Vaccine Shortages?
The U.S. Department of Agriculture (USDA) regulates vaccines for infectious animal diseases. For information about these vaccines, including shortages, contact the Center for Veterinary Biologics within USDA’s Animal and Plant Health Inspection Service. (Infectious animal diseases are diseases caused by harmful organisms, such as some viruses and bacteria, and can spread from animal to animal or from animals to people.)