From APC's President

The only thing constant is change

Many of us have settled into a nice, compliant practice with respect to USP <795> and USP <797>. 

We have been working with <797> since 2008 and <795> since 2014. We know these chapters well and are comfortable with them. Yet despite how long they have been enforceable, when visiting other pharmacies, I still see some areas of confusion and misinterpretation of the chapters. 

On June 1, 2019, the USP published revisions to <797> and <795>. Despite input from many stakeholders around the country, USP’s revisions were deeply concerning. Not only did the chapters present compliance challenges, but they also implemented restrictions not rooted in science. Worse yet, we were concerned that the revisions could expose patients to potentially more harm, not less—which should always be the goal.  

For example, if a CSP’s BUD cannot extend 45 days, no matter what testing is completed, who would subject themselves to the expense of a test in the first place? The pharmacists I have spoken with have opined that they will just freeze everything (if the formulation allows) and put a 45-day BUD on the product. In my mind, this potential reduction in sterility testing puts patients at more risk, not less.

On July 31, 2019, APC and its partners appealed the revision to both chapters on the grounds that the USP expert committee did not follow proper process in seeking input and relevant expertise from stakeholders. The appeal put the chapters “on hold” until the USP could review and respond to the appeal and re-work the chapters. USP also wisely applied that pause to USP <800>, since it is a closely related chapter to USP <795> and <797>.

Now USP has announced that it will publish new versions of <795> and <797> on November 1, 2022. This should make them (and USP <800>) enforceable on May 1, 2023. Because of the potential confusion these chapters could introduce, I have convened a USP task force to help APC members interpret the chapters and comply appropriately.  

So please stay tuned. There is MUCH more to come.

–   Dave 

• • •

David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at drdave@keystonepharm.com.

This week

It takes a lot of money to make nothing happen.

It has been two years since we started talking about FDA’s implicit threat to restrict compounded hormones. So far, the agency has done nothing.

We’d argue that the fact FDA has so far done nothing publicly to make good on that threat—which started with the release of the now discredited NASEM report in mid-2020—is in part due to the pressure APC has exerted on the agency via our Campaign to Save Compounded Hormones.

Our digital ads have reached 25 million Americans. We’ve collected more than 6,000 patient testimonials, and patient and APC member messages have reached majority of Congressmembers. Dozens of members of Congress have written or reached out to FDA, putting the agency on notice that it must not impede patient access to compounded hormone therapy based on a flawed report. It’s clearly been enough to make the agency pause.

But now APC’s Campaign to Save Compounded Hormones is low on funds, and we don’t know what 2023 holds. Yes, we’re happy to take credit for FDA’s delay thus far in moving to restrict hormone compounding, but we’re not naïve. The agency could announce its intention to add hormones to the “difficult to compound” list at any time. Our job must be to forestall that effort as long as we can and to make the agency think twice before it meddles with therapies that benefit millions of Americans.

We can only do that with your help. Whether you are a regular giver to our campaign or someone who has not yet given, your patients and your profession need you. 

We are currently about $200,000 short of our 2022 cBHT Campaign goal. That doesn’t bode well for continuing this campaign, does it? 

Nothing has happened. Not yet, anyway. Without your help, the chances of FDA moving to restrict compounded hormones only increases. PLEASE invest NOW in APC’s ability to sustain this campaign.

Advocacy was on the agenda yesterday at PCCA’s International Seminar in Houston. APC’s David Pore (second from left) participated in a compounding regulatory update with (from left) Lizzie Harbin, Ronna Hauser, and Amy Shank during the Industry Panel/Regulatory Update with PCCA, NCPA and APC.

Burch, Brunner recently featured on menopause-focused podcast

APC member Jennifer Burch (owner of Central Compounding Center in Durham, NC) and APC CEO Scott Brunner recently did their part to clear the confusion regarding compounded hormone therapy and enhance awareness of its many benefits. 

