Sunday, March 31, 2013

New Bill: Compounding vs Manufacturing

The US Senate
 HELP Committee link
     I have been following the NECC meningitis outbreak since
it was first identified in the fall of 2012. I even attended a 5 hour
long meeting in January about this topic held by the Iowa College of Pharmacy. That event really helped answer a lot of my questions about how
something like this could happen. What it couldn't answer was, "Where do we go from here?" and "What does this mean for the future of compounding pharmacy?" I knew that regulations would change and their enforcement would be stricter, but I was anticipating a change for the worse. I was afraid that this would be such a negative blow to the world of pharmacy that it would force smaller, independent compounding pharmacists out of business.
     While looking around for any updates about the meningitis outbreak and its effect on pharmacy law, I found news that a new bill is being drafted addressing these issues. I was very pleased to see it included a point I thought about from the onset of the tragic events: the NECC was not acting as a compounding pharmacy. It was acting as a manufacturer and therefore should be subject to inspection and oversight by the FDA not the state of Massachusetts. Also, compounding pharmacies in general should not get a bad reputation for what this one greedy company did.
  •      A compounding pharmacy by law operates as such:
    • receives specific written order for a drug product from a licensed prescriber
    • this drug product is for a specific patient
    • this drug product is not made until the pharmacy receives the order to make it (some products that are shown to "move" in the pharmacy may be made ahead of time in limited quantities)
    • they DO NOT produce large amounts of drug products to sell and ship all over the country!
If a "compounding" pharmacy is making huge batches of injectable steroids without doctor's orders or for a specific patient, selling and shipping them all over the country they cease to be a compounding pharmacy and are now a drug manufacturing facility.
     The HELP committee is writing this bill to help define "compounding" versus "manufacturing" and who is responsible for overseeing each of these entities. The bill will see to it that compounding pharmacies are still held up to the highest standards and answer to the state. Compounding pharmacies that stray into the area of manufacturing will answer to the FDA and must uphold the even more strict standards of a drug manufacturing facility.

Side note: Iowa's own Senator Tom Harkin serves on the HELP committee. Go Iowa!

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