Compounded drug products that are essentially copies of a commercially available drug product under Section 503A of the Federal Food, Drug, and Cosmetic Act Compounded drug products that are essentially copies of a commercially available drug product under Section 503A of the Federal Food, Drug, and Cosmetic Act

Collection: Health Policy and Services Research Series Title(s): Guidance for industry Contributor(s): 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. Publication: Silver Spring, MD : Center for Drug Evaluation and Research, January 2018 Language(s): English Format: Text Subject(s): Drug Compounding -- standards United States United States. Department of Health and Human Services United States. Food and Drug Administration United States. Genre(s): Guideline Technical Report Copyright: The National Library of Medicine believes this item to be in the public domain. (More information) Extent: 1 online resource (1 PDF file (12 pages)) Illustrations: Illustrations NLM Unique ID: 101720065 (See catalog record) Permanent Link: http://resource.nlm.nih.gov/101720065