One of the requirements included within the Drug Quality & Security Act of 2013 was for the Government Accountability Office (GAO) to conduct analysis of animal compounding with specific focus on the extent to which that practice occurs, FDA's approach to regulating compounded animal drugs, and the benefits and risks of drug compounding for animals. The report was released yesterday and is entitled: DRUG COMPOUNDING FOR ANIMALS: FDA Could Improve Oversight with Better Information and Guidance (GAO 15-671). IACP staff were interviewed at length last summer on pharmacists' services, issues and concerns with veterinary compounding and our input was included in the GAO report.
Some of the report's conclusions include:
• Drugs compounded for animals offer certain medical benefits but also pose risks of causing harm or being ineffective.
• States have primarily exercised responsibility for pharmacies that compound drugs for animals, the states and not FDA generally review pharmacy compounding processes.
• The extent to which drugs are compounded for animals is unknown because the information FDA and states collect is not aggregated or comprehensive for various reasons.
• FDA does not know the extent to which compounded drugs are associated with adverse events, in part because the form used to voluntarily report such events does not ask if a compounded drug was involved.
Please click here to read the full GAO report.