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The voice for pharmacy compounding | November 20, 2020

THIS EDITION SPONSORED BY PCCA

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In this issue

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From the President

Shawn Hodges
APC President

Dear ,

My father passed away this past Monday evening. Earlier in the day, he'd enjoyed a wonderful round of golf with his sons and other friends on a world-class course on a beautiful afternoon. As we cooked dinner that evening at the condo, he was singing Here Comes the Sun as he diced onions for our supper. Later, sitting in an easy chair, he slipped away. Heart attack.

My heart is broken. Of course it is.

And so, for the first time in as long as I can remember, I've spent a week thinking very little about my compounding business. I'm fortunate to have a great pharmacy team, and it's their professionalism that has allowed me to focus this week on what's most important.

I wouldn't wish such a loss as I've had on anyone -- although I know many of you have suffered losses of your own, and you know where I'm coming from. So as Thanksgiving approaches, as we're all limited by pandemic concerns and we may be far from family this year, I do wish for you a few moments to be grateful for what you have and for the folks you love and for those who love you. A few moments of focus on what matters most. And may it bring you joy.

I miss my dad, but I'm so thankful for that final wonderful day I had with him, a day filled with the joy of family and friends.

"Here comes the sun," he sang. And I say: It's alright.

May your Thanksgiving holiday be just as bright.

Yours In Health,
Shawn


 

You can reach Shawn at [email protected].

APC joins amicus in lawsuit against FDA

APC's board of directors this week voted to join in the filing of a proposed amicus curiae brief in support of litigation challenging FDA's MOU with states. The lawsuit was filed in federal court three weeks ago by seven compounding pharmacies and alleges that "[T]he Final Standard MOU is defective both procedurally and substantively."

"We strongly support the lawsuit's arguments that FDA has not adhered to Congress's instructions or the statute regarding the MOU," said APC Board Chair Jenn Burch of Durham, NC. "The board's decision to join this 'friend of the court' brief demonstrates that support and allows us to shed additional light on several of the points raised in the litigation for the court."

APC (and other amici) are represented in this filing by Karla Palmer of Hyman, Phelps & McNamara, P.C. Funding for the amicus filing comes in part from APC's Legal Action Fund, which is supported by APC member contributions.

Here's APC's 2021 Board of Directors

Congratulations to the incoming members of the APC Board of Directors, elected earlier this month. They'll officially take office on January 1, 2021.

Chair of the Board: Shawn Hodges, PharmD, Kennesaw, GA

President: Michael Blaire, RPh, FIACP, Scottsdale, AZ

Vice President: Anthony Grzib*, Swedesboro, NJ

Treasurer: Alexander Pytlarz, PharmD, St. Petersburg, FL

President-elect (automatic): Dave Miller, Grand Rapids, MI, will assume the post

Chief Executive Officer: Scott Brunner, CAE

District II: Joseph Navarra, RPh; Woodbury, NY

District III: Ginny Isbell, PharmD, Huntsville, AL; Chad Thompson*, Cincinnati, OH;

District IV: Jeffrey Reses, RPh, Holly Springs, NC; Tara Thompson*, Kennesaw, GA

District V: A.J. Day, PharmD, Houston, TX; Jim Hrncir, RPh, Las Colinas, TX

District VI : Gina Besteman*, Madison, WI; Cheri Kraemer, RPh, Sioux Falls, SD

District VII: Tenille Davis*, Scottsdale, AZ; Erin Michael, MBA, MS, CPhT, Cottonwood, CA

At large: Amy Frost, PharmD, Missoula, MT; Marina Holt, RPh, Matraville, NSW

Pharmacy Compounding Foundation President: Tracy Acosta, PharmD, Dallas, TX

* Newly elected

GFI #256: The empire, er, FDA writes back

As a result of APC's lobbying effort, Representative Mark Pocan -- along with Reps. Donald Norcross, Ted Yoho, and 31 other members of Congress -- sent a joint letter to the FDA concerned about the agency's GFI #256 on animal compounding. They questioned its authority to regulate compounded veterinary medicine the way GFI #256 lays out.

Those congressional letters don't get ignored. The FDA has now responded with a letter to Rep. Pocan from Steven Solomon, director of FDC's Center for Veterinary Medicine.

While the letter mostly reiterates the agency's position (i.e., nothing to see here, folks), the important takeaway is that these grassroots efforts -- and the help of our friends in Congress -- keep FDA on notice that issues like GFI #256 are important to a lot of people.

Wanted: Your expertise and engagement

2021 is coming (finally!), and with it new opportunities for you to serve and advance your profession.

One of those opportunities is to lend your expertise as a member of a 2020 APC volunteer committee. Committees are the workhorses of the alliance -- you'll help develop programming, chase possibilities, and recommend policy to the APC Board of Directors.

We're seeking knowledgeable members for several 2020 APC standing committees:

  • Communications Committee
  • Education Committee
  • Finance & Audit Committee
  • Federal Legislative Committee
  • State Legislative Committee
  • Membership Committee
  • CompPAC Trustees

Applying to serve on any of these committees is simple: just send an email to [email protected] telling us who you are and what committee you're interested in.

Deadline for nominations is December 4, 2020.

Compounding Connections takes a break

APC's offices will be closed next Wednesday, Thursday, and Friday -- so we can prepare for, celebrate, and recover from Thanksgiving, respectively -- so your next Compounding Connections will be in two weeks. See you December 4!

Coming up

December 2 -- Live CE webinar: The Truth about Peptide Compounding; 2:00 to 3:00 pm EST

December 8 -- Live CE Webinar: State and Federal Regulation of PBMs: Legislative and Regulatory Efforts to Open the Black Box of PBMs and Bring Transparency and Equity to Independent Pharmacies; 2:00 to 3:00 pm EDT

December 15 -- Live CE Webinar: E-Prescribing in Compounding; 2:00 to 3:00 pm EDT

ICYMI

We've hit the 2100 2200 mark for testimonials about the effectiveness of cBHT (from patients, prescribers, and compounders). That sounds like a lot, but we need more! The more testimonials we have for each congressional district, the better, so please continue to spread the word: Go to A4PC.org/cbhtandme and tell us your story!