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    Patient FDA Response

    This is a message regarding your prescription. We need your help in responding to the FDA.

     

    You are at risk of losing access to your (compounded VIP Medication) VIP treatments.  The FDA has created a list known as the Bulk Drugs Substances for use in Compounding and has accepted submissions for ingredients to review for inclusion.  However, while VIP was on the list of substances being considered for inclusion, the FDA has proposed to deny VIP from being included on the Bulk Drugs list.  If that happens, compounding pharmacies will no longer be allowed to compound prescriptions with it as a component.  

    Therefore, we are asking you to contact the FDA and tell them about your experiences with (compounded)VIP as a treatment option.  With enough support we hope to convince the FDA that VIP should remain on the bulk drug substance list so patients can continue to have access. The FDA has already considered use of VIP for CIRS and has recommended against including VIP used to treat CIRS on the Bulk Drugs Substances list. If you have been using VIP for an alternate condition, we especially urge you to contact the FDA with your story before                       DECEMBER 4, 2019. 

    This link can be used to submit comments: 

    https://www.regulations.gov/comment?D=FDA-2018-N-4845-0001

    We ask that you personalize your response as much as possible. It is much easier for many copies of stock responses to be ignored, but if you wish you may feel free to use the following as a guide for creating your (own) comments:

     

    To whom it may concern,

     I have been using (compounded) VIP for _______ (years/months) to treat ________. Without VIP, I would ________________. VIP has allowed me to ______________. I urge you to preserve access to compounded VIP. I believe you create these regulations to protect patient safety, yet this decision would put my health in jeopardy.

    Sincerely,

     


    Please note, these comments are published in the Federal Register, which is part of the public record of US Government business and will be publicly available after submission. 

     

    Thank you for your support.

    PDlabs