Compounded drug products that are essentially copies of approved drug products under Section 503B of the Federal Food, Drug, and Cosmetic Act
Guidance for industry
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.). Office of Compliance. Office of Unapproved Drugs and Labeling Compliance, issuing body.
Silver Spring, MD : Center for Drug Evaluation and Research, January 2018