The voice for pharmacy compounding | February 25, 2022

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➤ From APC’s President

APC, SWOT, and your business

David J. Miller, RPh
APC President

Last week I gave a taste of what’s called a SWOT analysis — something many of you, as business owners, know of. If you don’t, the acronym stands for:

  • Strengths: characteristics of our alliance that gives it an advantage
  • Weaknesses: characteristics that place us at a disadvantage
  • Opportunities: elements in the environment that APC could exploit to its advantage
  • Threats: elements in the environment that could cause trouble for our alliance

SWOT has both internal and external components. Strengths and weaknesses are usually considered internal, while opportunities and threats usually come from outside your business.

For APC, our strengths are awesome. Our weaknesses are things we can overcome. Our opportunities are vast. Our threats are real.

Last week I talked about APC’s strengths, and over the next three weeks, I‘ll address APC’s weaknesses, opportunities, and threats, completing the brief SWOT analysis.

I’ll write about APC issues, but they also impact your business — both positively and negatively. Your participating with APC can ensure our strengths and opportunities far outweigh our weaknesses and threats. Stay tuned.

David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at

➤ This Week

FDA concedes in MOU lawsuit

In a significant legal victory for pharmacy compounders, FDA has conceded that yes, it must conduct formal notice-and-comment rulemaking in order to implement an MOU with states regarding interstate shipments of compounded medications.

The case, Wellness Pharmacy v. Azar, brought in federal court against the agency in 2020 by seven compounding pharmacies. APC was party to an amicus filing in support of the plaintiffs

Last autumn, Judge Chris Cooper of the Federal District Court of D.C. ruled that the way FDA created the MOU violated the law, and the agency cannot enforce it. The MOU was remanded back to FDA, and the agency was told to “either certify that it will not have a significant economic effect on small businesses or prepare a regulatory flexibility analysis.”

On Wednesday, FDA responded by filing a status report with the court saying it would suspend implementation of the MOU and do what it should have done in the first place: engage in a formal rulemaking process. That process, the agency said, may take “several years” to complete.

“We’re pleased that compounders’ concerns and arguments have prevailed in this case,” said APC President Dave Miller. “While this litigation resulted from what we view as FDA overreach, we do support the agency’s desire that pharmacies that ship the majority of their compounded medications out of state report those shipments. With this case settled, we’re committed to work with FDA and Congress to enact an effective reporting framework that meets FDA’s need for information and doesn’t threaten patients’ access to compounded medications. And I would add: We think there are ways to bring about that result that won’t take years and years to effect.”

Click here to read the full press release about this latest development, which includes background on the case.

Read the Reuters story.

It’s a CompPAC-alooza at Owner Summit!

Some conferences are so great that everybody wants to attend — even members of Congress. That’s surely the case with APC’s upcoming Owner Summit March 24-26 in Scottsdale.

CompPAC logo

We’re happy to report that not only will Congressman Tom O’Halleran (AR-1) will be our guest for a CompPAC fundraiser during the conference, but Congressman Buddy Carter (GA-1) will speak at a Medisca-sponsored luncheon on Friday. Both congressmen are members of the House Energy & Commerce Committee, where most compounding legislation is assigned. CompPAC is also hosting APC member Rich Moon, who is running for Congress in New York and will speak briefly at the Thursday evening opening reception. (HINT: Bring your checkbook.)

O’Halleran, Carter, Moon

Those are in addition to the meaty, no-BS education sessions we’re featuring at the conference, of course.

The Owner Summit hotel is full, but…

… if you plan to attend and have not booked a room — don’t worry — we have (limited!) space at a great ‘overflow’ hotel:

The Sonesta ES Suites Scottsdale Paradise Valley is a 10-minute walk to the Hilton. You can click here to make your reservation.

Just remember: We’ll need to cap Owner Summit registrations at 150, and we’re closing in on that number. So if you plan to attend, don’t just reserve your hotel room. Get registered for the conference NOW!

