Why the Change?
The FDA’s decision is rooted in its mandate to protect public health by ensuring the safety and efficacy of drugs. FDA-approved drugs undergo rigorous testing and review processes to meet these standards, while compounded drugs do not receive the same level of scrutiny.
While compounding pharmacies are subject to certain quality standards, the FDA emphasizes the importance of patients having access to fully approved brand-name versions.
The agency clarified its policies, reminding compounders of the legal restrictions on making copies of FDA-approved drugs once a drug shortage list designation is resolved. Section 503A of the FD&C Act includes restrictions on compounding drugs that are essentially copies of a commercially available drug, except under specific circumstances of documented medical necessity.
Similarly, Section 503B restricts outsourcing facilities from making compounded drugs that are essentially copies of one or more FDA-approved drugs unless the approved drug is on the FDA’s drug shortage list.
What This Means for Patients
The discontinuation of readily available compounded tirzepatide has several significant implications for patients:
Need to Transition: Individuals currently using compounded versions of tirzepatide will need to discuss alternative treatment options with their healthcare provider well before the March 2025 deadline. This may involve switching to an FDA-approved GLP-1 and GIP medication like Zepbound or Mounjaro.
Potential Financial Concerns: Compounded versions were often more affordable than brand-name drugs, particularly for those without comprehensive insurance coverage. FDA-approved GLP-1 and GIP medications can be expensive, with retail prices for Zepbound averaging around $1,300 per month.
Patients will need to explore options for insurance coverage, drugmakers’ discounts, coupons, or patient assistance programs to mitigate the cost burden. Eli Lilly has introduced some discounted, direct-to-consumer options for Zepbound, but these may still be unaffordable for many.
Disruption to Treatment: Switching medication can take time and may require adjustments to routines and dosages. Some pharmacists are already discussing the situation with customers, with some not refilling prescriptions or starting new patients on compounded medications due to the impending changes.
Emotional Impact: Many patients are expressing worry, sadness, and anger over losing access to compounded tirzepatide, which has proven effective for their weight loss or blood sugar control.
Navigating the Transition: Tips for Patients
The transition away from compounded tirzepatide requires proactive steps:
Be Proactive: Schedule a discussion with your prescriber as soon as possible to explore FDA-approved alternatives.
Address Financial Concerns: Investigate insurance coverage, manufacturer discounts, and patient assistance programs.
Stay Informed: Keep informed of updates from reputable news sources and the FDA.
Consider Lifestyle Changes: Remember that weight loss medication is often most effective when combined with dietary changes, exercise, and regular medical check-ins.
Explore Alternatives: If one FDA-approved medication doesn’t feel right, discuss other options with your provider.
The Role of Healthcare Providers and Pharmacies
Healthcare providers and pharmacists play a crucial role in guiding patients through this transition. They can provide information about FDA-approved drugs, discuss potential side effects and contraindications, and help navigate insurance and cost-saving strategies.
Pharmacists (like Jennifer Burch of the Pharmacy Compounding Foundation) emphasize the importance of informing patients upfront about the temporary nature of compounded drugs when brand-name versions are in short supply. They advise against starting compounded medications if patients won't be able to access or afford the brand-name drugs later.
Industry Response and Legal Challenges
The FDA’s decision has not been without pushback. The Outsourcing Facilities Association (OFA) and the Alliance for Pharmacy Compounding have voiced concerns about the impact on patients and have pursued legal challenges.
The OFA filed lawsuits against the FDA’s decision to declare the shortages of tirzepatide and semaglutide over, arguing that this effectively constitutes a new rule requiring a more comprehensive regulatory process. While a motion to delay the enforcement of the tirzepatide compounding cessation was denied, legal challenges regarding semaglutide remain.
Drugmakers like Eli Lilly have also been active, sending cease-and-desist letters and filing lawsuits against clinics and spas distributing unauthorized tirzepatide. They have also petitioned the FDA to place GLP-1 receptor agonists on the “Demonstrably Difficult to Compound List,” which would further restrict compounding.
The Online Market and the Gray Area
Despite the impending deadlines, some telehealth companies and online platforms continue to advertise and sell compounded tirzepatide. Some argue that their formulations are personalized with different dosages or combinations with other commercially available drugs like vitamin B12, which they believe may exempt them from the FDA’s strict definition of an “essential copy”.
However, the FDA guidance is relatively clear on what constitutes a copy. Scott Brunner, CEO of the Alliance for Pharmacy Compounding, cautions that pharmacies continuing to prepare copies of tirzepatide injections after the deadline are taking legal risks.
Concerns have also been raised about a potential “gray market” where individuals attempt to buy the active ingredient from overseas and compound the obesity drugs at home. Healthcare professionals warn against this practice due to the challenges of ensuring sterility and safety for injectable meds.
