The landscape around compounded GLP-1 medications like Semaglutide and Tirzepatide is shifting fast—and independent pharmacies are caught in the middle. In a recent webinar hosted by Atrium24, pharmacy owner and founder Nicolette Mathey, PharmD, sat down with legal expert Dae Lee, PharmD, Esq., CPBS of Buchanan Ingersoll & Rooney PC to unpack what every pharmacy needs to know about the latest FDA updates and legal implications.
If you missed it, the full webinar is available now inside Dotti, the pharmacy marketing platform built by pharmacists, for pharmacists.
❌ Injunction Denied. FDA Enforcement is Here.
As Nicolette explained, “We were all kind of hopeful on the pharmacy side that the judge would allow a preliminary injunction… but the judge didn’t. Since that didn’t happen, the FDA came out and said in black and white: we’re going to enforce those dates.”
That means pharmacies can no longer rely on the courts to delay enforcement. The FDA is moving forward with its timelines:
- Tirzepatide: Enforcement began March 19th for 503B facilities.
- Semaglutide: Enforcement begins May 22nd for 503Bs, and April 22nd for 503As.
⚖️ Legal Gray Areas: What Pharmacies Can—and Can’t—Do
“There’s a lot of gray,” said Dae Lee, referencing whether pharmacies can dispense stock post-deadline. “From the conservative point of view, pharmacies shouldn’t dispense. But if the product was purchased before the cutoff and within normal patterns, they may be able to dispense to existing patients.”
Some pharmacies are exploring alternatives like adding ingredients or adjusting dosages to avoid producing a “commercial copy.” But this comes with legal nuance and is not encouraged. The added ingredients and/or dose change should be medically necessary and carefully documented. Dae advises, “The more annotation, the better” …to show the product is not essentially a copy and is medically necessary to the patient.
📎 Documentation Matters More Than Ever
Whether it’s shortage documentation, prescribing notes, or inventory tracking, Dae emphasized the need for airtight records. “Documenting a local shortage is definitely helpful,” he said. “In any regulatory or legal situation, those records can make all the difference.”
Nicolette added: “We’ve had providers write extended supplies due to uncertainty. If it’s medically appropriate—but pharmacies need to be prepared for that uptick.”
🗣 What to Tell Your Patients
Patients are confused and they’re scared of not being able to receive their medication. Many will turn to unregulated and untrusted sources if they lose access. This is where clear communication from your pharmacy becomes a powerful differentiator.
“We’ve seen patients panic-buy,” Nicolette said. “We’ve also seen shady companies pushing unregulated powders to providers. Patients are going to get hurt.”
That’s why Dotti includes customizable, pre-branded patient education materials to help you explain:
- Why access is changing
- What’s compliant and safe
- What alternatives may be available
💼 Strategies to Stay Competitive
Independent pharmacies need to walk a fine line—protecting patient access, remaining compliant, and staying profitable.
Dae shared: “Compounding GLP-1s has been a lifeline for many pharmacies. But with PBMs dominating the branded space and enforcing low reimbursement rates, the window is tightening.”
Nicolette emphasized a multi-faceted approach:
- Partnering with compliant 503Bs and 503As
- Documenting every step of procurement and dispensing
- Using Dotti to streamline marketing, patient communication, and prescriber outreach
🎯 Final Takeaway: Stay Informed, Stay Protected
As Nicolette closed the session, she reminded attendees: “Don’t ignore cease and desist letters. Don’t keep operating in the dark. And don’t try to figure this out alone.”
🎥 Watch the Full Webinar Inside Dotti
The full conversation, including Q&A, legal insights, and business strategy, is now available in Dotti Learn.
🔒 Dotti members can log in now to watch.🚀 Not a member yet? Start your 14-day free trial and access the webinar instantly:👉 Dotti Sign-Up Link
Dotti is your all-in-one marketing and sales platform designed to help independent pharmacies grow in a compliant, sustainable way.
📲 Stay compliant. Stay competitive. Stay connected—with Dotti.
This blog post is brought to you by Dotti, your partner in empowering independent pharmacies through advanced marketing and data analysis tools. With Dotti, transform the way you connect with prescribers and patients, and turn prescriber marketing into a cornerstone of your growth strategy. Learn more at www.atrium24.io