Compounded tirzepatide has been a game changer for hundreds of thousands of patients unable to find or afford Eli Lilly’s branded versions, Mounjaro and Zepbound. Over the past year, telehealth companies and compounding pharmacies have leveraged the FDA’s drug shortage designation to create a parallel market that made the medication more accessible. But with supply improving, the FDA may soon remove tirzepatide from its shortage list, leaving pharmacies and telehealth providers to navigate a much more restrictive landscape.
Right now, all eyes are fixed on December 19th, the next date that the OFA and FDA report back to the district court in Texas for a status update in the ongoing lawsuit over the FDA's decision to remove tirzepatide from the shortage list. If the FDA officially ends the shortage at that time, the rules for compounding tirzepatide will shift dramatically. The FDA’s framework around what constitutes an “essentially a copy” of a branded drug will become a significant barrier. Outsourcing facilities operating under 503B rules, which have been the backbone of large-scale compounding efforts, will no longer be able to produce tirzepatide without individual prescriptions. Only traditional compounding pharmacies operating under 503A rules will be able to continue, but even they will need to justify the clinical necessity of their compounded formulations. Of course, the OFA will go down swinging, and likely proceed with their lawsuit, at which point the appointed judge would have to make a decision on what happens to the 503B "essential copies" in the meantime.
A removal from the shortage list doesn’t mean compounded tirzepatide will disappear altogether, but the shift could severely limit access. Telehealth providers are already preparing for this reality. Mochi, for example, has introduced non-commercially available doses like 2.2 mg and 4.4 mg, which don’t directly overlap with Eli Lilly’s products. This strategy takes advantage of a key loophole: compounded medications that deviate by 10% or more from the branded version may not be considered “essentially a copy.” What constitutes a "non-essential compounded copy" is largely determined by individual state pharmacy boards. As a result, we are likely to see various strategies employed by pharmacies across the country, offering slightly modified doses—whether through custom dosing, as mentioned above, or additives combined with tirzepatide. However, the common requirement for all pharmacies is that any custom formulation of tirzepatide must be supported by a well-documented patient need. This requirement could pose significant challenges for patients who, until now, have relied on the "essential copy" compounded versions.
The ongoing lawsuit between the Outsourcing Facilities Association (OFA) and the FDA complicates this picture further. The OFA argues that shortages are not binary and that removing a drug from the shortage list doesn’t necessarily mean the supply meets patient demand. If the OFA wins, outsourcing facilities might retain their ability to compound tirzepatide, preserving broader access. If the lawsuit fails, compounded tirzepatide will be limited to patient-specific cases through 503A pharmacies.
Meanwhile, Eli Lilly is likely watching all of this closely. The company has already issued cease-and-desist letters to compounding pharmacies producing tirzepatide, even during the shortage. Should the shortage designation end, Lilly is almost certain to escalate its legal campaign, pressuring pharmacies and telehealth providers to halt production. This legal pressure could extend to prescribers as well, discouraging them from documenting the clinical need for compounded versions.
For patients, the landscape is poised to become more challenging. Compounded tirzepatide will likely remain available in some capacity, as OTP industry sources are indicating that telehealth companies and compound pharmacies have no appetite to end the compounded versions. One thing they all agree on, accessing it will require navigating more restrictive rules and some definite legal gray areas. Prescribers will need to document specific clinical differences, such as non-standard dose adjustments or allergies to inactive ingredients, to justify compounded prescriptions. Pharmacies will need to ensure compliance with evolving regulations, all while bracing for potential legal challenges from Lilly.
The compounded tirzepatide market is entering uncharted territory. The FDA’s eventual decision on the shortage status, combined with the outcome of the OFA lawsuit and Eli Lilly’s legal strategy, will determine how this market evolves. For now, telehealth providers like Mochi are signaling that they intend to adapt, focusing on customized dose adjustments to stay within FDA guidelines. But this strategy hinges on prescribers’ willingness to advocate for patients and on pharmacies’ ability to withstand legal scrutiny.
Stay tuned to On The Pen for continued coverage of this rapidly changing landscape. Sharing this article is a powerful form of advocacy—help spread the word to ensure patients and providers remain informed about their options in the face of these challenges. Together, we can navigate this new era of GLP-1 access.
The FDA has declared that the shortage is resolved. 503A pharmacies have 60 days and 503B have 90 to comply. In their letter, they acknowledge that compounding is important to a lot of people but they say it is not their (FDA’s) problem.
Sorry folks, Eli Lilly’s money speaks louder than your need for affordable access to a life changing medication.