Recently, the FDA changed the availability status of most forms of semaglutide and tirzepatide from its drug shortage list to “Available”. This move has significant implications for those of us in the weight loss and aesthetics industry, especially if you’ve been leaning on compounded copy versions of these drugs to meet your patients’ needs.
In this blog, we’ll dive deep into the history of semaglutide compounding, unpack what the FDA shortage list really means, and, most importantly, lay out actionable steps for how you can continue to offer top-tier treatments without running afoul of the law.
The Rise of Semaglutide: A Game-Changer in Weight Management
Semaglutide, originally developed as a treatment for type 2 diabetes, quickly became a hot topic in the aesthetics world for its remarkable weight loss properties. The drug’s ability to help patients shed pounds when nothing else seemed to work was a game-changer. But as demand soared, so did the challenges. Supply couldn’t keep up, and suddenly, semaglutide and tirzepatide became a scarce commodity. Enter compounding pharmacies. These specialized pharmacies started offering compounded copy versions of semaglutide and tirzepatide.
What’s the Deal with Compounding Pharmacies?
Compounding pharmacies are a bit like the custom tailors of the pharmacy world. This could mean altering a drug’s dosage, combining it with other ingredients, or even changing its form, like turning a pill into a cream.
Now, why does this matter to you? Because compounding allows you to offer personalized treatments that aren’t available off-the-shelf. Whether it’s adjusting the dose of semaglutide to fit a patient’s specific needs or adding vitamins like B6 or B12 to enhance the treatment, compounding can give you an edge in delivering results that keep patients coming back. However, compounding is tightly regulated. The FDA has strict rules to ensure that compounded drugs are safe and effective.
The FDA’s Drug Shortage List: Friend or Foe?
The FDA’s drug shortage list is designed to manage the supply of critical medications. When a drug is on this list, compounding pharmacies have more leeway to produce it, even if there are commercially available versions. They can even create an exact copy. This is because the shortage creates a gap that compounding can fill. But once a drug is removed from the list, the rules change. Compounding pharmacies are no longer allowed to create exact copies of the drug, as it’s now readily available through traditional channels.
So, when the FDA recently announced that most forms of semaglutide and tirzepatide were no longer in short supply, it signaled a shift. For professionals who have been relying on compounded semaglutide, this news means it’s time to plan for when the drug come off of the shortage list.
Navigating the “Currently in Shortage” Status: What Medspa Professionals Need to Know
As of August 6, 2024, both semaglutide and tirzepatide are still listed as “Currently in Shortage” by the FDA. Now, what does that mean for you? Simply put, it means you can still compound copies of these drugs—if you’re meeting all the conditions laid out in section 503A of the Federal Food, Drug, and Cosmetic (FD&C) Act.
Here are the links to the FDA shortage website: Semaglutide and Tirzepatide.
The Confusion Around “Currently in Shortage”
There’s been some confusion. You’re seeing semaglutide and tirzepatide listed as AVAILABLE on the FDA’s website, so why are they still considered “in shortage”? The key is understanding the FDA’s terminology. If a drug is marked as “Currently in Shortage,” you’re in the clear to compound it as a copy. But once it’s labeled as “Resolved,” that’s your cue to stop using copy versions.
Prepare for the Shift: Compounding Copy Could End
The FDA’s decisions to change the status of semaglutide or tirzepatide as “Resolved” depends on many requirements that must be fulfilled prior to removal from shortage lists. And when the FDA finally marks the shortage as “Resolved,” it’s game over for compounding the copy of these drugs. You’ll need to transition to the commercially available, manufacturer-sourced products or real compounded versions. Right now, it is “Currently in Shortage.”
Why Defend Compounding? The Case for Customization
You might be wondering, with the FDA regulations, why should you bother with compounding at all? The answer lies in customization. In aesthetics and weight management, one size rarely fits all.
Compounded semaglutide allows you to offer personalized solutions. For instance, some patients might benefit from a lower dose of semaglutide combined with Vitamin B12, which can help boost energy and support metabolism. Others might prefer an oral formulation over an injection, which can be easier to integrate into their daily routine. The ability to offer these customized treatments sets you apart in a crowded market.
Navigating the Changes: How to Keep Offering Compounded Semaglutide
With the FDA’s recent changes, you might feel like your hands are tied. But that’s far from the truth. There are still plenty of ways to leverage compounding to offer effective, legal, and safe treatments. Here’s how:
- Altering Dosages: Once semaglutide is no longer on the shortage list, you can’t just compound a copy of the commercially available drug. But you can offer it in dosages that aren’t available through traditional channels. This is particularly useful for patients who may need a lower or higher dose than what’s typically prescribed. By customizing the dosage, you can fine-tune the treatment to maximize efficacy and minimize side effects.
- Adding Vitamins or Supplements: One of the biggest advantages of compounding is the ability to combine medications with other beneficial ingredients. For example, adding Vitamin B6 or B12 to semaglutide or tirzapatide can enhance its effects, particularly in terms of energy levels and metabolic support. These vitamins are known to help with weight management, making them a perfect complement to semaglutide or tirzepatide in a compounded formulation.
- Alternative Forms: Not every patient is a fan of injections, and this is where compounding really shines. You can offer semaglutide or tirzapatide in alternative forms, such as pills or sublingual drops. These options can improve compliance, as they’re often more convenient and less intimidating than injections. Plus, they allow you to cater to a wider range of patient preferences, which is key in a competitive market.
The Legal Landscape: Stay Compliant, Stay Ahead
It’s crucial to understand the legal landscape when it comes to compounding. IF semaglutide and tirzepatide comes off the FDA’s shortage list, then compounding pharmacies can no longer create direct copies of these drugs. But that doesn’t mean you’re out of options—it just means you need to get creative within the bounds of the law.
Start by planning closely with your compounding pharmacy to develop formulations that meet your patients’ needs by anticipating future FDA changes. This might involve adjusting dosages, incorporating additional ingredients, or offering alternative forms of the medication. By staying informed and proactive, you can continue to provide high-quality, personalized treatments that comply with all legal requirements.
Why This Matters for Your Practice
In the medspa and aesthetics industry, your ability to adapt to regulatory changes can make or break your practice. The FDA’s recent announcement is a reminder that we operate in a highly regulated environment, and staying compliant is non-negotiable. With the right strategies, you can continue to offer cutting-edge treatments that meet your patients’ needs and keep your practice thriving.
The changes regarding semaglutide and tirzepatide on the FDA’s shortage list is a significant development, but it’s far from the end of the road for compounding in the medspa and aesthetics industry. While it may be true that both drugs MAY be taken off and placed back on the shortage list at anytime, this may be an opportunity to demonstrate your expertise and commitment to personalized care.
If you need expert help with your medical weight loss practice, then contact us at (212)470-8059.
Thanks.
Jay Park MD
References
- FDA. (2023). Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss. Retrieved from FDA
- GoodRx. (2023). Compounded Semaglutide: What You Need to Know. Retrieved from GoodRx
- Alliance for Pharmacy Compounding. (2023). Defense of Compounding Amid Regulatory Scrutiny. Retrieved from APC
- FDA. (2023). Drug Compounding and Drug Shortages. Retrieved from FDA