From APC's Chairman

5 things you need to know right now

2) PRO user group forming. Read more about it below, but it’s another step in our effort to push you to embrace patient-reported outcomes—and help us build a compelling set of outcomes data on compounded hormone therapy to present to FDA. 

3) California scheming. Confronting the California BOP’s proposed compounding restrictions requires a group effort. Best we can tell, those proposals are not rooted in any science that demonstrates they make patients safer. Read our comment letter here. If you are interested in being a part of a coalition—which might include providing some funding—shoot an email to scott@a4pc.org.

4) Montana drops pharmacist:technician ratio change. Montana HB 152 is dead, thanks to our intervention. We wrote a few weeks ago to oppose provisions on pharmacies licensed in Montana limiting the pharmacist to supervise no more than one supportive person at any one time if the state where an out-of-state pharmacy is located does not establish the ratio or define the role of the pharmacist in compounding. You’re welcome. 

5) That NBC story about “knock-off” semaglutide. Yeah, we saw it. Yeah, it’s a mess. We’ve reached out to producers at NBC in hopes of correcting the errors and offering a more informed perspective. 

Those are highlights. Read on for more news…

– Anthony

Anthony Grzib is VP of quality and compliance, state-regulated pharmacies at Wedgewood Pharmacy in Swedesboro, New Jersey. You can reach him at agrzib@wedgewoodpharmacy.com.

ICYMI

Catch up on these recent stories that you might've missed:

• FDA clarifies position on compounding semaglutide sodium
• Share this with your prescribers: The threat to compounded hormone therapy affects them, too
• Another NASEM conflict of interest

This week

State-by-state USP 800 doc updated

We have updated our USP state-by-state implementation tracking spreadsheet, and it’s available online here—but only to APC members. This resource shows the status of implementation of USP 795, 797, and 800 chapters in every state. 

And by the way, it’s one of three members-only resources covering state-level compounding issues, one of which—the State Compounding Legislation and Regulation Tracker (a weekly update on proposed compounding legislation and regulation in states)—is available only to Pharmacy/Facility Members.

Interested in patient-reported outcomes? Join our user group

Free patient testimonial videos: Play ‘em in your waiting area

Showcasing patient testimonials in your compounding pharmacy's waiting area can have a significant impact on building trust with your patients and improving their experience.

APC offers members several patient testimonials specifically about compounded hormones that can provide your patients current information about the threat to this therapy. It's a simple and effective way to enhance your patients' experience and engage them in the Campaign to Save Compounded Hormone Therapy.

Consider incorporating these testimonials into your waiting area to help build trust and drive business to your compounding pharmacy. Find them halfway down the page here. (Members only, so you’ll need your login.)

MEMBER ALERT: Compounding “essentially a copy” of an FDA-approved drug

As Chairman Grzib wrote in last week’s Compounding Connections, three state boards of pharmacy recently issued licensee communications that contained incorrect information about FDA guidance on shortage drug compounding by 503A pharmacies.

FDA guidance states that if a drug is listed as “currently in shortage”—that’s the exact language—it may be compounded. While the FDA website is confusing in that it does speak of availability of certain drugs, availability is not mentioned in the FDA guidance. “Currently in shortage” is the determinative language, and as of this writing, semaglutide remains in that category. (To assure compliance, we advise that licensees compounding semaglutide should refer to the FDA drug shortage list daily; a substance’s status on the list can change without notice.)

In this matter, APC’s concern is not so much about semaglutide compounding in particular. Rather our concern is that states may misread FDA guidance and apply that misreading to the compounding of other FDA-approved drugs in shortage in the future.

Last Thursday, at APC’s urging, FDA sent a letter to NABP, to be shared with state boards of pharmacy, clarifying the issue described above. The FDA letter also included a statement on compounding of semaglutide sodium.

Save these dates

Now available on-demand: The FDA Compounding Quality Center of Excellence is announcing the availability of two self-guided, online courses:

• Aseptic Process Simulations (Media Fills)
• Stability and Beyond-Use Dates

May 16-17: PCCA ACT Legislative Conference, Washington DC

May 25: An APC webinar, IV Nutrition in Compounding

June 1: APC and OutcomeMD Express Lunch & Learn for Existing Users. Details coming soon!

June 1: APC Fellows Program application deadline

June 6: An APC webinar, Popular Compounds and Unique Ingredients for Cosmetic Compounding

June 29: An APC webinar, Trends in Veterinary Pharmacy: What Compounders Need to Know. More details coming soon.

September 19-20: APC's Compounders on Capitol Hill 2023; Hilton National Mall; Washington, DC

2024

April 4-6: Owner Summit, La Jolla, CA

Short takes

We respond on Twitter: In reply yesterday to a tweet by American College of Physicians chair-elect Dr. Bill Fox, we set the record straight on the compounding of semaglutide base.

This court case bears watching: The US Supreme Court is set to reconsider the ruling in Chevron v. Natural Resources Defense Council, which states that federal agencies’ interpretation of an ambiguous statute should be deferred to as long as it’s reasonable. The court is reviewing the Loper Bright Enterprises v. Raimondo case, which challenges the National Marine Fisheries Service’s demand that herring fishing companies pay for third-party observers to monitor compliance. The fishing companies are willing to have a monitor onboard but refuse to pay for it. The case could lead to a game-changing impact, with the Supreme Court potentially overruling Chevron or clarifying whether statutory silence on payment constitutes ambiguity. The FDA and the courts’ tendency to defer to the agency’s interpretation of laws such as DQSA make the case significant to compounders.

Novo Nordisk cuts some US supply of obesity drug. The Wegovy drug maker announced earlier this week that it was halving the supply of starter doses being sent to the US. 

DEA requests telemedicine extension. Earlier this week, DEA announced it had submitted a temporary rule request to the Office of Management and Budget entitled “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.” This action was the result of the agency receiving a record 38,000 comments during its public 30-day comment period earlier this year.

Quick links



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Current issues:

• GFI #256 on animal compounding

• Urgent-use compounding

• Prohibition on peptide compounding

• La Vita Case amicus filing

• Insanitary Conditions amicus filing

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Prescriber Briefing Resources

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• Shipment Trackers, a shipping costs auditor  

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.