Thursday, May 3, 2007

Medically Necessary Veterinary Imports Request II

Posted to EC List by Dr. Kellon May 3, 2007 Msg #91069

Answers for the "13 Questions" in the request letter.
Answers in [brackets]. You can cut/paste this into a word file so most of the information does not need to be retyped for printing on letterhead.

Michael Zimmerman
Food and Drug Administration
Center for Veterinary Division of Compliance, HFV-235
7519 Standish Place
Rockville, MD 20855
Fax: (240)276-9241

Re: Medically Necessary Personal Veterinary Imports

Please determine the following in the initial contact:

How did the veterinarian learn of this product?
[Pergolide has been the drug of choice for Cushing's in equines at least 10 years.]

Please submit the following information:

1. Veterinarian's name
2. Clinic's name, address, & phone number
3. Client's name and address
4. Patient name and non-food species
[1-5 are obvious]

5. Name of drug

6. Drug family or class
[Dopamine agonist]

7. Name and address of drug supplier
[You will have to have picked out a pharmacy in another country
before this question can be answered and the application submitted.
Fairly easy to do on line. You don't have to actually place an order
or open an account, etc. They just need to know where it will be
coming from. Be prepared to be shocked at these prices.
See list below for suppliers.]

8. Legal status of the drug in the foreign country

9. Amount of drug to be imported, must be small, non-commercial
quantities. Please be sure to specify # of mg as well as # of
bottles (each bottle contains 100 capsules)
[Need to specify the strength of the pills you are importing and
how many pills each time - e.g. a 100 count bottle of 0.5 mg generic
pergolide pills.]

10. Disease condition to be treated

11. Reason why an approved human or animal drug will not treat the
disease condition
[There are no approved human or animal drugs other than pergolide
which are known to adequately treat the condition.]

12. A statement that:
- you will notify the animal owner that the drug is not approved
- that the drug will not be used in any food animal
- and that you agree to notify the FDA if there are any adverse reactions?
[Veterinarian needs to answer "yes" to all three questions.]

13. Please include your email address.
[Veterinarian's email address]

Example Suppliers for Question 7:

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