Chris Moreton, Brian Carlin, Sophia Zhang, Timothy Frigo, Anthony Hickey, Guirag Poochikian, Huimin Sun, Jiasheng Tu, Umesh Kestur, Nashwa El-Gendy, Venkateswara Pavuluri, Anni Chang, Kahkashan Zaidi, Catherine Sheehan, Tong (Jenny) Liu

Correspondence should be addressed to: Tong (Jenny) Liu, Ph.D., Principal Scientist, US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790; tel: +1.240.221.2072; email: JYL@usp.org.

In this Stimuli article, the United States Pharmacopeia (USP) responds to comments received concerning the Stimuli article “Revisions to the USP–NF Lactose Monographs—Focusing on Inhalation and Injection Grades” that was published in PF 46(5) [Sep.–Oct. 2020]. In the 2020 Stimuli article, the Simple Excipients Expert Committee (SE EC) presented proposals to include quality testing requirements for inhalation and injection use in the lactose monographs. The 2020 Stimuli article also proposed four tests relevant to the use of lactose in inhalation and injection dosage forms. Additionally, the revision proposals for the Anhydrous Lactose (2) and Lactose Monohydrate (3) monographs were published in PF 46(5). The comments received on the 2020 Stimuli article and Lactose monographs are summarized and addressed in this Stimuli article.

Response to Public Comments on the 2020 Stimuli article and the Lactose monographs: The USP Simple Excipients Expert Committee (SE EC) has considered comments from eleven commenters. This article will address the concerns and issues expressed by the commenters. The comments are organized by category.