The FDA has published a new draft antibiotic guidance for industry (GFI) #263 this week. The guidance aims to establish a process to voluntarily bring the remaining medically important drugs under the oversight of veterinarians by switching their status from over the counter to prescription.
The director of the FDA’s Centre for Veterinary Medicine, Steven Solomon stated, “The use of medically important antimicrobial drugs in animals should be under the oversight of licensed veterinarians that have the scientific and clinical training and knowledge to ensure that these important drugs are used judiciously”.
This new guidance has been an update to the guidance which was released in 2017 called industry 213. The guidance has previously worked to address many issues with over-the-counter, medically important antimicrobials used in livestock production.
When Karin Hoelzer, Senior Officer in health programs spoke to the online website FeedNavigator she stated, “The FDA brought most of the antibiotics that are important for human medicine under veterinary oversight in 2017. They then saw a dramatic decrease in the sales of antibiotics the following year which is encouraging to see”.
It is initially thought that the proposed changes in the new guidance are a small percentage of the actual products available. However, there is a fairly big proportion of these drugs sold in large quantities which is said to be the reason for the addition of these drugs.
The next stage of the process is finalisation of the guidance when pharmaceutical companies can weigh in, within three months of the guidance being finalised, on whether or not they are voluntarily willing to change the designation of their products.
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To read more about this story visit: https://www.feednavigator.com/Article/2019/09/27/FDA-releases-new-draft-guidance-for-antibiotic-use-with-livestock