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Posted: 10/30/2023
Farmer holding antibiotic near cow

Animal Antibiotic Changes are Coming in 2023. How Will They Impact Access to Everyday Medications?

How to navigate the GFI #263 Animal Antibiotic Changes...what is affected and what isn't?

The U.S. Food and Drug Administration (FDA) announced in June 2021 that all medically important antimicrobials for food-producing animals and pets will move from over-the-counter (OTC) to prescription (Rx) effective June 2023. This transition is the FDA's Guidance for Industry (GFI) #263.

This change, GFI #263, impacts animal antibiotic products that contain the following:

  • Oxytetracycline
  • Penicillin
  • Sulfa-based antibiotics (sulfadimethoxine and sulfamethazine)
  • Tylosin
  • Cephapirin and Cephapirin Benzathine
  • Swine medications Lincomycin and Gentamicin
These antibiotics are used to help treat or prevent illness caused by specific bacterial agents, these ARE the products moving to Rx.

The GFI #263 change does NOT include preventative vaccines commonly used in your farm's vaccination protocols. Animal vaccines are still available OTC (without a prescription).

In addition, GFI #263 does NOT include dewormers, implants or vitamins. These are still available OTC (without a prescription).

GFI #263 will have a major impact on how the affected antibiotics are used and acquired by livestock producers. However, you can be assured that we are here to help you with answers to your questions about the affected products and how to continue to obtain them.

Why Are Animal Antibiotics Going Prescription? How Will These Changes Affect Your Animals?

In 2018, the FDA laid out its 5-year action plan for supporting antimicrobial supervision by veterinarians. The plan aims to address antimicrobial resistance by only using medically necessary drugs assessed as necessary to treat, control or prevent certain diseases. A licensed veterinarian must determine the necessity, but you won’t be required to order the drugs from the vet directly. You will, however, need to have a Veterinary-Client-Patient Relationship (VCPR) with a veterinarian in order to obtain a valid prescription for a specific drug.

Popular Products Will Require Prescriptions

After months of a penicillin shortage that created supply challenges of their own, producers are hit with this GFI #263 change that impacts access to antibiotic therapy for animals. Yes, it's definitely going to take some time to adjust to this change since these products have been used for so long as OTC meds to treat pneumonia, mastitis or shipping fever in cattle or sheep...but we are in this together and we will get through it together.

Antibiotic Product Availability After June 11, 2023

Good News Flash! OTC labeled antibiotics that we have in stock at PBS Animal Health ARE AVAILABLE for purchase OTC until we run out of OTC labeled inventory! This means you may not need an animal prescription from your veterinarian just yet. However, if you do not have a VCPR with a veterinarian, do not delay in obtaining one.

Once current OTC antibiotic product inventories are depleted and labeling changes occur, a veterinarian's prescription WILL BE REQUIRED, GFI #263, to purchase these antibiotic products. Be sure to check out our Animal Prescription Ordering Service online or ask us for details on how to place your Rx order. Simply tell us your veterinarian's name and phone number, and our pharmacist will call your vet for you; and take care of the rest.

Below, you will find an updated list (as of June 1, 2023), sorted by active ingredient, of items we carry at PBS Animal Health that will require a prescription, GFI #263, June 11, 2023, unless, of course, we still have OTC Antibiotics with OTC labeling in stock and ready to ship!

For fast and easy ordering, check our website often for OTC antibiotic product availability and expiration dates on these items; or simply contact our Customer Care Specialists to get timely availability details on products; and help you navigate through these changes.

Most common question we have been asked: "Can I still buy OTC labeled antibiotics after June 11, 2023?" Yes...if we have OTC labeled antibiotic product in stock and available for sale, you can purchase it, and it will be promptly shipped to your door. Order now!

This list is as complete and current as possible. It is not an exhaustive list as there may be other affected items we do not carry. We've also created a printable version here for easy reference.

Rx Products

Antibiotics Moving to Rx

Cephapirin Based Active Ingredient

Gentamicin Active Ingredient

Lincomycin HCl Active Ingredient

Novobiocin Sodium Active Ingredient

Oxytetracycline Active Ingredient

Penicillin Based Active Ingredient

Spectinomycin Active Ingredient

Sulfonamides / Sulfa Based Active Ingredients

Tylosin Active Ingredient

NOTE: Some of these products have been pretty tough to find due to penicillin shortages, but that's a separate issue from the OTC antibiotic status change. When you find OTC labeled penicillin in stock, you can order it if it has an OTC label (and within expiration date). Once OTC labeled penicillin inventory is no longer available/depeleted and the newly Rx labeled penicillin is in the distribution channel, a veterinarian's prescription will be required to purchase Rx labeled penicillin. Questions? Just ask us, we are here to help.

Filling Prescriptions the Easy Way

Once OTC antibiotics transition to Rx, there will some extra time and effort involved in getting a prescription from your vet on these orders in the future, but, we do have some good news: PBS Animal Health’s Pharmacy Process streamlines the prescription filling for you. Our pharmacists will even call your veterinarian to get your prescription, check on refills and keep orders moving to ensure you get the animal Rx medications you need in a timely manner.


As inventory of OTC labeled antibiotics is depleted and these items change to Rx status, please know that you can count on us and our certified Safe Pharmacy. We are a trusted source and have sold animal prescription medications for decades; and we are committed to serving you and the ever changing needs of the animal health industry.

Stay Informed and Keep Stocked with PBS Animal Health

All your top brands, favorite OTC and prescription medication brands are available right here at PBS Animal Health, year-round. And as products like OTC antibiotics make the move to all-prescription status, we are here and will still be here helping guide and serve you for many years to come. You can count on us to offer the high-quality products you know, trust and use; backed by top-notch personal service, prompt fast shipping and great every day low prices to save you money! You deserve the best and we are here to give you our best...YOU ARE PRIORITY #1 with us! Visit our website often or call us at +1 (800) 321-0235. We look forward to serving you now and always!

FAQs for Upcoming Animal Antibiotic Changes, GFI #263

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