To Label or Not to Label - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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

Implementation

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.

Reference

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).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
Source: Pharmaceutical Technology,
Click here