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(DDU) and Aerodynamic Particle Size Distribution (APSD). e chapter also addresses the use of laser dif- fractometry for the determination of droplet size distri- bution of spray and aerosol drug products. is USP– NF chapter is among the most commonly used by stakeholders involved with assurance of OINDP qual- ity. erefore, it has undergone several major revisions since 2010 to keep it up to date. Significant changes have included eliminating the sec- tion that covers data analysis in association with APSD determination. In the near future, it is proposed to rein- state APSD-related data analysis as a new informative chapter (Figure 1, <160x>) that is more attuned to cur- rent FDA requirements. e most recent In Process Revision of <601> took place in 2016, appearing in volume 42(6) of Pharmacopeial Forum (PF). This version received extensive public feedback, reflecting the importance that stakeholders have attributed to the content of this chapter. In response, the sub-committee made several changes to improve readability and consistency of the text associ- ated with each section of the chapter. e sub-commit- tee also took this opportunity to reorganize sections and subsections (Table 3). • Section A, which covers DDU determinations, is largely unchanged from the version in the current official text. However, the illustrations of the dose collection apparatus configurations, (a) for use with inhalation powders and (b) for use with all other classes of inhalers, were clarified so that their cap- tions align with the content of the corresponding tables that define each apparatus. that are more specific to OINDPs which appear in Gen- eral Chapters <601> INHALATION AND NASAL DRUG PRODUCTS: AEROSOLS, SPRAYS, AND POWDERS—PERFORMANCE QUALITY TESTS, <602> PROPELLANTS, <603> TOPICAL AERO - SOLS, and <604> LEAK RATE. ese same perfor- mance quality tests also appear in the <1600> series of informative chapters that cover products for nebuliza- tion and spacers and valved holding chambers used with inhalation aerosols. Table 1 defines the different forms of OINDPs and introduces the class definitions that appear in all other chapters associated with this dosage form. e termi- nology may not always be the same as class names in common use (e.g., pressurized metered dose inhalers (pMDIs) are referred to as inhalation aerosols). However, these definitions were carefully developed to be highly specific for each OINDP class, as well as to avoid confu- sion where tests specific to each class of inhaler are speci- fied in this and other chapters associated with OINDPs. is chapter mainly contains the standard quality tests listed for each of the OINDP classes and descriptions of each test. A few minor changes to these lists of tests have been made in the latest revision to <5> to ensure consis- tency across all the OINDP classes (Table 2). General Chapter <601> INHALATION AND NASAL DRUG PRODUCTS: AEROSOLS, SPRAYS, AND POWDERS— PERFORMANCE QUALITY TESTS Chapter <601> is primarily concerned with the deter- mination of product Delivered Dose Uniformity 22 April 2018 Inhalation Figure 1 USP–NF General Chapters within the Responsibility of the Aerosols Sub-Committee. Chapters shaded green are official and chapters shaded in yellow are either in development or have been proposed through the Stimuli Article process in Pharmacopeial Forum. DDU = Delivered Dose Uniformity; APSD = Aerodynamic Particle Size Distribution <601> INHALATION AND NASAL DRUG PRODUCTS: AEROSOLS, SPRAYS, AND POWDERS —PERFORMANCE QUALITY TESTS Normative Chapters <5> INHALATION AND NASAL DRUG PRODUCTS—GENERAL INFORMATION AND PRODUCT QUALITY TESTS <602> PROPELLANTS <603> TOPICAL AEROSOLS <604> LEAK RATE Informative Chapters <1601> PRODUCTS FOR NEBULIZATION <1602> SPACERS AND VALVED HOLDING CHAMBERS USED WITH INHALATION AEROSOLS —CHARACTERIZATION TESTS <1603> GOOD CASCADE IMPACTOR PRACTICE (In development) <160x> APSD DATA ANALYSIS PRACTICE (Proposed)