APC and NCPA have sent a joint letter to the Oregon Board of Pharmacy expressing concern about the agency’s recent fiscal impact request regarding proposed rules on pharmacist licensure and counseling requirements. read more →
Today is the last day for members of Congress to add their names to a joint letter to FDA in support of maintaining access to compounded hormones. The letter is led by Rep. Jennifer Wexton (D-VA). read more →
APC members are invited to attend Informa Connect’s two-day program, Compounding Pharmacy Compliance at a special, members-only rate (use code 23A4PC15 to receive 15 percent off your registration fee). read more →
Earlier this week, APC’s Executive Committee and Federal Legislative Committee leaders met virtually with FDA’s Office of Compounding Quality + Compliance team to discuss a range of issues impacting pharmacy compounding. read more →
The voice for pharmacy compounding | February 25, 2022
THIS EDITION SPONSORED BY PCCA
Get in the know with The PCCA Blog — your free online destination for content on a wide variety of subjects, including: “Lidocaine vs. Lidocaine HCl in Pharmacy Compounding.” In this recent post, Andrew Glasnapp, PharmD, helps you understand the correct form of lidocaine to use in different situations. Read and subscribe to The PCCA Blog at pccarx.com/blog.
➤ 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 email@example.com.
➤ 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.”
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.
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:
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.
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!
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 A4PC.org/educon
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.
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.”