FDA removes tirzepatide from drug shortages list
Implications for compounding pharmacies and medical weight loss providers
Last updated: November 22, 2024 5:22 pm ET.
On November 21, 2024, the U.S. District Court for the Northern District of Texas released a joint status report in the case Outsourcing Facilities Association v. U.S. Food and Drug Administration, highlighting:
FDA is still reevaluating whether tirzepatide should be on the drug shortage list. A further status update is expected by December 19, or within seven days of the FDA reaching a decision on the issue.
Tirzepatide can be temporarily compounded. The case remains stayed as per the Court's October 11 order, which means for the time being, compounding pharmacies can continue to sell tirzepatide.
As of October 11, the FDA agreed to reconsider its decision to remove tirzepatide from the shortage list. The agency will allow compounding pharmacies to continue providing the drugs while it reevaluates.
We will continue to update this post as more information becomes available.
We are creating a consortium of cash-pay providers to collaborate with Eli Lilly and other pharmaceutical companies on negotiating pricing for weight loss medications. If you’d like to join to strengthen our collective voice, please email us at info@ottohealth.io or fill out the form below.
As of October 2, 2024, the FDA has removed tirzepatide from its drug shortage list. This means that compounding pharmacies can no longer produce exact copies of the ingredient, and it may also mean that certain patients will no longer have reliable access to the medication.
Given that many providers offer cash-based medical weight loss programs using compounded tirzepatide, this change is likely to have meaningful impacts on practice operations and patient experience. Below we share more information on:
Why is tirzepatide being removed from the FDA shortage list?
What are the implications of tirzepatide being removed for cash-pay providers and patients?
How are compounding pharmacies reacting to the FDA decision?
How are national weight management companies like Ro and Hims responding to the FDA decision?
What can cash-pay providers do to ensure continuity of care for their patients on compounded tirzepatide?
1. History of tirzepatide on the shortages list
Eli Lilly, the pharmaceutical company that patented tirzepatide, uses this medication as the active ingredient in two of its most popular medications: Mounjaro and Zepbound. The former is for patients with type 2 diabetes and was introduced in late 2022, and the latter is for patients with obesity and was brought to market in late 2023.
These medications have been in high demand for the past several years, leading to a supply shortage. In cases where there is more demand for an FDA-approved drug than the drug’s manufacturer can meet, the FDA will put that drug on its drug shortages list. When a drug is on this list, compounding pharmacies can create compounded versions of that drug, which are basically copies of the original drug.
Tirzepatide has been on the drug shortages list for nearly two years, since late 2022. Compounding pharmacies have stepped in to fill the supply gap in that time. This week, Eli Lilly informed the FDA that it has enough manufacturing capacity to handle current and future tirzepatide supply needs, resulting in the drug getting removed from the shortages list.
2. Implications for cash-pay providers and patients
This shortage, along with a lack of insurance coverage for the brand-name versions of tirzepatide, has proven beneficial for cash-pay medical weight loss providers. While brand-name Mounjaro or Zepbound can cost several hundreds or thousands of dollars, the compounded version of these medications are far more affordable since the drug itself is not very expensive to manufacture.
This lower price point has allowed providers to prescribe and patients to access tirzepatide even without insurance coverage for the medication.
Compounding pharmacies are working through how to comply with FDA regulations without stopping the production of tirzepatide. Compounding pharmacies may be able to continue creating compounded versions of medications by:
Modifying the dose: This might look like creating custom doses not offered by Eli Lilly.
Adjusting the medication formulation: This could mean changing the base ingredients or excipients, such as removing allergens like dyes, lactose, gluten, or preservatives.
Creating alternative forms: This could entail producing the medication in a different, non-injectable form not offered by Eli Lilly.
Combining medications: This might include combining multiple active ingredients into one formulation.
Developing custom release profiles: This means changing when or how the medication is released into the body (e.g., developing a custom immediate-release or extended-release version).
