The voice for pharmacy compounding │ 13 October 2023

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In addition to industry advocacy and thought leadership, Fagron Academy provides access to over 100 years of compounding experience, a growing formulary library, discounts and more. Check out this blog post on recent revisions to the Interim 503A and 503B Bulks Lists and what they mean for your compounding pharmacy.

From our Board Chair

It’s the 4th quarter. Can we come from behind?

It’s the start of the fourth quarter and we’re behind — and I’m not talking about a football game.

I’m talking about APC’s OneFund and CompPAC, the two entities we count on to fuel our legislative and political advocacy work. Member dues are not sufficient to fund all we do.That’s why these two funds are so important.

Your investment in OneFund supports our ability to lobby on your behalf. It’s money we spend on lobbyist who work with legislators and regulators to ensure we’re moving compounding legislation in Congress and advocating at FDA.

Your investment in CompPAC helps us support the election campaigns of members of Congress who think like you do about compounding, about your patients, and about small businesses like yours. It’s money given directly to the campaigns of members of Congress to let them know we support them and value their support for our industry. In short, CompPAC helps us cultivate compounding champions.

The graphic here indicates where we are here at the start of the fourth quarter. We can come from behind, but only with your help.

Here’s where to invest in OneFund. Consider setting up a monthly investment — although a one-time gift is fine, too.

And here’s where to invest in CompPAC.

Read on for news about how we’re working for you.

— 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.

APC President Anthony Grzib

ICYMI

This week’s news

FDA warns on compounded ketamine, lack of monitoring

FDA this week issued a statement warning of potential risks associated with compounded ketamine, including oral formulations, for treatment of psychiatric disorders. The agency had issued a previous statement on ketamine back in February 2022 related to compounded ketamine nasal sprays.

In this new statement, the agency expresses four particular concerns:

Ketamine is not FDA-approved for the treatment of any psychiatric disorder.
Compounded drugs, including compounded ketamine products, are not FDA approved.
Use of compounded ketamine products without monitoring by a health care provider may put patients at risk for serious adverse events.
FDA is not aware of evidence to suggest that compounded ketamine is safer, is more effective, or works faster than medications that are FDA approved for the treatment of certain psychiatric disorders.

It’s that third concern that seems to have necessitated the statement, but in its un-nuanced assertion that all compounded drugs are risky, “FDA once again has used a bazooka when a scalpel was needed,” said APC’s chief executive officer Scott Brunner. “Their sweeping generalizations marginalize other compounded therapies that are benefitting millions of Americans.”

APC is analyzing the agency’s statement on ketamine compounding and may issue a response. Stay tuned.

New PFM benefit: Best pricing from Capital Drug

APC has leveraged the strength of our large number of Pharmacy-Facility Members to strike a deal with Capital Drug on finished-form drugs.

“We’ve created an APC group within Capital Drugs with the buying power to achieve industry best pricing on finished-form brand and generic drugs,” said APC’s Jason Dunn. “Based on industry trends and member feedback, each PFM will receive the same group pricing, leveraging the larger group to drive the price discounts. In other words, if the price drops on a particular drug for one pharmacy, then that same price is loaded for all pharmacies in the APC buying group.”

Capital Drug is also offering PFMs a DSCSA Compliance Solution for as little as $0/month and no set-up fees. They have partnered with Advasur 360 to ensure pharmacies are compliant with current and future mandates of the Drug Supply Chain Security Act.

To take advantage of this pricing on finished-form drugs, contact Capital Drugs’ Cindy Retherford at 513-878-7914 or c.retherford@capital-drug.com.

Judge throws out one Novo lawsuit

Last week, a Florida District Court judge dismissed Novo Nordisk’s lawsuit against Brooksville Pharmacy, one of the four APC members the drugmaker sued back in June over semaglutide compounding in shortage. Though the order was issued, the opinion has not yet been released.

According to STAT News:

U.S. District Court Judge William Jung left the door open for Novo Nordisk to file an amended lawsuit. This suggests the case may continue if drug maker takes such a step. A Novo Nordisk spokeswoman told us the company plans to file an amended lawsuit explaining why it believes the pharmacy violated Florida state law.

APC intends to file amicus briefs in the remaining three Novo cases. Also, the APC Executive Committee this week voted to file amicii in similar lawsuits filed by Eli Lilly against APC members over tirzepatide compounding in shortage.

For now, congrats to Terry Myers and his crew at Brooksville Pharmacy and to his attorneys at Frier Levitt in this initial win. If you want to support APC’s Legal Action Fund, which fuels our ability to engage in cases like these, here’s where to do that: A4PC.org/legalactionfund.

Semaglutide statement and peptide brief updated

In light of recent developments, we’ve updated our official statement on shortage drug compounding and semaglutide, as well as our Prescriber Brief on peptide compoundin g.

The semaglutide statement was updated to indicate that a judge has dismissed Novo’s lawsuit against one compounding pharmacy for compounding semaglutide; and also to note that Eli Lilly is suing some compounding pharmacies over tirzepatide compounding.

The peptides brief was updated to include information about certain peptides that FDA recently added to Category 2, meaning the agency could take action against pharmacies that compound those substances.

Short takes

Remember to vote in APC elections. Voting for seats on the 2024 APC Board of Directors is open through October 25. Voting members of APC can click here to vote.

Oh, and don’t forget to complete the compounder profile survey. In the past two weeks, you should have received an email from our research partners at the University of Utah School of Pharmacy asking you to participate in our 2023 compounder profile survey. It’s a big deal. Look for it in your email box and please take time to complete it – the result are how we’ll define the compounding profession for policymakers over the next two years. Can’t find the link? Email as us at info@a4pc.org.

APC member quoted in Politico. Compounder Steve Moore of Condo Pharmacy in Plattsburg, NY, was quoted this week in a Politico piece on pharmacies stocking mifepristone tablets.

Online semaglutide vendors warned. FDA has published letters warning two online vendors (Semaspace and Gorilla Healing) to stop selling unapproved semaglutide, the active ingredient in Novo Nordisk’s Wegovy and Ozempic, and tirzepatide, the active ingredient in Eli Lilly’s Mounjaro. The agency says the drugs and claims made on both websites are examples of misbranding and demands corrective action by the vendors.