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

The FDA has been actively monitoring the market for compounded versions of GLP-1 agonists like semaglutide (commonly known by brand names like Ozempic and Wegovy) and liraglutide (commonly known by brand names like Saxenda and Victoza). These medications are highly sought after for weight loss and diabetes management, leading to shortages of the branded products.

Here's a breakdown of what's been happening and who is still operating legally:

What Happened with the FDA and Compounded GLP-1s:

The core issue revolves around the FDA's stance on using certain semaglutide salts in compounded medications.

• FDA's Concern: The FDA has stated that compounded versions of semaglutide made with semaglutide sodium salt or semaglutide acetate salt, when intended for injection, are not eligible for compounding under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This means these specific compounded products cannot legally be sold to patients directly through pharmacies that rely on this exemption.
• Why the Distinction? The FDA's concern is that the semaglutide salts used in some compounded formulations are not the same as the active pharmaceutical ingredient (API) in the FDA-approved drugs Ozempic and Wegovy. They are concerned about the safety, efficacy, and quality of these compounded products when they deviate from the approved drug's formulation.
• Impact: This FDA guidance has led to many compounding pharmacies ceasing the production and sale of these specific types of compounded semaglutide products. Some pharmacies have received warning letters from the FDA.

Who is Still Operating Legally (and Important Considerations):

It's crucial to understand that "legally operating" in this context depends on several factors, including the specific ingredients used in the compounding and the state-level regulations.

1. FDA-Approved Branded Medications:

   • Ozempic (semaglutide) and Wegovy (semaglutide) by Novo Nordisk: These are the gold standard and are fully FDA-approved for their intended uses (diabetes and weight loss, respectively). They are readily available through traditional pharmacies with a valid prescription.
   • Saxenda (liraglutide) by Novo Nordisk: Also FDA-approved for weight management.
   • Mounjaro (tirzepatide) by Eli Lilly: While not technically a GLP-1, tirzepatide is a dual GIP and GLP-1 receptor agonist, also FDA-approved for type 2 diabetes and in high demand for weight loss (often prescribed off-label for this purpose).

   Why they are legal: These are manufactured under strict FDA regulations and have undergone rigorous clinical trials to prove safety and efficacy.

2. Compounded Medications Meeting FDA Criteria (Potentially):

   • Compounding pharmacies that use APIs permitted for compounding: The FDA's guidance specifically targeted semaglutide salts used in injections. Some compounding pharmacies may still be able to legally produce compounded versions of semaglutide if they use an API that is eligible for compounding under FDA regulations and adheres to all other rules. This often means using a different form of semaglutide or a different drug entirely.
   • Pharmacies operating under state-specific regulations: State pharmacy boards have their own regulations. While the FDA provides guidance, state boards ultimately regulate compounding within their borders. It's essential for pharmacies to comply with both federal and state laws.
   • Compounded Sermorelin/CJC-1295 or other peptides: Some patients seeking weight loss are exploring compounded peptides that are not GLP-1 agonists but are marketed for similar effects. These are generally considered legal to compound and dispense if they are not copies of FDA-approved drugs and meet compounding criteria. However, their efficacy and safety for weight loss are not as well-established as GLP-1s.

   Why they might be legal: If a compounding pharmacy is using an API that is not on the FDA's list of drugs that cannot be compounded and is following all other compounding regulations, their products could be considered legal. However, this is a complex and evolving area, and consumers should exercise extreme caution.

Important Considerations for Consumers:

• Consult Your Doctor: Always discuss any medication, including compounded versions, with your healthcare provider. They can advise on the best and safest course of treatment for your individual needs.
• Verify Legitimacy: If you are considering a compounded GLP-1, ask the compounding pharmacy:
  • What specific API are they using?
  • Is it the same API as in Ozempic/Wegovy?
  • How do they ensure the quality and purity of their product?
  • Can they provide documentation regarding their compliance with FDA and state regulations?
• Beware of Unsolicited Offers: Be very wary of pharmacies or online services that market compounded GLP-1s aggressively or offer them without a thorough medical evaluation from your own doctor.
• Cost vs. Risk: While compounded versions may be cheaper, the potential risks associated with unapproved ingredients, lack of FDA oversight, and unknown efficacy are significant. The FDA's primary concern is patient safety.

In summary, the FDA's focus on specific semaglutide salts has created a complex landscape for compounded GLP-1s. While the branded, FDA-approved medications are the safest and most reliable option, a small number of compounding pharmacies may still be operating legally by using different ingredients or adhering to very specific interpretations of the regulations. However, due diligence and consultation with a healthcare professional are paramount.