By Eric Atienza, Assistant Director of Digital Marketing and Marketing Technology, American Med Spa Association (AmSpa)

(UPDATE 10/14/24: In a court filing on the 11th the FDA stated they would allow compounding pharmacies to continue to produce compounded tirzepatide medications while it reviewed whether there was a shortage of the active ingredient. See here for more information. )

The ability of compounding pharmacies to legally manufacture generic versions of the tirzepatide-based medications Mounjaro and Zepbound has ended. The FDA officially listed the shortage of these drugs as “Resolved” so med spas and medical weight loss clinics offering these compounded versions will need to update their protocols and treatment plans.

On Monday, October 7, a drug compounding industry group sued the FDA in Texas federal court over its decision to take Eli Lilly's tirzepatide weight loss drug off the drug shortages list. To read more about this story and follow updates, visit Industry News.

For more information on operating successful and legally compliant medical weight loss programs, visit our Medical Weight Loss Resource Page.

Can Med Spas Continue to Use Their Current Stock of Tirzepatide?

Yes, if your practice has stock on hand you may continue to administer according to your current processes.

“Current on-hand supplies can still be used, and pharmacies may be able to fill orders that have already been placed ,” said Patrick O’Brien, JD, General Counsel for AmSpa. “However, practices should begin making plans to transition to the name brand.”

According to a recent FDA policy clarification, medical aesthetic and weight loss practices may still be able to acquire compounded tirzepatide from compounding pharmacies under certain limited circumstances. But for regular ongoing purposes, they will need to implement a plan to move to the name brand. :

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Update Weight Loss Marketing and Documentation Immediately

If your practice mentions “compounded tirzepatide” in marketing materials or on your website, since the drug shortage is resolved you should remove these references. As we’ve mentioned before, however, until you actually transition to the brand name drug you also cannot use the brand names Mounjaro or Zepbound. You may use generic terms like “medical assisted weight loss” as long as such terms comply with your state’s advertising rules.

As you plan to move to the name brand Eli Lilly product, be sure to update your informed consents and SOPs to remove reference to “compounded tirzepatide.”

Reminder: As long as you are still using the compounded generic drug, you cannot use the term “FDA-approved.”

Can Med Spas Move to Compounded Semaglutide Instead of Mounjaro or Zepbound?

Technically, yes, if you want to continue offering compounded GLP-1 medications you may consider moving patients to semaglutide, as long as they are good candidates for the drug in your clinical opinion.

However, take caution with this path as a long-term solution since, as of August 6, several dosages of Ozempic and Wegovy were listed as “Available” on the shortage list. There isn’t a way to tell how long it will be until these drug shortages are also listed as “Resolved” at which point practices will no longer be able to use compounded semaglutide either.

If you do decide to consider compounded semaglutide instead of tirzepatide, you will need to administer a new Good Faith Exam to the patient, just as if you were starting them on any other new line of treatment.

“While they are treating the same condition the means are different so the patients would need to be re-assessed and a new treatment plan developed,” said O’Brien.

Things to Consider When Moving to Name Brand Drugs

If you plan to continue offering medical weight loss in your practice by moving to name brand Mounjaro or Zepbound, there are a few operational considerations to take into account during this transitional period.

You will need to secure a source for the name brand product, and make sure the timing and delivery methods integrate with your current practices. If not, you will need to revise your protocols and inform your patients if there will be any change.

It’s also very likely that the move to the name brand will change your costs. You will need to evaluate your program and understand if this transition will change your pricing so you can notify your patients.

Medical weight loss programs can be a powerful line of treatments for practices focused on the whole-body wellness of their patients. The FDA shortages of GLP-1 medications highlight the widespread appeal of these programs, and though the shortages are ending the demand is still high. To access resources on legally and safely running a successful med spa practice, become an AmSpa member today.