by Steve Buckner
Compounding represents the act of any changing of a Food and Drug Administration-approved drug product beyond what the product’s label specifies. And the practice of compounding is needed in veterinary medicine to provide individualized medication for specific patients with special needs not met by FDA-approved drug products.
Such manipulation could feature mixing, diluting, concentrating, flavoring or changing a drug’s dosage form to meet a specific patient’s needs. Compounding can be achieved in several ways:
- mixing two injectable drugs in the same syringe;
- creating an oral suspension from crushed tablets or an injectable solution;
- adding flavoring to a commercially available drug;
- creating a transdermal gel for a drug usually taken through different routes; and
- mixing two solutions for instilling into the ear.
The compounding of veterinary drugs should only be done based on a licensed veterinary prescription and to meet the medical needs of a specific patient.
Sometimes, the compounding of drugs can offer effective care for treating painful or life-threatening conditions in animal patients.
But if compounding is done incorrectly or inappropriately, compounded drugs can lead to prolonged treatment; situations such as treatment failure; liability; or enforcement action by federal or state authorities.
In brief, compounding should be used based on a licensed practitioner’s prescription and only to meet the medical needs of a specific patient.
Two items come to the fore involving compounding rules: compounding from FDA-approved drug products, and compounding from bulk drug substances. It’s legal to compound drugs from FDA-approved drug products, as long as FDA’s Extralabel Drug Use Rules and all state rules are followed.
For the record, Missouri has state laws and regulations that permit veterinary offices to administer compounded products but specifically prohibits them from dispensing or reselling products compounded by a pharmacy.
Kansas does not have laws or regulations addressing compounding.
FDA also has a Compliance Policy Guide that elaborates about how it regulates compounding for animals and what activities it defers to states. The FDA typically defers day-to-day regulation of compounding by veterinarians and pharmacists to state authorities.
Compounding from bulk drug substances represents more intricate issues. The FDA claims it has jurisdiction to bar any compounding from bulk items, but generally concedes that veterinarians sometimes need to use preparations compounded from these ingredients.
Compounded drugs are not the same as a generic drugs, which are non-brand-name version of a drug (and are FDA-approved). When a drug is compounded, the new drug no longer acts in the same manner as the approved drug. Compounding may cause changes in stability, bioavailability, metabolism and elimination of the drug.
Non-food animals may need compounding when approved drugs need to be altered to treat the patient. An example would be a cat that will not take a pill. In this case, a veterinarian might need to have the product compounded into a liquid form so the cat can be treated.
Compounding rules are much more stringent when treating a food-producing animal. Using a compounded drug in food animals is only reserved for times when there are absolutely no other choice for treating that animal’s medical condition and when safe use of that animal for human food purposes can be predicted following discontinuation of the drug. Be sure to refer to the FDA’s Compliance Policy Guide.
