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Update from Syndel

* 4x1 Gallon Parasite-S (Formalin)* - FDA approved 37% formaldehyde in 4 * 1 gallon cases.                                                       
AND…
*5 Gallon 35% Perox-Aid®* - 35% hydrogen peroxide solution in 5 gallon carboys.

Both products are FDA approved for aquaculture!

For more information please contact:
(800) 283-5292 or info@syndel.com

www.syndel.com

 

Animal Drugs at FDA' Searchable Database has been Updated
by the FDA Center for Veterinary Medicine

The October 25, 2016 FDA CVM Update, titled "Search Approved Animal Drugs on the Redesigned Animal Drugs at FDA", is posted at http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm526350.htm

The Animal Drugs at FDA website is available at http://animaldrugsatfda.fda.gov/

Questions about the redesigned Animal Drugs at FDA website may be directed to CVM by e-mail at CVMGreenBookandAnimalDrug@FDA.HHS.gov

Summary:

In our continued effort to improve transparency and public access to information about approved animal drugs, the U.S. Food and Drug Administration’s Center for Veterinary Medicine is launching Phase III of the redesigned Animal Drugs @ FDA website.

As before, the new Animal Drugs at FDA website provides a searchable database for veterinarians, pet owners, animal producers and others to get information about approved animal drugs by application number, sponsor name, proprietary name, ingredient, application status, dosage form, route of administration, indication and species.

With the completion of Phase 3 on December 6, 2017, Animal Drugs at FDA will now display animal drug information using the FDA Structured Product Labeling (SPL) style sheet. This enhancement will permit CVM to post, approved animal drug SPL files in the future. Once posted, approved animal drug SPL files will provide additional information that includes all content of labeling and images of labeling components. Additional enhancements that were completed in this phase include:

* Adding of the marketing status to the search results table to better distinguish between approved and voluntarily withdrawn applications
* Updating the Advance Search Logic to always use “and” searches instead of “or” searches when entering multiple search criteria

Additional enhancements made on November 9, 2017, include:

* Creation of an FOI Summary display page listed by Application number
* Creation of an Environmental Documents page with all Environmental Assessment and Findings of No Significant Impact documents listed by chemical entities
* Creation of a Non-Steroidal Anti-Inflammatory Drugs (NSAID) labeling page which displays package insert and client information sheets for some NSAID products

For more information about the redesigned Animal Drugs at FDA, contact CVMGreenBookandAnimalDrug@fda.hhs.gov .

 

NEW Antibiotic Resistance Interactive Research Tool
U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) has launched an interactive research tool called Resistome Tracker which is "... one of the first publicly available tools to provide visually informative displays of antibiotic resistance genes in bacteria. It is designed mainly for public health officials, academics and researchers who are using new genomics technologies to track and treat infectious diseases.

Resistome Tracker's interactive interface allows users to customize visualizations by antibiotic drug class, compare resistance genes across different sources, identify new resistance genes, and map selected resistance genes to geographic region ... The tool also provides alerts about new resistance traits as they emerge in a region or source to provide early warning on emergent trends ...

Currently, Resistome Tracker is focused on antibiotic resistance genes in Salmonella ... Future iterations of the tool will include data on other microorganisms such as E. coli and Campylobacter as well as additional gene categories such as serotype, sequence type and virulence genes ..."

Source: November 14, 2017 FDA CVM Update, titled "FDA Launches Resistome Tracker, an Interactive Research and Data Visualization Tool for Antibiotic Resistance Genes", posted at
http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm584389.htm

Rest of report and links

 

GAO Report

Imported Seafood Safety - Preventing Unsafe Drug Residues

The US Government Accountability Office (GAO) has issued a report which found that "... FDA could strengthen its efforts to ensure the safety of imported seafood from unsafe drug residues by pursuing agreements with other countries requiring that they test seafood exported to the United States for unsafe drug residues ... FDA has used country agreements with respect to pathogen hazards in molluscan shellfish intended for export to the United States. According to FDA officials, it might be worthwhile for the agency to pursue agreements with some countries, but FDA would have to carefully consider a number of factors in determining which countries would be appropriate, which it has not yet done ..." 

