Compounding Pharmacy Legislation and the Potential Dramatic Impact on Home Infusion
Wednesday, May 8th
1:00-2:30 PM EDT
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Due to the critical nature of this hot topic, and the impact it will have on ALL home infusion businesses—we've made the decision to hold this Talk Infusion forum as soon as possible. We realize this is short notice—but feel the information on this key compounding legislation needs to be shared immediately, and our members informed and prepared! This issue is of vital importance to every company in the home infusion field and will invariably change how you do business if Congress acts on the Senate Health, Education, Labor and Pensions (HELP) Committee's draft legislation, as it is currently written.
Where are we now? The Senate HELP Committee released their discussion draft on the proposed compounding legislation. If you would like to review the discussion draft, one-pager and section by section summary please click here.
NHIA has been actively working this issue on the Hill on behalf of our members since the NECC incident happened. We have already shared a great deal of information with the Senate HELP Committee and the House Energy and Commerce Committee. Some of those efforts are reflected in the draft legislative text, specifically the section that considers limited advanced compounding. We are providing comments to the HELP Committee.
Join us and your fellow home infusion colleagues and put it on your calendars now—registration is now open and is complimentary for all NHIA members!
1 comment:
It is my understanding that sterile products that are prepared for home or alternate site use according to FDA-approved labeling do not fall under 503A.
What is the business model that requires 503A and a liberal MOU? If pharmacies are mixing FDA-approved drugs off-label (extending expiry dating or storage conditions; mixing with ingredients with unknown stability), there is public health concern, regardless of whether or not the drugs are made on an individual basis. Even more concerning would be if the pharmacies are mixing with non-sterile chemical ingredients instead of FDA-approved products, for example, mixing a TPN solution with non-sterile amino acid powder. This is precisely what the MOU should place parameters around. Consider the premature neonate going home from the hospital on IV antibiotics. Or the child with short gut syndrome requiring stabilization in the hospital now going home on TPN. Lots can go wrong, and, the last thing we want to do is to introduce excess uncertainty by mixing drugs outside their FDA-approved labeling. There will be situations where patients cannot be treated with FDA-approved products prepared according to labeling, however, these occasions should be rare where individual patient needs are not subordinate to business opportunities.
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