Compounded tirzepatide

How is compounded tirzepatide regulated?

Pharmacy compounding prepares a drug for a patient who cannot be treated with an FDA-approved medication [1]. A 503A pharmacy compounds tirzepatide without current good manufacturing practice requirements, while a 503B outsourcing facility is FDA-registered and must follow them [1]. Compounded drugs are not FDA-approved, so the agency does not verify their safety, effectiveness or quality before marketing [1]. As of April 1, 2026, tirzepatide is off the 503B bulks list and FDA's shortage list, more than a year after its shortage was declared resolved on December 19, 2024 [2]. Compounded medications are not reviewed or approved by the FDA for safety or effectiveness.

What are the risks of compounded tirzepatide?

Poor compounding practices can cause serious quality problems, such as contamination or a drug with too much or too little active ingredient, which can lead to serious injury or death [1]. FDA has received adverse event reports, some serious, tied to compounded tirzepatide doses beyond approved product labeling, with symptoms including nausea, vomiting and abdominal pain [3]. As of May 31, 2026, FDA had logged more than 730 such reports [3]. FDA is also aware of fraudulent compounded tirzepatide with false labels, including pharmacies that do not exist, and warns against any injectable GLP-1 drug that arrives warm or under-refrigerated [3].