The Days of OTC Antibiotics Are Numbered

 

By Terry Smith

Written to make people aware of FDA changes

Information in this article was obtained from various web-sites dealing with GFI #263

 

        When the Food and Drug Administration (FDA) started  implementing Guidance for Industry #213 or the Veterinary Feed Directive (VFD) in 2017, it was focused on veterinary oversight of medically important antibiotics administered to livestock via feed and/or water. This  left a significant loophole for those products that were available over-the-counter (OTC). On June 11, 2021, FDA published Guidance for Industry #263 which allowed them to close this loophole by removing all remaining medically important antibiotics from OTC status.

       The rationale behind Guidance for Industry #263 is: “Any antibiotic use can contribute to antibiotic resistance, so it's important to avoid unnecessary or inappropriate uses of antibiotics. GFI #263 puts the responsibility for the use of medically important antibiotics into the hands of veterinarians, who are trained to understand not only when these medications are needed, but also what is the appropriate drug, dose, duration, and administration method to resolve infection and protect animal health and our food supply. The veterinarian's expertise is critical to ensuring the responsible use of antibiotics in animals.”

        Once this change is made, these important drugs can only be used in animals under the supervision of a licensed veterinarian, even if the animals are not intended for food production. From pet dogs and cats to backyard poultry, and from pet rabbits and pigs to large livestock, the same restrictions apply. All these medically important antibiotics will require a prescription from a veterinarian to be purchased and used.

        When Guidance #263 was published on June 11, 2021, drug manufacturers had a two-year period to make label changes and come into compliance with the guidance. It recommended that manufacturers of medically important antimicrobial drugs that continued to be available OTC and were approved for use in companion animals and food producing animals, regardless of how the medication was administered, to voluntarily bring these products under veterinary oversight or prescription marketing status. These product labels will now contain the prescription (Rx) statement, "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."  Products with the RX label can only be purchased with a prescription even if they are available before the June 11, 2023 date.

        All products covered under Guidance #263 will be removed from OTC availability by June 11, 2023. It is expected is that OCT products will disappear from store shelves as manufacturers finalize label changes and refine their marketing and distribution channels to assure compliance with prescription requirements.

        The FDA Center for Veterinary Medicine CVM will not object if OTC-labeled products that entered distribution channels before June 11, 2023, continue to be sold and used until such products have been depleted as long as the expiration date is good. Timelines for depletion may vary but should be consistent with normal sales volume and expiration dates for a given product. 

       When the VFD was put in place in 2017, some suppliers no longer stocked antibiotics and declined to offer products as they unable to meet the legal burden of acting as a “Pharmacy” which required them to review veterinary authorized prescriptions and track refills of those prescription products. Under Guidance # 263, licensed suppliers who continue to stock products with the Rx label  will only being able to sell to someone has a veterinary prescription.

       

Medications transitioning to Rx by June 11, 2023

· Oxytetracycline

· Sulfisoxazole

· Oxytetracycline, Polymyxin B

· Sulfamethazine

· Sulfabromomethazine

· Erythromycin

· Tylosin

· Sulfadimethoxine

· Sulfomyxin

· Sulfachlorpyridazine

· Spectinomycin

· Lincomycin

· Chlortetracycline

· Penicillin G Procaine, Novobiocin

· Dihydrostreptomycin, Penicillin G Procaine

· Tetracycline

· Penicillin G Procaine

· Dihydrostreptomycin

· Penicillin G Benzathine, Penicillin G Procaine

· Gentamicin

· Cephapirin

· Cephapirin Benzathine

 

        These antibiotics are not being removed from the market, but are being brought under veterinary oversight in order to combat overuse/misuse due to OTC access.   Guidance # 263 affects only medically important antibiotic products. Antiparasiticides, injectable and oral nutritional supplements, oral pro/prebiotics and topical non-antibiotic treatments will not be affected and will remain available OTC. 

        Farmers and breeders who already have a VCPR in place and purchase their animal health products from their veterinary office or distributors under an existing prescription system, will notice little change in their ability to obtain antibiotics. Farmers and breeders who don’t consult a veterinarian on a regular basis will need to establish a valid VCPR prior to purchasing these products as they start to disappear from OTC access. The definition of a valid VCPR may vary from state to state so check with the Animal Health Department in your state.