Making Sure Medicines are Safe to Use
The use of drugs approved by the U.S. Food and Drug Administration gives veterinarians and animal owners confidence that the drug is safe and will be effective.
Sometimes, however, a veterinarian needs a pharmacist to change a property of a drug in order to best treat an animal. For example, a pharmacist may create a liquid formulation of an approved animal drug that was previously only made in tablet form or may change the concentration (amount of drug per volume) so that a pet owner can more easily measure the current dose for a tiny pet. Animal medicine compounding is the customized manipulation of an approved drug to meet the health needs of a particular patient. Examples of compounding include:
- Mixing two injectable drugs
- Preparing a paste or suspension from crushed tablets
- Adding flavoring to a drug
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Compounding is clearly defined by the FDA’s Extra-Label Drug Use policies, and any deviation from those policies is considered illegal.
Veterinary drugs should only be compounded based on a licensed veterinarian’s prescription, and to meet the medical needs of a specific patient. It is not legal to make animal drugs from bulk substances for sale to the general pet population. Unfortunately, illegally compounded medicines are sometimes promoted to veterinarians under the guise of compounding. This puts animals at risk and undermines the drug approval process. The marketers of these illegal products attempt to circumvent the drug approval process and/or offer products that are less expensive than those that are FDA-approved.
The federal policy that regulates compounding is FDA Compliance Policy Guide 608.400 “Compounding of Drugs for Use in Animals.”
Compounding is Permitted When…
Under federal law, compounding is permitted when:
- The health of an animal is threatened or suffering or death may result from failure to treat.
- It is performed by a licensed veterinarian or licensed pharmacist on order of a veterinarian within the scope of professional practice.
- There is no approved animal or human drug that, when used as labeled or in conformity with the extra label drug use regulations, will, in the available dosage form and concentration, appropriately treat the condition diagnosed.
- Preparations are compounded from FDA-approved animal or human drugs for individual patients.
Compounding is Illegal When…
Animal drug compounding from bulk active, or raw pharmaceutical ingredients is not legal. Nevertheless, FDA does exert what is called “enforcement discretion” to allow some animal drug compounding from bulk substances. This is generally necessary when there is a need for a specific active ingredient and there is no approved human or animal drug with that active ingredient. The animal health industry also recognizes and supports these limited exceptions to the law in the interest of patient health.
In recent years, however, compounding pharmacists have performed drug manufacturing under the guise of compounding. Using bulk substances, they have compounded preparations in large quantities and advertised them as cheap alternatives to approved drugs. They have compounded drugs that mimic those of FDA-approved drug products. This widespread illegal activity has resulted in animal deaths – including 21 polo horses in Florida in 2009 – and has undercut the FDA approval process. It is difficult to justify the expense of millions of dollars and many years to get a drug approved by FDA only to find compounders will circumvent the drug approval process and make it from bulk so they can sell it cheaply.
This activity places veterinarians, and more importantly their patients, at some risk. Animal drugs compounded from bulk substances are illegal and do not come with the proof of safety and efficacy that approved drugs do. Both published research and FDA inspection reports have documented inconsistencies in potency and amounts of active ingredient in compounded products as well as lack of sterility testing of these products.