Members-only Site   |   Print Page   |   Contact Us   |   Sign In   |   Register
IACP Member Q&A
Share |

​This week's question involves Office Use guidelines in California.




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?




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.  

Association Management Software Powered by YourMembership  ::  Legal