Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4

This guidance is intended to provide information to applicants and manufacturers regarding compliance with the requirements in part 4 (21 CFR part 4) for ophthalmic drugs packaged with eye cups, eye droppers, or other dispensers. This guidance applies to products with pending applications, approved products, and products marketed pursuant to section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h) without an approved application under section 505 of the FD&C Act (21 U.S.C. 355) (commonly referred to as over-the-counter (OTC) monograph drugs).