In this episode of DarshanTalks, host and attorney-pharmacist Darshan Kulkarni deconstructs the legal "scorched-earth" offensive currently reshaping the weight loss drug industry. Following the February 2026 announcement that the GLP-1 shortage is officially resolved, the "Golden Age" for compounders has vanished overnight, leaving companies like Hims & Hers in the crosshairs of both the FDA and Novo Nordisk.
Darshan takes us from the tragic "ghost" of the 2012 NECC fungal meningitis outbreak to the modern-day "Compounding Wild West." We explore the crucial differences between Section 503A and 503B pharmacies and why adding Vitamin B12 to a patented molecule isn't the "customization" compounders claim it is.
Key topics include:
- The NECC Legacy: How a 2012 tragedy created the Drug Quality and Security Act (DQSA) and why the FDA is using it to end the mass-marketing of copycat drugs.The Science of the "Bluff": Why "not adulterated" does not mean "safe and effective" under the FD&C Act.Novo Nordisk vs. Hims & Hers: The billion-dollar patent battle and why the DOJ is now getting involved.The Shortage Shield: What happens to telehealth platforms the moment the FDA "Shortage" flag disappears.
Don't let your healthcare be decided by an Instagram ad. Understand the intersection of biochemistry and federal law to protect your health and your practice.
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