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Memorandum of Understanding
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Memoradum of Understanding (MOU)

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.

  

Click Here to Submit Your Comment

 

 

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."

 

Click Here for More Information

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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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