From APC's President

We know compounds help our patients. Here's how we can prove it.

We all see how our compounded medications help our patients on a daily basis, especially those taking compounded hormone replacements. 

We are also aware of the NASEM “study” that was released in 2020. We believe that FDA may act on conclusions of this “study” sometime in the near future. We do not know what action the agency may take, but at worst case, it could conclude that compounding of bio-identical hormones is “demonstrably difficult” and thereby make compounding them a violation of section 503 of the Food, Drug and Cosmetic Act. 

In order to make a strong case for compounded HRT to the FDA, we must demonstrate safety and efficacy.

Are compounded hormones safe? Although we cannot definitively claim that yet, there is an increasing body of evidence that demonstrates the safety of compounded hormone replacement therapy. Again, we cannot claim our compounds are safe as the agency has very specific requirements to qualify safety.

Does compounded hormone replacement therapy do what it is supposed to do? So far, we only have largely subjective data. But now we have hope via a tool I recently started using called OutcomeMD. 

OutcomeMD has created scientifically validated clinical outcomes assessments that your patients can complete at the beginning of therapy and then again at one-, three- and six-month intervals. This platform objectively measures the patient’s change in symptoms from baseline. By asking your patients to submit their results, you can help APC obtain vast amounts of HIPAA-compliant data to demonstrate to the FDA and other stakeholders that compounded HRT really, truly improves our patients' health.

By helping to provide APC this data, you help your patients, and you stay in business.

Will you join me in helping APC collect your patients’ objective, clinical outcomes? Oh, I should also mention that as an APC member, you receive special pricing.

Learn more about OutcomeMD here or contact Lorraine Kaiser at lkaiser@outcomemd.com.

• • •

David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at drdave@keystonepharm.com.

This week

In a joint letter to FDA Center for Veterinary Medicine Director Steven Solomon, five national pharmacy associations that represent veterinary compounding pharmacists requested that CVM delay enforcement of GFI 256 until fiscal year 2024, which begins in October 2023. GFI 256 asserts that FDA has regulatory oversight over animal compounding.

The associations include APC, the American College of Veterinary Pharmacists, the American Pharmacists Association, the National Community Pharmacists Association, and the Society of Veterinary Hospital Pharmacists.

"The ability of many of those pharmacists to serve animal patients will be affected by this GFI," the associations stated in the letter, “And we believe there remain too many unanswered questions for pharmacy compounders to have clarity about what constitutes compliance – much less achieve that compliance – in such a short time."

Read the letter here.

New PCCA-APC training deal supports compounder compliance

APC and PCCA are collaborating to ensure that all compounders have access to essential education in non-sterile compounding. Here’s how: PCCA has opened its registration for two key courses to all compounders, and APC is spreading the word throughout the industry.

This means that any compounding pharmacist or technician can now attend PCCA’s in-person USP Implementation Training ($1,595.00 per person) and virtual Quality & Compliance Webinar ($95.00 per person). Plus, APC will receive 20 percent of the course registration fee for each referral that results in registration.

Registrants simply select APC when asked how they heard about the course. Click on the course ad below to learn more and register.

OneFund is hurting, and that’s not good

Nearly seven months into 2022, APC’s CEO Scott Brunner is growing increasingly concerned about funding.

“APC depends on members contributions to OneFund to help fund our advocacy efforts on Capitol Hill in DC and with state legislatures and boards of pharmacy,” Brunner said. “But with over half of the year gone, we’ve only thus far raised 24% of the funding via OneFund we need to keep our association on firm footing.”

Would you consider making a 2022 investment – soon – so that we don’t have to begin to make difficult cuts in our advocacy budget? Think of it as an expression of confidence in what APC does for your business and your profession.

Bottom line: We need an infusion of funding in order to keep doing what we’re doing. You can make your 2022 investment here: a4pc.org/onefund.

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.

During the free webinar, two representatives from CMSPI, an international specialist in payment processing, gave attendees an overview of what a group purchasing arrangement for our Pharmacy/Facility Members on credit card processing fees might look like.

The presenters explained that CMSPI used APC member-provided data to estimate that the average APC member pays around $0.28 per transaction for credit card processing fees, also noting that this estimate, excluding high risk transactions.

CMSPI then merged its benchmarks for similarly-sized merchants with the APC data to then create a model to show potential levels of savings—depending on the number of participating PFMs—which showed that members could achieve processor margins as low as $0.07-0.15 per transaction. They key takeaway is: the more participants, the greater the potential for savings.

Next steps

The CMSPI presenters had two requests of APC PFMs that are interested in exploring this opportunity further:

• Fact check the assumptions CMSPI presented 
• Collect 1-3 months of invoices as well as provide the name of the current processing software they are using
• Send the above information to Jason Dunn (jason@a4pc.org).

While the CMSPI presenters didn't give a hard deadline for the above requests, they said the sooner the better.

Lastly, Scott pointed out that this group purchasing opportunity is open only to Pharmacy/Facility Members. To learn more about becoming a PFM, please click here.

For those who wish to watch the video recording, a link will be provided next week.

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 (registration link coming soon)

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, 2:00-2:30pm ET, Hilton National Mall, Washington, DC (details coming soon) 

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

Upcoming complimentary DEA training opportunities. Drug Enforcement Administration (DEA) is hosting live Virtual Diversion Pharmaceutical Awareness Training webinars in July, August, and September 2022 for pharmacists and pharmacy technicians employed by pharmacies, hospitals, or clinics that are registered with DEA. Learn more here.

Pharmacy groups express concern to HHS. Earlier this week, APhA led a coalition of 13 national pharmacy organizations in a meeting with Health & Human Services' Office for Civil Rights—demonstrating unity among the profession—to address concerns on the recent "Guidance to Nation’s Retail Pharmacies: Obligations under Federal Civil Rights Laws to Ensure Access to Comprehensive Reproductive Health Care Services." Full story here.

Oh, the places he'll go! Where in the world is Scott Brunner these days? Most recently he was in West Chester, PA, visiting owner Kevin Hennessy (at left, below) at The Compounding Pharmacist! Glad to have Kevin as an APC member.

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 info@a4pc.org.