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FDA Publishes Guidance to Limit Production Uses of Antimicrobials

The FDA is issuing three documents guiding veterinarians, farmers and animal producers on the judicious use of medically important antibiotics in food-producing animals by eliminating production uses and targeting their use to only address diseases and health problems.

• A final guidance for industry (Guidance #209), The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, that recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs.
• A draft guidance (Draft Guidance #213), open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels; adding, where appropriate, scientifically-supported disease prevention, control, and treatment uses; and changing the marketing status to include veterinary oversight.
• A draft proposed Veterinary Feed Directive regulation, open for public comment, that outlines ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient.

FDA is currently accepting comments on Draft Guidance #213 and on the VFD document. Submit comments on these documents by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

Now online:

The May and June 2012 issue of the Journal of Swine Health and Production is now online. [May 7, 2012]

The AASV and National Pork Board have published revised guidelines (PDF) for on-farm euthanasia of swine. [March, 2009]

Researchers at the University of Minnesota have compiled the Biosecurity Protocols for the Prevention of Spread of PRRSV. Development of this manual was funded in part through a grant from the AASV Foundation. [February 17, 2009]

Animal Drugs @ FDA -- FDA database of all approved veterinary drugs. This web site replaces FDA's "Database of Approved Animal Drug Products," or Green Book, and is updated monthly. The application allows users to search for detailed descriptions of all FDA-approved animal drugs.

Topical products for wound treatment -- There are currently no products approved by FDA for the topical treatment of wounds specifically in swine. However, two OTC products (Trypzyme Aerosol and Granulex Aerosol Spray) are labeled for use in animals and, according to FDA, can be used by producers for wound treatment without veterinary prescription. This spreadsheet provides a list of those two products as well as the other FDA-approved topical products that could be used in an extra-label manner under AMDUCA.

American Association of Swine Veterinarians
830 26th Street
Perry, IA 50220-2328
USA

Phone: (+1) 515-465-5255
Fax: (+1) 515-465-3832
Email: aasv@aasv.org