NOTE: Please see Oct. 15, 2009, JAVMA News article, "FDA no longer issuing letters for importation for unapproved animal drugs," for current FDA guidelines on drug imports.
The FDA's criteria for regulatory discretion
posted August 1, 2005
Occasionally, veterinarians determine that no FDA-approved drug can adequately treat a particular animal patient and a foreign drug is indicated. Can veterinarians obtain a needed foreign drug? If so, how? Is this legal?
The Federal Food, Drug and Cosmetic Act, Sec. 801 (a)(3), states that importation of an animal drug that is not the subject of an approval in the United States is forbidden. However, the FDA Center for Veterinary Medicine recognizes that the lack of certain drugs could result in undue animal suffering. To address this situation, the FDA-CVM has chosen to exercise regulatory discretion. FDA regulatory discretion essentially means that although the importation is illegal, the FDA will refrain under certain circumstances from enforcing the regulations that prohibit the importation. The FDA has chosen not to prosecute importers who obtain written authorization for which the following conditions apply:
- The drug does not pose a significant risk to animal or human health
- The drug is used to treat or prevent a serious disease or condition in an animal
- There is no other available source of that drug or alternative drug(s) that is judged by FDA-CVM veterinary staff to be an adequate substitute
- The request for importation is made by a licensed veterinarian within the context of a valid veterinarian-client-patient relationship
- A relatively small amount of drug is requested for import
- There is no active promotion or marketing of the drug in U.S. markets for the intended use of the product
The FDA indicates it is committed to working with veterinarians to supply drugs for legitimate medical needs; however, the agency cautions that drugs purchased outside the United States have not been subjected to FDA's high standards for drug manufacturing and quality control, and that drug labeling may not be as detailed and/or comprehensive as for U.S.-approved products.
Interested veterinarians may contact the CVM and request permission to import a foreign drug. It is the veterinarian's duty to identify a supplier. Discretion, if granted, is on a single-patient basis. The Personal Import Policy is not a means to import foreign versions of FDA-approved drugs for economic reasons. Moreover, actions can be taken against veterinarians who import illegal drugs for commercial distribution.
There is no specific governmental application form. The FDA-CVM prefers that veterinarians send a letter of request for personal importation of a drug on business stationery by facsimile. The FDA needs the following information to fully evaluate the request:
- How the veterinarian learned of the existence of the drug/product
- Veterinarian's name, address and phone number
- Clinic name and address
- Client's name and address
- Patient name and nonfood species
- Name of drug
- Drug family or class
- Name and address of drug supplier
- Legal status of the drug in the foreign country
- Amount of drug to be imported—must be small, noncommercial quantities
- Disease condition to be treated
- Reason why an approved human or animal drug will not treat the disease condition
- Statement that the veterinarian will notify the animal owner that the drug is not approved, that the drug will not be used in any food animal, and that the veterinarian agrees to notify the FDA if there are any adverse reactions
The current approximate turnaround time for a written response is four to six weeks, but efforts are under way to shorten this time, according to the CVM. Veterinarians should state it prominently in their letter if the situation is an emergency or there is an immediate need for the drug, so the FDA can give the request the appropriate priority.
Veterinarians who wish to use the Personal Import Policy for the treatment of a patient may direct their request to Toni Wooten, Division of Compliance, HFV-230, Center for Veterinary Medicine, Food and Drug Administration, Metro Park North IV, 7519 Standish Place, Rockville, MD 20855; phone, (240) 276-9220 or (240) 276-9200; fax, (240) 276-9241; or Toni.Wooten@fda.gov.
If the CVM grants permission, the veterinarian will receive an FDA letter authorizing the personal importation of a foreign drug for a specific patient. The department can withdraw regulatory discretion at any time.
Veterinarians should retain a copy of the FDA letter for their records. It would be beneficial for veterinarians to send a copy to the supplier and request that they include the letter with the shipping documents. If a customs broker is used, a copy of the letter should be supplied to the broker. There are no federal rules governing how long the letter must be kept.
The FDA and the U.S. Customs and Border Protection work cooperatively to monitor imported goods. Should Customs and Border Protection officials intercept a foreign drug during shipping, having an accompanying authorizing letter will enable FDA inspectors who review import documents to allow the shipment to proceed to the veterinarian.
If the letter is not with the shipping documents, the shipment will be delayed. The FDA will attempt to contact the veterinarian; however, FDA import operations at the ports of entry are very busy, so contact may not be immediate.
The FDA is often asked whether a copy of the letter should be supplied to the FDA district office for the state in which the veterinarian is located. Since an import shipment may enter the United States at any of several ports, it is impossible to know which district to notify in advance.
Should the patient need refills of medication, a new request for importation must be made. There is no renewal or refill option. If another patient needs the imported drug, the veterinarian should initiate a request in the new patient's name.
Only veterinarians with veterinarian-client-patient relationships are in a position to make science-based recommendations that are customized to the needs of an individual patient and owner/client. Information about the benefits and risks of various therapies are important to owners' decisions about therapy. There is potential legal liability for all medical procedures, including prescribing of drugs.