March 18, 2024
CC: October 20, 2023
From APC: 800K+ impressions, NCPA recap, and more | 20 Oct 2023
March 18, 2024
CC: October 13, 2023
From APC: An FDA warning, a 4th quarter adjustment, and more | 13 October 2023
March 18, 2024
CC: October 6, 2023
FROM APC: FDA puts peptides off limits, briefing prescribers, and more | 6 October 2023
March 15, 2024
APC Fellowship deadline is March 31
The deadline to apply for 2024 induction is March 31, so review the information on the APC Fellows webpage and start your application now. The induction will take place at APC’s Compounders on Capitol Hill event in September.
March 15, 2024
Big deal? Absolutely!
There are a half-dozen “big deals” that APC will announce in the next three weeks, every one of them focused one way or another on assuring patient access, pharmacy/facility compliance, and practice efficiency.
March 15, 2024
OMB concludes review of FDA ‘demonstrably difficult’ proposed rule
OMB concluded their review of FDA’s proposed rule on Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food Drug and Cosmetic Act and returned it with changes.
March 15, 2024
Federal appeals court accepts our amicus brief
The U.S. Court of Appeals for the Fifth Circuit has accepted an amicus brief filed by APC in the case Zyla Life Sciences v. Wells Pharma.
March 15, 2024
We’ve updated our shortage-drug/GLP-1 compounding statement
This week, we updated our statement on rules governing compounding, what FDA guidance says about permissibility of compounding “essentially a copy” of an FDA-approved drug – and what those have to do with GLP-1s.
March 8, 2024
A flurry of state activity
We’ve been busy this week on the state regulatory front, submitting comments on bills in Illinois and Maryland and sending our new statement on peptide compounding to all state boards of pharmacy. Here’s the lowdown.
March 8, 2024
Pharmacists and Technicians: Apply now for APC Fellowship
Are you a pharmacist or technician committed to patient care through quality pharmacy compounding and the highest ethical and professional standards? If so, you should apply to be an APC Fellow.
March 8, 2024
Kalchem rises, Hanszen Laporte comes in
Long-time APC booster Kalchem International has increased its support for APC to become a $25,000 Silver level Corporate Patron for this year. Hanszen Laporte law firm has also become a Bronze-level APC Corporate Patron this week.
March 8, 2024
Only 25 spots left for Owner Summit – register now!
There are only 25 spots left for the professional development event of the year for compounding pharmacy and facility owners and managers.
March 8, 2024
Lilly gets cute, we respond
In an open letter released yesterday, drugmaker Eli Lilly had plenty to say about compounded GLP-1s, and – surprise! – not all of it accurate.
March 4, 2024
Statement on Law and Regulation Governing Peptide Compounding
The APC Board of Directors has authorized release of a public statement, Understanding Law and Regulation Governing the Compounding of Peptide Products.
March 1, 2024
NCPA: Local pharmacies are running out of time
A new NCPA survey reveals local pharmacies are struggling to stay afloat after the January 1 implementation of the CMS DIR rule, requiring all pharmacy price concessions (i.e., DIR fees) to be assessed at the point of sale.
March 1, 2024
Florida will begin inspecting to new USP standards
The Florida Board of Pharmacy Compounding Subcommittee met last week to discuss the state’s USP 797 inspection process.
March 1, 2024
Letter asks justification for proposed Massachusetts fee increase
The Massachusetts Board of Registration in Pharmacy held a hearing February 28 on proposed new fees for pharmacy licenses in the state.
March 1, 2024
Peptides: Still complicated
A couple of years ago, APC released a brief for prescribers on peptide compounding. The title of that brief was “Compounded Peptides: It’s Complicated.” Since the release of that brief, it hasn’t gotten any less complicated.
March 1, 2024
PCCA is our newest Diamond-level supporter
Long-time APC partner PCCA is our newest Diamond-level Corporate Patron for 2024 and has committed additional funding to sponsor a series APC regional meetings this year.
February 29, 2024
Alliance for Pharmacy Compounding Statement in Response to FDA Commissioner Califf’s Misstatement Conflating Compounded Drugs and Counterfeit Substances
We presume that the Commissioner’s conflation of legitimate compounded drugs with illicit substances sold direct-to-consumer was inadvertent. Regardless, it requires a correction.
February 23, 2024
Welcome to our new PFMs
The number of APC Pharmacy-Facility Memberscontinues to grow (and grow and grow). We’ve added 23 since November, bringing the total number to 162.
February 23, 2024
If you’re licensed in NY State, you may want to be aware of this
As you know, New York currently requires pharmacists to directly supervise any pharmacy technicians who are compounding. What you may not know is that bills have been introduced in the state legislature to remove that requirement.
February 23, 2024
Apply now for APC Fellowship
Are you committed to patient care through quality pharmacy compounding and the highest ethical and professional standards? If so, you should apply to be an APC Fellow.
February 23, 2024
Insufficient funds
Our Campaign to Save Compounded Hormones is running out of money. I did not ever expect that to be news I’d need to deliver to you as your APC Board Chair, but here we are.
February 23, 2024
Seriously, folks: Owner Summit room block is 88% full
If you’re one of those owners or managers who’s thinking about registering for APC’s April 4-6 Owner Summit in La Jolla, Calif., you’d best think fast. The hotel room block at the Hilton La Jolla Torrey Pines is just about full.
February 20, 2024
Novo settles with med spa and weight loss clinic
Last week, Novo Nordisk reached confidential settlements in its trademark infringement lawsuits with a med spa and a weight loss clinic in Florida.
February 20, 2024
It’s THE course for new compounders
APC has partnered with the Pharmacy Compounding Foundation and the VCU School of Pharmacy to offer a 15-hour online CE program called “The Ethical Legal & Regulatory Foundations of Pharmacy Compounding."
February 20, 2024
Can 503Bs distribute to 503As yet? Well, maybe.
We’ve heard from a few APC members who received communication recently from an entity claiming to represent a 503B outsourcing facility marketing sterile products to 503A compounding pharmacies.
February 20, 2024
Let’s call it a first down
A single meeting is seldom a touchdown. But this past Monday I joined an APC work group in a presentation that definitely moved the ball down the field in terms of expanded patient access to compounded therapies.
February 9, 2024
Judge denies motion to dismiss in Novo Nordisk v. Brooksville
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.
