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The voice for pharmacy compounding │ 10 March 2023

From APC's Chair

GFI 256: Coming into compliance

There’s a lot we still don’t know about what full compliance with FDA Center for Veterinary Medicine’s GFI 256 on animal compounding looks like: How does it apply to 503Bs? Will the positives list be robust enough to assure vets have access to the range of compounded animal meds they need? Will states follow CVM’s lead and share CVM’s stated interpretations of the GFI so that there’s some semblance of consistency in enforcement across the nation?

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But here’s what we do know: FDA enforcement begins April 1, and though CVM has assured us they’ll err on the side of mercy in the early days of enforcement, that doesn’t mean you shouldn’t be ready. Now is the time to bring your practice into compliance with the GFI.


To help you do that, APC and PCCA are hosting an hour-long CE webinar on March 22 called GFI 256: Coming into Compliance. Led by PCCA’s Matt Martin and AJ Day, the webinar is designed to let you know what we know thus far about what compliance looks like, and we’ll offer you some solid recommendations to implement in your animal compounding practice.


In addition, as you’ll read below, APC is rolling out the fourth in our series of prescriber briefings, this one meant to advise veterinarians on noting medical rationale for the compounded medication on the prescription. Give it a look and begin now to share it with the vets you work with.


In these ways, we’re working to help you meet the requirements of the new GFI – so we can assure continued access to essential compounded therapies for animals.


Read on for more 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.

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ICYMI

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

This week

Compounding the Joy of Living:

It’s your story. Help us tell it.

For too long, the story of compounding has been told in the media by people with a vested interest in marginalizing our industry. They would decide your future.


But we are doing something about it.


Compounding the Joy of Living: The campaign for pharmacy compounding, is us taking back control of our own story. It’s us taking back control of our own destiny.  

Above is an example of the kinds of ads we are working on.


This phase of the campaign is the third year of our original 3-year initiative. We are expanding our message beyond compounded hormones, and we need your help. We need your your financial support.


Because the simple truth is that we cannot impact our world without money. 


We have a choice. To sit on the sidelines and let others determine our fate. Or get into the fight and tell our own story. 


You transform the lives of your patients every day. The world needs to know that.

  INVEST NOW  

NEW Prescriber Brief:

Documenting Medical Rationale

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With enforcement of FDA’s GFI 256 set to commence April 1, APC has developed a new Prescriber Brief to help you coach the veterinarians you work with on what they must document on prescriptions for compounded animal drugs.


It joins a suite of members-only Prescriber Briefs that include topics such as the regulatory framework of pharmacy compounding, compounding peptides, and the “Wet Signature” Act.


PS: You’ll need your a4pc.org member login to access the briefings themselves.

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We've (probably) got a webinar for that

Bummed that you missed our annual State of Compounding Law Changes live webinar in January?


Wish you could catch some of the CE sessions from this year's EduCon programming?*


No worries. APC has an extensive library of on-demand webinars availableincluding EduCon 2023for you to access whenever and wherever.

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*It’s not too late to still get credit if you registered for the live presentation of EduCon. You can also be a new registrant for the on-demand programs. All are available until April 30, 2023. Pharmacists and pharmacy technicians who view the on-demand CPE activities will be awarded home-study CPE credit.

Save these dates

March 14: A PCCA webinar, Quality & Compliance


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


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 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.


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

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Short takes

Hormones in the news. Makena, a hormonal injection that was approved more than a decade ago to reduce the risk of preterm birth, is being withdrawn from the market, according to its maker, Covis Pharma.


Owner Summit Fun Fact: Fairhope, AL, where this year's Owner Summit is being held, is known as an enclave for writers and artists. While you're in town, be sure to pop into local bookstore Page & Palette, which features signed copies of books by Alabaman authors like Winston Groom, Howell Raines, and Fannie Flagg. Register for APC’s Owner Summit (March 26-28) and be sure to schedule a "meeting" with a good book and a coffee (or, even better, a Tequila Mockingbird cocktail from its Book Cellar bar area).

Quick links



APC Career Center

• Job seekers

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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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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.