The voice for pharmacy compounding │ 17 November 2023

This edition sponsored by PCCA

It’s almost the most wonderful time of the year! Don’t miss out on PCCA’s 10 Days of Deals, coming Nov 27 – Dec 8. Get deal alerts by texting PROMO to 713.424.4004. Until then, the PCCA team wishes you, your staff and family a blessed Thanksgiving holiday!

From our CEO

Telling your story, one reporter at a time

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

P.S. This is a longer-than-usual edition this week. That’s because there’s lots of news, but also because we’ll be taking a break next week for the Thanksgiving holiday. APC offices will be closed Wednesday, November 22 through Friday, November 24. We’ll be back in your email box on Friday, December 1.

Scott Brunner, CAE, is APC’s chief executive officer. Contact him at scott@a4pc.org.

This week’s news

There’s a lot you can learn from errors

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?

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

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

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.

Welcome to our new PFMs!

The number of APC Pharmacy-Facility Members continues to grow. We’ve added 12 since September, bringing the total number to just over 140. We’re grateful for all our PFMs, but especially these brand spanking new ones:

Preston's Compounding Pharmacy, Oak Hill, VA
Brooksville Pharmaceuticals, Brooksville, FL
Fort Worth Pharmacy, Fort Worth, TX
Covetrus, Portland, ME
GreenLeaf Apothecary, Fishers, IN
Clarks Rx / The Compounding Lab, Huber Heights, OH
Rx CompoundStore, Miami, FL
Valor Compounding Pharmacy, Berkeley, CA
San Diego Optimum Pharmacy, Poway, CA
The Woodlands Compounding Pharmacy, Shenandoah, TX
Sierra Compounding Pharmacy, Reno, NV
Dakota Precision Rx, Bismarck, ND

FAQs and other new-chapter resources from USP

APC leaders met this week with USP staff for a touch-base. One outcome of that meeting is the need to spread the word about several USP compounding resources, including a newly updated frequently asked questions document on the new USP chapters. To access those:

USP has also just published a revised version of the Description and Relative Solubility of USP and NF Articles Reference Table that will become official May 1, 2024. More information can be found here.

USP is also offering blended live + self-paced courses on all three new chapters in December. The last day to register is December 4.

Short Takes

APC member interviewed in Medium. Christian Stella of Precision Compounding shares the five things you need to create a highly successful career in the health and wellness industry.

A few PFM benefits to remember (and take advantage of):