Nick Capman talks with Jesse Gillikan, President of cGMP Validation, about the challenges compounding pharmacies face with GMP compliance in 2025. After helping over 100 pharmacies navigate FDA regulations since the 2013 Drug Quality and Security Act, Jesse shares candid insights about this industry transformation.The conversation reveals how compounders have moved from resistance to acceptance of GMP requirements, though major hurdles persist. For 503B facilities, the primary challenge isn't knowledge but cost, particularly testing expenses that might be manageable for pharmaceutical giants making millions of units but become prohibitive for compounders producing just thousands.Jesse highlights practical space constraints, with many facilities not designed for GMP manufacturing. He recommends dedicating one-third of facility space to clean operations and another third to compliant warehousing, which targets many smaller operations that struggle to achieve.Jesse also sheds light on validation has shifted from qualifying individual technicians to validating entire processes, requiring completely new approaches to media fills and documentation. Despite these challenges, Jesse notes the industry's impressive information sharing and collaborative spirit.When discussing FDA inspections, Jesse emphasizes the importance of thorough deviation management — a common citation area. He also addresses the FDA shortage list volatility, sharing how clients invested in automated filling lines for GLP-1 products only to have those drugs removed from the list, creating significant business disruption.Jesse maintains that while compliance is non-negotiable, the FDA genuinely wants compounders to succeed. His practical advice focuses on risk-based prioritization, industry collaboration, and maintaining open communication with regulators._____The FDA Group connects compounding pharmacies with specialized consultants who understand the unique challenges of 503B compliance. Our experts provide practical solutions that balance regulatory requirements with business viability – from GMP implementation and environmental monitoring to documentation systems and FDA inspection support. Visit https://www.thefdagroup.com/ for more information.