The U.S. Food & Drug Administration announced on October 2, 2024, that the shortage of tirzepatide injection has been resolved. Previously listed as “Currently in Shortage,” its status is now “Resolved.” In contrast, semaglutide injections remain in shortage and may continue to be compounded until further notice.
What does this mean for compounding?
Tirzepatide injections, marketed under the brand names Zepbound and Mounjaro by Eli Lilly, can no longer be compounded by 503A Compounding Pharmacies or 503B Outsourcing Facilities, with limited exceptions (detailed below). For most prescribers and users of compounded tirzepatide, this change means they can no longer source compounded injections from pharmacies. Instead, tirzepatide must be obtained directly from the manufacturer, which will be expensive and potentially cost-prohibitive for many patients who have successfully used the drug for weight loss and other health improvements.
In its October 2 statement, the FDA reminded compounders of the legal restrictions on copying FDA-approved drugs. According to FDA guidance, 503B Outsourcing Facilities may gradually reduce production over a 60-day period following the cessation of the drug shortage (as of 10/02/24) to fill current orders. However, prescribers cannot continue to prescribe and order compounded tirzepatide during this ramp-down period. Orders must have been received while the drug remained on the shortage list. This means prescribers must quickly adapt their practices to comply with the FDA's compounding regulations.
Exceptions to 503A Compounding Regulations:
A drug product does not qualify for 503A exemptions if it is (1) essentially a copy of a commercially available drug product and (2) compounded regularly or in excessive amounts. These federal regulations can be complex, so consulting a lawyer is advisable to understand how they may impact your weight loss business.
Current shortage status of GLP-1 products (as of October 02, 2024):
Tirzepatide injection: Shortage resolved.
Dulaglutide injection: In shortage.
Semaglutide injection: In shortage. Manufacturer has reported all but one of the presentations are available.
Liraglutide injection: In shortage. Manufacturer has reported 2 presentations are available, and three have limited availability.
Source: U.S. Food and Drug Administration (October 03, 2024).
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