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On January 1, 2017, the world of over-the-counter (OTC) animal health antibiotics changed. This was the end of a three-year transition for manufacturers of feed grade and water-soluble antibiotics to change their product labels, removing growth promotion claims and restricting these items to veterinary oversight. Up until recently, injectable, bolus and intra-mammary antibiotic formulations did not change and were still available in your local feed store, but this is soon going to change. On September 23, 2019, the FDA issued a draft of GFI#263 (Guidance for Industry) for a 90-day comment period. Once this draft becomes final, all remaining dosage forms of antibiotics with OTC labels will change to Rx status. The current draft indicates the FDA expects no more than 2 years for companies to comply. The full list of drugs deemed important in human medicine and affected can be found in GFI#152.
As a producer or animal health supplier, what should you do? First, build a relationship with your local veterinarian. Having an established relationship with your veterinarian allows quicker access to prescription medication to treat sick animals. As the access to antibiotics becomes more limited, taking a proactive approach to animal health is increasingly important. Proper nutrition, clean facilities and reducing stress all help keep your animals healthy. Natural supplements are good alternatives and include probiotics, enzymes, and essential oils. A good vaccination program can also help prevent disease and reduce the need for treatment.
Durvet offers several alternatives for healthy animals that will continue to be available without a prescription. These products are on our website at durvet.com and are available from your local dealer or Durvet distributor.
Additional Resources:
- VFD and NGPs – Understanding What It All Means
- FDA “Injecting” New Restrictions on Antibiotic Sales
- VFD: It's Coming Like a Tidal Wave
- Antibiotic Regulations Are Changing Whether We Like It Or Not
- Moving On In a Post-Antibiotic Era
- VFD: D-Day Came on January 1, 2017
- Natural Alternatives Guide
- VFD: OTC to Script Infographic
- Durvet – Elanco VFD Info Guide
FDA Documents
- FDA Guidance for Industry (GFI) #152
- FDA Guidance for Industry (GFI) #209
- FDA Guidance for Industry (GFI) #213
- FDA Guidance for Industry (GFI) #263
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