From APC's President

It's been a great year...

thank you!

This is my swan song, my last newsletter as the president of our treasured organization. I hope you'll read this one until the end.

During my APC presidency, I had four goals for this year: 

1. Increase membership by 20 percent.  

2. Re-invigorate the APC Fellows recognition program.

3. Promote and advance engagement of the technicians.

4. Allow pharmacy technicians to become APC Fellows. 

I am pleased to report the following results of our work together this year:

We increased our membership from about 990 members to more than 3,400 members—an increase of 243 percent! Of course, I cannot take the credit for this: The pharmacies that became Pharmacy/Facility Members (PFMs) are primarily responsible for this tremendous growth. Thank you!

Now, if your pharmacy is not a PFM, this is the perfect time to make the change. It offers so many exclusive benefits, too many to list here. If you would like to learn more about the benefits and value of being a PFM, please contact APC's Director of Business Development Jason Dunn.

For my second goal, I'm pleased to announce that during this year's Compounding on Capitol Hill we inducted 13 new professionals as APC Fellows. And for the first time in the recognition program's history, we invited technicians to apply (more on that below). As an APC Fellow myself, I hope to see this program continue for many years to come.

My third goal was near and dear to me, as I believe technicians have held second-tier status to pharmacists for far too long. Techs are an integral part of pharmacy compounding and without their significant contributions to our profession, we couldn't function. To better engage them this year, we hosted a technician-only town hall, created a quarterly technician newsletter, and we set a fairer price point for tech contributions to CompPAC events.

With regards to my fourth goal, I am pleased that, for the first time ever, pharmacy technicians were invited to apply for the APC Fellows program and five were inducted in the FAPC Class of 2022. I am overjoyed that our colleagues have finally received the recognition they deserve. If you are a tech who is dedicated to our profession, please consider applying to become an APC Fellow in 2023.

Thank you everyone for your love and support. This past year has been amazing. You have all been extremely supportive. I love all of you, my compounding sisters and brothers. I appreciate all you do and your dedication to our profession. I look forward to pushing our agenda further with you in the future.

Until we next meet, I wish you much love, peace, hope and joy.

In gratitude,

• • •

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.

ICYMI

Catch up on these recent stories that you might've missed:

• APC briefs BOPs on GFI 256, DTE
• Dear Express Scripts...
• APC sends comments to Maine BOP

This week

Eight states get PCF grants

The Pharmacy Compounding Foundation is awarding $2,000 compounding continuing education grants to eight state pharmacy associations for 2023.

“This new grant initiative is very much in line with the Foundation’s mission to elevate the practice of pharmacy compounding, and we see state pharmacy associations as partners in that effort,” said Foundation Board President Stacy Hightower of Las Colinas Pharmacy in Texas. “By requiring the programming to be offered at state pharmacy association conventions or other live events, we believe we can help inform and equip the broadest audience of compounders.”

The 2023 PCF state grants will go to the following state associations and programs:

• Alabama Pharmacy Association: Threats to Pharmacy Compounding – A Public Policy Update
• Connecticut Pharmacists Association: USP Chapter <795> Update
• Florida Pharmacy Association: An Update to USP Chapters <795> and <797>
• North Carolina Association of Pharmacists: Threats to Pharmacy Compounding – A Public Policy Update
• Ohio Pharmacists Association: USP <797> Terminal Sterilization
• Tennessee Pharmacists Association: Threats to Pharmacy Compounding – A Public Policy Update
• Texas Pharmacy Association: Threats to Pharmacy Compounding – A Public Policy Update
• Washington State Pharmacy Association: USP <795> for the Occasional Compounder

TIME FOR SAVING IS RUNNING OUT!

Early-bird rates end January 4…

Leaders talk adverse events reporting with FDA

In a listening session this week with FDA officials, APC leaders outlined a draft of an adverse events reporting framework for 503As that could be incorporated into legislation in the next Congress. Still speculative for now, such legislation could eliminate the requirement that FDA sign an MOU with states regarding interstate shipments of compounded medications. It anticipates replacing the MOU—and having to cajole states sign it—with a requirement for reporting by pharmacies that ship more than 50 percent of their compounded drugs out of state and implementing reporting of adverse events by all 503As, among other possible measures.

The AE framework, developed by an APC work group earlier this year, would require reporting by pharmacies of “serious” adverse events (as defined in CFR 310.305) via the same NABP portal that was developed for reporting of interstate shipments under the MOU. The proposed framework would shield pharmacies from disciplinary action based simply on the filing of an adverse event and would require pharmacies to conduct and substantiate a reasonable investigation of the reported adverse event. It would also prohibit entities from denying certification or accreditation based merely on the reporting of adverse events by a pharmacy.

“Embracing reasonable AE reporting requirements could enhance the credibility of the compounding profession—'reasonable’ being the magic word, of course,” said APC’s Scott Brunner, “By limiting the reporting to only ‘serious’ adverse events, we shield pharmacies from specious charges, and by requiring investigation and reporting back, we can gain better, more nuanced root cause data than what can be derived from FDA’s FAERS database currently.”

Other issues discussed with FDA in the listening session include recent guidance on compounding beta lactams, FDA’s attempts to reclassify DTE as a biologic, APC’s patient-reported outcomes initiative, and the agency’s progress in speeding the closing of 483 files.

PFMs now sport snazzy logo on locator

We're at 92 Pharmacy/Facility Members and still growing! To celebrate and recognize them, we added a PFM logo to each of their listings on our website's "Find a Compounder" directory.

Not a PFM yet? Are you unsure of what exciting benefits are available to you as one? Learn more here or contact APC's Director of Business Development Jason Dunn at jason@a4pc.org or 918.770.6333.

Save these dates

2023

January 4: Early bird rates end for EduCon 2023.

Jan 12: An APC webinar: Pharmacy Finance 101 (no CE)

Jan 26: An APC webinar: Survey of State Compounding Law Changes – 2022 and Proposed 2023 (CE)

February 9–10: APC's EduCon 2023, virtual

March 26–28: APC's Owner Summit 2023; The Grand Hotel Golf Resort + Spa;

Point Clear, Ala. (more details coming soon)

September 19–20: APC's Compounders on Capitol Hill 2023; Hilton National Mall; Washington, DC

Short takes

A congratulatory visit on Capitol Hill. Earlier this week, APC's Scott Brunner and David Pore and PCCA's Amy Shank caught up with Congresswoman—and APC member—Diana Harshbarger (left) on Capitol Hill to congratulate her on her recent re-election. Congresswoman Harshbarger is a great champion for compounding!

Contact your state BOP on GFI 256, DTE. Please reach out to your state’s BOP members and director and urge them to attend to the recent memos APC sent them on GFI 256 and DTE. Please share any feedback you get at info@a4pc.org.

A sunny disposition can keep you healthy for longer. Surely by now you know regular exercise and healthy eating are the key to a long life, but research shows that having a positive outlook may factor into it, too. (Just don't call us Shirley.)

Study shows vaccine thwarts Covid deaths in US. According to a new study, the Covid vaccine has averted 3 million deaths and 18 million additional hospitalizations over the past two years.

Quick links



APC Career Center

• Job seekers

• Employers

APC's Code of Ethics

Compounding Connections archive

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

EduCon 2023

Prescriber Briefing Resources  

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

• Shipment Trackers, a shipping costs auditor  

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.