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

The FDA has been cracking down on compounded versions of popular GLP-1 agonists like semaglutide (Ozempic, Wegovy, Rybelsus) and liraglutide (Saxenda, Victoza). This is primarily because many compounding pharmacies were using a salt form of semaglutide called semaglutide sodium or semaglutide acetate instead of the specific active pharmaceutical ingredient (API) used in the FDA-approved drugs, which is semaglutide free acid.

Here's a breakdown of what happened:

• FDA's Stance: The FDA has stated that the salt forms of semaglutide are not the same as the semaglutide free acid used in the approved medications. Therefore, compounded versions using these salt forms are considered unapproved drugs and are not in compliance with federal law.
• Why the Distinction Matters: The FDA's concern is that the efficacy and safety of these salt forms have not been evaluated or proven through the same rigorous FDA approval process as the original medications. This raises questions about their potential effectiveness and any potential side effects.
• Enforcement Actions: The FDA has sent warning letters to compounding pharmacies and has been taking action to prevent the distribution of these unapproved compounded GLP-1s.

Who is Still Operating Legally with Compounded GLP-1s?

This is a complex and evolving area, and it's crucial to understand that the landscape can change. However, here's a general overview of who is generally considered to be operating legally within the FDA's current guidelines for compounded GLP-1s:

• Compounding Pharmacies using the Correct API: Pharmacies that are compounding semaglutide (or liraglutide) using the exact same active pharmaceutical ingredient (API) as the FDA-approved drugs – meaning semaglutide free acid for semaglutide – and are meeting all other compounding requirements are generally considered to be operating legally.

  • Why: These pharmacies are essentially creating a chemically identical version of the approved drug, which is permissible under compounding laws when certain conditions are met (e.g., a valid prescription, shortage of the commercially available drug, or when the compounded product offers a different dosage form or route of administration not otherwise available).
  • Difficulty in Verification: It can be challenging for consumers to independently verify which specific API a compounding pharmacy is using. Reputable compounding pharmacies will be transparent about their sourcing and practices.

• Pharmacies Sourcing from FDA-Approved Manufacturers: Some compounding pharmacies may be legally obtaining the API from manufacturers that supply the approved drug companies, ensuring they are using the correct semaglutide free acid.

Important Considerations for Consumers:

• Talk to Your Doctor and Pharmacist: This is the most critical step. Your doctor can prescribe the FDA-approved medication if it's appropriate for you. If you are considering a compounded version, discuss it thoroughly with both your doctor and a trusted compounding pharmacist.
• Ask Specific Questions: When inquiring about compounded GLP-1s, ask:
  • "Are you using semaglutide free acid as the active pharmaceutical ingredient?"
  • "Can you provide documentation about the sourcing of your API?"
  • "What is your process for ensuring the quality and purity of your compounded medications?"
• Be Wary of Unsolicited Offers: If you are receiving offers for compounded GLP-1s directly through social media or unsolicited marketing, exercise extreme caution.
• Understand the Risks: Compounded drugs, even those made with the correct API, carry inherent risks. They are not subject to the same level of FDA oversight as commercially manufactured drugs.
• Shortage Status: The FDA's guidelines for compounding often rely on the existence of a drug shortage or a specific patient need. If the FDA-approved versions are readily available, the justification for compounding may be weaker.

In summary, the FDA's crackdown is on compounded GLP-1s that use unapproved salt forms of the active ingredient. Pharmacies that are compounding with the exact same API (semaglutide free acid for semaglutide) and adhering to all compounding regulations are generally considered to be operating legally. However, due diligence and open communication with healthcare providers are paramount for consumers.