Live eLearning - PDA 739 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.

This live, virtual 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. Analyze FDA regulatory findings and prepare an action plan to respond to them