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.
2. Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies : guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023 Subject(s): Counterfeit DrugsDrug IndustryDrug and Narcotic ControlFraudGovernment RegulationSubstandard DrugsUnited StatesUnited States.