Type of Posting: Notice of Intent to Revise
Posting Date: 29‒Sep–2017
Targeted Official Date: 01–Aug–2019
Expert Committees: Botanical Dietary Supplements and Herbal Medicines (BDSHM) and Non-Botanical Dietary Supplements (NBDS)
In accordance with section 7.04 (c) of the 2015–2020 Rules and Procedures of the Council of Experts, this is to provide notice that BDSHM and NBDS Expert Committees intend to revise the General Chapter <2750> Manufacturing Practices for Dietary Supplements.
The purpose of the revisions will be to make General Chapter <2750> applicable to only dietary supplements (finished products) and establish a separate general chapter for dietary ingredients. Through this revision, the chapter will include aspects of Food cGMP requirements in 21 CFR 117 Subpart B revised April 2017 that are applicable to dietary supplements that are not currently addressed in the chapter, i.e., requirements focused on sanitation operations, sanitary facilities and controls, including allergen cross-contamination reduction controls. In addition, although it is not a regulatory requirement, the chapter will include additional requirements for Hazard Analysis and Risk-Based Preventive Controls in 21 CFR 117 Subpart C. Furthermore, the revision will include additional details regarding requirements for the Supply-Chain Program in 21 CFR 117 Subpart G and Sanitary Transportation in 21 CFR 1 Subpart O.
It is anticipated that the proposed revision will be published as an In Process Revision in Pharmacopeial Forum 44(3) [May–July 2018] pursuant to section 7.02 of the Rules and Procedures. The comment period for this revision will end on July 31, 2018. In the absence of any adverse comments, the proposed revision will become official on August 1, 2019.
Should you have any questions, please contact Seong Jae (SJ) Yoo, Scientific Liaison to BDSHM and NBDS Expert Committees (301–230–6366 or email@example.com).