Mid-Atlantic Health Law TOPICS

Ozempic® is the band name of one of the increasingly available glucagon-like peptide-1 (GLP-1) receptor agonists, created to treat Type 2 diabetes but increasingly used to promote extreme weight loss. GLP-1s include semaglutide (brand names Ozempic®, Wegovy®, and Rybelsus®) and tirzepatide (brand names Monjaro® and Zepbound®), two drugs that, until recently, were on the Food and Drug Administration’s (FDA) shortage list.

When a drug is placed on the FDA’s shortage list, compounding pharmacies, physicians, and manufacturers can create what is essentially a copy of the drug for sale. However, once a drug is no longer on the shortage list, the only generic compounding permitted is on a patient-by-patient basis for reasons of medical necessity (such as for a patient who is allergic to a particular ingredient in the commercially available drug).

Importantly, the FDA does not evaluate compounded generic, shortage drugs for efficacy or safety. Since 2022, when the GLP-1s went on the shortage list, the FDA has received numerous complaints about the quality of compounded generic GLP-1s available in the market, including dosing issues, inclusion of unapproved ingredients, and use of the wrong form of semiglutide, leading to adverse events.

In late 2024, the FDA announced that it would be removing tirzepatide from the shortage list. In early 2025, the FDA similarly announced that it would also be removing semaglutide from its shortage list. This action prompted a lawsuit by a trade association representing outsourcing facilities that want to continue compounding the drugs, arguing that the FDA’s decision to remove these two GLP-1s from the shortage list would negatively impact patient access.

In Spring 2025, the reviewing court sided with the FDA, denying the trade association’s motion for a preliminary injunction to stop the FDA from removing the drugs from the shortage list. The trade association has appealed the denials; however, in the meantime, the FDA moved forward with the following actions.

Tirzepatide

Those operating under state board of pharmacy oversight and issuing patient specific prescriptions (state-licensed pharmacies or physicians, or 503A compounders) were required to cease compounding tirzepatide as of March 5, 2025.

Outsourcing facilities who are registered and regulated by the FDA to compound and who manufacture large batches of sterile compounded medications for health care entities, which include drugs that are essentially a copy of an approved drug (or 503B compounders) had until March 19, 2025, to cease compounding tirzepatide.

Semaglutide

503A compounders were required to cease compounding semaglutide as of April 24, 2025, and 503B compounders were required to cease compounding as of May 22, 2025.

It is possible (but unlikely) that the appellate court will issue a decision that allows for an injunction of the FDA’s removal of the drugs from the shortage list. However, currently, any compounding pharmacies that still offer compounded GLP-1s outside of a suitable exception are risking FDA enforcement action and potential malpractice exposure.

Similarly, because the FDA is concerned with adverse reactions from the drugs and improper dosing, prescribers could face liability for failure to properly disclose the risks and benefits of these drugs or ensuring that the medication is appropriate for the patient.

Also, the result of the FDA taking these drugs off the shortage list means that patients will only be able to get brand name versions of the drugs at likely even higher costs.

Darci M. Smith
410-576-4153 • dsmith@gfrlaw.com