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

Short version

• After demand for GLP‑1 drugs (semaglutide, tirzepatide, etc.) exploded, many compounding pharmacies began making “compounded GLP‑1” products. The FDA’s position is that compounding pharmacies may not make unapproved copies of FDA‑approved drugs that are already commercially available. Starting in 2023 and continuing into 2024 the agency (and some state boards) warned and took enforcement actions against compounding operations that were compounding semaglutide/tirzepatide as essentially copies of brand products without a legitimate, patient‑specific medical need.
• That meant many compounding shops stopped offering these products, some received warning letters, and a number of services that marketed mass‑produced compounded GLP‑1s shut down or changed practices.
• Who can legally provide GLP‑1 therapy now: manufacturers’ FDA‑approved products prescribed by a clinician (e.g., Novo Nordisk’s semaglutide products and Eli Lilly’s tirzepatide), state‑licensed pharmacies filling patient‑specific prescriptions, and compounding operations that strictly follow the law (503A patient‑specific compounding or properly registered/inspected 503B outsourcing facilities that remain compliant). But compounding of “copies” of approved GLP‑1 drugs for mass distribution is what the FDA has been stopping.

More detail and what to do

1. Why the FDA acted

• Federal law (FD&C Act sections 503A/503B) allows some compounding but prohibits making essentially the same product as an FDA‑approved drug when that product is commercially available, except in narrow circumstances. The FDA concluded many compounded GLP‑1 offerings were unlawful copies or mass‑produced without patient‑specific prescriptions, so it issued warnings and worked with state boards to halt those operations.

1. Current legal/safe options

• FDA‑approved brand drugs prescribed by clinicians are the safest, legal route. Major FDA‑approved GLP‑1s include:
  • Novo Nordisk: Ozempic (semaglutide for diabetes), Wegovy (semaglutide for weight loss), Rybelsus (oral semaglutide)
  • Eli Lilly: Mounjaro (tirzepatide for diabetes), Zepbound (tirzepatide for weight loss)
  • Trulicity (dulaglutide) and others from established manufacturers
• State‑licensed pharmacies may legally fill a clinician’s prescription for these brand drugs or — in limited, lawful situations — compound a patient‑specific preparation.
• 503B outsourcing facilities that are registered with FDA and compliant with regulations may also legally produce certain compounded products, but they must still avoid producing unlawful copies of approved drugs.

1. How to verify a supplier is operating legally and safely

• Prefer prescriptions for FDA‑approved products dispensed by major retail/specialty pharmacies (CVS, Walgreens, major specialty/mail‑order pharmacies) or your health system’s pharmacy.
• If using a compounding pharmacy, ask:
  • Do you operate under 503A (state‑licensed, patient‑specific) or 503B (FDA‑registered outsourcing)? Can you provide your registration/license?
  • Will the drug be made only for a patient‑specific prescription?
  • Can you provide a Certificate of Analysis (COA) and sterility testing results?
  • Are you accredited (look for reputable accreditation and the state board of pharmacy license)?
• Check:
  • FDA’s list of registered 503B outsourcing facilities and the FDA Warning Letters database for enforcement history.
  • Your state board of pharmacy for complaints or disciplinary actions.

1. Practical recommendation (brands/services)

• Get an evaluation from your primary care doctor, endocrinologist, or an established weight‑management clinic and ask for an FDA‑approved prescription.
• Use established pharmacies and specialty pharmacies that routinely handle injectable biologics (chain or health‑system pharmacies, specialty pharmacies used by insurers).
• Prefer Novo Nordisk or Eli Lilly branded products when appropriate — these are regulated, FDA‑approved medicines with known dosing, safety data, and supply chains.

If you want, tell me:

• whether you’re asking as a patient (wanting a prescription) or checking a specific compounding company, and I can help you evaluate a particular pharmacy (license/registration checks, how to read an FDA warning letter, etc.).