- Why can’t I obtain beef or pork insulin manufactured in the U.S.?
- How can I obtain beef or pork insulin manufactured in a foreign country for my personal use?
- What are FDA’s concerns regarding the importation of beef or pork insulin for my personal use?
- Why will FDA allow me to import beef or pork insulin into the U.S. if the product is not approved?
- How does FDA determine whether it will allow me to import beef or pork insulin for my personal use?
- How do I request approval to import beef or pork insulin for my personal use?
- Where can I obtain information on USDA requirements to import beef or pork insulin from a foreign country?
- How much beef or pork insulin can I import?
- If FDA and USDA allow me to import beef or pork insulin, how long will the process take?
- Where can I obtain further information regarding FDA’s advice on personal importation?
Q-1. Why can’t I obtain beef or pork insulin manufactured in the U.S.?
A. The manufacturing of beef insulin for human use in the
Q-2. How can I obtain beef or pork insulin manufactured in a foreign country for my personal use?
A. You may be able to import beef or pork insulin for your personal use from a foreign country, if you follow certain FDA and USDA requirements. After your shipment of beef or pork 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.
Q-3. What are FDA’s concerns regarding the importation of beef or pork insulin for my personal use?
A. Manufacturers producing beef or pork 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 or pork insulin products that are not approved by FDA. There is particular concern regarding importation of a life-saving product such as insulin because it would be obtained from a source that has not had to meet FDA standards; therefore, it will be manufactured, stored and handled under conditions that have not been inspected by or approved as safe by the FDA.
Also, there is a possible threat of bovine spongiform encephalopathy (BSE) or "mad cow disease" transmission through the use of beef insulin if it is derived from tissues contaminated with the BSE agent. There may also be a possible threat of transmission through the use of pork insulin if it is manufactured in the same facility as beef insulin and adequate provisions to prevent cross-contamination are lacking.
- 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 (vCJD) in humans. BSE and vCJD are neurological diseases known as transmissible spongiform encephalopathies which have no cure at the present time.
Q-4. Why will FDA allow me to import beef or pork insulin into the U.S. if the product is not approved?
A. Importation of unapproved pharmaceutical products from a foreign country is illegal and potentially dangerous. FDA has not approved any applications from foreign manufacturers of beef or pork insulin to sell their product in the U.S. Therefore, under the Federal, Food, Drug, and Cosmetic Act, imported beef or pork 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 or pork 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 human insulin or its analogs, FDA may permit you to import beef or pork insulin into the U.S. for your personal use.
A. FDA’s decision to use enforcement discretion is made on a case-by-case basis.
A. In order to help FDA decide whether to use its enforcement discretion to allow you to import beef or pork insulin, FDA recommends that you send to your foreign supplier the following documents along with your beef or pork 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;
- 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 or pork insulin will help FDA to decide whether to use its enforcement discretion to allow importation of your beef or pork insulin.
Q-7. Where can I obtain information on USDA requirements to import beef or pork insulin from a foreign country?
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
Q-8. How much beef or pork insulin can I import?
A. You may only import beef or pork insulin for your personal use. You may not sell the product to others. In the case of beef or pork insulin, FDA may allow you to import for your own use up to a six-month supply.
Q-9. If FDA and USDA allow me to import beef or pork insulin, how long will the process take?
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 all 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.
Q-10. Where can I obtain further information regarding FDA’s advice on personal importation?
A. FDA has a web site devoted to its Import Program.
Date created: July 6, 2005; modified January 26, 2011