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What happened with the FDA and compounded GLP-1s, and who is still operating legally?

ClaudevalidationCollected Jun 30, 2026, 13:27 UTC

Verbatim response from Claude

FDA & Compounded GLP-1s: What Happened

The Key Events

The FDA declared semaglutide (Ozempic/Wegovy) no longer in shortage in early 2025, which triggered a deadline for compounding pharmacies to stop making copies. The deadlines were:

  • 503B outsourcing facilities - had until May 22, 2025 to wind down
  • 503A compounding pharmacies - had until April 22, 2025

There was significant legal fighting, with some compounders suing the FDA to extend operations.

Who Is Still Operating Legally

Legitimate ongoing options:

  • Hims & Hers - pivoted to offering personalized/combination formulations, though this is in a regulatory gray area
  • Ro - similar approach with combination formulas
  • Empower Pharmacy (503B) - was among compounders fighting the deadlines legally

The safest legal routes now:

  • Novo Nordisk's Wegovy/Ozempic through standard pharmacies
  • Eli Lilly's Zepbound/Mounjaro (tirzepatide, which had separate shortage status)

⚠️ Important Caution

The landscape is changing rapidly and some companies marketing "compounded semaglutide" now may be operating illegally. Always verify current status directly with the provider and consult your doctor.

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