Animal Drug Compounding: American Health Institute's Position

 

What is Animal Drug Compounding?

Compounding is the mixing of drugs to fit the unique needs of a patient. AHI and AVMA define it as “customized manipulation of an approved drug or drugs by a veterinarian, or by a pharmacist upon the prescription of a veterinarian, to meet the needs of a particular patient.” Examples can include:

• Mixing two injectable drugs;
• Preparing a paste or suspension from crushed tablets; and
• Adding flavoring to a drug.

Is Animal Drug Compounding Legal?

Animal drug compounding is legal only in very specific circumstances described in FDA regulation. According to the FDA, legal compounding is not the making a drug from bulk or raw active ingredients. Compounding should not be used to circumvent the drug approval process or to sell a specific drug at a cost below what is approved by the FDA. Consumers and animal health practitioners should be aware that products are being promoted to veterinarians under the guise of compounding that do not fit within the narrow legal definition, and present a threat to the health of the animal.

FDA Regulation of Animal Drug Compounding

The FDA Regulations and Compliance Policy Guide 608.400, “Compounding of Drugs for Use in Animals,” describe specific circumstances under which compounding is permitted.

For pets and food-producing animals, compounding is permitted when:

• A valid veterinarian-client-patient relationship exists.
• The health of an animal is threatened, or suffering or death may result from failure to treat.
• Compounding is performed by a licensed veterinarian or a licensed pharmacist upon the 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 diagnosed condition.
• Preparations are compounded from FDA-approved animal or human drugs. The regulations do not permit compounding from bulk (raw pharmaceutical ingredient) drugs.

Specifically for food-producing animals, compounding is not permitted when:

• An approved animal drug can be used in place of the compounding.
• The results in violative food residue or any residue may present a risk to public health.
• The drug in question is listed on the food animals prohibited list.

Veterinarians must comply with all aspects of the federal extra-label drug use regulations, including record-keeping and labeling requirements. In addition to federal laws, all relevant state laws relating to the compounding of drugs for use in animals must be followed. Adequate procedures and processes must be created to ensure that the compounded product is safe and effective.

Compounding from Unapproved Substances

Federal regulations describe specific circumstances under which veterinarians – or pharmacists acting upon veterinarians’ prescriptions – are legally permitted to compound drugs for extra-label use in animals. Under these regulations, compounding of drugs for non-food animals may only be performed using FDA-approved animal or human drug products, and only when there is no approved animal or human drug product available in the relevant dosage, form and concentration to appropriately treat the diagnosed condition. Compounding from human drugs for use in food animals is not allowed if an approved animal drug can be utilized.

Veterinarians may occasionally face situations where they diagnose conditions for which no FDA-approved product is available for use to relieve the animal’s suffering or prevent the animal’s death. Because there are so many different diseases and so many different species of animals, it is not possible to have an approved drug for every condition a veterinarian may be asked to treat. Although the FDA considers compounding a violation of the Federal Food, Drug and Cosmetic Act, it acknowledges the need for compounding from bulk active or raw ingredients within certain areas of veterinary practice.

How to Identify an FDA-Approved Animal Drug Product

FDA-approved animal drug products can be identified by the six-digit New Animal Drug Application (NADA) number for brand-name drug products, or the six-digit Abbreviated New Animal Drug

Application (ANADA) number for generic drug products. The NADA or ANADA number and the statement “Approved by FDA” can also be found on the drug product’s label or package insert. Additionally, the FDA’s online databases, Animal Drugs @ FDA and the FDA Orange Book contain lists of approved animal and human drug products. The presence of a National Drug Code (NDC) number on a product label does not confer FDA approval.

What is Considered Inappropriate Drug Compounding?

Examples of inappropriate compounding pharmacy practices can include:

• Compounded preparations that mimic those of FDA-approved drug products:

Beware of pharmacies that purport to sell compounded preparations that are the same as, or functionally similar to, commercially available FDA-approved products. Often these products are marketed as cheaper alternatives to the approved drug. The FDA has not identified price as a legitimate reason for prescribing a compounded preparation. Legitimate compounding is prescription-driven and predicated upon the need to customize a preparation to meet the individual needs of the animal.

• Manufacturing under the guise of compounding:

The use of commercial-scale equipment and the preparation of large quantities of compounded products in anticipation of receiving orders.

• Promotion and advertising of unapproved new animal drugs:

The FDA considers products compounded from bulk active ingredients to be unapproved new animal drugs.

• Wholesale distribution of compounded preparations:

It is not legal for compounded preparations to be developed in large quantities and sold to third-party vendors (including veterinarians and distribution companies) or wholesalers.

AHI’s Role

Veterinarians occasionally use compounded preparations to meet a specific animal’s medical need. AHI, the American Veterinary Distributors Association (AVDA), and the American Veterinary Medical Association (AVMA) are working together to help veterinarians understand FDA requirements for compounding preparations for veterinary use, and the distinction between drug products approved by the FDA and compounded preparations.

For more information on animal drug compounding, view the veterinary compounding guidelines developed by AHI, AVDA, and AVMA.

 

Article is found here. AHI also has a wonderful brochure that can be found here.