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Memorandum of Understanding
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FDA Memorandum of Understanding (MOU)—Updated May 2020

Many of you have taken action to have your voices heard as FDA has developed an MOU on compounding that will affect delivery of home parenteral nutrition (HPN) across state lines. (See our 2016 call for action below for background.)

  

Good news—your voice was heard! Due to your comments, the FDA had to explore home infusion further and define terms better to make the MOU clear, so your care would not be affected by misunderstandings. Under the new draft MOU, if your infusion pharmacy is in a different state from where you reside but in a state that has a Board of Pharmacy (BOP) that will sign the MOU and cooperate with the FDA for oversight of compounding activities, there is no longer a limit on your pharmacy’s ability to service you.

 

Bad news—there is still a very tight limit on pharmacies in states that will not sign the MOU. This could affect you if you use an out-of-state pharmacy that is in one of these states, or if you need to have HPN shipped to you in another state (while you are on vacation, or visiting family in another state, for example), and your state of residency has not signed the MOU.


How do you know which states will sign? They have up to 6 months to sign once the MOU is finalized. We are working to identify states that have expressed hesitation about signing. As we identify them, we will ask anyone who is served by pharmacies in those states to reach out to the BOPs and make your voice heard. Please contact Joan (bishopj@amc.edu or 518-262-5079) if you would like to join us in this effort if and when needed.

 

What can you do now? FDA is accepting public comments on the updated draft MOU through June 15. Please click here to comment now. Remind the FDA that nutrition support is a complex service and there are not a lot of pharmacies in the nation qualified to compound HPN. Patients may need to be serviced by one that is in another state. Ask the FDA to consider a pathway for exception for a provider of this service to continue to service out-of-state patients by meeting other requirements for oversight and reporting if they are in a state whose BOP will not sign the MOU. The FDA offers this type of pharmacy practice for standardized items that can be made in large batches with extended stability, but HPN is patient-specific and does not fit this pathway. Comment now with your story to put a face to the issue. Ask for a pathway so you can obtain quality care from a provider who meets your needs, not just your geography.

 

Comments that have already been submitted can be viewed at https://beta.regulations.gov/document/FDA-2018-N-3065-0046

Tips for submitting effective comments can be viewed at https://beta.regulations.gov/document/FS-2018-0053-0007

If you go into the Federal Register website (https://www.federalregister.gov/documents/2020/05/14/2020-10336/agency-information-collection-activities-submission-for-office-of-management-and-budget-review) and are referred to a "beta.regulations.gov" page to make or view comments, it is helpful to know the MOU FDA docket number: Docket No. FDA-2018-N-3065


Please click here to comment now.


FDA Memorandum of Understanding (MOU), 2016

In the wake of the meningitis outbreak in 2012 caused by drugs manufactured by the New England Compounding Center (NECC) in Framingham, MA, there has been a call for greater oversight of compounding pharmacies in the U.S. The Oley Foundation and the National Home Infusion Association (NHIA) believe that everything should be done to prevent a repeat of the failures of NECC, which claimed 53 lives and sickened 700+ others in 20 states. Patient safety is the first priority for all home infusion providers.  

 

Congress passed legislation that directs the FDA to institute a policy to prevent a repeat event and part of that legislation requires the FDA to propose a standard Memorandum of Understanding (MOU) to address distribution of compounded products over state lines. The proposed MOU has been released by the FDA and is entitled “Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the States and the U.S. Food and Drug Administration; New Proposed Draft; Availability.”

 

This memorandum of understanding (MOU) has the potential to interrupt the relationship that you have with your home care/home infusion provider. It clearly states that compounding facilities will not be allowed to distribute “inordinate amounts” of compounded products (which includes your parenteral nutrition) across state lines. If your home infusion provider does not have a compounding facility in your state, this will likely impact you. If you vacation out of the state where you reside, you may need to switch providers while you are away or carry your supplies with you.


It does seem that this MOU was constructed without complete familiarity of the needs of homePN consumers like YOU! It fails to consider the importance of continuity of care, the value of your relationship with your home care/home infusion provider and their contribution towards your safety, and/or the complicated nature of your underlying disorder. It does not distinguish between “distributing” a compounded drug product and “dispensing” such a product. “Dispensing” is to provide the drug product directly from the pharmacy to the individual for whom it is prescribed; “distributing” is to provide the product to another health care provider to then dispense to an individual.


Share your comments with the FDA now. Urge them to alter the MOU so it will be limited to interstate distribution (not dispensing) of compounded drugs. This is your opportunity to voice your opinion. Describe how you manage to “live” as full a life as possible supported by your home infusion provider and pharmacy. We sincerely believe that this effort to create a better understanding of your needs and relationships will be helpful in influencing the scope of the final MOU.

 

Sample comment (please personalize):

"I am commenting to the FDA to note my concern with the draft Memorandum of Understanding (MOU). As someone that needs parenteral (IV) nutrition, this draft MOU could harm or disrupt my care. By limiting the number of compounded products a pharmacy can ship interstate for direct dispensing to people like myself, the MOU could cause me to lose my current parenteral nutrition provider. It is vitally important that dispensing over state lines not be included in the calculation to determine what an inordinate amount of distributed compounded products is. Thank you for considering my perspective as someone that could be adversely affected by this issue."

 


This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.

 

Updated in 2015 with a generous grant from Shire, Inc. 

 

This website was updated in 2015 with a generous grant from Shire, Inc. This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.
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