According to FDA, if manufacturers believe they need to include a cautionary statement about an imminent life-threatening
situation on the ferrule or cap overseal of their product, they must provide a rationale to FDA regarding why the situation
addressed in the statement is considered to be life-threatening. FDA will expect manufacturers to provide data to support
the assertion that the statement is safe, unambiguous, and provides the best message to minimize the life-threatening situation.
Given the effects this change could have on manufacturers, the USP Nomenclature Expert Committee established a delayed official
date for the revised standard. The standard will be published formally on Nov. 1, 2010, in USP 34–NF 29 and will become official Dec. 1, 2013, thereby giving industry three years to implement the change.
USP appreciates the input of all parties regarding this revised standard, and recognizes the changes the standard will require
of manufacturers in the coming years. USP believes this activity will support healthcare professionals in their work and help
protect patients from serious medication errors that could result in death and disability.
1. USP, Commentary–General Chapter <1>, Aug. 4, 2010,
http://www.usp.org/pdf/EN/USPNF/genChapter1Commentary.pdf, accessed Aug. 31, 2010.
2. IOM, To Err is Human: Building a Safer Health System (National Academy Press, Washington, DC, 2000).