Licensed veterinarians in the United States may request the import of this antivenom (Polyclonal antivenom F(ab)2 fragment; Crotalus durissus and Bothrops asper; equine origin) from the United States Department of Agriculture.  To import antivenom, appropriate steps to comply with Federal and State regulations should be followed.  The following steps provide guidance on how to request authorization from the USDA for importing antivenom from Instituto Bioclon, the company that manufactures this particular antivenom.

Step 1:  Download and complete Form 16-3

Provided is suggested language to complete the form.

Section 1: "ANY"

Section 2: Indicate your State's port of entry or anticipated city of arrival.  You may want to check with your State Veterinarian and/or State Customs for further clarification.

Section 4: Instituto BioClon; S.A. de C.V. 2008. Calzada de Tlalpan # 4687, Col. Toriello Guerra. C.P. 14050, México D.F

Section 5: The Product is a polyclonal antivenom F(ab)2 fragment of equine origin produced by Instituto Bioclon in Mexico and derived from a qualified herd of horses hyperimmunized against the venoms of Crotalus durissus and Bothrops asper. The Product is supplied as a lyophilized, white-pale to yellow porous solid in a 20mL labeled injection vial containing specific equine derived binding fragments which are cross protective against numerous crotalid venoms. After reconstitution with 0.9% isotonic saline it appears as an opalescent slightly yellow liquid with a pH range of 6-7.  Purity: F(ab)2 : NLT 85%; Fab: NMT 2%; Low molecular weight protein: NMT 13%; IgG 0%

Section 6: provide the quantity (doses) you are requesting.

Section 7: you should indicate how this product is to be used in your facility, such as "for in-clinic use in dogs envenomated with pit vipers".

Section 9: equine immunoglobulins are purified by precipitation on non-IgG proteins with ammonium sulfate and acidic pH. After filtration the IgG solution undergoes diafiltration formulation and sterilization. The antibodies are cleaved by pepsin to form F(ab)2 fragment. The fragments then undergoe micron filtration to remove viruses.  Product is supplied as a sterile fill product.

Section 10: you should indicate how you will dispose of unused biologic, you may contact Animal Health Consulting for guidance on this matter.

Step 2. Upon completion of Form 16-3; it should be submitted (mail or fax) to:

United States Department of Agriculture -Center for Veterinary Biologics
4700 River Road, Unit 148
Riverdale, MD 20737
Telephone 301.734.8345
FAX: 301.734-4314

Step 3: Once you have received the approval to import from the USDA, then follow instructions as provided by the USDA.  We recommend that you notify your State Veterinarian's office, which may have additional requirements for import and use. 

Step 4: Please fax a copy of the Permit to 480.240.1335 (US Fax number for Veteria Animal Health); this way we can help coordinate the process if necessary and keep a record of any issued permits.

CONTACT INFORMATION (United States Liaison)
Craig Woods DVM, MS, MBA
Animal Health Consulting, LLC
928.713.2334 (direct cell phone for technical services)
email: cwoods@animalhealthconsulting.com

NOTICE: this information does not guarantee you will receive a Permit.  Information should not be considered advice from the United States Department of Agriculture or any other agency.  The product referenced in this docuemnt is NOT USDA approved, and any authorization to import should be followed according to USDA guidelines and the import requirements.