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The voice for pharmacy compounding | February 26, 2021

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THIS EDITION SPONSORED BY PCCA

40 incredible years. 1 inspiring commitment to compounding. PCCA has been proud to be a part of the evolution and growth of compounding since 1981. We’ll be celebrating our 40th anniversary all year long, and we’re kicking it off with this quick video sharing some favorite moments. The celebration will culminate at our International Seminar 2021 in Houston, October 20-23, and we invite all PCCA members to join us. Mark your calendars now!

Thank you for choosing PCCA to help you serve your patients and grow your business. We are honored to be a part of your success.

From APC's President: About your bread and butter


Michael Blaire, RPh, FIACP
APC President

Dear A4PC,

John Montagu was a British statesman who held various government offices, including Postmaster General, First Lord of the Admiralty, and Secretary of State for the Northern Department. He was educated at Eton and at Trinity College, Cambridge, and spent some time travelling, initially going on the Grand Tour around Continental Europe before visiting the more unusual destinations of Greece, Turkey, and Egypt.

On his return to England in 1739, he took his seat in the House of Lords. In his spare time, Montagu was an avid gambler who did not take the time to have meals during his long hours playing at the card table. Consequently, he would ask his servants to bring him slices of meat between two slices of bread, a habit well known among his gambling friends. Soon other people began to order the same thing as Montagu — who was also known as the 4th Earl of Sandwich — and thus the "sandwich" was born.

So, what does this have to do with pharmacy compounding? Not much. But it's a good story, and now you just might think about it next time you eat a sandwich. Stories are at the root of our ability to communicate and understand what's going on around us. Because understanding and memory are intertwined, we shouldn't be surprised that they are also very powerful mnemonic devices.

Three months ago, APC hired a company called FitzMartin to help us tell a story. It is a story about a group of bright, ethical and innovative pharmacists who strive, on a daily basis, to provide customized hormone therapies for their patients. It is a story of an overreaching governmental agency that continually tries to thwart the pharmacies. It involves politicians, prescribers and academics (some friends, some foes). And it tells of the agency's newest weapon, one that could finish the group of pharmacists for good! Sound memorable?

If you attended yesterday's cBHT Town Hall you will have seen and heard parts of our story, as well as the research and strategy for where and how we will tell it. The cBHT campaign has a number of moving parts. FitzMartin has worked diligently to determine how best to combine them into an effective narrative that shows the human face of compounded hormones and will be memorable to policymakers.

The campaign is set to launch next month. The price tag for the first year is $1.5 million, of which we have now raised almost $700,000. We need to raise the remaining $800,000 by June 30. Many of you have already invested in the campaign, and for that I thank you.

But this is not a one-and-done deal. For this campaign to be effective, we need an ongoing commitment from all of our members, a commitment of a substantive monthly investment. As an example, if your pharmacy contributed $800 a month to the campaign, that would total almost $10,000 for the year. $800 a month is less than $40 per day ... roughly the cost of a few sandwiches. (See what I did there?)

Please help us save cBHT and ensure continued access to the millions of patients who benefit from it. Invest here. Do it now.


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.

Owner Summit: Last day for hotel reservations

IMPORTANT
Today — Febraury 26 — is the last day to get APC's preferred rate for rooms at the Westin.

• • •

Rooms are available at the Westin for Thursday and Friday nights (March 25 and 26), but the hotel has sold out
for both Wednesday and Saturday nights
.

If you wish to arrive earlier or stay over Saturday, there are rooms available at the nearby Hampton Inn.
Information is available on the Owner Summit Web page.

Don't miss APC's Compounding Pharmacy Owner Summit — an incredible opportunity for compounding pharmacy owners and managers to discover business ideas, solutions, and new opportunities that can boost your businesses.

Check out the list of great sessions and events: Just tap the big green button below. Then register — and remember, book your room at the Westin TODAY to get the APC hotel rates.

CompPAC hosts fundraiser for new E&C member

CompPAC will be hosting a fundraiser for Representative Neal Dunn (FL-2) on March 26 at the Owner Summit. Dunn is a new member of the House Energy and Commerce Committee — a key committee for APC as most of the bills affecting compounding originate there. Dunn is a urologist by training, so he also understands healthcare ... and the issues patients face.

If you're attending the Owner Summit, tickets to the fundraiser are $1,000, with all proceeds going to Dunn's 2022 campaign. But you don't have to be at the summit to support Dunn! Click here to download a flyer and donation form you can use to donate to the campaign.

Neal Dunn is just one of the members of Congress who need our support, especially as we face unnecessary and ill-advised regulation (think cBHT limits or the FDA's MOU with states).

We'll be raising money for CompPAC itself at the Owner Summit, but you can invest in CompPAC — and your compounding operation — right now:

Did you miss our cBHT campaign sneak peek?

APC's open town hall meeting yesterday gave more than 120 compounders an exciting update on our campaign to save cBHT — a campaign set to launch next month.

While the bulk of the presentation concerned the media being developed for the campaign, it first touched on the two important but ancillary initiatives: the Pharmacy Compounding Foundation-sponsored third-party analysis of the flawed NASEM report and the collection of patient and prescriber testimonials related to the use of cBHT. The analysis will be released in March.

