Key Takeaways
- The regulatory environment for compounded weight loss medications remains fluid, with FDA decisions creating uncertainty for med spa owners and their patients.
- While tirzepatide (Mounjaro) faces regulatory challenges, semaglutide remains available through compounding pharmacies regardless of FDA decisions.
- Med spas should implement comprehensive protocols for weight loss treatments, including baseline testing, monthly check-ins, and complementary aesthetic services.
The medical aesthetics industry is facing a pivotal moment as regulatory decisions impact the availability of popular weight loss medications. Recent FDA rulings on tirzepatide have created significant confusion for compounding pharmacies, med spa owners, and patients alike. To navigate this complex landscape, we spoke with Vickie Paesano, a uniquely qualified expert who bridges both worlds as a third-generation pharmacy owner and med spa founder.
The Tirzepatide Shortage Rollercoaster
For med spa owners who have incorporated weight loss treatments into their practice, recent FDA decisions have created a whirlwind of confusion. On September 30th, the FDA removed tirzepatide (the active ingredient in Mounjaro) from its shortage list, effectively barring compounding pharmacies from producing it. Days later, the agency reversed course, acknowledging the shortage still existed.
“During that short period of time, everyone was scrambling because pharmacies had to stop immediately doing what they were doing,” explains Vickie Paesano, PharmD and president of Core Aesthetic. “All those patients currently on those medications could no longer continue. They had to get brand new prescriptions for the commercial product.”
This regulatory back-and-forth has left med spa owners uncertain about how to maintain continuity of care for their patients. The situation highlights the delicate balance between pharmaceutical manufacturers, compounding pharmacies, and healthcare providers.
How Eli Lilly Is Responding to the Compounding Challenge
While the FDA’s decisions created immediate disruption, pharmaceutical manufacturers like Eli Lilly have been implementing their own strategies to recapture market share from compounding pharmacies.
Paesano revealed that Eli Lilly has begun establishing direct portals for providers: “Eli Lilly opened up a satellite shop in Ohio, sent their reps in, and went into providers’ computers saying, ‘I’m going to make you a portal. All you have to do is prescribe our brand name products directly to us and we’ll ship it right to the patient.'”
This approach creates several concerns for med spa owners:
- It eliminates the crucial provider-patient interaction for medication education
- It bypasses the med spa’s ability to earn revenue from primary care services
- Patients end up paying more ($499 per vial directly to Eli Lilly versus lower costs through compounding pharmacies)
- The medication arrives without proper instruction on administration
For aesthetic practices that have built patient relationships around weight loss programs, this direct-to-patient model threatens both revenue streams and the quality of patient care.
Understanding the Difference Between Semaglutide and Tirzepatide
As med spa owners navigate this regulatory environment, understanding the key differences between these medications is essential.
“Semaglutide was on the market first, originally for diabetes type two, and then they found it does great for weight loss too,” Paesano explains. “Tirzepatide works on two different mechanisms in the body to do a very similar thing—make you feel fuller.”
The key differences include:
- Semaglutide (Ozempic/Wegovy) works through one mechanism and was first to market
- Tirzepatide (Mounjaro) works through two mechanisms, potentially offering better weight loss results with fewer side effects
- Tirzepatide tends to be more expensive and less likely to be covered by insurance
- Semaglutide’s patent has expired, allowing compounding pharmacies to continue producing it regardless of FDA decisions
This distinction explains why compounding pharmacies can continue offering semaglutide while tirzepatide remains in regulatory limbo.
Best Practices for Med Spas Offering GLP-1 Medications
When incorporating weight loss medications into their practice, Paesano emphasizes the importance of comprehensive patient care:
“The minimum requirement would be baseline blood work. We want to make sure the liver and kidneys are healthy enough for it. The medication is appropriate—I’m making sure there are no indicators that you are contraindicated.”
Her recommended protocol includes:
- Complete medical history review
- Baseline blood work to check liver and kidney function
- Clear weight loss goals (typically one pound per week)
- A structured weight loss program with nutritional guidance
- Monthly check-ins for accountability and monitoring
This approach not only ensures patient safety but also creates a valuable ongoing relationship between the med spa and the patient—something that’s lost in direct-to-consumer models.
The Aesthetic Opportunity in Weight Loss Treatments
For med spa owners, the integration of weight loss medications creates a natural pathway to additional aesthetic services. As Paesano notes, “You’re losing weight. You see them once per month, and then you see all this loose skin. Unfortunately, the skin doesn’t tighten up as fast as the weight loss.”
This creates opportunities for complementary treatments:
- Morpheus radio frequency machines for skin tightening
- Evolve Machine treatments to rebuild muscle tone
- Non-invasive body contouring services
These services address the aesthetic concerns that emerge during successful weight loss, allowing med spas to create comprehensive treatment plans that support patients throughout their transformation journey.
Finding Quality in a Crowded Market
As demand for weight loss medications has surged, so too have questionable products and providers. Paesano warns med spa owners to be vigilant about sourcing:
“There’s a lot of fake Chinese-made imported stuff out there. We’ve tested them just to see their purity, and it’s not so great. So there’s a huge difference in importance in that itself too. Don’t get scammed.”
Med spa owners should be careful and speak with our med spa growth consulting team to make sure they are partnering with a reputable compounding pharmacy that maintains FDA-compliant facilities and testing protocols that are essential for both patient safety and practice reputation.
Frequently Asked Questions
How do recent FDA decisions affect my med spa’s ability to prescribe weight loss medications?
Compounding pharmacies can continue producing semaglutide regardless of FDA decisions, as its patent has expired. For tirzepatide, the situation remains fluid, with the FDA recently acknowledging ongoing shortages after briefly removing it from the shortage list. Med spas should maintain relationships with reputable compounding pharmacies to ensure continuity of care.
What’s the difference between commercial products like Ozempic and compounded versions?
Commercial products like Ozempic typically come as auto-injectors with preset doses, while compounded versions come in vials requiring manual dosing. The active ingredients are identical when sourced properly, but compounded versions often cost less and remain available during shortages of commercial products.
How should my practice handle patient transitions if medication sources change?
Maintain clear communication with patients about any changes to their medication source or formulation. Ensure proper education on any differences in administration methods, and consider scheduling brief follow-up appointments to verify patients understand how to use new delivery methods correctly.
What complementary services should my med spa offer alongside weight loss treatments?
The most natural pairings include body contouring, skin tightening treatments like radiofrequency procedures, muscle toning technologies, and nutritional counseling. These services address the common aesthetic concerns that emerge during significant weight loss.
How can I ensure my practice is sourcing quality medications?
Partner only with FDA-registered 503A or 503B compounding pharmacies with clean inspection records. Request documentation of their testing protocols and quality assurance measures. Avoid unusually low-priced options that may indicate compromised quality or ingredients.
What baseline testing should we require before starting patients on GLP-1 medications?
At minimum, patients should receive comprehensive blood work to evaluate liver and kidney function, along with a thorough medical history review to identify contraindications. Some practices also incorporate body composition analysis to track changes beyond simple weight measurements.
How frequently should patients return for monitoring while on these medications?
Most successful programs incorporate monthly check-ins to monitor progress, adjust dosing if needed, address any side effects, and maintain accountability. These regular touchpoints also create opportunities to discuss complementary aesthetic treatments as patients progress in their weight loss journey.
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