From APC’s President

All in the presentation

Michael Blaire, RPh, FIACP
APC President

Fun facts: There are three species of peacock, all members of the pheasant family. The two most-recognizable are the blue, or Indian, peacock of India and Sri Lanka, and the — wait a moment. Oh, we’re talking about PCAC. That's different.

The Pharmacy Compounding Advisory Committee, or PCAC (pronounced “pea-cahck”), was established as part of the Drug Quality and Security Act of 2013. It’s job is to provide advice on scientific, technical, and medical issues concerning drug compounding, and to make appropriate recommendations to FDA. The committee consists of 12 voting members who are knowledgeable in the fields of pharmaceutical compounding, pharmaceutical manufacturing, pharmacy, and medicine. The current roster includes three members of APC.

Under the DQSA, active pharmaceutical ingredients that do not have a USP monograph and that are not components of an FDA-approved product must appear on the 503A Bulks List in order to be used for compounding. It is the PCAC's job to determine which APIs appear on that list.

PCAC is scheduled to meet on June 9, and will discuss four APIs nominated for inclusion on the 503A Bulks List: choline chloride, oxitriptan (or 5-HTP), melatonin, and methylcobalamin.

The nominators of these substances and other interested parties have been invited to make short presentations supporting their nomination. Speaking in favor of the nominations for melatonin and methylcobalamin will be APC board member A.J. Day, who has put a tremendous amount of time and energy into both the nominating process for these ingredients, as well as the presentation he will give supporting their nominations. We wish him success, as these are two ingredients that are used by a number of our member pharmacies to treat patients with autism spectrum disorder.

If you’re interested in the meeting, you can find background material (including the agenda) with the link to the online teleconference meeting room here.

Likewise, FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2021-N-0357, and the Regulations.gov electronic filing system will accept comments until 11:59 p.m. EDT on June 8, 2021. There have already been 746 comments filed, mostly from patients or parents of patients using methylcobalamin. As you can imagine, these comments are short, emotional appeals. I would encourage all members to submit well developed, science-based comments in support of these ingredients. And don't use abbreviations. They can cause confusion.

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.

Get the scoop: Three APC town halls coming in June

This June, APC will be holding three virtual town halls — meetings for compounding professionals in three areas of the country — to update you on the latest issues facing the compounding profession, what APC is doing about them, and how you can help.

They'll be run by local APC board members, and are open to both members and non-members — free, of course, and no registration required. More information will be coming to your inboxes soon, but here are the regions and meeting dates:

District III – Illinois, Indiana, Kentucky, North Carolina, Ohio, South Carolina, Virginia, West Virginia
With board of directors members Jeffrey Reses and Chad Thompson
▶ Tuesday, June 22 at 4:00 pm EDT (3:00 pm CDT)

District IV – Alabama, Arkansas, Florida, Georgia, Mississippi, and Tennessee
With board of directors members Tara Thompson and Ginny Isbell
▶ Wednesday, June 23 at 4:00 pm EDT (3:00 pm CDT)

District VII – Alaska, Arizona, California, Hawai'i, Idaho, Nevada, Oregon, and Washington
With board of directors members Tenille Davis and Erin Michael
▶ Thursday, June 24 at 2:30 pm PDT (5:30 pm EDT)

No registration is required. Just connect via Zoom at the meeting time for your district:

Click here for the Zoom meeting
Meeting ID: 867 8814 5153
Passcode: 261703
One tap mobile: +13126266799,,86788145153#,,,,*261703#

Letter shows broad support for provider status bill

You know a bill is popular across the pharmacy community when 135 organizations, large and small (including, of course, APC) sign onto a thank-you letter to the legislators who are sponsoring it in Congress.

Two senators and three representatives have introduced the Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 2759/S.1362), which would be a major step toward pharmacist provider status. It would have Medicare pay pharmacists for the services they provide, on a state-by-state basis. (So, for example, whatever services Iowa authorizes pharmacists to provide, Medicare would cover in Iowa.) It wouldn’t expand pharmacists’ scope of practice — it simply authorizes Medicare to pay pharmacists for the same services they already legally offer.

We'll keep you updated on the bill, and you can click here to read the joint letter we signed.

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 $19,550 in new money from individuals — meaning $39,100 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!

Is there a technician shortage?

We've heard from several members that you're struggling to recruit and retain qualified technicians in the current economy. We reached out to our friends at NCPA to see if they've heard anything similar from their members.

NCPA was curious enough to launch a quick survey to see if the issue is widespread among community pharmacies. (Click here to take it.) We’ll share results — thanks to NCPA! — soon.

PCCA's sanitizer campaign wins two awards

Congratulations to APC Corporate Patron PCCA, which won two awards for its #CompoundingHandoff campaign at the Houston Chapter of the American Marketing Association's 35th Annual Crystal Awards: for "Maverick Marketing" and for "PR Campaign."

The #CompoundingHandoff campaign was created by PCCA in response to the hand sanitizer shortage brought about by the Covid-19 pandemic in the spring and summer of 2020. It involved "a coordinated and integrated government affairs push" including APC's helping to spread the word, and it resulted in FDA fast-tracking approved formulas for compounding pharmacists to produce and supply sanitizer.

PCCA was also a finalist for the "Social Responsibility Campaign/Program," "Corporate Citizenship," and "2021 Resiliency Crystal" awards.