The Covid-19 national and public health emergencies are ending May 11, which means temporary guidance for industry that allowed 503As and 503Bs to prepare 13 COVID drugs for hospitals during the PHE will expire as well. read more →
The voice for pharmacy compounding | January 21, 2022
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From APC’s President
The power of one
David J. Miller, RPh APC President
I’m asking you for one. Only one. Let me explain.
One contact. We have many opportunities and face many threats in 2022. The best way we can take advantage of opportunities and fight the threats is by increasing our numbers.
Would you make one call or send one e-mail this week? Or one telephone call or e-mail? Would you call a colleague who is not an APC member and ask them to join, or enroll one of your technicians? Yes, only one. If every member gets another to join APC, we can double in size this week!
One percent. The threat we face with cBHT is tremendous. It is expected that the FDA will take action on the NASEM report sometime this year. For the past 20 years, I have taken the 1 percent rule: I donate 1 percent of revenue to defend my profession. I have taken this to heart with the cBHT campaign. I donate 1 percent of my cBHT revenue to APC to protect this important part of our profession.
For many of us, half our revenue could come from cBHT — without this important segment of our business, many of us would go out of business. Isn’t 1 percent worth it to help protect the other 99 percent? Please consider donating to the Campaign to Defend cBHT.
More one percent. Political action committees or (PACs) are the chief way that organizations can develop relationships with law makers who can influence legislation with is favorable to compounding. I donate 1 percent of my personal income to APC‘s CompPAC to ensure that these relationships are developed and strengthened.
Do you believe in the “power of one”? Will you join me making one contact this week, contributing 1 percent of your cBHT sales to the Campaign to Save cBHT, and 1 percent of your personal income to the CompPAC? It is vitally important to our profession. We need only one!
David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at email@example.com.
USP BUD changes: ‘Where’s the patient benefit?’ ask presenters in prescriber briefing
APC and NCPA hosted a briefing Thursday to explain USP’s proposal to restrict beyond-use dates in Chapters <795> and <797> — and the ramifications for patients. Nearly 800 registered for the briefing. The aim is that, seeing the risk to those patients, providers will join with pharmacy compounders to comment on the proposals — and to ask in particular that the proposed restrictions on BUDs for sterile compounds be reconsidered.
In the briefing, presenters Tenille Davis of Civic Center Pharmacy in Scottsdale, Ariz., and Anthony Grzib of Wedgewood Pharmacy in Swedesboro, N.J., asserted that USP has provided insufficient rationale or scientific evidence for how these proposed changes will benefit patients.
USP’s proposed changes to sterile compounding under Chapter <797>would require significant, expensive, and time-consuming testing be done on many compounded medications in order to extend BUDs. And add “likely cost-prohibitive” to that list: Stability studies have a price tag of around $30,000, Davis said.
The proposals would also limit batch sizes across the board to 250 units – a change that Grzib asserted will actually increase the potential for microbial contamination and errors, since on a need for 1,000 units, say, the compounder will have to enter the clean room not once but four different times.
USP’s proposals would also impose arbitrary upper BUD limits as low as 60 days — even if existing, rigorous stability data justify a longer BUD.
“At the end of the day, these proposals won’t do anything for patients except require them to refill more frequently and increase the costs of those refills,” said Grzib.
When you submit a comment, please include concrete patient-access examples — how overly short BUDs will unnecessarily complicate care for specific patients on specific therapies.
And more importantly, get the word out to more prescribers. Share those slides and the video, and explain how it’s critical they take a few minutes to understand the issue and submit a comment to USP.
APC’s Beyond-Use Date Working Group, chaired by Davis, will be preparing APC’s formal comments to USP in coming weeks.
The Rumor Mill: FDA might be starting its play
There’s a rumor going around — we’ve heard it a few times this week — that FDA will be coming after compounded hormones with a proposed ‘demonstrably difficult’ rule that should be released in the next couple of quarters.
If true, it’s no surprise. We knew it was coming, right? That’s why we raised and spent $1.5 million last year to engage patients and prescribers and educate members of Congress about the threat.
But now it’s 2022, and it seems we may be facing imminent action by FDA to restrict compounded hormones … while our coffers are practically empty. We planned on an $850,000 war chest for this year to continue our media campaign, but we’ve only raised about $150,000 so far. Sure it’s early, but many of last year’s campaign investors have not yet renewed their investment for 2022. Maybe that’s you?
PLEASE: If you’ve been waiting to invest in this effort, don’t.Make or renew your pledge to protect your compounded hormones for your patients and your business. Do it NOW, while we have some time to prepare for the fight.
Florida Congresswoman Kat Cammack paid a visit to Wells Pharmacy in Ocala, Fla., on January 5. During her tour, Kris Fishman, Melissa Stefko, and the staff explained the differences between 503A and 503B compounding and discussed a number of topics: the importance of pharmacy compounding, how the supply chain crisis impacts patients, how the pharmacy navigated the Covid-19 crisis, and how the industry can improve the manufacturing of specialized compounded medications in the United States.
EduCon 2022 Virtual has a ton of great courses for compounders (including a rather timely USP track): 11 hours of CE with great speakers — and it’s how you can keep your team operating smoothly and staying compliant.
But here’s a fun fact: When you register EduCon, YOU DON’T HAVE TO ATTEND.
Registering lets you attend live on February 3–4 (of course), but it also gives you on-demand access to the same content for 60 days (through April 8), including those 11 CE hours to help you maintain a well-run compounding operation.
So even if February 3–4 doesn’t work, register and ‘attend’ when you’re ready. Check it out at A4PC.org/educon!
EduCon 2022 Virtual: Best Practices in Compounding is February 3-4, 2022, presented by APC and the Ohio Pharmacists Association.
“GFI #256 presents too significant of a barrier in access to medications for pets, companions, and exotic animals for the agency to move forward with final guidance at this time,” they wrote. “Therefore, it is necessary for the FDA to issue another round of draft guidance to ensure there is fair evaluation of any new proposal or changes.”
APC is thrilled to have been chosen as one of the winners of Letco’s 2021 Holiday Charity campaign — the holiday cheer definitely spread here!
Remember to take a short survey: APC and the Institute for Local Self-Reliance and the Small Business Rising coalition‘s annual annual survey about issues like health care costs, access to financing, and the market power of dominant competitors such as Amazon. Just click here — it should only take about 10 to 20 minutes, and it will help strengthen advocacy efforts on behalf of smaller businesses.