This week, APC submitted a comment letter to the Massachusetts Board of Pharmacy about two issues on which the Board recently expressed concern. read more →
This week, APC wrote to state boards of pharmacy and FDA to make them aware of delays in completing stability studies as USP 797 is enforced across the country. read more →
You may know EduCon as APC’s “Ethical Compounding Conference” – a virtual event that delivers “best practices” training to compounding pharmacists and technicians. This year, it’s back with a new user-friendly format. read more →
With the passing of Dr. Loyd V. Allen, Jr., PhD, this week, our profession lost a giant. No hyperbole here: His passion for and influence over the ethical practice of pharmacy compounding is simply unequalled. read more →
This week, APC submitted a comment letter to the Massachusetts Board of Pharmacy about two issues on which the Board recently expressed concern. As our Board chair reported last week, the Massachusetts Board had indicated that compounding sublingual semaglutide violated FDA’s “essentially a copy” guidance. In our letter, we enunciated the statutory basis that clearly allows sublingual forms of semaglutide to be compounded.
Our letter also discusses the Massachusetts Board’s statements prohibiting Massachusetts-based 503B outsourcing facilities distributing compounded medications to resident 503A pharmacies for dispensing.
This week, APC wrote to state boards of pharmacy and FDA to make them aware of delays in completing stability studies as USP 797 is enforced across the country. Sterile compounding pharmacies are required to complete stability studies for category 3 sterile preparations. We’ve heard from some of you that analytical labs are experiencing considerably longer turnaround times — largely due to the increased volume of testing requests that the new 797 standard has prompted — leading to current and significant delays in obtaining results. The letters are FYI, so that boards and FDA are aware of the situation.
Wells Pharmacy Network is our newest Bronze-level Corporate Patron — a $10,000 investment.
“We’re glad to have Wells on board as a Corporate Patron,” said APC’s Scott Brunner. “We appreciate their support of the work APC is doing for pharmacy compounders.”
You can find a full list of our Corporate Patrons on our website.
You know this by now: You can’t believe everything you read in the news, especially when it comes to compounding. To combat the misinformation and lack of balance in reporting on compounding, our CEO has written this piece. Give it a read, and share it with your prescribers.
Three evenings over three months this summer — for 6 CE hours
You may know EduCon as APC’s “Ethical Compounding Conference” – a virtual event that delivers “best practices” training to compounding pharmacists and technicians. That hasn’t changed.
But this year, it’s back with a new user-friendly format. We know you’re busy, and setting aside time in a workday, even for professional development, is tough. And setting aside two days, as our former EduCon format required, was even tougher.
That’s why we’ve restructured EduCon as a LIVE virtual learning series that you don’t even have to take LIVE if you don’t want to.
Over three evenings – one each in July, August, and September – you can learn the latest on the hottest topics in compounding from some of the best presenters in the industry and earn six hours of CE credit while you’re at it.
We’ve reduced tuition for the event, too – so it may just be the best deal in compounding education you’ll find anywhere.
Employees of APC Pharmacy/Facility Members
Individuals: $129 per person
Bundles of 5 or more PFM registrations: $99 per person ($495 total)
All Other Registrants
Individuals: $159 per person
Bundles of 5 or more registrations: $139 per person ($695 total)
* Your PFM rep will receive a separate email with specific codes to use to access PFM pricing. Please check with them or reach out to info@a4pc.org for the codes.
With the passing of Dr. Loyd V. Allen, Jr., PhD, this week, our profession lost a giant.
No hyperbole here: His passion for and influence over the ethical practice of pharmacy compounding is simply unequalled.
If you are a long-time compounder, he is surely known to you. If you are newer to our profession and he is not known to you, he should be. Read his full obituary here, but here’s the gist:
A visionary leader, Dr. Loyd Allen revolutionized the field of pharmaceutical compounding, spearheading groundbreaking research and innovation. His contributions extended far beyond the classroom, as he served as a consultant to compounding pharmacists and the pharmaceutical industry. His scholarly output included over 100 experimental publications, 30 books, chapters, and monographs, and the award-winning Editor-in Chief of the 22nd edition of Remington: The Science and Practice of Pharmacy.
And that’s not half of it. A couple of other bits worth mention: He was also the long-time editor-in-chief of the International Journal of Pharmacy Compounding. A longtime supporter of IACP and APC as well, three years ago he led our work group that revitalized and rebooted APC’s Compounder Code of Ethics. That document is a direct reflection of Allen’s own ethic and participation in his profession.
