They really really like us

This past week, a single Facebook ad, part of our campaign to save compounded hormone therapy, garnered:

That’s just one ad among the hundreds our campaign is funding on Facebook and LinkedIn, targeting compounders, patients, prescribers, and policymakers. In addition, traffic at the campaign landing page, compounding.com, has risen exponentially in July, and we’re up about 100 new testimonials for the month. Best of all, those patients are sharing their stories with members of Congress, and we can track visits to the site and clicks by congressional staffers who are visiting.

Point is, our $1.5 million campaign to save cBHT is beginning to hit its stride. Only thing lacking is the last $40,000 that will put us over goal — and allow us to fully implement the remaining ad buys.

If you’ve invested in this effort, thank you. We wouldn’t be where we are without you. Consider now whether you can do more — just a bit more? And if compounded hormones are part of your practice but you’ve not yet given to our campaign: Stop hitchhiking. Stop allowing others to bear the burden of saving your bacon (so to speak). Invest now, do your part, and you just may put us over goal.

Best,
Scott

FDA’s MOU: Reining-in the rumor mill

We’ve been hearing several rumors about the FDA’s interstate-shipping MOU. Please help us make sure state boards of pharmacy are clear on the facts.

As a reminder, we believe the MOU has serious flaws. It’s the subject of litigation that could result in its being withdrawn — but that’s far from a certainty. But by taking action now, state boards of pharmacy can avoid severe curtailment of patient access to compounded medications if they don’t sign by the FDA’s October 2021 deadline.

Rumors to correct:

Individual states cannot negotiate their own customized MOU with FDA. There is only one version of the MOU; it’s a take-it-or-leave it document for every state. This is the MOU.

Signing the MOU absolutely does not commit the state board of pharmacy to review every single compounded prescription from a pharmacy. Rather, via NABP’s data collection tool, boards of pharmacy will require compounders to attest to data on out-of-state shipments once annually. Based on that attestation, the state board will report to FDA any compounder shipping more than 50 percent of compounded preparations out-of-state.

It’s NOT a done deal that the FDA will extend the enforcement deadline. A flurry of extension requests, including from APC and members of Congress, is pretty clear — and has been heard by FDA. CDER director Gail Bormel has mentioned publicly that they’re seriously considering an extension, but it’s far from a sure thing. Boards of pharmacy need to continue to act as if the October 2021 deadline is carved in granite.

Our request of boards of pharmacy hasn’t changed:

  1. Determine now if the board has the authority to sign and comply with the MOU. If state law must be amended, the board should notify FDA immediately and request a delay in enforcement. It should also advise FDA if it has concerns about costs associated with complying with the MOU.
  2. If the board has authority to sign and comply with the MOU, it should prepare to sign it — but wait until just before the deadline to do so to allow the litigation to run its course, and also to delay for the state having to comply with the MOU before its effective date.

We appreciate any help you can give keeping this high on your pharmacy board’s radar — and correcting any misperceptions!

Don’t miss this Stat op-ed

…and not just because it was penned by APC CEO Scott Brunner. “On compounding, the FDA marches to the beat of its own biases” is a detailed, point-by-point look at how often the agency puts its own agenda ahead of everything else.

[T]he FDA impugns pharmacy compounding by insinuating that because each of the millions of individually compounded preparations are not FDA-approved (which is true) they are therefore unsafe (which is a logical fallacy). Never mind that Congress specifically and intentionally exempted compounded medications from FDA approval.

No, you’re not safe from ransomware

If they can cripple a massive national oil pipeline, your pharmacy probably isn’t safe — and ransomware attacks are targeting pharmacies and other healthcare facilities.

You need to learn the threats to your practice, where you’re likely vulnerable, and what you can do about it. Conveniently, APC is offering a new live CE webinar, “Modern-day Cyber-security Threats for Pharmacies,” that will help you do just that.

It’s October 26 from 2:00–3:00 EDT, but you can learn the details and sign up today at A4PC.org/cybersecurity.

Don’t forget to claim your customized video

If you gave $5,000 or more to APC’s cBHT media campaign, don’t forget that you can receive customized 30- and 60-second “Compounding the Joy of Living” videos.

You should have received an email with details for getting the video. If you’ve misplaced it, please send a note to info@a4pc.org and let us know so we can send you the details.

Remember, the deadline to upload your information is September 15, 2021, and production won’t start until you provide everything in the proper file formats.

If you haven’t contributed $5,000, there’s still time. Go to A4PC.org/cbhtcampaign and increase your total support to $5,000 (or more) before we reach our $1.5 million goal, and you’ll receive a custom video as well.

Alabama compounder to run for state legislature

This week, APC member Philip Rigsby announced his campaign for the Alabama House of Representatives. He’s running for the Republican nomination to represent the state’s 25th district (Madison and Limestone counties in North Alabama).

