How is USP approaching the revision?
A. USP is taking a risk–based approach that focuses on the likelihood of a given impurity being found in a drug or dietary supplement and on a consensus-based evaluation of the health implications of the impurity at levels that may be found. We have included toxicologists as well as chemists in the group of experts revising the standards to obtain the best available input on both health and methodology issues.
Related Questions
- Why has USP waited until now to revise standards for elemental impurities? Was there a specific event that prompted the revision?
- Are Barrier Isolators / Isolators / Compounding Aseptic Isolators CAI/CACI compliant with the USP 797 revision?
- Is the current USP Heparin RS affected by the heparin monograph revision?
