Regulatory Brief

 Framework for Pharmacy Compounding: State and Federal Roles

Formal Title: Docket Number [FDA–2012–N–1154] Framework for Pharmacy Compounding: State and Federal Roles. Notice of public meeting; request for comments.

Brief Description:

The Food and Drug Administration (FDA) announced the following public meeting entitled “Framework for Pharmacy Compounding: State and Federal Roles” for FDA and State representatives to share their perspectives. 

AVMA Response:

The AVMA has historically advocated for a moderate approach to compounding, balancing the need for flexibility in medically necessary situations in practice, with the need for use of FDA-approved drugs whenever feasible. As the AVMA assesses current internal policies on Compounding and Compounding from Bulk (Unapproved) Substances, the AVMA is discussing the value of state boards of pharmacy overseeing appropriate compounding under individual orders by veterinarians and the need for balance with FDA authority when such compounding is, in fact, inappropriate manufacturing.
The AVMA asserts veterinary medicine is unique in that a multitude of species with an even greater number of diseases and conditions are treated. It is important to underscore the critical importance of FDA’s approvals of new animal drugs, as it would curtail the need for compounded preparations in veterinary medicine. Approval of new animal drugs is paramount to veterinary medicine and engaging with the Agency and Congress in facilitating that process remains a high priority for the Association.
The AVMA advises its members that the use of a compounded drug should be accompanied by the same precautions followed when using an approved drug, including counseling of the client regarding potential adverse reactions and attention to the potential for unintended human or animal exposure to the drug. The AVMA also firmly believes that the decision to use a compounded drug should be driven by the veterinarian within a Veterinarian-Client-Patient Relationship (VCPR), not the pharmacist.
The AVMA contends that compounding of drugs from unapproved, or bulk, substances for use in non-food animals should be allowed through enforcement discretion in these medically-necessary circumstances. This should be permitted if such compounded products are used under the conditions for extralabel use of approved drugs, which is delineated in the regulations written to implement the Animal Medicinal Drug Use Clarification Act (AMDUCA). Such compounding from bulk substances should be allowed only if effective regulatory mechanisms are in place and implemented to assure that such compounding is patient-specific and performed only in the context of a VCPR.
Anecdotally, the AVMA understands from its volunteer leaders that the need for compounding is substantial. The AVMA believes that much of the compounding occurring in veterinary facilities is done within FDA's extralabel drug use rules, such as mixing FDA-approved injectable agents into one syringe for administration to a patient being prepared for surgery. The AVMA is aware that there are certain species and specialties which rely upon compounding from bulk ingredients more than others. These include canine, feline, equine, and exotic animal pets; animals maintained in zoos, aquaria and wildlife rehabilitation facilities; and animals within conservational facilities.
The AVMA is dedicated to continuing to educate veterinarians on federal regulations regarding compounding and does this through presentations at AVMA's annual meeting, state conferences, and other large venues. The AVMA also engages in regular dialogue with the FDA's Center for Veterinary Medicine to assist the agency in supplying resources on compounding to its members and in identifying speaking or other communication opportunities for FDA staff to reach AVMA's members. 

Background Documents: