Type of Posting: Notice of Intent to Revise
Posting Date: 25-Mar-2022
Targeted Official Date: 01-May-2022, Revision Bulletin
Expert Committee: Biologics Monographs 4-Antibiotics (BIO4)
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Biologics Monographs 4-Antibiotics (BIO4) Expert Committee intends to revise the Vancomycin Injection monograph.
The Expert Committee proposes to revise the Vancomycin Injection monograph to accommodate products formulated with vancomycin free base, along with vancomycin hydrochloride:
- The Definition is revised to include vancomycin free base.
- The Sample solution in the Composition of Vancomycin test is revised to include concentration of vancomycin free base.
- The test for pH is revised to include acceptance criteria for products formulated with vancomycin and stored at room temperature.
- The Labeling statement is revised to indicate whether the product contains Vancomycin or Vancomycin Hydrochloride.
It is anticipated that the proposed revision will be published as an Revision Bulletin pursuant to the Rules and Procedures.
Should you have any questions, please contact Ying Han, Senior Scientist II (email@example.com).