AVMA Answers

What is compounding?

Simply put, compounding is the traditional, prescription-driven preparation, by a pharmacist or veterinarian, of a custom medication for a particular patient.

Veterinarians may find it necessary to use compounded drugs to treat a nonfood animal patient when no approved drug exists for the animal's diagnosed condition or when approved drugs need to be modified. This may involve adding flavoring, diluting the drugs, or changing the form of medications from tablet to suspension to sufficiently treat the patient.

In contrast, compounding drugs to circumvent the drug approval process and mass market products that have been produced with little or no verified quality control or manufacturing standards is clearly outside the bounds of traditional compounding. Such manufacturing of unapproved drugs might be considered "piracy" if the product mimics an FDA-approved animal or human drug. Veterinarians might have seen businesses that offer their version of a popular, approved, brand-name drug at lower prices than the approved product. Such a product is not custom compounded for a particular patient upon a veterinarian's prescription, and is illegal.

Veterinarians can prescribe and administer pharmacist-compounded drugs to patients in the office, but redispensing of these products by the veterinarian to a client is generally prohibited.

Why is piracy bad?

Piracy is bad for several reasons:

• It denies the patient treatment with an approved drug proven to be safe, effective, pure, potent, stable, and made under FDA-mandated "good manufacturing practices."
  
• It exposes the patient to substances that have not been proven safe and effective.
  
• It exposes parties involved in piracy to unnecessary liability.
  
• It undermines the incentive for pharmaceutical companies to market new animal drugs, which means veterinarians will have fewer approved therapies to use.
   
• It may involve the use of bulk ingredients. These bulk ingredients often are produced in developing countries that may lack a well-regulated chemical industry. These ingredients may not be of the same quality as the bulk ingredients that the FDA requires drug manufacturers to use.
  
• These bulk ingredients may come from countries where there is bioterrorism.
   
• It is illegal.

Does the FDA's recently released Compliance Policy Guide (CPG) on compounding for animals disallow all compounding from bulk pharmaceutical ingredients?

The fact is, compounding from bulk pharmaceutical ingredients for animals has been illegal for many years and continues to be illegal.

Although illegal, the FDA Center for Veterinary Medicine acknowledges that in some areas of veterinary practice, there may be a medical need for compounding from bulk ingredients. For instance, there may be no approved drugs to treat certain conditions. The current CPG contains an appendix of bulk drugs that the FDA-CVM has determined are needed by veterinarians. Normally, the FDA will not take action if materials are compounded from those bulk drugs. This is known as regulatory discretion.

What the FDA is concerned about is drug piracy. The new FDA guide makes it clear that piracy will not be tolerated.

What is the AVMA's position on the CPG?

The AVMA's Council on Biologic and Therapeutic Agents is talking with the FDA on the subject of the CPG. The council supports most aspects of the CPG, namely, that piracy is clearly denounced. The council would like the FDA to more clearly state, however, that regulatory discretion will be used for veterinarians who prescribe and pharmacists who prepare medically necessary drugs compounded from bulk ingredients for specific nonfood animals, when no such approved drugs exist.

At the current time, COBTA has not recommended to the AVMA Executive Board that the FDA-CVM be encouraged to withdraw the CPG, because there are advantages and disadvantages to this strategy. The primary advantage is that revoking the CPG may speed up necessary changes. The primary disadvantage is that the FDA would temporarily lose an enforcement tool for prosecuting drug pirates.

Is there anything else I should know?

Yes. Federal, extralabel drug use regulations specifically permit compounding from approved drugs when a veterinarian believes there is a need to alter the approved drug to adequately medicate a nonfood animal. So, veterinarians who are contemplating flavoring, diluting or changing the dosage form of an approved drug are unaffected by the discussions pertaining to bulk drugs and the CPG. For more information, view the CPG online at the FDA's Web site, www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg608-400.html.