Known as Guidance for Industry #263, the Food and Drug Administration (FDA) has released a recommended process for voluntarily bringing remaining approved animal drugs containing antimicrobials of human medical importance under the oversight of licensed veterinarians by changing the approved marketing status from over-the-counter (OTC) to prescription.

The guidance document outlines a new process for authorizing the use of these antimicrobials to treat animals, including livestock, equine, and companion animals. Owners will be required to obtain a prescription from a veterinarian before accessing antimicrobial drugs considered medically important to human health in forms such as injectables and boluses for their animals.

The change is expected to take effect June 11, 2023. Labels of OTC antimicrobials that are considered medically important to human health will be required to include the following: “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian,” and the purchaser must have a prescription or drug order to buy it. Existing inventory of OTC-labeled products that are already in distribution may continue to be sold.

Farmers can prepare by:

• Establishing a veterinary-client-patient relationship (if one does not already exist):
  • A bona fide veterinary-client-patient relationship (VCPR) is one in which a veterinarian has assumed the responsibility for making medical judgements regarding the health of an animal and providing medical treatment to an animal.
• Talking to their veterinarian to have a plan in place for securing antimicrobial products when needed, including when a veterinary visit is not feasible or considered necessary by the veterinarian.
• Becoming familiar with antimicrobial drugs impacted by the change:
  • Not every product will be moved to prescription-only status. For a full list of affected drugs, visit FDA’s website.
  • Examples of products moving to prescription only (source University of Missouri Extension; full list available here):
    • Oxytetracyclines
      • Liquamycin Injectable, Noromycin 300 LA, Bio-Mycin 200, Agrimycin 200, Terramycin Scours Tablets, OXY 500 Calf Bolus
    • Penicillins (Penicillin G procaine, penicillin G benzathine)
      • Dura-biotic, Pro-Pen-G, Combi-Pen 48, Masti-Clear, Go-Dry, Albadry Plus Suspension
    • Sulfa-based (Sulfadimethoxine, sulfamethazine)
      • Di-Methox Injection 40%, SulfaMed, Albon, Sustain III Bolus
    • Tylosin
      • Tylan 50, Tylan 200
    • Cephapirin, cephapirin benzathine
      • ToDAY, ToMORROW
    • Lincomycin
      • Lincomix 100 Injectable, Lincomix 300 Injectable, LincoMed 100, LincoMed 300
    • Gentamicin
      • Garasol Solution, Garaosol Injection, Gentamicin Piglet Injection

Helpful links:

• Guidance for Industry #263 (full document)
• FAQs for Farmers and Ranchers
• Full list of antibiotics affected  
• Virginia VCPR definition
• Using Medically Important Antimicrobials in Bees-Questions and Answers