From APC’s President

I would walk 500 miles

Dear A4PC,

Michael Blaire, RPh, FIACP
APC President

Before you judge a man, walk a mile in his shoes.* It’s an old proverb — a reminder to practice empathy. For pharmacy compounding professionals, though, it might read: Before you judge a compounder, gown up, scrub in, and put on a pair of booties.

This past Monday evening I had the pleasure of attending an event at MedQuest Pharmacy in honor of Congresswoman Cathy McMorris Rodgers. MedQuest is a state-of-the-art facility, and CEO Jeffrey Bray is no novice when it comes to hosting a congressional visit. Rep. McMorris Rodgers (or CMR, as her friends on Capitol Hill now refer to her) was provided a tour of the facility followed by a lengthy question and answer session culminating in dinner and schmoozing.

One of the most impactful moments of the tour was when Jeff's team, rather than try to explain the hundreds of thousands of dollars invested in the facility to comply with USP <800>, actually gowned up along with CMR and her staff and ran through the process of compounding a hazardous product. USP <800> was no longer an amorphous buzz word, it was a concrete set of rules and guidelines with visible costs for compliance and consequences for non-compliance.

Rep. Cathy McMorris Rodgers (in blue)
watches the compounding process at MedQuest Pharmacy.

While learning that bio-identical hormones were considered hazardous drugs, CMR and her staff were educated about the NASEM report on cBHT. Actually meeting the employees that would be out of work if FDA were to act on the NASEM recommendations was far more impactful than any story or number on a PowerPoint slide.

While Jeff did have numbers as to how many patients and physicians he served in CMR's home state of Washington, seeing the actual volume of prescriptions being compounded and packaged for shipping gave life to the number of patients that would lose access to their medications. It was also a perfect segué to bring up the MOU and the potentially devastating effects it would have on pharmacies and patient access.

And, although MedQuest does not perform any veterinary compounding, I did have the opportunity to spend about 20 minutes post-tour with CMR, explaining the FDA's assault on compounding for animals from bulk drug substances.

Following the tour, APC presented CMR with a "Friend of Pharmacy Compounding" certificate, and I was able to share insights that will help the congresswoman strategize a path forward for our legislative priorities.

APC President Michael Blaire presents CMR with
a Friend of Pharmacy Compounding certificate

In all, CMR and her staff spent about three hours with us, along with patients, prescribers and other area pharmacists. You do not get that kind of face time during a hill visit, a PAC function, or even an in-district fundraiser. So, if you haven't guessed by now, I am going to encourage everyone, once again, to step up and host a congressional visit at your pharmacy. They are the most effective advocacy tool that we have. Congress will be on recess the first week of June, the first week of July, and all of August. Call your representative's scheduler now and get a site visit on the calendar.

To make it easier, the State Legislative and Regulatory Committee has prepared a guide for planning and hosting a visit. Host a visit soon, and remember to take plenty of pictures. Just remember to remove your booties before entering the common areas.

* “That way, when you do criticize him, you'll be a mile away and have his shoes." —S. Martin

Michael Blaire is APC’s president, but his day job is vice president for government and regulatory affairs at Wedgewood Pharmacy in Scottsdale, Arizona. You can reach him at mblaire@wedgewoodpharmacy.com.

Associations ask FDA to delay MOU enforcement

APC, APhA, the National Alliance of State Pharmacy Associations, and NCPA, have submitted a joint letter to FDA asking that it delay enforcement of the final MOU until at least October 26, 2023.

We have learned that a number of states — including large ones such as Florida and Texas — are unable able to sign the MOU without their respective state legislatures amending state laws to comply with the final MOU’s requirements ... assuming they choose to.

For all the MOU’s flaws (and FDA’s overreach in crafting it), the implications of states not signing it could be catastrophic for patients, compounders — and even local economies.

That’s why we’ve asked for what we consider to be a reasonable postponement.

NASEM report on cBHT is tainted, analysis shows

Briefing this Tuesday on PCF’s bombshell report

A tainted process. Built-in bias. Faulty conclusions based on selective research. That's what a professional analysis found in an FDA-commissioned report on compounded hormones.

That report came from the National Academy of Science Engineering and Medicine (NASEM), paid for by taxpayers. It was supposed to be objective and impartial.

Instead an independent third-party analysis by the non-partisan Berkeley Research Group found a laundry list of obvious flaws in NASEM’s process and recommendations, making the report so thoroughly compromised it is useless in any discussion of compounded hormone therapy.

From reliance on a small fraction of the available studies, to "experts" with a demonstrated history of anti-compounding bias, to ignoring input from the clinicians most familiar with the subject, the NASEM report used outdated references, non-standard definitions, and a limited, cherry-picked selection of clinical data.

But perhaps most surprisingly for a medical study, it ignored the critical and well-documented body of patient-outcome data. The result is a study rife with bias.

This Tuesday, the Pharmacy Compounding Foundation will host a briefing on the Berkeley analysis of that NASEM report — and will detail the scope of the factual issues, as well as that inappropriate FDA interference.

Please join us — the briefing is free and open to all.

Tuesday, April 20
3:00pm EDT via Zoom
Please click here to register.

APC on the road

Down at the AMMG conference in Miami, CEO Scott Brunner and Director of Membership Drew Floyd were spreading the word to prescribers about the threat to compounded hormones — and convincing them of the need to invest in our cBHT media campaign. (We're still about $600,000 short of the funds we'll need to launch that campaign!)

Scott and Drew had a chance to connect with IACP past president (and continuing fan) Ray Mareno and staff. Ray's Universal Arts Compounding Pharmacy happened to be in the booth across the aisle. (That's Ray on the right, with Scott next to him. Drew, being a vampire, does not show up in photographs.)

Other APC members exhibiting at the AMMG meeting include Belmar, College Pharmacy, Medquest Pharmacy, University Compounding, and Wells Pharmacy.