As someone who has spent a lot of time covering GLP-1 medications and advocating for patient access, it’s clear to that the battle over compounded semaglutide has reached a pivotal point. Big pharma is attacking the foundation of compounding from multiple angles. The Alliance for Pharmacy Compounding (APC) recently shared their official response to Novo Nordisk’s request to add semaglutide to the FDA’s “demonstrably difficult to compound” (DDC) list. Their position? This move by Novo is more about protecting market share than protecting patients.
Let’s take a closer look at the key points of the APC’s response—and what this means for patients who rely on compounded semaglutide.
Timing That Raises Questions
The APC starts by addressing Novo Nordisk’s timing. Semaglutide has been on the FDA’s shortage list since March 2022, yet Novo waited two and a half years to file this request. Meanwhile, compounded semaglutide has filled a critical gap, with pharmacies across the country providing hundreds of thousands of doses to patients.
APC questions why, after years of widespread use, Novo is suddenly claiming that compounded semaglutide is unsafe or “too difficult” to produce. The answer, APC suggests, may lie in Novo’s desire to control the market rather than any newfound concern for patient safety.
Synthetic APIs: Fact vs. Fear
A key part of Novo’s argument is that the synthetic active pharmaceutical ingredients (APIs) used by compounders are inferior to their own recombinant APIs. However, APC dismantles this claim with evidence:
1. FDA-Approved Quality: Synthetic APIs used by compounders are sourced from FDA-registered manufacturers and meet rigorous quality standards.
2. No Host-Cell Impurities: Unlike recombinant APIs, synthetic APIs avoid impurities from biological host cells, such as viruses or prions, making them highly controlled and precise.
3. Existing FDA Evaluations: The FDA has already approved synthetic semaglutide APIs for use in generic drugs, confirming their safety and efficacy.
This is not some gray area of unregulated science. APC’s response demonstrates that synthetic semaglutide APIs are reliable and meet the FDA’s strict requirements.
Delivery Methods: A Questionable Argument
Novo also argues that the delivery methods used for compounded semaglutide—vials and pre-filled syringes—are unreliable. But APC points out the glaring contradiction here: Novo itself is transitioning its insulin products to the same vial-and-syringe setup it now calls “unreliable.”
Patients have been safely using these delivery methods for decades, and there’s no evidence to suggest they are suddenly unsafe when used by compounding pharmacies. Furthermore, as we have pointed out many times at On The Pen, potential mosdosing of insulin products can be fatal.
Adverse Events: The Bigger Picture
Novo’s filing cites 542 adverse events associated with compounded semaglutide since 2018, including 10 deaths. While these numbers may sound alarming in isolation, APC puts them in context:
• Novo’s FDA-approved semaglutide products (Ozempic, Wegovy, and Rybelsus) have reported 35,722 adverse events and 455 deaths over the same period.
• Adverse event reports don’t establish causation. They can reflect pre-existing conditions, other medications, or unrelated factors.
In fact, the side effects reported for compounded semaglutide largely mirror those already documented for Novo’s commercial products.
Compounding Complexity: A Misleading Claim
Toward the end of its filing, Novo argues that the process of compounding semaglutide is inherently complex. APC refutes this, stating that the techniques and controls used by 503A and 503B compounding pharmacies are well within the norm for pharmaceutical professionals.
The APC also highlights Novo’s own manufacturing issues, citing FDA Form 483 observations at Novo’s Denmark production facility earlier this year. If occasional deficiencies can happen at a state-of-the-art manufacturing plant, it’s unreasonable to use isolated incidents to discredit an entire industry of compounding pharmacies.
What’s at Stake
If semaglutide is added to the FDA’s DDC list, compounded versions will no longer be an option at all, no 503a and no 503b. This will leave patients entirely dependent on the high-cost, often unavailable commercial products, or worse yet, unregulated research grade products. This could be devastating for people who rely on compounded semaglutide as an affordable, accessible alternative.
The APC’s response makes a strong case that this nomination isn’t about patient safety—it’s about limiting competition. By shutting down compounded semaglutide, Novo Nordisk stands to secure its monopoly on a drug that has become essential for millions of people.
Why This Matters
As someone who’s been tracking this space closely, I see this as more than just a debate over semaglutide—it’s a fight for patient access and the broader role of compounding in healthcare. The APC’s response serves as a reminder that compounding pharmacies provide a vital role in our nation’s healthcare infrastructure, stepping in where commercial manufacturing capacity falls short.
We will continue to follow this story as it develops. If you’ve benefited from compounded semaglutide or have thoughts on this issue, now’s the time to share your voice. Let’s keep advocating for access and accountability.
Stay tuned to OnThePen.com for updates and analysis on this and other important topics in the world of GLP-1 medications. Sharing this article is a simple but powerful way to make sure more people understand what’s at stake. Together, we can make a difference.
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