A4PCnews

Hey you, look for APC’s Compounder Survey!

APC has launched its first-ever survey of compounders, in conjunction with the University of Mary Washington — canvassing more than 19,000 pharmacists, technicians, and others involved in pharmaceutical compounding.

The goal: The first comprehensive picture of the breadth and depth of compounding in the U.S.

Your answers will be crucial for informing policy makers, media, and even APC’s advocacy efforts.

The 10-minute survey will collect data on practice areas, the scope of your compounding (and how that has changed), the size of your business, and similar areas, as well as basic demographics.

If you’re a member of the compounding community, take the survey now!

Sneak video peek at the cBHT campaign

Part of APC’s big media campaign to save compounded hormones are deeply moving testimonial videos — real patients’ stories, read by professionals, to show how their lives have been improved. They’re just one tactic in the multi-pronged campaign we’re planning.

Check out one of those videos right now (but please, don’t share them yet — we’re hoping to make them part of a big public unveiling):

But there’s one little problem…

The videos are ready. The website, too. Ads — print and digital — are in the hopper. We’ve even got materials you can display in your pharmacy:

We raised $881,000 to create the content — to pay the models, the photographer, the videographer, and the designers.

But investments in the campaign have stalled. On the cusp of launching, we need the rest of our $1.5 million goal (about $619,000) to fund it.

If the funding stops, all this wonderful content sits gathering virtual dust.

That $819,000 came from only 15% of APC members and a handful of supportive vendors. We need you, the other 85%, to help. (Some of you must rely on compounded hormones for a good part of your business!)

If you haven’t invested in this campaign — in, really, the future of your business — think about what restrictions on compounded hormone therapy could mean for you and your patients, and invest now. It takes only three minutes, and we need and appreciate your support … urgently.

ICYMI: Remember to help spread the word about the cBHT media campaign. We’ve got a great four-page brochure you can download and print to share with the vendors and prescribers you work with. It explains why compounded hormones are under threat, how that will hurt their patients, and how APC plans to protect it. And it urges them to contribute to the effort.

Three new resources for your grassroots advocacy

One of APC’s 2021 priorities is to make more connections between compounding pharmacists and both legislators and the boards of pharmacy of all 50 states — one-on-one meetings, pharmacy tours, and positioning compounders as the go-to resource for questions related to pharmacy laws and regulations.

Working with attorney Stephen Snow and his team at Bendin, Sumrall, and Ladner, we’ve developed some new grassroots resources to help. Grab them below, or find them on A4PC.org/stateside.

APC’s goal is to have 12 congressional visits hosted among its member pharmacies during the year. Visits are one of the best ways to build relationships and bring attention to the issues faced by the compounding community. Check out Hosting A Pharmacy Visit With Your
State Or Federal Legislators and talk to us about scheduling one!

Reminder: Briefing on PCF’s independent NASEM analysis

The independent analysis of the NASEM cBHT report commissioned by the Pharmacy Compounding Foundation will be released in the next couple of weeks. It should serve as a counterweight to the deeply flawed, FDA-manipulated NASEM report.

The foundation is holding a live briefing to roll out that analysis, explain our next steps, and answer any questions. That’s on Tuesday, April 20 at 3:00pm EDT via Zoom. It will be open to all.

WSJ, others, pick up APC’s small-biz coalition

Check it out: The Small Business Rising coalition, of which APC is a member, was the subject of a WSJ story, “Amazon Is the Target of Small-Business Antitrust Campaign” — one that was picked up across the business world, in magazines like Inc. and in newspapers of the Bloomberg network.

APC asks FDA for clarification on HCG

As a result of legislation that took effect in March of last year, FDA stated that drugs transitioning to biologics would no longer be eligible for the exemptions for compounded drugs under the Food, Drug, and Cosmetic Act.

For compounders, that announcement seems inconsistent with existing law and with FDA’s own 2018 guidance (the Mixing/Repackaging Biologics GFI).

That guidance made clear that its provisions for biologics did not apply to drugs ‘for which a marketing application can be or has been submitted under section 505 of the FDCA.’ One good example: HCG. It has a USP monograph and is not on the demonstrably difficult list; it should be eligible for compounding.

All this in mind, APC submitted a comment letter to FDA this week asking for it to clarify these seemingly contradictory statements, and to “reconsider and rescind the March 23, 2020, notice until such time that FDA can work with stakeholders on a new GFI on this subject.”

Our letter follows a similar request of FDA from the Outsourcing Facilities Association. In addition, APC and OFA have jointly requested a meeting with FDA officials on this subject.

You can view or download this week’s letter here.

Reminder: Briefing on PCF’s independent NASEM analysis

cBHT campaign launches next week!

You’ll have to wait to see the big rollout (we’re still putting the finishing touches on some of the artwork and videos), but we’ve got some samples for you:

Owner Summit — you shoulda been there

APC’s first ever Owner Summit was a bigger success than we could hope for. More than 100 people came to Jekyll Island, along with almost a dozen exhibitors and our top-notch presenters — enough to fill our meeting rooms to capacity.

We’ve never tried anything like this, but, while continuing education is popular, a two-day conference focused on ownership and growth issues clearly filled a need. The response across the board was so positive that we’re already starting to plan for 2022 with plenty of feedback in our pockets.

Of course we owe a big thank-you to our sponsors and exhibitors who made it possible. Please consider doing business with these companies:

APC member sponsors: Mark Binkley, Jeff Bray, Janet Coleman, Ana Cristina Gil, John Kim, Jack Korbutov, Matt Lopatka, Shaun Noorian, Jorges Reyes, and Doug Yoch.

Exhibitors: ARL, DoseLogix, Eagle Analytical Services, Independent Rx Consulting, Integrated Financial Group, Letco Medical, Medisca, MediZap, PCCA, Revelation Pharma Corporation, and Überlube.

Mark Mandel passes away

The long-time APC member was an advocate for compounding and a devoted attendee of Compounders on Capitol Hill. He was owner of Mark Drugs in Roselle, Ill. He passed away Wednesday.