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 (see sidebar).
ELDU of a 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. (Additional conditions must be met for legal ELDU. See Title 21 Part 530 in the Code of Federal Regulations.)
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 use of sulfadimethoxine, sulfabromomethazine and sulfaethoxypyridazine)
- Phenylbutazone in female dairy cattle 20 months of age or older
- Cephalosporin (excluding cephapirin) for cattle, swine, chickens and turkeys IF any of these conditions apply:
- 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 used in both people and animals, with pork producers most familiar with 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 use of cephalosporin antibiotics in animals.FDA’s Center for Veterinary Medicine issued an order in 2012 prohibiting extralabel use of cephalosporin drugs (not including cephapirin) for disease prevention in cattle, swine, chickens and turkeys. Extralabel use of cephalosporin drugs is allowed for treatment or control of disease conditions not on the label, but only when:
- The drug is already approved for use in the species and animal production class, and
- Only when administered at dose levels, frequencies, durations and routes of administration as stated on the label for the species and production class of the animal.
*Note: This information has been updated from the January Pork Checkoff Report Newsletter.