The demand for GLP-1 receptor agonist medications — particularly tirzepatide (the active ingredient in Mounjaro and Zepbound) and semaglutide (the active ingredient in Ozempic and Wegovy) — has created unprecedented interest in compounded versions of these drugs from 503B outsourcing facilities.
This guide covers the current regulatory landscape, how to find legitimate 503B sources for compounded GLP-1 medications, and the safety considerations healthcare providers and patients should understand.
The Drug Shortage That Changed Everything
The surge in demand for GLP-1 medications for both type 2 diabetes management and weight loss has led to persistent supply shortages of the commercially manufactured versions. When a drug appears on the FDA Drug Shortage List, 503B outsourcing facilities are permitted to compound copies of that drug under Section 503B of the Federal Food, Drug, and Cosmetic Act.
Tirzepatide Shortage Status
Tirzepatide has been on the FDA drug shortage list, which opened the door for 503B outsourcing facilities to compound tirzepatide preparations. Healthcare providers should monitor the FDA's shortage list regularly, as the status can change — and when a drug is removed from the shortage list, 503B facilities may need to stop compounding it or transition to compounding it only under different regulatory provisions.
Semaglutide Shortage Status
Semaglutide has had a complex regulatory history regarding its shortage status and compounding eligibility. The FDA's position on semaglutide compounding has evolved, and healthcare providers should consult the current FDA drug shortage database and any relevant FDA guidance documents for the most up-to-date information.
How 503B Compounding of GLP-1 Medications Works
What Makes 503B Compounding Different
When a 503B outsourcing facility compounds tirzepatide or semaglutide, the process is fundamentally different from purchasing a commercially manufactured product:
- Active pharmaceutical ingredient (API): The facility sources the active ingredient (tirzepatide or semaglutide) as a bulk pharmaceutical ingredient from a qualified supplier
- cGMP manufacturing: The compounded product must be manufactured under current Good Manufacturing Practice conditions
- Quality testing: Finished products must undergo testing for potency, sterility, endotoxins, and other quality parameters
- FDA oversight: The facility is subject to FDA registration, inspection, and adverse event reporting requirements
What 503B Compounded GLP-1s Look Like
Compounded tirzepatide and semaglutide from 503B facilities are typically available as:
- Subcutaneous injection vials: Multi-dose vials at various concentrations
- Pre-filled syringes: Ready-to-inject preparations (less common)
- Custom concentrations: Doses that may not be available in the commercial product lineup
Note: Compounded versions are not identical to the commercially manufactured products (Mounjaro, Zepbound, Ozempic, Wegovy). They contain the same active ingredient but may differ in formulation, excipients, device, and delivery mechanism.
Finding a Legitimate 503B Source
The popularity of GLP-1 medications has unfortunately attracted bad actors. Here is how to verify that a 503B facility compounding tirzepatide or semaglutide is legitimate:
Step 1: Confirm FDA Registration
The facility must be on the FDA's registered outsourcing facilities list. If a facility claims to be a 503B outsourcing facility but does not appear on this list, do not use it. You can also search our 503B pharmacy directory to quickly verify registration.
Step 2: Review Inspection History
Check the facility's FDA inspection record:
- Has the facility been inspected recently?
- Were any Form 483 observations issued?
- Has the facility received any warning letters?
See our FDA Inspection Results page for current inspection data, or search individual facility profiles in our directory.
Step 3: Verify Quality Testing
Ask the facility about its quality control processes:
- Does the facility test each batch for potency and sterility?
- What are the beyond-use dates (BUDs) assigned to the product?
- Are BUDs supported by stability testing data?
- Can the facility provide Certificates of Analysis (CoA) for finished products?
Step 4: Confirm the Drug Is Eligible for Compounding
Before sourcing compounded GLP-1 medications, verify that the specific drug is currently on the FDA drug shortage list or otherwise eligible for compounding under Section 503B. The FDA's position on this can change, and facilities that compound drugs no longer eligible may face enforcement action.
