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Aquatic Animal Drug Approval Partnership -  AADAP Update
A Branch of the Fish and Aquatic Conservation Program 
The AADAP Update provides recent news and updates from the  Aquatic Animal Drug Approval Partnership program and its partners. For questions or to offer feedback, email Jim Bowker.
Happy New Year and Welcome to the AADAP Update!  
 
We've replaced our newsletter with a new format.  Gone is the PDF you received periodically and in its place, our new mobile friendly email newsletter.  If you're looking for fish medications approval updates, use information or  other pertinent fish health information, you  are in the right place. You'll still receive the same valuable information, just more often. A new way of sharing information for a new year. T hanks for your continued support and Happy 2017!
       Photo:  AADAP staff, located in Bozeman, MT

Saved by the Paperwork! By Jim Bowker

Every year it seems the volume of paperwork required for AADAP to be successful increases substantially. In the 1990s when AADAP program staff began to work within the U.S. Food and Drug Administration (FDA) drug approval process, the paperwork required was tenfold what the team had been expecting. Now, this paperwork load is second nature and virtually everything is filed and saved so that it can be readily retrieved at a later date.  AADAP staff can quickly respond to audits by FDA investigators or others who need to inspect the paperwork.

What about those of you working in the field? Do you need to be as conscientious about documenting and filing paperwork relative to using fish drugs?  The answer is yes! And if one day an FDA inspector shows up at your door like they recently did at a state natural resource agency office, you too will be saved by the paperwork. Read More

Need Halamid Aqua or 35% Perox Aid?  Help is here or on the way.

AADAP staff has worked nearly 30 years towards FDA approval of Halamid Aqua (100% chloramine-T), it was disheartening to hear the manufacturer had decided not to proceed with manufacturing the approved product. Their decision resulted in an immediate product shortage that was only relieved by sponsor requests for Emergency Release of chloramine-T. There have been two 3,000 kg releases and now Western Chemical has plenty of chloramine-T to fill all orders. A request for an additional 6,000 kg of chloramine-T has been made and, if granted, should further prevent a shortage and the ensuing scramble to get product to a hatchery.

Perox Aid 35%, the only hydrogen peroxide product approved for use in aquaculture, is a slightly different story. Turns out that there is plenty of product available but it can only be purchased in 55 gal drums. The sponsor is working through the system to get product moved from 55 gal drums into 5 gal carboys which should be available by summertime.

If you have questions about availability of Halamid Aqua or 35% Perox Aid, call Jason, Landon, or Eric at Western Chemical, Inc. (360-384-5898).

Notice of change to federal rule regarding access to antibiotic drugs and consequences for fish hatcheries:

The FDA has issued a new rule that all antibiotics will be accessible only with veterinary oversight. This rule was adopted to address concerns related to use of antibiotics in food-producing animals (including fish) and the development of antimicrobial resistance. 
Starting January 1, 2017:

1.  All in-feed treatments of FDA approved antibiotics will require a Veterinary Feed Directive (VFD). These include Aquaflor, Terramycin 200 for Fish, Romet 30, and Romet TC.  The FDA prohibits end-users from top-coating antibiotics on medicated feed.  Products that were previously “over the counter” will no longer be  used extra-label as prescribed by a veterinarian  as this type of use of a VFD drug is now prohibited.

2.  All immersion treatments with FDA approved antibiotics will require a veterinary prescription.  This  includes products like Oxymarine, Pennox343, and Terramycin 343 for marking skeletal tissue of fish.

The rule does not apply to other approved drugs that are not antibiotics (if used according to the label), such as Halamid Aqua (chloramine-T), 35% Perox Aid (hydrogen peroxide), Parasite–S (formalin); drugs used under a compassionate INAD authorization; or low regulatory priority/deferred regulatory status drugs. Continue Reading

FDA grants greater flexibility in using VFD drugs!

The FDA recently sent out a letter that should please most folks involved in aquaculture—veterinarians will now have more flexibility in directing treatment of fish.  The staff here at AADAP have condensed and translated some of the more technical jargon in this letter into layman’s terms for ease of understanding.

Although originally prohibited, FDA is now making exceptions for the extralabel use of Veterinary Feed Directive (VFD) drugs in fish and other minor species under certain conditions. This means that a veterinarian will be able to write a prescription for use of a VFD drug for the following:

1.  Use in species not listed in the labeling, 
2.  Use for indications (disease or other conditions) not listed in the labeling,
3.  Use at frequencies or routes of administration other than those stated in the labeling, and
4.  Deviation from the labeled withdrawal time based on these different uses.

The letter doesn’t state that it is legal to prescribe extralabel use of VFD drugs. Rather, the letter is intended to provide information to FDA field inspectors to let them know that their agency will no longer take enforcement action against the parties involved in extralabel use (aka, enforcement discretion for a veterinarian writing a prescription for extralabel use of a VFD drug).

This is especially timely good news, since all in-feed antibiotics became VFD drugs as of January 1, 2017. For aquaculture, this means products such as Terramycin 200 for Fish (active ingredient, oxytetracycline dihydrate; VFD drug no longer available over-the-counter) and Aquaflor (active ingredient, florfenicol; always a VFD drug). By granting greater flexibility to veterinarians, FDA is helping to make safe and effective treatments more accessible to fish and fish culturists in need.  For More Information 

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Brought to you by the Aquatic Animal Drug Approval Partnership Program 4050 Bridger Canyon Road Bozeman, MT 59715