Animal Antibiotic Changes Are Coming In 2023

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 change impacts any product that contains the following:

  • Oxytetracycline
  • Penicillin
  • Sulfa-based antibiotics (sulfadimethoxine and sulfamethazine)
  • Tylosin
  • Cephapirin and Cephapirin Benzathine
  • Swine medications Lincomycin and Gentamicin

It’s a big deal that’s making waves across the industry, so we want to make sure everyone understands the change and has time to prepare for it.

Changes That 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. Licensed veterinarians must determine the necessity, but you won’t have to order the prescriptions from the vet directly. You will, however, need to establish a Veterinary-Client-Patient Relationship (VCPR) if certain animals aren’t examined regularly.

Popular Products Will Require Prescriptions

After months of a penicillin shortage has created supply challenges of its own, soon producers will get hit with this change that once again impacts access to antibiotic therapy for animals. When you’ve used them for so long as OTC meds to treat pneumonia or shipping fever in your cattle or sheep, it’s going to take some getting used to.

Here’s an updated list (as of 11/15/22), sorted by active ingredient, of items we carry at PBS Animal Health that will require prescriptions starting in June 2023. We have tried to make the list as complete as possible and it includes the products we are aware of at this time. 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.

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 are tough to find in stock because of the penicillin shortage, but that’s a separate issue from the OTC status change. When you find them in stock, you can still order them through May 2023. Some customers mistakenly believe they need prescriptions now, but that’s not the case. The law won’t go into effect until June.