“As a pharmacist, I have learned to listen to my patient’s issues, even when it seemed no one else would,” Rigsby stated in his announcement. “As a compounding pharmacist, I can think outside of the box to become an advocate and problem solver for them.”

Philip is the owner of two pharmacies in Huntsville: Huntsville Compounding Pharmacy and the Medicine Shoppe Pharmacy. As his campaign is not yet accepting donations, you can help by – per Philip’s request – praying for him. Sending him a check at the proper time wouldn’t hurt, either.

The primary is on May 24, 2022. At this time, Rigsby is the only announced candidate.

Here’s opportunity knocking

Timing is everything, as they say. Right now, the timing is perfect for you to help drive home to policymakers the seriousness of the threat to compounded hormones.

Here’s what’s up:

Over the past six weeks or so, our cBHT media campaign has begun to get traction on Capitol Hill. Through the (slightly creepy) wonder of modern technology, I can tell you that over the past month, our campaign landing page at compounding.com has been accessed more than 200 times by more than 65 congressional offices. On top of that, our lobbying team has been socializing the issue with individual members of Congress, meeting with their staffers and sharing our briefing documents.

That alone is good news. But here’s the opportunity to capitalize on that good news:

Congress’s summer recess begins July 31. That means that for most of the month of August they’ll be back home, in district, and looking to interact with their constituents.

There’s no better time for you to schedule a pharmacy visit with your U.S. representative or senator. Next to Compounders on Capitol Hill, there’s no better opportunity for you to share one-on-one with your elected officials your concern about the threat to compounded hormones. (You can also tell them about the good our urgent-use legislation, HR 3662, will do in shoring up gaps in the drug supply chain).

It all starts with a phone call to your MOC’s office to make the invitation. Download our simple guide for scheduling and conducting the visit, and once it’s scheduled, contact us here at APC and we’ll share the latest talking points and background so you’ll be completely up-to-speed for the visit.

Please seize this opportunity to show your member of Congress what you do and talk with them about the challenges your compounding patients and practice are facing.

Your timing will be impeccable.

A tremendous gift

Lucy Malmberg, compounding hero and co-founder of Wedgewood Pharmacy, has contributed $225,000 to APC’s cBHT media campaign. Thanks to her generous gift, we’re now within a hair’s breath of our $1.5 million goal!

The campaign has already been running online ads targeting members of Congress and their staff as well as FDA staff, directing them to Compounding.com where they can learn the truth about cBHT and the people who rely on it … in those patients’ own words.

We’ve also increased our podcasting agenda, with our spokespeople having already been recorded on 14 shows, with 11 more scheduled for the next few weeks. In the works are print ads, more podcasts, and outreach through social media influencers … but it all depends on having the funds.

Lucy’s generosity is a huge boost to the campaign. Now we’re about $45,000 short of our goal. Help us cross that finish line — contribute to save cBHT directly, and don’t forget: If you’re shopping at Letco Medical, contribute to the cBHT media campaign when you checkout — it’s just one extra click:

Making the case on HCG to FDA

On Tuesday, representatives of APC and the Outsourcing Facilities Association participated in a listening session with FDA staff about patient access issues created by the 2020 reclassification of certain substances as biologics — particularly HCG.

OFA director Lee Rosebush led the presentation, asking FDA to immediately clarify that “Deemed BLAs” may continue to be compounded pursuant to Section 503A and Section 503B of the Food, Drug & Cosmetic Act, and that FDA’s March 23, 2020, Notice to Compounders does not apply to pharmacies compounding transitioned products like HCG, which has a USP monograph.

APC members Tenille Davis of Civic Center Pharmacy in Scottsdale, Ariz., and Kim Keiffer of Empower Pharmacy in Houston, shared input with FDA on drug shortage and patient access issues the reclassification has created.

“Compounders have been compounding some of these drugs for nearly 50 years,” Rosebush said. “As of March 23, 2020, nothing in these drugs changed. HCG is the same drug that it was in 1973 when it was approved by the FDA. Patients should not suffer due to access issues resulting from an administrative conversion from an NDA to BLA.”

While FDA officials did ask questions in the listening session, they offered no comments or opinion on the presentation. “There’s no requirement that they respond or act on our request at all,” said APC CEO Scott Brunner, CAE. “So, as usual, it’s ‘wait and see’.”

View the APC/OFA July 20 Listening Session presentation slides here.

Scott visits Leesburg and the Compounding Center

Here’s our CEO Scott Brunner on Tuesday with some of the team members at the Compounding Center in Leesburg, Virginia. Owner (and APC member!) Cheri Garvin, to Scott’s left, hosted him this morning for a tour … and good conversation.

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