The voice for pharmacy compounding │ 2 June 2023
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This issue sponsored by Topi-CLICK | | |
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Partnering together to Help Those Who Help Others!
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In defense of compounding
(and the pulled pork sandwich)
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As I write this, I’m sitting in a barbeque joint in Greensboro, NC, waiting on a chopped pork sandwich (Lexington-style, thankyouverymuch), reading media reporting about FDA’s statement, released earlier this week, on semaglutide compounding. And I’m shaking my head.
As you’ll read below, that statement generally warns against taking a compounded medication made from an active pharmaceutical ingredient that is not the same active ingredient as found in Wegovy and Ozempic. Fair enough.
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Somehow, though, that has been mischaracterized in several news stories as a warning not only to beware of properly compounded semaglutide itself—which is allowed under federal law when the FDA-approved drug is in shortage—but also to beware of compounded medications in general. It’s a terribly lazy reading of FDA’s statement. (I’m looking at you WedMD. Others, too.)
It’s gotten to where when I talk to reporters (when they actually reach out to APC, that is), I start with a disclaimer: Writing about pharmacy compounding—writing about it accurately, I mean—requires nuance. And if the reporter is unwilling to grasp nuance, then I’m unwilling to comment for the story. (You may be right to ask me: How’s that working for ya? Not so well, honestly.)
Here at APC we believe in the work you do, work that benefits millions of patients. It’s important that the media get it right, because what you do is noble and life-enhancing.
Just as life-enhancing as this chopped pork barbeque sandwich the waitress just plopped in front me. I intend to savor my sandwich, then it’s back to work, setting straight the record, one mistaken reporter at a time.
Read on for this week’s news.
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– Scott
Scott Brunner, CAE, is APC’s chief executive officer. Email him at scott@a4pc.org.
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Catch up on these recent stories that you might've missed:
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FDA issues public statement on compounded semaglutide | |
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Earlier this week, FDA issued its first public statement on semaglutide compounding. The statement elaborates on what the agency said in its April letter to NABP on the subject.
FDA permits the compounding of copies of FDA-approved drugs when those drugs appear on the agency’s drug shortage list to assure patient access to medications when the manufacturer cannot maintain its supply chain. “Semaglutide, the active ingredient in Wegovy and Ozempic, has appeared on that shortage list for well over a year, so it’s helpful that FDA has now provided some perspective,” said APC’s Scott Brunner.
“Like FDA, we’re concerned concerned about consumers purchasing substances purporting to be semaglutide online from unregulated, unlicensed sources without a prescription. That’s not compounding. Those aren’t even pharmacies,” said Brunner.
The agency’s statement warns against taking a compounded medication made from an active pharmaceutical ingredient that is not the same active ingredient as found in Wegovy and Ozempic.
Last month, APC released an extensive statement on compounding copies of FDA-approved drugs when those drugs are in shortage, as is the case with semaglutide.
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Call to Action on urgent use: Have you responded? | |
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A couple weeks ago, we asked you—our members and supporters—to send a message to your respective members of Congress, asking them to support legislative language that will allow pharmacy compounders to help fill urgent gaps in the drug supply chain.
Unfortunately, the response hasn’t been all that great. Only 148 individuals have sent messages—a total of 450 messages sent to 146 Members of Congress (86 House and 60 Senate).
“This legislation will be a huge boon to compounding pharmacies' ability to serve patients when their FDA-approved drugs are in shortage,” says APC CEO Scott Brunner. “Please send a message—for your industry and more importantly, for your patients.”
To contact your US House member and US senators, APC has made the process turnkey via our Voter Voice platform: Send the pre-written message as is, or you can customize it by adding the name of your store, how many patients you serve in your area or state, etc.
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Compounding Compliance Conference: APC members get a discount | |
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APC members are invited to attend Informa Connect’s two-day program, Compounding Pharmacy Compliance at a special, members-only rate (use code 23A4PC15 to receive 15 percent off your registration fee).
The conference is August 17-18 at The Westin Copley Place in Boston, and is an excellent opportunity to ensure inspection readiness for compounding professionals via regulatory updates, innovative technology solutions, industry best practices, and protocols to drive quality assurance facility-wide. Another incentive to attend: The presentation lineup starts with APC CEO Scott Brunner, who will be presenting on threats to pharmacy compounding.
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She’s got style, she’s got grace, she’s an SME. Congratulations to APC board member Cheryl L. Garvin, RPh, President/CEO of The Compounding Center in Leesburg, VA, for her appointment to PTCB’s Certification Council as a subject matter expert. The Certification Council impacts policies on how and what credentials PTCB offers. Congratulations, Cheryl!
“Nature’s Ozempic”? According to a recent article, a dietary supplement called berberine has been gaining traction on social media for its alleged weight loss and other health benefits. However, medical professionals quoted in the story advise consumers to be cautious, as the results so far are mostly anecdotal.
Semaglutide curbs other cravings, too! Patients taking Ozempic to treat type 2 diabetes and for weight loss have been experiencing an interesting side effect: reduced cravings for alcohol, caffeine and tobacco. As a result, researchers are looking into its potential as a possible addiction treatment.
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Now available on-demand: The FDA Compounding Quality Center of Excellence is announcing the availability of these self-guided, online courses:
June 6: An APC webinar, Popular Compounds and Unique Ingredients for Cosmetic Compounding
June 27: An ARL live webinar, Rapid Sterility Testing: An Alternative Microbiological Method, 12pm CST, free
June 29: An APC webinar, Trends in Veterinary Pharmacy: What Compounders Need to Know
August 17-18: Informa Connect's Compounding Pharmacy Compliance, The Westin Copley Place, Boston, MA
September 11-13: FDA's Compounding Quality Center of Excellence Annual Conference (free, virtual)
September 19-20: APC's Compounders on Capitol Hill 2023; Hilton National Mall; Washington, DC
2024
April 4-6: Owner Summit, La Jolla, CA
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