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Frequently Asked Questions about
Importing Beef or Pork Insulin for Personal Use
1.
Why can’t I obtain
beef or pork insulin manufactured in the U.S.?
2.
How can I obtain
beef or pork insulin manufactured in a foreign country for my
personal use?
3.
What are FDA’s
concerns regarding the importation of beef or pork insulin for my
personal use?
4.
Why will FDA
allow me to import beef or pork insulin into the U.S. if the product
is not approved?
5.
How does FDA
determine whether it will allow me to import beef or pork insulin
for my personal use?
6.
How do I request
approval to import beef or pork insulin for my personal use?
7.
Where can I
obtain information on USDA requirements to import beef or pork
insulin from a foreign country?
8.
How much beef or
pork insulin can I import?
9.
If FDA and USDA
allow me to import beef or pork insulin, how long will the process
take?
10.
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 U.S. was discontinued in 1998.
Beginning in January 2006, pork insulin (Iletin II) for
human use will no longer be manufactured or marketed in the U.S.
Although no FDA-approved insulin derived from beef or pork will be
available in this country after December 2005, newer insulin
therapies, including human insulin and its analogs, will continue to
be readily accessible to patients in the U.S.
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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.
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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.
o
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.
o
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.
o
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.
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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.
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Q-5. How does FDA determine whether it will allow me to import beef
or pork insulin for my personal use?
A.
FDA’s decision to use
enforcement discretion is made on a case-by-case basis.
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Q-6. How do I request approval to import beef or pork insulin for my
personal use?
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:
o
a
signed statement that the product is for your own personal use;
o
the
name, address, and phone number of the U.S.-licensed physician or
practitioner who is responsible for your treatment with this drug;
o
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.
If
you have questions for the FDA regarding the import of beef or pork
insulin, please contact William Nychis at
301-796-3298.
[back to question list]
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:
o
Veterinary Services Import Products Program
Website:
www.aphis.usda.gov/;
"Products That Do Not Require An Import Permit"
o
Automated Document FAX phone number: 1-301-734-4952, numbers 1001
and 1005
o
USDA
phone number: 1-301-734-3277
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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.
[back to question list]
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.
[back to question list]
Q-10.
Where can I obtain further information regarding FDA’s advice on
personal importation?
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:
o
The
Regulatory Procedures Manual, Chapter 9, Subchapter on Coverage of
Personal Importation;
o
Information on Importation of Drugs prepared by FDA’s Division of
Import Operation and Policy; and
o
Information on Purchasing Medications Outside of the United States.
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Date created: July 6, 2005; updated December 5, 2008 |
