Short Takes: October 17, 2025

“An unacceptable state of compliance.” Novo Nordisk’s Bloomington, Ind., plant is still not in compliance with FDA standards, most recently earning itself an “official action indicated” label, which, as Fierce Pharma explained, “is the most severe of the three inspection classifications issued by the agency.” It’s not just a problem for the Danes; it’s causing consternation (and lower stock prices) for companies that were counting on contracting with the plant to make their own medications.

USP: Diversify or face the consequences. You might think of APIs as the basic ingredients of a medication, but first come key starting materials — KSMs, which are used to make those APIs. And, as USP’s “Quality Matters” blog explains, “58% of KSMs used for U.S.-approved APIs are sole sourced from a single country,” either China or India. It’s critical, they say, to be aware of and diversify that supply chain, because at the moment we’re risking being overly reliant on unreliable sources, risking shortages … or worse. 

B5 to bulks list? A new submission to the FDA by the Outsourcing Facilities Association nominates vitamin B5 (D-calcium pantothenate) for the bulk compounding list. “There is no commercially available drug form of the product,” said the submission (PDF). “Accordingly, there is a clinical need for a compounded drug product because there is no other way to formulate a product via pharmacy compounding.”

Visit us in the Big Easy. APC will be in booth 802 at NCPA’s Annual Convention and Expo in New Orleans Oct. 18–21, and you’ll also be able to catch Scott’s show floor presentation, “How GLP-1s Have Changed Compounding.” 

Unfilled GLP-1 prescriptions. It’s not just a few GLP-1 prescriptions that go unfilled — it’s 40 percent of them. That’s according to a new study out of Harvard; Axios has the story.

Reminders!

New England regional meeting. If you’re in the area, don’t miss APC’s next regional meeting: It’s Wednesday, November 12 from 4:30 to 7:30 pm EST in Deep River, CT. The entire event — dinner, networking, a compounding issues briefing, and a cocktail hour — is free thanks to Colanar. Register here. 

Webinar: New California regs. If you dispense to California patients, you won’t want to miss a three-part free webinar series, “California Compliance,” from our friends at LP3, covering the state’s new (and tweaked) regulations, especially the requirements for compounding pharmacies operating or dispensing in the state. Important stuff, and the first session is Oct. 28.

Does your state association want free money? The Pharmacy Compounding Foundation’s annual education grant application is now open for 2026 state association meetings! Click here for a PDF with the deets, then urge your state pharmacy association to apply by clicking here. Tell them not to wait — the deadline to apply is November 7 at 8:00 pm EST.