APC was thrilled when the FDA announced it was taking action against illegal online businesses claiming to sell “research-grade” compounds. read more →
This week APC offered its final (and pointed) suggestions to the California Board of Pharmacy on their proposed significant – and we would say unjustified – changes to their compounding regulations. read more →
The voice for pharmacy compounding | March 11, 2022
➤ From APC’s President
SWOT, Part 4
Last week, I addressed APC’s greatest weakness: membership. (Did you make your one call?)
The “O” in SWOT stands for opportunity.
APC has many, many, many opportunities. I could write a series on this one alone. Our future is bright. Let’s talk about the positive direction of our alliance.
Membership. As I pointed out last week, we have tremendous opportunities to increase membership. To that end, in a few weeks APC will roll out an exciting new membership model, and we’re working on adding prescribers and patients to our rolls as well. Stay tuned.
Working with Tricare. It is no secret that the relationship between compounding pharmacies and Tricare has been strained. But that‘s starting to ease as APC works with the Defense Health Agency to build a better working relationship — one that will address Tricare’s concerns without sacrificing compounders‘ ability to care for current and former service members.
Working with FDA. Our sometimes-contentious relationship with FDA has been thawing, giving us a great opportunity to reach a consensus — understandings on the issues that are acceptable to both sides. We’ve already begun sitting down with higher-ups at the agency in ‘listening sessions,’ and APC has begun proposing new and innovative solutions to several key issues.
Expanding our relationships in Congress. Our political action committee (CompPAC) continues to do well, and we’ve built some strong relationships with law makers. Last year was a record year for PAC investments, and — with the midterm election looming — I’m confident we will break 2021’s fundraising record. (Hint: Give to CompPAC here.)
Saving cBHT. With potential FDA action hanging over us, APC’s Campaign to Save Compounded Hormones is perhaps our biggest opportunity this year — the second of the campaign. To meet 2022’s challenge we‘ll need to raise an additional $800,000 over last year’s $1.5 million. We know the campaign works. We just have to keep the funding going.
Increasing the professional standing of our technicians. Compounding pharmacies live and die by their technicians — we couldn’t care for our patients without them. It is my goal to give them more of the respect and recognition they deserve, starting with the first technicians honored as APC fellows at Compounders on Capitol Hill in September.
I could go on and on and on. The opportunities for us are tremendous in the next few years. Please join me in helping APC realize those opportunities.
David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at drdave@keystonepharm.com.
➤ This Week
FDA plans final version of GFI #256
Earlier this year, seven members of Congress wrote to FDA, asking that the agency release the next version of its Guidance for Industry #256 on animal compounding as a draft rather than a final GFI.
On Wednesday, FDA responded to that letter with one of its own. Notably, the agency says the guidance will be final when it’s issued — not a draft as requested. (And it’s expected soon.) But that final version, FDA says, has been substantively amended based on stakeholder input.
We look forward to learning exactly what that means.
Don’t miss out newest CE webinar
Just the cBHT facts, please
Last week, hundreds of cBHT prescribers received an email that purported to brief them on the threat to compounded hormones. It even urged them to go to compounding.com and send a message to their members of Congress (and maybe leave a testimonial on the way out). Many, many of the recipients did exactly that.
Problem: The email — which did not come from APC — had some misleading information, and it may have come across as crying wolf. The wolf is out there, make no mistake, but this message jumped the gun. It said FDA has announced plans to restrict compounded hormones. In fact, while FDA has dropped strong hints to that effect — stating it will base its next steps on that discredited NASEM report — no plans have been announced. (You would have heard from us if they had!)
The nuance matters: FDA has made no announcements and has taken no action thus far to restrict cBHT. To suggest they have — particularly to suggest it to members of Congress — undermines APC’s credibility. So please, take care how you portray this threat: We firmly believe restrictions are coming. But they haven’t yet been proposed.
However: That inadvertently inaccurate email last week was apparently a wake-up call to the prescribers who received it. Many rushed to compounding.com to send messages to Congress and alerted their patients to do the same.
That’s exactly what we need them doing BEFORE FDA ACTS: We need prescribers to engage and help us confront this threat.
We’ve got three resources to help you engage YOUR prescribers (and patients!) in confronting this very real threat to compounded hormones.
Share this short .pdf with all the cBHT prescribers you work with. It’s accurate and to-the-point about FDA’s implicit threat and how prescribers can help confront it. It ought to light a fire under ‘em.
Here’s a quick look at the campaign, including what we accomplished last year (as in raising $1.5 million and reaching 25 million Americans), how the money we raised last year was spent, and our plans for the $850,000 we need to raise by the end of April 2022 to continue the effort.
Here’s where you’ll find tools and resources to help reach patients and prescribers — window clings, bag-stuffers, posters, and more. They’re all free, by the way. Use them to spread the word to patients and prescribers about the threat!
And don’t forget what may be the most important thing of all: Invest NOW in the campaign.
Two new Corporate Patrons join APC
Please welcome — and visit — our two newest Corporate Patrons:
When will the flu come to your town?It’s all about the humidity, says NASA, and it varies by state. When the humidity gets below a certain point, two weeks later the flu breaks out. (NASA gives absolute humidity. This calculator will convert it to good ol’ relative humidity based on temperature.)
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