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

ClaudevalidationCollected Aug 14, 2026, 12:23 UTC

Verbatim response from Claude

FDA & Compounded GLP-1s: What Happened

The Short Version

The FDA declared the shortages of semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound) officially over in early 2025. This means 503A and 503B compounding pharmacies lost their legal right to mass-produce these drugs.

Key deadlines:

  • Tirzepatide compounding: deadline passed March 2025
  • Semaglutide compounding: deadline passed April/May 2025

Who Is Still Operating Legally

Personalized/503A compounding is still allowed IF:

  • A licensed prescriber writes a prescription requiring a specific customization (different dose, added ingredient, etc.) for an individual patient
  • It's not mass-produced

Legitimate current options include:

  • Hims & Hers – pivoted to FDA-approved brand medications
  • Ro – now primarily offering branded Wegovy/Zepbound
  • LifeMD / Nuvation – prescribing branded versions
  • Your personal doctor prescribing brand-name drugs

⚠️ Red Flags to Avoid

  • Any telehealth company still heavily advertising cheap "compounded semaglutide" at scale is likely operating in a legal gray area or illegally

Always verify your pharmacy's licensing and ask specifically what you're receiving.

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