FDA Regulatory Practice

Drug Compounding

Our attorneys have considerable experience with both human and veterinary drug compounding. We have assisted with FDA and state enforcement actions against pharmacies, appeals to third-party payers, and have provided advice to both pharmaceutical manufacturers and pharmacies on the appropriate limits of pharmacy compounding. In addition to traditional pharmacy compounding practice, we have experience with the Drug Quality and Security Act (DQSA), enacted in November 2013, which created a new type of compounding establishment under section 503B to the Food Drug & Cosmetics Act (FDCA). 503B established a new type of registration known as an “Outsourcing Facility.” Outsourcing Facilities are compounding establishments that, due to the nature of the compounding activity, are regulated by the FDA and required to adhere to requirements imposed on FDA-licensed manufacturers rather than as traditional state licensed pharmacies. Our FDA attorneys counsel clients on a wide array of legal issues related to FDA compliance, including Current Good Manufacturing Practices (CGMP) requirements, audits and inspections, FDA registration, recalls and responding to 483 inspectional observations, Warning Letters, and Untitled Letters.