The voice for pharmacy compounding │ 8 December 2023

This edition sponsored by Eagle Analytical

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From our CEO

A few sips

Years ago, I went to an informal dinner party at a friend’s house in which one of the guests saw a teapot of something good-smelling simmering on the stove, poured herself a cup, and took a swig — only to discover it wasn’t some aromatic tea at all. Thirty years later, my group of friends still recall and refer to it as “that time Virginia drank the potpourri.”

This week’s column is like that: A potpourri, a mixture. Drink up.

That OneFund deficit persists. Thanks to those of you who responded to our Board Chair’s call last week to help eliminate our $100,000 OneFund deficit. In the past week we’ve received about $20,000 in new money (thank you, TaylorMade, Brad McCloskey, and others!), but we still have a ways to go. If you’re inclined to help, here’s where to invest.
New ‘Best Practices’ Work Group. With some particular compounding therapies and practices on the radar of reporters and state boards of pharmacy, APC Board Chair Anthony Grzib is appointing a work group to help APC respond to media and other inquiries. In particular, the work group is expected to propose clarifying information and “best practices” guidance on three issues: ketamine compounding, IV vitamin nutrition (so-called “hangover clinics”), and the practice of clinic-billing of compounded medications. Pharmacist Gina Bestemen of Women’s International will chair the work group.
An election year approaches. 2024 is nigh, and with it the craziness of congressional (not to mention presidential) elections. You can help mitigate some of that craziness by investing NOW in CompPAC, APC’s political action committee, so that we have the funds we need to help elect non-crazy (mostly) compounding champions to the new Congress. Here’s where to do that.
What happens in Vegas … Your APC Board of Directors travels to Las Vegas this coming week for A4M’s LongevityFest 2023 and its final board meeting of the year. The board will be considering proposals for growing our media outreach, expanding compounding.com to become a go-to consumer site for all things compounding, and to implement technologies that enhance the member experience. Stay tuned for a report.
PCF offers compounding education grants. The Pharmacy Compounding Foundation is accepting proposals from state pharmacy associations for seven $1,500 compounding education grants for 2024. Among the stipulations is that the education must be offered at the state association’s annual convention. Deadline for applications is December 31. (If you wanna nudge your state association exec to apply for one of the grants, fine with us.)

That’s just a taste of some of what’s going on with APC. Here’s hoping your weekend sips don’t come with any surprises.

— Scott

Scott Brunner, CAE, is APC’s chief executive officer. Contact him at scott@a4pc.org.

ICYMI

This week’s news

FDA to end bulk drug categories

This week, FDA published a new draft guidance titled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry.” Comments are due January 8.

If finalized as presented, FDA will no longer categorize items for the bulks drug list prior to evaluating them for inclusion. For substances nominated before the guidance is finalized, FDA does not intend to take action against a compounder using that substance as long as it appears in current Category 1, the manufacturer of the bulk substance is registered, and a COA is present.

National reporters tour Preston’s Pharmacy

This week APC and Preston’s Pharmacy’s Scott Welch hosted three national healthcare reporters for an off-the-record tour and conversation about pharmacy compounding. It was supposed to be an hour-long tour, but with their questions, it lasted for about two hours.

The reporters, shown here garbing up, seemed to come away with a new appreciation for the compliance measures compounders take to assure patient safety and that the prepared medication is just right for a particular patient. APC’s Scott Brunner and Allie Jo Shipman accompanied the reporters. Thanks as ever to Scott Welch for hosting.

Got BOP emails? Share, please.

Admitting you have a problem is the first step, they say. Well APC has a problem, and we’re looking for you to help us solve it. Pretty simple really: We’re having a beast of a time getting correct email addresses for state board of pharmacy members – and even, in some instances, the executive director, too. It’s not for lack of trying, but many state boards will only share a public, catch-all email address with us. What that tends to mean is that when we want to share info and perspective with state boards of pharmacy, our emails often don’t make it to the director or – even less often – to the board members. So here’s the ask: If you have correct direct email addresses for your board members or director, will you share them with us? Send to savannah@a4pc.org.

Short Takes

Doctors and pharmacists push back: This New York Times opinion piece looks at unionization efforts by healthcare professionals to combat untenable working conditions.

Licensed in Connecticut? Read this: Starting January 1, all controlled substance and opioid prescriptions dispensed to patients in Connecticut will be required to have a fluorescent orange label. You can pre-order compliant labels from the Connecticut Pharmacists Association here.

Most restrained footnote ever: From FDA’s interim guidance on the 503A Bulks Lists, released this week, there’s the footnote below. We presume the words “you big doofus” were cut from the second sentence during the editing process:

¹⁷The nonprescription finished drug product Maalox was nominated. Maalox is not a bulk drug substance.

Welcome, Allie Jo. APC now has two pharmacists on staff. Mercer pharmacy grad Allie Jo Shipman joined our team this week as director of communications. She comes to us having worked previously for the National Alliance of State Pharmacy Associations and NCPA. (Our other pharmacist staffer? Director of Public Policy Savannah Cunningham.)