The Mamas and the Papas said you can’t trust Mondays, but that’s not always true. You can count on two things happening today, July 15. Whether you take advantage of them is up to you — but I hope you do. read more →
APC has just released the 2023–2024 edition of our Compounding Pharmacy Snapshot — a slick overview of the practice of pharmacy compounding in the US of A. read more →
Take our July 15 session (really, you should take it) where APC’s Tenille Davis is covering two of today’s critical topics: Best practices in both ketamine and GLP-1 compounding. read more →
Registration is open for Compounders on Capitol Hill! If you’re planning to attend, the sooner you register the better because we’re starting to schedule visits with legislators, and we want to be sure you’re included. read more →
APC CEO Scott Brunner and PCCA’s A.J. Day attended a forum in Washington, D.C., on the emergence of ketamine as an area of therapeutic interest. read more →
APC is always keeping track of what state boards of pharmacy are up to, and we’ll reach out when we think something needs clarification. Here’s a sampling of the kind of letters we’ve sent recently. read more →
You can count on two things happening today, July 15.Whether you take advantage of them is up to you — but I hope you do.
Today is the last day to get early-bird registration rates forAPC’s Compounders on Capitol Hill 2024. Come tomorrow, you’ll pay more to register — and boy, do we need you to register. Among issues we’ll be discussing in Hill visits with members of Congress are:
Eliminating the MOU in law and replacing it with mandatory reporting
Creating a 503A adverse events reporting framework
Preserving compounded hormone therapy
Expanding the definition of drug shortages to help APC better anticipate them (and to help compounders fill the gap).
It’s 24 hours in Washington, DC that can make a big difference for your practice and patients. You can register now or later, but do it now and you’ll save money.
• • •
This evening is the first live session of EduCon 2024, APC’s three-part ethical compounding webinar series. It’s a total of six CE hours via three webinars over three months. And it’s great practical training for your team. Monday’s topic: Ketamine and GLP-1 compounding best practices with APC’s Tenille Davis. You can attend live or take the session on your own schedule. But you have to be registered to do either one. So get going.
Every other day of the week is fine, yeah. But you can trust that if you register for these two today, you’ll be ahead of the game.
Bah-da bah-da-da-da.
—Scott
Scott Brunner, CAE, is APC’s chief executive officer. You can reach him at scott@a4pc.org.
APC has just released the 2023–2024 edition of our Compounding Pharmacy Snapshot — a slick overview of the practice of pharmacy compounding in the US of A.
The snapshot is a tool to provide a solid background and understanding of compounding, especially 503As — it’s perfect for sharing with policymakers, media, prescribers, and anyone else who could benefit from a primer on the practice.
The data are based on APC’s member survey from late 2023, and the project was made possible in part with the generous support of APC corporate patrons Fagron, Medisca, and PCCA.
EduCon: It’s more than APC’s “Ethical Compounding Conference” — it’s where compounding pharmacists and technicians can keep up with the latest best practices.
This year we’ve got a new format that doesn’t require you to set aside two days for professional development. We’ve restructured EduCon as a LIVE virtual learning series — and one that’s even going to be available on demand.
Over three evenings — one each in July, August and September — you can learn the latest on the hottest topics in compounding from some of the best presenters in the industry and earn six hours of CE credit while you’re at it.
Take our July 15 session (really, you should take it) where APC’s Tenille Davis is covering two of today’s critical topics: Best practices in both ketamine and GLP-1 compounding. It’s a deep dive into everything you need to keep in mind to handle compounding those two medications ethically, safely, and legally.
August 19: “Practice Pearls for Line Pharmacists and Technicians: USP 795, 797, and 800” with Michael Shafor, PharmD; LP3 Network
September 23: Law: Helping Prescribers Navigate Compounding’s Regulatory Environment” and “Patient Safety: What 795 Doesn’t Talk About” both with Matt Martin, PharmD, BCSCP; PCCA
Click the big image above or head over to a4pc.org/educon for the details and register today!
Registration is open for Compounders on Capitol Hill! If you’re planning to attend, the sooner you register the better because we’re starting to schedule visits with legislators, and we want to be sure you’re included.
CCH — September 17–18 this year — is our annual fly-in to DC and those face-to-face meetings are critical. They show legislators that compounders are concerned enough about their patients and practices to fly in to meet with them.
You’re not going in cold! We’ll update you with talking points on key issues like enhancing the FDA shortage list, eliminating the MOU in federal law, implementing adverse events reporting for 503As, and of course preserving compounded-hormone therapy.
APC CEO Scott Brunner and PCCA’s A.J. Day attended a forum in Washington, D.C., on the emergence of ketamine as an area of therapeutic interest, sponsored by the Reagan-Udall Foundation for the FDA. The best part: AJ was part of a panel discussion regarding APC’s ketamine compounding best practices document.
APC is always keeping track of what state boards of pharmacy are up to, and we’ll reach out when we think something needs clarification. Here’s a sampling of the kind of letters we’ve sent recently. (The links go to PDFs of the letters.)
To both North Carolina and New Jersey: Both states’ boards of pharmacy recently expressed concerns regarding compounding pharmacies dispensing sublingual semaglutide (based on crushed Rybelsus tablets), so we explained why this “is a legitimate compounding practice rooted in the Food, Drug and Cosmetic Act.”
To Mississippi: We submitted comments supporting the proposed physician dispensing facility permits that will require compliance with USP: “This will help ensure patients receive compounded medications made under the same conditions from both pharmacies and physician’s offices.”
To Virginia: We submitted comments on the state’s current technician licensing requirements. Virginia requires technicians attend ACPE/ASHP accredited technician training programs, and the expense of that program has resulted in a workforce shortage in the state. We urged the BoP to consider alternative training programs.
