The Aerosols Sub-Committee (SC) of the General Chapters—Dosage Forms Expert Committee revises United States Pharmacopeia (USP) chapters to reflect scientific developments and stakeholder input, as well as to align them with current and evolving regulatory requirements. The general chapters of United States Pharmacopeia –National Formulary (USP–NF) are subdivided. Those with numbers below <1000> are generally “normative” chapters, which have content that may be mandated in order to meet regulatory requirements. Chapters numbered above <1000> are “informative” and contain material that is useful to apply in performance testing but may not be mandatory with respect to use in regulatory submissions.
An overview of general chapter development for oral and nasal drug products (OINDPs) at the US Pharmacopeia (USP): Part 1—Normative chapters <5>, <601>, <602>, <603> and <604>
This is the first article of a two-part series that provides an overview of the work currently undertaken by members of the Aerosols Sub-Committee at the USP, focusing on recent updates to the normative and informative chapters within the committee’s remit.