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U.S. Department of Health and Human Services

Animal & Veterinary

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Buying Unapproved Veterinary Drugs From Abroad Can Expose Pets to Unnecessary Risks

FDA Veterinarian Newsletter September/October 2004 Volume XIX, No V

Buying an unapproved veterinary drug from outside the United States may expose a pet to an unnecessary health risk.

Drugs that are imported from other countries have not gone through Food and Drug Administration (FDA) review and are therefore considered unapproved new animal drugs under the Federal Food, Drug and Cosmetic Act. To be considered an approved new animal drug, FDA requires a manufacturer or sponsor to prove that the drug is safe and effective. Foreign drugs may not have gone through the study processes needed to meet the safety and efficacy requirements. Moreover, FDA has no way of guaranteeing that these unapproved drugs were properly formulated, stored, shipped and handled—even information about the unapproved drug’s country of origin is often questionable.

These concerns apply both to unapproved prescription and over-the-counter drugs. Neither can be legally imported.

FDA has the authority, in conjunction with the U.S. Customs Service, to detain unapproved animal drugs that are being imported into the country. Significant civil and criminal penalty action can be taken against parties seeking to import illegal drugs for commercial distribution.