Comment and Question from Reader Regarding 503A and MOUs

AnonymousJanuary 12, 2014 at 10:22 AM

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.