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The voice for pharmacy compounding | December 4, 2020

EMERGENCY MEETING TODAY
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From the President

Shawn Hodges
APC President

Dear ,

If you're a pharmacy owner or manager, I hope you'll be at today's emergency meeting about the cBHT crisis. And yes, it certainly looks like a crisis -- the FDA has made it clear that cBHT restrictions are on the table. Those restrictions could be devastating not only for the pharmacies who provide compounded hormones, but for the millions of people whose health is at stake.

APC is preparing a fight like none we've ever faced. Today at noon Eastern Time we're briefing compounding pharmacy owners and managers (members and non-members alike) on our plans. We are not going to let FDA take cBHT away.

Please, join us. The meeting is free, but we need you to register. We need you in this fight. Click here -- it'll only take a minute or two. I hope you see you later today.

Potential cBHT restrictions are a huge threat to compounding pharmacies. But you know what isn't? The $1.6 trillion (!) elephant in the room: Amazon, which finally and as expected, entered the mail-order pharmacy market.

Let us pause a moment for those of you who need to wring their hands. Done? Good. Because honestly, there's not all that much reason to worry.

What, you worry?

If your business is all or mostly compounding, you probably aren't sweating anyway. Amazon doesn't do compounding, and it doesn't fit into its mass-quantities business model anyway.

For those of you with retail businesses, well, mail order is nothing new. Insurers and PBMs have promoting it for years, so it's not as if consumers will suddenly discover it. ("Promoting" being a charitable term, I know.)

What you need to keep in mind is that Amazon, like the other mail-order companies, isn't really competing on price -- most people with insurance have set co-pays, after all -- but on simplicity and convenience. Why should I drive to Joe's Pharmacy when I can just click a couple of times? (Heck, McDonald's has online ordering kiosks in the restaurants for people who don't want to talk to a human.)

Your job is to remind your customers of the reasons to walk in your door. Sure, there are loss-leader ads, but honestly how many people will jump at "Motrin Liquid Gels only $10.95 this week"?

More important is to focus on what you do better every day. That's service: "Meet Sue. She can help you." That's knowledge: "Med not working? Let's talk." That's availability -- just walk in or call, and never hear "Please hold for the next available operator."

And, of course, compounding. Parents know about flavoring for kids' meds, but do they know you can make a lollipop version instead? Or that a prescription that makes them nauseated might be available as a cream? Spread the word.

But don't ignore the lesson from Amazon (and McDonald's). Think about that convenience side, too, and appeal to it. You don't necessarily need a slick online ordering system that keeps track of every customer prescription. Maybe a simple "Email [email protected] with your prescription number and we'll reply when it's ready."

The point is, Amazon and other big boxes will always have some advantages over the little guy. Your job isn't to try to beat them at their strengths, but to remind people of yours. And you've got plenty.

Yours In Health,
Shawn


 

You can reach Shawn at [email protected].

EMERGENCY MEETING TODAY

Today, Friday, December 4 at noon EST (11am CT / 10am MT / 9am PT), is APC's EMERGENCY MEETING of compounding pharmacy owners and managers to hear our plan to defend compounded hormone therapy.

Make no mistake: FDA's threat to restrict cBHT is an existential threat to compounding pharmacies -- and to the health of millions of people. Restricting it based on flawed research is unconscionable, and APC is taking extraordinary steps to counter this unjustifiable effort by FDA.

We'll brief you on how we plan to engage and oppose any attempt to restrict cBHT. We need you if we're going to win this battle.

The meeting is free, but we need you to register. We'll also ask you to complete a short survey about your cBHT practice -- that data will be crucial for our effort.

 

FDA, HHS, looking for feedback

FDA is looking for info about challenges and opportunities encountered by compounding outsourcing facilities. You have until Dec. 28 to offer your perspective.

And HHS is looking for info about regulatory relief during the pandemic, including the temporary policies involving compounding. If you'd like to weigh in, you have until December 28.

A word to the wise

The FDA isn't going for subtlety points with an article it posted -- an interview with CDER division director Ian Deveau in which he's clear that compounders are very much on the agency's radar. "[T]he NECC tragedy was not unique," he says, and "we continue to see harm to patients because of poor compounding procedures."

Insanitary conditions -- "filth, dirt, mold, peeling paint, chipped drywall, damaged air filters and so on" -- are one focus for inspectors, who are looking with a careful, pharmaceutical eye. Keep that in mind, and do it yourself before an inspector does.

As Deveau points out, "So many of our findings are the kinds of things most people would look at and not recognize as dangerous. But when you are assessing them in terms of preparing drugs that will be injected into peoples' bodies, they really matter. "

Last chance: Share your expertise as an APC volunteer

APC wants you to lend your expertise as a member of a 2021 APC volunteer committee. Committees are the workhorses of the alliance -- you'll help develop programming, chase possibilities, and recommend policy to the APC Board of Directors. See the list of committees and get more info here. The deadline is today, December 4, 2020.

BUDs: An update on USP <795> and <797>

The USP Compounding Expert Committee is -- thanks to APC's earlier work -- in the process of reconsidering BUDs. It met Wednesday to discuss revisions to USP <795> and <797>.

The gist: The <795> subcommittee has been reviewing appeal letters and stakeholder engagement reports to get a handle on the issues stakeholders had with the proposed chapter. It's looking at ways to provide explanations for the scientific rationale used in establishing the default BUDs for nonsterile compounds.

The <797> subcommittee has also been going through stakeholder feedback. It's looking at the overall framework for assigning BUDs to sterile items. Current thinking: Keep the current category 1 and category 2 CSP structure for assigning BUDs, but create a framework for allowing the extension of BUDs beyond the current defaults. (Subcommittee chair Connie Sullivan made it clear that the subcommittee has heard and understands the gap that exists between small 503A pharmacies and 503B outsourcing facilities.)

Both reports were somewhat encouraging in the sense that the subcommittees seem to have taken a deep dive into the comments and rationale provided by us -- comments that point out the practical problems with the BUDs in both chapters.

Coming up

TODAY -- Emergency meeting of compounding owners and managers: How APC is planning to counter the threat to cBHT. Noon EST (11:00 am CST, 10:00 MST, 9:00 PST). Free for all; registration required.

December 8 -- Live CE webinar: State and Federal Regulation of PBMs: Legislative and Regulatory Efforts to Open the Black Box of PBMs and Bring Transparency and Equity to Independent Pharmacies; 2:00 to 3:00 pm EST

December 15 -- Live CE webinar: E-Prescribing in Compounding; 2:00 to 3:00 pm EST

ICYMI

Mrs. Peel, we're needed: "Feds Look to Pharmacists to Boost Childhood Immunization Rates"

We've hit the 2200 2400 mark for testimonials about the effectiveness of cBHT (from patients, prescribers, and compounders). That sounds like a lot, but we need more! The more testimonials we have for each congressional district, the better, so please continue to spread the word: Go to A4PC.org/cbhtandme and tell us your story!