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The voice for pharmacy compounding | June 4, 2021

From APC’s President

It oughta be a law


Michael Blaire, RPh, FIACP
APC President

Civics 101: Every law starts with an idea, and that idea can come from an individual or an organization. Ideas that elected officials like are written into bills, which can start in either chamber of Congress, where its first stop is a committee. The committee will research, debate, and make changes to the bill. If they’re satisfied with the final version, they’ll vote to send it to a subcommittee for further research or to the House or Senate floor. Assuming it gets to the floor, it’s debated, possibly edited or amended, and eventually voted on. If it passes, it moves to the other chamber and the process repeats. When both houses agree and pass the same text, it goes to the president who can sign or veto it.

Seems simple enough — and maybe "Schoolhouse Rock's" explanation is more memorable — but the missing piece of either explanation is politics. Politics is why even the most beneficial bills never come to fruition.


Reps. Cuellar and Griffin

As you will read below, H.R. 3662 was introduced last Tuesday by Reps. Morgan Griffith and Henry Cuellar and represents the culmination of months of discussion, drafting, and negotiation by the APC Federal Legislative and Regulatory Committee, our lobbyist, and those sponsors' offices.

Here’s why H.R. 3662 is so important:

During the peak of the Covid-19 pandemic, FDA released temporary guidance allowing 503A pharmacies to compound Covid medications that were in severe shortage, when those drugs could not be acquired from manufacturers or 503B outsourcing facilities. That temporary guidance includes a number of essential conditions under which 503As can source drugs to hospitals. And the key word is temporary.

While the Covid pandemic is receding, it is likely that drug shortages will be here to stay. This legislation will create what’s essentially a permanent version of FDA’s 2020 temporary guidance, allowing 503A pharmacies to provide urgent-use and shortage drugs to hospitals and physicians.


...and I'm sitting here on Capitol Hill

Here's where the politics start. The bill has been assigned to the House Committee on Energy and Commerce, which … well let’s say it isn’t always supportive of pharmacy compounding. Nevertheless, we do have some champions on the committee from both parties: Morgan Griffith, Buddy Carter, Kurt Schrader, as well as some newer friends like Cathy McMorris-Rogers, Neal Dunn, and Dianna DeGette. Others, too. The more members of the committee we can get to sign onto H.R. 3662 as co-sponsors, the greater our chances of it passing.

If you recognize most of the names above, that’s because they have either spoken at CCH or have been guests at CompPAC-hosted events. Now, more than ever, your support of CompPAC is critical as we educate legislators about the benefits of pharmacy compounding — and this bill — and the benefits both can have for patient care and access.

Likewise, with summer upon us, your representative and senators will be back home in their districts. Now is the time to schedule a visit for them to come see your pharmacy and to learn how H.R. 3662 will benefit your patients.

Scheduling a pharmacy visit with a legislator isn’t difficult, and it can be tremendously rewarding. APC even has a handy guide for doing it, based on feedback from pharmacy owners who’ve hosted visits themselves.

It's a wonderful thing when the system works. Let's make sure it works for us.


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.

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This Week

APC's urgent-use bill introduced in Congress

A bipartisan bill aimed at confronting pervasive drug shortages like those hospitals and clinics experienced during the pandemic was introduced in the U.S. House of Representatives this week.

The Patient Access to Urgent-Use Pharmacy Compounding Act of 2021, HR 3662, is sponsored by representatives Henry Cuellar (D-TX) and Morgan Griffith (R-VA). It would create a permanent path for 503A pharmacies to provide urgent-use and shortage drugs to hospitals and physicians under strict regulatory guidelines.

The bill is an APC advocacy priority. You can read our briefing paper on the bill here.

Help us attract more sponsors: Contact your representatives and ask them to support and sponsor HR 3662. (And why not send a note of thanks to Reps. Cuellar and Griffith?)

Is your town hall coming up? (Hint: Better check)

Check your mail: Three APC town halls coming in June. If you're in APC district III, IV, or VII (see the list of states below), your district's virtual town hall is coming later this month. Be sure to check your email for date and time — it's free for APC members and non-members! (Missed the email? Click here to send us a quick message and we'll let you know!)

What's on the agenda, you ask?

