Some cBHT campaign ads suspended

No, you didn’t misread the headline. In an effort to preserve our remaining cBHT media campaign funds, we’ve suspended digital ad placements for the month of August and will likely need to do the same for December.

The support for this campaign by pharmacy compounders and vendors like you has been extraordinary, and we have come so, so close to our $1.5 million goal — and we’ve done it in just eight months. It’s pretty amazing.

But now, it all comes down to needing that last $35,000 — not only to help us achieve the campaign goal, but to fully fund those all-important digital ad placements through year-end. It’s those placements, remember, that are driving patients and policymakers to compounding.com, where they’re learning more about the threat to compounded hormones.

The campaign is hitting its marks. Our digital ads are popping up all over — we hope you’ve seen them, like this one that ran last Saturday morning in the New York Times online:

 

It may be that you have already invested in this campaign to save cBHT. If so, thank you, sincerely.

But if you have not yet given — and compounded hormones are a significant business line for your pharmacy or outsourcing facility — now is the time to step up.

With that additional $35k, we can reactivate our August campaign plans — and get the job done for the year.

Cheri Garvin named to Virginia BoP

Congrats to APC member Cheri Garvin, RPh, of Leesburg, Va., owner of the Compounding Center — she was just named to the state’s board of pharmacy by Governor Ralph Northam.

“With pharmacy compounders unrepresented or under-represented on so many state boards of pharmacy, this is an important appointment in Virginia,” said APC’s CEO Scott Brunner. “We salute Governor Northam and congratulate Cheri Garvin on her appointment.”

Strong language in Senate approps bill

There’s strong language about animal compounding in the proposed Senate’s Ag/FDA appropriation bill. That’s thanks in part to APC’s work with the Senate Appropriations Committee to have senators include a strong admonition to FDA to not exceed what the statute allows related to proposed guidance on animal compounding from pure ingredients.

The committee note to the FDA appropriation reads as follows:

Animal Drug Compounding. The Committee is concerned that the Guidance for Industry [GFI] #256, Compounding Animal Drugs from Bulk Drug Substances, issued on November 20, 2019, raises similar issues to the GFI #230, which has been withdrawn. The Committee encourages the FDA to draft and finalize guidance on compounding animal drugs that is consistent with statutory authority and will ensure access to appropriate treatment is available for veterinarians, animal shelters, zoos and other stakeholders.

The bill awaits action by the Senate.

A congressional visit with a Washington pharmacy

APC member Dawn Ipsen of Kusler’s Compounding Pharmacy in Snohomish, Wash., arranged a pharmacy visit with Cameron Caldwell, the northwest Washington outreach director for U.S. Senator Maria Cantwell. “We had a fabulous visit and informative conversation,” Dawn said, that included an introduction to compounding, a facility tour, and a visit to the pharmacy’s NIOSH lab where they were making various compounded hormones.

“It piqued his attention when I mentioned the importance of progesterone suppositories and the risk of the FDA making it illegal to compound such products,” Dawn said — good news for our cBHT campaign. She also discussed the FDA’s MOU with states, and why it’s important to delay enforcement.

This kind of face-to-face meeting is the best way to get legislators’ attention on our most important issues. If you’ve never met with your senator or representative, now’s a great time — they’re on recess. Check out our handy guide for setting up a visit, then invite your member of Congress for a tour!

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.

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