This edition sponsored by PCCA

From our Board Chair

In life, we might not get what we wish for, but we will definitely get what we work for.

I wished to be and worked hard to become your APC Board Chair. But the plan was for that to happen in 2025. Yet here I find myself, one month into 2024, taking the reins from my colleague Tenille Davis, who started work yesterday as APC’s chief advocacy officer.

That’s why I’m practically jumping for joy, and you should be, too—not about me becoming board chair, but about Tenille joining our APC staff team. She brings the number of pharmacists on our staff to three, and her extensive experience and expertise in non-sterile and sterile compounding certainly bring depth to our team. My hat is off to Tenille and our CEO Scott Brunner for the conversations and creative thinking that led to this outcome. 

But I don’t mean to make light of my earlier-than-planned board chair role. I love our profession and I love APC and I’m happy to bring my leadership abilities to this role.

We are an organization with a 34-year tradition of capable leaders and leadership. As I begin in this role, I want to recognize and express appreciation to the men and women who have preceded me and worked hard for you. It’s their efforts—and those of the passionate board and committee members with whom they served—that have brought us to this place.

We begin 2024 with big challenges, yes, but we’re also at a place of big opportunities. Over the next several weeks, I hope to discuss some of these in this column, so please keep reading, okay?

Here’s another quote I like, from President Dwight Eisenhower: "In preparing for battle I have always found that plans are useless, but planning is indispensable."

I’d say we’ve got the planning and the hard work down pat. Now we execute and adjust as needed. With your partnership and support, we’ll get what we’re working for.

– Joe

P.S. As you’ll see below, you only have a couple more weeks to take advantage of early-bird registration rates for APC’s Compounding Pharmacy Owner Summit, set for April 4-6 in beautiful La Jolla, Calif. Thirty presenters, two dozen fast-paced sessions focused on your business, and the promise you’ll come away with ideas and solutions that you can take home and implement immediately. REGISTER HERE.

Joseph P. Navarra, RPh, FACA, FAPC is the owner of Town Total Compounding Center in Woodbury, New York. You can reach him at joseph.navarra@towntotalcompound.com.

ICYMI

• Federal judge rules FDA can’t publish unsupported concerns
• Calling all owners and managers: You don’t want to miss this.
• APC responds to CVM environmental scan request
• Are you throwing away $5,000 a month?

This week's news

FDA has added a new section to its Q&A webpage for GFI #256 - Compounding Animal Drugs from Bulk Drug Substances. Here are the high points:

• The medical rationale has to originate from the veterinarian, not the pharmacy. 

• A drop-down menu with prefilled medical rationales of the five reasons listed in GFI #256 is not considered sufficient documentation—more specificity for that particular patient must be included (e.g., the specific ingredient to which the patient is allergic). 

• If an FDA-approved drug product comes in multiple dosage forms with the same route of administration, a separate medical rationale is needed for each dosage form (e.g., “patient cannot be safely pilled” covers the capsule form but not necessarily chewable tablets or oral solutions). 

• Pharmacies can generally rely on the medical rationale from the original prescription for refills, but should consider if the rationale remains applicable and contains adequate detail (e.g., if a new FDA-approved drug is available, consider whether the new drug negates the medical rationale provided).  



• A patient-specific rationale can be applied to all applicable animals in the same identified location only if they share the characteristic that makes the FDA-approved drug unsuitable (e.g., an FDA-approved product containing xylitol could be applied as a medical rationale to all dogs in the same group, but patient-specific flavor preferences cannot).

Short takes

There's a big gap in the new federal rules to speed up prior authorizations: They don’t apply to drugs. 

KFF Health News: Ketamine therapy for mental health is a ‘Wild West’ for doctors and patients.

“Hungry brain” v. “hungry gut”: Could a genetic test help decide who should get which weight loss drugs?

Save these dates

This month

• February 22: APC webinar: Patient Communications - Are You HIPAA Compliant?

This year

• March 21: APC webinar: Demystifying the DSCSA for Compounders (registration link available soon)
• March 21: APhA Sterile Compounding Recertification Course
• April 4-6: Owner Summit, La Jolla, CA 
• June 20-21: EduCon Virtual: The Ethical Compounding Conference
• September 17-18: Compounders on Capitol Hill (CCH) in Washington, DC

On demand

• The FDA Compounding Quality Center of Excellence provides these self-guided online courses:
• Aseptic Process Simulations (Media Fills)
• Regulatory Framework for Human Compounding
• Stability and Beyond-Use Dates

Quick links

Alliance for Pharmacy Compounding | A4PC.org

APC is committed to addressing any concerns or complaints within one business day. Please send them — and, of course, any compliments — to info@a4pc.org.