1. Importation of certain FDA approved human prescription drugs, including biological products, and combination products under section 801(d)(1)(b) of the Federal Food, Drug, and Cosmetic Act Publication: Silver Spring, MD : Center for Drug Evaluation and Research, September 2020 Subject(s): Biological ProductsDrug LabelingPrescription DrugsCounterfeit DrugsUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.