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The voice for pharmacy compounding │ 24 February 2023

This edition is sponsored by PCCA

If your pharmacy fills compounded HRT and/or veterinary prescriptions–and wants to continue doing so–we need you in D.C. Congressional lawmakers need to hear directly from you about regulatory threats to patient access.


Join us for the 2023 ACT Legislative Conference, May 16-17 at The Pendry on the Wharf in Washington, DC. Register now to secure your Congressional appointments and save $100 with Early Bird pricing.

From APC's chair

When The New York Times calls…

It’s not like I could ignore itthat email last week from The New York Times. Not on a story about compounding. And not as the industry trade association.

 

I had to respond. That, or read “The Alliance for Pharmacy Compounding declined to comment” in the finished article.

 

Maybe you saw the piece, published this past Monday, about at-home use of ketamine. Maybe you read about how “so-called compounding pharmacies” occupy “a murky regulatory space” and how, with the loosening of restrictions during the Public Health Emergency, compounding “found a market for tablet and lozenge versions of ketamine.”

 

One might think you’d been out panning for controlled-substance compounding gold andlo and behold!ketamine was what landed in your bucket.

 

I’m both quoted and paraphrased in the piece – and not in a way that illuminates compounding’s essential role in healthcare or the un-murky regulatory framework in which you operate or our concerns with FDA’s arguments about interstate shipments (which the reporter raises).

 

No. In fact, I had a lot more to say about those things, contextualizing those issues in my responses to the reporter’s questions.

 

Why am I telling you this? Because you shouldn’t take at face value everything you read in the newspaper. Because I want you to know what we did say to that reporter. (You can read my written responses here.) And because people are watching your professionwhich is just another reason to do what you always do with the highest integrity, care, and compliance.

 

Scott Brunner, CAE, is APC’s chief executive officer. Contact him at scott@a4pc.org.

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ICYMI

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

This week

Owners: Don’t miss this one

APC’s annual Owner Summit—March 26-28 at the Grand Hotel, Point Clear, Alabama—is THE conference that is 100 percent designed just for owners like you.


Owner Summit packs two intense days with practical, actionable presentations from experts that cover issues critical to pharmacy compounding in 2023: Online payments, software solutions, sales-team management, preventing medication errors, and much, much more.


We’re less than 5 weeks away. The cutoff date on our special (incredible) hotel rate of $189 at Marriott’s Grand Hotel is March 3.


You’re making a smart business investment—one that will begin delivering an ROI as soon as you're back at work. Registration is $999 for PFMs and $1299 for all others.

Share CVM’s GFI 256 reply with your BOP

Earlier this week, APC sent an updated briefing memo to all 50 state boards of pharmacy regarding GFI #256 and CVM’s recent responses to our questions regarding compliance. 


Our communication went to the BOP director, not to the board members. We encourage you to share the CVM replies with your board of pharmacy members, to ensure they see it and can help guide state enforcement of the GFI that syncs with FDA’s approach and is reasonably uniform across states.

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APC Fellow nominations are OPEN

Designation as an APC Fellow is the highest distinction awarded by APC, and the nomination process for 2023 is now open.


Established in 1997, the APC Fellows Program distinguishes pharmacists and pharmacy technicians who are exemplary in their professionalism and commitment to the practice of pharmacy compounding. Since the program’s inception, 112 compounding professionals have been honored as members of this elite group.


All interested candidates must be registered pharmacists or pharmacy technicians who are APC members, who have practiced pharmacy for at least five years, and who have practiced in the compounding pharmacy profession for at least three years.


The application deadline is April 1, 2023. Click here to learn more about the requirements and to submit an application.

HHS projects October 2023 MOU release

HHS has released its plan of work for the coming year, including a proposed release date for the latest iteration of the MOU on interstate shipments of compounded medications. The agency’s semiannual regulatory agenda targets October 2023 for that release.

 

This re-do of the MOU by FDA is the result of successful litigation filed by seven compounding pharmacies against the agency in 2021. In February 2022 a federal judge sent FDA back to the drawing board on the MOU after FDA admitted it had not followed notice-and-comment rulemaking in promulgating the MOU. APC filed an amicus brief in the case in support of the compounder plaintiffs.

 

APC is developing legislation to eliminate the MOUand the 5 percent cap on shipments in states that don’t sign the MOUand replace it with mandatory reporting by states that ship more than 50 percent of their production out-of-state.

EduCon continues...

For those of you who weren’t able to register for this year's EduCon, there’s still time to sign up to access the 11 on-demand programs for CE credit. Click here to register and get started.


For those who did register for the live programs earlier this month but weren’t able to attend, the EduCon on-demand programs will be available February 14 – April 30, 2023. Questions or need assistance? Contact Janice Johnson at (614) 389-3236 or jjohnson@ohiopharmacists.org.

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Save these dates

February 28: An APC webinar, The Cost of Non-Compliance: DUR and Regimen Review


March 2–3: A PCCA in-person program, USP Implementation Training, in Houston, TX


March 14: A PCCA webinar, Quality & Compliance.


March 23: An APC webinar, Weight Loss Lifestyle. More details coming soon.


March 2628: APC's Owner Summit 2023, The Grand Hotel Golf Resort + Spa;

Point Clear, Alabama.


April 6: An APC webinar, Making the Case for Advanced Pharmacy Technicians. More details coming soon.


April 20: An APC webinar, Compounding for Women’s Health Conditions. More details coming soon.


May 25: An APC webinar, IV Nutrition. More details coming soon.


June 6: An APC webinar, Compounding for Cosmetic Needs. More details coming soon.


June 29: An APC webinar, Trends in Veterinary Compounding. More details coming soon.


May 1617: PCCA's ACT Legislative Conference, Washington, DC


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

Short takes

Xylazine-laced fentanyl poses new trouble. Xylazine, an animal tranquilizer not suitable for human use, has been showing up in illicit fentanyl. The addition of xylazine causes users’ injection sites to become necroticand, to add further complicationsdoesn’t respond well to overdose medication treatment.


CVM's Solomon retires, Forfa takes over. On February 17, FDA’s Center for Veterinary Medicine announced that Tracey Forfa, a distinguished 30-year veteran of the agency, is its new director.


APC members in the news…

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


Owner Summit 2023


Prescriber Briefing Resources

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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  

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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.