February 17, 2021
If you ship out of state: Read this — and respond!
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.
SO … PLEASE — CLICK HERE TO DOWNLOAD THE LETTER. (It’s a Word document.) Customize it carefully and send it to your state board of pharmacy ASAP.
- Tells your board a bit about your compounding pharmacy.
- Outlines the implications of the 5% cap on your pharmacy if your state doesn’t sign the MOU.
- Encourages your state board to consult with compounders as it determines what it will do on the MOU.
- Urges your state board to write ASAP to FDA and the National Association of Boards of Pharmacy to express their concerns about signing the MOU.
Also, here’s a list of state boards of pharmacy and their addresses — physical and email — so you’ll know where to send the letter.
Thank you for reaching out to your state board of pharmacy on this urgent matter.