In the July 3, 1996, Federal Register, FDA announced the availability of a new Compliance Policy Guide (CPG) entitled, "Compounding of Drugs for Use in Animals." The text of the CPG is included in the Federal Register announcement.

The CPG defines compounding as "any manipulation to produce a dosage form drug other than that manipulation that is provided for in the directions for use on the labeling of the approved drug product, for example, the reconstitution of a sterile powder with sterile water for injection."

The Federal Food, Drug, and Cosmetic Act (the Act) does not distinguish compounding from manufacturing or other processing of drugs for use in animals. Under the Act, compounding is limited to the preparation of drug products which do not meet the definition of new animal drugs. This restriction severely limits the compounding of animal drugs. In the absence of an approved new animal drug application (NADA), the compounding of a new animal drug from any article, including an approved or unapproved finished human or animal drug, or a bulk drug, is a violation of the Act. FDA's Center for Veterinary Medicine recognizes the medical need for compounded animal drugs extending beyond the statutory limitations. This CPG outlines criteria and boundaries for regulatory discretion in respect to the compounding of animal drugs.

When the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) goes into effect, it will allow the "extra-label" use of approved animal and human drugs. Under AMDUCA "extra-label" use, which includes compounding, will be subject to conditions specified by regulation. AMDUCA becomes effective after the promulgation of the regulations.

The new Compounding CPG states that FDA recognizes that circumstances exist when it may be necessary for a veterinarian to compound, or direct a pharmacist to compound, an article that will result in an unapproved new animal drug. There is occasionally a need to utilize drugs labeled for human use, and much less commonly, bulk drug substances, for compounding into an appropriate dosage form. The Agency will exercise regulatory discretion and ordinarily will not take regulatory action against violations of the Act resulting from the compounding of an unapproved new animal drug if the criteria described in the CPG are met, within the confines of a legitimate practice. The following general criteria apply:

• A legitimate medical need is identified (the health of animals is threatened and suffering or death would result from failure to treat the affected animals),

• There is a need for an appropriate dosage regimen for the species, age, size, or medical condition of the patient, and

• There is no marketed approved animal drug which, when used as labeled or in an extra-label manner in conformity with criteria listed in CPG 615.100 ("Extra-label Use of New Animal Drugs in Food-Producing Animals"), or human-labeled drug when used in conformity with criteria listed in CPG 608.100 ("Human-Labeled Drugs Distributed and Used in Animal Medicine"), may treat the condition diagnosed in the available dosage form, or there is some other rare extenuating circumstance. For example, the approved drug cannot be obtained in time to treat the animal(s) in a timely manner, or there is a medical need for different excipients.

The CPG lists additional specific criteria that should be met and precautions that should be observed if the above conditions are met. Among those criteria are that dispensing should be done by a licensed veterinarian or by receipt of a prescription from a licensed veterinarian by a pharmacist. Dispensing should be within the confines of a valid veterinarian-client-patient relationship. In addition, veterinarians need to take measures to ensure that when used in food-producing animals no illegal residues occur, sufficient time is assigned for drug withdrawal, and steps are taken to assure that the assigned time frames are observed. In addition, procedures should be instituted to assure that appropriate patient records for the treated animals are maintained. All drugs dispensed to the animal owner by the veterinarian or a pharmacist must bear adequate labeling information. The CPG lists a number of other criteria for the exercise of enforcement discretion.

Copies of the Compliance Policy Guide are available from the FDA Veterinarian.

A link to the text of the Federal Register announcement containing this portion of the Compliance Policy Guide is available for review or downloading on CVM's Internet Website at http://www.cvm.fda.gov/

Additional information is available from, Richard E. Geyer, Deputy Director, Office of Surveillance and Compliance, Food and Drug Administration, 7500 Standish Place, HFV-200, Rockville, MD 20855.