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APC News

Here’s your 6-day warning: APC’s ‘Best Practices’ Conference is coming fast

Published February 2, 2023

Register now for a skillset refresh…and 12 CE hours!

The clock is ticking: Don’t run out of time!

EduCon 2023—two days of virtual education, February 9-10—is all about learning best practices, sharpening your skillset, and equipping you to be 100% compliant with new compounding laws and regs.

Here are three highlights (out of 12 total sessions):

  • Common Mistakes, Uncommon Consequences (And How to Avoid ‘Em) – There are “sins of omission” and “of commission” – practices that are either being done incorrectly or not performed at all. In this presentation, we’ll share valuable tips for improving the efficiency, safety, and effectiveness of your practice.
  • Cleaning and Organizing is a Practice, Not a Project: Tools to Avoid Insanitary Conditions in Your Pharmacy – Much of FDA’s inspection activity in compounding facilities has been focused on what the agency considers to be insanitary conditions. Speaker Matt Martin will review inspection findings and discuss strategies to avoid these from happening in your practice.
  • Healthier Patients = Healthier Practice – Are you helping your patients be their healthiest? Meeting the client where they are can increase their health in measurable ways. In this session, we’ll present ways to show your patients how the time, money and effort you spend with them is actually making them healthier.

But wait, there’s more: Here’s the complete program schedule.

EduCon is your key to being an effective team member in a well-run compounding operation. Don’t miss it!

PHE to end—and with it—temporary compounding GFIs

Published February 2, 2023

On Monday, Biden Administration announced it will end the Covid-19 national and public health emergencies on May 11. That means temporary guidance for industry that allowed 503As and 503Bs to prepare 13 COVID drugs for hospitals during the PHE will expire as well.

Responses to a 2021 APC survey indicated that at least 80 503As had sourced COVID shortage drugs to hospitals under that temporary guidance. Last September in an interview at APC’s Compounders on Capitol Hill event, FDA Director of the Office of Compounding Quality and Compliance Gail Bormel said she was not aware of any adverse events reported as a result of 503As compounding shortage drugs under the guidance.

“We’d like to see that guidance broadened to include not only all shortage drugs, but also urgent use drugs needed by hospitals and clinics, within tight regulatory guidelines,” said APC’s Scott Brunner. “HR3662 in the last Congress would have done that. We’re working now on a possible legislative proposal for this new Congress that would implement some provisions of that previous legislation, as well as eliminate the MOU in law (and replace it with mandatory reporting) and create a federally mandated adverse events reporting framework for 503A compounding pharmacies.”

When it comes to your financial future, it’s wise to have a plan

Published February 2, 2023

On February 14, APC is hosting an hour-long webinar designed to help our pharmacists and technician members get a clue about the value of planning now— while you’re young (at heart?)—to assure you have the funds you need to live well into your, um, maturity.

It’s $25, and we promise it will be worth your time.

Webinar details:
Planning, Saving, Investing, and Retiring Strong
February 14, 2023 • 2:00pm – 3:00pm EST
$25 per person
Register here: a4pc.org/WealthPlanning

Note: This webinar does not offer CE credit

Maine BOP accepts APC suggestions

Published February 2, 2023

In November 2022, APC submitted comments to Maine Board of Pharmacy on its proposed rule in Chapter 42 regarding compounding drugs for veterinary office use.

This week, the Maine BOP met to discuss the proposed rule, and the board decided to move forward with several amendments based on APC’s comments:

1. Removal of the requirement for a signed acknowledgement from the veterinarian

2. Increasing the day supply limit from 5 days to 14 days or the smallest unit-of-use

3. Removal of some of the labeling requirements

The rule should go into effect within the next 60 to 90 days.

It’s time to take back your profession. On Feb 16, we’ll share our plan.

Published February 2, 2023

For the past few years, we’ve talked at length about how the future of compounding is at risk.

Other voices have been telling the story of compounding—to the world, in the halls of FDA, in the chambers of Congress. These voices have a vested interest in marginalizing compounding.

They do not value the incredible impact you have on the lives of your patients and they would decide your future.

Compounding the Joy of Living: The Campaign for Pharmacy Compounding is us taking control of our own destiny.

Compounding the Joy is the third year of our 3-year initiative to protect compounding. We initially focused on hormones (and that fight continues) but we are expanding our mandate to secure the future of all compounding.

Join us on February 16 for a Virtual Town Hall. We will discuss the campaign, as well as the different ways that your involvement will help secure the future of our industry.

Only together can we hope to secure the future—for our patients, for our businesses, for our communities.

 

 

Hole-y expertise, Batman! What to do?

Published January 1, 2023

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.

Please DON’T attend our 2023 Owner Summit…

Published January 1, 2023

…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.

If that’s you—Stay home. Relax. Maybe sign up for a French cooking class or take up pickleball.

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

Here’s the scoop:

  • This event is for compounding pharmacy or facility owners and managers only.
  • We have room for only 150 registrants, and they’re already coming at a pretty good clip…The venue 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. (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 maybe the French cooking and pickleball can wait. Take care of business by registering for APC’s Owner Summit.

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

Published January 1, 2023

Last Friday, FDA issued guidance on compounding certain ibuprofen oral suspension products that allows 503Bs to compound ibuprofen suspension under certain conditions. But buried in the FAQs FDA published regarding the GFI is some guidance for 503As, too.

The agency said the action was in response to increased demand due to the early start and severity of this year’s cold and flu season. It said the guidance was intended to provide temporary flexibility to hospitals and health systems in helping ensure treatment options are available when those facilities are unable to obtain oral suspension drug products for the treatment of pediatric patients with fever, and for adults who are unable to swallow solid oral ibuprofen products.

“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 clarifies whether 503A compounders can make ibuprofen and acetaminophen oral suspensions if a shortage has not been declared:

In other FDA guidance, the term “regularly or in inordinate amounts” has been defined as no more than four units.

“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.

Speaking of semaglutide…

Published January 1, 2023

Semaglutide seems to be everywhere. News stories in The Wall Street Journal. Vanity Fair. The New York Times.

Which reminds us to remind you about our Prescriber Brief about the rules and regs governing the compounding of peptides. You can find it here. (You’ll need your member login and password to access it.) Share it with the prescribers you work with. Maybe use it as a refresher for your own team members.

And while you’re at it, check out our Prescriber Brief on the regulatory framework that governs pharmacy compounding.

Are the compounding gods listening?

Published January 1, 2023

With release of the revised USP <797>, the compounding gods have spoken. But like Job in the Bible, we’ve got questions.

Read our CEO’s op-ed in Compounding Today…
https://compoundingtoday.com/Newsletter/Newsletter.cfm

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