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Subject:
From:
Peter Loring Borst <[log in to unmask]>
Reply To:
Informed Discussion of Beekeeping Issues and Bee Biology <[log in to unmask]>
Date:
Sun, 3 Apr 2016 12:08:05 -0400
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Mark writes:
> I hear you have to have a prescription from a Vet. Yet Mann Lake had it on the shelf and sold it to me, no questions.

Pretty good bet the vendors know the laws, as they generally don't want to be caught selling illegal products. The confusion seems to be over the timeline for eliminating these drugs from sale. Tylosin appears to be already unavailable for bees, yet it is still being sold, for example:

> Tylovet Powder treats bacterial infections in chickens, turkeys, swine and honey bees. Product Expiration date is : 6/2017

The general plan:

In 1999, the Animal Drug Availability Act (ADAA) of 1996 implemented a new category of drugs called veterinary feed directive (VFD). The VFD category is a part of the FDA’s overall directive to ensure the judicious use of human medically important antibiotics. Recently, the VFD category was expanded to include medically important antibiotics fed to animals and is defined in FDA Guidance Document #213. The revised VFD policy puts into place important control factors that dictate the appropriate use of feed-grade antibiotics.

In the past they have allowed antibiotics to have label claims for therapeutic (prevention, control, treatment) reasons, growth promotant and feed efficiency. As a part of judicious use strategy, the FDA has aligned with drug sponsors to voluntarily revise label claims, removing growth promotant and feed efficiency. Since these products cannot be used extra-label, and the removal of label claims will discontinue their use for non-therapeutic purposes. This action will result in some feed products being withdrawn from retail.

On April 11, 2012, FDA finalized a guidance document entitled "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals" (Judicious Use Guidance, GFI #209). That final guidance represents the Agency’s current thinking regarding antimicrobial drugs that are medically important in human medicine and used in food-producing animals. 

Specifically, the final guidance discusses FDA’s concerns regarding the development of antimicrobial resistance in human and animal bacterial pathogens when medically important antimicrobial drugs are used in food-producing animals in an injudicious manner. 

When will this take effect?

The expansion of the order went into effect on October 1, 2015, however, only a small number of antibiotics (tilmicosin, florfenicol, and avilamycin) were affected. Full implementation of FDA Guidance #213 including phasing numerous over-the-counter feed-grade antibiotics to VFD status will take place on January 1, 2017.

What products does the VFD cover?

Medically important antibiotics, which are essential to human medicine as outlined in Guidance Document 213, are being added to the list of drugs being moved to VFD status. This includes products that contain: tetracyclines, lincosamides, macrolides, penicillin, streptogramins, aminoglycosides, aminopenicillins and sulfonamides.

* * *

Basically, opinions on antibiotic use fall into at least 4 categories:
1) Never going to feed drugs to my bees.
2) Use antibiotics only if needed and fully approved.
3) Use antibiotics as long as they are still on the market.
4) Find a way to get this stuff any way I can and use it however I feel like it.

I think y'all know which is you.

PLB

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