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IACP Member Q&A
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​This week's question involves Office Use guidelines in California.

 

Question:

 

Our state says office use compounding is legal....but this seems like a clear statement from the FDA now.

Should I NOT be doing any office use compounding?

 

Answer:

 

As IACP predicted, there are clear disconnects now between state laws that permit office-use compounding and dispensing and the FDA's position and interpretation of 503A. We already have several Congressional offices up-in-arms given that there are multiple statements made by Senators and Representatives on the record that specifically state the enactment of the Drug Quality & Security Act still defers to the state Boards to regulate things like office-use. A technical correction/change to the law is something IACP is working on for the 2015 Congressional session… but that's months in the future.

California, and many other states, clearly provides for office-use and regulates it quite clearly.  

Our advice to all IACP members is to follow your state law to the letter until your state tells you to do something else.  

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