Submitter's message Please note that a new version of this document has just been published. NSF employees will be able to view it in MasterControl (document #20054); others can use the link below. Thank you for your contributions to this document! -- Amanda Zeoli Document Name : NSF/ANSI 455-4-2022: Good Manufacturing Practices for Over-the-Counter Drugs Description This Standard is intended to define a standardized approach for auditing to determine the level of compliance of over-the-counter (OTC) drug products to 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General and 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals, well as incorporating additional retailer requirements. It refers to the requirements for good manufacturing practices (GMPs) applicable to all OTC drugs. It will assist in the determination of adequate facilities and controls for OTC drug manufacture with sufficient quality to ensure suitability for intended use. Download Latest Revision Submitter : Amanda Zeoli Group : Joint Committee on GMP for Over-the-Counter Drugs Folder : Standards Date submitted : 2023-05-02 08:38:19 Revision : 3