Type of Posting: Publication Announcement
Posting Date: 01–Feb-2022
Official Date: 01-August-2025
Expert Committee: Botanical Dietary Supplements and Herbal Medicines
In Pharmacopeial Forum 46(6) [November–December 2020], Sennosides was revised as an In-Process Revision (IPR). The purpose of the proposed revision was to define Sennosides in terms of sennosides A and B as marker compounds for strength, supplemented with the requirement of determining the presence of other minor sennosides in standardized ratios as defined in the Identification test. This approach utilizes pure sennosides A and B as reference standards, making the analytical determination traceable to SI mass units instead of percentage relative to USP Sennosides RS.
Recognizing that the current proposal represents a significant change that may impact industry, a delayed implementation period was proposed to allow sufficient time for manufacturers to implement related changes in labeling, certificates, and any regulatory documents.
The Botanical Dietary Supplements and Herbal Medicines Expert Committee approved the delay of the implementation date from August 1, 2022 to August 1, 2025, with changes to be published in USP–NF 2022, Issue 2 (publication date of February 1, 2022).
Should you have any questions, please contact Nam-Cheol Kim, Senior Scientist II (nck@usp.org).
CN-22-035-00