The critical importance of the Beyond-Use Date (BUD)
Unlike FDA-approved drugs with long-term expiration dates based on extensive testing, compounded tirzepatide is assigned a Beyond-Use Date (BUD) by the compounding pharmacy. This date, typically ranging from 28 to 90 days when refrigerated, is determined using United States Pharmacopeia (USP) guidelines considering stability and potential microbial growth. The BUD marks the final day the medication is guaranteed stable and sterile, and it's crucial for patients to follow this date on their pharmacy label, as it overrides storage guidelines for brand-name versions like Mounjaro or Zepbound.
Storage requirements for compounded tirzepatide
Compounded tirzepatide, a peptide-based injectable, requires specific storage due to its sensitivity to heat, light, and agitation.
Refrigeration is essential
Store compounded tirzepatide in the refrigerator between 36°F and 46°F (2°C and 8°C). This temperature range is vital for maintaining the peptide's structure and preventing contamination. Never freeze the medication, as this will destroy the active ingredient; discard any vials that have been frozen. Protect the medication from light by keeping it in its original or an opaque container.
Limited room temperature exposure
Unlike brand-name tirzepatide, which can be stable at room temperature for a period, compounded formulations should generally remain refrigerated unless directed otherwise by your pharmacy. For travel, use an insulated cooler with gel packs, ensuring the medication doesn't directly touch the packs to avoid freezing.
The current landscape: FDA changes for compounded tirzepatide
As of March 2025, the FDA no longer broadly permits compounding pharmacies to produce compounded tirzepatide because the shortage of brand-name Mounjaro and Zepbound has resolved. The FDA had temporarily allowed compounding during the shortage but ended this policy to ensure patients receive approved drugs. This means compounded tirzepatide is generally not legally available for routine prescriptions, requiring patients to transition to FDA-approved options.
Risks of using expired or improperly stored medication
Using compounded tirzepatide past its BUD or storing it incorrectly poses significant risks:
- Reduced Efficacy: The medication's potency can decrease due to degradation of the active ingredient, making it less effective for its intended use.
- Contamination Risk: Improper storage or handling of injectable compounds can lead to bacterial contamination and potential infection at the injection site. Sterility is only guaranteed until the BUD under proper storage conditions.
- Visual Degradation: Always check the medication's appearance before use. It should be clear and colorless to slightly yellow. Discard immediately if it is cloudy, discolored, or contains particles.
- Unknown Side Effects: As compounded drugs lack the extensive testing of FDA-approved medications, using a degraded version may lead to unpredictable side effects.
Comparison of Compounded vs. FDA-Approved Tirzepatide
| Feature | Compounded Tirzepatide | FDA-Approved Tirzepatide (Mounjaro/Zepbound) |
|---|---|---|
| Availability | No longer widely available for routine prescriptions following FDA action in March 2025. | Widely available from the manufacturer since drug shortages are resolved. |
| Regulatory Status | Not FDA-approved; made by a pharmacy for a specific patient need. | FDA-approved, ensuring safety, quality, and efficacy through rigorous testing. |
| Stability and Testing | Shorter stability timeline based on Beyond-Use Date (BUD); less extensive testing. | Extensive stability data from manufacturer testing validates a longer expiration date. |
| Storage Life (Refrigerated) | Typically 28 to 90 days, depending on the pharmacy's BUD determination. | Lasts until the manufacturer's expiration date if kept refrigerated. |
| Room Temperature Storage | Limited or no room temperature stability; keep refrigerated at all times unless advised otherwise by the pharmacy. | Can be kept out of the refrigerator for up to 21 days (below 86°F / 30°C). |
Conclusion
Patients who used compounded tirzepatide must understand its short Beyond-Use Date and the recent FDA decision to end widespread compounding due to resolved drug shortages. Compounded versions lacked the long-term stability of brand-name products. Any remaining compounded supply must be used according to its BUD and refrigeration requirements and safely discarded thereafter. All patients should consult their healthcare provider to transition to FDA-approved Mounjaro or Zepbound and follow their established storage guidelines. Never use expired or improperly stored medication to ensure safety and effectiveness.
For more information on the FDA's stance on unapproved GLP-1 drugs, you can visit the official FDA website.(https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss)
Transitioning from compounded to brand-name tirzepatide
If you previously used compounded tirzepatide, it is essential to consult your healthcare provider to transition to FDA-approved Mounjaro or Zepbound. Your provider can assist with prescriptions and discuss cost and insurance coverage. Planning this transition in advance is crucial to maintain your treatment.
Important considerations for storage and disposal
Proper handling and monitoring are key to maintaining compounded tirzepatide's integrity.
- Safe Handling: Handle vials and syringes gently to avoid agitation, which can impact peptide stability.
- Monitoring Temperature: Using a refrigerator thermometer helps ensure correct storage temperatures.
- Proper Disposal: Expired medication and used needles should be disposed of in an FDA-cleared sharps container, not regular trash.
Following these guidelines protects your health and ensures safe medication use, especially with the recent changes in regulations for compounded products.
