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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information on the Use of Antivenoms

Antivenoms for human use are subject to Section 262 of Title 42 of the U.S. Code which prohibits the sending, carrying, or bringing for sale, barter, or exchange from any State or possession into any other State or possession or from any foreign country into any State or possession any biologic product unless manufactured at an establishment holding an unsuspended and unrevoked license issued by the Secretary of Health and Human Services.

Antivenoms produced by a foreign manufacturer not licensed by the U. S. are considered experimental drugs, and the Department of Health and Human Service requires an Investigational New Drug filing to permit their importation. Since institutions may maintain species for which no licensed antivenoms are produced, the Department of Health and Human Services will permit importation of foreign antivenoms to be made available in the event an attack occurs, providing the institution submits the following information in triplicate to the Director, Center for Biologics Evaluation and Research (CBER), requesting an Investigational New Drug (IND and often called the "BB-IND") number:

  1. An Investigational New Drug Application (Form FDA 1571) must be submitted.
  2. A statement naming a local physician, selected by your institution, under whose supervision the antivenom will be maintained and administered. A Statement of Investigator (Form FDA 1572) must accompany this statement for your new BB-IND or when there is a change.
  3. The name of each product, the name and address of the manufacturer, the species against whose venom the antivenom is claimed to be effective, and when available, the lot number(s) of the product, together with a statement by the manufacturer that the antivenom has passed the applicable safety and sterility tests. (One method of accomplishing this is by having the statement typed across the invoice sheet.) The lot number and safety and sterility test results can be submitted to CBER upon receipt of the antivenom.
  4. A copy of the package insert for each of the product(s) to be imported.
  5. A statement that the antivenom is being imported solely for emergency use and that the product will not be resold.
  6. A statement to the effect that, in the event the product is administered, a complete case report will be submitted to the Director, CBER.

You need apply for the BB-IND number only once. The BB-IND number is permanent provided that your annual reports are appropriately submitted to CBER, stating either that no antivenom was used, or that the antivenom was used. If the antivenom was used during the year, a summary report about the incident must be included in the annual report.

All subsequent submissions to CBER related to this BB-IND will be in triplicate and should be accompanied by a completed and signed FDA Form 1571, citing the correct BB-IND number.

The BB-IND number should be included on all correspondence with CBER, and should be included on all orders of foreign antivenom with instructions to the manufacturer to include the BB-IND number on all shipping labels to aid in clearing the material through customs.

If additional information is required, please contact the Division of Blood Applications, at (301) 827-3524.

All mail concerning antivenoms directed to CBER should be sent to the following mailing address:

Center for Biologics Evaluation and Research
Attention: Office of Blood Research and Review
HFM-99, Room 200N
1401 Rockville Pike
Rockville, Maryland 20852-1448


Summary Steps To Be Taken When Importing Antivenom

It is important to remember that three Federal agencies are involved in importation: The Department of Health and Human Services, The Department of Agriculture, and the U.S. Customs Service.

  1. Apply to the Center for Biologics Evaluation and Research (CBER), for a BB-IND number. Foreign manufacturers should include the BB-IND number on all shipping labels.
  2. Notify CBER of your intention to import antivenom. Include the BB-IND number on all correspondence so that your IND file can be updated to include the newly ordered antivenom. Sterility and safety reports should be submitted to CBER upon receipt.
  3. For each importation, apply to the U.S. Department of Agriculture, Animal and Plant Health Inspection Service (APHIS) for a permit to import antivenom, and when the permit is approved, send red labels to foreign manufacturer prior to shipment of product.
  4. Clear all antivenom importations through U.S. Customs. U.S. Customs will hold most shipments until you or your customs broker clear them. Occasionally a shipment will not be held or cleared by customs. It will appear at your institution with no customs stamps indicating clearance. Your broker should clear these parcels.
  5. Each institution should keep an informal "Disposition Log", indicating how much of which antivenoms were imported, when and what the final disposition of the stock was, and the dates of disposal.
  6. Each institution should keep an informal "Disposition Log", indicating how much of which antivenoms were imported, when and what the final disposition of the stock was, and the dates of disposal.

All submissions to CBER related to a BB-IND will be in triplicate and accompanied by a completed and signed FDA Form 1571, citing the correct BB-IND number.

Finally, it is important to remember that, in the event any foreign antivenom is used clinically, a complete case report must be submitted to the Center for Biologics Evaluation and Research.