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APC News

PCF names new directors

Published December 12, 2023

The Pharmacy Compounding Foundation has elected five board members, including Michael Blaire of Scottsdale, AZ, Lloyd Levidow of Scottsdale, AZ, Lisa Everett Andersen of Olathe, KS,  Greg Lake of Hideout, UT, and Katie Lewis of Lincoln, NE. Congratulations to these newly appointed directors.

Here’s the entire 2024 PCF Board of Directors:
  • President: Jennifer Burch, Durham, NC
  • President-elect: Michael Blaire, Scottsdale, AZ
  • Treasurer: Lloyd Levidow, Scottsdale, AZ
  • Liza Chapman, Atlanta, GA
  • Lisa Everett Andersen, Olathe, KS
  • Barbara Exum, Glen Allen, VA
  • Greg Lake, Hideout, UT
  • Katie Lewis, Lincoln, NE
  • Robert Nickell, Torrance, CA
  • APC Chair: Tenille Davis, Scottsdale, AZ

Our state-by-state 795-797-800 chart has been updated

Published December 12, 2023

APC has posted an updated version of our compilation of state by state adoption of USP <795>, <797>, and <800>. It’s an APC members-only resource, and provides information about the method by which each state adopts USP chapters, the current status of USP chapter adoption and effective dates by state, and links to state websites where USP-related law and/or regulations may be found.

Though we cannot guarantee accuracy, it’s based on recent data-gathering and is a helpful resource for compliance. You’ll need your APC member login and password to access it.

Novo alleges potency discrepancy, impurities in compounded semaglutide

Published December 12, 2023

We’ll let you read it for yourself. Interesting how the reporter seems to take Novo’s word for it, no? 

(This is a late-breaking story. APC and its attorneys are reviewing and may issue a statement.)

APC files amicus in Novo case against Tennessee compounder

Published December 12, 2023

A U.S. District Court judge approved APC filing an amicus brief this week in Novo Nordisk’s lawsuit against Tennessee compounder (and APC PFM) DCA Pharmacy. 

“This is great news,” said APC’s Scott Brunner. “It means the brief, which explains the essential role compounding pharmacies play in preparing copies of FDA-approved drugs when those drugs appear on the FDA drug shortage list, was accepted and will be considered by the court. The brief also clarifies for the court that pharmacy compounding is authorized in state and federal law and is not, as Novo asserts, ‘unauthorized drug manufacturing.’”   

APC awaits responses from courts to its requests to submit the amicus brief in the three other Novo lawsuits against compounding pharmacies. 

APC is represented by Boesen & Snow Law, Scottsdale, Arizona. The legal action is supported by APC’s Legal Action Fund, which is funded by contributions from APC members.

A $100,000 deficit

Published December 12, 2023

One of the challenges of being an ambitious but resource-poor association is that we have to spend a lot of time asking members like you for money.

I suspect you’ve noticed?

That’s because dues dollars – either dues your company pays as a PFM or that you pay as an individual member — only cover about half of APC’s expenses each year. It’s only thanks to a combination of other revenue sources — including conference, education, corporate patron, royalty, and OneFund revenues — that we’re able to represent you the way we do.

This year, we’ve done really well with all of those funding sources except one: OneFund. It’s the fund that fuels our advocacy work, and it’s supported by gifts from individual compounding pharmacies and members.

OneFund gifts have been falling for the past two years, and we’re not really sure why. In 2021, more than $310,000 was given to OneFund. Last year, that amount fell to $285,000. This year, we dropped the goal, and even at that, if things don’t change, we’ll miss that goal by $100,000 or more.

There’s a lot we could do with that $100,000 — or, to put it more bluntly, a lot we can’t do without it. I’m talking, in particular, about confronting wrong-headed state or FDA policies we won’t have the funds to tackle.

So yeah, once again, I’m asking for money. If those of you who have given to OneFund in previous years but not yet in this year would make your 2023 investment, we’d more than make up that $100k. And if you’ve never given, well, there’s never been a more needful time.

Click the button below and do your part: A one-time gift, or better yet, set up a recurring monthly investment. 

We sure do need it — just as much as you need APC to continue to protect your profession.

—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.
 

Telling your story, one reporter at a time

Published November 11, 2023

The photo inset below on the left was taken last Friday morning at Preston’s Pharmacy (a PFM, I might add) in Arlington, Virginia. It’s not a pharmacist or technician in the photo. It’s a healthcare reporter for a national media organization whose beat includes pharmacy compounding.

She and I connected initially during Compounders on Capitol Hill back in September when she reached out with questions about shortage drug compounding and HR 167. When I asked her if she’d never even been in a compounding pharmacy, she admitted she had not, but would like to see one.

