Inhalation

INH0418

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Inhalation April 2018 27 USP. USP 40–NF 35 S2. <602> PROPELLANTS. Rockville, MD: United States Pharmacopeial Conven- tion; 2017. p. 498–499. USP. USP 40–NF 35 S2. <603> TOPICAL AERO- SOLS. Rockville, MD: United States Pharmacopeial Convention; 2017. p. 499–500. USP. USP 40–NF 35 S2. <604> LEAK RATE. Rock- ville, MD: United States Pharmacopeial Convention; 2017. p. 500–501. e relationship between the United States Phar- macopeial Convention (USP) and the US Food and Drug Administration (FDA) dates back to the 1906 Pure Food and Drug Act, which deemed the United States Pharmacopeia and the National For- mulary official compendia under federal law. For more information about the relationship between the FDA and USP, please visit: http://www.usp. org/about/public-policy/usp-fda-roles. Kahkashan Zaidi, PhD; Paul Curry, PhD; Anthony J. Hickey, PhD, DSc; Stefan Leiner, PhD; Jolyon P. Mitch- ell, PhD; Guirag Poochikian, PhD and Jason Suggett, PhD are members of the Aerosols Sub-Committee of the General Chapters—Dosage Forms Expert Committee, United States Pharmacopeial Convention (USP), Rock- ville, Maryland, US. Corresponding author: Kahkashan Zaidi, Ph.D., Principal Scientific Liaison, General Chapters, USP, 12601 Twinbrook Parkway, Rockville, MD, 20852, US. Tel.: +1 (301) 816-8269, E-mail: kxz@usp.org. e USP Chemical Medicines Expert Committee is responsible for the content of product monographs. e Aerosols Sub-Committee's role is to be aware of the content in these monographs, given that the testing methodology contained in these monographs takes pre- cedence over the procedures in the corresponding Gen- eral Chapter(s). It should be noted that these product monographs each refer to the use of a specific induction port (throat) as inlet to the cascade impactor, even though this entry port is not included in <601>. It remains to be seen whether other OINDP manufactur- ers will offer text for future product monographs, given the precedent set by these additions to the USP–NF. Conclusions e Aerosols Sub-Committee continues the process of developing the General Chapters assigned by the parent General Chapters Committee, with the primary goal of supporting the needs of the FDA. e secondary goal is to harmonize methods with the other major compendia (European and Japanese Pharmacopeias) through the inter-compendial Pharmacopeial Discussion Group (PDG) process. Readers of this article are encouraged to maintain awareness and contribute to the public feed- back process through Stimuli Articles and comments on In Process Revisions that appear from time to time in the Pharmacopeial Forum (PF), which has free online access, following a one-time registration, at http:// www.uspnf.com/pharmacopeial-forum. Disclaimer is article is the work of the USP's Aerosols Sub-Com- mittee and has been provided as a means of helping readers of Inhalation be aware of developments with USP–NF chapters that are of concern to the commu- nity involved with OINDPs. It does not represent offi- cial text and readers are advised to consult the current issue of the USP–NF at http://www.uspnf.com/ for up-to-date information concerning chapter content. Please watch for the second article in this series, sched- uled for publication in December 2018. It will focus on the informative chapters in the <1600> series, which are currently undergoing significant changes. References USP. USP 40–NF 35 S2. <5> INHALATION AND NASAL DRUG PRODUCTS—GENERAL INFORMATION AND PRODUCT QUALITY TESTS. Rockville, MD: United States Pharmacopeial Convention; 2017. p. 90-98. USP. USP 40–NF 35 S2. <601> INHALATION AND N A S A L D RU G P RO D U C TS : A E RO S O L S , SPRAYS, AND POWDERS—PERFORMANCE QUALITY TESTS. Rockville, MD: United States Pharmacopeial Convention; 2017. p. 472-498.

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