APC News

FDA to exercise enforcement discretion on compounded FIP treatment

Published May 5, 2024

This week, FDA announced that it does not intend to enforce new animal drug approval requirements for products compounded from GS-441524, when prescribed by a veterinarian for a specific cat patient for the treatment of Feline Infectious Peritonitis under the conditions listed in GFI #256. There is currently no FDA-approved drug available to treat FIP. 

Just because FDA is exercising enforcement discretion doesn’t mean your marketing language doesn’t matter, though. If you are compounding GS-441524 for FIP under the circumstances described above, you can’t say that it is now “legally available.” Animal drugs compounded from bulk drug substances are unapproved drugs (and therefore not legal), but in this specific case, FDA is exercising its enforcement discretion since no other treatment option exists.

Advocacy in ACTion

Published May 5, 2024

APC’s Scott Brunner and Savannah Cunningham attended PCCA ACT Legislative Conference this week — as did APC Board Vice President Gina Besteman and many other APC members — to meet in person with members of Congress and advocate for pharmacy compounding. If you missed out this week (or even if you didn’t), join your fellow compounders in September and meet with your own members of Congress at APC’s Compounders on Capitol Hill.

 

Get the scoop on the hottest topics in compounding

Published May 5, 2024

Over three evenings this summer – one each in July, August, and September – you can learn the latest on the hottest topics in compounding from some of the best presenters in the industry (and earn six hours of CE credit while you’re at it). EduCon’s first session is in less than two months, and you don’t want to miss it. 

On July 15, Best Practices x2: Ketamine and GLP-1 Compounding will equip you with the essential knowledge and skills you need to dispense compounded ketamine and GLP-1 medications, covering everything from legal obligations and diversion concerns to documentation requirements and patient education. And you’ll learn it all from none other than APC’s Tenille Davis, a board-certified sterile compounding pharmacist and member of the Arizona State Board of Pharmacy with 16 years of experience in compounding pharmacy operations under her belt. 

What are you waiting for? Register today — and if you get some peers and coworkers on board, you can all get a discount with bundle pricing.

 

South Carolina allows 503B sourcing

Published May 5, 2024

Kudos to the Outsourcing Facilities Association for their work in shepherding through South Carolina HB 3592. Signed into law on Monday, it allows “a pharmacy, institutional pharmacy, or practitioner to purchase drugs compounded or repackaged by an outsourcing facility directly from the outsourcing facility without an order from a practitioner” — explicitly permitting 503B sourcing.

A terrific tool to train the team

Published May 5, 2024

Our 15-hour virtual course is convenient, affordable … and excellent

Do you have a team member who needs a foundation in compounding compliance? Want a refresher for yourself? Our 15-hour virtual course is a thorough, convenient, and affordable resource for learning the ethical, legal, and regulatory framework in which compounding is done.

Technicians — Complete the course for free

The Pharmacy Compounding Foundation is awarding up to 10 pharmacy technicians a grant valued at up to $495 to complete the 15-hour course. All applications must be submitted by June 30 and can be found here.

 

We’re headed for Tampa! (Oh, and Boston, too)

Published May 5, 2024

We’ll be in the Tampa/St. Pete area on June 12 for our next CompoundED UpDATE — part of a series of regional meetings made possible by a grant from PCCA. Join us, and you’ll get two hours of live CE, a compounding issues briefing, dinner, and networking time with other compounders in your area — all for only $25. 

 

 

We’ll also be in Boston on June 18 for a compounder get-together hosted by Acton Pharmacy and sponsored by Topi-CLICK. No CE, but you’ll still get dinner, networking time, and a compounding issues briefing. Register here.

Celltechgen is APC’s newest supporter

Published May 5, 2024

Celltechgen, a testing lab for microbe endotoxin and sterility, potency, and more, has joined APC as a Bronze-level Corporate Patron.

“We’re glad to have Celltechgen as a new Corporate Patron,” says APC’s Scott Brunner. “We appreciate their support of pharmacy compounding and the work APC is doing.”

You can find out more about Celltechgen and a full list of all our Corporate Patrons on our website.

Meet our compounding defenders (and guardians and champions)

Published May 5, 2024

A few weeks ago, we offered you a deal — invest in one of our new investment packages, and we’ll remove you from all subsequent solicitations for contributions to OneFund, Legal Action Fund, Compounding the Joy of Living Campaign, and the Pharmacy Compounding Foundation for the rest of the year. 

Since then, several of you have taken us up on it — so here’s a big thank you to our Package Deal investors. 

Here’s also an earnest plea for more of you to invest. Funding those four entities is essential to our being able to represent and defend you and your practice and elevate the profession.

Cheers to enjoying fewer emails in your inbox – and becoming a compounding champion whose financial support fuels our good work.

GUARDIANS

  • James Axtell, Axtell’s Rite-Value Pharmacy Inc
  • Jeff Barton, Custom Dosing Pharmacy
  • Dawn Ipsen, Kusler’s Pharmacy
  • Stuart Johnson, Family Pharmacy South Aiken
  • Josh Morgan, Morgan Compounding
  • Charlie Morland, International Filter Products
  • John Voliva, Hook’s Apothecary

DEFENDERS

  • Erik Nelson, Koru Pharmacy

CHAMPIONS

  • Randy Davis, Designer Drugs
  • Ross Jordan, Tailor Made Compounding
  • Shaun Noorian, Empower Pharmacy

Exploring career path options for technicians

Published May 5, 2024

APC’s Jen Petska is the featured guest on the latest CPhT Connect podcast, “the only weekly podcast specifically for pharmacy technicians.” She shares her journey, how being a pharmacy technician plays into her career, and the variety of career paths available to pharmacy technicians. Give a listen.

 

Journalistic malpractice

Published May 5, 2024

This piece is appalling – both the bias and error in the article itself AND that Pharmacy Times would take a swipe at a legitimate pharmacy practice like pharmacy compounding. The author seems to have swallowed what the drugmakers fed her without chewing it. But then, note all those drug ads surrounding the online piece. And no, APC was not asked to provide perspective.

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