INTRODUCTION

This general chapter provides definitions and standards for labeling of official articles. Labeling standards for an article recognized in USP–NF are expressed in the article’s monograph and applicable general chapters. It is intended that all articles in USP or NF will be subject to the labeling requirements specified in this chapter by means of a provision in General Notices, 10 Preservation, Packaging, Storage, and Labeling, unless different requirements are provided in a specific monograph. As with compendial standards for naming, identity, strength, quality, and purity, compendial requirements for labeling have a role in the adulteration and misbranding provisions of federal law [see the Federal Food, Drug, and Cosmetic Act (FDCA) sections 501(b), 502(e)(3)(b), 502(g), and 502(h)]. Exceptions or additional requirements specific to animal drug products and compounded preparations are provided in separate sections. Vaccine labeling is not included in this general chapter.