The September 15, 2017 GAO Report is posted at  http://www.gao.gov/products/GAO-17-443

 

 from AADAP Updates

Catching Up With The AADAP Team

Looking for a little light reading and an opportunity to find out what the AADAP research team has been doing? Check out the recently published AADAP Drug Research Information Bulletins that will soon be posted on the AADAP website. And if you just can’t wait for them to get posted, contact Jim Bowker (jim_bowker@fws.gov) for a reprint.

Bowker, J.D., M. Bowman, N. Wandelear, J. T. Trushenski, and David Burbank. 2017. Effectiveness of AQUI-S®20E (10% eugenol) to Lightly Sedate Rainbow Trout, Cutthroat Trout, and Chinook Salmon. USFWS AADAP DRIB 52.

Owens, C., J. Bowker, and N. Wandelear. 2017. Use of AQUI-S®20E, Tricaine-STM, and AQUACALMTM to Sedate Rainbow Trout to Handleable. USFWS AADAP DRIB 53.

Bowker, J. N. Wandelear, and C. Silbernagel. 2017. Use of AQUI-S®20E to Sedate California Yellowtail and White Seabass to handleable. USFWS AADAP DRIB 54.

Wandelear, N, J. D. Bowker, and G. Eckerlin. 2017. Efficacy of Terramycin 200 for Fish (Oxytetracycline dihydrate) to Control Mortality in Tiger Musky Due to Columnaris. USFWS DRIB 55.

 

Dr. Alistair Dove presentation hosted by University of Miami/Miller School of Medicine

"The Ocean: Your Friend for Life"
CLICK HERE

 

from AADAP Updates

FDA Clarifies Policy Guideline on Extralabel Use of Veterinary

Feed Directive Drugs

 One of the highlights of the 23rd Annual Aquaculture Drug Approval Coordination Workshop held August 1-3, 2017 in Bozeman, MT, was the series of presentations and panel discussion of Veterinary Feed Directives (VFDs) led by Dr. Mike Murphy (CVM Office of the Director, Science Policy Team). 

The VFD-themed session was organized because there has been considerable confusion over extra-label use of VFD drugs as described by the Compliance Policy Guideline (CPG) released in December 2016. Although such use is illegal, Dr. Murphy pointed to the sentence in the Guideline (CPG 615.115; page 5) that states "In general, the Agency [FDA] will not recommend or initiate enforcement action against the veterinarian, animal producer, feed mill, or other distributor when extralabel use is consistent with this document."

Compliance Policy Guideline 611.115 is for Minor Species only and can be viewed on this web page.

The document contains useful information and veterinarians will probably are probably very familiar with what is described in the (1) General Considerations and (2) Veterinarian Considerations sections. 

What may be of most interest in this document is the Veterinary Feed Directive (VFD) Medicated Feed subsection that covers what a veterinarian must do when authorizing the extralabel use of a VFD medicated feed for a minor species (i.e., fish). 

It should also be pointed out that CPG 615.115 can be rescinded. Therefore, there needs to be a concerted effort to ensure compliance with extralabel use of VFD medicated feeds. In addition, it would be well advised, to let the sponsor, AADAP, and CVM know when extralabel use occurs so we can more strategically coordinate research to expand the approved label accordingly. 

For more information on veterinarian responsibilities when authorizing extralabel use of a VFD medicated feed for fish visitFDA Revises CPG on Extralabel Use of Medicated Feeds for Minor Species.

 

USDA ARS News Release

A Big Step towards Reducing Strep in Farm-Raised Tilapia

Researchers with the USDA Agricultural Research Service (ARS) Aquatic Animal Health Research Unit in Auburn, Alabama and industry partners have developed tilapia that are resistant to both Streptococcus iniae and Streptococcus agalactiae, the "... main culprits [that cause] tilapia farmers lose about $1 billion annually due to streptococcosis ..."

The researchers showed that "... selective breeding for disease resistance is a promising alternative [to] vaccines and antibiotics ... They found that crosses between the best performing fish were more resistant to the bacteria than other tilapia ... This milestone research paves the way for developing more lines of tilapia with resistance to other pathogens ... Data shows that the improved tilapia lines will save an average-size farm nearly $635,000 a year annually ..."