If compounding pharmacies are no longer able to offer tirzepatide with such competitive prices, cash-pay providers may have to explore moving patients to other compounded medications like semaglutide and liraglutide.
Even though Eli Lilly now has adequate supply to meet the demand, it is unlikely that prices for the name-brand medications will be meaningfully reduced because of U.S. patent and exclusivity regulations, pharmacy benefit manager (PBM) incentives, and a lack of negotiating power against pharmaceutical companies.
We will continue to update this information as we learn more.
3. What compounding pharmacies are saying
The Alliance for Pharmacy Compounding
"Pharmacies must immediately cease preparing and dispensing compounded copies of Mounjaro, Zepbound"
Belmar Pharma Solutions
"According to FDA, when a drug on the FDA Drug Shortage List indicates that the shortage is ‘resolved,’ compounding pharmacies must immediately cease compounding the copy of the manufactured drug.
These regulations affect ALL compounding pharmacies.
Belmar Pharmacy adheres to all FDA regulations regarding compounding drugs on and off shortage."
Town & Country Compounding
"Can I prescribe or get tirzepatide injections filled at your pharmacy?
Not at this time. Mounjaro and Zepbound (tirzepatide) were just removed from the FDA shortage list and therefore, can no longer be compounded.
We can contact your prescriber to request a prescription for semaglutide instead. Another option is you can try to find the commercial product at a traditional retail pharmacy."
Empower Pharmacy
Nothing, although yesterday Empower announced price reductions on GLP-1s. Tirzepatide is still available on its website.
Hallandale Pharmacy
Nothing. Tirzepatide is still available on its website. As of October 4, providers are reporting they are unable to place tirzepatide orders and/or having orders cancelled.
Olympia
As of October 4, Olympia says it will continue producing and selling for the next 60 days. Tirzepatide is still available on its website, but not mentioned on its drug shortage list.
American Wellness Pharmacy
Nothing. They plan to continue compounding a different strength than advertised by Eli Lilly.
Wells Pharmacy Network
Nothing.
Southend Pharmacy
Nothing. Tirzepatide is still mentioned on its website.
South Lake Pharmacy
Nothing.
4. What direct-to-consumer (DTC) companies offering compounded tirzepatide are saying
Ro
Removed compounded tirzepatide from their list of weight loss offerings. The compounded tirzepatide page now leads to a page without any purchase options.
Hims
Although they do not offer compounded tirzepatide, but their stock still fell almost 10%. A Hims spokerperson told the Wall Street Journal, “products that are not essentially copies can continue to be made.”
Henry Meds
Nothing. Compounded tirzepatide is still advertised on their website.
Alan Meds
Removed compounded tirzepatide from their offerings.
Eden
“Eden can no longer offer access to pharmacies to fulfill compounded tirzepatide prescriptions…we are committed to ensuring a smooth transition to other weight loss alternative treatments, including compounded semaglutide.”
5. What cash-pay medical weight loss providers can do
At Otto Health, we support several clinicians using compounded medications to offer cash-pay medical weight loss programs.
We are forming a consortium of cash-pay medical weight loss providers in order to work with Eli Lilly and other pharmaceutical companies on weight loss medication pricing. Our goal is to amplify our bargaining power, making it more likely to achieve favorable pricing and terms that individual practices might not be able to secure on their own. The more providers that join, the stronger our collective voice becomes, leading to potential cost savings for your practice and patients.
If you’d like to join, please email us at info@ottohealth.io or fill out the form below.
Additional resources
WSJ: Eli Lilly’s Weight-Loss, Diabetes Drug Shortages Are Over, FDA Says
NYT: Mounjaro and Zepbound Are No Longer in Shortage, F.D.A. Says
FDA: Compounding when Drugs are on FDA’s Drug Shortages List
FDA: Frequently Asked Questions about Drug Shortages
BioPharma Dive: FDA makes end of Zepbound, Mounjaro shortage official
Sign up for FDA updates here
This is intended solely for general informational purposes. It does not constitute legal or medical advice.