To Label or Not to Label - Pharmaceutical Technology

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To Label or Not to Label
In light of compendial changes, representatives of the US Pharmacopeia and an industry consortium provide perspectives on cap and ferrule labels.

Pharmaceutical Technology
Volume 10, Issue 34, pp. 96-98


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,, accessed Aug. 31, 2010.

2. IOM, To Err is Human: Building a Safer Health System (National Academy Press, Washington, DC, 2000).


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