From APC's Chair

Here's one thing you can do now

I’ve been APC’s Board Chair for almost a month, and already I’m seeing a consistent theme.

Some of the biggest “federal” issues we’re grappling with—from USP <797> to GFI #256—have tentacles that reach down to the states. And what the state boards of pharmacy do with those issues can matter as much or more to your practice as what happens in Washington, DC.

We all know we need more pharmacy compounders on state boards of pharmacy. There’s lots of ways to make that happen, including cozying up to your state’s governor if you have those ambitions. 

But in the meantime, you can help your profession by beginning to cultivate relationships with your state board of pharmacy members and staffers and to position yourself as a trusted advisor on compounding issues.

To help with that, we’ve developed a resource for you in making a case to your board members that expertise like yours is needed. It’s called Critical Compounding Policy Issues Confronting State Boards of Pharmacy. Download it and share judiciously with those who need a tutorial on the complex compounding issues facing states—and let them know that you and your association (that’s APC, by the way) can help.

Read on here for this week’s news.

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.

ICYMI

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This week

FDA’s guidance on compounding ibuprofen isn’t just for 503Bs

Last Friday, FDA issued guidance on compounding certain ibuprofen oral suspension products that allows 503Bs to compound ibuprofen suspension under certain conditions. 

“This guidance comes not a moment too soon and provides a path by which 503Bs can help meet the urgent need for ibuprofen suspension that hospitals are experiencing,” said APC’s Scott Brunner. “But included in the Frequently Asked Questions FDA published on its website is a tiny reminder to 503As, too.”

That FAQ enunciates a rather narrow path (and limited quantity) by which 503A compounders can make ibuprofen and acetaminophen oral suspensions if a shortage has not been declared.

“It’s not new, and it may not amount to much—and it’s entirely possible the costs of preparing a compounded version of ibuprofen and acetaminophen oral suspensions may be more than consumers would expect to pay—but in emergency situations, that permission might make a difference,” added Brunner.

The guidance—which was immediately effective on Jan. 20—specifies circumstances under which 503Bs can compound ibuprofen suspension. Read details here. 

Hole-y expertise, Batman! What to do?

Last week we surveyed compounders about their knowledge of new laws, regs, and practice protocols. The results are in, and we’re seeing some holes in your expertise. Here’s an overview—the percentages shown are respondents who say they are up-to-speed on this issue, which means that on most issues, a lot of folks, well…aren’t:

If you’re concerned about holes in your expertise, we’ve got the solution: EduCon 2023, APC’s “Best Practices in Compounding” Conference, coming up February 9-10. You can earn up to 12 hours LIVE CE, it’s all virtual, and best of all, you’ll get the latest on the topics above and more.

It’s coming fast. Get registered.

DON’T attend our 2023 Owner Summit… 

…if you’ve got hiring, motivating, and inspiring your team down pat.

…if you can handle your next FDA inspection with your eyes closed.

…if your pharmacy couldn’t possibly be any more efficient than it is.

…if you’ve got more revenue-producing ideas than you know what to do with.

But if you’re a pharmacy owner who’s always looking for business-growing ideas and techniques to improve your operations, well…our 2023 Owner Summit, March 26-28, is for you. 

Here’s the scoop:

• We have room for only 150 registrants, and they’re already coming at a pretty good clip…
• The site for the Summit—The Grand Hotel Golf Resort & Spa at Point Clear, Alabama—is a hidden jewel, and trust us, you’ll want to bring your family. Our hotel block is filling up fast, too. (APC’s preferred hotel rate is only available until March 3.)  
• We're a little biased, but programming will be first-rate. You’ll come away feeling energized and full of new ways to enhance your compounding business.

So take care of business by registering for APC’s Owner Summit. 

Save these dates

February 9–10: APC's EduCon 2023, virtual (up to 12 CE credits)

February 14: An APC webinar, Planning, Saving, Investing, and Retiring Strong

February 28: An APC webinar, The Cost of Non-Compliance: DUR and Regimen Review

March 26–28: APC's Owner Summit 2023, The Grand Hotel Golf Resort + Spa;

Point Clear, Alabama.

May 16–17: PCCA's ACT Legislative Conference, Washington, DC

September 19–20: APC's Compounders on Capitol Hill 2023; Hilton National Mall; Washington, DC

Short takes

Prep for PREP’s end. The PREP Act for COVID-19 countermeasures—which allows pharmacists and technicians to provide vaccines for the virus nationwide—is going to sunset in October 2024. Hopefully COVID-19 gets the memo, too.

An anti-aging drug is in the works. Apparently scientists are closing in on a drug that can treat aging. Hopefully they think through the many repercussions of this before going to market. Better beef up those 401k contributions, just in case. Learn about planning for retirement at our Feb 14 webinar.

Quick links



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Current issues:

• GFI #256 on animal compounding

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