Drug Information

Frequently Asked Questions about 
Importing Beef Insulin for Personal Use

A. Eli Lilly has discontinued marketing Iletin-1 (a combination beef-pork insulin product). Although other types of insulin are available in the U.S., including human insulin and pork insulin, no FDA-approved insulin derived from beef is now available in this country.

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A. You may be able to import beef insulin for your personal use from a foreign country, if you follow certain FDA and USDA requirements. After your shipment of beef insulin arrives in this country, the United States Customs Service will notify FDA. FDA then will decide whether or not to allow the shipment to enter the country.

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A. There is a possible threat of bovine spongiform encephalopathy (BSE) or "mad cow disease" transmission through the use of beef insulin if derived from tissue contaminated with BSE agent.

• What is BSE? BSE is a chronic disease affecting the central nervous system of cattle. This disease may have an incubation period of several months to several years, during which time there is no visible indication of disease. The incubation period among cattle ranges from three to eight years.

• How can BSE affect me? There is scientific evidence supporting an association between BSE disease in cattle and a similar disease called new variant Creutzfeldt-Jakob disease (nvCJD) in humans. BSE and CJD are neurological diseases known as transmissible spongiform encephalopathies which have no cure at the present time.

Also, manufacturers producing beef insulin for sale in foreign countries do not have to comply with FDA requirements.

• How can lack of FDA approval of a product affect me? FDA will not be able to evaluate the safety or effectiveness of imported beef insulin products that are not approved by FDA. Additionally, FDA will not have information about the product’s manufacture or quality control.

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A. FDA has not approved any applications from foreign manufacturers of beef insulin to sell their product in the U.S. Therefore, under the Federal, Food, Drug, and Cosmetic Act, imported beef insulin is considered to be an unapproved new drug in the U.S. FDA may refuse admission to the U.S. of any unapproved drug when offered for importation into this country. However, FDA staff may use enforcement discretion to allow the importation of unapproved drugs into the U.S. under certain conditions. One such condition is personal importation of unapproved drugs, like beef insulin, that are medically necessary and not available in the U.S. If you are a person with diabetes who can’t be treated with either human or pork insulin, FDA may permit you to import beef insulin into the U.S. for your personal use.

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A. FDA’s decision to use enforcement discretion is made on a case-by-case basis.

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A. In order to help FDA decide whether to use its enforcement discretion to allow you to import beef insulin, FDA recommends that you send to your foreign supplier the following documents along with your beef insulin order:

• a signed statement that the product is for your own personal use;
• the name, address, and phone number of the U.S.-licensed physician or practitioner who is responsible for your treatment with this drug;

• a statement from your U.S.-licensed physician or practitioner that the available products in the U.S. do not effectively control your diabetes; and

• shipping documentation information required by the U.S. Department of Agriculture (USDA) to assure compliance with their requirements.

You should request that your foreign supplier include with your shipment a copy of the above documents. The inclusion of these documents with your shipment of beef insulin will help FDA to decide whether to use its enforcement discretion to allow importation of your beef insulin.

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A. You can obtain information about the USDA documentation requirements from the following sources:

• Veterinary Services Import Products Program
  Website: www.aphis.usda.gov/; "Products That Do Not Require An Import Permit"
• Automated Document FAX phone number: 1-301-734-4952, numbers 1001 and 1005
• USDA phone number: 1-301-734-3277

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A. You may only import beef insulin for your personal use. You may not sell the product to others. In the case of beef insulin, FDA may allow you to import for your own use up to a six-month supply.

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A. It varies. You should allow enough time for the supplier to process your request and then ship the insulin. Also, you must allow additional time for the clearance procedure once the product has arrived in the U.S. Generally, most overnight carrier (i.e., FedEx, UPS, etc.) packages are cleared by FDA within two to three days. Packages entering the U.S. via other means may take longer. Remember that your supplier should include with your shipment all the documentation listed in the answer to question number 6. If your package does not contain any of this documentation, the process of clearing your shipment may be delayed until FDA resolves any of its concerns related to your shipment’s entry into the U.S.

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A. FDA has a website devoted to personal importation:

http://www.fda.gov/ora/import/ora_import_program.html

At this site you will find:

• The Regulatory Procedures Manual, Chapter 9, Subchapter on Coverage of Personal Importation;
• Information on Importation of Drugs prepared by FDA’s Division of Import Operation and Policy; and
• Information on Purchasing Medications Outside of the United States.

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FDA/Center for Drug Evaluation and Research
Last Updated: December 14, 2001
Originator: OTCOM/DLIS
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