Introducing the Malmberg Award — and your chance to nominate someone

Created this year by the APC Board of Directors to honor long-time compounding advocates George and Lucy Malmberg, APC is proud to announce a call for nominations for the the inaugural George & Lucy Malmberg APC Advocacy Champion Award.

(Read more…)

A compounder in Congress!

Compounding pharmacist (and APC member) Diana Harshbarger (https://www.votediana.com) won the Republican primary for Congress in TN-1 last night. The deep-red demographics of TN-1 mean she’s a near shoo-in to win the general election in November. Congrats on your primary win, Diana, and we’re looking forward to another congrats in November!

cBHT Coalition emerges in wake of NASEM report

Compounders and prescribers of cBHT are organizing in the wake of the recently released NASEM study of compounded Bioidentical Hormone Therapy, released July 1. A loose coalition convened by Dr. Daved Rosensweet has begun to develop strategies and tactics aimed at demonstrating to FDA and others the clear safety and effectiveness of cBHT. APC’s CEO Scott Brunner, CAE, is co-chairing the coalition with Dr. Rosensweet, and several APC members are serving on committees the coalition has formed.

“The NASEM study was flawed in numerous ways,” said APC President Shawn Hodges, “APC made that case in its public statement after it was released. But because its findings support FDA’s longstanding opposition to cBHT, it’s likely to be influential in FDA’s anticipated attempts to prohibit or curtail cBHT. We must confront the errors of that NASEM report with solid peer-reviewed research and patient outcomes data. We’ll need to make that case to FDA, to members of Congress, and to the media if we want to preserve cBHT as a viable therapy for millions of Americans. That’s why it’s important for APC and its members to engage with patients and prescribers in this emerging coalition. We’ll have a much greater chance of success together than separately.”

Here’s the plan for the coalition, and what it’s trying to achieve:

First and foremost, the coalition is dedicated to demonstrating the safety and effectiveness of compounded bioidentical hormone therapy and preserving its place as a treatment option for millions of Americans.

It will do that through a combination of advocacy, communications, and presentation of compelling scientific data. The goal: a regulatory framework in which cBHT remains a viable, accessible treatment option for patients.

The outcomes its working toward:

The coalition committee will begin meeting soon, and we would love to have you join. You can volunteer here to serve on a cBHT Coalition committee.

Stay tuned for updates and likely calls-to-action as the coalition ramps up.

Two pharmacy students scored a couple of great scholarships from the foundation

Congratulations to the first winners of the new Pharmacy Compounding Foundation and Pharmacists Mutual Compounding Scholarship!

Brianna Hassett
PharmD Candidate 2021
Southwestern Oklahoma State University
Weatherford, OK

 

 

Natalia Swiderski
PharmD Candidate 2020
Fairleigh Dickinson University
Florham Park, NJ

 

 

 

Through the generosity of the Pharmacists Mutual Insurance Company, the Pharmacy Compounding Foundation awarded each a $2,500 scholarship for demonstrating a commitment to a career in compounding pharmacy in the United States.

The Pharmacy Compounding Foundation and Pharmacists Mutual Compounding Scholarship is one of several student scholarship opportunities offered by the Pharmacy Compounding Foundation. You can find more information about all of them at A4PC.org/scholarships.

And remember: You can support programs like this by giving to the Pharmacy Compounding Foundation!

503B bulk: What’s in? What’s out? Who tells the story?

Finally! Guess what, 503B pharmacies? The FDA is — after half a decade — considering updating the bulk drug substances list, and it wants your input.

IN (proposed): DPCP, glycolic acid, SADBE, TCA — see https://www.federalregister.gov/d/2020-16649/p-58

OUT (proposed): 19 other substances — see https://www.federalregister.gov/d/2020-16649/p-78

Where to comment: https://beta.regulations.gov/comment/FDA-2018-N-3240-0054

ACT NOW: Tell your representatives to sign onto the letter to FDA

We need to stop the FDA’s GFI #256 on veterinary compounding, and you can help — ACT NOW.

Three members of Congress — Ted Yoho (R-FL, also a veterinarian), Mark Pocan (D-WI), and Donald Norcross (D-NJ) — have written a “Dear Colleague” letter to their peers, asking for signatures on a letter to FDA Commissioner Stephen Hahn. They want Hahn to withdraw GFI #256.

Contact your member of Congress and ask them to contact Norcross, Pocan, or Yoho to sign this letter.

These proposed guidelines would dramatically curtail access to compounded medications. They are dangerous, unnecessary, and outside the FDA’s jurisdiction.

GFI #256 includes both positive and negative lists of bulk ingredients that may — and may not — be used for office-stock compounding. The positive list includes only seven of the more than 450 commonly used bulk ingredients, while the negative list has 11 prohibited ingredients.

What meds would be affected? GFI #256 can restrict virtually every common medication that compounding pharmacies prepare from bulk ingredients for veterinarians: amlodipine, budesonide, buprenorphine, chlorambucil, desmopressin, enrofloxacin, fluconazole, fluoxetine, gabapentin, ketoconazole, lomustine, methimazole, penicillamine, pentosan, phenylbutazone, piroxicam, prazosin, prednisolone, sildenafil, theophylline, trilostane, tylosin, ursodiol, zonisamide, and more.

PLEASE ACT NOW! Ask your representative to look for the “Dear Colleague” letter — or reach out to Norcross, Pocan, or Yoho — and sing onto the message asking FDA to withdraw GFI #256.

We make it easy to send a comment to your representative — we’ve even written a sample message to get you started.

Please, send your message today. Let’s stop this intrusion into the practice of veterinary medicine.

Don’t miss the Midwest Compound Conference

Don’t forget: APC and the Ohio Pharmacists Association have joined forces for the Compound Conference — part of the Midwest Independent Pharmacy Expo, October 3 and 4 in Columbus, Ohio or virtually.

It’s two conferences in one: Oct 3 is for indy pharmacists, and Oct 4 is just for compounders. Register for one or both!

No good deed…

Worth a read: Small distilleries and hand sanitizer — a “messy financial calculus“.

They stepped up when Covid-19 first appeared, but a confusing response from the feds and a fluctuating future has left them in a financial and production limbo.

This is why we need provider status

Okay, so CMS will now compensate “healthcare providers” for telling — sorry, counseling patients to stay home during the pandemic, but won’t compensate pharmacists as providers for the extraordinary counsel they provide their patients every day on medications, diet, exercise, and more. Yeah, that makes sense.

Keepin’ it safe

We’ve got a new live CE webinar in partnership with APMS that’s pretty darned timely: “Putting Safety at the Center of Your Compounding Operation.”

Learn the operational and transformational changes you need to put safety at the center of your compounding practice — and more!

It’s Tuesday, August 11 from 2:00 – 3:00 pm EDT. Get the deets and sign up at A4PC.org/safetycenter.

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