And more, of course.


District III: Illinois, Indiana, Kentucky, North Carolina, Ohio, South Carolina, Virginia, West Virginia
District IV: Alabama, Arkansas, Florida, Georgia, Mississippi, and Tennessee
District VII: Alaska, Arizona, California, Hawai'i, Idaho, Nevada, Oregon, and Washington.

IT’S CRUNCH TIME.

We’ve got just four weeks left to raise the final $500,000 to fund APC’s campaign to save compounded hormones.

In this brief, 5-minute video update, APC’s CEO Scott Brunner explains what’s at stake and provides a brief tour of the tools we’re providing members like you to use in supporting the campaign. We’re talking tools for your pharmacy team, tools for reaching prescribers and patients, and tools for communicating with your members of Congress about the threat to compounded hormones. They’re at A4PC.org/cBHTtools, and they are available to APC members.

About campaign funding:

We’ve got one month left to raise the last $500,000 to fund campaign ad placements. Come June 30, if we haven’t met the goal, we’ll have to immediately scale back our plans. The campaign will slow to a standstill. Please don’t let that happen.

We need your financial support to preserve your ability to treat patients. Please invest now and help us reach our $1.5 million goal before month-end.

Owner Summit: Thrice more, with feeling

After APC's maiden Owner Summit event this past March was such a success, we're making it a permanent annual event. Last week the APC board approved the dates and sites through 2024. Mark your calendars!

March 24-26, 2022: Hilton Scottsdale Resort; Scottsdale, Arizona
March 25-27, 2023: The Grand Hotel Golf Resort and Spa; Point Clear, Alabama
April 4-6, 2024: Hilton La Jolla Torrey Pines, La Jolla, California

It IS harder to hire technicians!

Last week, an NCPA survey asked if you were having trouble finding or recruiting pharmacy technicians. It seems the answer was a resounding “yes!”

The results:

“This is a major challenge for community pharmacies that are seeing many more patients because of the pandemic,” NCPA CEO Doug Hoey said. “Finding qualified workers is tough under normal circumstances. This is an acute problem for local pharmacies that should be at full strength now.”

MEDISCA Challenge update

Since Medisca offered to match individual contributions to APC's cBHT Media campaign up to $100k last week (hint: click here to give), we have received $21,950 from individuals — meaning $43,900 with Medisca's dollar-for-dollar match.

The challenge runs through the end of June, so now is the time to have your contribution doubled!

Coming Up

June 9 — FDA virtual meeting of its Pharmacy Compounding Advisory Committee (10:00 am to 5:05 pm EDT)

June 10–11PCCA ACT Conference (virtual)

June 16–17 — Informa Connect's Compounding Pharmacy Compliance Virtual (APC members: Use code A4PC10 for 10% off registration!)

June 23; 2:00–3:00pm EDT — APC CE: Controlled Substances and the Corresponding Responsibility of the Pharmacist

APC CE: Leveraging a COA (three-part course bundle):

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

November 8–10 — Informa Connect's Compounding Pharmacy Compliance East In Person

November 15–17 — Informa Connect's Compounding Pharmacy Compliance East Virtual

Short Takes

California AB 1533, which would require the state's board of pharmacy to have at least one representative from a compounding pharmacy, passed the California Assembly this week and now awaits action in the state senate. The legislation is supported by the California Pharmacists Association.


Thomas Siepka was named vIce president for hospital and health systems by APC Corporate Patron Gates Healthcare Associates, a pharmaceutical and healthcare consulting firm in Middleton, Mass. He "will lead a team of experts providing clients clinical, programmatic, and regulatory counsel and support."


Your prescriber list? Please? Reminder: We'd like you to share with us — confidentially, of course — a list of the prescribers you work with. We will not sell or share this information in any way — we simply want to reach out to them about the threat to cBHT. We need names, addresses (physical and email), and phone and fax numbers. Simply email the file to info@a4pc.org.


Write for us: We're still looking for cBHT columnists with some solid insight into the use of compounded hormones for compounding.com. If you can write some expert opinion with voice for patients and policy makers, drop a message to Scott Brunner at scott@a4pc.org.


Look who's supporting our cBHT Media Campaign!