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The voice for pharmacy compounding | May 21, 2021

From APC’s President

Play ball!


Michael Blaire, RPh, FIACP
APC President

Billy Beane, general manager of the Oakland A's had a problem: how to field a winning team in the majors with a budget much smaller than that of most other teams. Conventional wisdom long held that home-run hitters and young pitchers with rocket arms were the ticket to success. But Beane and his staff, informed by mountains of carefully interpreted data, believed that wins could be had by more affordable methods: hitters with high on-base percentages and pitchers who got lots of ground outs. Given this information and a tight budget, Beane defied tradition (and his own scouting department) to build winning teams of affordable young players and inexpensive veterans.


Billy "Moneyball" Beane

The data Beane and the A's used comes out of sabermetrics (named for the Society for American Baseball Research, where it originated in 1971) and it's made possible in part because every baseball game generates a ton of data. In a pharmacy, every time a prescription is processed, massive amounts of data are also produced and recorded. Most pharmacy software systems can generate a myriad of reports, and the data they contain can be sliced and diced in any number of ways.

At this moment one set of your data is extremely important to APC: your prescriber list. In short, that list can be a tremendous help to our cBHT Media Campaign. We need to reach out to them, and to ask for their support.

While you may be reluctant to share your prescriber list, you can rest assured that your association will only use it to disseminate information about the threat to cBHT. Let’s face it, you’re not going to do it yourself, so generate that spreadsheet and send it to APC today.

Using big data, Billy Beane’s Oakland A’s won a record 20 consecutive games between August 13 and September 4, 2002. Using our combined big data, we can prevail against NASEM and the FDA. But our cBHT Media Campaign is stuck in a run-down between third and home. Let’s do what it takes to score.

P.S. We're delighted to welcome Steri-Tek as a Bronze-level APC Corporate Patron. We're grateful for their support!


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

Announcing the MEDISCA Challenge:

Starting now and throughout the month of June, Medisca will match all individual contributions to APC's cBHT Media Campaign, dollar for dollar, up to $100,000.

That means just what you think: Medisca will be supporting APC’s campaign by matching all donations made starting now and throughout the month of June, 2021 up to $100,000. With your support, we have the potential to add $200,000 to the fund in just one month by working together! Your support is vital for preserving access to compounded hormone therapy.

If you haven't chipped in yet, there is no better time to help us reach our $1.5 million goal. Click here to contribute to the campaign NOW — and have your money doubled!

We are deeply grateful to Medisca for their support — and we encourage you all to join the initiative.

To learn more about APC's campaign to preserve access to compounded hormone therapy visit compounding.com — and tell your patients and prescribers, too!

More about the cBHT media campaign

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're looking for names, addresses (physical and email), and phone and fax numbers. Simply email the file to info@a4pc.org (and note in the subject line that it's a prescriber listing).


We've got the tools: Bag stuffers, posters, images for social media — smart and easy ways to get the word out about the threat to cBHT. They're members-only, and you'll find them all through our cBHT campaign support page — and thanks to our connection with VistaPrint, you can have them printed and shipped to your door with just a few clicks.


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.

FDA to NABP: Biologics shouldn't be compounded

FDA has written to NABP expressing concern about biologics — like HCG, for instance — being compounded without a biologics license application (BLA) being filed.

Biologics, it points out, have been subject to licensure under the Public Health Service Act since March 2020, and "are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act."

The letter asks NABP to reach out to state pharmacy boards (which, presumably, will contact compounding pharmacies) to ensure everyone is clear about the legal situation: "federal law does not provide a legal pathway for marketing biological products that have been prepared outside the scope of an approved BLA."

Your takeaway: Don’t compound biologics — including HCG — without a biologics license. Period. You can click here to read the FDA's letter (PDF).

Engage your prescribers

How well do you know COAs?

Reading & Leveraging a Certificate of Analysis: A three-part learning series from the Alliance for Pharmacy Compounding

Ask any competent compounder and they’ll tell you: The Certificate of Analysis matters — and your ability to correctly read one, and leverage it in producing compounded medications, is key to delivering a product that is not just safe, but precisely prepared for your patients’ specific needs.

