The voice for pharmacy compounding • May 29, 2020
Enjoy our latest edition. Send your suggestions and questions to info@a4pc.org
Shawn Hodges
APC President
I can’t remember the last time I went months without seeing so many of my compounding colleagues. Those opportunities for coming together have been severely curtailed this year thanks to the coronavirus public health emergency.

But maybe — just maybe — we’re beginning to see light at the end of this long, dark tunnel we’ve been in. Maybe, as prevention efforts become normalized nationwide and the virus abates, we can begin to look forward to coming together again.

To my thinking, the next, best, time to do that will be at APC’s Compounders on Capitol Hill — our congressional fly-in — coming up September 9-10 in Washington, DC. Right now, our plan is to proceed with the event — making it the one and only opportunity for APC members to come together this year, and for the most important of purposes: to meet with members of Congress on Capitol Hill and advocate for your profession on several priority issues. Those include:

  • FDA’s draft animal compounding GFI.
  • FDA’s Final MOU on interstate hipments.
  • Restrictions on dietary supplement compounding.
  • Showcasing how compounders have step up to meet patient needs during the COVID pandemic — and why we should be able to continue to do so.

As you’ll read below, this year’s CCH format has been shortened to a day and a half — just one overnight stay — with maximum focus on congressional meetings. Given the really great hotel rate we’ve negotiated with the Omni Shoreham Hotel, we estimate most members can participate for less than $1,000 all inclusive.

And of course we’ll find time for networking — for strategizing and sharing ideas and simply catching up, since it’s been so long since we were last together.

APC and the hotel are making every effort to assure your safety — and we’ll be documenting those efforts to help you feel better about this important trip.

I hope you’ll plan to attend. We sure do NEED you to attend. Your profession is counting on you.

Thanks for your support for APC. Read on about the 5 BIG THINGS YOU NEED TO KNOW RIGHT NOW....
You can reach Shawn at shodges@innovationcompounding.com .
June 2 — Live CE Webinar: " Touching the Bug: Topical Anti-Infectives"; 2:00 to 3:00 pm EDT

June 10 — Live CE Webinar: " Evidence Based Pharmacotherapy of Pediatric Traumatic Brain Injury"; 3:00 to 4:00 pm EDT

September 9 - 10: APC's Compo unders on Capitol Hill (Washington, D.C. Fly-In)
2020 OSHA Training:
Bloodborne Pathogens

June 12; 3:00 to 4:00 p.m. EDT
July 21; 1:00 to 2:00 pm EDT
August 19; 6:00 to 7:00 pm EDT

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. USP to revisit BUDs, prepares to take input

USP has announced that it will be " conducting additional stakeholder engagement activities " about the beyond-use date provisions in Chapters <795> and <797>.

What does that mean for you (and APC)? Nothing yet; this is just the announcement. But it's an one worth noting.

The agency is opening those chapters for input as a result of APC's appeal last year of the new USP compounding chapters. USP's Appeals Panel sent those chapters back to the Compounding Expert Committee in January "with recommendation for further engagement on the issues raised by stakeholders concerning beyond-use date provisions."

USP will be turning to an independent third party to facilitate that outreach, but it hasn't named one yet. The new CEC will start work this summer, led by APC member Brenda Jensen, when it will begin the process of soliciting input.

"Stakeholder engagement sessions will include smaller roundtable discussions with invited participants, as well as broader open forums to collect stakeholder feedback. USP will announce the dates of these sessions once they are available."

APC is looking forward to working with the CEC on these issues, and we'll certainly keep membership up to date once the process begins.
2. Compounders on Capitol Hill: Registration is OPEN

That's right — it's time to register and make plans to make your voice heard on Capitol Hill. 2020's biggest advocacy event for compounding professionals — APC's Compounders on Capitol Hill — is coming September 9–10 in Washington, DC.

CCH will be the only face-to-face APC event this year, and your best chance to meet with the lawmakers affecting your practice and your patients. This is how you can make a difference for your profession!

This year we've got a smart, streamlined schedule: Only one overnight stay. Fly in Wednesday, get briefed that evening at our networking event, then head to Capitol Hill Thursday for meetings with members of Congress.

We do (almost) all the work. We'll brief you, give you talking points, and handle the scheduling so you're back at the airport by 5:00 pm. You need to bring your enthusiasm and concern for compounding — and let it show.

The Omni is ready. The hotel is taking a host of extra precautions to ensure a safe meeting environment for everyone, including daily disinfection of all public spaces. Plus: The hotel room rate is our lowest in years!

These face-to-face interactions will do more to advance pharmacy compounding than any one person can do alone. CCH is when our voices are loudest and clearest. Add yours and help your profession — start by clicking here to read the agenda and register to be one of our Compounders on Capitol Hill.
3. Two appointments, two high-fives

Congratulations are in order for APC member Tim Fensky , who assumed the office of president of the National Association of Boards of Pharmacy .

Tim had already served on NABP's executive committee, as its treasurer, and as its president-elect, and currently represents the association on the FDA's Pharmacy Compounding Advisory Committee. He's also pharmacy administrator at Bournewood Health Systems in Chestnut Hill, Mass., and the chief pharmacy officer at Sullivan’s Health Care in Boston.

We're looking forward to working with Tim and even more closely with NABP.

AND...

Congrats as well to APC member Linda McElhiney , who was appointed to the FDA's Pharmacy Compounding Advisory Committee, where she'll be advising the FDA commissioner on compounding issues.

Linda is a past member of both the APC and Pharmacy Compounding Foundation's boards of directors, and an APC Fellow for more than a decade. The president-elect of the American College of Apothecaries, she's currently the team lead compounding pharmacist at Indiana University Health, where she's worked since 1993.
4 . HHS: PREP act overrides state laws, allows pharmacist-administered COVID tests

HHS has released an Advisory Opinion that says the agency believes the PREP act overrides state laws: Pharmacists can order and administer FDA-approved Covid-19 diagnostic tests.

"[W]e conclude that the PREP Act, in conjunction with the Secretary’s March 10, 2020 declaration, preempts any state or local requirement that prohibits or effectively prohibits a pharmacist from ordering and administering a COVID-19 diagnostic test that the Food and Drug Administration (FDA) has authorized."

However, it also makes clear: "It is not a final agency action or a final order. Nor does it bind HHS or the federal courts. It does not have the force or effect of law."

5. Scott 'casts the case for APC

APC CEO Scott Brunner was featured on PCCA's "The Mortar and Pestle" podcast, speaking on APC's rebranding — and why advocacy is critical for the survival of pharmaceutical compounding. (Thank you, PCCA!)

Click here for the episode on Stitcher ; you can also find it on iTunes, Google Podcasts, and your favorite podcasting app.

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