Compounded Semaglutide & Tirzepatide in 2025: What Patients Should Know
- Joshua Silva, MD
- 4 hours ago
- 4 min read
On February 21, 2025, the FDA announced that the nationwide shortage of semaglutide injections was resolved. In the months following, the agency also confirmed the end of broad “enforcement discretion” for tirzepatide compounding. As of spring 2025, both semaglutide and tirzepatide may only be compounded under very limited circumstances.
Yet online ads continue to promote compounded vesrions of GLP-1 products. Some of these are legitimate, but others are not safe or FDA-compliant.
If you’re considering compounded semaglutide, here’s what you should know to stay safe and avoid low-quality or counterfeit products.
What are compounded medications?
Compounded medications are custom preparations made by licensed pharmacies to meet a patient’s unique needs when:
A patient requires a dose, concentration, or formulation not commercially available.
There’s a temporary shortage of the FDA-approved product.
A patient has allergy or intolerance to an inactive ingredient in a commercial formulation.
Are compounded medications FDA-approved in 2025?
Compounded semaglutide and tirzepatide are not FDA-approved medications, but when produced by U.S.-licensed compounding pharmacies that follow state laws, USP standards, and FDA oversight for 503A/503B facilities, they can be FDA compliant and safe when used under medical supervision.
Why did the FDA stop broad compounding of semaglutide & tirzepatide after the shortage in 2025?
During the Wegovy®/Ozempic®/Mounjaro®/Zepbound® shortage, the FDA exercised temporary “enforcement discretion” so patients could access semaglutide and tirzepatide when commercial supply couldn’t meet demand. This allowed licensed U.S. compounding pharmacies to prepare patient-specific versions under 503A/503B rules while the shortage persisted.
Now that production has stabilized in 2025, compounding of semaglutide and tirzepatide must return to standard federal and state compounding regulations that were in place before the shortage.
Safe compounding vs. High-Risk sources of semaglutide & tirzepatide
Compounded semaglutide and tirzepatide can still be a safe option when prepared by U.S.-licensed pharmacies using pharmaceutical-grade active pharmaceutical ingredients (APIs) and with verified sterility and potency testing.
However, major red flags include:
Ultra-low online pricing — prices far below typical market cost often signal substandard sourcing.
No physical address or phone contact — reputable pharmacies and medical clinics are transparent and easy to reach.
“Research chemical” disclaimers or products labeled as semaglutide/tirzepatide salts instead of the correct base form.
DIY kits requiring you to mix your own powder and diluent — safe compounded medication should arrive sterile and ready to use.
Lack of a Certificate of Analysis (COA) verifying potency and purity for each batch.
Missing lot number or Beyond-Use Date (BUD) — legitimate compounded medications should be traceable to a lot and have a clear BUD for safe use.
No prescription or medical oversight — legitimate GLP-1 therapy requires evaluation by a licensed clinician.
How to safely choose compounded semaglutide and tirzepatide when needed
Compounding can be a safe and valuable option — but only if done by the right pharmacy under proper oversight.
Look for:
U.S.-licensed pharmacy: Confirm the supplier of the medication is licensed in the U.S. and can provide its state license number.
Pharmaceutical-grade ingredients — Ask if the semaglutide or tirzepatide active ingredient comes from an FDA-inspected manufacturer listed on the Green List (Import Alert 66-80).
Certificate of Analysis (COA): This verifies each batch for identity, purity, and potency.
Finished, ready-to-inject medication: Be wary if you’re asked to mix powder with diluent yourself; reputable pharmacies and clinics provide sterile, ready-to-use products.
Lot number and Beyond-Use Date (BUD) — Legitimate compounded medications should be labeled with a batch/lot number and a clear BUD to ensure traceability and safe use.
Physical address & phone number: Avoid companies that hide their location or use only email/web forms.
Realistic pricing — Prices that seem too good to be true often mean lower-quality or non–pharmaceutical-grade chemicals
Considering compounded semaglutide or tirzepatide? Book your free consultation with Potere Health MD in St. George or Cedar City — with both in-person and virtual appointments available.
Disclaimer:
This article is for educational purposes only and is not a substitute for medical advice.
About the Author
Dr. Joshua Silva, MD, is a licensed physician and Medical Director of Potere Health MD. He completed residency training in Occupational and Environmental Medicine from the University of Utah and now specializes in evidence-based weight management, including GLP-1/GIP therapies (semaglutide, tirzepatide). Dr. Silva provides in-person and virtual care for patients throughout Utah.
Sources:
FDA Clarifies Policies for Compounders as National GLP-1 Supply Stabilizes
FDA “Import Alert 66-80” / Green List for GLP-1 APIs
FDA Launches Green List to Protect Americans From Illegal Imported GLP-1 Drug Ingredients
FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
FDA Warning Letter: GLP-1 Solution / Compounding Violations & Regulations (Sept 2025)
FDA Declares Semaglutide Injection Products Shortage Resolved (Declaratory Order)
Alston & Bird Commentary: FDA Resolves Semaglutide Shortage — Next Steps for Providers
FDA Declaratory Order: Resolution of Tirzepatide Injection Product Shortage
FDA “Clarifies policies for compounders…”
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