The voice for pharmacy compounding • August 21, 2020
Enjoy our latest edition. Send your suggestions and questions to [email protected]
Shawn Hodges
APC President
Dear friend,

It should go without saying — but from the looks of our COMP-PAC coffers, which are pretty skimpy right about now, I’ll say it anyway: APC’s political action committee, COMP-PAC, is how we elect and support candidates who think like you do about your compounding business and the patients you serve.

In this election year, COMP-PAC has made strategic contributions to several candidates who have demonstrated their support for compounding — they’ve made a floor speech, signed on to legislation, drafted a letter to FDA, or asked questions in committee meetings about the issues affecting you right now.

But our funding is running low, which means we can’t make additional, needed contributions between now and Election Day to other compounding champions in Congress — or who are running for Congress — who need our help.
Take, for instance, pharmacy compounder Diana Harshbarger, an APC member who is the Republican nominee for Congress from Tennessee’s 1st District. APC and COMP-PAC have been instrumental in Diana’s campaign so far, but we’re quite limited in how we can help her in the general election because our COMP-PAC balance is low. It’s low for a good reason: We’ve been using it to support Diana and other good candidates. Now we need to do more, but we can’t unless members like you INVEST IN COMP-PAC.
You’ll read below about registering for our September 10 Compounders on Capitol Hill VIRTUAL and letting us know which of the 55 virtual visits with members of Congress you’d like to attend in September and October. Both of those things are very important, and I urge you to sign-up.

But I’m also asking to you register for the COMP-PAC Fundraising Reception set for the evening of September 10 at 6:45pm and featuring Diana as our special guest. Admission is $250 per person (PERSONAL contributions only), and every penny goes to COMP-PAC … so we can continue to support candidates who grasp the challenges compounders face, and who can assist in enacting policy outcomes that benefit your patients.

We’re three weeks out from CCHv, with lots still to do. Counting on you to come through and support us.

Now, read on about the five big things you need to know this week.

You can reach Shawn at [email protected].
August 25 -- Live CE webinar: Accreditation, Inspection, Credentialing, Oh My!; 2:00 to 3:00 pm EDT

September 29 -- Live CE webinar:

2020 OSHA Training:
Bloodborne Pathogens

September 17; 11:00 am to noon EDT

October 13; 1:00 to 2:00 pm EDT

November 18; 3:00 to 4:00 pm EST
1. Don't miss this chance to tell Congress what you think
If you had an opportunity to sit down with your member of Congress to discuss pharmacy compounding, what issues would you bring up?

Maybe you’d start by mentioning how compounders have stepped up in this pandemic, many of them preparing hand sanitizer to meet demand, and some even helping provide scarce COVID-19 medications to hospitals under temporary FDA guidance.

Or maybe you’d talk about NASEM’s flawed cBHT study and FDA’s threat to impose restrictions on compounders — based on flimsy research at best.

Or you might bring up FDA’s draft animal compounding GFI, proposed without congressional authorization, which will almost certainly make compounded medications for pets more expensive and will likely jeopardize animal health.

You could also mention FDA’s MOU with states and tell how FDA cut corners in assessing the impact on state boards of pharmacy, so that now several states have said they won’t sign it — a catastrophic outcome for compounders in those states who ship out-of-state, not to mention for the patients they serve.

And you might also want to tell about the recent ESI/Tricare recoupment effort, a brazen money grab that attempts to make compounders responsible for validating that a physician actually met with a patient.

In September and October, APC is providing you the opportunity to discuss those issues with select members of Congress. We’ll be scheduling virtual visits with about 55 key members of Congress who sit on committees with oversight over compounding. We’ve selected them in particular because we believe may be willing to help us take action on the issues above.

We want to include you in meetings with any of those members of Congress who may be from your state, but we need a couple of things from you pronto:

1. Mark your calendar for September 10. That’s when we’ll be briefing compounders on the issues we’ll be discussing in those virtual congressional visits. We’ll give you talking points, you’ll hear from the lobbyists, interact with Congressman (and pharmacist!) Buddy Carter and get 3 hours of CE in the process. We’re calling it Compounders on Capitol Hill VIRTUAL, and you need to register for it NOW at

2. Tell us NOW which of the virtual visits with members of Congress you will attend. You’ll find a link at where you can mark which ones you can meet with.

