The voice for pharmacy compounding │ 6 January 2023
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Never stronger, never more essential | |
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Happy new year!
I’m honored to be APC’s new Board Chair, I’m grateful for your confidence in me, and I deeply appreciate the leadership of the two individuals who preceded me as APC leaders, Michael Blaire and David Miller.
Thanks to their work—and those of our Board, staff, and committees—our Alliance has never been stronger or more credible or more essential to your success. In 2023, we are committed to leveraging our relationships and resources in ways that serve your patients and protect your livelihood as pharmacy compounders.
This year our CEO Scott Brunner and I intend to use this column each week to focus on what’s important right now—what you and your team need to know, in brief, to be well informed pharmacy compounders. So let’s get going:
- As you’ll read below, APC has notified USP of our intent to appeal certain provisions of revised USP Chapter <797>.
- APC has sent to FDA a comment letter raising concerns about the agency’s reclassification of DTE as a biologic. Please share the letter with your state board of pharmacy members to help inform their decision-making on this issue.
- APC now has 100 Pharmacy facility members, and our membership has grown from about 900 at this time last year to more than 3,700 at present. Those additional members greatly amplify our voice and effectiveness, so thank you. Here’s where to learn more about becoming a PFM.
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EduCon 2023—our “Best Practices in Compounding” conference—is about a month away. Pharmacists and technicians earn up to twelve CE hours and get the latest/greatest on a range of compounding practice issues. Register here.
- APC’s lobbying team was successful in getting key notes added to the recently passed FDA appropriation legislation. It’s a big deal and puts the agency on notice. Read more below.
Until next week…
Anthony Grzib
2023 APC Board Chair
| 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. | |
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ICYMI
Catch up on these recent stories that you might've missed:
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Now open: Owner Summit registration | |
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APC’S Owner Summit 2023 is the year's premier in-person learning, planning, and idea-sharing event for compounding pharmacy owners and managers.
The annual event is focused on helping you assure efficient compliance, equip and inspire your team, enhance your leadership vision and skills, and seize new opportunities. Being held this year in Point Clear, Alabama, the program offers 13 different business-focused sessions, to help you learn and grow your business and influence. Presentation topics include:
- Trust-Busting is Back, and That's Good for Your Small Business
- What You See is Seldom What You Get: How Asking the Right Questions in the Job Interview Can Help You Avoid a Lot of Heartache Later On
- In Case You Get Hit By a Bus: Getting (and Keeping) Your Pharmacy Affairs in Order
Please visit our webpage to learn more about Owner Summit and to register.
| APC appeals USP <797> provisions | |
APC has notified USP that it will appeal certain provisions of the revised USP Chapter <797> and has requested 30 days to file the substance of that appeal.
In a letter to USP, APC CEO Scott Brunner states that the grounds for the appeal “will be narrowly tailored, process-based, and designed to ensure that the 2022 Revisions do not unintentionally cause harm to the public.”
In question is USP’s procedural failure to document the scientific basis for restrictions on beyond-use dates and batch sizes in the revised chapter or to demonstrate how the restrictions serve to improve patient safety or health.
The APC Board of Directors approved the filing of the appeal at a specially called meeting on December 22. The next step will be for USP to determine whether it will grant the appeal, including APC’s request for the 30 days to submit evidence.
| Share our DTE comment letter with your BOPs | |
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APC recently submitted a comment letter on DTE to the FDA docket outlining our concerns with the recent reclassification of DTE.
We ask you to please share this letter with your boards of pharmacy members and director in an effort to assure continued patient access to compounded thyroid medications. It includes a summary memo that may aid you in your communications.
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We salute our 2022 major investors | |
"Best practices" conference is Feb 9-10 | |
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EduCon is the conference for keeping your team members current and compliant, and it’s coming up February 9-10, 2023. Best of all, you can earn up to 12 CE hours.
With this in mind, here are two programs to further incentivize your EduCon registration: one on pharmacy law and another on patient safety:
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And Now a Word from Legal Counsel… Beta lactams? Semaglutide compounding? Insanitary conditions? Animal compounding? This session will address law and regulations pertaining to compounders, including the current state of the Federal Food, Drug and Cosmetic Act Section 503A on compounding shortage medications and substances such as peptides, DTE and bHRT therapies. Implementation of revised USP guidelines for sterile and non-sterile drug products, as well as the future of interstate distribution of compounded drug products, will be discussed.
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Ask the Testing Lab: Common Questions from Compounders: The new versions of USP <795> and <797> will become official on November 1, 2023. The presentation will provide details of several microbiological, biological, and analytical tests utilized in extending BUDs within the framework of the new <795> and <797>. Case studies will be provided to highlight the outcomes which can occur when the CSP/CNSP does not meet the expected outcomes.
For the complete list of speakers and presentations, and to register, please visit our EduCon web page.
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A HUGE milestone: 100 PFMs | |
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APC now has 100 Pharmacy/Facility Members!
We launched our new "company" membership category in March 2022. As a result, we've grown from about 900 individual members last March to nearly 4,000 total members today—and we're still growing.
Big thanks to our 100 PFM members for their confidence in the work APC does for their patients and their compounding practice. Wondering if PFM is right for you? Learn more.
Image by MatissDzelve from Pixabay
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In memoriam. We're saddened by the recent death of Robert O. (Bob) Boudreaux, Boudreaux's Specialty Compounding Pharmacy, Shreveport, LA. Bob was a charter member of IACP (APC's former name) and our first President.
Ophthalmologist sings compounding’s praises. In a recent article, an ophthalmic surgeon endorses compounded preparations for his cataract patients. "These medications are convenient and cost-effective for patients and reduce the workload on staff," he says.
20 percent discount extended. A 2023 APC Corporate Patron, Specialty Process Labs, is offering APC members a 20 percent discount on its Thyroid USP API through the month of January. You can reach SPL at customerservice@rlclabs.com.
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