FDA/USDA Requirements

The FDA and USDA appear to have resolved this issue and we are advised that USDA will take up to 8 weeks to issue permits and renewals!! However the USDA permits are now good for 5 years.

Mr. Morrison is the FDA's Ombudsman for consumer matters:

Jim Morrison,

There is no longer a requirement on the part of the USDA for diabetics to obtain an import permit. See Kris Caraher's letter pasted below. Also, attached please find the ruling from the USDA which has an impact on the FDA's guidelines for the personal importation of beef insulin by US diabetics . For diabetics this is very important; the cost was considerable for uninsured individuals such as myself.

As things now stand the FDA's CDER guidelines, set out on its beef insulin web-site, do not cover the new arrangements; they refer to the need for a permit. Please would you arrange for the guidelines to be modified and brought up to date.

I should be very grateful if you would also alert your agents who check the documentation for medicines at their port of entry to the fact that the previous requirement of the USDA for a permit has now been dropped. None of us would wish the legal entry of insulins into the United States to be unnecessarily delayed. I am sending CP Pharmaceuticals a copy of this attachment of the USDA's regulations so they can follow the precise instruction with each parcel they send to the US, for the avoidance of any doubt at the port of entry.

I should then be grateful, on some separate occasion, to receive your advice relating to the current views of the FDA on issues surrounding BSE and beef insulins." Hoping you are aware of the FDA's Transmissible Spongiform Encephalopathies report of July 27, 2000, stating there is no possibility of BSE/CJD in beef pancreas. Also, that no IDD [sic Insulin Using Diabetic meant] has ever gotten CJD.

Respectfully,
Margie Baker
53 Freshwater Dr
Palm Harbor FL 34684

727-938-6572

-->Below copied is the APHIS LETTER received -->

Mrs. Baker and Mr. Groves -

The attached letter contains the information you need to show that you do not need a USDA-APHIS permit to import the insulin. No permit means no user fee charge. Please let me know if there is any further information I can provide at (301) 734-5743.

Kris Caraher,

APHIS, MRP-BS, FMD, FSSB, User Fees Section
(See attached file: humnphar.PDF)

The USDA ruling to which Ms. Caraher is referring to says:

This is in reply to your request to import pharmaceuticals or vaccines that are prepared for use in humans.

The U.S. Department of Agriculture (USDA) does not regulate the importation of certain pharmaceuticals and vaccines for use in humans (in final dosage form). This is true for pharmaceuticals in gelatin capsules or in individual use vials as well as inactivated, modified live, and some non-viable recombinant vaccine preparations, but not for those live recombinant vaccine preparations which use animal or poultry viral agents. Such vaccine vectors and the viruses themselves involved in the vaccine may require a USDA import permit because they are animal or poultry infectious agents or are customarily prepared in eggs or on tissue cultures which use bovine material as a growth stimulant for the cells.

Materials exposed to and/or containing bovine products and eggs are controlled by the USDA due to the potential risk of introducing exotic animal diseases into the United States. In addition, animal or poultry viruses that have been altered by insertion of genetic material for recombinant vaccines need to be evaluated in light of their being changed and, therefore, constitute new and potentially exotic viruses.

The U.S. Food and Drug Administration has primary jurisdiction over human pharmaceuticals, contact the Division of Import Operations and Policy at (301) 443-6553. The U.S. Public Health Service has primary jurisdiction over human vaccines and should be contacted for their importation requirements. A U.S. Public Health Service permit or authorization may be obtained by contacting the Office of Biosafety, Department of Health and Human Services, Centers for Disease Control, Atlanta, GA 30333, or by telephoning Area Code (404) 639-3235.

Imported human pharmaceuticals and vaccine preparations being imported should be accurately labeled and have an accompanying written declaration that states: "Human pharmaceuticals/vaccines, ready for use, not containing live animal or poultry viruses as the vector" to facilitate port-of-entry inspection by USDA inspectors. It would be helpful to include the trade name and package inserts with these documents as well. You may also wish to send a copy of this letter along with the shipment.