What does an equine owner or veterinarian do when there is no FDA-approved, commercially available animal or human drug that is available in the dosage form and concentration needed to treat an equine patient? A compounded drug may be the answer.
According to Dr. S. D. Stanley at the School of Veterinary Medicine, University of California at Davis, a suitable drug can be compounded by a veterinarian or a pharmacist upon receipt of a veterinarian's prescription. To legally prescribe or prepare a compounded product, a valid vaterinarian-client-patient relationship must exist.
In addition, these rules apply:
- There must be no FDA-approved drug commercially available in the dosage form and concentration needed to appropriately treat the equine patient,
- The product must be compounded by a licensed veterinarian or a licensed pharmacist on the order of a veterinarian within the practice of veterinary medicine,
- Veterinarians must comply with all aspects of the federal extra-label drug use regulations including recordkeeping and labeling requirements.
With the ability to reach a number of consumers via the internet, many commercial websites have started specializing in veterinary compounding, often offering subjective treatments based on testimonials and compounded therapies that are not permitted by the criteria established for compounded drugs.
Currently, the FDA does not have the resources to enforce these regulations; however veterinarians and horse owners should be aware that abuse of these regulations can result in legal action.
Equine practitioners and horse owners are put in a position of having to evaluate the integrity of the compounding pharmacy, as well as the quality and consistency of the pharmaceuticals, they product. In some instances loose oversight has allowed negligent compounders to prepare products from unregulated raw materials with no quality standards.
Some of these raw materials are chemical grade bulk products that were never intended for use in the preparation of legitmate pharmaceuticals. Some coupounding pharmacies distribute medication without a valid prescription.
Compounding of drugs to meet the needs of equines is a necessary and beneficial component of veterinary practice and FDA Compliance Policy Guides permit licensed practitioners to manufacture, prepare, propagate, compound or process drugs during the regular course of business, as long as the compounded product is not a new animal drug.
Horse owners and veterinarians should be aware that:
- It is illegal to compound a specific product when there is an approved drug form of that specific product available except to make a different dosing form,
- It is illegal to mark up prices on compounded drugs,
- If a veterinarian compounds a product, he/she assumes liability for any adverse effects or efficacy failure,
- Pharmacies are not required to carry product liability insurance, but drug manufacturers are required to carry that insurance,
- It is illegal to have a drug compounded in order to obtain the drug at a lower price.
All horse owners should be wary about unsubstantiated claims that a specialty compounded drug will work wonders for equines or treat conditions that should be treated only by a knowledgeable veterinarian. If a compounded drug is needed, your veterinarian has the expertise to make sure that the best treatment available is being used and that any drugs or medications are legally prescribed and prepared.