As we enter the 4th quarter, we’re reflecting on the year behind us and looking ahead to how we can better serve you in the year to come. Your feedback will guide us, helping us shape content that’s both relevant and impactful to your compounding pharmacy practice. Now, more than ever, we want to hear from you—what topics do you want us to cover? Are there new trends or challenges you’re facing where additional insights would be valuable? Your input will help us deliver content that is relevant, useful and accessible, ensuring we provide the tools and knowledge to support your growth and success. To help us best deliver the content you need, please take a few minutes to share your thoughts on this survey. IJPC Survey

Likewise, we know you’re looking ahead at the opportunities and challenges that lie ahead for your practice. The past year has been eventful for compounding pharmacists, particularly with the injectable glucagon-like peptide-1 (GLP-1) compounds, which were available for compounding due to their inclusion on the FDA’s drug shortage list. However, in early October, the FDA removed tirzepatide from the shortage list, effectively directing compounders to cease dispensing it. This decision quickly led to a lawsuit by the Outsourcing Facilities Association (OFA), which represents FDA-registered 503B outsourcing facilities, challenging the FDA’s action. After some back-and-forth, a reversal was announced, allowing pharmacists to compound GLP-1 products again—at least for now.

Adding another twist, both Eli Lilly and, more recently, Novo Nordisk have submitted requests for the FDA to place GLP-1 compounds on the "demonstrable difficulty" list, which could prevent the compounding of these products. All these activities can result in a compounding pharmacy feeling like they are caught in a regulatory pendulum, having to continually watch closely to see how this situation will unfold.

Beyond GLP-1s, the FDA has also issued guidance this October on compounding certain intravenous fluids and parenteral drug products, which may provide additional opportunities for pharmacies that can meet these needs safely and compliantly. Natural disasters, including recent hurricanes, highlight the essential role compounding pharmacists play in addressing these shortages that are critical to patient needs.

As always, quality and regulatory adherence are paramount. For 503A, 503B, and hospital compounding facilities, this is a moment to focus on delivering safe, effective compounded medications that meet the highest standards.

Here are some essential resources to help you stay updated on current drug shortages. The American Society of Health-System Pharmacists (ASHP) maintains a comprehensive Drug Shortages List, which is frequently updated. You can also find the FDA’s official Drug Shortages List, providing details on current shortages and the agency’s response efforts. Additionally, pharmacy organizations such as the Alliance for Pharmacy Compounding (APC) offer resources and guidance for compounders, accessible via their APC Resource. These links can help you stay informed and prepared to meet patient needs.

Important Reminder: Given the shifting regulatory environment, we encourage you to check with your legal counsel and your state board of pharmacy to determine the current status and guidelines on compounding any medications listed on the shortage list.

Thomas C. Kupiec, Ph.D. President 405.330.0094 Phone 122 N. Bryant Avenue, Suite B4 Edmond, OK 73034 tkupiec@ijpc.com IJPC.com Compounding​Today.com

Thought for the Week

“Don't judge each day by the harvest you reap but by the seeds that you plant." — Robert Louis Stevenson

Advertise with IJPC!

IJPC has advertising space available for 2025 in the Journal, IJPC.com, and CompoundingToday.com. Reach industry professionals with the only journal solely dedicated to the art and science of pharmacy compounding.

Email Advertising@ijpc.com for a media kit today!

From Out of the Past

Here's the winning
Shaving team
The perfect blade
The perfect cream
     Burma-Shave

Thanks to our advertisers in the Sep/Oct 2024 issue. Please support them when possible.