USDA ARS News Release is posted at
http://www.ars.usda.gov/news-events/news/research-news/2017/a-big-step-towards-reducing-strep-in-farm-raised-tilapia/

 

AVMA applauds bill that would increase access to vet care in rural areas

WASHINGTON — The AVMA welcomes the introduction of S. 487, the Veterinary Medicine Loan Repayment Program Enhancement Act (VMLRPEA), by Senators Mike Crapo (R-Idaho) and Debbie Stabenow (D-Mich.). This bill will increase funding available for grants through the Veterinary Medicine Loan Repayment Program (VMLRP), which implements loan forgiveness for veterinarians who commit to serving in federally designated veterinary shortage areas. Representatives Adrian Smith (R-Neb.) and Ron Kind (D-Wis.) introduced companion legislation, H.R. 1268, in the U.S. House of Representatives. Rest of article

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Updated "Guide to Using, Drugs, Biologics and Other Chemicals in Aquaculture" Now Available

All aquaculture operations have occasional demand for drugs, biologics, and other chemicals.  It is critical that these products are utilized in a manner that is consistent with their intended use, best management practices, and relevant rules and regulations.  A companion treatment calculator is also available in Excel formats.

The Guide was developed by the American Fisheries Society, Fish Culture Section, Working Group on Aquaculture Drugs, Chemicals, and Biologics, as a comprehensive introduction to the use of regulated products in aquaculture and a resource for fish culturists, fish health specialists, veterinarians, and others.

Click here to download the Guide and Treatment Calculator.

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Veterinary Feed Directive

Information on the new animal drug regulations to implement the Veterinary Feed Directive (VFD), there are links to 5 sites with more information. Click here

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FDA Searchable Database for Animal Drugs FDA Center for Veterinary Medicine 

Animal Drugs @ FDA Searchable Database has been Redesigned by the Center for Veterinary Medicine - The database allows "... veterinarians, pet owners, animal producers and others to get information about approved animal drugs by application number, sponsor name, proprietary name, ingredient, application status, dosage form, route, indication and species ... When completed, the new site will also provide a “one-stop shop” for additional information related to approved animal drugs, including: Freedom of Information Summaries; Environmental Assessments; Findings of No Significant Impact; Blue Bird Labels; Green Book reports
http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm526350.htm

The Animal Drugs @ FDA website: http://animaldrugsatfda.fda.gov/

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Merck Animal Health and GlobalVetLINK have partnered to develop Aquaflor eVFD's

GlobalVetLINK website

Aquaflor eVFD’s

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NAA/NCRAC/USAS have 14 webinars available for viewing. To access these webinars, visit http://thenaa.net via your desktop computer or mobile device and select "Webinars" from the menu.
Please explore NAA’s webpages to find downloadable publications, Frequently Asked Questions (FAQs), Kids Corner, recipes, video interviews describing aquaculture sustainability and the value and benefits of seafood to human health, and a wealth of additional information. If there is a topic that is missing, please contact the NAA office at 850-216-2400 or naa@thenaa.net.

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The National Veterinary Accreditation Program (NVAP) Module #28: Significant and Emerging Viral Diseases of Carp, Koi, and Goldfish is now available online.
The link for the module is http://aast.cfsph.iastate.edu/AQDZ/index.htm.

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Don't have time to read the full article? Read the DRIB!  By Jim Bowker 

How many times have you heard about a project that was underway or you’ve seen a presentation of some really useful information, but you had to wait months or even years to see the results in print? And when was the last time you actually read an entire technical article from front to back? AADAP has developed Drug Research Information Bulletins, or DRIBs. These are 1 - 2 page manuscripts that summarize successful fish drug field effectiveness and target animal safety work. In addition, AADAP is reaching out to others who are doing fish drug work that wouldn’t normally publish in peer-review journals and encouraging them to write a DRIB which will be shared through the AADAP website. All DRIBs are reviewed by internal and external sources before posting.  

Visit the AADAP site for more than 50 AADAP published DRIBs  

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NAHMS Aquaculture Studies -Catfish

Click here

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Significant and Emerging Viral Diseases of Carp, Koi, and Goldfish

 

The National Veterinary Accreditation Program (NVAP) Module #28: Significant and Emerging Viral Diseases of Carp, Koi, and Goldfish is now available online.

The link for the module is http://aast.cfsph.iastate.edu/AQDZ/index.htm.