It is critical to address the copyright status of the USP–NF. The USP Convention holds the copyright over all editions, including USP 39.
– A technical note in Pharmaceutical Technology (2016) that specifically maps the changes in General Chapters <476> (Organic Impurities) and <232> (Elemental Impurities) introduced in USP 39. usp 39 pdf
Using non-authenticated copies of pharmacopeial standards during an FDA or localized audit can result in observation citations or warning letters due to poor data integrity. It is critical to address the copyright status