From APC's President

I'm asking you for a third cup of coffee

You know I love my coffee analogies. I watch my pharmacists and techs all walk in with their morning Starbucks almost every day. They tell me it gets—and keeps—them going. 

It's funny, isn't it? They need a strong Starbucks coffee to start their jobs each day, but without their jobs, they couldn't afford this luxury, nor would they need it.

Most of you reading this are new to APC. In 2022, we have grown from 900 members to about 3,300 members, which means that the majority of our members are brand new to APC. WELCOME! I suspect most of you 2,600 neophytes also drink coffee for the above reasons.

I bring this up because our profession also has its own needs to get and keep going so all of us can maintain our livelihoods.

APC receives its funding from a variety of sources, including member dues, corporate support, conferences, educational courses, etc. But no one single source is enough to sustain APC. 

The truth is, your dues just support the day-to-day operations of APC including salaries, rent, telephones...you know, the same necessities that keep your homes and pharmacies operating on a daily basis. 

For everything else, we rely on a fund called OneFund to cover APC's entire advocacy operation on behalf of pharmacy compounding.

OneFund is made possible by gifts from members and corporate supporters ABOVE and BEYOND their annual dues. These donations help fund—among other important initiatives—our lobbying and our public policy communications.

In 2021, APC budgeted $300,000 last year for OneFund and exceed this goal by $15,000. We budgeted the same amount for this year but have only raised $74,000. Projected out, this means that we are only going to raise $127,000 or 42% of our goal this year. This will severely curtail the work you expect APC to do for you on Capitol Hill, work with the FDA and USP, and even our work with the state boards of pharmacy.

We need your help, and we need it fast. 

Ask yourself, Without my pharmacy compounding career, can I afford my coffee (or anything else, really)? Is an investment in my profession as valuable as my morning investment in Starbucks? 

If every member gave a contribution equivalent to two Starbucks monthly ($10), we would easily meet our goals. And just for the record, I personally donate 100 Starbucks a month to OneFund (almost three per day!). That’s how important this is to me. 

To donate $10 per month (or any amount) to OneFund, please click here.

• • •

David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at [email protected].

We’re out of money, honey

Sadly, APC’s Campaign to Save Compounded Hormones is out of funding and without an infusion of cash will be forced in the next ten days or so to pull the digital ads that are driving patients and prescribers to compounding.com to share their cBHT stories with members of Congress.

We need a total of $350,000 more between now and year-end to keep going. We need another $100,000 in the next week or so in order not to suspend our ads. Those ads are proving extraordinarily successful, by the way. If you prepare compounded hormones but haven’t yet given this year, well … now might be a good time to think about it. (And if you’ve already given, thank you. More is needed.)

Hear what your colleagues have to say here about saving cBHT.

This week

If compounding hormones is a part of your compounding business, we know you’re concerned about FDA’s implicit threat to introduce restrictions. But do the prescribers you work with share that concern?  

We’re hearing from members of Congress that they’ve heard a lot from pharmacists on this issue, but not much at all from physicians. 

To address that issue, we’re asking for your help in engaging physicians in the campaign to save compounded hormones. If you have a database of cBHT prescribers, we’re asking you to reach out to them and urge them to sign a joint physician letter to FDA Commissioner Robert Califf (and to congressional leaders) expressing concern about FDA’s stated intention to rely on the discredited NASEM report in considering restrictions to compounded hormones.

The landing page we’ve created for this effort is www.a4pc.org/physicianletter.

Please click, then cut-and-paste the notice there into an email from you to your prescribers. The sign-on letter itself and the form for a physician to add their name to the letter are listed and linked at that landing page. This letter is ONLY for physicians, not for pharmacists or others. 

Please share the message with prescribers pronto! The deadline for signing the letter is August 15.

APC, NCPA ask CVM for GFI 256 clarity

A joint APC-NCPA letter submitted this week to the FDA Center for Veterinary Medicine’s Dr. Bill Flynn includes more than two dozen questions on which the associations seek great clarity regarding the agency’s animal compounding GFI.

“We believe your answers can provide much-needed clarity on how the agency views the processes enumerated in the guidance document and can help compounding pharmacists, veterinarians, and state boards of pharmacy better understand how the agency will view compliance with the GFI,” the letter states. “We also believe that the questions contained in this letter demonstrate the range and depth of what is as yet unknown about the effect and enforcement of the GFI, and therefore support the recent joint letter submitted by several pharmacy trade associations requesting an enforcement delay on the GFI until at least FY2024.”

