GLP-1 Drugs: FDA Removes Lilly’s Zepbound® and Mounjaro® (tirzepatide injection) from its Drug Shortage List

On October 2, 2024, the U.S. Food and Drug Administration (FDA) determined the shortage of the tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been “resolved”. The tirzepatide injection had appeared on FDA’s drug shortage list since December 2022. Although all available strengths of Lilly’s tirzepatide products Zepbound and Mounjaro have been listed as “available” since August 2, 2024, it has taken FDA an additional two months to determine that there is sufficient supply to allow removal from the drug shortage list. After removing it from the drug shortage list, FDA stated the following:

FDA confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand. Patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.

See FDA’s press release “FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize.”

Under current FDA guidance, a compounded drug cannot be “essentially a copy of an approved drug,” unless it meets an exemption (e.g., appearing on the drug shortage list). Essentially a copy means:

A drug that is “identical or nearly identical” to an approved drug, unless the drug appears on the drug shortage list; or
A drug, a component of which is a bulk drug substance (i.e., active pharmaceutical ingredient) that is a component of an approved drug, unless “there is a change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded drug and the comparable approved drug.” See Section 503B(d)(2)(A)-(B) (codified at 21 U.S.C. § 353b(d)(2)(A)-(B)).

Following the resolution of a drug shortage, a 503B facility has 60 days to dispense any orders it has already received, but the facility must stop taking new orders once the drug shortage is listed as “resolved.” FDA’s “Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act” guidance states the following:

FDA does not intend to take action against an outsourcing facility for filling orders that it received for a compounded drug that is identical, or nearly identical, to an approved drug that was on FDA’s drug shortage list at the time that the outsourcing facility received the order, provided the drug also appeared on the FDA drug shortage list within 60 days of the outsourcing facility distributing or dispensing the drug….

FDA may take regulatory action, however, if an outsourcing facility continues to fill new orders for the compounded drug after the approved drug is removed from FDA’s drug shortage list, or if it continues to fill orders more than 60 days after the drug has been removed from FDA’s drug shortage list.

With respect to possible enforcement of this policy, in FDA’s press release “FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize” issued on October 2, FDA stated: “FDA reminds compounders of the legal restrictions on making copies of FDA-approved drugs.”

This language suggests that FDA, in conjunction of with state Boards of Pharmacy may pursue enforcement action against compounders that continue to compound with this ingredient and possibly related combinations outside of the guidance and exemptions noted above.

Key Takeaways:

As of October 2, 2024, Lilly’s tirzepatide, the active ingredient in both Zepbound® and Mounjaro® was removed from FDA’s Drug Shortage database and listed as “resolved”.

FDA does not permit the compounding of a product that is “essentially a copy” of an approved product unless it appears on the drug shortage list.

Under current FDA guidance for 503B pharmacies, they are no longer permitted to accept new orders for tirzepatide that are essentially copies of the Lilly product. They are permitted to dispense orders that were received before the shortage resolved for the next 60 days.

In a press release issued by FDA on October 2, the agency stated: FDA reminds compounders of the legal restrictions on making copies of FDA-approved drugs.

Given that the shortage of tirzepatide has been resolved and FDA’s reminder of what can be legally compounded, this suggests possible enforcement in the future for continued compounding of tirzepatide and combinations.

We will continue to monitor this situation very closely. Foley is here to help you address the short and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group and Health Care & Life Sciences Sector with any questions.

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