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RE: Antivenom, where to buy?

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Posted by: SnakesAndStuff at Sat Sep 11 17:23:54 2010  [ Report Abuse ] [ Email Message ] [ Show All Posts by SnakesAndStuff ]  
   

Unfotunately, obtaining antivenom is quite a bit of paper work and jumping through hoops. Here is a (loose) guide to how it is done. Others may wish to jump in and fill it in better as I'm really experienced in this field. This information may be outdated as well...



You need to apply for a Center for Biologics Evaluation and Research (CBER) for a BB-IND number. The foreign AV manufacturer should include this number on all of their shipping labels. Then you need a 1572 form (Statement of Investigator). This is needed when applying for the BB-IND number. (I think more info on this can be found at Aphis.usda.org).



Notify CBER of the intention to import antivenom. Apply to US Department of Agriculture Animal and Plant Health Inspection Service (APHIS) for a permit to import antivenom. When this is approved, send these labels to the foreign antivenom manufacturer.



Clear all AV through customs.



Submit annual report to CBER stating that no AV was used, or what AV was used and an incident report. Anytime a foreign AV is used a complete case report should be sent to CBER.


   

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