Speaking of Costa Rican poly....

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Posted by tj on April 09, 2003 at 11:23:14:

In Reply to: Re: How do exotic snake keepers get antivenom? posted by Matt Harris on April 09, 2003 at 09:03:21:

any news on the shortage?

::I am planning on getting an exotic snake, but I want to be sure that I will have access to the appropriate antivenom. Whether it is by getting it myself, or having a reliable source. I know there are a bunch of holes to jump throught to be able to get it yourself...so, my question is this,
::How do you all have, or get access to exotic snake antivenom (I live in the U.S. - Ohio). I've heard of the Florida antivenom bank, but would not want to wait antivenom in case of an accident. What do you all do?
::Thanks for any info,
::Tim

:
:It's really not "A LOT" of paperwork, but since few people really sit down to understand how to do it, it can seem overwhelming. Basically you apply to the USFDA for an Investigational New Drug # as would any pharmaceutical company testing a new drug (exotic AV is considered an experimental drug in the US). This allows you to possess the A/V
:
: Once you obtain this, you then just get a 30-Day Import permit for a biologic product from the USDA allowing you to import the product.

: There are some other details to it as well, e.g., you will need to contact the supplier to request they mail you a few package inserts (You sumbit the FDA application in triplicate of which 1 must contain an original insert, the other 2 can be photocopies). Also you should request a pro-forma invoice with a price quote for the amount you wish to purchase.

:Also, before you start the process.....talk to your physician. He/she will have to agree to be the principal investigator for the IND #. Basically this means that, while you may keep the A/V to take with you to the emergency room (or elsewhere if you are life-flighted)....you will not administer the A/V yourself, and your physician (or another attending physician in communication with yours) will actually oversee the administration of the A/V.

:If you wish, I have a "Simplified" how-to document which I can email you with the basic outline of the application proccess....then if you have specific questions along the way, you can email me with questions as you complete the process.

: From the time you send in the application, you should have an IND and the import permit within about a month. I think it took me about 3 months from the time I first contacted the supplier in Costa RIca to get the package inserts and invoice, until I actually had the A/V in hand. At the time, though I didn't know you could apply for the IND and Import permit simultaneously. I kind of plodded along and had to figure it out along the way.....but the FDA/CBER is very helpful in the process.

:Matt
:

Follow Ups:

Re: Speaking of Costa Rican poly.... Nightflight99 04/11/03 (1)
- Thank you Thomas. n/p tj 04/14/03 (0)