There are some changes coming to the availability of over-the-counter antibiotics that the livestock producer will want to familiarize themselves with soon in order to make sure they are properly prepared before the changes are implemented in 2023.
What is being implemented is the Food and Drug Administration’s guidance for industry (GFI) No. 263 titled “Recommendations for sponsors of medically important antimicrobial drugs approved for use in animals to voluntarily bring under veterinary oversight all products that continue to be available as over-the-counter.”
The reason for this change is to make sure that there is veterinary oversight of medically important drugs to human medicine and to address the growing resistance of antimicrobials in human medicine by multiple bacteria that have become resistant to this antibiotics.
The rationale for this is described in the September 2018 document from the FDA’s Center for Veterinary Medicine document, Supporting Antimicrobial Stewardship in Veterinary Settings Goals for Fiscal Years 2019-2023.
As follows: “Antimicrobial resistance is a national and worldwide public health challenge.
1. Have been successfully and widely used in human and veterinary medicine for more than 60 years. When used judiciously, antimicrobials can effectively fight bacterial infections. Their use and misuse, however, can promote the development of antimicrobial-resistant bacteria. When bacteria develop resistance to an antimicrobial drug, that drug may be less effective in fighting infection caused by that bacteria.
It is critical that we apply a One Health approach to address this important public health concern, including implementing good antimicrobial stewardship practices in human healthcare and veterinary settings to slow the development of resistance and extend the useful life of antimicrobials. One Health is the integrative effort of multiple disciplines working locally, nationally, and globally to attain optimal health for people, animals, and the environment.
2. The focus of this plan is on actions being taken by the Food and Drug Administration’s Center for Veterinary Medicine and other stakeholders to support antimicrobial stewardship in veterinary settings.”
Key to understanding
I recognize that further regulations that fall on livestock producers can be onerous and a potential burden. The key to understanding this change is knowing that while this affects livestock (and companion animals), the real reason for this change is to ensure the continued effectiveness of antibiotics for human use to treat disease.
This is an extension of the same plan that gave us the Veterinary Feed Directive in 2017. Back in July of 2021, I wrote about the importance of having a Veterinary-Client-Patient relationship in place.
That relationship, the foundation of how we care for our patients and clients, was shown to be critical during the COVID pandemic and will play as important a role when the new antibiotic access regulations go into effect in 2023.
If you have questions about how the antibiotic changes will affect you and your livestock production, reach out to your vet to learn more now so that you have a complete understanding of the upcoming changes.
Sources: Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available as Over-the-Counter; Guidance for Industry; Availability federalregister.gov/documents/2021/06/11/2021-12297/recommendations-for-sponsors-of-medically-important-antimicrobial-drugs-approved-for-use-in-animals Supporting Antimicrobial Stewardship in Veterinary Settings, US Food and Drug Administration, fda.gov/media/115776/download FDA Regulation of Animal Drugs, US Food and Drug Administration, fda.gov/animal-veterinary/resources-you/fda-regulation-animal-drugs.
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