Short Takes: June 20, 2025

Our new Corporate Patron. Welcome, Madison, WI–based Pharmetika, APC’s newest bronze-level Corporate Patron and maker of the ElectricLab compounding system.

This week in Compounding Interests. Scott explains a nonsensical criteria the FDA uses to determine whether a substance qualifies for addition to its bulk lists: It wants evidence of clinical efficacy. The problem is, “under federal law, traditional compounding pharmacies aren’t allowed to make any efficacy claims about the compounded preparations they dispense.” Read the rest of “The illogic of demanding efficacy data — for drugs that can’t make efficacy claims.”

APC in the news: NPR’s article, “A new chapter for online sales of obesity drug alternatives tests legal limits” focuses on Georgia-based compounder OrderlyMeds and looks at how compounding pharmacies are offering GLP-1s in the post-shortage world. It quotes our own Scott Brunner to bring the story home and remind readers that there’s a lot of nuance in play. 

OFA v. FDA update(s). A federal judge has ruled that the FDA was in its right to declare an end to the semaglutide shortage, granting the agency a summary judgement in its case against the Outsourcing Facilities Association. But in case you think it’s over, OFA has appealed the decision to the Fifth Circuit Court of Appeals.

Trademark suit settled. Novo Nordisk and Apollo Health Optimization have reached a confidential agreement that ends Novo’s lawsuit against the company. The pharma giant has accused the Ohio clinic of trademark infringement for comparing its compounded products to Novo’s Ozempic and Wegovy.

Colorado PDMP decision. A new law in Colorado that affirms the right to gender-affirming care says that pharmacies do not have to report testosterone dispensings to the state’s prescription drug monitoring program, and it “blocks archived records concerning testosterone use from view.”