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The U.S. Food and Drug Administration’s (FDA) new regulations regarding on-farm use of medically important (to human health) antibiotics were effective Jan. 1, but it’s important to note that extralabel drug use (ELDU) rules remained in place.
Under the Animal Medicinal Drug Use Clarification Act of 1994, veterinarians can prescribe extralabel uses of approved animal and human drugs when the health of an animal is threatened, or when suffering or death may result from failure to treat animals. So, these drugs can be used for conditions not listed on the label, but only through a prescription from a veterinarian.
Extralabel use of medicated feeds, including medicated feed containing a veterinary feed directive (VFD) drug or a combination VFD drug, remains illegal. This includes feeding pigs a VFD feed for a length of time different than specified on the label, feeding VFD feed formulated with a drug level different than specified on the label and feeding VFD feed to an animal species different than specified on the label.
ELDU use of injectable drugs is allowed under a valid Veterinary Client Patient Relationship (VCPR) with limits. For example, under a VCPR, a producer with veterinary oversight or a veterinarian could use injectable drugs to treat a joint infection in a sow despite not being a listed use on the label.
Criteria for a ELDU:
- A valid VCPR is a prerequisite for all ELDU.
- Only a veterinarian can determine that ELDU is needed and can prescribe or dispense a medication in an extralabel way.
- A veterinarian must direct or supervise ELDU in an animal.
- ELDU rules only apply to FDA-approved animal and human drugs.
- ELDU is intended for prevention, treatment and control purposes only when an animal’s health is threatened. ELDU of drugs for production use and/or in feed is not approved.
- ELDU is not permitted if it results in an illegal food residue or any residue that may present a risk to public health.
- A veterinarian must not pursue use of certain FDA-prohibited drugs in food-producing animals.
This post was brought to you by the National Pork Board, a Checkoff-funded research, promotion and consumer information projects and for communicating with pork producers and the public. For more industry news, visit pork.org.