Actually, Fumagilin B has different status in USA compared to Canada.
In USA, Fumagilin B has no FDA approval (New Animal Drug Application or
NADA number), so it is illegal.
The FDA Center for Veterinary Medicine Minor Use Minor Species office says
that it may have use for bees, there was a similar product that was
registered that is no longer marketed, and there were no complaints about
it. So, they allow its importation and use via "regulatory discretion."
This means that for now, it can be imported, sold and used and the FDA will
not prosecute it.
I think that there is some effort going into obtaining a USA label (NADA),
though I am not sure. That process can be very expensive. The drug
manufacture did recently obtain a National Drug Code (NDC) number. That
makes the importation a lot easier because the customs inspectors can look
it up and see the FDA CVM MUMS office ruling that it should be allowed to
be imported despite the lack of an NADA number.
The medication is not listed in the "medically important" list. That means
if it was legal in the USA, it could obtain an "over the counter"
approval. The medically important antibiotics that are given to major
species food producing animals in feed or water now require a veterinarian
to issue an antibiotic order, either a veterinary feed directive or a
prescription. Veterinary feed directives are like prescriptions, but were
set up by the FDA as a means of avoiding requiring feed mills to run like
pharmacies since many states have stringent laws about how pharmacies are
run and there is no way for most feed mills to operate in that manner.
Why did the FDA make the rules it did requiring prescriptions or VFDs for
antibiotics? There are increasing numbers of cases of antibiotic resistant
bacteria. According to the CDC, in 2013, over 2 million illnesses per
year and 23,000 deaths per year in the USA were blamed on antibiotic
resistant bacteria. When we feed antibiotics to animals, we are putting
antibiotics into the system which creates opportunities for bacteria that
are resistant to survive and pass on their genes. Antibiotic resistance
can happen in many ways, and some of these will give resistance to multiple
drugs. The FDA is looking to make sure that when we put antibiotics into
the system and take the risk of developing antibiotic resistant bacteria,
it is for a legitimate reason. I hope if I ever have a bacterial
infection, it is sensitive to antibiotics and I don't end up as one of the
23000. While the rules certainly can make life difficult for beekeepers
and veterinarians, it seems the big picture is worth looking at.
Chris
--
Christopher J Cripps, DVM
Betterbee
8 Meader Rd
Greenwich, NY 12834
800-632-3379 ext 8001
518-290-3168 direct line, fax and text
[log in to unmask]
--
This email message and any files transmitted are for the sole use of the
intended recipient(s) and may contain confidential and privileged
information. Any unauthorized review; use, disclosure or distribution is
prohibited. If you are not the intended recipient, please contact the
sender by reply email and destroy all copies of the original message.
Please note that any views or opinions presented in this email are solely
those of the author and do not necessarily represent those of the Betterbee
®. Betterbee ® accepts no liability for any damage caused by any virus or
any other malicious software transmitted by this email.
***********************************************
The BEE-L mailing list is powered by L-Soft's renowned
LISTSERV(R) list management software. For more information, go to:
http://www.lsoft.com/LISTSERV-powered.html
|