What a loss his death is – but what a life of service.
Dr. Allen was a man of faith. One couldn’t read his weekly Compounding Today e-newsletter without picking up on that fact (well that, and that he loved Burma Shavesigns). He lived a life of humble work in and to the communities he was a part of. His efforts to instill competence, care, and integrity in the practice of pharmacy compounding will continue to benefit patients for years to come. For all these reasons, allow me to borrow a bit of Christian scripture here and say: Well done, good and faithful servant.
To his family we extend our deepest sympathy. May he rest in peace.
— Joe
Joseph P. Navarra, RPh, FACA, FAPC is the owner of Town Total Compounding Center in Woodbury, New York. You can reach him at joseph.navarra@towntotalcompound.com.
Be aware: FDA has issued a number of 483s related to the water used in nonsterile compounding. Water for nonsterile compounds needs to be USP-grade purified water. If you use a water purification system to produce “purified water” for your nonsterile compounds, make sure to test the water produced for compliance with the USP Purified Water monograph. This includes testing for Total Organic Carbon (TOC), conductivity, and microbial content. If you are not or cannot test the water to ensure it falls within appropriate parameters, discontinue the use of the water system and buy USP grade purified water instead.
Issue brief on OTC compounding: Several states have recently addressed OTC compounding in legislation or regulation. Our new issue brief outlines those changes and other considerations for compounding OTCs
Also, as a reminder, all PFM members get access to NABP’s Survey of State Pharmacy Law, a compendium of all laws governing pharmacy practice, by state. If you haven’t accessed yours, contact jason@a4pc.org.
APC’s Scott Brunner and Tenille Davis are guests on the latest GameChangers Pharmacotherapy Podcast, where they cover facts and misinformation around compounded GLP-1s. It’s a good condensation of the compounding message APC has been sharing with reporters and others. Give a listen — it’s accredited for CE — and feel free to share with colleagues and prescribers alike. Big thanks to CEimpact for inviting Scott and Tenille to participate.
This week we were made aware that the Massachusetts Board of Pharmacy was questioning a compounder in the state for compounding what the pharmacy had incorrectly referred to as “oral semaglutide.” The Board said what the pharmacy was doing violated FDA’s “essentially a copy” guidance. The only oral semaglutide is FDA-approved Rybelsus, of course. It’s not listed as “currently in shortage” on the FDA Drug Shortage List, and so preparing a compounded version of it would be illegal.
But what the pharmacy was actually compounding was sublingual semaglutide, using crushed, FDA-approved Rybelsus tablets as the API. That’s a formulation that is not governed by FDA’s “essentially a copy” guidance but instead is at the core of what compounding is: creating an alternative dosage form or strength of a drug when, in the judgment of a prescriber, it produces a clinical difference for the patient. And in this instance, the pharmacy wasn’t starting with bulk API; they were using the FDA-approved drug. Perfectly legal (well, except for incorrectly referring to it as oral rather than sublingual).
But the Board didn’t seem to see it that way. We think that’s wrong, of course, and we’re writing to them to comment on the matter.
Why am I telling you this? Because with the advent of sublingual semaglutide as a compounded therapy, you need to take care that you’re using the proper syntax in your marketing. It was the use of the word “oral” in this case that caught the inspector’s attention in the first place.
But not only that. You need to be able to demonstrate to inspectors that preparing and dispensing sublingual semaglutide pursuant to a legitimate prescription falls well within what is allowed in the Food, Drug & Cosmetic Act. For most boards, this is a new therapy, so best you be ready to educate them when they pay a visit to your pharmacy.
That’s not the only news out of Massachusetts this week. We also got wind that the Board has determined that, at least until FDA finalizes its 503B wholesaling guidance, 503A pharmacies based in the state may not source compounded drugs from 503B outsourcing facilities. However, the board says out-of-state 503As may ship patient-specific compounded drugs into Massachusetts that were sourced from an FDA-registered 503B.
Mass confusion is what I’d call it. We’re sharing it here so you won’t be confused. It’s just another way your APC team is watching out for you.
— Joe
Joseph P. Navarra, RPh, FACA, FAPC is the owner of Town Total Compounding Center in Woodbury, New York. You can reach him at joseph.navarra@towntotalcompound.com.
With the passing of Dr. Loyd V. Allen, Jr., PhD, this week, our profession lost a giant.
Joseph P. Navarra, RPh, FACA, FAPC is the owner of Town Total Compounding Center in Woodbury, New York. You can reach him at 