Get it wrong, and you don’t just waste ingredients — you may be putting your patients at risk. This three-part series from APC is designed for compounding pharmacy teams, to polish their skillset, grow their expertise, and keep them complaint with the Compounder’s Code of Ethics.

It’s such an important topic that we’re providing a special $99 rate for pharmacists, $69 for technicians that includes all three sessions.

Click here to register.

Leveraging a COA: Raw Material Revealed

June 22; 2:00–3:00pm EDT
Presenter: Dr. Tom Kupiec, ARL Bio Pharma; Oklahoma City, OK

Leveraging a COA: The Arithmetic

July 13; 2:00–3:00pm EDT
Presenter: Anthony Campbell, PharmD, BCSCP, Wells Pharmacy Network; Ocala, Florida

Leveraging a COA: Risk Mitigation

August 10; 2:00–3:00pm EDT
Presenter: Anthony Grzib, RPh, Wedgewood Pharmacy; Swedesboro, NJ

Click here to registerall three courses are only $99 for pharmacists and $69 for technicians.

NABP to FDA: Delay the MOU enforcement

NABP has written to FDA, adding its voice to that of APC and others and requesting delay of enforcement on the interstate-shipment MOU.

Several states have indicated that regulatory changes, which involve lengthy processes and require extensive public comment periods, are needed. Others have indicated that statutory amendments are necessary, and the legislatures are placing a great deal of focus on COVID-19-related legislation.
Click here to read the letter (PDF).

APC supports New York bill to allow office-use veterinary compounding

Two companion bills in front of the New York State legislature would permit compounding pharmacists to supply veterinarians with office-use medication so long as those meds were "prescribed or ordered by any [licensed] practitioner of veterinary medicine."

APC this week wrote to New York Senate and Assembly leaders to urge passage of the bills, S4247 and A6704.

We support the proposed legislation because we believe it will serve the needs of veterinarians to have wider access to the compounded medications they require for their patients. It will also ensure that those medications are provided in a manner that protects the public safety.

You can click here to read the letter (PDF).

You need to be thinking about online credentialing

So these were in the news this past week:

"Senators want to make pandemic telehealth changes permanent"

     = and =

"Hims & Hers Q1 revenue jumps 74% as company looks to expand virtual behavioral health services"

Both those stories are reminders of how important telehealth has become, and how likely it is to stick with us even after the Covid-19 pandemic.

Compounders who want to be a part of that, and be able to serve telemedicine prescribers, will find it may not be so simple. That's why APC is offering — this coming Tuesday, May 25 — a one-hour webinar on online pharmacy sales credentialing: "Nice Work if You Can Get It."

Coming Up

May 25 — APC CE: Online Pharmacy Sales Credentialing: Nice Work if You Can Get It

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 APC10 for 10% off registration!)

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

Short Takes

Congrats to Innovation Compounding — whose president and CEO, Shawn Hodges, is APC's board chair — for being named one of the Top 5 Small Businesses of 2021 by the Cobb Chamber Of Commerce in Marietta, Ga.


Inspection prep, part 2: The good folks at FDA Law Blog have the second in their series "I Hear You Knockin’… Preparing for and Managing DEA Inspections." This one focuses on the inspectors and what they're looking for.


Skipping meds: A British study found that “Nearly half of people with bipolar disorder do not take their medication as prescribed” — and often for reasons pharmacists maybe help with, including fear of side effects, not realizing how important the medications were, and lack of encouragement from family or clinicians.


Mixing vaccines: A study out of Spain has answered the question (for the moment) “Can you mix the Pfizer and AstraZeneca vaccines?” The answer: Yes, “giving a dose of Pfizer’s drug to people who already received a first shot of AstraZeneca vaccine is highly safe and effective.”


Bringing back MAOIs — for cancer? Apparently so. The old-school antidepressants seem to be able to boost the power of checkpoint inhibitors (according to UCLA immunologists).