You may have heard about extralabel drug use (ELDU) of certain drugs over the years, but it’s never been more important to be knowledgeable about the critical role both veterinarians and producers play in keeping people and pigs healthy as it relates to proper and legal antibiotic use. Of course, only a licensed veterinarian can authorize the use of a drug in an ELDU manner and only if it is allowed by law.
Under the Animal Medicinal Drug Use Clarification Act of 1994, an ELDU is an FDA-regulated veterinary medical activity that allows veterinarians to 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. In short, producers and veterinarians can use these drugs for conditions not listed on the label, but they are only available through a prescription from a veterinarian.
As before FDA’s new antibiotic rules went into effect on Jan. 1, extralabel use of medicated feeds, including medicated feed containing a veterinary feed directive (VFD) drug or a combination VFD drug, remains illegal. Examples considered extralabel uses and therefore not permitted include:
- Feeding pigs a VFD feed for a duration of time different from what is speciﬁed on the label.
- Feeding VFD feed formulated with a drug level different from what is specified on the label.
- Feeding VFD feed to an animal species different than what is speciﬁed on the label.
Unlike medicated feeds, the use of injectable drugs in an ELDU manner remains allowable under a valid Veterinary Client Patient Relationship (VCPR), but with certain 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 it not being a listed use on the label.
Specific Criteria Must Be Followed for ELDU, Including:
- A valid VCPR is a prerequisite for all ELDU.
- Only a veterinarian can determine that ELDU is needed and can administer, 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.
Extralabel Drug Use of an FDA-Approved Drug May Be Allowed If:
- There is no approved animal drug that is labeled for such use (a specified diagnosis) or that contains the same active ingredient in the required dosage form and concentration.
- Alternatively, an approved animal drug for that species and condition exists, but a veterinarian finds, within the context of a VCPR, that the approved drug is clinically ineffective for its labeled use.
Per federal regulations, ELDU of the following drugs is prohibited in food-producing animals, regardless of whether or not the criteria for ELDU are met:
- Diethylstilbestrol (DES)
- Other nitroimidazoles
- Sulfonamide drugs in lactating dairy cattle (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine)
- Phenylbutazone in female dairy cattle 20 months of age or older
- Cephalosporin (excluding cephapirin) use in cattle, swine, chickens and turkeys
- Using cephalosporin drugs at unapproved dose levels, frequencies, durations or routes of administration is prohibited.
- Using cephalosporin drugs in cattle, swine, chickens or turkeys that are not approved for use in that species (e.g., cephalosporin drugs intended for humans or companion animals)
- Using cephalosporin drugs for disease prevention
A Special Note on Cephalosporins
Cephalosporins are a family of drugs that are used in both people and animals. The cephalosporins most pork producers are familiar with are the injectable ceftiofur-based products, such as Naxcel®, Excede® and Excenel®.
Because this class of drugs is used in human medicine, the FDA has sought to reduce the uses of cephalosporin antibiotics in animals. FDA’s Center for Veterinary Medicine issued an order in 2012 that prohibited the extralabel use of cephalosporin drugs (not including cephapirin) in cattle, swine, chickens and turkeys. Since then, these drugs can only be used strictly according to their labels, even by veterinarians. In addition, the current rules prohibit use of cephalosporin drugs to prevent disease in all food animals.As always, pork producers should create a whole-herd health plan with their veterinarians. This should include how, if needed, they will use antibiotics in any part of their farm to ensure that they are abiding by all federal regulations.