The voice for pharmacy compounding │ 3 November 2023

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From our Board Chair

A procedural pathway to Category 1

The addition by FDA of several peptides to Category 2 on September 29 officially placed them out of reach for compounding, at least for the time being. That has raised alarms from some prescribers and pharmacy compounders.

They’re concerned that patient access to what they say are legitimate therapies that are clinically effective has been taken away and that the agency has not substantiated the “safety risks” it says it identified related to those substances.

While we would argue that those peptides did not meet the criteria for compounding, APC agrees that in not showing its work – the evidence of safety risk – FDA has once again failed to document its action. “Trust us” is not a sufficient explanation for agency actions.

As we reported here last week, APC has written to FDA to request details of both the process the agency followed in determining safety risks and the risks identified with each of the added substances.

But when it comes to the 503A bulks lists, the agency is not the only one that needs to show its work. Those peptides don’t have to be parked in Category 2 forever. The best way to have them considered in the Pharmacy Compounding Advisory Committee and recommended for inclusion on the Category 1 list – which means they can be compounded – is to make a compelling case for clinical efficacy and submit it to FDA. Such a case would rely on rigorous science, credible research, and potent patient outcome data. It might also want to rebut whatever evidence FDA produces for adding them to Category 2 in the first place – if we can get our hands on that evidence.

Which is all to say there is a procedural avenue for responding to FDA’s recent action. Building such a case is an obvious next step if we think FDA has gotten it wrong.

— Anthony

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

This week’s news

What do BOPs think about compounding?

This week APC sent a 15-question survey to members and directors of state boards of pharmacy to gauge their views on the regulation of pharmacy compounding in their state. The survey also seeks input on how APC might be helpful in providing board information and perspective on compounding issues that boards grapple with.

If you are a member of a state board of pharmacy, please take the survey. We also ask that all APC members reach out to the members and director of their BOP and urge them to complete the survey.

Perplexed by new USP standards?

We’ve got resources for you!

New USP chapters <795> and <797> (and maybe USP <800>, too) took effect in many states this past Wednesday. In case you or your teammates have questions about the new compliance standards, we’re sharing here a handful of training resources from APC and its partners that can inform your compliance efforts.

From APC:

Our 15-hour online continuing education program on the regulatory framework for pharmacy compounding includes three modules on the new USP chapters. The course is $495 — or only $395 for employees of PFMs.

From PCCA:

From LP3 Network, a Medisca Partner:

From Fagron:

From Wedgewood:

Blog: What the New USP Standards Mean for Veterinarians and Their Clients

Meet your 2024 Board of Directors

In elections that closed last week, the APC membership elected (or re-elected) five board members, including Matt Martin of Crestwood, KY, Melissa Stefko of Odessa, FL, Stacy Hightower of Aubrey, TX, Gina Besteman of Madison, WI, and Peter Koshland of Berkeley, CA. Congratulations to these newly elected directors.

Here’s the entire 2024 Board of Directors:

Chair: Tenille Davis, Scottsdale, AZ (photo, right)

Chair-elect: Joseph Navarra, Woodbury, NY

Vice President: Michelle Moser, Mount Vernon, WA

Immediate Past Chair: Anthony Grzib, Swedesboro, NJ

Treasurer: Alexander Pytlarz, St Petersburg, FL

District II: Gopesh Patel, New Hyde Park, NY

District II: Philip Smyth, Lebanon, OH

District III: Cheri Garvin, Leesburg, VA

District III: Matt Martin, Crestwood, KY

District IV: Mark Filosi, Plant City, FL

District IV: Melissa Stefko, Odessa, FL

District V: Stephanie Chacon, Houston, TX

District V: Stacy Hightower, Aubrey, TX

District VI: Gina Besteman, Madison, WI

District VI: Dave Hill, Golden, CO

District VII: Peter Koshland, Berkeley, CA

District VII: Erin Michael, Cottonwood, CA

At-large: Amy Frost, Missoula, MT

At-large: Shaun Noorian, Houston, TX

PCF President: Jennifer Burch, Durham, NC (ex officio)

CEO: Scott Brunner, Auburn, AL

Updated PCAB standards available

PCAB announced this week that updated PCAB Accreditation Standards are now available to download. Standards were revised to align with new USP compounding requirements, which took effect November 1, and are enforceable by regulatory agencies, such as state boards of pharmacy.

“Compounding pharmacies will be surveyed against the updated PCAB Accreditation Standards beginning January 1, 2024,” ACHC said in the announcement. Standards can be downloaded from the ACHC customer portal.

Short takes

APC members honored by PCCA. Kevin Borg of Potter’s House Apothecary, Peoria, AZ, was awarded the 2023 M. George Webber Compounding Pharmacist of the Year during PCCA’s International Seminar in Houston last week. Ashley Berthelot, Professional Arts Pharmacy, Lafayette, LA, was awarded the 2023 L. David Sparks Advocacy Award. Congratulations to both of these APC members for their leadership.

Ozempic casts a spell on markets. Krispy Kreme shares fell this week over worries that Novo Nordisk’s Ozempic and other drugs that are being used for weight loss will shrink demand for donuts, Bloomberg reported — and that’s not all. With its outsized power to grab headlines, upend entire industries and dominate the public conversation, Ozempic has become the Taylor Swift of the stock market, reports Axios.

Save these dates

November 9: An APC webinar, Automation and USP 797 Don't Mix

November 10: PCF Pharmacy Technician Education Grant deadline.

December 12: An APC webinar, Quality assurance programs for compounding pharmacies: A medication safety survival guide for the compounding pharmacy. Registration coming soon.

December 14–16: A4M Longevity Fest 2023 in Las Vegas

2024

January 28: An APC webinar, Survey of State Compounding Law Changes 2024. More details coming soon.

April 4–6: Owner Summit, La Jolla, CA

June 20–21: EduCon Virtual: The Ethical Compounding Conference

September 17–18: Compounders on Capitol Hill (CCH) in Washington, DC

On demand

Now available: The FDA Compounding Quality Center of Excellence is announcing the availability of these self-guided, online courses: