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                Product Safety Information

Product Safety Information

                        Adverse Event Reports for Animal Drugs and Devices
          Animal Drug Shortage Information
          Arsenic-based Animal Drugs
          Bovine Somatotropin (bST)
          Letters to Veterinary Professionals
          Risk Minimization Action Plans (RiskMAPs) for Approved Products
          Steroid Hormone Implants Used for Growth in Food-Producing Animals
          Veterinary Medication Errors
          Veterinary Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Home
          Animal & Veterinary
          Safety & Health
          Product Safety Information
          Animal Drug Shortage InformationProduct Safety Information Animal Drug Shortage Information
  
  	
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**Report Animal Drug Shortages to CVM:**

AnimalDrugShortages@fda.hhs.gov

How Can a Sponsor Report an Animal Drug Shortage?What Causes Animal Drug Shortages?What Can Veterinarians Do During an Animal Drug Shortage?What are CVM's Roles during an Animal Drug Shortage?What is a Medically Necessary Veterinary Product?What about Human Drug Shortages?What about Animal Vaccine Shortages?

Current Animal Drug ShortagesResolved Animal Drug Shortages

A drug shortage may involve either an actual or a potential shortage of a drug product. Sponsors and manufacturers provide most drug shortage information and FDA works closely with them to help prevent or reduce the impact of shortages. FDA does not have the authority to require a company to make or increase production of any product, even if the product is medically necessary.

How Can a Sponsor Report an Animal Drug Shortage?

Please see Guidance for Industry (GFI) #271: Reporting and Mitigating Animal Drug Shortages. The guidance is intended to assist sponsors in providing FDA timely, informative notifications about changes in the production of animal drugs that will, in turn, help the Agency in its efforts to prevent or mitigate shortages of these products.

What Causes Animal Drug Shortages?

Animal drug shortages can occur for many reasons. Some of these include:

Unavailability of active pharmaceutical ingredients (APIs), drug substance intermediates, or inactive ingredients.
	Unavailability of containers and closures such as vials and stoppers
	Shortages of manufacturing equipment or supplies
	Labor shortages
	Transportation issues
	Business decisions by API and finished product manufacturers
	Manufacturing changes or quality issues
	FDA enforcement issuesBack to the top

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 AnimalDrugShortages@fda.hhs.gov.

For the most current supply information, veterinarians should contact the manufacturer.

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.

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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 and communicating with sponsors/manufacturers 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.
		Exercising enforcement discretion (certain situations when the FDA decides not to strictly enforce approval requirements found in the Federal Food, Drug, and Cosmetic Act).Back to the top

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.

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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)Back to the top

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.)

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                                                                                  Content current as of:
      09/13/2023Product Safety Information

          
                        Adverse Event Reports for Animal Drugs and Devices
          Animal Drug Shortage Information
          Arsenic-based Animal Drugs
          Bovine Somatotropin (bST)
          Letters to Veterinary Professionals
          Risk Minimization Action Plans (RiskMAPs) for Approved Products
          Steroid Hormone Implants Used for Growth in Food-Producing Animals
          Veterinary Medication Errors
          Veterinary Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
 
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