Update on Tirzepatide Shortage: Or is There One?

Per the mutually agreed upon motion filed on October 11, 2024, the Food and Drug Administration (“FDA”) and the Outsourcing Facilities Association (“OFA”) agreed to file a joint status report to the court updating on their progress on reconsidering whether Tirzepatide was in shortage by November 21, 2024. A link to the original complaint can be found here:

Since October 11, 2024, the entire industry has been wondering what was going to happen next. Most of the prudent marketers and medical professionals used this time to move to 503B produced Tirzepatide due to their flexibility in production post a “coming off the list” event, while others just crossed their fingers and followed the strategy of hope. An ill-advised and potentially dangerous strategy creates a significant number of medical challenges for those companies and their patients.

Well, when the Status Report came out on the afternoon of November 21st, the update was that there is… no update.

The Status Report which you can find here:

It states, “FDA has made substantial progress re-evaluating the challenged decision,”… “FDA is carefully assessing the challenged decision and continues to prioritize issuing a new decision.” Notice the last part “a new decision.” Basically, saying that they need more time.

While the OFA said it was monitoring Tirzepatide supply, it also stated: “Production of compounded Tirzepatide products by members of Plaintiff Outsourcing Facilities Association has remained steady or grown, reflecting still more market demand and medical need that is unable to be met by branded Tirzepatide products." Additionally, the OFA said: “Survey data from this month shows increasing numbers of patients unable to obtain branded GLP-1 agonist products, including specifically branded Tirzepatide products.” While also saying “Pharmacy distributors continue to list branded Tirzepatide products as out-of-stock or available in only limited quantities.”

The number of Americans currently being prescribed compounded GLP-1’s is unknown, but could be in the hundreds of thousands, maybe even the millions.

The challenge for the FDA today is how to determine that a shortage is over, and how to manage continuity of care for patients. While also wrestling with compounding pharmacies that are producing inferior products with suspect base ingredients and processes.

What’s Next? What to Do?

The FDA and the OFA said they would file another updated report by December 19, 2024, and we will keep our customers up to date. The delay is good news for patients currently prescribed compounded Tirzepatide and also good news for companies that are struggling to find a consistent and quality supply.

At BlueVaseRX we only offer the highest quality GLP-1’s on the market. Our GLP-1’s are made at our partner drug manufacturing facility and 503B Outsourcing Facility with the highest standards in the industry, the longest BUD dates and the ability to produce large batches. We are able to ensure continuity of care for your patients while giving companies peace of mind knowing that by offering our products, you will have the longest possible runway if and when an “off the list” event happens.

While 503A compounders are racing to the bottom, we are rising to the top of quality, safety and efficacy. If you aren’t a customer yet and you want to be one, please reach out today or fill out this information here and we will help protect your brand, your long-term sustainability and most importantly your patients’ health.