From:
Sukie Crandall
Date: 2009-09-04 15:49:43 UTC
Subject: [ferrethealth] Re: Deslorelin
To: fhl <ferrethealth@yahoogroups.com>
These currently have to be imported from Peptech and that
means that FDA importation papers must be filed. There
are things in the archives on this:
http://ferrethealth.org/archive/FHL9577
The form that is approved for use in the U.S. is a NON-implant form;
what is
holding up approval of the ferret form is if the implant technology
needs and
can get FDA approval. That also appears to have caused some confusion
between branches of the FDA since the drug being delivered has a prior
approval.
Mare (NON-implant) form:
Date of Approval: June 18, 1998
http://www.accessdata.fda.gov/scripts/animaldrugsatfda/details.cfm?dn=14
1-044 for the entry in the Animal Drugs @ FDA database.
Drug sponsor:
Peptech Animal Health Pty. Limited
19 - 25 Khartoum Rd.
Macquarie Par, New South Wales, 2113
Australia
http://www.peptech.com/
http://www.peptech.com/HTML/Animal_Health/Animal_Health.html
The form for ferrets can also be used by dogs and cats for temporary
chemical neutering.
Info on how to begin the importation process:
> From: Sukie Crandall
> Date: Wed, 29 Jul 2009 22:20:04 -0400
> To: fhl <ferrethealth@yahoogroups.com>
> Subject: [ferrethealth] on deslorelin implants in the U.S.
>
> I have received a response which mentions a step people in the U.S.
> need to take into regard if their vets try to import the right
> deslorelin implant.
>
> Importing medications can be very tricky. Several years back I helped
> a family find info because their infant daughter has a genetic
> condition for which the meds can be hard to get. In fact, later they
> moved from HI to CA specifically because compounding pharmacies are
> better for getting that med and HI had (still has?) so few compounding
> pharmacies. Anyway, the FDA let them know at that time that even with
> a permit sometimes imported meds are confiscated. I do NOT know the
> penalties for importations that are done outside the law and would NOT
> advise an illegal approach.
>
> CDER of the FDA wanted me to point out that besides using
> > http://www.fda.gov/ForIndustry/ImportProgram/default.htm
>
> There is something more to take into account, an application. I DID
> let them know that this is information I planned to pass on to the FHL
> membership so their letter was sent with the knowledge that it would
> be shared.
>
> QUOTE
> >
> > Dear Ms. Crandall:
> >
> > Thank you for your inquiry to the Division of Drug Information in
> > Center
> > for Drug Evaluation and Research at the Food and Drug
> Administration.
> >
> > We apologize for the delay in response, it appears the information
> > that
> > you have collected regarding the import policy is correct. However,
> > please keep in mind that unapproved drugs are not to be imported
> with
> > out the submission of an investigational new drug application. For
> > additional information we are forwarding your inquiry to the
> Center of
> > Veterinary Medicine.
> >
BUT remember that the recent importation by multiple vets seems to have
raised some eyebrows at the FDA so the process is becoming harder and
the restrictions greater.
Sukie (not a vet)
Recommended ferret health links:
http://pets.groups.yahoo.com/group/ferrethealth/
http://ferrethealth.org/archive/
http://www.afip.org/ferrets/index.html
http://www.miamiferret.org/
http://www.ferrethealth.msu.edu/
http://www.ferretcongress.org/
http://www.trifl.org/index.shtml
http://homepage.mac.com/sukie/sukiesferretlinks.html
all ferret topics:
http://listserv.ferretmailinglist.org/archives/ferret-search.html
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