Fundraising update: APC has raised almost $700,000 toward the $1.5 million media campaign goal. We still have almost $800,000 to go to reach our goal so we can realize the full potential of the campaign. (Please contribute today!)

The toolkit: Close to being final, it includes the images, video, and stories we'll be using to get the message out:

Media campaign update: Shared some of the collateral and the way it will be used to help shape the opinion of three target groups: patients, prescribers and pharmacists, and legislators and FDA staff.

You can view the full video of the one-hour briefing here.

The Ethical Thing to Do: Attorney Q&A

With this issue of Compounding Connections, we debut an occasional column in which an attorney responds to an ethical question compounders may confront. Today’s attorney respondent is Stephen Snow of Bendin, Sumrall & Ladner in Atlanta. (You can email Stephen at ssnow@bsllaw.net.)

Question: What do you think about a compounding pharmacy offering a local physician lower prices than the pharmacy would charge for a compound at the pharmacy, in return for the doctor referring prescriptions to that pharmacy, and then the pharmacy sending the compounded drugs to the patient and the bill to the physician, the physician upcharging the prescription bill to the patient, and the physician taking that mark-up as profit?

Response: The federal anti-kickback statute (42 U.S.C. § 1320a-7b(b)) is extremely broad and makes it a felony offense to, among other things, knowingly and willfully pay or receive “any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind” to any person to induce a referral for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program.

Many states have similar anti-kickback laws that broadly prohibit direct or indirect remuneration to induce a referral, even where a federal or state healthcare program is not involved. The concern is that such remuneration creates a conflict of interest for the prescriber and limits the patient’s freedom to choose the source of its healthcare services.

In addition to violating federal and state anti-kickback laws, allowing prescribers to upcharge patients for the drugs (essentially re-selling the drugs) creates the risk that the compounder could be seen as engaging in wholesale activities, which is not permitted under Section 503A of the FDCA.

From an ethical perspective, APC’s Code of Ethics provides that compounders should “comply with all applicable state and federal laws and regulations” (COE #2), and that compounders should “assure the credibility of the pharmacy compounding profession by avoiding conflicts of interest and not engaging in business practices that are detrimental to the patient, [their] colleagues, or [their] profession” (COE #9). Participating in kickback or upcharging schemes violates both mandates.

This response is intended for general information only, as all situations are unique. If you have legal questions related to your specific compounding activities, you should seek the advice of competent legal counsel.

Letter to FDA: APC is focused on ethics

APC CEO Scott Brunner sent a letter this week to FDA's acting director of its Office of Compounding Quality and Compliance, Gail Bormel. His message: APC is focused on compounder ethics, and has been working toward "encouraging and elevating the highest standards of ethical behavior among pharmacy compounders."

From the updating, distribution, and promotion of the Pharmacy Compounding Professional’s Code of Ethics, to the publication of Pharmacy Compounding Leader, to the ethical-behavior focus on this year's EduCon conference, Scott laid out the steps the association is taking — and plans to take — to assure patients are well cared for.

You can read the two-page letter here.


Constructive transfer: Two new resources

APC has two new resources on the issue of "constructive transfer" — i.e., transferring a controlled substance to the prescribing/treating physician or veterinarian for administration or safekeeping.

You'll find other great resources on our Compounders Stateside page, too — including useful state-by-state regulation guides only for APC members.

FDA issues warning on thymosin and remdesivir

The FDA has published its concerns about compounding during the pandemic, specifically regarding two drugs: thymosin and remdesivir.

Per the agency:

Visit FDA’s COVID-19 Compounding Activities webpage for more information or contact compounding@fda.hhs.gov with any questions.

Coming up

March 2; 2:00-3:00p.m. EST — CE webinar: "Survey of State Compounding Law Changes 2020 and Proposed 2021"

March 26–27, 2021 — APC’s 2021 Compounding Pharmacy Owner Summit

April 6, 7, 8USP webinars on chapters <797>, <800>, and <795>, respectively

April 13; 2:00-3:00p.m. EST — CE webinar: "Pharmacy Fulfillment for Consumer-Focused Telehealth Platforms"

June 10–11, 2021 — PCCA Act Conference (virtual)

September 14–15, 2021 — Compounders on Capitol Hill (mark your calendars!)

ICYMI

A big town hall for APC's District II: If you're a compounder in the Northeast/Mid-Atlantic (Maine to DC) please join us for a virtual town hall on compounding issues: Wednesday, March 10 from 4:00-5:00pm EST.

It's free and open to all compounding professionals — no registration required. It's a perfect chance to hear about the issues facing compounding, and to meet and connect with other folks in your neck of the woods.

On March 10, just join the Zoom meeting by going to A4PC.org/310townhall!


Don't forget to download, print, and display the new APC Compounder's Code of Ethics at A4PC.org/downloadthecode.

And don't forget to share with your team Jon Pritchett's powerful video, "The APC Code of Ethics: Ensuring Your Reputation and Legal Standing" on APC's updated Code of Ethics page.


We've hit the 3,400 3,600 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!


A4PC.org