Remember, you can always keep up with what’s happening with our weekly recap email covering what’s happening at the state level, or visit our state-level resources page — both are members-only benefits from APC.
We blasted through our expectations for our virtual town hall on compounding semaglutide on June 26, with almost 700 people registered.
We explained not only how some drug makers are trying to muddy the waters about legit (and legal) pharmacy compounding of GLP-1s, but what APC has been doing to correct these “alternative facts” in the media. (Reporters are getting better — see “Short Takes” below.)
That kind of misinformation is a problem not just for pharmacies compounding semaglutide, but for all compounding pharmacies, because it tarnishes the entire profession’s reputation. That’s why we’re being proactive with the media, and why we’re sharing best practices for marketing if you’re compounding any GLP-1s.
Didn’t have a chance to attend? No worries — we’ve got you covered: Click here to watch the town hall from the comfort of your favorite hotspot.
APC Board Chair Joe Navarra, pharmacist Ndidiamaka “Didi” Okpareke, Chief Advocacy Officer Tenille Davis, lobbyist David Pore, and CEO Scott Brunner were in Washington, D.C.’s Rayburn building on June 25, briefing about four dozen House of Representatives healthcare staffers on the practice of pharmacy compounding — and clearing some of the muddied waters.
Didi opened the briefing with an intro to pharmacy compounding, then Scott, Joe, and Tenille talked specifically about GLP-1 compounding, including recent lawsuits against compounders. Most importantly, they explained the regulatory framework for compounding — something that’s often glossed over in mainstream coverage of the practice.
Keeping in mind the audience, David got into the nitty-gritty with some details about potential bills that could allow pharmacy compounding to step in during drug shortages — a critical issue as the country faces record levels of medications in shortage.
Maintaining this kind of connection with legislators and their staff is how we — APC and its members — protect the practice of pharmacy compounding.
The “…and its members…” part is important, and that’s why you need to join hundreds of APC members in Washington on September 17–18 for Compounders on Capitol Hill. Our voices are louder together!
We learned a couple weeks ago that several compounding pharmacies have received a cease-and-desist letter from a law firm representing Eli Lilly.
The letter says the pharmacy is selling compounded tirzepatide that “pose[s] serious risks to the American public.” We’ve seen a handful of those letters, and though each appears to allege specific illegal marketing claims by the individual pharmacy to which the letter is addressed, those pharmacy-specific allegations are inserted into what appears to be a form letter.
That form letter makes some pretty astonishing allegations, many of which, to my non-lawyer thinking, are demonstrably false, maybe even nonsensical.
To wit:
They accuse the pharmacies of “attempting to sell mass-manufactured drugs without any of the safety protections that apply to FDA-approved commercial manufacturers.”
They assert that the FDA’s “essentially a copy” guidance “does not apply to medications that are listed as ‘available’ on the FDA shortage website.”
They state that compounders “cannot distribute compounded drugs out-of-state in quantities that exceed 5% of orders dispensed.”
They state that FDA has “issued multiple warning letters to compounding pharmacies purportedly selling compounded tirzepatide products because they are not safe or effective.”
Let’s dispense with these particular claims quickly:
Pharmacy practice acts in every state differentiate compounding from manufacturing, and the small-business pharmacies to which this letter has been sent — at least the ones I’ve heard about based on what we know about their businesses — are doing patient-specific dispensing and certainly are not engaging in “mass manufacturing.”
FDA’s “essentially a copy” guidance applies to medications that are listed as “currently in shortage” on the FDA shortage website — not “available” – and FDA has stated on-the-record that semaglutide and tirzepatide injectables meet that definition at present.
Traditional compounding pharmacies don’t “distribute” anything. They dispense, and FDA has long stated it will not enforce the 5% limitation on out-of-state shipments until an MOU with states is finalized.
Those warning letters from FDA were sent to entities claiming to be compounding pharmacies, but they weren’t pharmacies at all. They were illegal operations posing as pharmacies, and the agency was right to shut them down.
I suspect Lilly’s lawyers know that some of their claims in these letters are hooey. Perhaps they’re meant to scare the recipient into ceasing shortage-drug compounding of GLP-1s. Still, I suspect it can be jarring for a pharmacy owner to receive one. So yes, if you’re one of those recipients, get a lawyer.
As for those of you who are not compounding GLP-1s during this prolonged shortage: These letters are an assault on you, too – on your ability to serve patients by preparing copies of any FDA-approved drug when the drug is on the shortage list.
So: Keep your noses clean. Mind your marketing claims. And above all else, keep serving those patients.
We’ll have more to say on this topic on June 26 at our Town Hall on GLP-1s. You can register here.
— Scott
Scott Brunner, CAE, is APC’s chief executive officer. You can reach him at scott@a4pc.org.
Demonstrate your commitment to your patients and practice at APC’s annual DC fly-in for pharmacy compounders, September 17-18 at Hilton National Mall.
It’s 18 hours that can make a big difference for your compounding practice and patients.
On the agenda:
Meet with your members of Congress. Show ’em you’re concerned enough about your patients and practice to fly to DC to meet with them.
Key issues include enhancing the FDA drug shortage list, eliminating the MOU in federal law, implementing adverse events reporting for 503As, and preserving compounded hormone therapy.
Learn the latest from policymakers and influencers from FDA, Congress, and industry.
Network with your fellow compounders. There’s strength — and idea-sharing — in numbers.
NEW! Prior to kicking off CCH, we’re hosting APC’s first ever three-hour Legal Issues in Compounding symposium. It’s 7:30 – 11:30 am on Tuesday, September 17, a separately ticketed event including:
