The voice for pharmacy compounding │ 2 February 2024             

This edition sponsored by PCCA

Don’t miss PCCA’s HRT Symposium in Las Vegas, Feb. 15-17! Earn 12.25 CE hours and learn the latest on weight loss, menopause, the microbiome, insulin resistance, thyroid/adrenals, detoxification and more. Join us at Caesars Palace or online. Register today!

From our Board Chair

Getting what we work for

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


This week's news

FDA adds Q&A on medical rationales for animal drug compounding

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).

Dear Illinois BOP: Please tell us that's a typo


APC submitted comments this week to the Illinois Board of Pharmacy regarding its proposed rule on nonresident pharmacies (Section 1330.550). The rule would require pharmacists-in-charge at out-of-state pharmacies to be licensed in Illinois.


The rule was introduced December 15, 2023, but apparently went into effect January 1, 2024, giving pharmacies little time to get into compliance—a concern we raise in our comment letter.

New personalized medicine certification in endocrinology


Dr. Pam Smith and the University of South Florida Health Morsani College of Medicine just launched a program designed for pharmacists and focused on a practical approach to BHRT and functional medicine.


The course will be offered in Scottsdale, Ariz. in April and St. Petersburg, Fla. in November.

Check out the website for more information.

Welcome, Tenille!


Pharmacist Tenille Davis officially started in her new role as APC’s chief advocacy officer yesterday. She brings a wealth of knowledge and experience in compounding advocacy from her 16 years at Civic Center Pharmacy in Phoenix, Ariz. and her time on the APC Board of Directors. Her shiny new APC email address is tenille@a4pc.org—if you have questions or suggestions, reach out to her. 


Savannah Cunningham is the other part of our dynamic advocacy duo—if you have questions about state advocacy or CompPAC, email her at savannah@a4pc.org.

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


This year


On demand

Quick links

APC Career Center

• Job seekers

• Employers


APC's Code of Ethics


Compounding Connections archive


Compounders on Capitol Hill


Continuing education

• Live webinars

• On-demand webinars


Current issues:

GFI #256 on animal compounding

Urgent-use compounding (HR 167)

Adverse events reporting framework 

Saving compounded hormones


EduCon


Owner Summit


Prescriber Briefing Resources


Invest in APC efforts

• CompPAC

• Campaign to save cBHT

• OneFund


Membership

• Renew

• Pharmacy/Facility Membership (PFM)

• APC Logo agreement for PFMs

• APC Logo agreement for individual members


Affinity service providers

Accounting & Tax Services: Rx Advisors

Audible Sunshine

Office Equipment: TUI Solutions

Online Payments Platform: HealNow

Patient-Reported Outcomes: OutcomeMD

Pharmacy Technician Certification Board

• Shipment Trackers, a shipping costs auditor 

• TUI Total Solutions

• TxtSquad


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.

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