APC News

Demonstrably difficult list, demonstrably problematic

Published June 6, 2024

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). 

APC to CA BOP: How does this make patients safer?

Published June 6, 2024

The California Board of Pharmacy has proposed several new regulations for pharmacy compounding, some of which, to put it bluntly (and we did put it bluntly), are not rooted in science or evidence.

APC Chief Advocacy Officer Tenille Davis outlined our objections to these proposals in a presentation at a CA BOP public hearing this week. Her comments were a summary of APC’s comment letter to the agency about the proposal.

“In total we identify 57 specific places where the proposed regulations exceed what is required in federal law and by the compounding chapters of the U.S. Pharmacopeia,” she told the board. “In none of those instances has the board demonstrated how these excessive regulations make patients safer.”

Those 57 include California’s proposed prohibition on compounding with FDA Interim Bulks list items in Category 1, which includes glutathione, methylcobalamin, and DMPS; and stringent regulations on allergenic extract compounding that will adversely affect patient access.

In some cases, she explained, the proposed regulations would be difficult to comply with because they don’t match industry standards: “For example, excipient suppliers that must be FDA registered manufacturers, and the printed original manufacturer name and address being printed on the certificate of analysis of the API.”

You can listen to Tenille’s testimony here (4-minute MP3) or read it here (PDF).

Truth and GLP-1s

Published June 6, 2024

Compounded GLP-1 drugs. Perhaps you’ve heard about them?

Unfortunately, many are hearing a drugmaker-spun narrative about GLP-1 compounding that simply isn’t accurate, and in some cases, it’s downright nonsense. 

To help confront the issue — and set the record straight — we feature at the top of our homepage at a4pc.org a box containing links to accurate explanations about compounding and GLP-1s. It’s useful info not only for reporters, but for you, your team, and even (especially!) prescribers you work with. Give ’em a look, get briefed, and share. It’s the only way the truth about compounding will prevail.

When media does its job

Published June 6, 2024

Well check this out: A news story about compounded GLP-1s that’s actually accurate, sans all the usual hand-wringing and fear-mongering. It aligns pretty well with the message APC has been shouting from the rooftops, too. Coincidence? With all the effort we’ve put into that message, we think not, especially considering it quotes CEO Scott Brunner several times. Here’s a snippet:

Compounding pharmacies exist to help patients whose needs aren’t met by existing approved drugs. The compounded drugs are not generics, nor do they go through the Food and Drug Administration’s approval process. Instead, compounding pharmacists tailor drugs for individual patients who need them and are mostly regulated on the state level by boards of pharmacy.

 

For patients who want a quick primer on how they can be sure their compounded meds are safe, APC’s Scott Brunner has a video you should check out — and share far and wide.

The cover of the Rolling Stone?

Published June 6, 2024

Okay, not quite the cover, but APC has certainly been quoted in that and dozens of other publications over the past several months as the GLP-1 phenomenon has shone a bright light on pharmacy compounding. We ain’t bragging — well maybe a little — but below is a sample of some of the news organizations we’ve worked with (or are working with) to tell the real story of compounding:

GLP-1 misinfo affects you — here’s what to do about it

Published June 6, 2024

GLP-1 drugs are drawing attention to compounding pharmacists, thanks to lawsuits, fearmongering, baseless accusations from pharma manufacturers, and uninformed media reporting.

Learn what’s at stake and what APC is doing about it — and how you can help … even if you don’t compound them.

FDA listened, we spoke

Published June 6, 2024

The FDA held a listening session on the “Use and Processes of Advisory Committees” on Thursday. APC’s Tenille Davis and PCCA’s AJ Day were there. Our comments to the FDA covered our concerns about the agency’s Pharmacy Compounding Advisory Committee (PCAC). We want that committee to give greater consideration to the merits of compounded therapies, provide more transparency in its decision-making, and improve its engagement with stakeholders.

To give you the gist, here’s a quote from her presentation:

[T]here is a prevalent perception among pharmacists that the FDA does not give adequate consideration to the scientific and clinical merits of compounded therapies. Though the agency continually reminds the public about the risks associated with compounded medications, it rarely reinforces the proper and essential role compounded drugs play in our healthcare system and drug supply chain.

How does this protect patients?

Published June 6, 2024

In comments submitted earlier this week, APC took issue with provisions of proposed new compounding regulations from the California Board of Pharmacy.

“We have serious concerns about the Board’s proposed regulations and the ongoing failure of the Board to root its regulation and enforcement of compounding in applicable law and science,” the letter states.

In addition to a cover letter enunciating five broad concerns about the Board’s proposal and its oversight of compounding in general, APC submitted detailed comments on specific provisions of the proposal. 

During the board’s public hearing on June 18, 2024, APC’s Tenille Davis will present the association’s concerns. Members and licensees in the state of California are urged to register to attend either virtually or in person. Details here.

Tampa with us: It’s next Wednesday

Published June 6, 2024

APC will be in Tampa next Wednesday, June 12 for a CompoundED UpDATE regional meeting, made possible by a grant from PCCA. You can get two hours of live CE (on LDN benefits and restoring thyroid balance), a briefing on current compounding issues, the chance to network with compounders in your area, and a nice dinner — all for only $25. 

We only have 10 spots left, though — so register today, or you could miss out.

ALSO: Please come to Boston (for our dinner)

Topi-CLICK is sponsoring an APC ‘Compounder Get-Together” on the evening of June 18. It’s hosted at Acton Pharmacy. No CE, but you’ll still get dinner, networking time, and a compounding issues briefing. Registration closes next Friday, so don’t dilly-dally. Register here.

Ketamine? GLP-1s? We’ve got tips for you

Published June 6, 2024

We’re less than six weeks from EduCon 2024, APC’s hot-topics-and-best-practice webinar series for compounding pharmacists and technicians. It’s six hours of great training – two hours, three sessions, over a three month period – from some of the best presenters in compounding.

The first session, on July 15, is with Tenille Davis, a board-certified sterile compounding pharmacist and member of the Arizona State Board of Pharmacy with 16 years of experience in compounding pharmacy operations under her belt. She’ll cover best practices for ketamine and GLP-1 compounding — from some of the best presenters in the industry.

The other two sessions are:

  • August 19: Practice Pearls for Line Pharmacists and Technicians: USP 795, 797, and 800 – Michael Shafor, PharmD; LP3 Network
  • September 23: Law: Helping Prescribers Navigate Compounding’s Regulatory Environment; and Patient Safety: What 795 Doesn’t Talk About – Matt Martin, PharmD, BCSCP; PCCA

It’s a package deal: One great fee for six great hours. Oh, and employees of PFM members get discounted pricing.

What are you waiting for? Register today.

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