Med Spas Under the Microscope – The View From The FDA Practice Management & Operations

As regulatory scrutiny of medical aesthetics grows, med spas are increasingly under the microscope. As a practice owner and provider, it can be hard to stay informed in an ever-changing landscape. This session explores how the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) are approaching oversight of med spa specifically from a Federal regulatory and enforcement perspective, including an overview of the first regulatory inspection conducted, and first form 483 issued, at a MedSpa by FDA. Senior Regulatory Counsel from the FDA will break down Federal requirements for med spa owners with respect to prescription drugs and compounded medications. Madison Dini, General Counsel for Lynch Regenerative Medicine will discuss the regulatory landscape of PDGF and clarify the legal boundaries that govern manufacturers.