March 01, 2003

 

 Reporting veterinary drug shortages to the FDA - March 1, 2003

Posted on February 15, 2003
 

To prevent or alleviate undue animal suffering and animal production hardships caused by shortages of medically necessary veterinary products, the Food and Drug Administration's Center for Veterinary Medicine has developed the Medically Necessary Veterinary Drug Product Shortage Management guidance.

The guidance establishes a protocol for CVM staff to follow after they receive a report of a drug shortage from veterinarians, producer associations, the animal health industry, media or consumer groups, or normal FDA surveillance. All reports are reviewed, and if a shortage is confirmed, the FDA will consider taking action to alleviate the shortage. Actions may range from discussions with the industry to acceleration of new animal drug application review, and/or in extraordinary circumstances, to enforcement discretion.

The FDA defines a medically necessary veterinary product as a product that is used to treat or prevent a serious disease or condition, or is needed to ensure the availability of safe food products of animal origin and there is no other available source of that product or an alternative drug judged to be an adequate substitute by CVM staff. Inconvenience is not sufficient to classify a drug as an MNVP.

To report an medically necessary veterinary product shortage to the FDA, call the CVM shortage coordinator at (301) 827-6641.