With brand-name GLP-1 medications often in shortage and costing $1,000+ per month, compounded versions have become increasingly popular. But are they safe? Here's what you need to know about compounded semaglutide and tirzepatide.
What Is Compounding?
Compounding pharmacies create custom medications using FDA-approved active ingredients. When brand-name drugs are on the FDA shortage list, compounders can legally produce versions of those medications. Compounded semaglutide and tirzepatide are made from the same active ingredients as Ozempic/Wegovy and Mounjaro/Zepbound.
Types of Compounding Pharmacies
503B Outsourcing Facilities
- • FDA-registered and inspected
- • Must follow current Good Manufacturing Practices (cGMP)
- • Can produce larger quantities
- • Higher quality standards
- • More reliable potency and sterility
503A Traditional Pharmacies
- • State-regulated, not FDA-inspected
- • Patient-specific prescriptions
- • Variable quality controls
- • More risk of sterility issues
- • Potency may be less consistent
Benefits of Compounded GLP-1s
- Cost savings: Often $200-400/month vs $1,000+ for brand-name
- Availability: Accessible during shortages of brand-name products
- Flexible dosing: Can be made in custom doses
- Legitimate option: Legal when brand is on FDA shortage list
Risks and Concerns
- No FDA approval: The compounded product itself isn't FDA-approved
- Potency variation: May not contain exact claimed amount of medication
- Sterility concerns: Contamination risk, especially from 503A pharmacies
- Different salt forms: Some use semaglutide "salts" that may behave differently
- Limited recourse: No manufacturer support if problems occur
- Future legality: May become unavailable if shortage ends
How to Choose a Safe Compounding Pharmacy
1. Verify 503B Status
Check the FDA's list of registered 503B outsourcing facilities. These undergo regular inspections and follow stricter manufacturing standards.
2. Ask About Third-Party Testing
Reputable compounders test each batch for potency and sterility. Ask to see certificates of analysis.
3. Use a Licensed Provider
Get your prescription from a legitimate telehealth provider or in-person doctor who will monitor your treatment properly.
4. Beware of Red Flags
Avoid: prices that seem too good to be true, no prescription required, overseas sources, or inability to verify pharmacy credentials.
The Salt Form Controversy
Some compounders use "semaglutide sodium" or "semaglutide acetate" rather than base semaglutide:
- Salt forms may have different pharmacokinetics
- Less clinical data on these specific forms
- Dosing equivalence isn't fully established
- Some argue this falls outside FDA shortage exemption
What Happens When Shortages End?
Once brand-name medications are no longer on the FDA shortage list, compounders can no longer legally produce copies. You would need to transition to brand-name products or explore other options.
The Bottom Line
Compounded GLP-1 medications can be a legitimate, more affordable option when obtained from reputable 503B pharmacies with proper medical supervision. However, they carry more risk than brand-name products. If you choose this route, do your due diligence on the pharmacy and provider, and understand that availability may change as shortage status evolves.