Because she is DC-based, I reached out to Scott Welch, the PIC at Preston’s, about his interest in conducting a tour of his pharmacy for a reporter — a tour that would include allowing the reporter to garb-up and scrub-up just like compounders do. Scott said yes, of course, and that’s how that reporter and I found ourselves at Preston’s last Friday. 

Because the conversation was “on background” and informational — nothing we said could be quoted or attributed — it was wide-ranging. We talked about the difference between traditional dispensing and compounding, about sourcing FDA-approved drugs versus API for compounding, about vendor validation and testing and USP standards. We covered non-sterile versus sterile compounding, and hazardous drug compounding and the NIOSH list. We discussed how FDA talks about compounding and the need for reporters to dig a little more, rather than taking those statements at face value. And of course she had questions about semaglutide and ketamine and other therapies that are making headlines lately. 

She seemed to come away impressed with the sophistication and high compliance rigor of pharmacy compounding. That’s largely a credit to her tour guide, Scott Welch (pictured with me in the lower photo), who was well-informed, easy-going, and non-defensive in his explanations. He did a tremendous job guiding the tour and fielding questions. I suspect the 60 minutes that reporter spent in his pharmacy will shape the way she reports on compounding from here on — which is the point, of course. 

This model — bringing healthcare reporters into compounding pharmacies (particularly sterile compounding pharmacies) to allow them to see what compounders actually do — has legs. We’ve now scheduled pharmacy tours in coming weeks with healthcare reporters from four major national news organizations. Three will be touring Preston’s in Arlington; one will tour Joe Navarra’s Total Town Compounding on Long Island. I’m happy I’ll get to tag along and provide color commentary for those. 

It’s yet another way APC is helping take back your story. One reporter at a time, we’re sharing what you do in your labs and how it benefits patients.

—Scott

There’s a lot you can learn from errors

Published November 11, 2023

Patient safety is job one in any pharmacy, but especially in compounding pharmacies. So on those rare occasions when errors occur — in your pharmacy or someone else’s — you want to be able to learn from them. Join us December 12 for Compounding, Medication Errors and Patient Safety: What the Data Says, a $25 webinar with John M. Kessler, the Chief Medication Safety Officer for the Alliance for Patient Medication Safety. APMS is a Patient Safety Organization, and membership in APMS is included in PFM dues.

An effective pharmacy quality assurance program is more than simply reporting errors and close-calls, says Dr. Kessler. The sweet spot for a compounding pharmacy is to have management’s total buy-in, employees who embrace safety as part of the job, and basic tools to assess improvement. The important goals are to shift a team’s focus: 

  • From errors to harm 
  • From individual heroism to group risk mindfulness 
  • From fixing problems to preventing problems.

Using real world medication error and mitigation data from actual compounding pharmacies, the webinar will provide lessons and strategies that assure your safety program is comprehensive, pragmatic, and effective.
 

What does FD&C Act really say about USP compliance?

Published November 11, 2023

In response to inquiries from state boards of pharmacy regarding the enforceability of revised USP Chapters <795>, <797>, and <800>, a recent memo aims to clarify references in the Food, Drug & Cosmetic Act. APC issued the memo this week as a resource for state boards of pharmacy.

The focus is on Section 503A of the FD&C Act, which pertains to compounded drugs. Contrary to concerns, the memo emphasizes that the reference to USP standards in Section 503A applies specifically to bulk drug substances only — the API must be USP-compliant — and not to all compounding. It underscores that compliance with USP compounding chapters’ references to bulk drug substances is mandated, but it does not require states to adopt entire USP chapters for all compounding practices. 

APC’s clarifying memo aims to guide state boards in navigating the complex landscape of the new USP chapters.

Letter seeks clarity on semaglutide compounding in California

Published November 11, 2023

Last week, we sent a letter to the California Board of Pharmacy requesting clarification of its position on compounding semaglutide.

The letter is the result of several reports of conflicting statements from California BOP staff that seemed to deviate from current FDA guidance on shortage drug compounding.

There’s a committee for that

Published November 11, 2023

APC is recruiting committee members for 2024. We rely on the work of our committees to help our Board of Directors determine our policy positions and tactics. We couldn’t do what we do without their expertise. Best of all, most committees only require an hour or so of your time each month.

Committees available for appointment are:

  • Communications
  • Education
  • Federal Legislative and Regulatory
  • Membership
  • State Legislative and Regulatory
  • Technician Services

If you’re interested in serving (and sharing!), send an email to info@a4pc.org and tell us which committee you’re interested in, and include a brief explanation of your expertise or interest in that committee’s functional area. We’ll announce appointments in December.

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