APC intends to communicate Flynn’s responses to our members and other stakeholders so that they can build processes and SOPs to attain compliance with GFI 256.

Social media is buzzing about our "Save cBHT" campaign

When’s the last time you got 500+ comments and 250+ shares on just one of your social media posts? That’s what has been happening with APC’s "Save cBHT" campaign. We've also seen an uptick in new testimonials and messages to Congress.

But we still have miles to go.

Help us continue to spread the message to your patients, physicians (see above story), FDA (via PRO) and your members of Congress.

Lastly, you can help support our efforts to save compounded hormones by making a financial commitment at a4pc.org/cbht

Cheap, cheap! CCH early bird rate ends this Sunday, July 31

APC's Compounders on Capitol Hill is your once-a-year opportunity to engage your members of Congress in-person. As you already know, this facetime is crucial to assuring continued patient access to the medications you compound.

Need an additional incentive? Register today and take advantage of our early-bird pricing $495 through July 31 (on August 1 it goes up to $549). 

Please click here for more information on CCH—including hotel rates and how to schedule your Hill visits.

Thank you to the more than 40 people who joined us on our July 21 virtual briefing regarding an opportunity for our Pharmacy/Facility Members to save on their credit card processing fees.

You can learn more about the group purchasing opportunity here.

To watch the video recording of the July 21 briefing, please click here.

Save these dates

August 16, October 6: A joint APC/PCCA program, Quality & Compliance Webinar

August 18: An APC Webinar: Hazardous Drug Decontamination – Understanding its Purpose and Validating Best Practices with Abby Roth

August 18–19: A joint APC/PCCA, in-person program, USP Implementation Training, Houston, TX

September 6–8: FDA's virtual Compounding Quality Center of Excellence Annual Conference

September 14: APC's Annual Meeting during Compounders on Capitol Hill, 2:00-2:30pm ET, Hilton National Mall, Washington, DC

September 14–15: APC’s Compounders on Capitol Hill 2022, Hilton National Mall, Washington, DC

September 22: An APC Webinar: Keeping it Legit: Best Authentication Practices for Compounders, PART I - PROVIDERS AND PRESCRIPTIONS (registration link coming soon)

October 13: An APC Webinar: Keeping it Legit: Best Authentication Practices for Compounders, PART II - WHOLESALE DISTRIBUTORS (registration link coming soon)

October 26–29: PCCA's International Seminar, Houston, TX (in-person + virtual)

Short takes

This PFM benefit spreads sunshine while you're out enjoying it. Audible Sunshine, one of APC's PFM affinity service providers, is offering PFMs a special rate for their "we're closed on Labor Day" voicemail greeting. Click here to learn more about this benefit and how to take advantage of it. Not a PFM yet? Head over here to learn more.

For you 503Bs out there, Ecomplyin is offering a 90-minute webinar on August 17, Raw Materials Risk Management in GMP Facilities: Avoiding GMP Non-Compliance Due to Raw Material Issues. For details and to register, click here.

FDA publishes proposed rule on revising NDC format and drug label barcode requirements. The proposed rule, Revising the National Drug Code Format and Drug Label Barcode Requirements (Docket No. FDA-2021-N-1351), is intended to minimize the impact of FDA running out of 10-digit NDCs by adopting a single, 12-digit format for FDA-assigned NDCs. Additionally, FDA is proposing to revise the drug product barcode label requirements.

Quick links



APC Career Center

• Job seekers

• Employers

APC's Code of Ethics

Compounding Connections archive

Compounders on Capitol Hill 2022

Continuing education

• Live webinars

• On-demand webinars

Current issues:

• GFI #256 on animal compounding

• Urgent-use compounding

• Prohibition on peptide compounding

• La Vita Case amicus filing

• Insanitary Conditions amicus filing

Invest in APC efforts

• CompPAC

• Campaign to save cBHT

• OneFund

Membership

• Renew

• Pharmacy/Facility Membership (PFM)

• APC Logo agreement for PFMs

• APC Logo agreement for individual members

Affinity service providers

• Accounting & Tax Services: Rx Advisors

• Audible Sunshine

• Office Equipment: TUI Solutions

• Online Payments Platform: HealNow

• Patient-Reported Outcomes: OutcomeMD

APC is committed to addressing any concerns or complaints within one business day. Please send them — and, of course, any compliments — to [email protected].