Are compounded Glucagon-Like Peptide (GLP) products FDA-approved?

Compounded GLP Products Are Not FDA-Approved

Compounded Glucagon-Like Peptide (GLP) products are not FDA-approved, and their use is not recommended due to uncertainty about their content and resulting concerns about safety, quality, and effectiveness. 1

Understanding Compounded Medications vs. FDA-Approved Products

Pharmacy compounding involves the preparation of customized medications that aren't commercially available for individual patients with specialized medical needs. However, compounded medications differ significantly from FDA-approved products in several critical ways:

• Compounded drugs are exempt from Good Manufacturing Practice regulations (GMPs) that FDA-approved drugs must follow 2
• Compounded products lack standardized quality testing
• Compounded preparations have not undergone clinical evaluation for safety or efficacy
• Compounded products lack standard labeling or prescribing information with safety instructions
• Compounding pharmacies aren't required to report adverse events to the FDA 2

FDA Position on Compounded Products

The American Diabetes Association's 2025 Standards of Medical Care in Diabetes explicitly states:

• "Use of compounded products that are not approved by the FDA is not recommended due to uncertainty about their content and resulting concerns about safety, quality, and effectiveness." 1

This recommendation is given an evidence level E, indicating expert consensus or clinical experience.

FDA-Approved GLP-1 Receptor Agonists

Several GLP-1 receptor agonists have received FDA approval for specific indications:

1. Liraglutide: FDA-approved for improving glycemic control in adults with T2D and reducing risk of major adverse cardiovascular events in adults with T2D and cardiovascular disease 1
2. Semaglutide: FDA-approved for improving glycemic control in adults with T2D 1
3. Lixisenatide: FDA-approved for improving glycemic control in adults with T2D 1
4. Exenatide QW: FDA-approved for improving glycemic control in adults with T2D 1

Risks of Compounded Products

The risk-benefit profile strongly favors FDA-approved medications over compounded alternatives:

• Published reports consistently show compounded drugs fail to meet specifications at a considerably higher rate than FDA-approved drugs 2
• Compounded sterile preparations pose additional risks of microbial contamination 2
• Multiple outbreaks of serious infections have been traced to contaminated compounded medications 2, 3
• The 2012-2013 fungal meningitis outbreak from contaminated compounded injections resulted in 751 infections and 64 deaths 3

What To Do During Medication Shortages

If an FDA-approved GLP-1 medication is unavailable due to shortage:

1. Switch to a different FDA-approved medication with similar efficacy, as clinically appropriate 1
2. Upon resolution of the shortage, reassess the appropriateness of resuming the original FDA-approved medication 1

FDA Oversight and Reporting

The FDA has established a Compounding Incidents Program with pharmacists dedicated to surveillance and review of adverse events related to compounded drugs 4. Healthcare professionals should report adverse events from compounded products to FDA's MedWatch reporting system.

Key Takeaway

When it comes to GLP medications, always use FDA-approved products. The risks associated with compounded GLP products far outweigh any potential benefits, especially considering the availability of multiple FDA-approved options in this class.