From APC's Chair

Walking the talk

But having a strong, effective national advocate in APC requires more than goodwill or talk. 

It requires funding. It requires investment in our work that goes beyond the dues you or your pharmacy pays. 

We’re looking out over the next three quarters of 2023 and already seeing new challenges pop up that we must be equipped—funded—to tackle: Proposed compounding restrictions in California, the likelihood FDA will move to restrict compounded hormones, and more.

So yeah, this is an ask for money. It’s a plea for you to walk the talk. 

OneFund is what fuels our entire advocacy operation. You can invest in it here.

CompPAC is how we support members of Congress who think like you do about your compounding profession. It needs your investment, too. Do that here. 

I won’t belabor it, and I won’t tell you how much to invest. Just INVEST. It’s the only way we’ll be able to protect your profession.

— Anthony

P.S. Read on for this week’s news – oh, and pay attention to all the upcoming webinars. Lots of good stuff ahead.

Anthony Grzib is VP of quality and compliance, state-regulated pharmacies at Wedgewood Pharmacy in Swedesboro, New Jersey. You can reach him at agrzib@wedgewoodpharmacy.com.

ICYMI

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

• OPEN TO ALL COMPOUNDERS: GFI 256 webinar
• We've (probably) got a webinar for that
• Compounding the Joy of Living: It’s your story. Help us tell it.
• NEW Prescriber Brief: Documenting Medical Rationale

This week

CVM issues Letter to Industry on GFI 256 phase-in

In response to a request from APC and NCPA, FDA’s Center for Veterinary Medicine last week issued a Letter to Industry explaining the phased-in approach to enforcement the agency plans to take on GFI 256. 

“We’re grateful to CVM for this important communication,” said APC Board Chair Anthony Grzib. “In tandem with the answers to our technical questions CVM shared with us last month, it helps pharmacy compounders and state boards of pharmacy understand FDA’s thinking.”

Extended: APC Fellows application date (now June 1)

The APC Fellows Program recognizes the distinguished contributions our compounding pharmacist and pharmacy technician members have made to the profession and to their respective communities.

All applicants must be registered pharmacists or pharmacy technicians who have practiced pharmacy for at least five years and practiced in the compounding pharmacy profession for at least three years. 

The deadline for 2023 nominations has been extended to June 1, which provides plenty of time for you to learn more about eligibility requirements and submit your application. Get started on our APC Fellows web page.

Explain yourself to prescribers

Best of all, you can brand them with your pharmacy name and logo. Topics in the series so far:

• The regulatory framework of pharmacy compounding
• Compounding Peptides: It’s Complicated
• Compounding and the Wet Signatures Act
• NEW: GFI 256 and Documenting Medical Rationale

And remember: These are member-only tools, so you’ll need your APC login to access them.

Save these dates

Now available on-demand: The FDA Compounding Quality Center of Excellence is announcing the availability of a self-guided, online course: Aseptic Process Simulations (Media Fills).

March 21: A FREE ARL Bio Pharma webinar, USP 51 Antimicrobial Effectiveness Testing & USP 71 Sterility Testing

March 21: An NABP webinar, The Importance of CAG 003 to the Successful Certification of Sterile Compounding Environments

March 22: An APC/PCCA webinar, Vet GFI 256: Coming Into Compliance.

March 23: An APC webinar, Compounding Health - As an "Adjunct to Diet and Exercise"

March 26–28: 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.

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 1: APC Fellows Program application deadline

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

June 29: An APC webinar, Trends in Veterinary Pharmacy: What Compounders Need to Know. More details coming soon.

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

Short takes

What happens when the PHE expires May 11? FDA explains what will happen to CDER guidances and emergency use authorizations as the public health emergency ends officially in a couple months.

Owner Summit Fun Fact: The US Army used the Grand Hotel (site of this year's Owner Summit) as a training base during World War II. The hotel honors its military history with a cannon firing, which takes place daily at 3:45 pm. 

Quick links



APC Career Center

• Job seekers

• Employers

APC's Code of Ethics

Compounding Connections archive

Compounders on Capitol Hill

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  

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.