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May you live in interesting times...

By Dennis Tribble posted 09-05-2013 10:53

  
I have been reading with interest both the postings in Connect and in the Connect Blogsphere about the proposed legislation on compounding. As I think about the positions we are urged to take, I find the following points worth considerting:

  1. Compounding appears to be necessary - while ASHP, ISMP and much of our profession believe that it would be far better if each and every dose given to a patient had been manufactured under Good Manufacturing Practices (cGMP), physical and economic realities essentially prohibit that. As a result, there are doses that our patients require that must be compounded, including some that must be compounded in what seem to us to be large amounts.
  2. USP Chapters on Compounding are Minimum Standards, not Best Practices -Eric Kastango made this very clear in his presentation at the Summer Meeting this year. USP <797> is not something we should aspire to in our sterile compounding, it is table stakes. It does not describe the pinnacle of our practice; it should describe the floor. This means that the higher our risk of hurting a lot of patients, the farther above USP <797> our practice must reside. As compounding comes more and more to resemble manufacturing, the minimum standards in our USP chapters become less and less adequate to govern such activity.

 Are the state boards up to the task of this governance? Is the FDA the best group to provide it? Who knows? 

There are two bills before congress; one in the Senate that proposes a third layer of regulation between manufacturing and compounding and one in the House, that focuses more on the communication between the federal and state levels. If you haven't read them, I would encourage you to read them, and come to your own conclusions. 

What do you think?

Dennis A. Tribble, Pharm. D., FASHP
Ormond Beach, FL
DATdoc@aol.com

The opinions expressed herein are my own and not those of ASHP or of my employer.



#Advocacy #Compounding
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10-02-2013 10:13

I need to clarify something from this blog. There are no official statements from ASHP indicating that all doses should be manufactured. I believe that ASHP recognizes, as do I, that compounding is a necessity.
Having said that, rhetoric in support of the FDA position that compounding should not be used to replicate commercially available products indicates to me that there is a clear preference for products that have been manufactured under Good Manufacturing Practices as described in FDA regulations. And that was my only point. If it were practical, we would probably all sleep better at night if all doses were manufactured under those conditions. Reality indicates that it is not practical.