From our Board Chair

Below, you can read about the amicus brief — also known as a “friend of the court” brief —APC submitted last week in a compounding-related case pending in the U.S. Fifth Circuit Court of Appeals. It’s a big deal, so please pay attention to it.

That filing is the first of 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 your patients can continue to access compounded drugs, assuring your pharmacy or facility stays scrupulously compliant, and assuring your practice can operate at maximum efficiency.

The other five “big deals” will be rolled out at APC’s Owner Summit in La Jolla, California on April 5. 

BY THE WAY: This is shaping up to be our biggest Owner Summit ever, with more than 200 attendees already signed up. If you’re not one of those, there’s still time to register — but hurry: As you read above, the preferred hotel rate of $209/night ends tonight.

Those include announcement (and discussion!) of the following:

• Best Practices for Ketamine Compounding, a document developed by APC’s Best Practices Work Group.
• Best Practices for Clinic Direct Billing, another document developed by that Best Practices Work Group.
• APC’s 2023-24 Snapshot of Pharmacy Compounding, a demographic profile of your profession that we’ll use to educate policymakers.
• A step forward in collecting patient-reported outcomes, featuring the first full integration of a compounding software with the OutcomeMD platform (and what may be a work-around solution for those of you using other software).
• A new, simpler way to support APC — and stop all those fundraising emails we keep sending you. 

Hopefully, your curiosity is piqued. If you want to know more, get registered for Owner Summit. Because these are big deals, and you’re gonna want to know about them.

Stay tuned and stay informed!

— Joe

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

• Lilly gets cute, we respond
• Kalchem rises, Hanszen Laporte comes in
• Pharmacists and Technicians: Apply now for APC Fellowship
• A flurry of state activity
• Statement on Law and Regulation Governing Peptide Compounding

This week's news

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.

In that case, the Southern District of Texas, relying on Ninth Circuit precedent and case law, found that state-law unfair competition claims by a drug manufacturer against a compounding pharmacy are preempted by “the FDA’s sole authority over enforcement of the FDCA’s drug approval requirements.” Zyla appealed that ruling to the Fifth Circuit.

The outcome of that appeal could impact the practice of pharmacy compounding in a couple of significant ways. APC’s Scott Brunner said that’s why APC’s Executive Committee allocated funding from the alliance’s Legal Action Fund for the amicus.

“The principle at stake here is who has oversight over the substances used in pharmacy compounding and the products produced: Is it the federal government and FDA, or is it each of the states?” said Brunner. “Both Novo Nordisk and Eli Lilly have filed lawsuits against pharmacies that compound GLP-1s within FDA’s ‘essentially a copy’ guidance. Those suits rely on state law – not the federal Food, Drug & Cosmetic Act – to assert that compounding is ‘unauthorized drug manufacturing’ and a violation of state deceptive practices laws. The Ninth Circuit has already ruled that federal law preempts state law in this regard. If the Fifth Circuit rules likewise in Zyla – and we believe it will – there’ll be firm precedent that states may regulate pharmacy practice, but only federal law and FDA regulate pharmaceutical substances and products.”

Not only will that provide lower courts direction in the Novo and Lilly lawsuits against compounders, Brunner said, but it will also be a shot across the bow for state pharmacy boards that are attempting to impose restrictions on the use of certain APIs in compounding.

The amicus brief filed by APC in Zyla does not take sides in the dispute. Instead, it enunciates for the court what law and policy say about pharmacy compounding, so that the court has clear understanding, and plaintiff’s lawyers will be less successful in muddying the issue for the court.

APC is represented in this matter by Boesen & Snow. APC’s Legal Action Fund is funded by gifts from pharmacy compounders and service providers like you. Make contributions to the fund here.

The APC Fellows Program recognizes distinguished contributions APC member compounding pharmacists and technicians have made to the profession and to their respective communities. Since the program’s inception in 1997, 162 professionals have been honored as members of this elite group. This could be your year to join them. 

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.

Short takes

Advanced BHRT and functional medicine course features Dr. Pam Smith. The University of South Florida Health Morsani College of Medicine has 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.

From STAT: Medicare may finally cover Wegovy now that it’s a heart drug

From CNBC: Amazon Pharmacy will now fill and deliver Zepbound ordered through Eli Lilly’s direct-to-consumer service

Save the date

This month

• March 21: APC webinar: Demystifying the DSCSA for Compounders
• March 21: APhA Sterile Compounding Recertification Course, Orlando, Fla.
• March 31: APC Fellows Program applications due

This year

• April 4-6: APC Compounding Pharmacy Owner Summit, La Jolla, CA
• April 11: APC webinar: Vet GFI 256 One Year Later – Where Are We? 
• April 12-14: Personalized Medicine Certification Course 1: Endocrinology in Scottsdale, Ariz.
• May 9: APC webinar: Soft Skills for Hard Jobs (registration link available soon)
• May 14-15: PCCA ACT Legislative Conference, Washington, DC
• September 17-18: Compounders on Capitol Hill (CCH) in Washington, DC
• November 15-17: Personalized Medicine Certification Course 1: Endocrinology in St. Pete Beach, Fla.

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.