Animal Drug Shortage Information
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?
CVM Updates About Animal Drug Shortages
What about Human Drug Shortages?
This page contains up-to-date information on potential, current, and resolved shortages of animal drugs. It also includes links to information on human drug shortages that may impact veterinary practice.
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.
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.
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).
Many reasons for animal drug shortages exist. Some of these include:
- Unavailable raw materials
- Unavailable packaging materials
- Marketing decisions by manufacturers
- FDA enforcement issues
The American Society of Health Systems Pharmacists (ASHP) has a helpful article, ASHP Guideline on Managing Drug Shortages. The article describes factors causing drug shortages and ways veterinarians can manage their drug inventory so they’re prepared for drug shortages.
Under certain conditions, the Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994 allows for the use of approved human drugs in animals. Because veterinarians, especially those in the companion animal field, often use human drugs in their patients, shortages of human drugs can affect veterinary medicine. There is an FDA group that addresses human drug shortages, and CVM is represented on this group. The following links provide information about human drug shortages:
- FDA Center for Drug Evaluation and Research (CDER) Drug Shortages Web page
The Web page provides information on human drug shortages, including the drug name, formulation(s) affected, and manufacturer(s).
- FDA's Role in Responding to Drug Shortages.
Am J Health Systems Pharm. 2002. 59(15):1423-5.
The article provides background information on the role FDA Center for Drug Evaluation and Research plays in resolving shortages of human drugs.
- FDA-Approved Product Recalls, Alerts, and Warnings Web page
The website posts press releases and other recall notices from drug manufacturers as a service to the general public and the media.
- American Society of Health-System Pharmacists (ASHP) Drug Shortages Web page
The ASHP Drug Shortages Web page provides useful information on current and resolved human drug shortages and information on drugs which are no longer being manufactured. The website also includes several articles on how to handle drug shortages, why drug shortages occur, and a way to report drug shortages to the ASHP.
You may also find the following links about shortages of veterinary biologics helpful.
- U.S. Department of Agriculture (USDA) Center for Veterinary Biologics
The USDA Center for Veterinary Biologics regulates veterinary biologics, such as vaccines, bacterins, antisera, diagnostic kits, and other products of biological origin, to ensure their safety and effectiveness.
- Center for Veterinary Biologics Contact Information Web page
- To report veterinary biologics shortages, call the USDA Center for Veterinary Biologics at (515) 337-6100.