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U.S. Department of Health and Human Services

Animal & Veterinary

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Animal Drug Shortage Information

Report Animal Drug Shortages to CVM:

Email: AskCVM@fda.hhs.gov
Phone: 240-276-9300
Fax: 240-276-9115
 

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?
Helpful Links 

Current Drug Shortages
Resolved 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. 

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?

The American Society of Health Systems Pharmacists (ASHP) has a helpful article, ASHP Guideline on Managing Drug Shortages.disclaimer icon The article describes factors causing drug shortages and ways veterinarians can manage their drug inventory so they’re prepared for drug shortages.

CVM Updates About Animal Drug Shortages

What about Human 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:

Helpful Links

You may also find the following links about shortages of veterinary biologics helpful.