Save cBHT with these great (free!) flyers

Here’s a slick way to spread the word about the threat to your patients’ compounded hormones: Michelle Moser of Makers Compounding Pharmacy & Hallmark in Mt Vernon, Wash., commissioned some slick flyers from a professional designer, and she’s making them available to everyone.

A pic of four lovely flyers

You can grab the 8½ x 11 versions here, or the poster-size 18 x 24 versions here.

Download them, choose your favorites, then print and distribute them — spread the word! And be sure to encourage your patients taking compounded hormones to share their stories on

Don’t forget the Topi-CLICK match!

Remember, if you make a new contribution to APC’s Campaign to Save Compounded Hormones by the end of the month, Topi-CLICK will match it, dollar for dollar — an easy way to double your support!

Big red button to save cBHT

Hrncir named Pharmacist of the Year by PDS

Congratulations to APC member Jim Hrncir of Las Colinas Pharmacy Compounding & Wellness, named PDS Pharmacist of the Year at the PDS Super-Conference in Orlando.

(You must have a Facebook account and be logged in to view the video. Younger members, ask your grandparents if you don’t have one of your own.)

“Anyone who knows him understands how well deserved this is — from guiding Las Colinas Pharmacy Compounding & Wellness to a 100% increase in supplement sales last year to exemplifying the qualities and values of a true leader. Congratulations from everyone here at PDS!

Pic of Jim accepting award

EduCon isn’t over yet! You can still register and get all those CE credits (and keep your team compliant). It‘s on-demand for six more weeks!

Click for info and to register (if you haven’t already) — or go to

Join in the CompPAC Challenge

Here’s a great reason to invite your member of Congress on a pharmacy or facility tour: Have your donation to their campaign doubled.

It works like this:

  • Host a member of Congress — representative or senator — for a visit to your pharmacy.
  • Donate at least $500 to their campaign and present it during the visit.
  • CompPAC will match your donation up to $500. (You’ll need to let us know in advance, of course.)

It’s that simple!

A contribution of $1,000 (or more!) is a great incentive for a legislator to stop by — and a great opportunity for you to talk about the issues you face every day. You’ll have a chance to educate and create a compounding champion who we can count on to support our issues in Congress.

Not sure how to set up, prepare for, and conduct a good visit? No worries. Check out APC’s guide, “Hosting a Pharmacy Visit With Your State or Federal Legislators.”

➤ Short Takes

Our condolences to the family and friends of former APC member Bill Swail, owner of Peoples Rx in Austin, Texas, who passed away on January 25. He was so appreciated by the community as an advocate of functional medicine that the Austin City Council proclaimed February 28, 2022 — Bill’s birthday — as Bill Swail Day.

Bubbly danger: Dissolvable, fizzy acetaminophen (aka paracetamol) contains a lot of salt — too much, in fact, according to a study published in the European Heart Journal. Researchers found it increased patients’ risk of heart attack, stroke, heart failure, and death after just a year of use. The longer patients took the bubbly drugs, the higher the risk. The issue isn’t the acetaminophen, but the additives that make it fizz.

What the people want: A full 86 percent of Americans surveyed say they want to know why the FDA doesn’t approve a drug (and they’re apparently confident they’d understand the reasons). And 91 percent “supported the FDA correcting any misleading information spread by drug manufacturers.”

➤ Coming Up

Now through April 8, 2022EduCon Virtual 2022

March 24–26, 2022APC Owner Summit, Hilton Scottsdale Resort; Scottsdale, Ariz.

May 10 — PCCA ACT Virtual Legislative Conference
May 12 — PCCA ACT Virtual Hill Visits

June 21–23, 2022 — Informa Connect’s Compounding Pharmacy Compliance, College Park, Md.

September 14–15, 2022 — APC’s Compounders on Capitol Hill 2022, Hilton National Mall, Washington, DC

APC is committed to addressing any concerns or complaints within one business day. Please send them — and, of course, any compliments — to