The two were featured guests on an episode of the Hotflash Inc. podcast, during which they discussed the benefits of pharmacy compounding, the role it plays in treating menopause, examples of when compounded medications help where pharmaceuticals cannot, and the looming threat that could potentially take this valuable treatment away from millions of women.

Click here to listen to the full podcast.

Image by StockSnap from Pixabay.

Share this: The PCF scholarship application is now open

Through the generosity of the Pharmacists Mutual Insurance Company, the Pharmacy Compounding Foundation (PCF) will award up to two $2,500 scholarships in 2023 to pharmacy students who have demonstrated commitment to a career in compounding pharmacy in the United States.

If you know a P3 or P4 pharmacy student, please pass on this information— they may be eligible to apply for one of two $2,500 scholarships being awarded in 2023.

Please feel free to share this link: A4PC.org/scholarships for more information. Or simply...

Win BIG at APC's Quiz Show on Nov 10*

All right contestants, grab your buzzers. You only have 10 seconds to answer: A doctor has sent in a prescription for semaglutide.

Tell me, CAN YOU COMPOUND THAT?

Buckle up and test your compounding can-do and can-not knowledge at our live webinar on Thursday, November 10: Can you Compound That? A Quiz Show.

Set in a game show style format led by Tenille Davis, PharmD, RPh, BCSCP, FACP, this fun and interactive webinar aims to enhance your knowledge on which active ingredients can (and cannot) be compounded, as well as provide guidance on general recommendations for facilitating decision-making.

Drug preparations explored in this activity will cover FDA’s current recommendations on drug shortage list, drugs not to be used in compounding medications, and bulk drug substances.

Webinar details

• November 10th, 2022, 2:00pm EST
• CE credit eligible
• Click here for details and registration

*By "win BIG" we mean that the knowledge you gain will help you be the best gosh darn compounding pharmacist you can be.

Coming soon: EduCon 2023

Knowing and implementing best practices are the keys to a well-run compounding operation. You also need them to keep your patients safe and to preserve your reputation.

Assure your team has the current expertise it needs to practice with high competence and integrity by joining us for EduCon 2023 Virtual: Best Practices in Compounding. 

Please note these dates:

• Registration opens Friday, November 11, 2022
• Early-bird deadline is Tuesday, January 10, 2023

More details coming soon.

Save these dates

November 10: An APC webinar: Can You Compound That? A Quiz Show Webinar (details coming soon)

December 1: An APC Webinar: Uncovering Tax Incentive Opportunities for Your Compounding Pharmacy

December 8: An APC webinar: How to Use Medical Literature to Identify and Support Compounded Therapies

December 14: An FDA CDER webinar, What to Expect after an Inspection: 483s, Responses and Beyond

2023

February 9–10: APC's EduCon 2023, virtual (more details coming soon)

March 26–28: APC's Owner Summit 2023; The Grand Hotel Golf Resort + Spa;

Point Clear, AL (more details coming soon)

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

Short takes

Congratulations, Shawn!

Last weekend, Shawn Hodges received the Distinguished Alumni Award from Texas Tech University's College of Pharmacy. He is CEO of Revelation Pharma in Kennesaw, Georgia, and APC's immediate past board chair. Shawn is pictured here accepting his award with the President of the TTU Health Sciences Center Dr. Lori Rice-Spearman.

Quick links



APC Career Center

• Job seekers

• Employers

APC's Code of Ethics

Compounding Connections archive

Compounders on Capitol Hill 2022

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

Prescriber Briefing Resources  

Invest in APC efforts

• CompPAC

• Campaign to save cBHT

• OneFund

Membership

• Renew

• Pharmacy/Facility Membership (PFM)

• APC Logo agreement for PFMs

• APC Logo agreement for individual members

Affinity service providers

• Accounting & Tax Services: Rx Advisors

• Audible Sunshine

• Office Equipment: TUI Solutions

• Online Payments Platform: HealNow

• Patient-Reported Outcomes: OutcomeMD

• Shipment Trackers, a shipping costs auditor  

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.