Recall of USP 33-NF 28!

This is a truly unprecedented move: The American Pharmacopoeia (USP 33 / NF 28) is being recalled!

On 8 January 2010, a first notice on this action was published by the USP Convention, and on 12 January 2010, a more detailed public notice.

The official text says: "USP 32-NF 27 is official at this time and remains official until further notice. USP 33-NF 28, which was released on November 1, 2009 and recalled on January 8, 2010, was not scheduled to become official until May 1, 2010 and should not be used. The current official standards in USP 32-NF 27 can be used with confidence."

As the reason for this, the USP Convention indicates that errors have occurred during the conversion of monographs to a new format. The conversion aimed among other things at facilitating the use of the monographs and at harmonising the terminology. However, it was not intended to change the requirements laid down in the monographs. Approx. 4,000 monographs were converted accordingly, and most of them correctly. But a significant number of monographs now contains errors.

Evidently, these errors cannot be rectified with the normal, established USP errata process. For this reason, the USP Convention recalls USP 33-NF 28 as a whole.

A renewed release of USP 33-NF 28 is planned in the electronic version (CD) in March 2010, which will come into force 6 months after reissue. And at the same time, a printed version shall also become official.

The "USP 33-NF 28 Recall - Second Public Note" publication can be found here.

Dr. Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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