APC News

FDA issues public statement on compounded semaglutide

Earlier this week, FDA issued its first public statement on semaglutide compounding. The statement elaborates on what the agency said in its April letter to NABP on the subject.

FDA permits the compounding of copies of FDA-approved drugs when those drugs appear on the agency’s drug shortage list to assure patient access to medications when the manufacturer cannot maintain its supply chain. “Semaglutide, the active ingredient in Wegovy and Ozempic, has appeared on that shortage list for well over a year, so it’s helpful that FDA has now provided some perspective,” said APC’s Scott Brunner.

“Like FDA, we’re concerned concerned about consumers purchasing substances purporting to be semaglutide online from unregulated, unlicensed sources without a prescription. That’s not compounding. Those aren’t even pharmacies,” said Brunner.

The agency’s statement warns against taking a compounded medication made from an active pharmaceutical ingredient that is not the same active ingredient as found in Wegovy and Ozempic. 

Last month, APC released an extensive statement on compounding copies of FDA-approved drugs when those drugs are in shortage, as is the case with semaglutide. 

Call to Action on Urgent Use: Have you responded?

A couple weeks ago, we asked you—our members and supporters—to send a message to your respective members of Congress, asking them to support legislative language that will allow pharmacy compounders to help fill urgent gaps in the drug supply chain.

Unfortunately, the response hasn’t been all that great. Only 148 individuals have sent messages—a total of 450 messages sent to 146 Members of Congress (86 House and 60 Senate).

“This legislation will be a huge boon to compounding pharmacies ability to serve patients when their FDA-approved drugs are in shortage,” says APC CEO Scott Brunner. “Please send a message—for your industry and more importantly, for your patients.”

To contact your US House member and US senators, APC has made the process turnkey via our Voter Voice platform: Send the pre-written message as is, or you can customize it by adding the name of your store, how many patients you serve in your area or state, etc.

Compounding Compliance Conference: APC members get a discount

APC members are invited to attend Informa Connect’s two-day program, Compounding Pharmacy Compliance at a special, members-only rate (use code 23A4PC15 to receive 15 percent off your registration fee).

The conference is August 17-18 at The Westin Copley Place in Boston, and is an excellent opportunity to ensure inspection readiness for compounding professionals via regulatory updates, innovative technology solutions, industry best practices, and protocols to drive quality assurance facility-wide. Another incentive to attend: The presentation lineup starts with APC CEO Scott Brunner, who will be presenting on threats to pharmacy compounding.

FDA hears from APC leaders

On Wednesday, APC’s Executive Committee and Federal Legislative Committee leaders met virtually with 30+ representatives of FDA’s Office of Compounding Quality and Compliance team to discuss a range of issues impacting pharmacy compounding. OCQC director Gail Bormel initiated the twice-a-year listening sessions with APC two years ago so her team could benefit from hearing our suggestions and concerns.

This week’s topics included:

• Appreciation for the agency’s beta lactam guidance document and the recent agency response to NABP on BOP “essentially a copy” confusion
• Proposed MOU/adverse events legislation
• HR 167: Urgent use legislation
• Status of DTE reclass in light of APC’s substantive comments and recommendations
• Compounded hormones and patient-reported outcomes
• Status of rulemaking for 503A bulk list interim items
• Agency summary of 483s over past year (relevant findings, recurring themes) for industry use in training
• Agency’s ibuprofen/acetaminophen shortage response and the 503B direct-to-503A model – pros and cons
• Requesting and update on our previous input about the PCAC process: lack of deliberation, short time limit on presenters, and limitation on industry rep participation in discussions

Show ‘em your briefs!

Now that we have your attention: APC and the Pharmacy Compounding Foundation offer a series of briefing papers to help you educate prescribers about a range of pharmacy compounding topics—things they need to know about what you can and can’t compound. About what the law says about peptides. About medical rationales required under GFI 256. And more.

We call them Prescriber Briefs (yes, it’s an awkward title). They are APC members-only resources. And you can brand them with your logo, just as Triad Compounding in Torrance, California has done in the photo here.

Find them here and put them to use.

Tennessee expands State BOP

Tennessee Governor Bill Lee has approved Senate Bill 753, which expands the state’s Board of Pharmacy.

The Tennessee Board of Pharmacy will now be nine (up from seven) members appointed by the governor (one consumer, one pharmacy technician, and seven pharmacists) but does not include any specific requirements around practice area or special training in compounding as previously published by APC as amendments to the original language removed those provisions.

There’s still time: Call to action on Urgent Use

We’re asking our members and supporters to send a message to your member of Congress, urging your elected officials to support legislative language enabling pharmacy compounders to help fill urgent gaps in the drug supply chain.

CONTACT YOUR U.S. HOUSE MEMBER AND YOUR TWO U.S. SENATORS via our Voter Voice platform. It’s easy: You can send our pre-written message as is, or you can customize it as you wish (maybe add the name of your store, how many patients you serve in your area or state, etc.).

Moser elected 2024 APC vice president

At its meeting this week in Alexandria, the APC Board of Directors unanimously elected Michelle Moser, Revelation Pharma/Makers Compounding Pharmacy, Mount Vernon, WA as Board Vice President for 2024. Under the APC bylaws, she will ascend to the board chairmanship in three years.

Moser is a 35-year pharmacy veteran, a 2022 APC Fellow, and has served on the APC Board of Directors since 2021. She is the 2023 vice chair of APC’s education committee and a regular presenter at our programs and events.

Under bylaws amendments that took effect January 1, responsibility for electing APC officers is shifted from the membership, as was formerly the case, to the Board of Directors. Henceforth, the Board will elect its own officers from the board itself.

ACT Conference notches 130+ Hill visits

PCCA hosted its ACT Conference in Washington, DC, this week, with more than 80 compounders attending and more than 130 Hill visits conducted. Here’s a photo composite recapping just a few of those.

Top row, from left: Peter Koshland met with Cong. Jared Huffman (CA). Physician Sarah Zielsdorf, Kevin Borg, and Michael Blaire met with Cong. Debbie Lesco (AZ). Gina Besteman met with Cong. Mark Pocan (WI). Bottom row, from left: PCCA’s Jim Smith, Rep. Clay Higgins (LA), Ashley Berthelot and Jason Fura. PCCA team is shown with Cong. Morgan Griffith (VA) a lead sponsor of HR 167. Saad Dinno is with Dr. Christian Furman, an advisor to Senator Elizabeth Warren (MA). 

APC issues statement on shortage-drug compounding and semaglutide

Earlier this week, APC released an extensive statement on compounding copies of FDA approved drugs when those drugs are in shortage. The statement focuses in particular on semaglutide.

“This statement represents our understanding of the regulatory framework regarding compounding ‘essentially a copy’ of an FDA-approved drug when that drug is listed as ‘currently in shortage’ on the FDA drug shortage website,” said APC Chief Executive Officer Scott Brunner.

Brunner said the statement also addresses the issue of compounding drugs containing semaglutide active pharmaceutical ingredient (API) during this period when the FDA-approved drugs containing that API are listed as “currently in shortage” on the FDA drug shortage website.