Please do this. Please plan to join us for these conversations. Help speak up for pharmacy compounding, The fact is, we can’t be successful without you.
2. We’re collecting cBHT patient testimonials (and we need you!)
With the NASEM study on cBHT released, the FDA is considering restricting the use of compounded hormone therapy, something that would affect patients across the country.

NASEM ignored at least one critical piece of information: patient outcomes. We aim to correct that by collecting and aggregating clinical outcome data, as well as by collecting testimonials form the patients themselves.

Working with our grassroots organization, the Partnership for Personalized Prescriptions (P3), APC has created a Patient Testimonial Portal where cBHT patients (as well as prescribers and compounders) can share their cBHT experiences.

If you have patients who are taking or have taken compounded hormone therapy, ask them to take a few minutes to share their experiences. If you have received patient testimonials, please share those, too (minus identifying information). And if you work with cBHT prescribers, share the link with them for sharing with their patients.

It’s The site allows patients (or you) to type in a short testimonial, or even upload a document or an audio or video recording.

The more information we can gather, and the more detailed it is, the better we can support the millions of patients who rely on cBHT.

Please share that link!
3. The push to withdraw GFI #256 still needs your (congressperson's) help

We're still working hard to get as many members of Congress to sign onto the Norcross/Pocan/Yoho "Dear Colleague" letter to FDA — the letter asking the agency to withdraw its horrendously misguided GFI #256 on veterinary compounding.

Has yours signed it? Make sure they have.

Call their office. "Hi, my name's and I'm a constituent of Representative Jones. I wanted to leave a quick message. Please ask him to sign the 'Dear Colleague' letter from representatives Norcross, Pocan, and Yoho. It's the one to Stephen Hahn at FDA asking him to withdraw GFI number 256 on veterinary compounding." (You won't need to go into a lot of detail — you'll be speaking with an assistant, and the Norcross/Pocan/Yoho letter explains it all.)

Write or fax. The message is the same, but be sure to include your name and address to show that you live in the district.

Use our form. Click here for a simple web page that will send a detailed message to your representative's office explaining the issue.

Tell pet owners and vets. They can send a message to their members of Congress as well via P3's website at

Please, send your message today. NOW. We need to stop this intrusion into the practice of veterinary medicine and compounding!
4. Two (more) virtual conferences for you

Sure, we (and we hope you) are thinking about the upcoming Compounders on Capitol Hill — Virtual. (September 10! Register now!) But there are a couple of other great conferences coming up in the next few months — both with a different focus than CCHv — that you should add to your calendar.

The Midwest Independent Pharmacy Expo
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. October 3 is for indy pharmacists, and October 4 is just for compounders. Register for one or both for the great speakers, 9.5 hours of practical, applicable CE, tons of exhibitors, and a lot more, right here.

Compounding Pharmacy Compliance
Join your peers — virtually — November 16-19 for four days of content from more than 50 industry thought leaders including interactive panel discussions, live Q&As and polling, a keynote from the FDA, live town hall, and more than 20 on-demand CE sessions to watch at your convenience. Click here for more info! (And even better, get $200 off by using the code A4PC20!)
5. Huge news from HHS: For now, pharmacists can give all childhood vaccinations

The Department of Health and Human Services has given pharmacists in all 50 states — regardless of state laws or regulations — the right to provide all CDC-approved childhood vaccinations during the Covid-19 emergency.

Yes, that means that regardless of state law, during the emergency:

  • Pharmacists and interns (subject to limits) can give all vaccines on the CDC’s ACIP immunization schedules.
  • They can provide the vaccines to children three years and older.
  • No prescription is required.
  • No physician protocol agreement is required.

There are some caveats regarding training requirements, supervision of interns who give the shots, record-keeping, and more. Go to for those details.

This big, unexpected development gives pharmacists everywhere a perfect opportunity to demonstrate their critical place as healthcare providers, and the value they bring to patients and entire communities.
APC is committed to addressing any concerns or complaints within one business day. Please send them — and, of course, any compliments — to [email protected].