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10 timely questions for owners and managers | |
If you own or manage a compounding pharmacy, here are 10 questions to think about:
- What will the coming FDA guidance on 503B wholesaling mean for your pharmacy business?
- How do you know your compounded meds are doing for patients what they’re supposed to do?
- Are you sure you’re following best practices in your ketamine compounding?
- Do you know the difference between sales and marketing – and why it matters for your business?
- What can you learn from former owners who sold their compounding pharmacy?
- Patient follow-up programs: Did you even know you needed one?
- Are you missing opportunities in research clinical trials involving compounded meds?
- Do you know the law on compounded meds and marketing claims?
- Also, your true cost of compliance: Do you know it?
- How will current compounding litigation affect your compounding practice?
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As an owner myself, I don’t find many opportunities to slow down and contemplate questions like these – questions about ensuring compliance, streamlining operations, growing my business.
It’s why I’ve come to look forward each year to APC’s Compounding Pharmacy Owner Summit. For me, it’s become a don’t-miss getaway for thinking about my business and the issues I can’t get to during my busy work day. And this year’s conference just happens to feature sessions on every one of the issues raised in my questions above.
It’s coming up April 4-6 at the Hilton Torrey Pines in La Jolla, California – and sure, you’ve still got plenty of time to register … but not if you want to save $300.
Early-bird registration ends next Thursday, February 15. Starting Friday you’ll pay more. So take the hint and get registered now. Because APC’s Owner Summit is where you’ll not only find answers to your questions but solutions to take home and put to work in your business.
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– 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.
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Now accepting APC Fellow applications | |
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It may seem early, but now is the time to get started on your application for the APC Fellows Program.
Fellowship is the highest distinction we award. The program distinguishes pharmacists and pharmacy technicians who are exemplary in their professionalism and commitment to the practice of pharmacy compounding. APC Fellows meet stringent requirements designed to demonstrate their commitment to patient care through quality pharmacy compounding and the highest ethical and professional standards.
The application requirements are stringent, too—and it’ll take you more than a couple of days to pull everything together. The deadline to apply for 2024 induction is March 31, so review the available information and start your application now.
And by the way, we’ve updated the application, so if you started one last year and didn’t submit it, make sure you’re using the new form.
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Judge denies motion to dismiss in Novo Nordisk v. Brooksville
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Last week, a Florida District Court judge denied Brooksville Pharmacy’s motion to dismiss Novo Nordisk’s amended lawsuit alleging potency discrepancies in the pharmacy’s compounded semaglutide. Novo claims that its amended suit is about patient safety instead of trying to take out competition (yeah, okay). The judge, who had thrown out Novo’s original claim that Brooksville was engaged in “unauthorized drug manufacturing,” says he’s going to hold them to that representation.
There’s a lot of background to this case, which was one of four lawsuits brought by Novo against compounding pharmacies. APC filed an amicus brief in all four. If you want a refresher on the details, catch up with our past coverage of the case:
We’ll keep you updated on future developments.
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New year, new guidance: FDA publishes 2024 Guidance Agenda
FDA recently released this year’s CDER Guidance Agenda, a list of new, revised draft, and immediately-in-effect guidance documents it plans to publish this year.
There are five listed in the compounding category:
- Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Draft
- Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Revised Draft
- Nomination of Bulk Drug Substances for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act
- Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Draft
- Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors-Guidance for Outsourcing Facilities Under Section 503B of the FD&C Act
HHS’ semiannual regulatory agenda is also scheduled to be published today in the Federal Register. Proposed rules related to the 503A bulks list and the MOU are on the agenda.
We’re keeping an eye out and will let you know when they’re published, what they say, and any comments we may offer FDA.
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APC submits comments on Hawaii, Mississippi bills
This week, APC submitted letters to two state legislatures—a joint letter with NCPA to Hawaii and a letter to Mississippi.
The Hawaii bill, HB 2554, would require "pharmacies, other than on-site pharmacies in institutional facilities, to make a pharmacy intern, pharmacy technician, pharmacy employee, or an employee of the retail establishment the pharmacy is located in available to assist a registered pharmacist at all times the pharmacy is open to the public.” Our comment letter asserts that there are conditions in which the Board of Pharmacy should not take action against a pharmacy for not complying with those requirements—for example, if the owner is the pharmacist-in-charge and is the only employee, or if there are sudden, reasonably unanticipated circumstances affecting an employee scheduled to work. The bill was deferred in a committee hearing on Tuesday.
This Mississippi bill, HB 648, would remove the requirement for IV vitamins to be prepared in a compounding pharmacy, allowing nurses and nurse practitioners to prepare IVs in a clinic with no mention of sterility requirements, putting patient safety at risk. APC strongly opposes the bill.
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This month
This year
On demand
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Alliance for Pharmacy Compounding | A4PC.org | 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. |
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