This Food and Drug Administration (FDA) guidance is intended to help small entities better understand the final rule “ Importation of Prescription Drugs ,” published October 1, 2020 (85 FR 62094). The secretary of the United States Department of Health and Human Services issued the final rule to implement Section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act (21 USC 384(b) through (h)) to allow importation of certain prescription drugs from Canada. The document offers information on topics such as who may submit an importation program proposal, what prescription drugs are eligible for importation, and whether the final rule provides for importation of drugs from countries other than Canada.