GMPs for Compounders

Pharmacy compounding has become an important means of providing specialized drug products for patients for whom commercially available drug products are not appropriate. Compounding operations may take place in an institutional setting (e.g., hospital, nursing home, etc.), a 503 A or B compounding pharmacy or a conventional pharmacy. Because compounded drug products have not undergone the FDA review and approval process, they have an increased potential to present a risk to the patients who take them. Typically, pharmacists do not receive extensive academic training in compounding operations and the FDA requirements governing compounding, and why these requirements exist. These requirements are intended to ensure that compounded products are safe and effective. There have been numerous inspections of compounding operations which have resulted in adverse regulatory findings (FDA-483 observations and Warning Letters). A number of recalls of compounded drug products have occurred, often due to lack of assurance of sterility.

This training course will provide an overview of the FDA regulatory oversight process, and will discuss FDA’s regulations and guidances which govern the compounding of drug products, especially in outsourcing (503B) operations. The training course will include a review and analysis of actual FDA citations found during inspections of compounding operations and will provide insights into how to avoid adverse regulatory findings and how to respond to them should they occur.

1. Describe FDA’s role and mission and how they accomplish it
2. Explain FDA’s GMP requirements and the special requirements for compounded drug products
3. Illustrate how the FDA requirements help ensure compounded drug products which are safe and effective
4. Recognize how poor compounding practices can impact the quality of compounded drug products
5. Analyze FDA regulatory findings and prepare an action plan to respond to them