Animal & Veterinary

Timeline of FDA Action on Antimicrobial Resistance

  • 1980’s - All new medically important antibiotics have been approved with veterinary oversight.
  • 1996 - National Antimicrobial Resistance Monitoring System (NARMS) established.
  • 1997 - Extralabel use of fluoroquinolones and glycopeptides prohibited (FR Doc No: 97-13677). Note: While other countries approved the glycopeptide, avoparcin, for use in food-producing animals, this class was never approved or marketed for such uses in the U.S.
  • 2003 - FDA established industry guidance for assessing antimicrobial resistance risks as part of the drug approval process (Guidance for Industry #152 [PDF – 290KB], FR Doc No: 03-27113).
  • 2005 - Withdrawal of approval of fluoroquinolones for use in poultry (FR Doc No: 05-15223 [Final Rule], Docket ID: FDA-2000-N-0109). Note: fluoroquinolones are still used in some other countries for poultry; see Withdrawal of Enrofloxacin for Poultry for more information.
  • 2005 - FDA incorporated a step-wise approach to evaluate the effect of antimicrobial residues on human intestinal flora into the pre-approval safety assessment of agents for food-producing animals; one of the end points of concern is the increase of antimicrobial resistant bacteria. (Guidance for Industry #159 [PDF – 533KB], Docket ID: FDA-2003-D-0433).
  • 2010 - Initiated judicious use effort with issuance of draft Guidance #209 (Docket ID: FDA-2010-D-0094).
  • 2010 – First publication of annual summary report of antimicrobials sold for use in food-producing animals (ADUFA Reports).
  • 2012 - Prohibited certain extralabel uses of cephalosporins (FR Doc No: 2012-35 [Final Rule]; Docket ID: FDA-2008-N-0326). Note: 4th generation cephalosporins have never been approved for use in food-producing animals in the U.S.
  • 2012 - published final Guidance for Industry #209 (PDF – 251KB), draft Guidance #213 (Docket ID: FDA-2011-D-0889), and draft Veterinary Feed Directive (VFD) proposed rule (Docket ID: FDA-2010-N-0155).
  • 2012 & 2013 Solicited public input on data collection and reporting related to antimicrobial use in food-producing animals. In response to the comments received on reporting, FDA proposed additional tables to enhance annual summary reports of antimicrobials sold for use in food-producing animals (Docket ID: FDA-2012-N-0447).
  • 2013 - Published final Guidance for Industry #213 (PDF – 115KB) and proposed VFD rule (Docket ID: FDA-2010-N-0155).
  • 2013 - FDA revised its animal sampling structure in NARMS to get more representative animal data on all four target organisms under surveillance.
  • 2013 - FDA partnered with three State public health laboratories to collect more data on resistance in bacteria from retail meats.
  • 2014 - FDA is working with USDA and CDC to explore mechanisms for gathering representative antibiotic use information for food producing animals.
  • NARMS partners at CDC and USDA have published over 150 peer-reviewed research articles examining the nature and magnitude of antimicrobial resistance hazards associated with antibiotic use in food producing animals.
  • 2014 - First publication of annual summary report of antimicrobials sold for use in food-producing animals in expanded format (ADUFA Reports).
  • 2015 - FDA issued the Veterinary Feed Directive (VFD) final rule, which lays out what veterinarians must do when they need to authorize the use of these products in feed to protect the animals they serve. This is another element to FDA’s overall judicious use strategy, one that recognizes the important role that veterinarians fulfill as guardians of animal health and preservers of judicious use of medically important antimicrobials.
  • 2016 – Implementation of GFI #213 is anticipated to be completed.

 

Page Last Updated: 02/26/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English