A group of five organizations, led by APC, this week filed a “friend-of-the-court” brief in support of litigation challenging FDA’s MOU with states. That litigation was filed in federal court in October 2020 by seven compounding pharmacies, alleging the final MOU is flawed both substantively and procedurally.
Joining APC on this week’s amicus filing are Central Admixture Pharmacy Services, Professional Compounding Centers of America, National Community Pharmacists Association, Nutrishare, and Medisca USA.
The amicus was filed on APC’s behalf by Karla L. Palmer of Hyman, Phelps & McNamara, P.C. Funding for the amicus filing comes in part from APC’s Legal Action Fund, which is supported by APC member contributions.
Have you downloaded the new APC Compounder’s Code of Ethics? Central Compounding in Durham, NC, and Stanley Compounding in Charlotte, NC, did, and they’re displaying it proudly. You can, too. Download the code at A4PC.org/downloadthecode.
And don’t forget you can also watch and share Jon Pritchett’s powerful video, “The APC Code of Ethics: Ensuring Your Reputation and Legal Standing” on APC’s updated Code of Ethics page.
This is a bit lengthy, but if your compounding pharmacy ships out of state, please pay attention.
In recent weeks we’ve heard that many state boards of pharmacy have heard very little from compounding pharmacies in their state about FDA’s MOU and its implications for patients and compounders.
We’ve also heard that some compounders mistakenly believe the MOU does not affect them because they don’t ship more than 50% of compounded preparations out of state.
The first is a real concern. The second is just flat wrong.That’s why we’re issuing this CALL TO ACTION: to correct misunderstandings and to urge you to reach out to your state board of pharmacy to let them know how your state’s action (or inaction) on the MOU will affect patient access to compounded medications and your business.
A quick tutorial
Problems for states that DO sign:
The MOU has serious flaws. It conflates definitions of ‘distribute’ and ‘dispense’ in a way Congress never anticipated. As a result, in states that sign the MOU, FDA will gain oversight of certain aspects of traditional dispensing, which has long been the purview of state boards of pharmacy, NOT a federal agency.
FDA seriously underestimated the administrative burden on states that sign the MOU — the costs of staffing, reporting, etc., required of states in order to comply. The MOU creates, in effect, an unfunded mandate on states that sign.
Problems for states that DON’T sign:
It doesn’t matter that you don’t ship 50% of your compounded preparations out of state. If you state does not sign the MOU, you will be limited to shipping NO MORE THAN 5% of your compounded preparations out of state. Do the math. If you prepare 20 compounds a day and you are based in a state that does not sign the MOU, you’ll be limited to shipping only ONE of those compounds out of state.
For many, many compounders, that 5% cap could seriously hurt their business, and impede countless patients from getting their medications. It may even put some compounders out of business and create a loss of jobs (and tax revenue) in your community. (This 2020 op-ed by Virginia’s Morgan Griffith (VA-9) makes that point well.)
So are states damned if they do and damned if they don’t? Candidly, yes. But the implications for patient access and your compounding pharmacy are what matter most to us.
Here’s what we’re asking
There may soon come a time soon when we’ll be asking you to URGE your state board of pharmacy to find a way to sign the MOU, despite its flaws. Why? Because that 5% cap that will be imposed if the state doesn’t sign will be catastrophic.
BUT … We’re not at that point yet, and we think your input to your board of pharmacy can be helpful in encouraging them to reach out NOW to FDA and the National Association of Boards of Pharmacy with their concerns about signing the MOU. Our sense is that some state boards of pharmacy that don’t have compounders as board members are not aware of the implications of the MOU in their state. They need to understand the concerns and express these concerns to FDA and NABP.
If you’re a compounder in the Northeast/Mid-Atlantic (Maine to DC) — even if you’re not an APC member — please join us for a virtual town hall on compounding issues: Wednesday, March 10 from 4:00-5:00pm EST.
This APC District II meeting is free and open to all compounding professionals — no registration required. It’s a perfect chance to hear about the issues facing compounding, and to meet and connect with other folks in your neck of the woods.
As a compounding pharmacy owner or manager, you wear at least two hats.
Sure, you’re a healthcare provider, and you take seriously your responsibilities to your patients. But you’re also a businessperson, and your ability to care for those patients relies in no small part on navigating marketplace challenges: seizing opportunities, reducing risks, ensuring efficiencies. Success, in other words, depends on how well you run your business.
It’s where owners and managers like you can discover business ideas, solutions, and new opportunities that can boost your businesses.
From “The Best Decision I Made All Year: Ideas from Fellow Owners” to “Maximizing Your Sales Team’s Effectiveness” to “Office Systems That Work” and more, we’re willing to bet you’ll come home with an idea or two that will more than pay for the cost of attending.
Tap the big green button below for complete program, registration, and hotel information.
And hurry: Special APC hotel rates at the Westin are only guaranteed for reservations made by February 26. (Wednesday night March 24 is already sold out, so plan to arrive on the 25th.)
If you attended EduCon 2021, you probably saw Jon Pritchett’s session, “The APC Code of Ethics: Ensuring Your Reputation and Legal Standing.” It’s a powerful video (and a great training tool) with an important message — important enough that we’ve made it free for everyone to watch and share on APC’s updated Code of Ethics page.
Yes, updated. The page (A4PC.org/code) now includes not only the Code itself, but Jon’s video, a high-res printable version of the Code, and the latest Pharmacy Compounder Leader newsletter.
NOTE: You can’t get CE credit for Jon’s presentation unless you attend EduCon. And yes, you still can attend! Every session, including all the CE credit, is available until April 4. Visit A4PC.org/educon2021 to see how.
Please join APC on February 25 for an important Town Hall briefing: an update on our multi-pronged, multi-year media campaign to save cBHT and protect the lives of millions of Americans who rely on it.
The campaign launches next month! We’ve raised more than $556,000 toward our goal of $1.5 million, and we’ve started production on print ads, video presentations, websites, and more.
Get a sneak peek at ad designs, the new website, and our plans for the next six months — plus an update on the production and fundraising.
The Town Hall is February 25, from 3:00–4:00pm EST, via Zoom. It’s free and open to all, but you need to register: A4PC.org/225townhall.
(Once you register, check your email and be sure to click the link to add it to your calendar.)
Independent pharmacies achieve superior results not despite being small, but because they are small. It’s their local ownership that makes the difference. […] Lacking top-heavy bureaucracy and rich with local knowledge and relationships, independent pharmacies possess what you might call economies of small scale.
Still, author Stacy Mitchell points out, U.S. business law is aimed at the “ideology of bigness” that it believes — incorrectly — to be more efficient.