FDA Signals Tougher Approach to Animal Drug Compounding


James A. Boiani, a Member of the Firm, and John S. Linehan, an Associate, in the Health Care and Life Sciences practice, in the firm's Washington, DC, office, authored an article in Law360, titled “FDA Signals Tougher Approach to Animal Drug Compounding.” (Read the full version — subscription required.)

Following is an excerpt:

On May 18, 2015, the U.S. Food and Drug Administration withdrew its 2003 Compliance Policy Guide — Section 608.400, Compounding of Drugs for Use in Animals and signaled new plans to constrain animal drug compounding in its Draft Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Drug Substances. The draft guidance suggests that a dramatic shift in the FDA’s enforcement approach may be underway and provides insight into the FDA’s enforcement priorities and its interpretation of the applicable regulatory regime. Stakeholders have until Aug. 17, 2015, to submit comments that could influence the final guidance and policies adopted by the agency.

The draft guidance states that, like human drug compounding, the FDA aims to ensure that state-regulated traditional compounding of animal drugs is permitted only in response to prescriptions for individually identified patients. This conflicts with laws in several states that currently authorize the practice of “office use” compounding, in which animal drugs are compounded in advance of receiving patient-specific prescriptions. In addition, the FDA encourages sterile animal drug compounders to register as “outsourcing facilities” — a category of federally regulated entities that was established through enactment of the Drug Quality and Security Act of 2013 and has been utilized for human drug compounding facilities.

This article is based on an Epstein Becker Green Health Care and Life Sciences Client Alert, “FDA Signals Restrictive Regulatory Approach in Draft Guidance on Animal Drug Compounding,” authored by Mr. Boiani and Mr. Linehan.