Our Peptide, IV, GLP-1 Course Users Learned about Illegal Drug Copies… Before the FDA Took Action.

On September 18, 2026, FDA issued a warning letter over compounded semaglutide and tirzepatide to one of the nation’s largest compounded GLP-1 suppliers to medical offices. The products it named were tirzepatide with niacinamide and semaglutide with cyanocobalamin. Our course had already identified that exact pattern and told learners what it was.

What the Peptides, IVs and GLP-1s course taught upon release, August 2026 … “Do not buy these Compounds”

• The additive is cosmetic. “First B12, now niacinamide at a flat 2 mg/mL across every strength.”
• The justification is a smokescreen. “Compounded semaglutide on a monthly subscription, justified by the ‘personalized reason’ excuse. Illegal post-shortage.”
• The window is closed. “Routine compounding of these molecules is no longer legal.”
• Do not write what you cannot defend. A justification that fits every patient documents nothing except that you knew one was required.

What the FDA letter revealed, September 18, 2026

• The named products were tirzepatide with niacinamide and semaglutide with cyanocobalamin.
• “The volume of products you are producing suggests that differences between products you are compounding and the FDA-approved products are pretextual.”
• The evidence included “purported prescriber determinations of ‘significant difference’ that appear to be repeated verbatim,” and orders containing no prescriber determination at all.
• The products “appear to be essentially copies of FDA-approved semaglutide and tirzepatide products,” compounded “regularly and in inordinate amounts.”
• Enforcement discretion ended March 5, 2025 for tirzepatide and April 24, 2025 for semaglutide.

The determination of significant difference is written by the prescriber. Not the pharmacy’s marketing department, not the label. If you signed one, you wrote it.

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Download the one-page brief.  Course language and FDA language side by side, with the source citation.

Beyond Injectables: Peptides, IVs, GLP-1s and the Wellness Frontier. Accredited CME for physicians, nurse practitioners, physician assistants and nurses in wellness and aesthetics. 11.5 AMA PRA Category 1 Credits, 11.5 ANCC contact hours including 6.5 pharmacotherapeutic, jointly accredited by Amedco LLC.

*A warning letter sets out the agency’s allegations and requests a response. It is not a final determination, a finding of liability, or an adjudication. We have not named the recipient because the pharmacy is not the point. This post is education, not legal advice, and guarantees no outcome. Source: FDA Warning Letter 738238, September 18, 2026, fda.gov.*