From APC's chair

3 things you need to know right now:

1) We’re changing your future. Yesterday in a Town Hall Briefing, we rolled out our plans for taking back your profession via a planned media campaign we’re calling Compounding the Joy of Living. Though we’re continuing our efforts to save compounded hormones, this year’s campaign will focus on telling a broader story about how compounding allows patients to live better lives. That’s what you do: Not “prepare medications,” but you compound their joy. If you missed the town hall, watch the hype video here, then invest to support this important initiative.

2) Together at last: PTCB and APC… This is just a teaser, but we’ve joined with the Pharmacy Technician Certification Board to offer our PFM Technician Members discounts on the Pharmacy Technician Certification Exam, as well as the official PTCE practice exam. We’re big on technicians and technician certification, so we’re delighted to have PTCB as a Corporate Patron. Stay tuned as we develop the portal for you to access those new discounts.

3) We asked, CVM answered. Be sure to read below about FDA’s Center for Veterinary Medicine’s informative responses to our technical questions on GFI 256. While the document is not definitive, I think it will go a long way toward helping us better comply with the guidance.

Read on for other good news…

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:

• Welcome 2023 Corporate Patrons
• Phased-in GFI enforcement? Put it in writing, associations tell CVM
• Here’s what you need to know right now
• FDA amends 503B ibuprofen compounding guidance. Yawn.

This week

CVM responds to GFI 256 questions

FDA’s Center for Veterinary Medicine responded this week to a July 26, 2022, letter from APC and NCPA requesting answers to more than 30 technical questions about GFI 256 compliance. 

“There’s a good amount of helpful information in CVM’s response,” said APC Board Chair Anthony Grzib. “It appears the agency took seriously our concerns about clarity in the GFI and has made a good-faith effort to describe its view of compliance. We’re grateful to Dr. Bill Flynn and his CVM team for that.”

Among the highlights of CVM’s answers to the associations’ questions:

• FDA does not intend to conduct inspections at 503B outsourcing facilities until it provides clarification on how GFI 256 applies to those facilities.
• FDA does not expect compounding pharmacies to confirm a valid VCPR exists.
• FDA will not question pharmacists’ professional judgment as to the documented reason a bulk ingredient was used instead of an FDA-approved drug. 
• FDA does not expect compounders to retroactively obtain medical rationale for prescriptions written prior to April 1, 2023.
• CVM does not have a program to share with state licensing boards individual adverse events reports the agency receives. 
• FDA generally intends to refrain from taking enforcement action for bulk drug substances that are currently under review so that veterinary access to those compounded products is not restricted during the review process.

“APC’s next steps will be to share CVM’s responses with stakeholders, including state boards of pharmacy,” said Grzib. “We want to cement among regulators an understanding of what compliance looks like that is consistent with CVM's. That can help assure more consistent enforcement across the country.”

Beset by business challenges? We’ve got the cure for what ails you.

For compounding pharmacy and facility owners, APC’s Owner Summit is the top learning, planning and idea-sharing event of the year—and it’s only five weeks away.

It’s also being held in sunny, warm Point Clear, Alabama. For many of you, it has been a while since you’ve seen sunshine and blue skies. 

But seriously, Owner Summit is ALL about learning, networking, and idea-sharing. Don't just take our word for it:

This year’s fast-paced Owner Summit program is guaranteed to boost you out of your wintertime blahs, with sessions on growing your pharmacy leadership, incorporating innovation and increasing operational efficiency. We guarantee you’ll take home new ideas you can implement immediately.

THIS PART IS IMPORTANT!

You can register for the conference itself whenever you like, but the cutoff date for our special hotel room rate at Marriott’s Grand Hotel ends March 3. That room block is already 75% full, so don’t snooze or you’ll lose.

Announcing: 2023 PCF/PMIC Scholarship recipients

Congratulations to the 2023 recipients of the Pharmacy Compounding Foundation and Pharmacists Mutual Insurance Compounding Scholarship.

These awards are given to pharmacy students who have demonstrated commitment to a career in compounding pharmacy in the USA.

Olivia Behnfeldt

Ohio Northern University 

Ada, OH

Courtney Ma

Nova Southeastern University

Fort Lauderdale, FL

EduCon: It’s a wrap…or is it?

For those of you who weren’t able to register for EduCon last week, 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 last week 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.

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 23: An APC webinar on weight loss and lifestyle. More details coming soon.

March 26–28: APC's Owner Summit 2023, The Grand Hotel Golf Resort + Spa;

Point Clear, Alabama.

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

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

May 16–17: PCCA's ACT Legislative Conference, Washington, DC

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

Short takes

Missed our ‘State of the Alliance’ report? For those of you who weren’t able to join us for APC’s State of the Alliance last week during EduCon, here’s a link to the video recording. We’d like to think you’ll be impressed with all the stuff we’re working on–for you!

Spread the news: the X-waiver is gone. In late December 2022, President Biden signed the Mainstreaming Addiction Treatment Act, which eliminated the redundant, outdated requirement that practitioners apply for a separate waiver through the DEA to prescribe buprenorphine for substance use disorder treatment.

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  

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.