Reinstate regulatory discretion for treating nonfood animals
Posted Sep. 1, 2004
The AVMA has requested that the Food and Drug Administration amend its policy on drug compounding for animals so veterinarians have the discretion to compound bulk pharmaceutical ingredients to produce a medically necessary product that is otherwise unavailable for a specific nonfood animal patient.
The FDA has long held that compounding from bulk ingredients is illegal. The department has, however, exercised regulatory discretion for many years with respect to veterinarians and pharmacists compounding drugs from bulk ingredients for nonfood animals.
But in 2003, when the FDA Center for Veterinary Medicine issued an updated Compliance Policy Guide on compounding drugs used for animals, the agency narrowed that regulatory discretion, which had been available since 1996.
The International Academy of Compounding Pharmacists responded with a lobbying campaign to get the FDA to rescind the current CPG and reinstate the former policy (see JAVMA, June 1, 2004).
Although recognizing that the CPG isn't ideal, the AVMA, on advice from its Council on Biologic and Therapeutic Agents, would rather see the policy amended than withdrawn because much of it is valuable.
In a June 30 letter to the FDA, AVMA Executive Vice President Bruce W. Little said the AVMA understands that the current CPG was written to crack down on the illegal use of bulk pharmaceutical ingredients.
Drug compounding from bulk ingredients is of particular concern when it is done for food animals, involves mass-produced and wholesale preparations, and copies commercially available, FDA-approved products.
The activities undermine the FDA drug approval system, expose many animals to unapproved drugs, and potentially threaten animal and public health. The AVMA readily supports enforcement against such acts, Dr. Little wrote.
Nevertheless, the AVMA considers the CPG to need improvement because veterinarians and pharmacists aren't afforded the regulatory discretion to compound unavailable but medically necessary drugs from bulk ingredients for specific nonfood animal patients.
While legal compounding can only begin with approved drugs, the AVMA believes it is medically necessary for veterinarians to prescribe bulk pharmaceutical ingredients in limited circumstances, Dr. Little wrote.
Although the current CPG makes some mention of regulatory discretion, appendix A does not cover many medically necessary situations for nonfood animals.
There are situations in which the need for such therapy is great and the risk is small, Dr. Little wrote. The compounded drug is administered under professional supervision, and public health and animal safety are not threatened.
"There are not enough FDA-approved drugs to treat the numerous nonfood species under the veterinary profession's care," Dr. Little wrote. "In certain limited circumstances, compounding drugs from bulk pharmaceutical ingredients for nonfood animals is a necessary part of relieving pain and suffering."
There are any number of circumstances when an approved drug may not be a treatment option. For instance, the drug could be temporarily unavailable, the concentration of the active ingredient in the drug could be too low to produce the needed compounded preparation in a practical dosing volume, or compounding from the approved drug could negatively affect the quality of the preparation.
The letter goes on to identify two general sets of circumstances in which the AVMA believes compounding from bulk pharmaceutical ingredients may be necessary: the approved drug is not commercially available, or the needed compounded preparation cannot be made from the approved drug.
Dr. Little identified several elements the AVMA believes are necessary for the legitimate use of preparations compounded from bulk pharmaceutical ingredients. They are as follows:
- Requested discretion is limited to nonfood animals.
- Compounding must be prescription-driven by a licensed veterinarian within a veterinarian-client-patient relationship.
- Compounded preparations should not be wholesaled.
- Compounded preparations should not mimic commercially available, FDA-approved drugs.
- A licensed veterinarian may compound or direct a licensed pharmacist to compound.
- Drugs should be compounded for a specific patient or for "in-office use" where allowed by state law.
- There must be a legitimate medical need for the customized preparation.
- There must be no approved animal drug or human drug that used as labeled, in an extralabel manner, or compounded that can adequately treat the condition.
- Veterinarians and pharmacists should comply with all applicable laws and regulations governing their practice, incorporating regulatory discretion.
- Bulk pharmaceutical ingredients must be purchased from a state-registered, if applicable, and FDA registered source that is subject to FDA Good Manufacturing Practices inspections and provides accompanying certificates of analysis for the ingredients.
- Bulk pharmaceutical ingredients must meet or exceed the appropriate compendia standards.
- Veterinarians and clients should be informed when compounded products are made from bulk ingredients.
- Pharmacists should provide copies of the certificates of analysis and compendia standards for bulk pharmaceutical ingredients to veterinarians, upon request.
Otherwise, the AVMA believes drugs should be compounded only from approved drugs. Animal health and patient medication compliance are legitimate reasons for compounding from bulk pharmaceutical ingredients, whereas cost is not.
Dr. Little concluded, "It is our sincere hope that AVMA has helped distinguish between illegal acts of large scale that may cause harm versus individual, medically legitimate circumstances that would benefit from regulatory discretion.
"We urge that the FDA-CVM amend the CPG to acknowledge regulatory discretion for veterinarian supervised, legitimate compounding from bulk pharmaceutical ingredients that relieves the pain and suffering of nonfood animals."