503B Facilities Known for GLP-1 Compounding
Several FDA-registered 503B outsourcing facilities have become known for compounding GLP-1 medications. Some of the facilities that have been associated with tirzepatide and/or semaglutide compounding include:
- Empower Pharma (Houston, TX) — One of the largest 503B facilities with a broad product portfolio. View profile
- BPI Labs (Largo, FL) — Active in the compounding space with significant search interest. View profile
- Olympia Pharmaceuticals (Orlando, FL) — Known for a wide range of compounded products. View profile
Always verify current product availability directly with the facility, as compounding portfolios change based on regulatory status and ingredient availability.
Safety Considerations
Healthcare providers prescribing compounded GLP-1 medications should be aware of several safety considerations:
Quality Variability
Unlike FDA-approved products manufactured by large pharmaceutical companies with decades of experience producing specific molecules, compounded products come from smaller facilities. While 503B facilities are required to follow cGMP standards, the degree of quality assurance may vary. Key considerations:
- Potency accuracy: Is the stated dose actually what is in the vial? Ask for batch-specific Certificates of Analysis
- Sterility assurance: For injectable products, sterility is non-negotiable. Verify the facility's sterility testing protocol
- Stability data: Beyond-use dates should be supported by real stability testing, not estimated from literature
Patient Education
Patients receiving compounded GLP-1 medications should understand:
- The product is not the same as the commercially manufactured brand (Mounjaro, Ozempic, etc.)
- The compounded product has not been through the FDA approval process
- Dosing instructions may differ from the commercial product
- How to properly store the medication
- What side effects to report and to whom
Adverse Event Monitoring
Healthcare providers should report any adverse events associated with compounded GLP-1 medications to both:
- The 503B facility that produced the product
- The FDA MedWatch program
Regulatory Landscape: What Is Changing
The regulatory environment around compounded GLP-1 medications is among the most dynamic areas of pharmacy regulation. Key developments to watch:
- Drug shortage list changes: If tirzepatide or semaglutide is removed from the FDA drug shortage list, the legal basis for 503B compounding changes significantly
- FDA enforcement actions: The FDA has been increasingly active in enforcing compounding regulations, particularly for high-profile drugs
- Manufacturer litigation: Brand manufacturers have pursued legal action against some compounders
- State-level regulation: Some states have additional requirements for facilities compounding GLP-1 medications
Frequently Asked Questions
Is compounded tirzepatide safe?
Compounded tirzepatide from an FDA-registered 503B outsourcing facility that follows cGMP standards is produced under regulatory oversight. However, compounded products have not been through the same FDA approval process as commercially manufactured drugs. The safety depends significantly on the quality of the specific facility producing it. Always verify the facility's FDA registration, inspection history, and quality testing protocols.
Is compounded semaglutide the same as Ozempic?
No. Compounded semaglutide contains the same active ingredient as Ozempic but is not the same product. The formulation, excipients, delivery device, and manufacturing process differ. Compounded semaglutide from a 503B facility is produced under cGMP standards but has not been through the FDA's drug approval process.
How do I find a 503B pharmacy that compounds tirzepatide?
Start with our 503B pharmacy directory and search for facilities, then contact them directly to confirm they currently compound tirzepatide. You can also check our 503B Pharmacies by State page to find facilities in your area.
Can any compounding pharmacy make tirzepatide?
No. Only FDA-registered 503B outsourcing facilities can legally compound tirzepatide for distribution without patient-specific prescriptions (and only while the drug is eligible for compounding, typically during an active drug shortage). Traditional 503A pharmacies may also compound it, but only with individual patient prescriptions and under state pharmacy board oversight.
What should I look for in a Certificate of Analysis?
A Certificate of Analysis (CoA) from a 503B facility should include: batch/lot number, date of manufacture, beyond-use date, results for potency/assay (typically within 90-110% of label claim), sterility test results, endotoxin test results, particulate matter results, pH, and appearance. If a facility cannot provide a CoA, this is a significant red flag.
Resources
- 503B Pharmacy Directory — Search all FDA-registered outsourcing facilities
- How to Verify if a Compounding Pharmacy Is FDA Approved
- 503B Pharmacy FDA Inspection Results 2025-2026
- Understanding FDA Form 483 for 503B Facilities
- 503B Pharmacies by State