The Covid-19 national and public health emergencies are ending May 11, which means temporary guidance for industry that allowed 503As and 503Bs to prepare 13 COVID drugs for hospitals during the PHE will expire as well. read more →
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.
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.”
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
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.
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’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.
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.