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Compliance Outlook: RF Microneedling, Compounded Drugs, and the FDA's New Enforcement Priorities

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Manage episode 521191259 series 3005277
Content provided by Business of Aesthetics. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Business of Aesthetics or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

In this episode of the Business of Aesthetics Podcast, host Don Adeesha is joined by Sara Shikhman and Samara Bell of Langea Law to discuss the seismic shift in the regulatory landscape as we approach 2026. With the FDA moving from a reactive stance to proactive enforcement, the attorneys explain why compliance can no longer be an afterthought, specifically highlighting the new federal scrutiny on RF microneedling devices and compounded GLP-1 medications.

Sara and Samara break down the dangerous misconception that popular treatments like RF microneedling are merely "cosmetic add-ons". They clarify that these are medical procedures requiring strict medical oversight and scope of practice, warning that the recent wave of FDA warning letters is a direct result of thousands of patient complaints regarding burns and scarring. They urge practice owners to abandon "one-size-fits-all" consent forms and manufacturer-provided protocols, advocating instead for procedure-specific legal documentation to protect against liability.

From a business perspective, the conversation frames compliance as a critical driver of valuation. Samara warns that in the world of mergers and acquisitions, buyers are increasingly walking away from "fixer-upper" practices with poor legal structures or unlicensed activity. The duo provides actionable advice on fortifying supply chains for biologics and hiring the correct talent, arguing that the cost difference between hiring an RN versus an esthetician is a small price to pay to avoid catastrophic legal exposure and ensure a "turnkey" exit.

  continue reading

261 episodes

Artwork
iconShare
 
Manage episode 521191259 series 3005277
Content provided by Business of Aesthetics. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Business of Aesthetics or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

In this episode of the Business of Aesthetics Podcast, host Don Adeesha is joined by Sara Shikhman and Samara Bell of Langea Law to discuss the seismic shift in the regulatory landscape as we approach 2026. With the FDA moving from a reactive stance to proactive enforcement, the attorneys explain why compliance can no longer be an afterthought, specifically highlighting the new federal scrutiny on RF microneedling devices and compounded GLP-1 medications.

Sara and Samara break down the dangerous misconception that popular treatments like RF microneedling are merely "cosmetic add-ons". They clarify that these are medical procedures requiring strict medical oversight and scope of practice, warning that the recent wave of FDA warning letters is a direct result of thousands of patient complaints regarding burns and scarring. They urge practice owners to abandon "one-size-fits-all" consent forms and manufacturer-provided protocols, advocating instead for procedure-specific legal documentation to protect against liability.

From a business perspective, the conversation frames compliance as a critical driver of valuation. Samara warns that in the world of mergers and acquisitions, buyers are increasingly walking away from "fixer-upper" practices with poor legal structures or unlicensed activity. The duo provides actionable advice on fortifying supply chains for biologics and hiring the correct talent, arguing that the cost difference between hiring an RN versus an esthetician is a small price to pay to avoid catastrophic legal exposure and ensure a "turnkey" exit.

  continue reading

261 episodes

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