Released: Compounding Pharmacy Snapshot
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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.)
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:
Let’s dispense with these particular claims quickly:
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:
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:
Click here for info and to register — and we’ll see you on the Hill!
The FDA is proposing a rule that would add categories to both the 503A and 503B demonstrably difficult to compound (DDC) lists — a plan that has a host of issues.
In a letter this week to the agency, APC laid out the majority of those issues, starting with the fact that the FDA doesn’t have the authority to make that kind of change to the 503A list. In short, “FDA’s intention to introduce categories to the 503A DDC list is not authorized by Congress; FDA does not have the statutory authority to add categories of products to the 503A DDC list.” Adding drug products, sure, but adding entire categories is not stipulated in the authorizing statute.
We pointed out other problems with the proposed rule. Terms like “complex” and “complexity” — both of which are used — are vague and subjective. It’s one thing to use them in conversation, but quite another to craft a regulation around them.
“We ask that the agency include specific limitations to define ‘complex’ and ‘complexity’ as used in the evaluation criteria,” we wrote, “and delineate exactly what level of complexity and evidence of potential adverse events would exceed the acceptable threshold.”
There are also the facts that 1) it isn’t clear when or whether the agency will allow public comments on the DDC lists, and 2) that there’s no procedure for removing items from the lists. And, of course, there’s no evidence any of the items the FDA plans to add to the DDC lists are even compounded by either 503A or 503B pharmacies — it’s a solution (and a poor one at that) without a problem.
You can read the full text of our letter here (PDF).