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This guide has been written to help you if you have not been able to find a suitable replacement for Iletin^® 1 Beef/Pork insulin and Iletin II pork insulin in the United States and wish to obtain them from CP Pharmaceuticals.

Although CP's natural animal insulins have been approved and used in the United Kingdom and other countries for the last 30 years, they are not yet approved for use in the United States. Therefore, CP cannot supply insulin to you as a U.S. resident until you have received permission from the relevant U.S. authorities to bring the insulin into the United States.

This is what to do:

1. Contact the U.S. Department of Agriculture (USDA)

Because CP Pharmaceuticals' insulins are derived from cows and pigs, you need permission from the United States Department of Agriculture to bring CP's insulins into the country.  Each species requires a separate permit. 

An "Application for Permit to Import Controlled Material or Transport Organisms or Vectors" is required and a new, simplified form (VS form 16-6A) is available online at: http://www.aphis.usda.gov/permits/learn_epermits.shtml  NOTE:  At this time the application fee has been waived by the USDA for insulin.  Help to fill out the form can be found at: https://members.tripod.com/USDA_Beef_Pork_VS16-3_app.htm

U.S. Department of Agriculture
Animal and Plant Health Inspection Service
Veterinary Services
National Center for Import-Export Products Program
Riverdale MD 20737-1231.

Tel (301) 734-3277

The USDA will send you an official import permit that is valid for five years.

2. Contact CP Pharmaceuticals

Personal importation of small amounts of unapproved medicines under specific circumstances may be allowed at the discretion of the U.S. Food and Drugs Administration (FDA). So that FDA officials can release your insulin when it arrives in the U.S. you need to send some documents to CP when you order your insulin. CP Pharmaceuticals will enclose a copy of these documents with your shipment of insulin for the FDA officials to look at when it arrives in the U.S. Please also ensure to quote your personal Social Security Number when contacting CP, or add it to your certificate for personal use.  See below in item 3.

You should send these documents to CP Pharmaceuticals:

A copy of the USDA import permit. (see section 1 above) 

1. A completed order form (Available by request from our Export Department- Phone 011+44 1978669221 or Fax 011+44 1978669230) or email export@wockhardt.co.uk or

Beef Order Form      Pork Order Form

2. A letter from your U.S. licensed practitioner saying that the insulins available in the U.S. do not effectively control your diabetes and are therefore unacceptable. Make sure the letter has the name, medical license number, address, and telephone number of your physician. (Certificate of medical necessity or COM letter, click link and print for your MD's signature) NOTE: We now must have a new doctor's letter of medical necessity every time we order!!!

3.  See new required doctor's letter sent for use by Wockhardt, LTD. (you still must have the letter from you doctor as per #2)

4. A statement, signed by you, saying that the insulin is for your own personal use in treatment of your diabetes and that the number of vials being ordered is no more than six (was three) months supply. (Include your name, social security number, address, telephone and fax number, if you have one, on this statement.)NOTE: We now must have a new Certificate of personal use statement from you every time we order!!!

5. The USDA Permit 

Please note that CP Pharmaceuticals cannot supply you with insulin without these five documents.

It is also important to note that once we have dispatched your insulin, release of this product to you is entirely at the discretion of the U.S. authorities; CP Pharmaceuticals cannot guarantee that the authorities will allow all shipments through. CP can take no responsibility for delay, loss, damage or improper storage of your insulin in transit. However, we will do our best to ensure you get the insulin you need.

Contact us:  

• Please use our Index/TOC  and Search pages.

If you have any questions, suggestions, please E-mail us.  We will get back to you as soon as possible.