Compounded vs Brand-Name: The Safety Data Compared

Head-to-Head Comparison

The Potency Problem

FDA testing of compounded semaglutide products found significant variation in actual drug content:

What this means for patients:

• 42% potency: You're getting less than half the expected dose—likely ineffective
• 170% potency: You're getting nearly double the dose—increased side effect risk
• 0% potency: You're injecting something with no active ingredient at all

For detailed FDA testing data, see: Potency Variation in Compounded GLP-1s: FDA Testing Data →

The Supply Chain Issue

A Brookings Institution analysis titled "The Wild East of semaglutide" documented serious concerns about where compounded semaglutide API comes from:

Key findings from the Brookings report:

• No external quality standard: Manufacturers determine their own specifications—there's no universal reference standard
• New entrants: ~60% of facilities with NDC codes were not registered with FDA before the shortage began
• Import surge: Dramatic increase in semaglutide imports from China during shortage period

For pricing analysis, see: GLP-1 Pricing Exposed: From API Cost to Your Pharmacy Bill →

Adverse Event Data (FAERS)

As of March 31, 2024, the FDA Adverse Event Reporting System (FAERS) contained 442 adverse event cases associated with compounded semaglutide.

Important context:

• FAERS is a self-reporting system—reports are not verified
• A report doesn't prove the drug caused the event
• Reporting rates may reflect media attention, not actual risk differences
• Brand-name products also have adverse event reports (expected for any medication)

However, compounded products carry unique risks:

• Potency variation can cause unpredictable side effects
• Unknown impurities may have their own effects
• No systematic safety monitoring during production

Novo Nordisk Legal Findings

In court filings from their 111+ lawsuits against compounders, Novo Nordisk has documented specific product quality issues:

• 24%+ impurities: One product tested contained more than 24% impurities, including unknown substances
• Zero active ingredient: An oral product labeled 1 mg/mL semaglutide contained no semaglutide
• Unauthorized salt forms: Products using semaglutide sodium or acetate instead of the base form

For lawsuit details, see: Novo Nordisk's 111+ Trademark Lawsuits: Full Tracker →

What About 503B Outsourcing Facilities?

Not all compounding pharmacies are the same. 503B outsourcing facilities have additional oversight:

503A pharmacies (traditional compounding) have less oversight and are primarily state-regulated.

For the full regulatory framework explanation, see: 503A vs 503B: The Compounding Framework Explained →

Current Legal Status

As of late 2025:

• FDA removed semaglutide from shortage list in February 2025
• 503A pharmacies can no longer legally compound "essentially a copy" of brand-name products
• 503B facilities had grace period through May 22, 2025
• Enforcement actions ongoing; Novo Nordisk lawsuits continue

For current legal status, see: Is Compounded Semaglutide Legal? 2025 State-by-State Update →

Making the Decision

When choosing between compounded and brand-name semaglutide, consider:

Choose Brand-Name If:

• Insurance covers the medication
• You have serious health conditions requiring consistent dosing
• You're risk-averse about medication quality
• You qualify for manufacturer savings programs

Compounded May Be Considered If:

• Cost is prohibitive and no insurance coverage available
• You choose a 503B facility with documented quality testing
• You understand and accept the quality variation risks
• It remains legally available in your state (check current status)