Verbatim response from Perplexity
The FDA has ended its exemption for compounding GLP-1 drugs (like semaglutide and tirzepatide) once the U.S. shortages resolved in early 2025, and it is now aggressively cracking down on mass-marketed compounded versions that lack FDA approval, citing over 1,150 adverse events and at least 10 deaths linked to these products. The agency has sent warning letters to 30 telehealth firms, restricted the use of GLP-1 active pharmaceutical ingredients (APIs) in unapproved compounds, and established a “green list” import alert to block unsafe APIs from entering the U.S. market.
Who is still operating legally?
Only pharmacies and telehealth providers that:
- Offer customized doses or unique formulations that are not “essentially copies” of FDA-approved drugs (e.g., non-standard doses, different delivery forms),
- Use FDA-vetted APIs from the green list of compliant foreign manufacturers,
- Do not claim their compounded products are equivalent to, generic versions of, or clinically proven to match FDA-approved drugs.
Major companies like Hims & Hers have already removed their compounded GLP-1 pills from the market in response to the FDA’s February 2026 enforcement announcement. Other firms arguing their products are lawful due to “customization” remain under scrutiny, but no specific telehealth company is currently confirmed as fully compliant without ongoing legal challenges. For safe, legal options, consumers should rely on FDA-approved GLP-1 medications (e.g., Ozempic, Wegovy, Mounjaro, Zepbound) prescribed through licensed healthcare providers.
For personalized weight-loss treatment, consult a provider who can prescribe FDA-approved GLP-1 agonists or, if medically necessary, a legitimately customized compounded version that meets all FDA criteria—avoiding any service that markets compounded drugs as “the same as” approved ones.