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APC News

cBHT emergency briefing: Three big asks

Published August 8, 2022

Yesterday, APC’s cBHT Campaign Steering Committee hosted an emergency briefing for APC members and compounding supporters and made three urgent asks of APC members and supporters to help ensure our patients can continue to have access to cBHT:

Click here to watch the video recording of yesterday’s briefing.

SURVEY: Are you ready for GFI 256?

Published August 8, 2022

In April last year, the FDA’s Center for Veterinary Medicine released its GFI #256, “Compounding Animal Drugs from Bulk Drug Substances.” The GFI expresses the agency’s “current thinking” on the subject of compounding from bulk drug substances for animal health.

Maybe you knew this. But did you know that FDA plans to begin enforcement of the GFI on October 1, 2022? Compliance will mean that veterinary practices and compounding pharmacies will have to navigate through transformative changes in their policies, practices, and procedures.

We’re conducting a survey of compounding pharmacies to help APC understand your readiness for compliance with the GFI #256 – so that we can provide tools and training to support you in this transition and so that we can advise FDA about whether an enforcement delay is warranted.

Would you mind completing it? It should only take you about seven minutes.

Click here to take the survey. Deadline to complete it is Friday, August 26.

CCH hotel room block filling up fast

Published August 8, 2022

APC’s Compounders on Capitol Hill is a little more than a month away. PLEASE consider attending, as THERE’S A LOT AT STAKE THIS YEAR, from countering the threat to compounded hormones, to addressing the unrealistic ambiguity in FDA’s animal compounding GFI, to educating Congress about how compounders can help fix drug shortage and supply chain issues.

We’ve never needed you more—joining us in DC for a mere 18 hours—it’s a QUICK TRIP—for meeting with your members of Congress and protecting pharmacy compounding and the patients you serve.

But don’t wait too much longer, as the APC room block at the Hilton National Mall is filling up fast, and there’s no overflow hotel.

The sooner you register, the earlier and better chance we have of scheduling you for an in-person visit with your members of Congress. (Note: Due to scheduling deadlines, Hill visit requests are not guaranteed for any registrations received after August 26, 2022.)

Find full details, get registered, and make your hotel reservation here.

Notice of APC Annual Meeting

Published August 8, 2022

As required under its Bylaws, the 2022 annual meeting of the Alliance for Pharmacy Compounding will be held on Wednesday, September 14, 2:00-2:30pm, at the Hilton National Mall in Washington, DC, in conjunction with the Compounders on Capitol Hill (CCH) conference. Board Chair Michael Blaire of Scottsdale, Arizona, will preside.

No registration is required to attend the annual meeting; however, registration is required to attend any other CCH events.

Carter, Harshbarger request GFI 256 enforcement delay

Published August 8, 2022

In a letter last week to FDA Center for Veterinary Medicine Director Dr. Steven Solomon, Congressman Buddy Carter (GA) and Congresswoman Diana Harshbarger (TN) respectfully requested that CVM and FDA delay enforcement of GFI #256 until at least FY2024, and continue to work with pharmacy and veterinarian stakeholders, including state regulatory agencies, to provide clarification as to how the guidance will be implemented and enforced.

The authors explained that the ability of many veterinarians and pharmacists to serve animal patients will be affected by this GFI, and there remain too many unanswered questions for pharmacy compounders and veterinarians to achieve compliance in such a short time.

Click here to read the full letter.

Board nominations open for APC and Foundation

Published August 8, 2022

APC
We’re seeking passionate, informed, influential compounding leaders to help guide our alliance as members of the APC Board of Directors.

Learn more about APC’s open Board roles here.

Click here to self-nominate to APC’s Board of Directors.

 

Pharmacy Compounding Foundation
The Pharmacy Compounding Foundation is seeking compounding professionals who want to advance the practice of pharmacy compounding as board members of the foundation.

Learn more about the Foundation’s open Board roles here.

Click here to self-nominate to the Pharmacy Compounding Foundation Board of Directors.

Emergency briefing on cBHT is August 11

Published August 8, 2022

APC’s cBHT Campaign Steering Committee has scheduled an emergency briefing at 3pm EDT on August 11, and all APC members who compound hormones for their patients are urged to attend.

“FDA’s implicit threat to restrict compounded hormones is not going away,” said APC CEO Scott Brunner. “The agency could act at any moment, and we’re facing three urgent needs for action that can make a difference in slowing down the effort to restrict cBHT. We’ll provide marching orders at this briefing.”

The briefing is free, but registration required: a4pc.org/cbhtbriefing.

NEW: Physician briefing papers from APC

Published August 8, 2022

Hard to believe, but there are still physicians out there who question the legitimacy of pharmacy compounding, so they’re reluctant to consider the compounded therapies you can provide their patients. That, or they press you to compound substances that are prohibited.

To help you educate prescribers, APC and the Pharmacy Compounding Foundation have developed two member-only briefing documents you can share with physicians and other prescribers. One is “The Truth About Pharmacy Compounding.” It explains the regulatory framework in which compounders operate and provides an overview of what can and cannot be compounded under federal law. The other is “Compounding Peptides: It’s Complicated.” It explains restrictions on peptide compounding as well as uncertainty surrounding the list of semaglutide on FDA’s Drug Shortage List.

The APC and PCF logos give credibility to the documents, and both are designed so you can add your pharmacy logo as well.

Download the new briefing papers here and share them with the physician offices you or your sales reps visit. (It’s an APC member-only tool, so you’ll need your login and password to access it.)

1,000 signatures and growing

Published August 8, 2022

Last week, we asked for your help in encouraging physicians to sign our letter to FDA expressing concern about its implicit threat to restrict cBHT—and you heard the call and answered.

Thank you.

We now have about 1,750 prescriber signatures on the letter. Please send a reminder to prescribers you work with who may not have signed yet. With your continued help, it’s not out of the question that we could hit 2,000 or more signatures before the newly extended August 17 deadline.

You’ll find everything you and your prescribers need to know at a4pc.org/physicianletter.

Sen. Rosen, Rep. McMorris Rodgers to speak at CCH

Published August 8, 2022

APC has confirmed that two members of Congress who serve on key committees with oversight over pharmacy compounding in the U.S. Senate and House will speak at Compounders on Capitol Hill:

  • Rep. Cathy McMorris Rodgers (WA), Ranking Member, House Energy & Commerce Committee, will attend the CompPAC Reception on Wednesday afternoon, September 14. Please note that this is a separate, ticketed event.
  • Senator Jacky Rosen (NV), member of Senate HELP Committee, will speak at breakfast on Thursday morning, September 15.

You should already know that APC’s Compounders on Capitol Hill is your once-a-year opportunity to engage your members of Congress in-person, on their turf.

Here are two things you may not know:

  • The APC room block at the Hilton National Mall is filling up fast, and there’s no overflow hotel.
  • The sooner you register, the earlier and better chance we have of scheduling you for an in-person visit with your members of Congress. Wait until the last minute, and all bets are off.

Find full details, get registered, and make your hotel reservation here.

Get going! It’s the best thing you’ll do for your compounding practice all year.

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